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					    HACCP and ISO 22000
Application to Foods of Animal Origin
                      Dedicated to
my beloved wife Nicole for her continuous and unfailing
 support throughout the long preparation of this book
                          and
  my children Iason, Artemis-Eleni and Nefeli-Kallisti,
  whose presence has lightened and warmed our lives.

                                      Ioannis S. Arvanitoyannis
    HACCP and ISO 22000
Application to Foods of Animal Origin



        Ioannis S. Arvanitoyannis
       Department of Agriculture, Ichthyology
              Aquatic Environment,
          School of Agricultural Sciences,
           University of Thessaly, Greece




              A John Wiley & Sons, Ltd., Publication
This edition first published 2009
C 2009 by Blackwell Publishing Ltd


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Library of Congress Cataloging-in-Publication Data
HACCP and ISO 22000 : application to foods of animal origin / Ioannis S. Arvanitoyannis.
   p. cm.
   Includes bibliographical references and index.
   ISBN 978-1-4051-5366-9 (printed case hardback : alk. paper) 1. Food of animal origin–Contamination.
2. Hazard Analysis and Critical Control Point (Food safety system) I. Arvanitoyannis, Ioannis S.
   TX555.H33 2009
   363.19 262–dc22
                                                                                             2008017935
A catalogue record for this book is available from the British Library.
Set in 9.5/11 pt Times Ten by Aptara r Inc., New Delhi, India
Printed in Singapore by C.O.S. Printers Pte Ltd
1 2009
                                         Contents




    Contributors                                                                                    vi
    Preface                                                                                         vii
    Abbreviations                                                                                  viii


Part I   Introduction
1   HACCP and ISO 22000 – A Comparison of the Two Systems                                            3
    Ioannis S. Arvanitoyannis and Aikaterini Kassaveti
2 A Summary of EU, US and Canadian Legislation Relating to Safety in Foods of Animal Origin        46
  Ioannis S. Arvanitoyannis and Persefoni Tserkezou


Part II Implementing HACCP and ISO 22000 for Foods of Animal Origin
3 Dairy Foods                                                                                      91
  Ioannis S. Arvanitoyannis, Theodoros H. Varzakas and Maria Koukaliaroglou-van Houwelingen
4 Meat and Meat Products                                                                           181
  Ioannis S. Arvanitoyannis, Theodoros H. Varzakas and Persefoni Tserkezou
5 Poultry                                                                                          277
  Ioannis S. Arvanitoyannis and Theodoros H. Varzakas
6 Eggs                                                                                             309
  Ioannis S. Arvanitoyannis, Theodoros H. Varzakas, Konstantina Tzifa and Demetrios Papadopoulos
7 Seafood                                                                                          360
  Ioannis S. Arvanitoyannis and Theodoros H. Varzakas
8 Catering                                                                                         453
  Ioannis S. Arvanitoyannis and Theodoros H. Varzakas


9 Conclusions and Future Directions                                                                530
  Ioannis S. Arvanitoyannis


    Index                                                                                          539



                                                   v
                                   Contributors




Ioannis S. Arvanitoyannis                    School of Agricultural Sciences
Department of Agriculture,                   University of Thessaly
  Ichthyology and Aquatic Environment        Fytokou Street
School of Agricultural Sciences              Nea Ionia Magnessias 38446 Volos
University of Thessaly                       Hellas, Greece
Fytokou Street
Nea Ionia Magnessias 38446 Volos             Persefoni Tserkezou
Hellas, Greece                               Department of Agriculture,
                                               Ichthyology and Aquatic Environment
Maria Koukaliaroglou-van Houwelingen         School of Agricultural Sciences
Department of Agriculture,                   University of Thessaly
  Ichthyology and Aquatic Environment        Fytokou Street
School of Agricultural Sciences              Nea Ionia Magnessias 38446 Volos
University of Thessaly                       Hellas, Greece
Fytokou Street
Nea Ionia Magnessias 38446 Volos             Konstantina Tzifa
Hellas, Greece                               Department of Processing of Agricultural
                                               Products
Aikaterini Kassaveti                         TEI Kalamata
Department of Agriculture,                   Kalamata, Hellas (Greece)
  Ichthyology and Aquatic Environment
School of Agricultural Sciences              Theodoros H. Varzakas
University of Thessaly                       Department of Processing of Agricultural
Fytokou Street                                 Products
Nea Ionia Magnessias 38446 Volos             TEI Kalamata
Hellas, Greece                               Kalamata, Hellas (Greece)

Demetrios Papadopoulos
Department of Agriculture,
 Ichthyology and Aquatic Environment




                                        vi
                                               Preface




Numerous food crises have occurred globally in recent               This book aims at addressing a current gap in the
years, originating in both primary agricultural produc-          food safety field by providing a number of examples il-
tion and in the food manufacturing industries. Cases             lustrating the application of ISO 22000 to products of
have included:                                                   animal origin. The book includes nine chapters bear-
                                                                 ing the following titles: (1) HACCP and ISO 22000 –
the outbreak of ‘mad cow disease’
                                                                 a comparison of the two systems, (2) A summary of
the presence of dioxins in animal feed
                                                                 EU, US and Canadian legislation relating to safety
the use of the dye Sudan Red I
                                                                 in foods of animal origin, (3) Dairy foods, (4) Meat
the presence of acrylamide in various fried/baked foods
                                                                 and meat products, (5) Poultry, (6) Eggs, (7) Seafood,
the presence of pesticides, nitrates, dioxins, furans in
                                                                 (8) Catering and (9) Conclusions and future directions.
  foods and mislabelled or unlabelled genetically mod-
                                                                    Several examples per food category are provided
  ified foods
                                                                 and numerous references are cited (more than 1600).
Both governments and consumers lost confidence that                  It is anticipated that this book will be a useful tool
applied quality (ISO 9001:2000) and safety (HACCP)               for undergraduate and postgraduate students, univer-
control systems were being effectively operated. In              sity professors, researchers, consultants and industrial-
view of the fact that the previously applied HACCP               ists who would like to have access to applied examples
system did not manage to solve all food safety and               of ISO 22000 and how it differs from HACCP.
quality-related problems (mainly due to chemical and
microbiological hazards), another system, ISO 22000:                                         Ioannis S. Arvanitoyannis
2005, quality and safety, was put forward which is                                                 Associate Professor
anticipated to improve the situation.                                           University of Thessaly, Hellas (Greece)




                                                           vii
                                 Abbreviations




ADI      Acceptable dairy intake                       E. coli   Escherichia coli
AEA      Association of European Airlines              EDP       Experimental dairy plant
AFB1     Aflatoxin B1                                   EHEC      Enterohaemorrhagic E. coli
AFLP     Amplified fragment length                      EHS       Environmental health specialist
         polymorphism                                  EL        Extruded linseed
AFM1     Aflatoxin M1                                   ELISA     Enzyme-linked immunosorbent
AHS      African horse sickness                                  assay
ALARA    As low as reasonably achievable               EMAR      Eco-Management and Audit
ALOP     Appropriate level of protection                         Regulation
AMI      American Meat Institute                       EO        Electrolysed oxidising
APC      Aerobic plate count                           EPA       Environmental Protection Agency
APMV-1   Avian paramyxovirus serotype-1                EU        European Union
AR       Antimicrobial resistant                       FAO       Food and Agriculture
ASF      African swine fever                                     Organization
ATP      Adenosine triphosphate                        FDA       Food and Drug Administration
AVC      Aerobic viable count                          FFQ       Food frequency questionnaire
BHT      Butylated hydroxytoluene                      FIFO      First in first out
BMPs     Best management practices                     FMD       Foot-and-mouth disease
BSE      Bovine spongiform encephalopathy              FMEA      Failure, mode and effect analysis
BVD      Bovine viral diarrhoea                        FMI       Food Marketing Institute
CBI      Computer-based instructions                   FMM       Food MicroModel
CCPs     Critical control points                       FPLC      Fast protein liquid chromatography
CFIA     Canadian Food Inspection Agency               FSMS      Food safety management system
cfu      Colony forming unit                           FSO       Food safety objectives
CP       Commercial plant                              GAP       Good agriculture practice
CPs      Control points                                GATT      General Agreement on Tariffs and
CPU      Central processing unit                                 Trade
CSF      Classical swine fever                         GC        Gas chromatography
DDD      Dichlorodiphenyldichloroethane                GFP       Good farming practice
DDE      Dichlorodiphenyldichloroethylene              GHA       Green Health Authorities
DDT      Dichlorodiphenyltrichloroethane               GHCP      Good hygiene control point
DEFT     Direct epifluorescent filter technique          GHP       Good hygiene practice
DIS      Draft International Standard                  GL        Ground linseed
DM       Dry matter                                    GLC       Gas–liquid chromatography
DSI      Direct sample introduction                    GMDP      Good manufacturing and
DSP      Diarrhetic shellfish poisoning                           distribution practice
EAN      European article number                       GMOs      Genetically modified organisms
EBL      Enzootic bovine leucosis                      GMP       Good manufacturing practice


                                                viii
                                       Abbreviations                                          ix

GRAS    Generally recognised as safe           MRL       Maximum residue limit
GTX     Gliotoxin                              MRM       Mechanically removed meat
HACCP   Hazard analysis critical control       MSRV      Modified semi-solid
        point                                            Rappaport–Vassiliadis
HAH     Halogenated aromatic hydrocarbons      MUG       Methylumbelliferyl-b-glucuronide
HCP     Hygienic control point                 NACMCF    National Advisory Committee on
HDPE    High-density polyethylene                        Microbiological Criteria for Foods
HFP     Histamine fish poisoning                NASA      National Aeronautics and Space
HHP     High hydrostatic pressure                        Administration
HIMP    HACCP-based inspection model           ND        Newcastle disease
        project                                NDV       Newcastle disease virus
HMM LPS High-molecular-mass                    NF        Nanofiltration
        lipopolysaccharide                     NFDM      Non-fat dried milk
HP      High pressure                          NIR       Near-infrared
HRAs    Halogen-releasing agents               NIRS      Near-infrared reflectance
HTST    High-temperature short time                      spectroscopy
HUS     Haemolytic uraemic syndrome            NOAEL     No-observed-adverse-effect level
IARC    International Agency for Research      NOP       National Organization of
        on Cancer                                        Pharmaceuticals
ICMSF   International Commission on            NRA       National Restaurant Association
        Microbiological Specifications for      NRTE      Non-ready to eat
        Foods                                  NSLAB     Non-starter lactic acid bacteria
IDF     Internal Dairy Federation              NTMS      Non-traditional meat starter
IEF     Isoelectric focusing                   OCDD      1,2,3,4,5,6,7,8,9-
IgC     Immunoglobulin C                                 Octachlorodibenzo-p-dioxin
IID     Infectious intestinal disease          OCPs      Organochlorinated pesticides
IMF     Instant milk formula                   OIE       Office International-Epizooties
IT      Information theory                     OR        Odds ratio
JD      Johne’s disease                        PAGE      Parametric analysis of gene set
LAB     Lactic acid bacteria                             enrichment
Lb      Lactobacilli                           PAHs      Polycyclic aromatic hydrocarbons
LCA     Life cycle analysis/assessment         PCBs      Polychlorinated biphenyls
LDA     Linear discriminant analysis           PCDF      Polychlorinated dibenzofurans
LEW     Liquid egg white                       PET       Polyethylene terephthalate
LEY     Liquid egg yolk                        PFGE      Pulsed-field gel electrophoresis
LIFO    Last in first out                       PFMEA     Production failure mode and effect
LISA    Longitudinally integrated safety                 analysis
        assurance                              PP        Polypropylene
Ln      Leuconostoc                            p,p-DDE   Dichlorodiphenyldichloroethylene
LPS     Lipopolysaccharide                     PPR       Peste des petits ruminants
LSL     Long shelf life                        PRM       Process risk model
MAP     Modified atmosphere packaging           PRP       Prerequisite programme
MBR     Methylene blue reduction               PS        Polystyrene
MDM     Mechanically deboned turkey meat       PUFA      Polyunsaturated fatty acids
MF      Microfiltration                         QA        Quality assurance
MILP    Mixed-integer linear programming       QACs      Quaternary ammonium compounds
MIR     Minimal infectious range               QCM       Quality control methodology
MMT     Million metric tonnes                  QRA       Quantitative risk assessment
MP      Minimally processed                    RASFF     Rapid Alert System for Food and
MPC     Milk protein concentrate                         Feed
MPN     Most probable number                   RFID      Radio-frequency identification
MR      Multi-resistant                        RLU       Relative light unit
MRA     Microbiological risk assessment        RO        Reverse osmosis
x                                          Abbreviations

RP-HPLC   Reversed phase high-performance          TLC     Thin liquid chromatography
          liquid chromatography                    TPC     Total plate count
RPN       Risk priority number                     TSE     Transmissible spongiform
RTE       Ready to eat                                     encephalopathy
RTU       Ready to use                             TTI     Time–temperature indicators
SCAP      Self-care action programme               TVBN    Total volatile basic nitrogen
SCM       Standard cultural method                 TVC     Total viable count
SE        Salmonella enteritidis                   UCFM    Uncooked comminuted fermented
SMEs      Small- and medium-sized enterprises              meat
SOP       Standard operating procedure             UF      Ultrafiltration
SPC       Statistical process control              UHT     Ultra-high temperature
SPF       Specific pathogen-free                    USDA    United States Department of
SPR       Surface plasmon resonance                        Agriculture
SPS       Sanitary and phytosanitary               VEE     Viral equine encephalomyelitis
SSOP      Sanitation standard operation            VS      Vesicular stomatitis
          procedure                                VSP     Very small plant
Str       Streptococcus                            VT1     Verotoxin 1
SVD       Swine vesicular disease                  VT2     Verotoxin 2
TBARS     Thiobarbituric acid-reactive             VTEC    Verocytotoxin-producing
          substance                                        Escherichia coli
TBT       Technical barriers to trade              WOF     Warmed over flavour
TEQ       Toxic equivalent quantity                WPC     Whey protein concentrate
TGI       Tierges and Heits Index                  WTO     World Trade Organization
    Part I
Introduction
                    1
   HACCP and ISO 22000 – A Comparison
           of the Two Systems
                 Ioannis S. Arvanitoyannis and Aikaterini Kassaveti




1.1 HACCP                                                       2003). A ‘hazard’ is ‘a biological, chemical or physical
                                                                agent in, or condition of, food with the potential to
1.1.1 Introduction to HACCP                                     cause an adverse health effect’ (Codex Alimentarius,
                                                                1997). A HACCP system should be developed for ev-
Food safety in the early twenty-first century is an in-          ery food production line and adapted for the individual
ternational challenge requiring close cooperation be-           products and processes (da Cruz et al., 2006). HACCP
tween countries in agreeing standards and in setting            systems have become mandatory for food industry in
up transnational surveillance systems. The lessons of           the European Union (European Community Directive,
the past two decades are plain to those engaged in the          1993).
food industry. No longer can farmers grow just what               ‘Food complaints fall into 7 broad categories within
they want or use technical aids to farming without tak-         which there are a number of possible subcategories’:
ing into account the effect on the quality of the food
produced (Rooney and Wall, 2003). The behaviour of              1. A complaint from a consumer
European consumers has been gradually changing.                    (a) Food complaints fall into four broad categories:
They currently require not only much higher dietary                       (i) foreign objects found in food or food not
quality, hygiene and health standards in the prod-                             meeting the consumers’ expectations
ucts they purchase, but they also look for certifica-                     (ii) poor food premises conditions
tion and reassurance of products’ origins (national or                  (iii) poor food handling practices, or
geographical) and production methods. This height-                      (iv) alleged cases of food poisoning
ened consumer awareness is reflected in the demand                              (www.campaspe.vic.gov.au/hardcopy/
for products endowed with individual characteristics                           111314 186479.pdf).
due to specific production methods, composition or               2. A complaint from the regulatory authorities
origin (national or geographic; Anon, 2004).                       (a) Often instigated by a complaint from consumers
   No matter how professional and effective a com-                      and falling into the same broad sub-categories
pany may be, there is always the possibility of a serious               as given above
problem arising which is unforeseen or eventually de-              (b) As a result of routine monitoring and premise
velops into a major crisis. However, thinking through                   visits
the possible ramifications of such an eventuality and               (c) As a result of investigations into events such as
preparing responses and scenarios to deal with it, al-                  outbreaks of ‘food poisoning’
ways ensures that an organisation is better prepared            3. A phone call from the police
for the unexpected (Doeg, 1995). The Hazard Anal-                  (a) For example, warning of
ysis and Critical Control Point (HACCP) system is a                      (i) an incidence of food poisoning in the area
science-based system created to identify specific haz-                   (ii) detection of ‘food fraud’
ards and actions to control them in order to ensure                    (iii) malicious action or intended action against
food safety and quality. It can be considered an efficient                     the company or its products.
tool for both the food industry and health authorities          4. A threatening message direct to the company as
in preventing foodborne diseases (Vela and Fernandez,               per 3 (iii) above

                                                            3
4                      HACCP and ISO 22000 – Application to Foods of Animal Origin

5. An enquiry from the media                                ical safety of foodstuffs, HACCP has been broadened
6. The knock-on effect of a problem in another coun-        to include chemical and physical hazards in foods.
   try                                                      The recent growing worldwide concern about food
7. An industry issue, such as the use of an ingredient      safety amongst public health authorities, consumers
   (Doeg, 1995).                                            and other concerned parties, fuelled by the continu-
                                                            ous reports of foodborne ‘disease’ outbreaks have been
To be effective, a food safety management system            a major impetus in the introduction and widespread
(FSMS) as exemplified by HACCP and mandatory un-             application of the HACCP system (http://www.unido.
der 2001/471/EC requires monitoring and control (of         org/userfiles/cracknej/fgfs1.pdf). HACCP is merely a
critical limits) of those process stages deemed critical    tool and is not designed to be a stand-alone pro-
to food safety. These process stages, identified as criti-   gramme. To be effective, other tools should include
cal control points (CCPs), should be monitored and all      adherence to good manufacturing practices (GMPs),
non-compliances immediately corrected by removing           use of standard sanitation operating procedures and
the offending material, by re-skilling staff and by rec-    personal hygiene programmes (Rushing and Ward,
tifying identified process or equipment faults (Ryan,        1999).
2007). HACCP procedures should be documented at                The HACCP system for managing food safety
all times. Record keeping is essential for providing doc-   concerns grew from two major developments. The
umentation to the HACCP system and to verify the            first breakthrough was associated with W.E. Deming,
proper functioning of the system. Documentation and         whose theories of quality management are widely re-
record keeping examples are given in Codex Alimen-          garded as a major factor in turning around the qual-
tarius (2001).                                              ity of Japanese products in the 1950s. Dr Deming
   Consumer awareness of the benefits that the               and others developed Total Quality Management
HACCP approach provides is absolutely essential             (TQM) systems, which emphasised a total systems ap-
for effective implementation of HACCP programmes.           proach to manufacturing that could improve quality
What should be avoided is a consumer’s misconception        while lowering costs (FAO, 1998). The second break-
that HACCP represents only an extension of industry         through was the HACCP proposal by the Pillsbury
self-certification programmes without food authority         Company, NASA and the US Army laboratories. This
control over the process (Kvenberg, 1998). HACCP            was based on the failure, mode and effect analysis
systems are often seen as unnecessary, burdensome           (FMEA) as used by engineers in construction designs.
and bureaucratic in the food industry. They are of-         The HACCP concept was introduced in the United
ten ineffective because the premise of the system is not    States in 1971 at the Conference of Food Protection
emphasised. HACCP was intended to be ‘a minimal-            where it was ‘recommended for widespread use’ (Bau-
ist system that ensures maximum control’. It is im-         man, 1974; FDA, 1972). The call for change was gal-
portant that employees understand its many benefits,         vanised in the early 1990s with a tragic outbreak of
including reduced waste and downtime. The system            Escherichia coli O157:H7 foodborne illness in the
can become overly complicated due to a lack of in-          Northwest of the United States. Four children died
ternal knowledge of microbiological and toxicological       and hundreds of people were taken ill in this outbreak,
issues, forcing those involved to seek advice from out-     which resulted from the consumption of undercooked,
side sources (Mortimore, 2003). A study revealed that       contaminated ground beef. Food Safety and Inspec-
in companies with less than 50 employees, HACCP             tion Services (FSIS) developed the regulatory proposal
implementation decreased proportionally as the num-         that became the Pathogen Reduction/HACCP Sys-
ber of employees decreased (Panisello et al., 1999).        tems Rule (published as a final rule in 1996; Hulebak
An analysis of the barriers to HACCP implementa-            and Schlosser, 2002). Subsequently, as a means of
tion which include availability of appropriate training     safe food production, HACCP principles were adopted
in HACCP methodology, access to technical expertise         worldwide as given in Codex Alimentarius Commis-
and the required resources (infrastructure and person-      sion (1997) and the National Advisory Committee on
nel) is available. The burden that this places on the       Microbiological Criteria for foods (NACMCF, 1992).
small business are documentation, validation and ver-       HACCP became a mandatory programme for approx-
ification (Taylor, 2001).                                    imately 4000 seafood processors in December 1997
                                                            and also for foreign processors that ship seafood to
                                                            the United States (FDA, 2001). The following month,
1.1.2 History of HACCP – outbreaks
                                                            in January 1998, the USDA’s Food Safety and Inspec-
The acronym HACCP is one which evokes ‘food                 tion Service (FSIS) began implementing HACCP in the
safety’. Originally developed to ensure microbiolog-        meat and poultry industry, starting with the largest
                            HACCP and ISO 22000 – A Comparison of the Two Systems                                        5

Table 1.1 Overview of HACCP systems.

Date       Highlights of HACCP

1959       The Pillsbury Company develops concept for NASA
1971       US national conference on food protection (1st mention of HACCP)
1972       The Pillsbury Company in the United States began the application of its HACCP concept to the manufacture of
           its consumer food products
1973       The Pillsbury Company published the first HACCP text in ‘Food Safety Through the Hazard Analysis and Critical
           Control Point System’
1980       WHO/ICMSF report on HACCP
1983       WHO Europe recommends HACCP
1985       National Academy of Science report on HACCP
1988       Formation of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF)
1989       National Advisory Committee of Microbiological Specification for Food document endorsing HACCP approach
1990       Richmond Report advocated use of HACCP
1991       Codex HACCP draft
1992       The NACMCF system defined HACCP as ‘a systematic approach to be used in food production as a means to
           assure food safety’
1993       EU Commission 93/43/ECC recommended use of 5 HACCP principles Codex’93 Guidelines
1995       5 HACCP principles mandatory in EU
1997       Codex Document on HACCP principles and application
1998       FAO/WHO provide guidance for regulatory assessment of HACCP
2003       FAO/WHO develop HACCP guidelines
2004       EC 852/2004 requirement for all food businesses to adopt HACCP principles in EU
2006       Legal requirements to apply HACCP in food businesses (other than primary production) across EU
2006+      Increased worldwide use of HACCP in food safety legislation

Adapted from Corlett (1998), Griffith (2006), Linton (2001), Sperber (2005).



plants (FSIS, 1996). Meat and poultry HACCP im-                   Hayes, 1998). The Codex Alimentarius (Latin, mean-
plementation was completed in January 2000 (FSIS,                 ing Food Law or Code) is a collection of internation-
2000a, b). At the 35th Session of the Codex Com-                  ally adopted food standards presented in a uniform
mittee on Food Hygiene in 2003, it was agreed that                manner. It also includes provisions of an advisory na-
FAO and WHO would develop HACCP guidelines for                    ture in the form of codes of practice, guidelines and
small and/or less developed businesses (SLDBs), high-             other recommended measures to assist in achieving
lighting potential obstacles and approaches to over-              the purposes of the Codex Alimentarius (FAO/WHO,
come these obstacles. The FDA defines the term ‘small              2005). The Codex Alimentarius has gained a greater
and/or less developed businesses’ shall mean businesses           significance since the formation of the World Trade
that because of their size, lack of technical expertise,          Organisation (WTO). The Agreement on the Technical
economic resources, or the nature of their work, en-              Barriers to Trade (TBT), which was introduced follow-
counter difficulties in implementing HACCP in their                ing the Tokyo Round on World Trade in 1979, had a
food business. The term ‘less developed business’ refers          substantial impact on the establishment of policies on
to the status of the FSMS and not to the number of                food control. The TBT agreement did not specifically
staff or volume of production (FAO/WHO, 2006a).                   mention Codex but dealt with the aspects of food not
The highlights of the HACCP system are presented in               directly related to safety such as labelling, quality and
Table 1.1.                                                        packaging and thus impinged on Codex. The WTO,
                                                                  however, recognised Codex as the preferred interna-
                                                                  tional organisation for the arbitration and settlement
1.1.3 Codex Alimentarius
                                                                  of disputes related to food trade (Ottaway, 2003).
A Codex Alimentarius programme was initiated in the                  The Codex Alimentarius Commission is commit-
early 1960s under FAO/WHO control with the spe-                   ted to protecting the health of consumers, ensures fair
cific aim of getting international agreements on food              practices in the food trade and facilitates international
standards and codes of practice which would safe-                 trade in food. The Codex General Principles of Food
guard the health of consumers and generally encour-               Hygiene has recommended a HACCP-based approach
age good practices in the food trade (Forsythe and                as a means to enhance food safety and has indicated
6                      HACCP and ISO 22000 – Application to Foods of Animal Origin

how to implement the principles (Codex Alimentarius,         Motivations for adopting HACCP may include the
1997). All member nations and associate members of         need to:
the FAO and WHO can become members of Codex.
The membership has increased over the years and 165        r reduce the incidence of foodborne disease
countries were Codex members in 2000, representing         r ensure a safe food supply for the population
97% of the world’s population (Ottaway, 2003).             r promote (facilitate) trade in food products
   The Codex Guidelines for the application of the          (http://www.unido.org/userfiles/cracknej/fgfs1.pdf).
HACCP system published in 1993 have been revised
and the revised text entitled Hazard Analysis and Crit-
                                                           1.1.5 Hazards (physical, chemical, microbiological)
ical Control Point (HACCP) system and guidelines for
its application was adopted by the Codex Alimentarius      The regulation defines a food safety hazard as ‘Any
Commission in June 1997 in the document ‘Codex Al-         biological, chemical or physical property that may
imentarius Commission, Report of the Twenty-Second         cause a food to be unsafe for human consumption’
Session of the Codex Alimentarius Commission,              (USDA, 1997). While consumers have historically been
Geneva, June 1997’ (http://www.unido.org/userfiles/         most concerned with chemical hazards such as pes-
cracknej/fgfs1.pdf).                                       ticide residues and heavy metal contamination, mi-
   The Codex general principles of food hygiene are as     crobiological contaminants and allergens have been
follows:                                                   the recent focus of public health officials’ concerns
                                                           (Fig. 1.1). The HACCP system addresses and con-
1. Identify the essential principles of food hygiene ap-   trols all significant hazards associated with a particu-
   plicable throughout the food chain, in order to         lar product (Goodrich et al., 2005). At a cost of about
   achieve the goal of ensuring that food is safe and      $1000 per case of disease (Canadian and USA esti-
   suitable for human consumption.                         mates), the economic impact in the Federal Republic
2. Recommend a HACCP-based approach as a means             of Germany had been valued at more than 10 billion
   of enhancing food safety.                               DM (Untermann, 1995). There are three categories of
3. Indicate how to implement those principles.             hazards that are considered in a HACCP plan. These
4. Provide guidance to specific codes which may be          are physical, chemical and biological. All types of
   needed for sectors of the food chain, processes or      hazard can enter a food product at any stage during
   commodities, to amplify the hygiene requirements        processing (Harris, 1999). Potentially hazardous foods
   specific to those areas (FAO/WHO, 2005).                 include meats, dairy products, poultry, eggs, cooked
                                                           foods (beans, pasta, rice and potatoes), cut cantaloupe
Although Codex claims to have ‘broad commu-                and raw seed sprouts (McSwane et al., 2000).
nity involvement’ to increase consumer protection
with internationally recognised scientific food stan-
                                                           1.1.5.1 Physical hazards
dards, its achievements fall flat under scrutiny. The
Codex does not rely on community involvement in            Physical hazards include glass, metal, stones, wood,
its decision-making process; decisions are made by         plastic, rubber or pests (typically larger pests). Sand
governmental appointees behind closed doors (http://       may also be an undesirable foreign material in a pre-
www.citizen.org/documents/codexfactsheet.pdf).             pared salad but it is not likely to cause human illness
                                                           (Harris, 1999). However, foreign objects which cannot
                                                           or do not cause illness or injury are not hazards, even
1.1.4 The need for HACCP
                                                           though they may not be aesthetically pleasing to the
To successfully implement HACCP in the food supply         consumers (USDA, 1997). Physical hazards commonly
system, authorities responsible for food safety should     result from accidental contamination and poor food
first be aware of the need to move to a system such as      handling practices that can occur at various points in
HACCP. Until this need is acknowledged, it is unlikely     the food chain from harvest to consumer (McSwane
that a commitment at any level can be expected (http://    et al., 2000). Confirmed cases of foreign materials in
www.unido.org/userfiles/cracknej/fgfs1.pdf). In a sur-      US food versus time are presented in Fig. 1.2.
vey conducted to find out whether HACCP was a more             The Canadian Food Inspection Agency (CFIA) de-
effective strategy than their current or other method(s)   fines three classes of physical hazards depending on
industry groups had used to secure food hygiene, 41%       their likelihood and the severity of the consequences:
strongly agreed, 50% agreed, while only 9% did not
think that the strategy was more effective than their      r Category I (high likelihood)
current provisions (Ehiri et al., 1997).                   r Category II (moderate likelihood)
                                                    HACCP and ISO 22000 – A Comparison of the Two Systems                                              7


                                                        35.0% 32.0%




                         Percentage (%) of complaints
                                                        30.0%

                                                        25.0%
                                                        20.0%
                                                        15.0%                   12.0%                                              12.5%
                                                                                        10.0%
                                                        10.0%            7.5%                   8.0%
                                                                                                         5.5% 5.0% 6.0%
                                                        5.0%                                                                               3.0%

                                                        0.0%




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                                                                                           Deficiencies
                                                                M




Fig. 1.1 Problems in the international trade in food that are related to deficiencies in basic hygienic measures (FAO, 2000;
Orriss and Whitehead, 2000).


r Category III (low risk)                                                                          (McSwane et al., 2000). Nowadays, there are various
  (http://www.gov.mb.ca/agriculture/foodsafety/                                                    methods for the detection of foreign materials such as
  processor/pdf/cfs02s74.pdf).                                                                     metal detectors, low-energy X-rays etc. which are used
                                                                                                   in the food industry.
To prevent physical hazards, wash raw fruits and veg-
etables thoroughly and visually inspect foods that can-
                                                                                                   1.1.5.2 Chemical hazards
not be washed (such as ground beef). Food workers
should be taught to handle food safely to prevent con-                                             Chemical hazards include cleaning chemicals, pesti-
tamination by unwanted foreign objects. Finally, food                                              cides (including those not applied in or around food
workers should not wear jewelry when involved in the                                               processing establishments), allergens, toxic metals,
production of food, except for a plain wedding band                                                nitrites and nitrates (when added to the product),



                                 9
                                 8
                                 7
                                 6
                                 5
                                 4
                                 3
                                 2
                                 1
                                 0
                                                          1999         2000        2001        2002         2003            2004      2005
                                                                                                Time

                                                                                          Foreign materials

Fig. 1.2 Determined cases of foreign materials in United States versus time. (Adapted from Arvanitoyannis et al., 2006)
8                        HACCP and ISO 22000 – Application to Foods of Animal Origin

plasticisers and packaging migration, veterinary                 r environment (air, water and equipment)
residues (when animals have been given drugs to treat            r inadequate cooking
disease in the animal, e.g. antibiotics treatments for           r improper storage/holding temperature
mastitis in cows) and chemical additives (when added;            r improper reheating
Harris, 1999). Between 5 and 8% of children and 1–               r cross-contamination – improper segregation of raw and
2% of adults are allergic to certain chemicals in foods            cooked foods
and food ingredients. These chemicals are commonly               r past use – by time (http://www.jphpk.gov.my/
referred to as food allergens (McSwane et al., 2000).              Agronomi/KAV/5HACCP1.pdf; Forsythe and Hayes,
   Chemical hazards fall into two categories:                      1998).
r Naturally occurring poisons, chemicals or deleterious
                                                                 An annual consumer survey carried out by the Food
  substances are those that are natural constituents of          Marketing Institute (FMI) from 1993 through 1997
  foods and are not the result of environmental, agricul-        showed that the number of people who said they were
  tural, industrial or other contamination (e.g. aflatoxins,      ‘very concerned’ about chemical contaminants such as
  mycotoxins, shellfish toxins).                                  pesticides declined from 79 to 66%. The FMI survey
r Added poisonous chemicals or deleterious substances
                                                                 first included questions on microbial contamination in
  are those which are intentionally or unintentionally           1995. From 1995 to 1997, microbial contamination
  added to foods at some point in growing, harvesting,           topped the list of consumer concerns. By contrast, con-
  storage, processing, packing, or distribution (e.g. pesti-     sumers ranking themselves as very concerned about
  cides, fungicides, insecticides, fertilisers, drug residues,   foods produced using biotechnology have hovered
  antibiotics, food additives, lubricants, cleaners, paints,     around 15% for the same 3 years (FMI, 2000). Food-
  coatings; USDA, 1997).                                         borne infections are caused when micro-organisms are
                                                                 ingested and these can multiply in the human body. In-
Because it is impossible to provide a comprehensive
                                                                 fections result when microbial or naturally occurring
list of contaminants, it would be much better to fo-
                                                                 toxins are consumed in contaminated foods. Micro-
cus on purity of water, raw material supply, workers’
                                                                 organisms or toxins may be introduced directly from
poor hygiene and lack of GMP in order to reduce the
                                                                 infected food animals or from workers, other foods, or
probability of occurrence of chemical hazards.
                                                                 the environment during the preparation or processing
                                                                 of food. Poisonous substances may also be produced
1.1.5.3 Biological hazards                                       by the growth of bacteria and moulds in food (Rooney
Biological hazards include food poisoning bacteria               and Wall, 2003).
such as Salmonella, E. coli and Bacillus cereus, which              The numbers and types of bacteria vary from one
are hazardous because they can survive inadequate                food or animal species to another, from one geographic
cooking, grow to harmful levels in stored food given             region to another, and with production and slaughter
the right conditions and spread from raw foods                   or harvesting methods. During production, processing
to ‘ready to eat foods’ (cross-contamination) (www.              packaging, transportation, preparation, storage and
cardiff.gov.uk/ObjView.asp?Object ID=3968). After                service any food may be exposed to bacterial contam-
World War II, serious food safety incidents occurred in          ination. The most common biological hazards in meat
the nascent food processing industry. These typically            and poultry are microbiological, although biological
involved Salmonella contamination of dried egg or                hazards may also be due to parasites or zoonotic dis-
dairy products, Campylobacter spp. in canned meat or             ease processes (USDA, 1997). Six conditions are re-
Clostridium botulinum growth or presence in canned               quired for bacterial growth. They need a nutrient (e.g.
foods. The most pressing food safety issues in the               meat, poultry, seafood, dairy products, cooked rice,
food industry nowadays are due to the presence of                beans, potatoes), a mildly acid environment (pH =
E. coli O157:H7 and salmonellae in raw meat and                  4.6–7.0), a temperature between 5 and 60◦ C, time
poultry products and in produce (Sperber, 2005). E.              (approximately 4 hours to grow to high enough num-
coli O157:H7 is usually transferred to foods like beef           bers to cause illness), different oxygen requiring en-
through contact with intestines of slaughtered animals.          vironments (aerobic, anaerobic and facultative micro-
Apples used for juice from orchards where cattle or              organisms), and enough moisture (water activity >85
deer graze are also suspected (McSwane et al., 2000).            for disease-causing bacteria; Marriott, 1997; Mc-
Pathogens come from:                                             Swane et al., 2000). Microbial cells have a growth cycle
                                                                 of five phases: lag phase (adaptation period), logarith-
r low quality of raw materials                                   mic growth phases (bacteria multiplication), station-
r poor personal hygiene                                          ary growth phase (slowdown of growth), accelerated
                                    HACCP and ISO 22000 – A Comparison of the Two Systems                                                 9


                                   100%
                                                     90%
                                         90%
                                         80%
                                                          66%



                        Percentage (%)
                                         70%
                                         60%
                                         50%
                                         40%
                                         30%                                                   25%
                                         20%
                                         10%                             6%5%
                                                                                            3%                  1% 4%
                                         0%
                                                     Bacteria            Viruses          Chemicals            Parasites
                                                                         Agents of contamination
                                         Data: McSwane et al., 2000


                                         Data:
                                         http ://www.healthandwelfare.idaho.gov/_Rainbow/Documents/Heatlh/Food%20Safety%20&%2
                                         0Sanitation%20Manual.pdf


Fig. 1.3 Types of contamination (McSwane et al., 2000; http://www.healthandwelfare.idaho.gov/ Rainbow/Documents/
Health/Food%20Safety%20& %20Sanitation%20Manual.pdf).



death phase (rapid death of microbial cells) and re-                                management of food safety within such systems (Anon,
duced death phase (slowdown of death rate; Marriott,                                2000). One of the benefits of the HACCP system is that
1997). Examples of biological hazards are disease-                                  it focuses attention on areas where problems poten-
causing bacteria, viruses, parasites, moulds, yeasts and                            tially may occur, and requires that food service facili-
naturally occurring toxins (Fig. 1.3). Biological haz-                              ties be prepared to deal with problems immediately if
ards cause the most foodborne illness outbreaks and                                 they occur (Puckett and Schneider, 1997). The HACCP
are of the greatest concern to food service managers                                system consists of seven principles (Fig. 1.4). These
and health inspectors (http://www.sfdph.org/eh/pubs/                                principles make up the Codex standard, which has be-
foodsafetyfacts/food hazards.pdf).                                                  come the reference for international food safety and
   Quantitative scientific assessments of the risks from                             identified as the baseline for consumer protection un-
micro-organisms in foods and water on the basis of                                  der the Agreement on Sanitary and Phytosanitary Mea-
dose–response relationships and exposure assessment,                                sures agreed at the General Agreement on Tariffs and
customarily carried out for chemical contaminants,                                  Trade (GATT) negotiations in 1995 (Slatter, 2003).
have been developed for some pathogens, especially
in drinking water. Two particular difficulties have to                               Principle 1 Conduct a hazard analysis. A hazard
be mentioned for the quantification of microbiological                                 analysis is the identification of any hazardous bi-
hazards associated with the consumption of foods: the                                 ological, chemical or physical properties in raw ma-
determination of the minimal effective dose and the                                   terials and processing steps, and an assessment of
complicated kinetics of bacterial survival, growth and                                their likely occurrence and potential to cause food
death in foods which necessitate greater care in the                                  to be unsafe for consumption (USDA, 1997). The
monitoring of bacterial contaminations (Untermann,                                    HACCP team conducts a hazard analysis and iden-
1998).                                                                                tifies appropriate control measures (Corlett, 1998).
                                                                                      Hazard analysis is accomplished in two stages: (a)
                                                                                      hazard identification based on a review of the ori-
1.1.6 The seven principles of HACCP
                                                                                      gins of possible hazards and (b) hazard evaluation
The application of HACCP is compatible with the im-                                   within the frame of the potential significance of
plementation of quality management systems such as                                    each hazard is assessed by considering its sever-
the ISO 9000 series and is the system of choice in the                                ity (referring to health consequences) and its like-
10                     HACCP and ISO 22000 – Application to Foods of Animal Origin

                                                             Hadjicostas, 2001). If the hazard analysis is not
                                                             done correctly and the hazards warranting control
                      Identify                               within the HACCP system are not identified, the
                   hazards, assess                           plan will not be effective regardless of how well it is
                    risk and list                            followed (Corlett, 1998).
                      controls                             Principle 2 Identify the critical control points (CCPs)
                                                             in the process. CCPs are steps at which control
                                                             can be applied and a food safety hazard can be
                                                             prevented, eliminated or reduced to acceptable lev-
               Identify critical control                     els (Rushing and Ward, 1999). The HACCP team
                        points                               should identify the steps in the production process
                                                             which are essential for the elimination or significant
                                                             reduction of the identified hazards from Principle 1.
                                                             These CCPs are identified through the use of the
                   Establish critical                        decision tree (Fig. 1.5). A CCP should be a quantifi-
                        limits                               able procedure in order for measurable limits and
                                                             monitoring to be achievable in Principles 3 and 4
                                                             (Forsythe and Hayes, 1998). It is not possible to find
                Establish monitoring                         CCPs for all types of products and hazards. Espe-
              system for control points                      cially in low-processed products such as fresh meat,
                                                             there is almost no site at which microbial hazards
                                                             can be eliminated. Thus, only hygiene concepts us-
                                                             ing the basic HACCP methodology can be developed
                 Establish corrective                        (Upmann and Jacob, 2004). Some common points
                      actions                                where control can be applied in a process include:
                                                             1. chilling to temperatures that minimise microbial
                                                                 growth
                                                             2. testing ingredients for chemical residues
                Establish verification                       3. cooking to specific temperatures for exact times
                     procedures                                  in order to destroy microbial pathogens
                                                             4. product formulation control, such as the addition
                                                                 of cultures or adjustment of pH or water activity
                                                             5. testing product for metal contaminants
                                                             6. processing procedures such as filling and sealing
                                                                 cans
                  Establish record–
                                                             7. slaughter procedures such as evisceration or an-
                    keeping and
                                                                 timicrobial interventions
                   documentation
                                                                 (Corlett, 1998; USDA, 1999).
                     procedures
                                                           Principle 3 Establish critical limit(s) for preventive
                                                             measures associated with each identified CCP. Once
                                                             the CCPs have been determined, a critical limit or the
Fig. 1.4 Seven principles involved in developing and         amount of acceptable deviation has to be established
operating a HACCP programme (http://www.nzfsa.govt.          for each CCP (http://www.qsae.org/web en/pdf/
nz/processed-food-retail-sale/fsp/haccp.pdf; NACMCF,         HACCPImpGuide.pdf). Critical limits for CCPs are
1997).                                                       expressed as numbers or specific parameters on vi-
                                                             sual observation, such as time/temperature, humid-
                                                             ity, water activity, pH, salt concentration and chlo-
                                                             rine level (Corlett, 1998; USDA, 1997). There are
  liness to occur (based on experience, epidemiologi-        two types of critical limits. A critical limit can be
  cal data and available information in the literature).     an upper limit where a set amount or level can-
  Hazard analysis is completed by listing all signifi-        not be exceeded. A critical limit can also be a lower
  cant hazards associated to each step, and all con-         limit where a minimum amount is required to pro-
  trol measures that can eliminate or control these          duce the safe effect (USDA, 1999). Critical limits
  hazards to an acceptable level (Arvanitoyannis and         are set for product safety and not product quality.
                          HACCP and ISO 22000 – A Comparison of the Two Systems                                     11




Fig. 1.5 Process step CCP decision tree. (Adapted from Corlett, 1998; Efstratiadis and Arvanitoyannis, 2000; Horchner
et al., 2006; http://www.jphpk.gov.my/Agronomi/KAV/5HACCP1.pdf.)
12                     HACCP and ISO 22000 – Application to Foods of Animal Origin

  For example, the critical limit for frozen raw poultry   Principle 5 Establish corrective actions to be taken
  storage and shipping would require the product be          when monitoring indicates that a particular CCP is
  held below 5◦ C, which does not constitute frozen          not under control. The regulation defines corrective
  but prevents bacterial growth. In a cooked prod-           action as ‘Procedures to be followed when a devia-
  uct, an example of a critical limit would be that          tion occurs’. A deviation is a failure to meet a critical
  an internal temperature of the product reaches             limit (USDA, 1997).
  at least 71◦ C (http://www.qsae.org/web en/pdf/               The purpose of corrective actions is:
  HACCPImpGuide.pdf).                                        1. to adjust the process, such as cooking tempera-
Principle 4 Establish CCP monitoring requirements                tures or cooling rates to maintain control or pre-
  and procedures for using monitoring results to ad-             vent a deviation
  just processes and maintain control. Monitoring            2. to correct the cause of the deviation
  consists of observations or measurements taken to          3. to re-establish control over the process and CCP
  assess whether a CCP is under control. Monitor-            4. to determine the safety and proper disposition
  ing is used to determine when a deviation occurs               of the food being produced while a defect was
  at a CCP and, if it is not continuous, needs to be             occurring
  conducted at a frequency sufficient to ensure that          5. to maintain records of corrective actions
  the CCP is under control (Hulebak and Schlosser,               (Ropkins and Beck, 2000).
  2002). Continuous monitoring is always preferred           All corrective actions cannot be anticipated. An un-
  when it is feasible. When it is not possible, then         listed corrective action should be incorporated into
  the HACCP team will need to decide what will               the corrective action document. The corrective ac-
  be their non-continuous monitoring procedures and          tion will consist of the decision regarding disposal
  how frequently they will be performed. There are           of non-complying material, correcting the cause of
  several issues to consider when deciding the fre-          deviation, demonstrating that CCP is once again in
  quency of non-continuous monitoring checks; the            control, and, finally, maintaining records of the cor-
  most important is that the procedures should be per-       rective action (Deodhar, 1999).
  formed sufficiently often to accurately reflect that       Principle 6 Establish procedures for verification to
  the process is under control (USDA, 1999). The             confirm that the HACCP system is working effec-
  most important steps in food production to monitor         tively. Verification is the application of methods,
  are:                                                       procedures, tests and other evaluations, in addi-
  1. cooking                                                 tion to monitoring to determine compliance with
  2. cooling                                                 the HACCP plan (FAO/WHO, 2001). The verifica-
  3. reheating                                               tion typically consists of two phases. First, verifica-
  4. hot holding                                             tion that the critical limits established for CCPs will
     (Ropkins and Beck, 2000).                               prevent, eliminate or reduce hazards to acceptable
  The three basic requirements for developing moni-          limits. Second, verification that the overall HACCP
  toring procedures for the HACCP plan are:                  plan is functioning effectively. Once critical limits
  1. defining the monitoring procedure                        at each CCP are met, minimal sampling of the final
  2. determining the frequency for monitoring                product is needed (McSwane et al., 2000). Basic ver-
  3. determining who will do the monitoring                  ification procedures include the following:
     (Corlett, 1998).                                         1. initiation of appropriate verification inspection
  The following forms are representative of those                schedules
  needed for monitoring the HACCP system in most              2. review of HACCP plan for completeness
  food plants:                                                3. confirmation of the accuracy of flow diagram
  1. raw material evaluation sheet                            4. review of CCP records
  2. supplier’s guarantee                                     5. review of records for deviations and corrective
  3. cooker log                                                  actions
  4. pack room inspection report                              6. review of critical limits to verify if they are ade-
  5. cooking process validation letter                           quate to control significant hazards
  6. cooking equipment validation letter                      7. validation of the HACCP plan, including on-site
  7. equipment calibration log                                   review
  8. corrective action report                                 8. review of the modifications made to the HACCP
  9. employee training report                                    plan
     (Corlett, 1998).                                         9. a random sample collection and analysis
                         HACCP and ISO 22000 – A Comparison of the Two Systems                                    13

 10. visual inspection of food production operations       is interdisciplinary and its members (their number is
     to determine that CCPs are under control              4–6) could be:
 11. a review of departures from critical limits and
     how they were corrected                               r   production manager
      (Corlett, 1998; McSwane et al., 2000).               r   head of analytical laboratory
Principle 7 Establish documentation concerning all         r   head of microbiological laboratory
  procedures and records appropriate to these prin-        r   personnel manager
  ciples and their application. The level of documen-      r   technical manager
  tation required will depend upon the needs and the       r   logistics manager.
  complexity of the food business. In a small busi-
  ness, a simple log book or diary may be all that is      The HACCP team has to provide the production-
  needed. In a bigger or more complicated business,        specific expertise and experience which are neces-
  more detailed or formal documentation will be nec-       sary for the development of the HACCP plan (Unter-
  essary. Record keeping and documentation systems         mann, 1999). The responsibilities of the HACCP team
  should meet the needs of the business and be ad-         are:
  equate to show that the food safety programme is
  working (http://www.nzfsa.govt.nz/processed-food-        r organising and documenting HACCP study
  retail-sale/fsp/haccp.pdf).                              r reviewing deviation from critical limits
  The HACCP will incorporate documents such as the         r internal auditing of HACCP plans
  following:                                               r communicating, educating and training employees in
  1. the HACCP plan                                          the operation of HACCP system
  2. hazard analysis                                       r understanding the stages of the process the team will be
  3. CCP determinations                                      monitoring
  4. CCP monitoring sheets                                   (http://www.jphpk.gov.my/Agronomi/KAV/5HACCP1.
  5. corrective actions                                      pdf).
  6. audit records
  7. HACCP team meeting minutes
                                                           1.1.7.2 Describe product
  8. calibration records
     (Slatter, 2003).                                      A complete description of the product by providing in-
                                                           formation about the ingredients, processing methods,
                                                           retail, packaging and storage conditions should aim at
                                                           identifying any possible hazards occurring to the prod-
1.1.7 The 12 stages of the HACCP plan                      uct and that which the product may cause (Arvanitoy-
                                                           annis and Hadjicostas, 2001). The following questions
It is no accident that HACCP evolved at the food pro-
                                                           should be answered for the product description:
cessing step of the farm to table supply chain. It is at
this step that effective controls, such as cooking, dry-
                                                           1. What is the common name of the product?
ing, acidification or refining are available to eliminate
                                                           2. How is the product to be used?
significant hazards. Two categories of processed food
                                                           3. What type of packaging encloses the product?
exemplify this fact superbly – pasteurised dairy prod-
                                                           4. What is the length of shelf life of the product, at
ucts and canned foods; note that, with both of these
                                                              what temperature?
food categories, food safety is assured by process con-
                                                           5. Where will the product be sold? *Who is the in-
trol, not by finished product testing. It is time to stop
                                                              tended consumer and what is the intended use?
talking about ‘Farm to Table Food Safety’ (Sperber,
                                                              (*Regulatory requirement)
2005).
                                                           6. What labelling instructions are needed?
                                                           7. Is special distribution control needed? (USDA,
                                                              1999).
1.1.7.1 HACCP team formation
The first step is the formation of the HACCP team
which should be trained. Training is often provided by
                                                           1.1.7.3 Identify intended use
people who are not HACCP practitioners – who are
instead lecturers, academics, regulators or former hy-     Describe the normal expected use of the food. The
giene trainers (Mortimore, 2001). The HACCP team           intended use consists of information on whether the
14                     HACCP and ISO 22000 – Application to Foods of Animal Origin

product has to be prepared prior to consumption, e.g.
by heating or whether it can be consumed directly.
With regard to a possible acceptable risk level for a
food safety hazard it has to be stated for which group
of the population the food is intended (Untermann,
1999). The intended consumers may be the general
public or a particular segment of the population (e.g.
infants, immunocompromised individuals, the elderly
etc.) (NACMCF, 1997).

1.1.7.4 Construct flow diagram
The flow diagram should be constructed by the
HACCP team which should be fully familiar with the
process. The flow diagram should cover all steps in
the operation. When applying HACCP to a given op-
eration, consideration should be given to steps preced-
ing and following the specified operation (FAO/WHO,
2001). A correct flow diagram that identifies all the
steps involved in the process should be drawn. The
flow diagram may also include steps prior to and
after the processing that takes place in the estab-
lishment (Fig. 1.6; Arvanitoyannis and Hadjicostas,
2001).

1.1.7.5 On-site confirmation of flow diagram
It is important to check that the flow diagram is ac-
curate by physically checking it against activities and
that it includes exceptional items such as breakdowns,
rework and cleaning. The team should also check that
the flow diagram is correct for any shift pattern (Slat-
ter, 2003). The on-site assessment will normally in-
volve an initial meeting with relevant personnel to
explain the nature and extent of the review and to
promote cooperation during the assessment. At this
stage, any additional documentation required for an
on-site review could also be requested and examined
(Motarjemi, 2000).

1.1.7.6 On-site verification of flow diagram
The HACCP team should confirm the processing op-
eration against the flow diagram during all stages         Fig. 1.6 Generalised flow diagram of typical production
and hours of operation and amend the flow diagram          process (FDA, 1999; Harrigan and Park, 1991;
where appropriate (FAO, 1998). Modifications should        http://www.foodsci.purdue.edu/publications/foodsafety/
be made to the flow diagram as necessary and docu-         food safety-3.html).
mented. After these five preliminary tasks have been
completed, the seven principles of HACCP are applied
(Corlett, 1998).
                                                          Determine CCPs (see Principle 2)
List all potential hazards associated with each step,     Establish critical limits for each CCP (see Principle 3)
  conduct a hazard analysis and consider any mea-         Establish a monitoring system for each CCP (see
  sures to control identified hazards (see Principle 1)      Principle 4)
                            HACCP and ISO 22000 – A Comparison of the Two Systems                                  15

Establish corrective actions (see Principle 5)              1.1.9 Prerequisite programmes
Establish verification procedures (see Principle 6)
                                                            The HACCP system will incorporate other existing
Establish documentation and record keeping (see
                                                            management systems into its procedures. Typical areas
  Principle 7)
                                                            are personal hygiene, GMP, supplier quality assurance
                                                            and maintenance schedules. These are termed ‘Prereq-
                                                            uisite Programmes’ (PRPs) and are normally in place
1.1.8 HACCP failure                                         before the HACCP plan is developed. Prerequisites are
                                                            systems in their own right and will support the HACCP
The paradox between the increase in foodborne dis-
                                                            by taking the control of general hygiene and GMP out
eases and the implementation of the HACCP system
                                                            of the HACCP plan (Slatter, 2003). PRPs to HACCP,
originates from a misunderstanding of what HACCP
                                                            including training, should be well established, fully op-
is, its role in public health and what can be achieved
                                                            erational and verified in order to facilitate the success-
by its application. The HACCP system per se does
                                                            ful application and implementation of the HACCP sys-
not make food safe, but it is its ‘correct application’
                                                            tem (FAO/WHO, 2006a). A HACCP system can be ef-
that can make a difference. Neither is the HACCP sys-
                                                            fective only if it is based on sound good manufacturing
tem the magic wand which can turn unsafe food into
                                                            and hygienic practices (GMP/GHP). Consequently, it
safe food. The HACCP system should not be a tool
                                                            is the responsibility of the government agencies to en-
for politicians to gain the confidence of consumers
                                                            sure that these PRPs are properly implemented before
                     ¨
(Motarjemi and Kaferstein, 1999). Like any other sys-
                                                            assessing HACCP implementation (Ababouch, 2000).
tem, HACCP has some vulnerable points, and these
                                                            Food safety is not synonymous with HACCP. Food
may be the major drawback for its non-international
                                                            safety is HACCP plus PRPs (Sperber, 2005).
application during recent years (Arvanitoyannis and
Traikou, 2005). A list, by no means complete, of some
of the most common problems reported when review-           1.1.9.1 Training of personnel
ing HACCP plans:
                                                            Training is crucial to any food safety system. Poor staff
                                                            training in food hygiene is a real threat to the safety of
r Only some of the principles are applied (mainly failure   food. Staff should understand how food safety knowl-
    to apply Principles 4 and 5).                           edge is applied in the food safety programme. Any staff
r The principles have not been applied appropriately (not   member without commitment to food safety threat-
    identifying hazards properly).                          ens the entire programme (http://www.nzfsa.govt.nz/
r The HACCP plan is a ‘paper exercise’ and is not imple-    processed-food-retail-sale/fsp/haccp.pdf). It is impor-
    mented in practice.                                     tant to recognise that employees should first under-
r The HACCP plan is over-complicated.                       stand what HACCP is and then learn the skills nec-
r Critical limits that are not adequate and not supported   essary to make it function properly. Specific training
    by scientific studies.                                   activities should include working instructions and pro-
r Corrective actions do not address the product involved    cedures that outline the tasks of employees monitor-
    in a deviation.                                         ing each CCP. Management should provide adequate
r Lack of coordination among responsible authorities,       time for thorough education and training. Personnel
    public and private sectors.                             should be given the materials and equipment neces-
r   Lack of understanding and staff training.               sary to perform these tasks. Effective training is an im-
r   Lack of commitment by management.                       portant prerequisite to successful implementation of a
r   Regulations and procedures that are not efficient.       HACCP plan (NACMCF, 1997). Staff should have an
r   Insufficient education and motivation of consumers and   understanding of:
    food handlers on food protection task
    (Arvanitoyannis and Traikou, 2005; Bernard, 1998;       1. what hazards are and their importance in food
    Forsythe and Hayes, 1998; Marriott, 1997; McSwane          safety
    et al., 2000; Mitchell, 1998; NACMCF, 1997).            2. CCPs and their role in the assurance of product
                                                               safety
                                                            3. critical limits which should be met
The question that still remains is ‘When HACCP ap-          4. corrective actions and responsibilities
pears to fail, is it the fault of the HACCP system itself   5. record-keeping requirements
or does the real failure lie with the people who are        6. the objective of verification procedures
trying to implement it?’ (Mitchell, 1998).                     (Slatter, 2003).
16                      HACCP and ISO 22000 – Application to Foods of Animal Origin

The first step in training is usually motivation – ex-        Micro-organisms vary in their degree of susceptibility
plaining that everybody could be a vital link in a chain     to disinfectants. In general, Gram-positive bacteria
of events leading either to food poisoning or to prod-       are more susceptible to chemical disinfectants while
uct safety. It is important to link ‘hygiene conscience’     mycobacteria or bacterial endospores are more resis-
with ‘product safety’ from the very beginning (Engel,        tant. The hydrophilic, non-enveloped viruses (adeno-
1998). The trainer most often achieves the best results      viruses, picornaviruses, reoviruses, rotaviruses)
by keeping the talk short and by working through a           are more resistant to disinfection than lipophilic,
set sequence of discrete steps as follows:                   enveloped viruses (coronaviruses, herpesviruses,
                                                             orthomyxoviruses, paramyxoviruses, retroviruses;
1. show the trainees the actual skill they are to            Dvorak, 2005).
   acquire                                                      Commonly used sanitisers in food establishments
2. demonstrate and explain the operations involved           are presented below. Sanitisers destroy disease-causing
3. have trainees imitate the necessary actions               organisms which may be present on equipment and
4. have trainees practise performing the operations          utensils even after cleaning (McSwane et al., 2000).
5. devote at least 50% of the session to trainee practice
   time
                                                             Heat
   (FAO, 1998).
                                                             Heat is the most common method of killing spoilage
                                                             and pathogenic bacteria in foods (Marriott, 1997).
There are many benefits to proper employee training
                                                             Heat in the form of pressurised steam is the most
including:
                                                             effective method of sterilisation; moist heat kills
                                                             micro-organisms at relatively low temperatures by
1. improved customer satisfaction – a well-trained
                                                             denaturation of protein but proteins are far more
   staff provides the service and the quality that cus-
                                                             stable in dry conditions so that far higher tempera-
   tomers expect
                                                             tures and/or longer times are necessary to effect a kill
2. lower turnover – money savings to the organisation,
                                                             using hot air. Moist heat is a favoured disinfecting
   better life quality for the employees, higher client
                                                             or sterilising agent because it is non-corrosive, eco-
   satisfaction
                                                             nomical, has excellent penetration powers, leaves no
3. lower costs – fewer mistakes by well-trained
                                                             residue and is active against the majority of micro-
   employees
                                                             organisms (Forsythe and Hayes, 1998). Bacterial
4. fewer accidents due to experience and good training
                                                             populations killed by heat or chemicals tend to die at
   of employees
                                                             constant rates – for example, 90% every 10 minutes
5. better quality of products
                                                             (http://webhome.broward.edu/∼dweber/MCB2010/
   (McSwane et al., 2000).
                                                             Study%20Guides/Ch07 Micro8eStudyGuide.pdf).

1.1.9.2 Sanitation
                                                             Chemicals
Sanitation is broadly defined by ‘all precautions and         Many chemical compounds that destroy micro-
measures, which are necessary in the production, pro-        organisms should not be used to kill bacteria in or on
cessing, storage and distribution, in order to assure an     food. Food processors use chemicals to sanitise equip-
unobjectionable, sound and palatable product which           ment and utensils that can cross-contaminate food.
is fit for human consumption’ (Bakka, 1997). Sanita-          These chemicals are rinsed off, so they cannot con-
tion is not sterilisation (McSwane et al., 2000). The        taminate food. Sanitising, using heat, has become more
first step of sanitisation is the pre-wash, with the ob-      expensive, so the food industry uses chemical sanitis-
jective of removing gross dirt, followed by alkaline         ers more often (Marriott, 1997). Lactic acid, acetic
and acid washing (to remove proteins, carbohydrates,         acid and citric acid also are lethal to many micro-
lipids and minerals, respectively) (da Cruz et al., 2006).   organisms. Several other weak acids (e.g. benzoic acid,
This dirt usually contains micro-organisms and nu-           sorbic acid, sulphur dioxide etc.) are used as preserva-
trients that allow the microbes to grow (Marriott,           tives (Harrigan and Park, 1991). The basic character-
1997).                                                       istics of the ideal chemical agent are:
   Micro-organisms die at a relatively constant rate in
the accelerated death phase. Some things can change          1.   capacity to kill all microbes
the death rate, such as lethal agent or a mixed popula-      2.   soluble in water
tion of sensitive and resistant cells. Heat, chemicals and   3.   stable on standing
radiation can all destroy microbes (Marriott, 1997).         4.   not lose activity over time
                          HACCP and ISO 22000 – A Comparison of the Two Systems                                    17

5. non-toxic to humans and animals                          1.1.9.3 Good manufacturing practices
6. low persistence/OM binding
                                                            Within the food factory, there should be management
   (http://www.eeescience.utoledo.edu/Faculty/Sigler/
                                                            procedures aimed at the application of codes of Good
   COURSES/Microbial%20Ecology%20Lecture/
                                                            Manufacturing Practices (GMPs; Harrigan and Park,
   12%20-%20Controlling%20microbes.pdf).
                                                            1991). GMPs provide general rules for the manufac-
                                                            ture, handling and preparation of various kinds of
                                                            food products. It aims at safeguarding good hygienic
Radiation
                                                            and sensory quality traits and may be regarded as
The process involves exposing the food, either pack-
                                                            an obligation to bestow great care upon production.
aged or in bulk, to carefully controlled amounts of ion-
                                                            GMP principles have been developed over a number
ising radiation for a specific time to achieve certain de-
                                                            of years and are now regarded as the foundation on
sirable objectives. When microbes present in the food
                                                            which the production of safe food is based (Upmann
are irradiated, the energy from the radiation breaks
                                                            and Jacob, 2004). In July 2002, Food and Drug Ad-
the bonds in the DNA molecules, causing defects in
                                                            ministration (FDA) formed a Food GMP Moderniza-
the genetic instructions. Unless this damage can be re-
                                                            tion Working Group to examine the effectiveness of
paired, the organism will die or will be unable to repro-
                                                            current food GMPs given the many changes that have
duce (http://mightylib.mit.edu/Course%20Materials/
                                                            occurred in the food industry since 1986. The Work-
22.01/Fall%202001/food%20irradiation.pdf). Many
                                                            ing Group has been researching the impact of food
different kinds of irradiated food were tested over the
                                                            GMPs on food safety, as well as the impact (including
years such as fruits (bananas, strawberries, mangoes);
                                                            economic consequences) of revised regulations. Part of
vegetables (onions, potatoes, peas, carrots, cabbage);
                                                            the group’s current effort, as of June 2004, is to find
grains (wheat flour); meat (fish, chicken, beef); beans
                                                            out which elements of the food GMPs are critical to re-
(cocoa beans, coffee beans) and various combinations
                                                            tain and which should be improved. FDA is now hold-
of these and other foods (Hammond et al., 1996). Ef-
                                                            ing public meetings to obtain the public’s comments to
ficiency of irradiation is affected by a variety of fac-
                                                            assist in this effort (U.S. Food and Drug Administra-
tors such as temperature, protein content of the sus-
                                                            tion, 2004). In the UK, the Institute of Food Science
pended medium, water activity, presence of oxygen etc.
                                                            and Technology publishes guides to GMP (GMP 5,
The greater the dose of irradiation the more extensive
                                                            2007).
is the change in organoleptic quality of the food. One
                                                               Industries that have adopted the GMPs have the fol-
of the anxieties surrounding the introduction of irra-
                                                            lowing results amongst others:
diation of foods is that the process may be used to
treat food that would otherwise be detectable as un-
acceptable, in which possibly toxins had already accu-      1. Better quality, safer products, decrease in incidence
mulated, for example (Harrigan and Park, 1991).                of consumer complaints.
                                                            2. Better, more agreeable, cleaner and safer working
                                                               environment.
Filtration                                                  3. Greater employee motivation and productivity and
Filtration can act as a consistent and effective bar-          improved psychological conditions
rier for microbial pathogens and may in some cases             (da Cruz et al., 2006).
be the only treatment barrier (e.g. for removing Cryp-
tosporidium oocysts by direct filtration when chlorine
                                                            The plant management is expected to take all reason-
is used as the sole disinfectant) (http://www.who.int/
                                                            able measures and precautions to ensure the following:
water sanitation health/dwq/wsp170805chap6.pdf).
   Bacteria and larger micro-organisms can be re-
                                                            Personnel
moved from otherwise clear liquids by filtration
through membranes which have holes with a mean
pore size of 0.2 µm (Harrigan and Park, 1991). The            r disease control
membrane processes most commonly used to remove               r adequate personal cleanliness
microbes from drinking water are microfiltration               r washing hands thoroughly before starting work, and
(MF), ultrafiltration (UF), nanofiltration (NF) and               after using the toilet, handling money, handling any-
reverse osmosis (RO). There are very few contami-               thing dirty
nants that cannot be removed by membrane processes            r use of gloves
(http://www.who.int/water sanitation health/dwq/              r wear protective clothing, suitable footwear, hair cov-
wsp170805chap6.pdf).                                            erings
18                          HACCP and ISO 22000 – Application to Foods of Animal Origin

     r avoid smoking, eating, chewing, spitting, sneezing or            McSwane et al., 2000; http://www.hi-tm.com/RFA/
       coughing in the production area                                  Mfg-ppsm/3-prereq-5-06.pdf).
     r removing all unsecured jewelry and other objects
       that might fall into food (Corlett, 1998; FAO, 1998;       Production and process controls
       Forsythe and Hayes, 1998; Marriott, 1997).
                                                                    r no raw material or ingredient should be accepted if
                                                                        it is known to contain parasites, undesirable micro-
Buildings and facilities
                                                                        organisms, pesticides, veterinary drugs or toxic, de-
     r located away from environmentally polluted areas,                composed or extraneous substances
                                                                    r   checking of raw materials that come into the plant
         areas subject to flooding, areas prone to infestations
                                                                        by collecting samples to decide if they should accept
         of pests and areas where wastes cannot be removed
                                                                        or reject deliveries
         effectively                                                r
     r   adequate supply of potable water, natural gas, elec-
                                                                        raw material should be washed or cleaned (if neces-
                                                                        sary) to remove soil or other contaminants
         tricity, fuel and other utilities                          r
     r   adequate drainage and waste disposal systems, ven-
                                                                        inspection of the overall condition of the trucks used
                                                                        to transport low-moisture raw materials, for areas
         tilation system to minimise odours and vapours, air
                                                                        where food and dust collect, for insect activity (frozen
         conditioning and dust control
     r   walls should be smooth, waterproof, with no ledges
                                                                        raw materials and other ingredients should be kept
                                                                        frozen)
         and overhangs                                              r
     r   floors made of materials that are impervious,
                                                                        the storage rooms used for food materials should be
                                                                        clean, provide adequate space for inspection, good
         durable, resistant to grease, cleaning agents and to
                                                                        air circulation, correct temperature and humidity.
         biochemical and microbial attack, free from cracks,
                                                                        Food materials should not be placed directly on the
         crevices, non-slip-surface, easy to clean
     r                                                                  floor
         doors should generally be either opened automat-           r   equipment should be sited so that it can be easily op-
         ically, or provided with heavy-duty plastic strips
                                                                        erated, cleaned, inspected and maintained, not close
         which permit easy access by personnel and essential
                                                                        to walls, ceilings or other equipment
         traffic (e.g. fork-lift trucks)                             r
     r   roofing is normally flat or slightly pitched and is sup-
                                                                        packaging materials should be hygienic, odourless,
                                                                        not reacting with either the contained food or the
         ported by trusses or beams, can be a source of natural
                                                                        surrounding atmosphere
         light, opening windows not recommended                     r
     r   adequate lighting in hand-washing areas, dressing
                                                                        waste food materials should be disposed of in an ap-
                                                                        propriate manner
         and locker rooms, toilet and rooms where food is           r   cleaning materials should not be left in processing
         examined, processed or stored
     r                                                                  areas
         pest control (insects, flies, cockroaches, moths and        r   finished products should be labelled and isolated
         beetles, rodents)
                                                                        pending checks for conformity with the product spec-
         (Corlett, 1998; FAO, 1998; Forsythe and Hayes,
                                                                        ification
         1998; Jarvis, 1999; Marriott, 1997; McSwane et al.,        r   defective products should remain isolated pending a
         2000).
                                                                        decision on reworking, recovery or disposal
                                                                    r   final products approved for release should be re-
                                                                        moved into the relevant warehouse area
Equipment
                                                                        (Corlett, 1998; FAO, 1998; Forsythe and Hayes,
     r all surfaces in contact with food should be smooth,              1998; Jarvis, 1999; Marriott, 1997).
       not porous, inert, visible for inspection, accessible
       for manual cleaning, made of non-toxic material,           1.1.10 Control measures
       corrosion-resistant, designed to resist the extended
       use, cleaning compounds and sanitising agents              Control measures are grouped into three groups as
     r equipment should be readily disassembled for in-           follows:
       spection and manual cleaning, designed to protect
       the contents from external contamination, sanitised        r PRPs that manage the basic conditions and activities
       with approved sanitiser and rinsed with potable wa-        r operational PRPs that manage control measures that
       ter if required, equipped with rounded corners and          the hazard analysis identifies as necessary to control
       edges (Corlett, 1998; Forsythe and Hayes, 1998;             identified hazards to acceptable levels
                         HACCP and ISO 22000 – A Comparison of the Two Systems                                       19

r a HACCP plan to manage control measures that the          Parasite hazards
 hazard analysis identifies as necessary to ensure control     1. dietary control
 of identified hazards to acceptable levels (CCPs; ISO         2. inactivation (heating, drying, freezing)
 22000:2005b).                                                3. visual examination for parasites (seafood.
                                                                 ucdavis.edu/haccp/training/slides/chapt05.ppt;
After biological, chemical and physical hazards iden-            FAO).
tification for each processing step and each ingredient,
it is time to identify measures needed to prevent haz-
ards from compromising the safety of the final product
                                                            1.1.11 Advantages of HACCP
(FAO, 1997).
   The following are examples of control measures for       Food companies that have had effective sanitation and
physical hazards:                                           HACCP programmes have a number of positive oper-
                                                            ating characteristics that distinguish them from com-
1. Specifications for raw materials and ingredients and      panies that do not have these programmes (Corlett,
   vendor certification that unacceptable physical haz-      1998).
   ards or levels are not present.
2. Use of magnets, metal detectors, sifter screens, de-
   stoners, clarifiers and air tumblers.                     r Application of HACCP system throughout the food
3. Ensuring that GMPs are followed and that no phys-            chain from the primary producer to the consumer.
   ical contamination occurs to the food through the        r More effective use of resources, savings and more timely
   building facilities, work surfaces or equipment              response to food safety problems.
   (FAO, 1998).                                             r Internationally recognised.
                                                            r The application of HACCP systems can promote in-
Some of the measures you can use to prevent chemical            ternational trade by increasing confidence in food
hazards are:                                                    safety.
                                                            r   The HACCP system allows for the identification of con-
1. use only approved chemicals                                  ceivable, reasonably expected hazards, even where fail-
2. have detailed product specifications for chemicals            ures have not previously been experienced. It is there-
   entering the plant                                           fore particularly useful for new operations.
3. maintain letters of guarantee from suppliers             r   Staff and business owners gain confidence and are better
4. inspect trucks used to ship final product                     equipped for informed discussion on food safety mea-
5. proper labelling and storage of chemicals                    sures with food inspectors, third-party auditors, con-
6. proper training of employees who handle chemicals            sultants, trading partners, consumers and others.
   (Corlett, 1998).                                         r   The development of a HACCP system can lead to im-
                                                                proved education and awareness of staff working in
Control measures taken to prevent biological hazards            SLDBs and staff members are empowered when their
are:                                                            input is sought and valued.
                                                            r   The HACCP system has strengthened the regulatory
Bacterial hazards                                               approach to food safety by providing food control au-
  1. time/temperature control (refrigeration, storage           thorities with an opportunity to revisit their method of
     time)                                                      food inspection and the training provided to food in-
  2. heating and cooking processes to eliminate or re-          spectors.
     duce micro-organisms                                   r   More focused control on processes critical to food
  3. cooling and freezing                                       safety, with the flexibility to accommodate additional
  4. fermentation and/or pH control                             changes in production, quality or other specific mea-
  5. addition of salt or other preservatives which may          sures, e.g. control of allergens or emerging pathogens.
     inhibit micro-organism growth                          r   Demonstrable improvements to food quality and safety
  6. drying which may use heat to kill or remove                standards, thereby reducing the potential for foodborne
     micro-organisms                                            disease, customer complaints, wastage and damage to
  7. source control (examination of raw materials and           the reputation of the business
     ingredients from suppliers).                               FAO/WHO, 2006a; FSA, 2001; http://www.jphpk.gov.
Viral hazards                                                   my/Agronomi/KAV/5HACCP1.pdf;
  1. cooking processes (heating, cooking, steaming,             http://www.unido.org/userfiles/cracknej/fgfs1.pdf;
     frying, baking) which may destroy viruses                                     ¨
                                                                Motarjemi and Kaferstein, 1999).
20                        HACCP and ISO 22000 – Application to Foods of Animal Origin

1.1.12 Disadvantages of HACCP                                     Organisations are cognisant of the need to demon-
r Resource-intensive during development, unless sup-           strate and provide evidence of their ability to provide
                                                               safe food (http://www.nsai.ie/IR/index.cfm/area/page/
    ported by extensive structure of trade associations or
                                                               information/ISO 22000). ISO 22000 will help these or-
    other industry groupings.
r   Needs to be validated for effectiveness.
                                                               ganisations to establish an FSMS and implement it in
r   Difficult to anticipate all hazards introduced by subtle
                                                               the food plant with proper improvement and update of
                                                               the FSMS system. This standard promotes conformity
    variations on seemingly standard processes thus needs
                                                               of products and services to international standards by
    constant vigilance and updating.
r   Element of technical knowledge required to adopt
                                                               providing assurance about quality, safety and reliabil-
                                                               ity (Tajkarimi, 2007).
    them.
r   Perceived complexity and bureaucracy – many smaller
                                                                  The ISO 22000 standard intends to define the
                                                               food safety management requirements that companies
    businesses regard HACCP as complicated and bureau-
                                                               need to meet and exceed in order to comply with food
    cratic.
r   Lack of knowledge and adequate training – many small
                                                               safety regulations all over the world. It is intended
                                                               to be one standard that encompasses all the con-
    businesses remain unaware of HACCP or lack sufficient
                                                               sumer and market needs. It speeds and simplifies pro-
    in-house knowledge and training about the risks asso-
                                                               cesses without compromising other quality or safety
    ciated with their procedures to put in place or maintain
                                                               management systems (http://www.foodsafety.sgs.com/
    effective HACCP-based controls.
r   The costs of ongoing training against a backdrop
                                                               what is iso 22000). ISO 22000 uses generally recog-
                                                               nised methods of food safety management such as in-
    of high staff turnover, typical in the industry, can
                                                               teractive communication across the food chain, system
    also be prohibitive for many smaller food businesses
                                                               management, control of food safety hazards through
    (FAO/WHO, 2006a; FSA, 2001).
                                                               PRPs and HACCP plans, and continual improvement
                                                               as well as periodic updating of the management sys-
                                                               tem (http://www.degrandison.ie/275-FSMS.htm). Fur-
                                                               thermore, the requirement of Emergency preparedness
1.2 ISO 22000
                                                               and response plan (see 5.7) of ISO 22000 is also a
                                                               basic requirement of ISO 14001 which is the world-
1.2.1 Introduction to ISO 22000
                                                               wide Environmental Management System (EMS; Cul-
ISO 22000 is the new international generic FSMS stan-          ley, 1998). This standard has many elements in com-
dard for food safety management systems. It defines a           mon with ISO 9001, it has its roots in BS 7750 (Quality
set of general food safety requirements that apply to all      Standard), and it is also related to Eco-Management
organisations in the food chain. These requirements            and Audit Regulation (EMAR). One of the strengths
are listed in sections 4, 5, 6, 7 and 8 of ISO 22000 (see      of ISO 14001 is that it is not a performance standard.
Section 2.8). Recognised worldwide, this universal             It does not specify how the requirements of any section
standard harmonises key requirements and overcomes             should be satisfied, nor does it specify levels of envi-
the difficulties of various food safety standards by            ronmental performance that an organisation should
region, country, activity, organisation and food-type          achieve (Ritchie and Hayes, 1998).
(http://www.foodsafety.uk.sgs.com/westbury dairies                The standard has become necessary because of the
case study-4.pdf).                                             significant increase of illnesses caused by infected
   If an organisation is part of the food chain, ISO           food in both developed and developing countries. In
22000 requires the establishment of a food safety man-         addition to the health hazards, foodborne illnesses
agement system (FSMS) and usage of this system to en-          can give rise to considerable economic costs including
sure that food products do not cause adverse human             medical treatment, absence from work, insurance pay-
health effects (http://www.praxiom.com/iso-22000-              ments and legal compensation. As a result, a number
intro.htm). The requirements of ISO 22000 may ap-              of countries have developed national standards for
ply to all types of organisations within the food chain        the supply of safe food and individual companies and
ranging from feed producers, primary producers, food           groupings in the food sector have developed their own
manufacturers, transport and storage operators, sub-           standards or programmes for auditing their suppliers
contractors to retail and food service outlets, together       (http://www.iso.org/iso/en/commcentre/pressreleases/
with inter-related organisations such as producers of          archives/2005/Ref959.html).
equipment, packaging materials, cleaning agents, ad-              While ISO 22000 can be implemented on its own, it
ditives and ingredients (http://www.nsai.ie/IR/index.          is designed to be fully compatible with ISO 9001:2000
cfm/area/page/information/ISO 22000).                          and companies already certified to ISO 9001 will find
                         HACCP and ISO 22000 – A Comparison of the Two Systems                                      21




Fig. 1.7 The standards/systems that led to the development of ISO 22000.



it easy to extend this to certification to ISO 22000            the way certification has been wanted to their suppliers.
(Fig. 1.7) (http://www.iso.org/iso/en/commcentre/              Published in the first quarter of 2006.
pressreleases/archives/2005/Ref959.html). ISO 9001:          r ISO/TS 22004, Food safety management system –
2000 on quality management does not deal specif-               Guide-related practicing of ISO 22000:2005, provides
ically with food safety. As a result, many countries,          generic guidance that can be applied in the use of ISO
such as Denmark, the Netherlands, Ireland and Aus-             22000. Published in November 2005.
tralia amongst others developed voluntary national           r ISO 22005, Monitoring in bait and food chain –
standards and other documents specifying auditable             General principles and guide for system preparation
requirements for FSMS (Faergemand and Jespersen,               and design, is in preparation at the time of publication
2004).                                                         of this text and will initially be circulated as a Draft
                                                               International Standard
                                                               (http://www.wcs.com.tr/certification/ISO22000 haccp.
1.2.2 An introduction of ISO 22000                             htm;
The challenge for ISO 22000 is that it should be               http://www.iso.org/iso/en/commcentre/
recognised by all segments in the food chain. It seems         pressreleases/archives/2005/Ref959.html;
certain that the HACCP standards will be replaced              http://www.bulltek.com/English Site/ISO9000
with ISO 22000. What is not yet certain is whether             Introduction English/HACCP English/ISO 22000/
the retailer will accept it. One factor in favour of           iso 22000.html).
ISO 22000 is that its intent is global. Thus, as pro-
duce is increasingly sourced globally, confidence can        The standard has three parts:
be gained from one single universally accepted ISO
                                                             r Requirements for GMP or pre-requisite programme
standard (http://bvqi.com/webapp/servlet/FileServlet?
                                                             r Requirements for HACCP principles of the Codex Ali-
mode=download&...+Magazine.pdf).
   ISO 22000:2005 is the first in a family of standards        mentarius.
                                                             r Requirements for management system
that includes the following documents:
                                                              (http://www.nsf-isr.org/newsroom/press release.asp?
r ISO/TS 22003, Food safety management system – Con-          p id;
                                                              http://www.lrqa.co.uk/products/otherproducts/ISO
 dition for organisations which make certification and
                                                              22000/).
 inspection of food safety management system, defines
 the rules applicable for the audit and certification of     The standard has the following objectives:
 a food safety management system (FSMS) complying
 with the requirements given in ISO 22000 (or other sets     r to enhance food safety
 of specified FSMS requirements), and provides the nec-       r to ensure consumer protection
 essary information and confidence to customers about         r to strengthen consumer confidence
22                         HACCP and ISO 22000 – Application to Foods of Animal Origin

r to improve cost efficiency throughout the food supply           Table 1.2 Timetable for the development of ISO 22000.
    chain
r   to comply with the Codex HACCP principles                    Date                 Event
r   to harmonise the voluntary international standards
r                                                                2001                 Development of the standard
    to provide an auditable standard that can be used ei-        3 June 2004          Draft International Standard
    ther for internal audits, self-certification or third-party                        ISO/DIS 22000
    certification                                                 3 November 2004      Deadline for comments on the draft
r   the structure to align with ISO 9001:2000 and ISO                                 International Standard
    22000:2005                                                   5 July 2005          Final draft of the International
r   to provide communication of HACCP concepts inter-                                 Standard
    nationally
    (http://www.degrandison.ie/275-FSMS.htm;
    http://www.ourfood.com/foodsafety/FoodSafetyAnd              1.2.4 Relationship of ISO 22000 to HACCP
    ControlSystem15.pdf; Tajkarimi, 2007).
                                                                 The design and implementation of an organisation’s
                                                                 food safety management system are influenced by vary-
1.2.3 History of ISO 22000                                       ing factors, in particular food safety hazards, the prod-
In 2001, ISO started the development of an auditable             ucts provided, the processes employed and the size and
standard, which further defines HACCP’s role in                   structure of the organisation. This Technical Specifica-
FSMS and culminated in the newly formed ISO 22000                tion provides guidance on the use of ISO 22000, which
(http://www.foodsafety.sgs.com/what is iso 22000).               is based on the principles of HACCP as described by
The publication of ISO 22000 was complemented by                 the Codex Alimentarius Commission and is designed
an ISO Technical Specification (ISO/TS 22004) giving              to be applied together with relevant standards pub-
guidance on the implementation of the standard, with             lished by that organisation (ISO 22000:2005b). ISO
a particular emphasis on small- and medium-sized en-             22000 will dynamically combine the HACCP princi-
terprises. Working Group 8 (WG 8) on FSMS prepared               ples and application steps with PRPs, using the hazard
ISO 22000 and ISO/TS 22004, which were both pub-                 analysis to determine the strategy to be used to en-
lished in 2005 (FAO/WHO, 2007). Another Technical                sure hazard control by combining the PRPs and the
Specification (ISO/TS 22003) was also published                   HACCP plan (Table 1.3; Faergemand and Jespersen,
explaining certification requirements applicable when             2004).
third-party certification is used (Frost, 2005). The
Draft International Standard ISO/DIS 22000 was is-               1.2.5 Application of ISO 22000
sued on 3 June 2004. The deadline for comments was               ISO 22000:2005 applies to all organisations, regard-
3 November 2004. ISO 22000 was expected to be                    less of their size, that impact the food chain (http://
available as an International Standard in 2005 (Faerge-          www.nsf-isr.org/newsroom/press release.asp?p id=
mand and Jespersen, 2004). ISO circulated the final               11944;      http://www.nsai.ie/IR/index.cfm/area/page/
draft of the standard to the national standard bodies            information/ISO 22000). The standard was drafted to
that make up its membership for a 2-month voting                 serve the needs of not just food producers and manu-
period, ending on 5 July 2005. The standard can be               facturers, but also virtually every other organisation
applied on its own, or in combination with other man-            that participates in the food supply chain. ISO 22000 is
agement system standards such as ISO 9001:2000,                  written with a structure compatible to other manage-
with or without independent (third party) certification           ment system standards in the light of ISO 9001:2000
of conformity (Frost, 2005). The working group                   (applying ISO 15161 as guideline) while combining
that developed ISO 22000 has representatives from                HACCP MS/Codex HACCP (http://www.bulltek.
14 countries and input from 13 others represent-                 com/English Site/ISO9000 Introduction English/
ing all continents. In the working group, there are              HACCP English/ISO 22000/iso 22000.html). Direct
also representatives from organisations such as the              or indirect organisations which can be certified with
Codex Alimentarius, the Global Food Safety Initiative            ISO 22000 standard are the following:
(GFSI) and the Confederation of Food and Drink
Industries of the EU (CIAA) (http://www.haccp.com.               (a) Direct organisations
au/bulletins/bulletin3.pdf;                                          r farmers
http://www.lrqa.co.uk/products/otherproducts/ISO                     r harvesters
22000/). The timetable for the development of ISO                    r bait producers
22000 is given in Table 1.2.                                         r food component producers
                          HACCP and ISO 22000 – A Comparison of the Two Systems                                          23

     Table 1.3 Cross-references between the HACCP principles and application steps and clauses of ISO
     22000:2005 (ISO 22000:2005a; Surak, 2003b).

     HACCP                                        ISO 22000:2005

     Assemble HACCP team                          7.3.2 Food safety team
     Describe product                             7.3.3 Product characteristics
                                                  7.3.5.2 Description of process steps and control measures
     Identify intended use                        7.3.4 Intended use
     Construct flow diagram                        7.3.5.1 Flow diagram
                                                  7.4.1 Hazard analysis
                                                  7.4.2 Hazard identification and determination of acceptable levels
     Principle 1
     Conduct hazard analysis                      7.4.3 Hazard assessment
                                                  7.4.4 Selection and assessment of control measures
     Principle 2
     Determine CCPs                               7.6.2 Identification of CCPs
     Principle 3
     Establish critical limits                    7.6.3 Determination of critical limits for CCPs
     Principle 4
     Establish a monitoring system                7.6.4 System for the monitoring of CCPs
     Principle 5
     Establish corrective actions                 7.6.5 Actions when monitoring results exceed critical limits
     Principle 6
     Establish verification procedures             7.8 Verification planning
     Principle 7
     Establish documentation and                  4.2 Documentation requirements
     record keeping                               7.7 Updating of preliminary information and documents specifying
                                                  the PRPs and the HACCP plan



     r food producers                                        r   a uniformly auditable standard
     r food sellers                                          r   a drive for continuous improvement
     r food services                                         r   improved internal and external communications
     r ready made food companies                             r   improved documentation
     r organisations which service cleaning, sanitising      r   improved compliance with hygiene regulations
     r carriers, storage, distribution etc.                  r   improved food safety hazard control
(b) Indirect organisations                                   r   easy to understand, apply and recognise
     r producers of equipment                                r   facilitates traceability and clear communication across
     r package materials                                         the supply chain
     r ingredients and additives                             r   clear responsibilities and authorities agreed for all staff
     r organisations etc. producing other elements which     r   resource optimisation (internally and along the food
     contact with food                                           chain)
     (http://www.wcs.com.tr/certification/ISO 22000           r   valid basis for taking decisions
     haccp.htm;                                              r   provides a framework for third-party certification
     http://www.qmi.com/registration/foodsafety/ISO          r   can be applied independently
     22000/Default.asp?language=english; Pillay and          r   allow small and/or less developed organisations to im-
     Muliyil, 2005).                                             plement an externally developed system
                                                             r   speeds and simplifies processes, increases efficiency and
                                                                 reduces costs without compromising existing or other
1.2.6 Benefits of ISO 22000                                       quality or management systems
                                                             r   applicable to all organisations in the global food supply
Adopting the ISO 22000 standard provides the com-
pany with competitive efficiencies worldwide. With                chain
                                                             r   the structure aligns with the management system
registration to ISO 22000, the ensuing advantages are:
                                                                 clauses of ISO 9001 and ISO 14001
r incorporation of legal and regulatory requirements re-     r   all control measures are subjected to hazard analysis
  lating to food safety including HACCP systems              r   better planning – less post-process verification
24                       HACCP and ISO 22000 – Application to Foods of Animal Origin

r systematic management of PRPs                               with terms and vocabulary used in the ISO standard
r a systematic and proactive approach to identification of     document (Pillay and Muliyil, 2005). Standards are en-
    food safety hazards and development and implementa-       couraged to investigate the possibility of applying the
    tion of control measures                                  most recent edition of the normative document indi-
r   enables streamlined communication and collaboration       cated below. For undated references, the latest edition
    for quicker, more informed decision making about haz-     of the normative document referred to applies (Arvan-
    ards with supply chain partners                           itoyannis and Hadjicostas, 2001). Codex normative
r   increased international acceptance of food products       texts fall into three groups (FAO/WHO, 2005):
r   reduces risk of product/service liability claims
r   ensures safety of food products
r                                                             r the standards, usually related to product characteristics
    greater health protection                                 r the code of practices, defining the production, process-
r   job productivity and satisfaction of employees are in-
    creased                                                     ing, manufacturing, transport and storage practices that
r   employees become conscious about hygiene and food           are essential to ensure the safety of food for consump-
    safety                                                      tion
r                                                             r the guidelines, which can be principles that set out pol-
    can be applied by all manufacturers and participants in
    the entire food chain supply                                icy in certain key areas, or interpretative guidelines for
r   food wastes (food decaying etc.) fees decrease to mini-     the understanding of these principles or for the interpre-
    mum                                                         tation of the provisions of the Codex general standards
r   work environment gets better                                (FAO, 2006).
r   it is a trusted system which was confirmed by
    FAO/WHO
    (http://www.wcs.com.tr/certification/ISO22000 benefits.     3 Terms and definitions
    htm;                                                      In an attempt to maintain consistency and encourage
    http://www.bis.org.in/cert/fsms.htm;                      the use of common terminology, the ISO 22000 stan-
    http://www.organaqsis.com/Domaines/anglais/               dard terms and definitions section makes reference to
    Hyg secu alim.htm;                                        the use of 82 definitions occurring in ISO 9000:2000
    http://www.bsi-global.com/en/Assessment-and-              and lists definitions that are specific to this applica-
    certification-services/management-systems/Standards-       tion. The rationale behind the definition section is to
    and-Schemes/ISO-22000/Benefits/;                           provide clarity of terminology and promote the use of
    http://www.degrandison.ie/275-FSMS.htm;                   a common language (Pillay and Muliyil, 2005).
    http://www.qmi.com/registration/foodsafety/ISO
    22000/default.asp?language=english;
    http://www.foodsafety.uk.sgs.com/westbury dairies         3.1 Food safety
    case study-4.pdf;                                         The basic food safety concept is this: food will not
    Faergemand and Jespersen, 2004;                           harm the consumer so long as intended use guidelines
    Pillay and Muliyil, 2005; Surak, 2003a).                  are followed when it is prepared or eaten. Conversely,
                                                              food is potentially harmful whenever it has been ex-
                                                              posed to hazardous agents and intended use guidelines
1.2.7 ISO 22000 standard clauses                              have not been followed (http://www.praxiom.com/iso-
                                                              22000-definitions.htm).
1 Scope
The scope focuses on control measures to be imple-
mented to ensure that processes are in place to meet          3.2 Food chain
customer and regulatory food safety requirements. The         Sequence of the steps and operations involved in the
types of organisations in the food chain to which this        production, processing, distribution, storage and han-
standard can be applied are the ones that are directly        dling of a food and its ingredients, from primary pro-
or indirectly involved in one or more steps of the food       duction to consumption (ISO 22000:2005a).
chain, regardless of the size or complicatedness of the
organisation (Pillay and Muliyil, 2005).                      3.3 Food safety hazard
                                                              Any biological, chemical or physical property that
                                                              may cause a food to be unsafe for human consump-
2 Normative references
                                                              tion (http://a257.g.akamaitech.net/7/257/2422/14mar
Normative reference deals with reference materials            20010800/edocket.access.gpo.gov/cfr 2003/pdf/
that can be used to determine definition associated            9CFR417.1.pdf).
                          HACCP and ISO 22000 – A Comparison of the Two Systems                                      25

3.4 Food safety policy                                       3.10 Critical control point (CCP)
A food safety policy statement formally defines an or-        A point in a step or procedure at which a control is to
ganisation’s commitment to food safety (see 3.1). It         be applied to prevent or eliminate a hazard or reduce
expresses, in general terms, what top management in-         it to an acceptable level (PAHO, 2005).
tends to do about food safety and describes the direc-
tion the organisation wishes to take. More precisely, a
                                                             3.11 Critical limit
food safety policy statement should express an organ-
                                                             The maximum or minimum value to which a physical,
isation’s commitment to the implementation and on-
                                                             biological or chemical hazard should be controlled at
going maintenance of its FSMS. The food safety policy
                                                             a CCP to prevent, eliminate or reduce to an acceptable
should drive the establishment of the FSMS and should
                                                             level the occurrence of the identified food safety haz-
also encourage people to update and improve its over-
                                                             ard (http://a257.g.akamaitech.net/7/257/2422/14mar
all effectiveness (http://www.praxiom.com/iso-22000-
                                                             20010800/edocket.access.gpo.gov/cfr 2003/pdf/
definitions.htm).
                                                             9CFR417.1.pdf).

3.5 End product
Product that will undergo no further process-                3.12 Monitoring
ing or transformation by the organisation (ISO               Observations or measurements to assess whether con-
22000:2005a).                                                trol measures (see 3.7) at a critical point are being
                                                             effectively implemented (http://www.qsae.org/web
                                                             en/pdf/HACCPImpGuide.pdf).
3.6 Flow diagram
A diagram which identifies process steps, inputs and
outputs (materials), sequential relationships (consecu-      3.13 Correction
tive, feedback) and food safety controls (http://www.        Action to eliminate a detected non-conformity (ISO
nzfsa.govt.nz/processed-food-retail-sale/fsp/haccp.          22000:2005a).
pdf).
                                                             3.14 Corrective action
3.7 Control measure                                          Remedial procedures to be followed when a deviation
Any action or activity that can be used to prevent or eli-   occurs. Action to be taken when the results of mon-
minate a food safety hazard (see 3.3) or reduce it to an     itoring indicate a loss of control (http://www.nzfsa.
acceptable level (http://www.codexalimentarius.net/          govt.nz/processed-food-retail-sale/fsp/haccp.pdf).
download/standards/10087/CXC 057 2004e.pdf).
                                                             3.15 Validation
3.8 Prerequisite programme (PRP)
                                                             Validation is the initial phase in which the plan is
Describes all those activities other than specific
                                                             tested and reviewed. The choices made while working
HACCP plans, which affect food safety. Universal
                                                             through the preliminary steps and HACCP principles
steps or procedures that control the operational ac-
                                                             should be repeatedly tested and shown to prevent or
tivities within a food establishment allowing produc-
                                                             control identified hazards in the ‘real world’. In this
tion of safe end food products (see 3.5). Managed and
                                                             phase, microbial or residue testing can be effectively
documented (Griffith, 2006).
                                                             used to verify that the process is in control and is pro-
                                                             ducing acceptable product. Such testing provides clear
3.9 Operational PRP                                          evidence that the techniques and methods adopted by
Operational prerequisite programmes (OPRPs) are              the plant to control hazards are not just effective in the-
prerequisite programmes (PRPs; see 3.8) that are             ory but will work in this specific plant (USDA, 1999).
essential. They are essential because a hazard analysis
has shown that they are necessary in order to control
specific food safety hazards (see 3.3). OPRPs are used        3.16 Verification
to reduce the likelihood that products will be exposed       Application of methods, procedures, tests and other
to hazards, that they will be contaminated, and that         evaluations, in addition to monitoring to determine
hazards will proliferate. OPRPs are also used to reduce      compliance with the HACCP plan (PAHO, 2005).
the likelihood that the processing environment will
be exposed to hazards, that it will be contaminated,         3.17 Updating
and that hazards will proliferate in that environment        Immediate and/or planned activity to ensure ap-
(http://www.praxiom.com/iso-22000-definitions.                plication of the most recent information (ISO
htm).                                                        22000:2005a).
26                        HACCP and ISO 22000 – Application to Foods of Animal Origin

4 Food safety management system (FSMS)                         4.2.2 Control of documents
                                                               Documents required by the FSMS are controlled by
4.1 Establish a FSMS
                                                               documented procedures, which provide for the:
In the food safety management system section, the
emphasis is on establishing, documenting, implement-
                                                               r approval of documents for adequacy prior to issue
ing and maintaining an effective FSMS. This includes
                                                               r review and update as necessary and re-approval of doc-
procedures and records required for ensuring effec-
tive development, implementing and updating the                 uments
                                                               r assurance that occurring changes and the current ver-
FSMS (Pillay and Muliyil, 2005). The organisation
should:                                                         sion status of documents are identified
                                                               r assurance that relevant versions of applicable docu-
                                                                ments are available at points of use
r ensure that food safety hazards that may be reason-          r assurance that documents remain legible and readily
  ably expected to occur in relation to products within         identifiable
  the scope of the system are identified, evaluated and         r assurance that relevant documents of external origin
  controlled                                                    are identified and their distribution controlled and
r communicate appropriate information throughout the           r prevention of the unintended use of obsolete documents
  food chain                                                    and apply suitable identification to them if they are re-
r communicate information concerning development,
                                                                tained for any purpose (ISO 22000:2005a; http://www.
  implementation, and updating FSMS, and                        qualitycouncil.com/samples/iso.pdf).
r evaluate periodically and update the FSMS (ISO
  22000:2005a).
                                                               4.2.3 Control of records
                                                               Records should be established and maintained to pro-
4.2 Document your FSMS                                         vide evidence of conformity to requirements and of
4.2.1 General                                                  effective operation of the FSMS. Records should re-
The operator shall ensure that all documents, records          main legible, readily identifiable and retrievable. A
and data critical to the management of product quality         documented procedure shall be established to define
and safety are in place and effectively controlled. All        the necessary controls for the identification, storage,
documents should be approved, signed and dated by              protection, retrieval, retention time and disposition of
appropriate authorised persons, and kept up-to-date;           records (Arvanitoyannis and Hadjicostas, 2001).
correct versions should be readily available to appro-
priate staff. No documents should be changed without
authorisation (PAHO, 2005). Documentation enables              5 Management responsibility
communication of intent and consistency of action. Its         5.1 Management commitment
use contributes to:                                            Management responsibility outlines the commitment
                                                               of top management to the implementation and main-
r achievement of conformity to customer requirements           tenance of the FSMS (Fig. 1.8). Assigning a food
    and food safety                                            safety system manager and team, setting clear policies,
r   provision of appropriate training                          goals, emergency contingency plans and responsibili-
r   repeatability and traceability                             ties, along with establishment of effective communi-
r   provision of objective evidence and                        cation mechanisms within the organisation and with
r   evaluation of the effectiveness and continuing suitabil-   suppliers or customers are key elements of this clause.
    ity of the FSMS                                            Regularly scheduled management reviews ensure that
    (ISO 9000:2000).                                           top management is made aware of the status of the
                                                               system and that actions are authorised to correct non-
                                                               conformities and continually improve the FSMS (Pillay
The FSMS documentation includes:                               and Muliyil, 2005).
                                                                  Management should demonstrate their commitment
r documented statements of the food safety policy and          to developing and improving their FSMS by:
    related objectives
r documented procedures and records (see 5.2) and              r conducting regular management reviews
r documents to ensure the effective development,               r establishing organisational objectives and food safety
    implementation and updating of the FSMS (ISO                policies
    22000:2005a).                                              r ensuring the availability of necessary resources and
                          HACCP and ISO 22000 – A Comparison of the Two Systems                                       27




Fig. 1.8 Management responsibility. (Adapted from Arvanitoyannis and Hadjicostas, 2001; Tricker, 2001.)


r ensuring that everyone is aware of the importance of       ganisation. The requirement for the policy to be sup-
  meeting customer, regulatory and legal requirements        ported by measurable objectives should provide au-
  (Tricker, 2001).                                           dit evidence of the effectiveness of the policy (IRCA,
Food safety management systems ensure that all food          2005). Top management should ensure that the food
producers:                                                   safety policy:
r comply with the requirements of relevant legislation
r identify all hazards and controls relating to their food    r is appropriate for the purpose of the organisation in the
  business, e.g. temperature control, microbiological,            food chain
  chemical or physical contamination
                                                              r conforms with statutory and regulatory requirements,
r identify points in the food process that are critical to        and with agreed food safety requirements for the cus-
  food safety and                                                 tomers
r put in place control and monitoring procedures at these     r   is communicated, implemented and maintained at all
  points (University of Sussex, 2006).                            levels of organisation
                                                              r   is reviewed for continuing suitability (see 5.8)
5.2 Establish food safety policy
                                                              r   addresses communication (see 5.6) and
The food safety intentions of top management need to
                                                              r   is supported by measurable objectives (ISO
be documented and communicated throughout the or-                 22000:2005a).
28                     HACCP and ISO 22000 – Application to Foods of Animal Origin

5.3 Planning of FSMS                                        r non-governmental organisations
Top management should ensure that:                          r the media and
                                                            r stockholders (Culley, 1998).
r planning of the FSMS is carried out towards meeting
  requirements explained in 4.1 as well as the objectives   5.6.2 Internal communication
  of the organisation that support food safety and          It is the responsibility of top management to facilitate
r the integrity of the FSMS is maintained when changes to   the communication processes within the organisation
  the food safety management system are planned and im-     (Fig. 1.9; Arvanitoyannis and Hadjicostas, 2001). In-
  plemented (http://www.bsiamericas.com/Food/Update/        ternal communication should be from the ‘top down’
  BackIssues/December2006.xalter).                          – from the highest manager within the organisation
                                                            down to the production worker who is at the heart
5.4 Clarify your FSMS responsibilities and                  of making the product (Culley, 1998). The food safety
authorities                                                 team should be informed including the following:
Top management should ensure that responsibilities
and authorities are defined and communicated within          r   products or new products
the organisation to ensure the effective operation and      r   raw materials, ingredients and services
maintenance of the FSMS. All personnel should have          r   production systems and equipment
responsibility to report problems with the FSMS to          r   production premises, location of equipment, surround-
identified person(s). Designated personnel should have           ing environment
defined responsibility and authority to initiate and         r   cleaning and sanitation programmes
record actions (ISO 22000:2005a).                           r   packaging storage and distribution systems
                                                            r   personnel qualification levels and/or allocation of re-
5.5 Appoint a food safety team leader                           sponsibilities and authorisations
A food safety team leader performs a similar role in an     r   statutory and regulatory requirements
FSMS to that provided by the management representa-         r   knowledge regarding food safety hazards and cont-
tive in a Quality Management System (QMS) although              rol
the establishment of a food safety team of two or more      r   customer, sector and other requirements that the organ-
people is also required. The team leader’s role should          isation considers necessary
be known throughout the organisation (IRCA, 2005).          r   relevant enquiries from external interested parties
Top management appoints a food safety team leader           r   complaints indicating food safety hazards associated
who shall have the responsibility and authority:                with the product and
                                                            r   other conditions that have an impact on food safety and
r to manage a food safety team (see 7.3.2) and organise         quality (ISO 22000:2005a;
 its work                                                       http://bis.org.in/sf/fad/FAD15(1681).pdf).
r to ensure relevant training and education of the food
 safety team members (see 6.2.1)
r to ensure that the food safety management system is
                                                            5.7 Emergency preparedness and response
  established, implemented, maintained and updated and      A risk management approach will be normally adopted
r to report to the organisation’s top management on the
                                                            when implementing this clause, based on the risk of
  effectiveness and suitability of the FSMS (http://www.    compromising food safety during emergency incidents.
  bsiamericas.com/Food/Update/BackIssues/                   Auditors should be familiar with the concepts used
  February2007.xalter).                                     to determine risk levels, taking into account such fac-
                                                            tors as incident severity, duration, likelihood of occur-
5.6 Establish your communication                            rence and the degree of control already in place. In
5.6.1 External communication                                addition to the identified risk levels, auditors should
The organisation should establish, implement and            focus on the process for identifying risks and deter-
maintain effective arrangements for communicating           mining any necessary responses from a food safety
with:                                                       standpoint (IRCA, 2005). Emergency situations may
                                                            include, for example, fire, flooding, food contamina-
r suppliers and vendors                                     tion, poisoning, bio-terrorism, sabotage, energy fail-
r customers                                                 ure, vehicle accidents and contamination of the envi-
r regulatory agencies                                       ronment (http://bis.org.in/sf/fad/FAD15(1681).pdf).
                         HACCP and ISO 22000 – A Comparison of the Two Systems                                   29




Fig. 1.9 Example for communication within the food chain (arrows indicate interactive communication; Faergemand and
Jespersen, 2004; ISO 22000:2005a).

  This requirement is also found in ISO 14001. The          r emergency system evaluations and surveys
preparation for accidents or emergencies can be man-        r training of the appropriate personnel
aged through:                                               r staff or department meetings to keep personnel aware
                                                              of their responsibilities and roles and
r orientation of classes for new employees                  r emergency scenarios and the implementation of prac-
r hazard evaluations                                          tice drills (Culley, 1998).
30                        HACCP and ISO 22000 – Application to Foods of Animal Origin

Response actions include all those activities that oc-          Scheduled, documented training and evaluations of
cur from the initial report of the incident through             key personnel and provision of a safe work environ-
the decontamination and equipment clean-up phases               ment and infrastructure are crucial to the continuity of
of the incident. The focus of response actions is to            system. This section is addressed under resource man-
stabilise, confine, contain and control the release of           agement (Fig. 1.11; Pillay and Muliyil, 2005).
hazardous materials, transfer and recover materials,
prevent unnecessary damage and stabilise the situation          6.2 Provide adequate human resources
for the final clean-up operations (Ritchie and Hayes,            6.2.1 General
1998).                                                          The food safety team and other personnel carrying out
                                                                activities having an impact on food safety should be
5.8 Review of management                                        competent and have appropriate education, training,
5.8.1 General                                                   skills and experience. Where the assistance of external
Management shall review, at defined intervals, the               experts is required for the development, implementa-
continuing suitability and effectiveness of quality and         tion, operation or assessment of the FSMS, records
safety management systems. This review shall include            of agreement or contracts defining the responsibil-
assessing opportunities for improvement and the need            ity and authority of experts should be available (ISO
for changes to the quality and safety management sys-           22000:2005a).
tems (PAHO, 2005). Records from management re-
views should be maintained (see 4.2.3) (Arvanitoyan-            6.2.2 Competence, awareness and training
nis and Hadjicostas, 2001).                                     The organisation is responsible for ensuring that all
                                                                personnel are trained and experienced to the extent
5.8.2 Review input                                              necessary to undertake their assigned activities and
The input to management review should include cur-              responsibilities effectively. Thus, whenever training
rent performance and improvement opportunities re-              needs have been identified, top management should
lated to the following:                                         endeavour to make the relevant training available and
                                                                full records should be maintained of all training un-
r results of external audits or inspections                     dertaken by employees (Tricker, 2001).
r customer feedback (see 5.6.1)                                    The organisation should:
r emergency situations, accidents (see 5.7) and with-
    drawals (see 7.10.4)                                        r determine the necessary competencies for personnel
r   analysis of results of verification activities (see 8.4.3)    performing work affecting food safety
r   follow-up actions from previous management reviews          r provide training
r   changes possibly affecting the FSMS (see 5.6.2) and         r assess the effectiveness of the actions taken
r   reviewing results of system updating activities (see        r make sure its personnel are aware of their activities and
    8.5.2) (ISO 22000:2005a; Tricker, 2001).                      its importance for the achievement of the food safety
                                                                  objectives and
5.8.3 Review output
                                                                r keep appropriate records of training, skills and experi-
The output from the management review should in-                  ence (Arvanitoyannis and Hadjicostas, 2001).
clude decisions and actions related to:
                                                                6.3 Provide adequate infrastructure
r   assurance of the food safety (see 4.1)                      The organisation shall determine, provide and main-
r   improvement of FSMS effectiveness (see 8.5)                 tain the required infrastructure for:
r   resource needs (see 6.1) and
r   revisions of the organisation’s food safety policy and      r workplace and associated facilities
    related objectives (see 5.2; ISO 22000:2005a).              r process equipment (both software and hardware) and
                                                                r supporting services (such as transport or communi-
                                                                 cation; Arvanitoyannis and Hadjicostas, 2001; http://
6 Resources management                                           www.qualitycouncil.com/samples/iso.pdf).
6.1 Providing of adequate resources
An effectively implemented FSMS requires that top               6.4 Provide adequate work environment
management provide adequate resources, budgets and              The organisation identifies and manages the human
personnel to effectively run the system (Fig. 1.10).            factors (e.g. work methodologies, achievement and
                          HACCP and ISO 22000 – A Comparison of the Two Systems                                    31




Fig. 1.10 Various types of resources (adapted from Tricker, 2001).



involvement opportunities, safety rules and guidance,         recall procedures) are required that address general re-
ergonomics etc.) and physical factors (e.g. light,            quirements to provide a foundation for the production
hygiene, vibration, noise, humidity, pollution, heat,         of safe food (Fig. 1.12; Pillay and Muliyil, 2005).
cleanliness and air flow) of the work environment
needed to achieve conformity of the product (http://          7.2 Establish prerequisite programmes (PRPs)
www.qualitycouncil.com/samples/iso.pdf;       Tricker,        Basic prerequisite programmes should be in place to:
2001).
                                                              r protect products from contamination by biological,
                                                                chemical and physical food safety hazards
7 Planning and realisation of safe product                    r control bacterial growth that can result from tempera-
7.1 General                                                     ture abuse and
                                                              r maintain equipment (FDA, 2006).
Planning and realisation of safe products incorporate
the elements of GMP and HACCP, including any regu-
latory requirements applicable to the organisation and        The existence and effectiveness of prerequisite pro-
processes. Adequate prerequisite programmes (e.g.             grammes should be assessed during the design and
training, sanitation, maintenance, traceability, sup-         implementation of each HACCP plan. All prerequi-
plier review, control of non-conforming product and           site programmes should be documented and regularly
32                     HACCP and ISO 22000 – Application to Foods of Animal Origin




Fig. 1.11 Resource management (Arvanitoyannis and Hadjicostas, 2001; Tricker, 2001).


audited. Prerequisite programmes are established           7.3.2 Food safety team
and managed separately from the HACCP plan                 In addition to the final resources needed to fund a team
(FDA/USDA/NACMCF, 1997). A tree diagram of pre-            of competent managers and specialists, it may prove
requisite programmes according to ISO 22000 is pre-        difficult to find appropriate training and recruit ex-
sented in Fig. 1.13.                                       perts. Nevertheless, an organisation can find a solution
  PRPs should:                                             such as:

r be appropriate to organisation’s needs with regard to     r exchanging or sharing HACCP team members
                                                            r integrating supplier or client experts into the team and
 food safety
r be appropriate to the size and type of the operation,     r using e-learning when the required vocational training
  and the nature of products being manufactured and/or       is not available in appropriate timeframes, locations or
  handled                                                    quality
r be implemented to the entire production system and         (Blanc, 2006).
r be approved by the food safety team
  (ISO 22000:2005a).
                                                           7.3.3 Product characteristics
7.3 Primary levels of hazard analysis materialisation      7.3.3.1 Raw materials, ingredients and product-
7.3.1 General                                              contact materials
The origin of the raw materials, ingredients and prod-     All raw materials, ingredients and product-contact
uct contact materials should be taken into account         materials shall be described in documents as appro-
when they might impact on the evaluation of the occur-     priate:
rence of hazards and the levels of these hazards. The
information to be taken into account may be differ-         r biological, chemical and physical characteristics
ent from the original information required to maintain      r composition of formulated ingredients, including addi-
traceability (ISO 22000:2005b).                              tives and processing aids
                            HACCP and ISO 22000 – A Comparison of the Two Systems                                     33




Fig. 1.12 Planning and realisation of safe product (Arvanitoyannis and Hadjicostas, 2001; Tricker, 2001).



r   origin                                                     r preparation and/or handling before use or processing
r   method of production                                         and
r   packaging and delivery methods                             r food safety-related acceptance criteria or specifications
r   storage conditions and shelf life                            of purchased materials and ingredients appropriate
34                     HACCP and ISO 22000 – Application to Foods of Animal Origin




Fig. 1.13 Tree diagram for determination of prerequisite programmes according to ISO 22000.
                             HACCP and ISO 22000 – A Comparison of the Two Systems                                    35

    to their intended uses (http://bis.org.in/sf/fad/FAD15   be described. The requirements should be described
    (1681).pdf; ISO 22000:2005a).                            (ISO 22000:2005a).

7.3.3.2 Characteristics of end products                      7.4 Carry out hazard analysis
Characteristics of end products should be described          7.4.1 General
including the following information:                         The hazard analysis for a specific food consists of a
                                                             systematic evaluation of all raw materials, ingredients
r product name or similar identification                      and production steps; identification of hazards that
r composition                                                are likely to occur; and consideration of control or
r biological, chemical and physical hazard specification      preventive measures for hazards (Corlett, 1998).
r intended shelf life and storage conditions
r packaging labelling relating to food safety and/or in-     7.4.2 Hazard identification and determination of
  structions for handling, preparation and usage and         acceptable levels
r methods of distribution                                    Food safety hazards identification should be based on:
  (ISO 22000:2005a).
                                                             r preliminary information and data collected (see 7.3)
7.3.4 Intended use                                           r experience
Intended use should indicate whether the product is          r external information (epidemiological and other histor-
to be sold at retail, to food service or as an ingredi-          ical data) and
ent for another food item (Harris, 1999). The HACCP          r information from the food chain on food safety haz-
team should specify where the product will be sold,              ards that may be of relevance for the safety of the end
as well as the target group, especially if it happens            products, intermediate products and the food at con-
to be a sensitive portion of the population (i.e. el-            sumption (ISO 22000:2005a).
derly, immune-suppressed, pregnant women, and in-
fants; FAO, 1998).                                           The acceptable level in the end product should be de-
                                                             termined through:
7.3.5 Flow diagrams, process steps and control
measures                                                     r objectives, targets or end product criteria established by
7.3.5.1 Flow diagrams                                            statutory and regulatory authorities
                                                             r specifications or other information communicated by
Flow diagrams should be clear, accurate and suffi-
ciently detailed. Flow diagrams should include the fol-        the organisation representing the subsequent step in the
lowing:                                                        food chain and
                                                             r the maximum levels found by the food safety team tak-
r the sequence and interaction of all steps in the             ing into account acceptable levels agreed on with the
                                                               customer and/or according to law, scientific literature
    operation
r any outsourced processes and subcontracted work              and professional experience (ISO 22000:2005b).
r where raw materials, ingredients and intermediate
    products enter the flow                                   7.4.3 Hazard assessment
r where reworking and recycling take place by products       Hazard assessment serves to determine which of the
r where end products, intermediate products and waste        potential hazards identified require specific control
    are released or removed and                              measures. To ensure such control, the standard re-
r pH and water activity during processing of food            quires the selection of (or combination of) control mea-
    (http://bis.org.in/sf/fad/FAD15(1681).pdf; ISO 22000:    sures (see 7.4.4; Blanc, 2006). In conducting the hazard
    2005a).                                                  assessment, the following should be taken into consid-
                                                             eration:
7.3.5.2 Description of process steps and control
measures
                                                             r   the sources of the hazard
The existing control measures should be described to
                                                             r   the probability of occurrence of the hazard
the extent needed to conduct the hazard analysis (see
                                                             r   the nature of the hazard and
7.4). External requirements (e.g. from regulatory au-
                                                             r   the severity of the adverse health effects that can be
thorities or customers) that may impact the choice and           caused by the hazard
the rigorousness of the control measures should also             (ISO 22000:2005b).
36                      HACCP and ISO 22000 – Application to Foods of Animal Origin

7.4.4 Selection and assessment of control measures             7.6 Establish HACCP plan
The selection and categorisation of control measures           7.6.1 HACCP plan
should be carried out according to:                            The initial focus of the HACCP coordinator and
                                                               the team is the development of the HACCP plan or
r the effect on identified food safety hazards                  plans for specific food products (Corlett, 1998). On
r the feasibility for monitoring                               the identification of the highest risks to food safety
r the place within the system relative to other control        within the hazard analysis, the HACCP plan becomes
                                                               the blueprint for their control in the production/
 measures
r the likelihood of failure or significant processing vari-     processing/service processes being audited. The audi-
                                                               tor does not need to be a HACCP expert but can eval-
 ability
r the severity of the consequences in case of failure          uate the process from decision making in the hazard
r whether the control measure is established and applied       analysis through the determination of control param-
                                                               eters including identification of critical control points
 to eliminate or reduce hazards and
r synergistic effects                                          (CCPs). Given the importance of this methodology to
                                                               the FSMS, the auditor should allocate a good propor-
 (ISO 22000:2005a).
                                                               tion of the audit duration to its evaluation (IRCA,
                                                               2005). The HACCP plan should include the follow-
The following may guide the organisation in the cate-          ing information for each identified CCP:
gorisation process:
                                                               r food safety hazards to be controlled at CCP (see 7.4.4)
                                                               r control measures (see 7.4.4)
r the impact of a control measure on the hazard level          r critical limits (CLs; see 7.6.3)
  (the higher impact there is, the more likely the control     r monitoring procedures (see 7.6.4)
  measure belongs to the HACCP plan)                           r corrections and corrective actions if critical limits are
r the severity on consumer health of a hazard that the
                                                                 not in control (see 7.6.5)
  measure is selected to control (the more severe it is, the   r responsibilities and authorities and
  more likely it belongs to the HACCP plan) and                r records of monitoring
r the need for monitoring (the more pressing the need,
                                                                 (ISO 22000:2005a).
  the more likely it belongs to the HACCP plan)
  (ISO 22000:2005b).                                           7.6.2 Identification of CCPs
                                                               CCPs may be located at any point in the food pro-
7.5 Establish operational prerequisite programmes              duction and manufacturing system for a food product
One of the outputs of the hazard analysis is the de-           where hazards need to be either prevented, eliminated
termination of operational PRPs. This sets up preven-          or reduced to acceptable levels (Corlett, 1998). The
tion and control measures which deal with food safety          identification of CCPs has two consequences for the
risk levels somewhat below those which need to be              HACCP team which should then:
included in the HACCP plan. Auditors should exam-
                                                               r ensure that appropriate control measures are effectively
ine the decision-making process at the hazard analysis
stage as well as how the necessary control and mon-              designed and implemented. In particular, if a hazard has
itoring activities for operational PRPs are determined           been identified at a step where control is necessary for
(IRCA, 2005). The operational PRPs should include                product safety and no control measure exists at that
the following information for each programme:                    step, then the product or process should be modified
                                                                 at that step or at an earlier or later stage, to include a
                                                                 control measure, and
r food safety hazards to be controlled (see 7.4.4)             r establish and implement a monitoring system per criti-
r control measures (see 7.4.4)
                                                                 cal point (Commission of the European Communities,
r monitoring procedures that demonstrate that opera-
                                                                 2005).
 tional PRPs are implemented
r corrections and corrective actions if operational PRPs
                                                               CCPs should be carefully identified and documented.
  are not in control (see 7.10.1 and 7.10.2, respectively)     They should be used only for purposes of product
r responsibilities and authorities and
                                                               safety or where use should be justified by the critical
r records of monitoring
                                                               nature of the CCP. CCPs should not be confused with
  (ISO 22000:2005a; http://bis.org.in/sf/fad/FAD15(1681).      control points that do not control safety but refer to
  pdf).                                                        quality issues (Corlett, 1998).
                             HACCP and ISO 22000 – A Comparison of the Two Systems                                   37

7.6.3 Determination of critical limits for CCPs             7.8 Verification planning
The establishment of critical limits succeeds the iden-     This clause sets in place those monitoring arrange-
tification of all factors associated with CCPs. Scientif-    ments at the process level which are designed to pro-
ically determined critical limits levels are established    vide assurance that the FSMS is performing effectively
for all the identified factors and components causing        on a daily basis. The food safety team is involved in re-
an unacceptable consumer health risk (Arvanitoyannis        sult evaluation (see 8.4.2) and failures are to be dealt
and Hadjicostas, 2001).                                     with through the potentially unsafe product disposi-
                                                            tion process (see 7.10.3). As with several other sec-
7.6.4 System for monitoring results exceed critical         tions of the standard, this clause is best audited as part
limits                                                      of a process audit of the verification processes in the
Most monitoring procedures for CCPs should pro-             FSMS (IRCA, 2005). The verification activities should
vide real-time information related to on-line processes.    confirm that:
Furthermore, monitoring should provide this informa-        r PRPs are properly implemented (see 7.2)
tion in time to make adjustments to ensure control          r input to the hazard analysis (see 7.3) is continually up-
of the process to prevent violating the critical limits.
Therefore, there may not be time for lengthy analytical       dated
                                                            r operational PRPs (see 7.5) and HACCP plan (see 7.6.1)
testing. Physical and chemical measurements that give
information about the degree of microbiological con-          are implemented and effective
                                                            r hazard levels are within the acceptable levels (see 7.4.2)
trol are often preferred to microbiological testing be-
cause they can be done rapidly (ISO 22000:2005b).             and
                                                            r other procedures required by the organisation are im-
The monitoring system should consist of procedures,
instructions and records that cover:                          plemented and effective (ISO 22000:2005a).

                                                            7.9 Establish a product traceability system
r measurements or observations                              A traceability system is mandatory in ISO 22000 but
r monitoring devices                                        happens to be a common process in the food indus-
r calibration methods (see 8.3)                             try, often as a result of legislation. The auditor should
r monitoring frequency                                      check the batch and/or lot identification in records
r responsibility and authority related to monitoring and    maintained throughout the process from material re-
  evaluation of monitoring results and                      ceipt to end product dispatch. Note that the organi-
r record requirements and methods
                                                            sation needs to define a retention period for traceabil-
  (ISO 22000:2005a).                                        ity records which is related to system assessment and
                                                            considers the implications for disposition of poten-
7.6.5 Action when monitoring results exceed critical        tially unsafe products and product withdrawal (IRCA,
limits                                                      2005).
The critical limits are set at a point where the products
become unsafe. In practice, therefore, it is common to      7.10 Non-conformity control
work against limits that give an early warning that a       7.10.1 Corrections
process might become out of control. The organisation       The organisation should ensure that product which
may choose whether any actions are going to be taken        does not conform to product requirements is iden-
when exceeding warning limits (ISO 22000:2005b).            tified and controlled to prevent its unintended use
                                                            or delivery. The controls and related responsibilities
                                                            and authorities for dealing with non-conforming prod-
7.7 Updating of documents and primary knowledge
                                                            uct shall be defined in a documented procedure (ISO
in determined operational PRPs and HACCP plan
                                                            9001:2000). A documented procedure should be es-
The organisation should update the operational PRPs
                                                            tablished and maintained defining:
and HACCP plan, if necessary:
                                                            r the identification and assessment of affected end prod-
r   product characteristics (see 7.3.3)                       ucts to determine their proper handling (see 7.10.3)
r   intended use (see 7.3.4)                                  and
r   flow diagrams (see 7.3.5.1)                              r a review of corrections carried out (ISO 22000:2005a).
r   process steps (see 7.3.5.2) and
r   control measures (see 7.3.5.2)                          When non-conforming product is corrected, it shall be
    (ISO 22000:2005a).                                      subject to re-verification to demonstrate conformity
38                      HACCP and ISO 22000 – Application to Foods of Animal Origin

to the requirements. When non-conforming product               7.10.3.3 Disposition of non-conforming products
is detected after delivery or use has started, the or-         Following evaluation, if the lot of product is not ac-
ganisation shall take action appropriate to the effects,       ceptable for release it shall be handled by one of the
or potential effects, of the non-conformity (ISO 9001:         following activities:
2000).
                                                               r reprocessing or further processing within or outside the
                                                                 organisation to ensure that the food safety hazard or
7.10.2 Corrective actions
                                                                 parameters not within specified limit, are eliminated or
Once the non-conformance has been identified, the
                                                                 reduced to acceptable levels and
next step is to initiate the corrective action process         r destruction and/or disposal as waste. Inadvertent use
(Culley, 1998). A documented procedure shall be es-
                                                                 of such material shall be prevented (http://bis.org.in/sf/
tablished to define requirements for:
                                                                 fad/FAD15(1681).pdf).

r reviewing non-conformities (including customer com-          7.10.4 Withdrawals
    plaints)                                                   To enable and facilitate the complete and timely with-
r   determining the causes of non-conformities                 drawal of lots of end products which have been iden-
r   evaluating the need for action to ensure that non-         tified as unsafe:
    conformities do not recur
r   implementing corrective action required                    r top management should appoint personnel having the
r   recording results of action taken (see 4.2.4) and            authority to initiate a withdrawal and personnel re-
r   reviewing corrective action taken                            sponsible for executing the withdrawal and
    (Tricker, 2001).                                           r the organisation should establish and maintain a docu-
                                                                 mented procedure for:
                                                                (a) notification to relevant interested parties (e.g. statu-
7.10.3 Handling of potentially unsafe products                      tory and regulatory authorities, customers and/or
7.10.3.1 General                                                    consumers)
The organisation should deal with non-conforming                (b) handling of withdrawn products as well as affected
product by one or more of the following ways:                       lots of the products still in stock and
                                                                (c) the sequence of actions to be taken (http://bis.org.in/
                                                                    sf/fad/FAD15(1681).pdf; ISO 22000:2005a).
r by taking action to eliminate the detected non-
    conformity
r by authorising its use, release or acceptance under con-     8 Validation, verification and improvement of FSMS
  cession by a relevant authority and, where applicable,       8.1 General
  by the customer                                              In order to maintain and demonstrate the effective-
r by taking action to preclude its original intended use or
                                                               ness of the FSMS, the organisation should validate
  application                                                  that all assumptions used within the system are sci-
  (ISO 9001:2000).                                             entifically sound. In addition, the organisation should
                                                               plan, conduct and document regular verification of all
7.10.3.2 Evaluation for release                                components of the system to evaluate whether or not
Each lot of product affected by the non-conformity             the system is operating as designed or if modifications
should be released as safe when:                               are needed. The verification should also form part of a
                                                               continual improvement process whereby the organisa-
                                                               tion reviews verification. This section is covered under
r there is an evidence that the control measures have been     validation, verification and improvement of the FSMS
    effective                                                  (Fig. 1.14; Pillay and Muliyil, 2005).
r there is evidence that the combined effect of the control
  measures for that particular product complies with the       8.2 Validation of food safety control measure
  performance intended (see 7.4.2) and                         combinations
r the results of sampling, analysis and/or other verifica-      Validation of control measure combinations, basically
  tion activities demonstrate that the affected lot of prod-   a new requirement introduced by ISO 22000 that
  uct complies with the acceptable levels for the food         relates to the control measures addressing hazards
  safety hazards concerned                                     having been assessed as needing control, control
  (ISO 22000:2005a).                                           measures that should then be validated before being
                          HACCP and ISO 22000 – A Comparison of the Two Systems                                        39




Fig. 1.14 Validation, verification and improvement of FSMS (Arvanitoyannis and Hadjicostas, 2001; Tricker, 2001).


implemented (Blanc, 2006). Steps prior to validation          8.3 Control of monitoring and measuring
include:                                                      This clause addresses the need for known accuracy of
                                                              measuring equipment and aligns with the correspond-
r identify the food safety hazards that are intended to be    ing requirement in ISO 9001. Note that it applies only
  controlled                                                  to monitoring and measuring of parameters used in
r identify the food safety outcome required                   the FSMS in relation to food safety. Standards used
r identify the necessary control measures and determine       for calibration should reflect the way the equipment is
  which are to be validated                                   used (IRCA, 2005). Where necessary to ensure valid
r identify whether the control measure has previously         results, measuring equipment should be:
  been appropriately validated or whether its perfor-
  mance is so well established for the application            r calibrated or verified at specified intervals against inter-
  and                                                          national or national measurement standards
r if necessary, prioritise control measures to be validated   r adjusted or re-adjusted
  (FAO/WHO, 2006b).                                           r identified to enable the calibration status to be deter-
                                                               mined
The organisation should validate (see 3.15) that:             r safeguarded from adjustments that would impair the
                                                               measurement and
r the selected control measures are capable of achieving      r properly handled, maintained and stored
  the intended control of food safety hazards and              (Arvanitoyannis and Hadjicostas, 2001).
r the control measures are effective and capable of en-
  suring control of the identified food safety hazards to      8.4 Verification of FSMS
  obtain end products that meet the defined acceptable         8.4.1 Internal audit
  levels                                                      The organisation should audit those systems and pro-
  (ISO 22000:2005a).                                          cedures, which are critical to product safety, legality
40                      HACCP and ISO 22000 – Application to Foods of Animal Origin

and quality, to ensure they are in place, appropriate         8.4.3 Analysis of results of verification activities
and complied with (http://www.pasa.doh.gov.uk/food/           Verification activities are carried out by individuals
docs/code of practice 2001.pdf). Each procedure is            within a company, third-party experts and regulatory
audited separately, products are audited, processes are       agencies. It is important that individuals doing veri-
audited and records are audited. All of these audits          fication have appropriate technical expertise to per-
are planned out only as far as the next audit – the fre-      form this function (microhttp://www.nzfsa.govt.nz/
quency is varied to suit the level of confidence in the        processed-food-retail-sale/fsp/haccp.pdf). The asses-
area being audited. Because the audits are small, less        sor should consider what, how, when and by whom
trained staff can be used, and this in turn reduces the       the verification procedures have been undertaken, and
negative connotations of an internal audit (since now         whether these are adequate and effective. This may
almost anyone can be used as an auditor). Periodi-            be indicated by an assessment of the validation data,
cally, a full internal audit is carried out to ensure that    sampling results, internal and external audit documen-
the overall system still complies with the standard (de-      tation as well as the frequency and thoroughness of all
Beer, 1993). The schedule for conducting internal au-         verification activities (Motarjemi, 2000). The analysis
dits shall be documented and include planning, reports        of results of verification activities should be carried out
and improvements. The detailed auditing programme             in order:
should include as a minimum:
                                                              r to confirm that the overall performance of the system
r preparation and issuing of audit plans                          meets the planned arrangements and FSMS require-
r scope of the audits                                             ments
r frequency of the audits                                     r   to identify the need for updating or improving the FSMS
r methods for conducting the audits                           r   to identify trends that indicate a higher incidence of
r reporting of findings                                            potentially unsafe products
r distribution of reports                                     r   to establish information for planning of the internal
r implementation of corrective actions and follow-up ac-          audit and
  tivities and                                                r   to provide evidence that any corrections and corrective
r selection and training of competent auditors (PAHO,             actions are effective (ISO 22000:2005a).
  2005).
                                                              8.5 Improvement
The organisation shall conduct internal audits at             8.5.1 Continual improvement
planned intervals to determine whether the FSMS:              By conducting routine internal audits and monitoring,
                                                              it will become evident that the policy, objectives, tar-
r complies with the planned arrangements, to the FSMS         gets and plans will have to be modified. Continual im-
                                                              provement is not really a last step but an integral part
  requirements established by the organisation, and to the
                                                              of every step in environmental management whether
  requirements of this International Standard and
r is effectively implemented and maintained                   it is mentioned or not (Lee Kuhre, 1995). Actions for
                                                              improvement include the following:
  (Arvanitoyannis and Hadjicostas, 2001).
                                                              r analysing and evaluating the existing situation to iden-
8.4.2 Evaluation of individual verification results              tify areas for improvement
If verification does not demonstrate conformity with           r establishing the objectives for improvement
the planned arrangements, the organisation should             r searching for possible solutions to achieve the objectives
take action to achieve the required conformity. Such          r evaluating these solutions and making a selection
actions should review:                                        r implementing the selected solution
                                                              r measuring, verifying, analysing and evaluating results
r existing procedures and communication channels (see           of the implementation to determine that the objectives
    5.6 and 7.7)                                                have been met and
r conclusions of the food safety hazard analysis (see 7.4),   r formalising changes
  established operational PRPs (see 7.5) and HACCP plan         (ISO 9000:2000).
  (see 7.6.1)
r PRPs (see 7.2) and
                                                              Management should ensure that the organisation
r effectiveness of human resource management and train-
                                                              continually improves the effectiveness of the FSMS
  ing activities (see 6.2; ISO 22000:2005a).                  through:
                             HACCP and ISO 22000 – A Comparison of the Two Systems                                         41

r   communication (see 5.6)                                       ISO/TS        ISO Technical Specification
r   management review (see 5.8)                                   MF            Microfiltration
r   internal audit (see 8.4.1)                                    NF            Nanofiltration
r   evaluation of individual verification results (see 8.4.2)      OPRPs         Operational prerequisite programmes
r   analysis of results of verification activities (see 8.4.3)     PRPs          Prerequisite programmes
r   validation of control measure combinations (see 8.2)          QMS           Quality management system
r   corrective actions (see 7.10.2) and                           RO            Reverse osmosis
r   FSMS updating (see 8.5.2)                                     SLDBs         Small and/or less developed businesses
    (ISO 22000:2005a).                                            TBT           Technical Barriers to Trade
                                                                  TQM           Total quality management
8.5.2 Updating of FSMS                                            TQS           Total quality system
Frequently upgrading the entire system will keep it               UF            Ultrafiltration
cost-effective and impacts will be reduced to the max-            WTO           World Trade Organisation
imum extent possible (Lee Kuhre, 1995). This clause
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                       2
     A Summary of EU, US and Canadian
   Legislation Relating to Safety in Foods of
                Animal Origin
                 Ioannis S. Arvanitoyannis and Persefoni Tserkezou



2.1 INTRODUCTION                                                  tered the carcasses of said cattle, sheep, swine, goats,
                                                                  horses, mules or other equines shall be subject to
Fundamentals of the science and technology are asso-              a careful examination and inspection, all as pro-
ciated with harvesting, processing, packaging, preser-            vided by the rules and regulations to be prescribed
vation, storage, distribution, marketing and safety of            by the Secretary (http://www .washingtonwatch-
food products of commerce (http://www.fst.vt.edu/                 dog.org/documents/usc/index.html).”
undergraduate.courses.html). Milk and milk products
for import into the European Union (EU) must fulfil                 The ‘fork-to-farm’ philosophy underlines the fact
certain basic animal health criteria. This ensures              that the quality and safety of food for those who eat it
that milk and a milk product also conform to the                is a major priority for the industry. Research is focused
animal health requirements laid down in legislation             on making food as safe and clean as possible. However,
and is intended to safeguard animal health in the EU.           these high standards may not be easy to meet in other
Legislation lays down sensory attributes of milk and            parts of the world (http://wyomcases.courts.state.wy.
dairy products important in evaluation and judging              us/applications/oscn/DeliverDocument.asp?CiteID=
product quality. It is also related to production and           205731).
processing methods affecting milk and dairy prod-
uct quality as determined by organoleptic evaluation            2.2 EU LEGISLATION FOR FOOD OF ANIMAL
(http://europa.eu.int/comm/food/animalproducts/milk/                ORIGIN
index en.htm).
                                                                2.2.1 Controls and food hygiene rules
  “Examination of animals before slaughtering; dis-             The Directive 85/591/EEC (entry into force 23/12/
  eased animals slaughtered separately and carcasses            1987) claims that the sampling and analysis are nec-
  examined. For the purpose of preventing the use in            essary because of the following criteria: (a) the need
  commerce of meat and meat food products which                 to ensure that Community law is uniformly applied,
  are adulterated, inspectors appointed for that pur-           (b) the existence of barriers to intra-Community trade
  pose, an examination and inspection of all cat-               and (c) the permanent or recurrent nature of the cri-
  tle, sheep, swine, goats, horses, mules and other             teria. The Directive shall take account of the state
  equines before they shall be allowed to enter into            of scientific and technical knowledge, in particular of
  any slaughtering, packing, meat-canning, rendering            proven methods of sampling and analysis. The intro-
  or similar establishment, in which they are to be             duction of the measures shall not preclude Member
  slaughtered and the meat and meat food products               States from using other tested and scientifically valid
  thereof are to be used in commerce; and all cat-              methods provided that this does not hinder the free
  tle, sheep, swine, goats, horses, mules and other             movement of products recognised as complying with
  equines found on such inspection to show symp-                the rules by virtue of Community methods. The meth-
  toms of disease shall be set apart and slaughtered            ods of analysis introduced shall comply with the cri-
  separately from all other cattle, sheep, swine, goats,        teria set out above. Where a Member State has de-
  horses, mules or other equines, and when so slaugh-           tailed evidence that a measure adopted in accordance

                                                           46
                          EU, US and Canadian Legislation Relating to Safety in Foods                              47

with the Directive is inappropriate in a particular case     process certain foodstuffs and (10) training of food
for technical reasons or because it is insufficiently         workers.
conclusive for the examination of an important health           In Directive 93/99/EEC (entry into force 1/5/1995),
question, that Member State may temporarily suspend          the laboratory assessment becomes very clear since
the measure in question in its territory but only for that   Member States shall (a) apply the criteria laid down
particular case. It shall immediately inform the other       in European Standard EN 45002 and (b) require the
Member States and the Commission thereof and give            use of proficiency testing schemes as far as appropriate.
reasons for its decision.                                    The Commission shall appoint and designate specific
   According to the Directive 89/397/EEC (entry into         officials to cooperate with the competent authorities of
force 20/6/1991), ‘official control of foodstuffs’ means      the Member States to monitor and evaluate the equiva-
an inspection by the competent authorities of the com-       lence and effectiveness of official food control systems
pliance: (a) of foodstuffs, (b) of food additives, vita-     operated by the competent authorities of the Member
mins, mineral salts, trace elements and other additives      States. The Commission shall send regular reports to
intended to be sold as such and (c) of materials and ar-     the Member States concerned on the work of its spe-
ticles intended to come into contact with foodstuffs,        cific officials. In criminal proceedings, the information
with provisions aimed at preventing risks to public          can be used only with the prior consent of the sending
health, guaranteeing fair commercial transactions or         Member State in accordance with, for those Member
protecting consumer interests, including provisions on       States who are parties to them, the international con-
consumer information. Control shall comprise one or          ventions and agreements in force on mutual assistance
more of the following operations in accordance with          in criminal affairs. Where a Member State has rules
the conditions laid down in Articles 6–9 and in the          permitting free access by persons to information held
light of the examination to be carried out: (1) inspec-      by competent authorities, this fact must be revealed at
tion, (2) sampling and analysis, (3) inspection of staff     the time of the request to another Member State or
hygiene, (4) examination of written and documentary          during the exchange of information if no such request
material and (5) examination of any verification sys-         occurs. If it is not possible for the receiving Member
tems set up by the undertaking and of the results ob-        State to restrict the giving out of the information in
tained. The following shall be subject to inspection:        this way, it shall not be contrary to the terms of this
(a) the state and use which is made at the different         Directive for the sending Member State to withhold
stages, premises, offices, plant surroundings, means of       the information.
transport, machinery and equipment, (b) raw mate-               Following the Directive 2002/99/EC (entry into
rials, ingredients, technological aids and other prod-       force 1/1/2005; came into force 1/1/2005), products of
ucts used for the preparation and production of food-        animal origin shall be obtained from animals which (a)
stuffs, (c) semi-finished products, (d) finished products,     do not come from a holding, establishment, territory or
(e) materials and articles intended to come into contact     part of a territory subject to animal health restrictions
with foodstuffs, (f) cleaning and maintenance products       applicable to the animals and products concerned, un-
and processes and pesticides, (g) processes used for the     der the rules, (b) in the case of meat and meat products,
manufacture or processing of foodstuffs, (h) labelling       were not slaughtered in an establishment in which an-
and presentation of foodstuffs and (i) preserving            imals infected or suspected of being infected with one
methods.                                                     of the diseases or carcasses or parts thereof of such an-
   In Directive 93/43/EEC (entry into force 14/12/           imals, were present during the slaughtering or produc-
1995), known as the HACCP (Hazard Analysis and               tion process, unless such suspicion has been ruled out,
Critical Control Point) requirements Directive, ‘food        (c) in the case of aquaculture animals and products.
hygiene’ means all measures necessary to ensure the          Laying down lists of the third countries or regions of
safety and wholesomeness of foodstuffs. The mea-             third countries from which imports of specified prod-
sures shall cover all stages after primary produc-           ucts of animal origin are permitted. A third country
tion, during preparation, processing, manufacturing,         shall appear on such lists only if a Community audit
packaging, storing, transportation, distribution, han-       of that country has taken place and demonstrates that
dling and offering for sale or supply to the consumer.       the competent veterinary authority provides appropri-
This Directive sets out the hygiene requirements for:        ate guarantees as regards compliance with Community
(1) food premises, including outside areas and sites,        legislation. Lists of the third countries or regions of
(2) transport conditions, (3) equipment, (4) food            third countries from which imports of specified prod-
waste, (5) water supply, (6) personal hygiene of per-        ucts of animal origin are permitted. A third country
sons in contact with food, (7) food, (8) wrapping and        shall appear on such lists only if a Community audit
packaging, (9) heat treatment, which may be used to          of that country has taken place and demonstrates that
48                      HACCP and ISO 22000 – Application to Foods of Animal Origin

the competent veterinary authority provides appropri-         ucts and certain other products of animal origin), (vi)
ate guarantees as regards compliance with Community           80/215/EEC (animal health problems affecting intra-
legislation. When drawing up or updating those lists,         Community trade in meat products), (vii) 89/362/EEC
particular account shall be taken of (a) the legislation      (general conditions of hygiene in milk production
of the third country, (b) the organisation of the com-        holdings), (viii) 89/437/EEC (hygiene and health prob-
petent veterinary authority and its inspection services       lems affecting the production and the placing on
in the third country, the powers of these services, the       the market of egg products), (ix) 91/492/EEC (lay-
supervision to which they are subject, and the means          ing down the health conditions for the production
at their disposal, including staff capacity, to apply their   and the placing on the market of live bivalve mol-
legislation effectively, (c) the actual animal health re-     luscs), (x) 91/493/EEC (laying down the health con-
quirements applying to the production, manufacture,           ditions for the production and the placing on the
handling, storage and dispatch of products of animal          market of fishery products), (xi) 91/494/EEC (animal
origin intended for the Community, (d) the assurances         health conditions governing intra-Community trade
which the competent veterinary authority of the third         in and imports from third countries of fresh poul-
country can give regarding compliance or equivalence          try meat), (xii) 91/495/EEC (concerning public health
with the relevant animal health conditions, (e) any ex-       and animal health problems affecting the production
perience of marketing the product from the third coun-        and placing on the market of rabbit meat and farmed
try and the results of any import controls carried out,       game meat), (xiii) 92/45/EEC (public health and ani-
(f) the results of Community inspections and/or audits        mal health problems relating to the killing of wild game
carried out in the third country, in particular the re-       meat), (xiv) 92/46/EEC (laying down the health rules
sults of the assessment of the competent authorities or,      for the production and placing on the market of raw
where the Commission so requests, the report submit-          milk, heat-treated milk and milk-based products), (xv)
ted by the competent authorities of the third country         92/48/EEC (laying down the minimum hygiene rules
on the inspections which they have carried out, (g) the       applicable to fishery products caught on board certain
health status of livestock, other domestic animals and        vessels) and (xvi) 94/65/EEC (laying down the require-
wildlife in the third country, with particular regard to      ments for the production and placing on the market of
exotic animal diseases and any aspects of the general         minced meat and meat preparations).
health situation in the country which might pose a risk          A summary of the Directives focused on controls
to public or animal health in the Community, (h) the          and food hygiene rules is given in Table 2.1.
regularity, speed and accuracy with which the third
country supplies information on the existence of in-
fectious or contagious animal diseases in its territory,      2.2.2 Imports from third countries and
particularly the notifiable diseases listed by the World             intra-Community trade; general provisions
Organisation for Animal Health (OIE) or, in the case          The Directive 89/662/EEC (entry into force 22/12/
of diseases of aquaculture animals, the notifiable dis-        1989) claims that for the purposes of this Directive
eases listed in the Aquatic Animal Health Code of the         veterinary check means any physical check and/or ad-
OIE and (i) the rules on the prevention and control           ministrative formality which applies to the products
of infectious or contagious animal diseases in force in       and which is intended for the protection, direct or oth-
the third country and their implementation, including         erwise, of public or animal health. Products not sub-
rules on imports from other countries.                        ject to Community harmonisation are (1) rabbit and
   Directive 2004/41/EC (entry into force 20/5/2004),         game meat, (2) raw milk and milk products, (3) aqua-
repealed certain Directives concerning food hygiene           culture products intended for human consumption,
and health conditions for the production and plac-            (4) fishery products intended for human consumption,
ing on the market of certain products of animal ori-          (5) live bivalve molluscs intended for human consump-
gin intended for human consumption. The Directives            tion, (6) game and rabbit meat products, (7) blood,
which are repealed are (i) 64/433/EEC (health condi-          (8) offal of animal fats, greaves and by-products of
tions of the production and marketing of fresh meat),         rendering, (9) honey, (10) snails intended for human
(ii) 71/118/EEC (health problems affecting the pro-           consumption and (11) frogs’ legs intended for human
duction and placing on the market of fresh poul-              consumption. Member States shall ensure that during
try meat), (iii) 72/461/EEC (health problems affecting        the checks carried out at the places where products
intra-Community trade in fresh meat), (iv) 77/96/EEC          from a third country may be brought into Community
(examination for Trichinella spiralis upon importa-           territory, such as ports, airports and frontier posts with
tion from third countries of fresh meat derived from          third countries, the following measures are taken: (a)
domestic swine), (v) 77/99/EEC (health problems af-           a documentary check is made on the product’s origin,
fecting the production and marketing of meat prod-            (b) where products are imported from third countries,
                            EU, US and Canadian Legislation Relating to Safety in Foods                                   49

Table 2.1 Directives (titles, main points and comments) on controls and food hygiene rules.

Title                               Main points                                              Comments

Directive 85/591/EEC (entry         r Methods of sampling and analysis must be adopted
into force 23/12/1987)                by the Commission and the Council when necessary
                                    r Member States may use tested and scientifically
Introduction of Community
methods of sampling and               valid methods provided that this does not hinder
analysis for the monitoring of        the free movement of products
foodstuffs intended for human
consumption
Directive 89/397/EEC (entry         r Member States must ensure that the competent
into force 20/6/1991)                 authorities have, or have access to, a sufficient
Official control of foodstuffs         number of suitably qualified and experienced staff
                                      in such areas as (veterinary) medicine, chemistry,
                                      microbiology, food technology, food hygiene and
                                      law
                                    r The authorities responsible for the evaluation of
                                      the laboratories must meet the general criteria
                                      applicable to the official laboratory accreditation
                                      bodies set out in European Standard EN 45003
                                    r This Directive shall not apply to metrological
                                      control
Directive 93/43/EEC (entry into     r This Directive lays down the general rules of
force 14/12/1995)                     hygiene for foodstuffs and the procedures for
Hygiene of foodstuffs                 verification of compliance with these rules
                                    r The preparation, processing, manufacturing,
                                      packaging, storing, transportation, distribution,
                                      handling and offering for sale or supply of
                                      foodstuffs shall be carried out in a hygienic way
                                    r Enforcement of European Standard of the EN
                                      29000 series
Directive 93/99/EEC (entry into     r Member States shall apply the criteria laid down in
force 1/5/1995 and 1/11/1998          European Standard EN 45002 in the laboratories
Article 3)                          r Member States must ensure that the competent
Additional measures concerning        authorities have, or have access to, a sufficient
the official control of foodstuffs     number of suitably qualified and experienced staff
Directive 2002/99/EC (entry         r This Directive lays down the general animal health
into force 1/1/2005)                  rules governing all stages of the production and the
Laying down the animal health         introduction from third countries of products of
rules governing the production,       animals
                                    r Member States shall take measures to ensure that
processing, distribution and
introduction of products of           food business operators do not cause the spread of
animal origin for human               diseases transmissible to animals
                                    r Member States shall ensure that products of animal
consumption
                                      origin intended for human consumption are
                                      subjected to veterinary certification
Directive 2004/41/EC (entry         r This Directive repeals 16 other Directives             Amendments – Directives
into force 20/5/2004)                                                                        r 89/662/EEC (entry into force
Repealing certain directives                                                                  31/12/1992) 00
                                                                                             r 92/118/EEC (entry into force
concerning food hygiene and
health conditions for the                                                                     30/6/1996)
                                                                                             r 95/408/EEC (entry into force
production and placing on the
market of certain products of                                                                 31/12/1996)
animal origin intended for                                                                    Replacements and repeals of
human consumption                                                                              Articles and Annex

Adapted from Arvanitoyannis et al. (2005).
50                     HACCP and ISO 22000 – Application to Foods of Animal Origin

they must be sent, under customs supervision, to in-       (iii) the establishment of herd-books, provided that
spection posts in order that veterinary checks may be      they comply with the requirements laid down to the
carried out and (c) products of Community origin shall     Directive, (iv) the recognition of organisations or as-
be subject to the rules.                                   sociations which maintain herd-books and (v) intra-
   According to Directive 90/425/EEC (entry into force     Community trade in bulls used for artificial insemina-
26/7/1990), diseases or epizootic diseases are foot-       tion. The following shall be determined in accordance
and-mouth disease (FMD), classical swine fever (CSF),      with this Directive: (i) performance monitoring meth-
African swine fever (ASF), swine vesicular disease         ods and methods for assessing cattle’s genetic value, (ii)
(SVD), Newcastle disease (ND), rinderpest, peste des       the criteria governing the recognition of breeders’ or-
petits ruminants (PPR), vesicular stomatitis (VS), blue    ganisations and associations, (iii) the criteria govern-
tongue, African horse sickness (AHS), viral equine         ing the establishment of herd-books, (iv) the criteria
encephalomyelitis (VEE), Teschen disease, avian            governing entry in herd-books and (v) the particulars
influenza, sheep and goat pox, lumpy skin disease, rift     to be shown on the pedigree certificate.
valley fever and contagious bovine pleuropneumonia.            Furthermore, another Directive 91/496/EEC (entry
This Directive applies to live animals (bovine and         into force 1/7/1992) claims that Member States shall
porcine animals, Equidae from third countries, bovine      ensure that (a) importers are obliged to give one work-
animals from third countries, sheep). However, it          ing day’s notice to the veterinary staff of the border
should be made clear that this Directive does not apply    inspection post where the animals are to be presented
to live animals (goats, live poultry, domestic rabbits)    specifying the number, nature and estimated time of
and products (waste pathogens and hatching eggs).          arrival of the animals, (b) the animals are conveyed
Member States shall ensure that only the animals and       directly under official supervision, where applicable,
products fulfilling the following conditions may be the     to a quarantine centre, (c) the animals may not leave
subject of trade: (a) the animals and products must        such post or centre unless proof has been supplied in
fulfil the animal health requirements of the Member         the form of the certificate and (d) the customs author-
State of destination, (b) they must come from holdings,    ity does not authorise release for free circulation in
centres or organisations which are subject to regular      the territories unless proof has been supplied that the
official veterinary checks, (c) they must be identified in   requirements have been fulfilled. Member States shall
accordance with the requirements of Community rules        submit to the Commission the list of border inspection
and be registered in such a way that the original or       posts responsible for carrying out veterinary checks on
transit holding, centre or organisation can be traced,     animals and shall provide the following information:
(d) they must be accompanied by health certificates         (a) nature of the border inspection post (port, airport,
and/or any other documents for the animals and prod-       road checkpoint, rail checkpoint), (b) nature of the
ucts, by the rules of the Member State of destination,     animals which could be checked at the border inspec-
(e) susceptible animals, or products of susceptible        tion post in question given the equipment and veteri-
animals, must not originate from holdings, centres or      nary staff available, indicating any animals that cannot
organisations comply with the requirements of this         be checked at those border inspection posts and for
Directive, (f) where the transport operation involves      registered Equidae the operating hours of a specially
several places of destination, animals and products        approved border inspection post, (c) staff assigned to
must be grouped together in as many consignments as        veterinary checks, number of official veterinarians and
there are places of destination and (g) where animals      number of specially qualified auxiliary staff or assis-
and products covered by the Directives referred            tants, (d) description of the equipment and premises
to in Annex of this Directive which comply with            available for carrying out the documentary check, the
Community rules are intended for export to a third         physical check, sampling, the general tests and the spe-
country through the territory of another Member            cific tests ordered by the official veterinarian, (e) capac-
State, the transport operation must – except in cases      ity of the premises available to house animals where
of urgent need duly authorized by the competent            necessary pending the test results, (f) nature of the
authority in order to ensure the welfare of the animals    equipment allowing a rapid exchange of information
– remain under customs supervision up to the point         and (g) volume of trade.
of exit from Community territory.                              The Directive 92/65/EEC (entry into force 29/7/
   In Directive 91/174/EEC (entry into force 1/1/1992),    1992) claims that diseases which are applied to this
the Member States should ensure that the follow-           Directive are Newcastle disease, avian influenza, psit-
ing shall not be prohibited, restricted or impeded         tacosis, American foulbrood, foot-and-mouth disease,
on zootechnical grounds: (i) intra-Community trade         brucellosis (Brucella spp.), tuberculosis, classical swine
in pure-bred breeding animals of the bovine species,       fever and African swine fever. Member States shall take
(ii) intra-Community trade in the semen and embryos        the necessary measures to (i) have the animals held
of pure-bred breeding animals of the bovine species,       examined regularly, (ii) notify the competent authority,
                          EU, US and Canadian Legislation Relating to Safety in Foods                              51

(iii) comply with the specific national measures to con-      uct, not only for the species from which the product
trol a disease which is of particular importance to a        originates but also for other species which could carry
given Member State, (iv) place on the market for the         the disease or become a focus of disease or a risk to
purposes of trade only animals which show no signs           public health. Experts from the Commission and the
of disease and which come from holdings or areas not         Member States shall carry out on-the-spot inspections
subject to any ban on animal health grounds and with         to verify whether the guarantees given by the third
respect to animals not accompanied by a health certifi-       country regarding the conditions of production and
cate or a commercial document and (v) comply with            placing on the market can be considered equivalent to
the requirements ensuring the welfare of the animals         those applied in the Community. The experts from the
held. Semen collection centres must (1) be placed under      Member States responsible for these inspections shall
the supervision of a centre veterinarian, (2) have differ-   be appointed by the Commission, acting on proposals
ent and physically separate premises for accommodat-         from the Member States. These inspections shall be
ing and isolating animals, collecting semen, cleaning        made on behalf of the Community, which shall bear
and disinfecting equipment, processing semen, storing        the cost of any expenditure involved.
semen, (3) be built or kept separate in such a way as           The Directive 96/23/EEC (entry into force 23/5/
to prevent any contact with animals outside the cen-         1996) is primarily focused on residues of therapeutic
tre and (4) have premises which are easily cleaned and       substances. For the purposes of this Directive, ‘residue’
disinfected.                                                 shall mean a residue of substances having a pharma-
    In Directive 92/118/EEC (entry into force 4/4/1993),     cological action, of their metabolites and of other sub-
products, in which this Directive applies, are milk for      stances transmitted to animal products and likely to be
human consumption, animal casings, hides and skins,          harmful to human health; ‘official sample’ shall mean a
pet food containing low-risk materials, bones and            sample taken by the competent authority which bears
bone products, processed animal protein, blood and           a reference to the species, the type, the quantity con-
blood products of animal origin, serum from Equidae,         cerned, the method of collection and particulars iden-
rabbit meat and farmed game meat and apiculture              tifying the sex of the animal and the origin of the an-
products. Member States shall ensure that (1) trade          imal or of the animal product. Monitoring plan for
in and imports of products of animal origin together         the detection of residues or substances shall (a) pro-
with gelatins not intended for human consumption             vide for detection of groups of residues or substances
are not prohibited or restricted for animal health or        according to type of animal, (b) specify in particular
public health reasons other than those arising from the      the measures for detection of the presence of residues
application of this Directive or from Community legis-       of the aforementioned substances in live animals, their
lation and in particular any safeguard measures taken,       excrement and body fluids and in animal tissues and
(2) any new product of animal origin intended for            products such as meat, milk, eggs and honey and (c)
human consumption, which placing on the market of            comply with the sampling rules and levels laid down
a Member State, must be checked the risk of spread of        in the Directive. The laboratories shall be responsible
serious transmissible diseases which could result from       for (a) coordinating the work of the other national
movement of the product and (3) the other products           laboratories responsible for residue analysis, in par-
of animal origin may not be the subject of trade or im-      ticular by coordinating the standards and methods of
portation from third countries unless they meet the re-      analysis for each residue or residue group concerned,
quirements of this Directive. Under the procedure pro-       (b) assisting the competent authority in organising the
vided: (a) specific requirements shall be established –       plan for monitoring residues, (c) periodically organis-
in particular for the protection of the Community from       ing comparative tests for each residue or residue group
certain exotic diseases or diseases transmissible to         assigned to them, (d) ensuring that national labora-
man – or guarantees equivalent to those conditions, (b)      tories observe the limits laid down, (e) disseminating
a Community list shall be drawn up of third country          information supplied by Community reference labora-
establishments which satisfy the requirements of this        tories and (f) ensuring that their staff are able to take
Directive and (c) the nature of any treatment or the         part in further training courses organised by the Com-
measures to be taken to avoid recontamination of             mission or by Commission reference laboratories.
animal casings, eggs and egg products shall be estab-           According to Directive 97/78/EEC (entry into force
lished. The decisions provided for in the Directive          19/2/1998), the official veterinarian shall carry out the
must be taken on the basis of evaluation and, if             following checks: (a) an identity check on each con-
appropriate, the opinion of the Scientific Veterinary         signment to ascertain that the products correspond to
Committee, of the real risk of the spread of serious         the information given in the accompanying certificates
transmissible diseases or of diseases transmissible to       or documents: [(i) where products of animal origin
man which could result from movement of the prod-            arrive in containers, verification that the seals fixed by
52                     HACCP and ISO 22000 – Application to Foods of Animal Origin

the official veterinarian, are intact and that the infor-    the freezing point of untreated milk are carried out ac-
mation appearing thereon corresponds to that given          cording to the following detailed procedures: (1) the
in the accompanying document or certificate and (ii)         untreated milk of each holding must be checked regu-
in other cases, for all types of product, a check that      larly by random sampling and (2) if the results of the
the stamps, official marks and health marks identify-        check refute the suspicion of water being added, the
ing the country and establishment of origin are present     untreated milk may be used for producing heat-treated
and conform to those on the certificate or document          milk. Where the milk of a single holding is delivered di-
and in addition, for wrapped or packaged products,          rectly to a treatment establishment, these samples are
a check on the specific labelling provided for in vet-       to be taken when the milk is collected from the holding
erinary legislation], (b) a physical check on each con-     with precautions, however, being taken to prevent any
signment [(i) in order to ascertain that the products       fraud during transport either before unloading at the
satisfy the requirements of Community legislation and       treatment establishment or when the milk is delivered
are in a fit state to be used for the purpose specified       there directly by the farmer. If the results of a check lead
in the accompanying certificate or document]. Border         the competent authority to suspect that water is being
inspection posts must (a) be located in the immediate       added, it shall take an authentic sample on the hold-
vicinity of the point of entry into an area which is des-   ing. An authentic sample is a sample representing the
ignated by the customs authorities and (b) be placed        milk of one completely supervised morning or evening
under the authority of an official veterinarian, who         milking beginning not less than 11 hours or more than
shall be effectively responsible for the checks. The of-    13 hours after the previous milking. Where milk is
ficial veterinarian may be assisted by specially trained     delivered from several holdings, samples may only be
auxiliary staff. Products which are to be monitored         taken when the untreated milk enters the treatment
pursuant to Community legislation from the border           establishment or collection or standardisation centre
inspection post of arrival to the establishment at the      with spot checks, however, being carried out on the
place of destination shall be forwarded under the fol-      holdings.
lowing conditions: (i) the consignments in question            Following the Directive 92/46/EEC (entry into force
shall be dispatched from the border inspection post         1/1/1994), milk and milk-based products must not
of arrival to the establishment at the place of des-        come from a surveillance zone established under this
tination under the supervision of the competent au-         Directive, unless the milk has undergone, under the su-
thority in leakproof vehicles or containers sealed by       pervision of the competent authority, initial pasteuri-
the competent authorities, (ii) the official veterinar-      sation (71.7◦ C for 15 seconds) followed by (a) a sec-
ian at the border inspection post concerned shall in-       ond heat treatment resulting in a negative reaction
form the veterinary authority in charge of the estab-       to the peroxidase test or (b) a drying procedure in-
lishment at the place of destination of the consignment     cluding heating having an effect equivalent to the heat
of the place of origin and the place of destination of      treatment or (c) a second treatment whereby pH is re-
the product via the ANIMO network, (iii) the prod-          duced and kept for at least 1 hour at pH less than 6.
ucts shall undergo, in the establishment at the place       If the milk is not collected within 2 hours of milking,
of destination, the treatment defined in the relevant        it must be cooled to a temperature of 8◦ C or lower
Community legislation and (iv) the official veterinar-       in the case of daily collection or 6◦ C if collection is
ian responsible for an intermediate warehouse, shall be     not daily. While the milk is being transported to the
informed by the management of the establishment of          treatment and/or processing establishment, the tem-
destination or of the intermediate warehouse of the ar-     perature of the cooled milk must not exceed 10◦ C
rival of the product at its destination, and shall within   unless the milk has been collected within 2 hours of
15 days notify the official veterinarian at the border       milking. In the case of treatment establishments, heat-
inspection post who notified him (supervisor) of the         treatment equipment approved or authorised by the
shipment.                                                   competent authority, fitted with (i) an automatic tem-
   Some representative points and comments (repeals,        perature control, (ii) a recording thermometer, (iii) an
amendments) of the Directives with regard to imports        automatic safety device preventing insufficient heating,
from third countries and intra-Community trade and          (iv) an adequate safety system preventing the mixture
general provisions are given in Table 2.2.                  of heat-treated milk with incompletely heated milk
                                                            and (v) an automatic recording device for the safety
                                                            system referred to in the preceding indent or a proce-
2.2.3 Production and placing on the market – milk
                                                            dure for monitoring the system’s effectiveness. How-
In Directive 89/384/EEC (entry into force 1/7/1990),        ever, when approving establishments, the competent
the Member States should ensure that the checks on          authorities may authorise different equipment with
Table 2.2 Directives (main points and comments) related to imports from third countries and intra-Community trade; general provisions.

Title                                   Main points                                                                Comments

Directive 89/662/EEC (entry into        r The Directive laid down detailed rules governing veterinary checks on    Amendments
force 22/12/1989)                         animals entering the Community from third countries                      r Directive 91/496/EEC (entry into force
Veterinary checks in intra-
                                        r Member States shall ensure that the products intended for trade have       24/9/1991)
                                          been obtained, checked, marked and labelled in accordance with           r Directive 92/67/EEC (entry into force
Community trade with a view to
the completion of the internal            Community rules                                                            14/9/1992)
                                        r A documentary check by the competent authorities must be carried         r Directive 92/118/EEC (entry into force
market
                                          out for each consignment of animals from third countries                   4/4/1993)
                                        r If a serious animal health reason warrants, the Commission may             Laying down the principles governing
                                          prohibit or apply special conditions to imports of animals originating      the organisation of veterinary checks
                                          directly or indirectly in the third country concerned                       on animals entering the Community
                                                                                                                      from third countries
Directive 90/425/EEC (entry into        r This Directive affected neither checks on the welfare of animals         Amendments – Directive
force 26/7/1990)                          during transport nor checks carried out as part of tasks conducted in    r 90/539/EEC (entry into force 1/1/1992)
                                          a non-discriminatory manner by authorities                               r 90/675/EEC (entry into force 31/12/91)
Veterinary and zootechnical checks
                                        r Checks at origin                                                         r 91/67/EEC (entry into force 1/1/1993)
applicable in intra-Community
                                        r Checks on arrival at destination                                         r 91/174/EEC (entry into force 1/1/1992)
trade in certain live animals and
                                        r If a serious animal health reason warrants, the Commission may           r 91/496/EEC (entry into force 1/1/1992)
products with a view to the
                                          prohibit or apply special conditions to imports of animals originating   r 91/628/EEC (entry into force 1/1/1993)
completion of the internal market
                                          directly or indirectly in the third country concerned                    r 92/60/EEC (entry into force 1/7/1992)
                                                                                                                   r 92/65/EEC (entry into force 1/1/1994)
                                                                                                                   r 92/102/EEC (entry into force 1/1/1994
                                                                                                                     for porcine animals and 1/1/1995 for
                                                                                                                     ovine and caprine animals)
                                                                                                                   r 92/118/EEC (entry into force 1/1/1994)
                                                                                                                   r 2002/33/EC (entry into force
                                                                                                                     19/11/2002)
                                                                                                                       Replacement of Articles and Annexes
Directive 91/174/EEC (entry into        r The Directive applies to the marketing of pure-bred animals and their
force 1/1/1992)                           semen, ova and embryos, other than those of bovine, porcine, ovine,
Laying down zootechnical and              caprine and equine species
                                        r Member States must ensure that intra-Community trade in pure-bred
pedigree requirements for the
marketing of pure-bred animals            animals and their semen, ova or embryos may not be prohibited,
                                                                                                                                                               EU, US and Canadian Legislation Relating to Safety in Foods




                                          restricted or impeded on zootechnical or pedigree grounds
Directive 91/496/EEC (entry into        r Veterinary checks in respect of animals from third countries entering    Repeal
force 1/7/1992)                           the Community shall be carried out by the Member States                  r Directive 72/462/EEC
                                        r Organisation and effects of checks
Laying down the principles
governing the organisation of
                                        r Requirements for the transportation of animals from one third            Amendment
                                          country to another                                                       r Directive 96/43/EC (entry into force
veterinary checks on animals
entering the Community from third
                                        r Veterinary experts from the Commission shall check that the                1/7/1996)
countries                                 inspection posts and quarantine centres satisfy the conditions for         Addition in the Annex of this Directive
                                          approval
                                                                                                                                            (Continues )
                                                                                                                                                               53
                                                                                                                                                                    54
Table 2.2 (Continued )

Title                                        Main points                                                               Comments

Directive 92/65/EEC (entry into              r The Directive laid down the animal health requirements for the          Amendments
force 29/7/1992)                               placing on the market in the European Union (EU) of animals and         r Regulation (EC) No. 998/2003 (entry
Laying down animal health                      products of animal origin                                                 into force 3/7/2003)
                                             r Laying down the animal health requirements applicable to trade in       r Directive 2004/68/EC (entry into force
requirements governing trade in
and imports into the Community                 ruminants, bees, lagomorphs, foxes, cats and dogs                         20/5/2004)
of animals, semen, ova and
                                             r Laying down the animal health requirements applicable to trade in          Changes in the lists of Annexes of com-
embryos not subject to animal                  semen, ova and embryos of certain animals like Equidae, sheep and          pulsorily notifiable diseases
health requirements laid down in               goats
specific Community rules
Directive 92/118/EEC (entry into             r The Directive covers certain products of animal origin, in particular   Amendments – Directive
force 4/4/1993)                                animal casings intended for human consumption and processed             r 94/466/EC (entry into force 1/12/94)
                                               animal proteins intended for human consumption. Trade in or             r 94/723/EC (entry into force 1/12/1994)
Laying down animal health and
                                               imports of any new product of animal origin must be authorised by       r 95/1/EC (entry into force 21/1/1995)
public health requirements
                                               the Council, following assessment by the Commission and an opinion      r 95/338/EC (entry into force 30/9/1995)
governing trade in and imports
                                               from the European Food Safety Authority                                 r 95/339/EC (entry into force 30/9/1995)
into the Community of products
                                             r Specific conditions may be imposed, especially in order to protect the   r 96/103/EC (entry into force 20/9/1996)
not subject to the said
                                               EU from certain exotic diseases and diseases transmissible to humans    r 96/340/EC (entry into force 1/7/1997)
requirements laid down in specific
                                                                                                                       r 96/90/EC (entry into force 16/1/1997)
Community rules
                                                                                                                       r 96/405/EC (entry into force 19/6/1997)
                                                                                                                       r 1999/724/EC (entry into force
                                                                                                                         1/6/2000)
                                                                                                                       r 2000/7/EC (entry into force 1/1/2001)
                                                                                                                       r 2003/721/EC (entry into force
                                                                                                                         1/1/2004)
                                                                                                                          Additions and replacements of
                                                                                                                          Articles and Annexes
Directive 96/23/EEC (entry into              r The substances to be monitored are divided into two groups:             Repeals
force 23/5/1996)                              substances having anabolic effect and unauthorised substances on the     r Directive 85/358/EEC
                                              one hand and veterinary drugs and contaminants on the other              r Directive 86/469/EEC
Measures to monitor certain
                                             r Definitions (official sample, approved laboratory and residue)            r Directive 89/187/EEC
substances and residues thereof in
                                             r Monitoring plans for the detection of residues or substances            r Directive 91/664/EEC
live animals and animal products
                                             r Official control measures                                                   These are repealed from 1/7/1997
                                                                                                                                                                    HACCP and ISO 22000 – Application to Foods of Animal Origin




Directive 97/78/EEC (entry into              r This proposal applies to products from third countries                  Amendment
force 19/2/1998)                             r Definitions (products, documentary check, import etc.)                   r Directive 1999/67/EC (entry into force
Laying down the principles
                                             r A documentary check by the veterinary staff of the border inspection      18/11/1999)
governing the organisation of                  post or by the competent authorities must be carried out on each           Correction in the definitions and
veterinary checks on products                  consignment of products from third countries                               changes in the Articles
                                             r The Directive defines the conditions governing the transportation of
entering the Community from third
countries                                      products from one third country to another

Adapted from Arvanitoyannis et al. (2005).
                            EU, US and Canadian Legislation Relating to Safety in Foods                                55

equivalent performance guarantees and equal assur-              that such retailer conducts his or her business in the
ances with regard to hygiene. The operator or man-              same locality as that of the producer or in a neigh-
ager of the processing establishment must take all nec-         bouring locality. The said possible derogation shall not
essary steps to ensure that the raw milk is heat treated        include itinerant sales, mail order sales and, as far as
or used, in the case of products made with raw milk: (i)        the retailer is concerned, sales on a market. The of-
as soon as possible after acceptance if the milk has not        ficial service may authorise the slaughter of farmed
been refrigerated, (ii) within 36 hours of acceptance if        game in the place of origin, where it cannot be trans-
the milk is kept at a temperature not exceeding 6◦ C,           ported, in order to avoid any risk for the handler or to
(iii) within 48 hours of acceptance if the milk is kept         protect the welfare of the animals. This authorisation
at a temperature not exceeding 4◦ C and (iv) within 72          may be granted provided that (i) the herd undergoes
hours for buffalo’s, sheep’s and goat’s milk. However,          regular veterinary inspection and is not under any re-
for technological reasons concerning the manufacture            strictions, (ii) a request is submitted by the owner of
of certain milk-based products, the competent authori-          the animals, (iii) the official service is informed in ad-
ties may authorise the times and temperatures referred          vance of the date of slaughtering of the animals, (iv) the
to in the above indents to be exceeded.                         holding has a centre for mustering wild animals where
    All the Directives dealing with production and plac-        an ante-mortem inspection of the group for slaugh-
ing on the market – milk – are given in Table 2.3.              ter can be carried out, (v) the holding has premises
                                                                suitable for the slaughter, sticking and bleeding of the
2.2.4 Production and placing on the market – meat               animals, (vi) slaughter by means of sticking and bleed-
In Directive 91/495/EEC (entry into force 1/1/1993),            ing is preceded by stunning, which must be carried out
the Member States may authorise (a) the direct sup-             in the conditions laid down in this Directive, (vii) the
ply of rabbit meat by a small producer to a private             slaughtered and bled animals are hung as quickly as
individual for his or her own consumption and (b)               possible after slaughter and are transported under sat-
the supply of fresh rabbit meat in small quantities, by         isfactory hygiene conditions to a slaughterhouse, in a
farmers who produce rabbits on a small scale either             container or means of transport in which the ambi-
directly to the final consumer at those local markets            ent temperature is maintained at between 0 and 4◦ C.
which are closest to their farms or to a retailer with          Evisceration must be carried out no later than 3 hours
a view to direct sale to the final consumer, provided            after stunning and (viii) during transportation to the

Table 2.3 Directives (main points and comments) related to production and placing on the market – milk.

Title                                  Main points                                        Comments

Directive 89/384/EEC (entry            r Laying down the health and animal health         Amendment
into force 1/7/1990)                     requirements for heat-treated milk intended      r Directive 92/608/EEC (entry
Establishing the detailed                for intra-Community trade                          into force 20/1/1993)
                                       r Technical descriptions of the various milk
procedures for carrying out
checks to ensure that the                treatments
                                       r Milk treatment establishments and
freezing point of untreated milk
                                         collecting and standardisation centres must
                                         be approved by Member States
                                       r Inspections of milk production holdings to
                                         ensure hygiene requirements are fulfilled
Directive 92/46/EEC (entry into        r General conditions of hygiene in treatment       Amendments
force 1/1/1994)                          establishments and processing                    r Directive 92/47/EEC (entry
Laying down the health rules for         establishments                                     into force 1/1/1994)
                                       r Production holdings (i.e. farms, where milk      r Directive 94/71/EEC (entry
the production and placing on
the market of raw milk,                  is produced) shall undergo regular checks to       into force 31/12/1994)
heat-treated milk and                    ensure that hygiene requirements are being          Addition and corrections in
milk-based products                      fulfilled                                            the Articles and Annexes
                                       r Measures for use by Member States in the            Repeal
                                         case of the outbreak of disease                  r Directive 85/397/EEC from
                                       r Veterinary experts are authorised to               1/1/1994
                                         undertake spot checks where this is required
                                         for uniform application of the Directive

Adapted from Arvanitoyannis et al. (2005).
56                      HACCP and ISO 22000 – Application to Foods of Animal Origin

slaughterhouse the slaughtered animals are accom-            +7◦ C or lower in the case of large game or +4◦ C or
panied by a certificate issued by the veterinary ser-         lower in the case of small game. If the external tem-
vice attesting to the favourable outcome of the ante-        perature is not sufficiently low, killed game must be
mortem inspection, the correct conduct of bleed-             moved as soon as possible, and in any event not more
ing and the time of slaughter. Rabbits shall be de-          than 12 hours after being killed, to a wild game pro-
clared totally unfit for human consumption where              cessing house or to a collection centre. Evisceration
the post-mortem inspection reveals the following:            must be carried out without undue delay upon arrival
(i) diseases transmissible to man or animals, (ii)           at the wild game processing house, if it has not been
malignant or multiple tumours, multiple abscesses,           carried out on the spot. The lungs, heart, liver, kidney,
(iii) extensive parasitic infestation in the subcuta-        spleen and mediastinum may either be detached or left
neous or muscle tissues, (iv) presence of residues of        attached to the carcase by their natural connections.
forbidden substances or residues in excess of per-           Supervision by the official veterinarian must include
mitted Community levels, including substances with           the following tasks: (i) supervision of the entry and
a pharmacological effect, (v) poisoning, (vi) exten-         exit of meat, (ii) health inspection of meat held in pro-
sive injuries or extensive blood or serum imbibition,        cessing houses, (iii) health inspection of meat prior to
(vii) anomalies as regards colour, smell or taste and        cutting and when it leaves the processing houses re-
(viii) anomalies as regards consistency, particularly        ferred to in the second indent, (iv) supervision of the
oedema or severe emaciation.                                 cleanliness of the premises, facilities and instruments
    The Directive 92/45/EEC (entry into force 4/10/          and of staff hygiene, including their clothing and (v)
1992) specifies that Member States shall ensure that          any other supervision which the official veterinarian
wild game meat comes from wild game which (i) has            considers necessary for ensuring compliance with this
been killed in a hunting area by means authorised un-        Directive.
der national legislation governing hunting and (ii) im-         According to Directive 94/65/EEC (entry into force
mediately after killing has been prepared and trans-         1/1/1996), minced meat must meet the following re-
ported within a maximum of 12 hours to a processing          quirements: (a) the fresh meat from which it is obtained
house. The official veterinarian must ensure that wild        must: (i) where it has been frozen or deep-frozen, be
game meat is excluded from human consumption: (i) if         obtained from fresh boned meat which has been stored
it is found to contain defects or if it has been seized in   for no longer than 18 months for beef and veal, 12
accordance with this Directive, (ii) if the checks have      months for sheep meat and 6 months for pig meat, af-
revealed the presence of a disease communicable to           ter freezing or deep-freezing, in a cold store. However,
man, (iii) if it comes from animals which have ingested      the competent authority may authorise the boning of
substances which are likely to make the meat danger-         pig meat and sheep meat on the spot immediately be-
ous or harmful to human health and on which a deci-          fore mincing where this operation is carried out in sat-
sion has been taken and (iv) if, without prejudice to any    isfactory conditions of hygiene and quality, (ii) where
Community legislation applicable to ionisation, it has       it has been chilled, be used within no more than 6 days
been treated with ionising or ultraviolet radiation or       after slaughter of the animals or within no more than
by means of substances likely to affect its organoleptic     15 days after slaughter of the animals in the case of
properties or using colourings other than those used         boned, vacuum-packed beef and veal; (b) the minced
for health marking. Wild game must undergo the fol-          meat must have undergone cold treatment within a
lowing operations immediately after killing: (i) large       period of not more than 1 hour after portioning and
wild game must be drawn and eviscerated, (ii) the tho-       wrapping, except where processes requiring the low-
racic viscera, even if detached from the carcase, and the    ering of the internal temperature of the meat during
liver and the spleen, must accompany the game and be         production are used; (c) the minced meat must be pack-
identified in such a way that the official veterinarian        aged and presented in one of the following forms: (i)
can carry out the post-mortem inspection of the viscera      chilled, in this case obtained from meat and cooled
in conjunction with the rest of the carcase, the other       to an internal temperature below +2◦ C in the short-
abdominal viscera must be removed and inspected on           est time possible and (ii) deep-frozen, and in this case
the spot. The head may be removed as a trophy and            obtained from meat and cooled to an internal tem-
(iii) small wild game may be totally or partially evis-      perature below −18◦ C as quickly as possible; (d) the
cerated on the spot or in a processing house where           minced meat must not have been subjected to ionis-
the game is transported to the said house at an ambi-        ing radiation or ultraviolet treatment and (e) possibly
ent temperature not exceeding 4◦ C within 12 hours of        combined with the name of the species of animal from
being killed. Wild game must be chilled immediately          which the meat was obtained, may be used on packages
after the operations so that the internal temperature is     only if the requirements are met for those designations.
                             EU, US and Canadian Legislation Relating to Safety in Foods                                57

Table 2.4 Directives (titles, main points and comments) for production and placing on the market – meat.

Title                               Main points                                              Comments

Directive 91/495/EEC (entry         r Laying down requirements concerning public             Amendment
into force 1/1/1993)                    health and animal health problems affecting the      r Directive 94/65/EEC (entry
Public health and animal                production and placing on the market of rabbit         into force 1/1/1996)
health problems affecting the           meat and farmed game meat                               Addition in the Annex
production and placing on           r   Definitions (rabbit meat, farmed game meat etc.)
the market of rabbit meat           r   Rules applicable to the production and placing
and farmed game meat                    on the market of rabbit meat
                                    r   Rules applicable to the production and
                                        marketing of farmed game meat
                                    r   Slaughtering, cutting and processing
                                        establishments must be approved by the Member
                                        States
Directive 92/45/EEC (entry          r   Laying down public health and animal health          Amendment
into force 4/10/1992)                   rules applicable to the killing of wild game and     r Directive 92/116/EEC (entry
Public health and animal                to the preparation and placing on the market of        into force 4/4/1993)
health problems relating to             wild game meat                                          Replacement and correction
the killing of wild game and        r   This Directive shall not apply to small numbers         of the Articles and Annexes
the placing on the market of            of wild game
wild game meat                      r   Definitions (wild game, large wild game, wild
                                        game meat, collection centre etc.)
                                    r   Provisions applicable to Community production
                                        and trade of wild game meat
Directive 94/65/EEC (entry          r   Laying down rules for the production, placing        Repeal
into force 1/1/1996)                    on the market in the Union and importing of          r Directive 88/657/EEC from
Laying down the                         meat preparations and minced meat                      1/1/1996
requirements for the                r   This Directive shall not apply to meat
production and placing on               preparations and minced meat which are
the market of minced meat               produced in retail shops
and meat preparations               r   This Directive shall not apply to mechanically
                                        recovered meat for industrial use
                                    r   Placing on the market of minced meat
                                    r   Placing on the market of meat preparations

Adapted from Arvanitoyannis et al. (2005).


Production plants must have at least (a) a room for               2.2.5 Specific provisions – bovine and
mincing and wrapping separate from the cutting room                     porcine animal
and equipped with a recording thermometer or record-
ing telethermometer, (b) a room for packaging, (c) a              The Directive 64/432/EEC (entry into force 30/6/1964)
room or cabinets for storing salt and (d) refrigeration           makes clear that for the purposes of this Directive, ‘an-
equipment enabling the temperatures. Conditions for               imal for slaughter’ means a bovine animal or swine
the production of minced meat: (1) meat must be ex-               intended to be taken on arrival in the country of des-
amined before mincing or cutting up, in accordance                tination direct to a slaughterhouse or to a market ad-
with Article 7. All soiled and suspect parts shall be             joining a slaughterhouse under whose rules all animals
removed and condemned before the meat is minced,                  may be removed, in particular after the market, only
(2) minced meat may not be obtained from scrap cut-               to a slaughterhouse approved for this purpose by the
tings, scrap trimmings or from mechanically recovered             competent central authority. In the latter case, the an-
meat, (3) minced meat may be deep-frozen only once                imals must be slaughtered at that slaughterhouse not
and (4) immediately after production, the minced meat             later than 72 hours after arriving at the market and ‘an-
must be hygienically wrapped and, after packaging, be             imals for breeding or production’ mean bovine animals
cooled to and stored at certain temperatures.                     and swine, including those intended for breeding, milk
   The titles, main points and comments of the Direc-             or meat production or draft purposes. Bovine animals
tives about production and placing on the market –                and swine covered by this Directive must (a) show no
meat – are summarised in Table 2.4.                               clinical sign of disease on the day of loading; (b) have
58                       HACCP and ISO 22000 – Application to Foods of Animal Origin

been obtained from a holding which officially fulfils             millilitre when given a sero-agglutination test comply-
the following conditions: (i) it shall be situated in the       ing with the provisions of the Directive.
centre of an epizootic-free area, (ii) it shall, for at least      According to Directive 72/462/EEC (entry into force
3 months prior to consignment, have been free from              1/1/1976), applicable to importations from third coun-
foot-and-mouth disease and bovine brucellosis in the            tries of (i) domestic bovine animals and swine for
case of bovine animals and from foot-and-mouth dis-             breeding, production or slaughter and (ii) fresh meat of
ease, bovine and porcine brucellosis, swine fever and           domestic animals of the following species: bovine ani-
contagious porcine paralysis (Teschen disease) in the           mals, swine, sheep and goats and solipeds. However, it
case of swine and (iii) it shall, for at least 30 days          shall not apply to (a) animals intended exclusively for
prior to consignment, have been free from all other             grazing or draft purposes, on a temporary basis, in the
compulsorily notifiable diseases which are contagious            vicinity of the Community frontiers, (b) meat forming
or infectious for the animal species in question; (c) in        part of travellers’ personal luggage and intended for
the case of animals for breeding and production, the            their personal consumption, in so far as the amount or
official veterinarian may certify that the animals have          quantity transported does not exceed 1 kg per person
remained on the holding during the 30 days preceding            and provided that the meat comes from a third country
loading and placed under official veterinary supervi-            or part of a third country, (c) meat sent as small pack-
sion, it being thus possible to certify that they belong        ages to private persons provided that such meat is not
to the holding; (d) be identified by an official or offi-          imported by way of trade, in so far as the quantity sent
cially approved earmark or, in the case of swine, by a          does not exceed 1 kg and provided that the meat comes
permanent identification stamp; (e) be sent direct from          from a third country or part of a third country and
the holding to the actual place of loading: (i) without         (d) meat for consumption by the crew and passengers
coming into contact with cloven-hoofed animals other            on means of transport using international routes. The
than bovine animals and swine which fulfil the con-              Member States shall only authorise the importation of
ditions laid down for intra-Community trade, (ii) seg-          the animals referred to in this Directive if they come
regated into animals for breeding or production and             from non-Member States: (a) free from any disease to
animals for slaughter and (iii) in transport vehicles or        which the animals are susceptible [(i) for 12 months, in
containers which have first been cleansed and disin-             respect of cattle plague exotic foot-and-mouth disease,
fected with a disinfectant officially authorised in the          contagious pleuropneumonia, African swine fever and
exporting country; (f) be loaded for transportation to          contagious porcine paralysis (Teschen disease), or (ii)
the country of destination at a specific place at the cen-       for 6 months, in respect of blue tongue disease and
tre of an epizootic-free area; (g) after loading be sent        contagious vesiculate stomatitis] and (b) which have
direct and as quickly as possible to the frontier post          not been vaccinated during the preceding 12 months
of the exporting country and (h) be accompanied dur-            against the diseases to which animals are susceptible.
ing transportation to the country of destination by a           The Member States shall authorise the importation of
health certificate which shall be drawn up on the day            bovine animals and swine only on production of a cer-
of loading, in the language of the country of destina-          tificate drawn up by an official veterinarian of the ex-
tion at least, and be valid for 10 days. Bovine animals         porting non-Member State. This certificate must (a) be
for slaughter, if over 4 months old, must in addition           issued on the day of loading of the animals for con-
(a) have been vaccinated not less than 15 days and not          signment to the country of destination, (b) be worded
more than 4 months before loading against types A,              at least in one of the official languages of the coun-
O and C of the foot-and-mouth disease virus, using              try of destination and in one of the official languages
an inactivated virus vaccine approved and controlled            of the country carrying out the import inspection,
by the competent authority of the exporting country,            (c) the original of this certificate must accompany the
however, the period of validity of the vaccination shall        animals, (d) provide proof that the bovine animals and
be extended to 12 months in the case of bovine animals          swine meet the conditions laid down in this Directive
revaccinated in Member States where such animals                and those laid down in pursuance thereof with regard
are vaccinated annually and where they are systemat-            to imports from third countries, (e) consist of one sin-
ically slaughtered when they contract foot-and-mouth            gle sheet of paper and (f) be made out in the name of
disease, (b) if they do not come from an officially              one single addressee.
tuberculosis-free bovine herd, have reacted negatively             Following the Directive 77/96/EEC (entry into force
to an intradermal tuberculin test and (c) if they do not        1/1/1979), fresh meat originating in third countries
come from an officially brucellosis-free bovine herd             which contains skeletal muscles shall be examined un-
nor from a brucellosis-free bovine herd have shown a            der the supervision and responsibility of an official vet-
brucella count lower than 30 IU of agglutination per            erinarian in order to be admitted to intra-Community
                             EU, US and Canadian Legislation Relating to Safety in Foods                               59

trade. The examination shall take place in a slaughter-       and associations shall continue to be governed by the
house approved in the exporting country. The exam-            rules at present in force in each Member State and (c)
ination shall take place before the health marking. If        the introduction of new herd-books shall continue to
it is not possible to carry out the examination in the        meet the conditions at present in force in each Member
exporting country, the Member State for which the             State. Until the implementation of Community rules
fresh meat is intended may authorise its importation          on the subject, the conditions applicable to imports of
provided that the examination is carried out within its       pure-bred breeding animals of the bovine species from
territory at the time of the public health inspection.        non-member countries must not be more favourable
                                                              than those governing intra-Community trade.
    The authorization for a slaughterhouse to carry out          In Directive 88/407/EEC (entry into force 1/1/1990),
    the examination and of a cutting plant to cut up or       the Member States shall, until 31 December 1992,
    bone meat which has undergone such examination,
                                                              authorise the admission of semen from bulls giv-
    or the authorization for an establishment to carry out
                                                              ing a negative reaction to the serum neutralisation
    the freezing treatment referred to this Directive. Ac-
    count shall be taken of the guarantees given in respect   test or the ELISA test for infectious bovine rhinotra-
    of compliance with this Directive and, in the case of     cheitis/infectious pustular vulvovaginitis or showing
    slaughterhouses, of:                                      a positive result after vaccination in accordance with
    (a) the presence of the rooms and apparatus necessary     this Directive. Member States may, until 31 Decem-
        for carrying out the examination;                     ber 1992, authorise the admission of semen of bulls
    (b) the qualifications of the personnel responsible for    giving a positive reaction to the serum neutralisation
        carrying out the examination.                         test or the ELISA test for infectious bovine rhinotra-
                                                              cheitis/infectious pustular vulvovaginitis and not hav-
The Member States shall draw up and communicate               ing been vaccinated in accordance with this Directive.
to the Commission the list of the inspection posts at         In that case, each consignment must pass an examina-
which the examination and the freezing may be car-            tion by inoculation into a live animal and/or a virus iso-
ried out. They shall ensure that these posts have the         lation test. This requirement shall not apply in respect
equipment necessary for carrying out the operations           of the semen of animals which, prior to their first vac-
in question.                                                  cination at the insemination centre, reacted negatively
   The Directive 77/504/EEC (entry into force 1/1/            to the tests. Member States shall make the admission
1979) specifies that the Member States shall en-               of semen conditional upon submission of an animal
sure that the following shall not be prohibited, re-          health certificate drawn up by an official veterinarian
stricted or impeded on zootechnical grounds: (i) intra-       of the Member State of collection. This certificate must
Community trade in pure-bred breeding animals of the          (a) be drawn up in at least one of the official languages
bovine species, (ii) intra-Community trade in the se-         of the Member State of collection and one of those
men and embryos of pure-bred breeding animals of the          of the Member State of destination, (b) accompany
bovine species, (iii) the establishment of herd-books,        the consignment to its destination in its original form,
provided that they comply with the requirements of            (c) be drawn up on a single sheet of paper and (d)
the Directive, (iv) the recognition of organisations or       be made out to a single consignee. A semen collection
associations which maintain herd-books and (v) intra-         centre may appear on the list provided for in this Di-
Community trade in bulls used for artificial insemi-           rective only if: (a) it is situated in one of the countries
nation. The following shall be determined in accor-           on the list, (b) it fulfils the requirements, (c) it has been
dance with the procedure laid down in this Directive:         officially approved for exports to the Community by
(i) performance monitoring methods and methods for            the veterinary services of the third country concerned,
assessing cattle’s genetic value, (ii) the criteria gov-      (d) it is under the supervision of a centre veterinarian of
erning the recognition of breeders’ organisations and         the third country concerned and (e) it is subject to reg-
associations, (iii) the criteria governing the establish-     ular inspection by an official veterinarian of the third
ment of herd-books, (iv) the criteria governing entry         country concerned at least twice a year. Consideration
in herd-books and (v) the particulars to be shown on          shall be given to (a) the health situation in the area sur-
the pedigree certificate. Until the entry into force of the    rounding the semen collection centre, with particular
provisions provided for in the first, second and third         reference to the diseases appearing on list A of the In-
indents of the Directive: (a) the official checks referred     ternational Office of Epizootic Diseases, (b) the state
to in the first indent of the Directive carried out in         of health of the herd in the semen collection centre,
each Member State and the herd-books in existence             including testing requirements, (c) the state of health
at present shall be recognised by the other Member            of the donor animal and testing requirements and
States, (b) the recognition of breeders’ organisations        (d) testing requirements in relation to semen. Semen
60                     HACCP and ISO 22000 – Application to Foods of Animal Origin

collection centres must (a) be placed under the per-        countries of fresh and frozen embryos of domestic ani-
manent supervision of a centre veterinarian, (b) have       mals of the bovine species. This Directive shall not ap-
at least animal housing including isolation facilities      ply to embryos resulting from in vitro fertilisation nor
such as semen collection facilities including a sepa-       to embryos subjected to sexing, splitting (twinning),
rate room for the cleaning and disinfection or steril-      cloning or any manipulation which interferes with the
isation of equipment, a semen processing room which         integrity of the ‘zona pellucida’. Each Member State
need not necessarily be on the same site and a semen        shall ensure that embryos shall not be sent from its
storage room which need not necessarily be on the           territory to that of another Member State unless they
same site, (c) be so constructed or isolated that con-      meet the following conditions: (a) they must have been
tact with livestock outside is prevented, (d) be so con-    conceived as a result of artificial insemination with se-
structed that the animal housing and the semen col-         men from a donor sire standing at a semen collection
lecting, processing and storage facilities can be readily   centre, (b) they must have been collected from domes-
cleaned and disinfected, (e) have isolation accommo-        tic animals of the bovine species whose health status
dation which shall have no direct communication with        complies with this Directive, (c) they must have been
the normal animal accommodation and (f) be so de-           collected, processed and stored by an embryo collec-
signed that the animal accommodation is physically          tion team, (d) they must be accompanied, during trans-
separated from the semen processing room and both           port to the Member State of destination, by an ani-
are separated from the semen storage room.                  mal health certificate. Importation of embryos from
   According to the Directive 88/661/EEC (entry into        the territory of a third country shall take place only
force 1/1/1991), Member States may not prohibit, re-        if the embryos (a) come from donor animals which,
strict or impede on zootechnical grounds: (i) intra-        immediately prior to the collection of their embryos,
Community trade in pure-bred breeding pigs or in            have remained for at least 6 months in the territory
their semen, ova and embryos, (ii) the establishment        of the third country concerned, and in a maximum of
of herd-books and (iii) the official approval of breed-      two herds complying with at least the requirements
ers’ associations or breeding organisations, which es-      and (b) comply with the animal health requirements
tablish or maintain herd-book. The following shall          imports of embryos from that country. Consideration
be determined in accordance with the rules: (i) meth-       shall be given to (a) the health situation in the area
ods for monitoring performance and assessing the ge-        surrounding the place of embryo collection, with par-
netic value of pure-bred breeding pigs, (ii) the criteria   ticular reference to the diseases appearing on list of
governing the establishment of herd-books, (iii) the        the International Office of Epizootic Diseases, (b) the
criteria governing entry in herd-books, (iv) the cri-       state of health of the herd concerned in the embryo
teria for approval and supervision of breeders’ asso-       collection, including testing requirements, (c) the state
ciations and/or breeding organisations which estab-         of health of the donor animal and testing requirements
lish or maintain herd-books and (v) the certificate.         and (d) collecting, processing and storing requirements
The following shall be determined in accordance with        in relation to embryos. If a contagious animal disease
the procedure laid down in this Directive: (a) meth-        which can be carried by embryos breaks out or spreads
ods for monitoring performance and assessing the ge-        or if any other reason connected with animal health
netic value of pure-bred breeding pigs, (b) the crite-      which might endanger the health of the livestock in
ria governing the establishment of herd-books, (c) the      a Member State so justify and where: (i) the territory
criteria governing entry in herd-books, (d) the crite-      of a Member State is concerned, the safeguard mea-
ria for approval and supervision of breeders’ associ-       sures are laid down and (ii) all or part of the territory
ations and/or breeding organisations which establish        of a third country is concerned, the Member State of
or maintain herd-books and (e) the certificate. Member       destination shall prohibit the importation of those em-
States may not prohibit, restrict or impede on zootech-     bryos whether imported directly or indirectly through
nical grounds: (a) intra-Community trade in hybrid          another Member State, either from the whole of the
breeding pigs or the semen, ova and embryos of such         third country or from part only of its territory.
animals, (b) the establishment of registers, provided          Directive 90/429/EEC (entry into force 31/12/1991)
that they meet the conditions laid down pursuant to the     laid down the animal health conditions applicable
Directive and (c) the official approval of breeders’ asso-   to intra-Community trade in and imports from third
ciations and/or breeding organisations and/or private       countries of semen of domestic animals of the porcine
undertakings which establish or maintain registers.         species. Intra-Community trade in semen requires
   The Directive 89/556/EEC (entry into force 1/1/          compliance with regulations concerning collection,
1991) defines the animal health conditions governing         processing, storage and transport as well as provisions
intra-Community trade in and importation from third         on protection against the spread of Aujeszky’s disease.
                          EU, US and Canadian Legislation Relating to Safety in Foods                               61

The Directive lays down that each Member State shall        whether a slaughterhouse, a cutting plant or a cold
send the list of semen collection centres and their         store situated outside a slaughterhouse or plant may
veterinary registration numbers to the other Member         appear on one of the lists referred to this Directive
States and to the Commission. It also lays down that        particular account shall be taken of: (a) the guaran-
each consignment of semen must be accompanied by            tees which the third country can offer with regard to
an animal health certificate drawn up by an official vet-     compliance with the provisions of this Directive, (b)
erinarian of the Member State of collection. Imports        the third country’s regulations with regard to admin-
of porcine semen may only be made from those third          istering to animals for slaughter any substances which
countries on the list of semen collection centres. Mem-     might affect the wholesomeness of the meat, (c) com-
ber States shall authorise the import of semen only         pliance in each particular case with the provisions of
on submission of an animal health certificate drawn          this Directive and (d) the organisation of the meat in-
up and signed by an official veterinarian of the third       spection services of the third country or part of the
country of collection. The semen must fulfil the ani-        country, the powers of these services and the super-
mal health requirements adopted for imports of semen        vision to which they are subject. The Member States
from those countries.                                       shall authorise the importation of bovine animals and
   According to Decision 1999/879/EC (entry into            swine if, before the day of loading for transportation
force 1/1/2000), Member States shall ensure that            to the country of destination, these animals have re-
the placing on the market of bovine somatotropin            mained in the territory or part of the territory of a
on Community territory or within their jurisdiction         non-Member State: (a) for not less than 6 months in
for the purpose of its marketing and administration         the case of animals for breeding or production and
thereof to dairy cows by any means whatsoever shall be      (b) for not less than 3 months in the case of animals
prohibited. Undertakings buying or producing bovine         for slaughter. This period shall date from birth in the
somatotropin substances and undertakings authorised         case of animals which are less than 6 or 3 months old,
in any capacity to market such substances shall be re-      respectively. The Member State which carried out the
quired to keep registers detailing, in chronological or-    inspection shall take all those measures which it deems
der, quantities produced or acquired and those sold or      to be necessary. The Member States shall authorise im-
used for purposes other than placing on the market          ports of fresh meat in the form of carcases, possibly
and the names of the persons to whom such quan-             cut in half in respect of swine, and cut in halves or
tities were sold or from whom they were purchased.          in quarters in respect of bovine animals and solipeds,
The above information must be made available to the         only if it is possible to reconstruct the entire carcase of
competent authority at its request and, in the case of      each animal. Such importation shall be subject to the
computerised records, in the form of a printout. The        following conditions: fresh meat must (a) have been
prohibition shall not affect the production of bovine       obtained in a slaughterhouse, (b) come from an ani-
somatotropin in the Member States, or imports, for          mal for slaughter which has undergone a post-mortem
the purposes of its export to third countries.              health inspection carried out by a veterinary official
   All the Directives with regard to specific provisions –   and been deemed suitable for slaughter in accordance
bovine and porcine animals – are given in Table 2.5.        with the provisions of this Directive, (c) have been
                                                            treated according to the hygiene conditions, (d) have
                                                            been inspected post-mortem by an official veterinarian
2.2.6 Specific provisions – ovine and caprine animals
                                                            and have shown no change except for traumatic lesions
The Directive 72/462/EEC (entry into force 1/1/1976)        incurred shortly before slaughter or localised malfor-
applies to imports from third countries of domestic         mations or changes provided that it is established, if
bovine animals and swine for breeding, production           necessary by appropriate laboratory tests, that these
or slaughter and fresh meat of domestic animals of          do not render the carcase and offal unfit for human
the following species: bovine animals, swine, sheep,        consumption or dangerous to human health, (e) be ac-
goats and solipeds. This Directive shall not apply to       companied by a public health certificate, (f) have been
(a) animals intended exclusively for grazing or draft       stored after post-mortem inspection under satisfactory
purposes, on a temporary basis, in the vicinity of the      hygienic conditions in storage plants and (g) have been
Community frontiers, (b) meat forming part of trav-         transported to the country of destination under satis-
ellers’ personal luggage and intended for their personal    factory hygienic conditions.
consumption, in so far as the amount or quantity trans-        In EU Directive 89/361/EEC (entry into force
ported does not exceed 1 kg per person and (c) meat         11/1991), all zootechnical problems arising from intra-
for consumption by the crew and passengers on means         Community trade in pure-bred breeding sheep and
of transport using international routes. In deciding        goats and the semen, ova and embryos thereof are
62                      HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 2.5 Directives (main points and comments) dealing with specific provisions – bovine and porcine animals.

Title                           Main points                                 Comments

Directive 64/432/EEC            r The Directive applies to                  Amendments – Directive
(entry into force                 intra-Community trade in bovine           r 80/1098/EEC (entry into force 20/11/80)
30/6/1964)                        animals or swine for breeding,            r 80/1274/EEC (entry into force 31/12/80)
Animal health problems            production or slaughter                   r 81/476/EEC (entry into force 1/7/1981)
affecting intra-Community       r Definitions (animal for slaughter,         r 82/61/EEC (entry into force 10/2/1982)
trade in bovine animals           animals for breeding or production,       r 82/893/EEC (entry into force 29/12/1982)
and swine                         brucellosis-free bovine animal,           r 83/642/EEC (entry into force 19/12/83)
                                  epizootic-free area etc.)                 r 83/646/EEC (entry into force 21/12/1983)
                                r Bovine and porcine animals, on the        r 84/643/EEC (entry into force 30/6/1984)
                                  day of loading, must not display any      r 84/644/EEC (entry into force 30/9/1985)
                                  clinical sign of disease and must be      r 85/320/EEC (entry into force 19/6/1985)
                                  accompanied by a health certificate        r 85/586/EEC (entry into force 24/12/1985)
                                  during transport to the country of        r 87/231/EEC (entry into force 10/4/1987)
                                  destination                               r 87/489/EEC (entry into force 30/10/1987)
                                r Animals for slaughter which have          r 88/406/EEC (entry into force 27/6/1988)
                                  been taken on arrival in the country of   r 89/360/EEC (entry into force 6/6/1989)
                                  destination must be slaughtered there     r 89/469/EEC (entry into force 28/7/1989)
                                  as soon as possible                       r 89/662/EEC (entry into force 22/12/1989)
                                                                            r 90/422/EEC (entry into force 9/7/1990)
                                                                            r 90/423/EEC (entry into force 26/7/1990)
                                                                            r 90/425/EEC (entry into force 26/7/1990)
                                                                            r 91/499/EEC (entry into force 16/7/1991)
                                                                            r 91/687/EEC (entry into force 19/11/1992)
                                                                            r 92/65/EEC (entry into force 29/7/1992)
                                                                            r 92/102/EEC (entry into force 8/12/1992)
                                                                            r 94/178/EC (entry into force 23/3/1994)
                                                                            r 94/42/EC (entry into force 24/8/1994)
                                                                            r 95/25/EC (entry into force 18/10/1995)
                                                                            r 97/12/EC (entry into force 25/4/1997)
                                                                            r 98/46/EC (entry into force 15/7/1998)
                                                                            r 98/99/EC (entry into force 31/12/1998)
                                                                            r 2000/15/EC (entry into force 3/5/2000)
                                                                            r 2000/20/EC (entry into force 4/7/2000)
                                                                            Regulation (EC)
                                                                            r No. 3768/85 (entry into force 1/1/1986)
                                                                            r No. 535/2002 (entry into force
                                                                              13/4/2002)
                                                                            r No. 1226/2002 (entry into force
                                                                              29/7/2002)
                                                                               Replacements and additions of Articles
                                                                               and Annexes
Directive 72/462/EEC            r This Directive applies to imports from    Amendments – Directive
(entry into force 1/10/1973       third countries of domestic bovine        r 75/379/EEC (entry into force 18/6/75)
Article 23 and 1/1/1976           animals and swine for breeding,           r 77/98/EEC (entry into force 1/7/1978)
other provisions)                 production or slaughter and fresh         r 81/476/EEC (entry into force 1/7/81)
Health and veterinary             meat of domestic animals                  r 83/91/EEC (entry into force 15/2/84)
inspection problems upon        r This Directive does not apply to          r 87/64/EEC (entry into force 1/1/1988)
importation of bovine             animals intended exclusively for          r 88/489/EEC (entry into force 1/1/89)
animals and swine and             grazing or draft purposes                 r 88/657/EEC (entry into force 1/1/92)
fresh meat from third           r On arrival in the country of              r 89/227/EEC (entry into force 30/6/90)
countries                         destination animals for slaughter must    r 90/423/EEC (entry into force 1/1/92)
                                  be taken immediately to a                 r 91/69/EEC (entry into force 31/12/92)
                                  slaughterhouse within three working       r 91/266/EEC (entry into force 29/5/91)
                                  days of entry therein                     r 91/497/EEC (entry into force 24/9/91)
                                                                            r 91/688/EEC (entry into force 1/1/92)
                                                                            r 96/91/EC (entry into force 16/1/1997)
                              EU, US and Canadian Legislation Relating to Safety in Foods                                  63

Table 2.5 (Continued )

Title                              Main points                                   Comments
                                   r This Directive sets procedures for de-      r 97/76/EC (entry into force 16/1/1998)
                                       termining the geographical zones and      r 97/79/EC (entry into force 19/2/1998)
                                       the establishments from which Mem-        ◦ Regulation (EC) No. 1452/2001 (entry
                                       ber States may authorise importation          into force 24/7/2001)
                                       of live animals and fresh meat                 Addition, replacement and amendment
                                                                                      of Articles and Annexes
Directive 77/96/EEC (entry         r The Directive establishes a                  Amendments – Directive
into force 1/1/1979)                 Community system for detecting the          r 77/96/EEC (entry into force 1/1/1979)
Examination for trichinae            presence of trichinae in fresh pig meat     r 81/476/EEC (entry into force 7/7/81)
(T. spiralis) upon                   and upon importation of fresh meat          r 83/91/EEC (entry into force 15/5/84)
importation from third               from third countries                        r 84/319/EEC (entry into force 1/1/85)
countries of fresh meat            r Meat, the examination of which              r 89/321/EEC (entry into force 1/9/89)
derived from domestic                revealed no trichinae, must be marked       r 94/59/EC (entry into force 12/12/94)
swine                                immediately                                 ◦ Regulation (EEC) No. 3768/85 (entry
                                   r A Member State may also admit into             into force 1/1/1986)
                                     its territory fresh meat which has not          Replacements and corrections in the
                                     been screened for trichinae in the              Articles
                                     exporting third country provided that
                                     the meat in question undergoes
                                     treatment by freezing
Directive 77/504/EEC               r These measures define certain rules on       Amendments – Directive
(entry into force 1/1/1979)            trade in pure-bred breeding animals of    r 79/268/EEC (entry into force 1/1/79)
Pure-bred breeding animals             the bovine species so as to enable        r 91/174/EEC (entry into force 1/1/92)
of the bovine species                  intra-Community trade in these            r 94/28/EEC (entry into force 12/7/94)
                                       animals to be progressively liberalised   ◦ Regulation (EEC) No. 3768/85 (entry
                                   r   Definitions (pure-bred breeding                into force 1/1/1986)
                                       animal of the bovine species etc.)             Corrections and replacements in the
                                   r   Performance monitoring methods and             Articles
                                       methods for assessing cattles’ genetic
                                       value
Directive 88/407/EEC               r   The Directive lays down the animal        Amendments – Directive
(entry into force 1/1/1990)            health conditions applicable to           r90/120/EEC (entry into force 1/4/90)
Laying down the animal                 intra-Community trade in and              r90/425/EEC (entry into force 26/7/90)
health requirements                    imports from third countries of both      r93/60/EEC (entry into force 1/7/1994)
applicable to intra-                   fresh and deep-frozen semen of            r2003/43/EC (entry into force 11/6/03)
Community trade in and                 domestic animals of the bovine species      Corrections of definitions and
imports of deep-frozen             r   Definitions (semen, semen collection         replacements of Articles
semen of domestic animals              centre, official veterinarian, centre
of the bovine species                  veterinarian, country of collection
                                       etc.)
                                   r   Imports of semen from third countries
                                       are restricted to a list of authorised
                                       countries to be determined
Directive 88/661/EEC               r Definitions (pure-bred breeding pig,         Amendment
(entry into force 1/1/1991)                                                      r Regulation (EC) No. 806/2003 (entry
                                     hybrid breeding pig, herd-book and
Zootechnical standards               register)                                       into force 5/6/2003)
applicable to breeding             r Performance monitoring methods for               Corrections in the Articles
animals of the porcine               assessing pigs’ genetic value
species                            r Member States may not prohibit,
                                     restrict or impede on zootechnical
                                     grounds intra-Community trade in
                                     pure-bred or hybrid breeding pigs or
                                     their semen, ova and embryos
64                       HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 2.5 (Continued )

Title                             Main points                                   Comments

Directive 89/556/EEC              r The Directive lays down animal health       Amendments – Directive
(entry into force 1/1/1991)         conditions for trade between Member         r 90/425/EEC (entry into force 26/7/90)
Animal health conditions            States in embryos of domestic cattle        r 93/52/EEC (entry into force 1/1/1994)
governing                           and imports from third countries            r 94/113/EEC (entry into force 11/2/94)
intra-Community trade in          r The Directive envisages a system for       ◦ Regulation (EC) No. 806/2003 (entry into
and importation from                approving the embryo collection               force 5/6/2003)
third countries of embryos          teams in the Member States and in              Corrections in the Articles
of domestic animals of the          third countries
bovine species                    r Imports of embryos from third
                                    countries are restricted to a list of
                                    authorised countries to be drawn up
                                    by a procedure involving the Standing
                                    Veterinary Committee
Directive 90/429/EEC              r The Directive lays down the animal          Amendments
(entry into force                   health requirements applicable to           r Decision 1999/608/EC (entry into force
31/12/1991)                         intra-Community trade in and                 1/10/1999)
Laying down the animal              imports from third countries of semen       r Decision 2000/39/EC (entry into force
health requirements                 of animals of the porcine species            8/2/2000)
applicable to                     r Imports of porcine semen may only be       ◦ Regulation (EC) No. 806/2003 (entry into
intra-Community trade in            made from those third countries on            force 5/6/2003)
and imports of semen of             the list of semen collection centres           Replacement of the Articles
domestic animals of the           r Intra-Community trade in semen
porcine species                     requires compliance with regulations
                                    concerning collection, processing,
                                    storage and transport as well as
                                    provisions on protection against the
                                    spread of Aujeszky’s disease
Decision 1999/879/EC              r This Decision is intended to regulate
(entry into force 1/1/2000)         the marketing and use of bovine so-
The placing on the market           matotropin or bovine growth hormone
and administration of               within the European Union
bovine somatotropin (BST)         r The Decision thus prohibits the plac-
                                    ing on the market of bovine soma-
                                    totropin on EU territory for the pur-
                                    pose of its marketing and the admin-
                                    istration thereof to dairy cows by any
                                    means
                                  r The production or importation of
                                    bovine somatotropin in the Member
                                    States for the purposes of exporting it
                                    to third countries continues to be au-
                                    thorised

Adapted from Arvanitoyannis et al. (2005).

covered. For the purposes of this Directive, the follow-         lish flock books. The Commission shall determine be-
ing definition shall apply ‘pure-bred breeding sheep              fore 1 January 1991: (i) the criteria for the approval of
and goat’: any sheep or goat the parents and grand-              breeders’ organisations and associations which main-
parents of which are entered or registered in a flock             tain or establish flock books, (ii) the criteria for entry
book of the same breed and which is itself entered               or registration in flock books, (iii) methods for moni-
or registered and eligible for entry therein. Member             toring performance and assessing the genetic value of
States may not prohibit, restrict or impede on zootech-          pure-bred breeding sheep and goats and (iv) the criteria
nical grounds: (i) intra-Community trade in pure-bred            for the approval of a breeding animal for the purpose
breeding sheep and goats and the semen, ova and em-              of using its semen, ova or embryos.
bryos thereof and (ii) the official approval of breeders’            The Directive 91/68/EEC (entry into force 4/2/1991)
organisations or associations which maintain or estab-           claims that ovine and caprine animals (a) must be
                           EU, US and Canadian Legislation Relating to Safety in Foods                              65

identified and registered, the time limit for notifying           The Directive 2004/68/EC (entry into force 20/5/
the national systems for identifying and registering          2004) specifies that the Commission, with the assis-
ovine and caprine animals begins running from the             tance of the Standing Committee on the Food Chain,
date of adoption of this Directive, (b) must show no          draws up a list of (parts of) third countries from which
clinical sign of disease when inspected by an official         importations of the animals concerned are authorised.
veterinarian, such inspection must take place during          In drawing up these lists, it takes particular account
the 48 hours preceding the loading of the ovine and           of (i) the legislation of the third country and the or-
caprine animals, (c) do not come from a holding, nor          ganisation and powers of the competent authority and
have been in contact with animals from a holding,             inspection services, (ii) the country’s health status and
which is the subject of a prohibition on animal health        procedures for notifying the Commission and inter-
grounds; the period of such prohibition shall last af-        national organisations and (iii) compliance or equiva-
ter the slaughter and/or the disposal of the last ani-        lence with the Community requirements and Commu-
mal suffering from or susceptible to one of the dis-          nity inspections carried out in the third country. Au-
eases referred to in the following points, for at least: i)   thorised third countries must guarantee that the an-
42 days in the case of brucellosis, ii) 30 days in the        imals have been checked by a veterinary official and
case of rabies, iii) 15 days in the case of anthrax, and      comply with certain animal health conditions taking
must not come from a holding or have been in contact          into account, in particular, the species, age and use of
with animals from a holding situated in an established        the animal concerned. Each consignment of animals
protection zone and from which animals are forbid-            must be accompanied by a veterinary certificate attest-
den to leave and (d) must not be the subject of ani-          ing that the animals concerned are hazard free and
mal health restrictions introducing Community mea-            providing certain information, such as details on pub-
sures for the control of foot-and-mouth disease. The          lic health, animal health or animal welfare. Deroga-
diseases, to which this Directive applies, are foot-and-      tions may be provided depending on the destination of
mouth disease, brucellosis (Brucella melitensis), conta-      the animals (zoos, circuses, pet animals) or when ani-
gious epididymitis (B. ovis), anthrax, rabies, scrapie,       mal movements have been prohibited, in the event of
contagious agalactia, paratuberculosis, caseous lym-          a change in the health situation of the country affected
phadenitis, pulmonary adenomatosis, maedi visna and           by the prohibition. Commission experts may carry out
aprine viral arthritis/encephalitis. An officially bru-        inspections in the third countries in order to verify the
cellosis (B. melitensis)-free ovine or caprine holding        compliance or equivalence of the animal health rules.
means (1) a holding: (a) in which all the animals which          Some representative points and comments (repeals,
are susceptible to brucellosis (B. melitensis) have been      modifications, amendments) of the Directives related
free from clinical or any other signs of brucellosis (B.      to specific provisions – ovine and caprine animals – are
melitensis) for at least 12 months, (b) which contains        given in Table 2.6.
no ovine or caprine animals which have been vacci-
nated against brucellosis (B. melitensis), save those
                                                              2.2.7 Specific provisions – poultry
vaccinated at least 2 years previously vaccine, (c) in
which two tests separated by an interval of 6 months          The Directive 71/118/EEC (entry into force 28/3/1971)
or more have been carried out, with negative results,         claims that it shall apply to trade in fresh meat of do-
on all ovine and caprine animals on the holding over          mestic animals of the following species: hens, turkeys,
6 months of age at the time of testing and (d) in             guinea fowls, ducks and geese. All parts of those an-
which there are only ovine or caprine animals born            imals which are fit for human consumption shall be
on the holding or which have come from an officially           considered to be poultry meat. All poultry meat which
brucellosis-free or brucellosis-free holding under cer-       has not undergone any preserving process shall be con-
tain conditions; (2) a holding situated in an officially       sidered to be fresh meat; however, for the purposes of
recognised brucellosis-free Member State or region.           this Directive, chilled and frozen poultry meat shall
The representative number of animals to be tested             be considered to be fresh meat. Each Member State
must, for each holding, consist of the following: (i) all     shall ensure that trade is allowed only in fresh poultry
non-castrated male animals over 6 months old, (ii) all        meat which meets the following requirements: (a) it
animals brought onto the holding since the previous           has been obtained from a slaughterhouse, (b) it comes
test and (iii) 25% of the females which have reached          from an animal inspected ante-mortem by an official
the age of reproduction (i.e. which are sexually mature)      veterinarian or by assistants and considered suitable
or are in milk, with a minimum of 50 per holding –            for slaughter for trade in fresh poultry meat, (c) it
except in holdings where there are fewer than 50 such         has been treated under satisfactory hygiene conditions,
females, in which case all females must be tested.            (d) it has been inspected post-mortem by an official
66                       HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 2.6 Directives (main points and comments) related to specific provision – ovine and caprine animals.

Title                     Main points                                               Comments

Directive 72/462/EEC      r This Directive sets procedures for determining the      Amendments – Directive
(entry into force           geographical zones and the establishments from          r 75/379/EEC (entry into force 18/6/1975)
1/10/1973 Article 23        which Member States may authorise importation of        r 77/98/EEC (entry into force 1/7/1978)
and 1/1/1976 other          live animals and fresh meat                             r 81/476/EEC (entry into force 1/7/1981)
provisions)               r Member States authorise importation of animals          r 83/91/EEC (entry into force 15/2/1984)
Health and veterinary       only on presentation of a certificate made out by an     r 87/64/EEC (entry into force 1/1/1988)
inspection problems         official veterinarian of the exporting third country     r 88/489/EEC (entry into force 1/1/1989)
upon importation of       r Member States ensure that immediately on arrival in     r 88/657/EEC (entry into force 31/12/88)
bovine animals and          the Community domestic goats and sheep are given        r 89/227/EEC (entry into force 30/6/1990)
swine and fresh meat        an animal health check by an official veterinarian       r 90/423/EEC (entry into force 18/8/1990)
from third countries      r On arrival in the country of destination, animals for   r 91/69/EEC (entry into force 31/12/1992)
                            slaughter must be slaughtered within three working      r 91/266/EEC (entry into force 29/5/1991)
                            days of entry therein                                   r 91/497/EEC (entry into force 24/9/1991)
                                                                                    r 91/688/EEC (entry into force 1/1/1992)
                                                                                    r 96/91/EC (entry into force 16/1/1997)
                                                                                    r 97/76/EC (entry into force 16/1/1998)
                                                                                    r 97/79/EC (entry into force 19/2/1998)
                                                                                    ◦ Regulation (EC) No. 1452/2001 (entry
                                                                                       into force 24/7/2001)
                                                                                        Replacement, correction and addition
                                                                                        of the Articles and the Annexes
Directive 89/361/EEC      r Definitions (pure-bred breeding sheep, pure-bred
(entry into force             breeding goat and flock book)
1/1/1991)                 r Member States may not prohibit, restrict or impede
Pure-bred breeding            on zootechnical grounds neither intra-Community
sheep and goats               trade in pure-bred breeding sheep and goats and
                              their semen, ova and embryos nor the official
                              approval of breeders’ organisations which maintain
                              or establish flock books
Directive 91/68/EEC       r   Defining the animal health conditions governing        Amendments – Decisions
(entry into force             intra-Community trade in ovine and caprine animals    r 94/164/EC (entry into force 2/3/1994)
4/2/1991)                 r   Definitions (ovine or caprine animals for slaughter,   r 94/953/EC (entry into force 1/1/1995)
Animal health                 ovine or caprine animals for breeding and fattening   r 2001/298/EC (entry into force 31/7/01)
conditions governing          etc.)                                                 r 2001/10/EC (entry into force 20/6/01)
intra-Community trade     r   Rules on control programmes for certain diseases      r 2002/261/EC (entry into force 6/5/02)
in ovine and caprine          including scrapie, maedi visna, caprine viral         r 2003/708/EC (entry into force 13/10/03)
animals                       arthritis/encephalitis, contagious agalactia and      r 2003/50/EC (entry into force 9/7/2003)
                              paratuberculosis                                      r 2004/554/EC (entry into force 1/6/2004)
                          r   A registration and approval system has been           ◦ Regulation (EC) No. 806/2003 (entry
                              organised to ensure adequate sanitary conditions         into force 5/6/2003)
                              during trading and during the time spent by animals       Replacement of the Annexes and
                              in their own premises                                     addition in the Articles
Directive 2004/68/EC      r This Directive lays down the animal health rules        Repeal
(entry into force             governing the importation from third countries and    r Directive 72/462/EEC
20/5/2004)                    transit through the European Union (EU) of certain
Laying down animal            live ungulates
health rules for the      r   List of authorised third countries
importation into and      r   Guarantees from the third countries
transit through the       r   Inspection in third countries
Community of certain      r   This Directive revises Community law, taking
live ungulate animals         account of the evolution of the international
                                                                        ´
                              standards of the Office International des Epizooties
                              (OIE)

Adapted from Arvanitoyannis et al. (2005).
                          EU, US and Canadian Legislation Relating to Safety in Foods                            67

veterinarian or by assistants and found to be fit for        ments are produced as foodstuffs or used in the manu-
human consumption, (e) it bears a health marking,           facture of foodstuffs: (a) they must have been obtained
(f) it has been stored after post-mortem inspection un-     from hens’, ducks’, geese’s, turkey’s, guinea fowl’s or
der satisfactory hygiene conditions in slaughterhouses      quail’s eggs, but not a mixture of eggs of different
or in cold stores and (g) it has been suitably packed and   species, (b) they must bear an indication of the per-
transported under satisfactory hygiene conditions con-      centage of egg ingredients they contain when they are
forming to certain requirements. The following shall        partially supplemented by other foodstuffs or by ad-
be excluded from trade: (a) fresh poultry meat treated      ditives, (c) they must have been treated and prepared
with hydrogen peroxide or other bleaching substances        in an establishment which satisfies the requirements
or with natural or artificial colouring matters, (b) fresh   of this Directive, (d) they must have been prepared
poultry meat treated with antibiotics, preservatives or     under hygienic conditions, (e) they must have under-
tenderisers and (c) fresh poultry meat treated with         gone a treatment process which enables them to meet
flavouring substances. All approved slaughterhouses          inter alia the analytical specifications, (f) they must
shall be registered on a list and each shall be given a     have undergone a health check, (g) they must have
veterinary approval number. Each Member State shall         been packed in accordance with this Directive, (h) they
communicate the list of approved slaughterhouses and        must be stored and transported in accordance with this
their veterinary approval numbers to the other Mem-         Directive, (i) they must bear the mark of wholesome-
ber States and the Commission and notify them of any        ness where intended for direct human consumption.
withdrawal of approval. Veterinary experts must be          Establishments must possess at least: (1) appropriate
nationals of a Member State other than those involved       materials (waterproof flooring; smooth, durable and
in the dispute. A Member State may, if there is a dan-      impermeable walls etc.) in areas where eggs are stored
ger that animal diseases may be spread by the intro-        and where egg products are manufactures or stored,
duction into its territory of fresh poultry meat from       (2) an appropriate number of changing rooms, with
another Member State, take the following measures:          smooth, impermeable and washable walls and floors,
(a) in the event of an outbreak of an epizootic dis-        wash basins and flush lavatories, (3) a separate area
ease in the other Member State, temporarily prohibit        and adequate facilities for cleaning and disinfecting
or restrict the introduction of fresh poultry meat from     fixed and mobile containers and tanks, (4) facilities
the affected areas of that Member State and (b) if an       for the supply of exclusively potable water within the
epizootic disease becomes widespread or if there is an      meaning of Council directive 80/778/EEC relating to
outbreak of another serious contagious or infectious        the quality of water intended for human consumption,
animal disease, temporarily prohibit or restrict the in-    (5) appropriate equipment for protection against pests
troduction of fresh poultry meat from the entire terri-     such as insects and rodents and (6) equipment, cou-
tory of that State.                                         plings and instruments or their surfaces which are in-
   The Directive 89/437/EEC (entry into force 31/12/        tended to come into contact with egg products must be
1991) prescribes the hygiene and health requirements        made of smooth material which is easy to wash, clean
concerning the production and the placing on the            and disinfect.
market of egg products for direct human consump-               Another Directive (90/539/EEC, entry into force
tion or for the manufacture of foodstuffs. However,         1/1/1992) specifies that hatching eggs, day-old chicks,
this Directive shall not apply to (i) finished foodstuffs    breeding poultry and productive poultry must come
manufactured from egg products and (ii) egg prod-           from (1) establishments which fulfil the following re-
ucts which are obtained in small-scale enterprises and      quirements: (a) they must be approved and given a
which, without having undergone any treatment, are          distinguishing number by the competent authority, (b)
used for the manufacture of foodstuffs intended for di-     they must not, at the time of consignment, be the
rect sale, without any intermediary, to the consumer or     subject of any animal health restrictions applicable to
consumed on the spot immediately after having been          poultry and (c) they must not be located in an infected
prepared. The following definition shall also apply to       area; (2) a flock which, at the time of consignment,
‘egg products’: products obtained from eggs, their var-     presents no clinical sign or suspicion of disease. How-
ious components or mixtures thereof, after removal          ever, poultry and hatching eggs must have come from
of the shell and membranes, intended for human con-         flocks which (i) have been held in the Community since
sumption, they may be partially supplemented by other       hatching or for at least 3 months, (ii) present no clin-
foodstuffs or additives; they may be liquid, concen-        ical signs of a contagious poultry disease at the time
trated, dried, crystallised, frozen, quick-frozen or co-    of consignment, (iii) if there is a vaccination require-
agulated. Member States shall ensure that only egg          ment, satisfy the vaccination conditions, (iv) are not
products which meet the following general require-          the subject of any animal health restrictions applicable
68                       HACCP and ISO 22000 – Application to Foods of Animal Origin

to poultry, (v) are not located in an area infected with       spection have been handled and stored under satisfac-
avian influenza or Newcastle disease, to be defined in           tory hygiene conditions, (g) have been suitably pack-
the framework of the measures to combat these dis-             aged, (h) have been transported in accordance with this
eases to be adopted and (vi) have been found nega-             Directive, (i) be accompanied during their transport
tive in serological tests for Salmonella pullorum and          by either a commercial document or health certificate.
Salmonella gallinarum antibodies. The status of Mem-           Member States shall ensure that (a) all farms deliver-
ber States or regions of Member States from the point          ing poultry of the species to slaughterhouses are kept
of view of Newcastle disease shall be established by the       under veterinary supervision and (b) it is guaranteed
Commission at the latest 6 months before the date on           that (i) in approved slaughterhouses at least one official
which the Member States must conform to this Direc-            veterinarian is present throughout the post-mortem in-
tive. The elements to be taken into consideration for          spection, (ii) in approved cutting plants a member of
determining this status shall satisfy the following cri-       the inspection team is present at least once a day when
teria: (i) no Newcastle disease shall have been detected       meat is being worked on, to check the general hygiene
in the poultry for at least the preceding 12 months, (ii)      of the plant and the register of fresh meat entering and
vaccination against Newcastle disease in the poultry           leaving it and (iii) in cold stores, a member of the in-
shall not have been authorised for at least the pre-           spection team referred to in this Directive is regularly
ceding 12 months, (iii) all breeding flocks shall have          present. Fresh poultry meat can be imported into the
been monitored at least once a year for the presence           Community only if it comes from (a) third countries or
of Newcastle disease and (iv) the holdings shall con-          parts of third countries listed in accordance with this
tain no poultry which have been vaccinated against             Directive and (b) establishments for which the com-
Newcastle disease. Where a Member State draws up or            petent authority of the third country has provided the
has drawn up a voluntary or compulsory control pro-            Commission with guarantees that these establishments
gramme for a disease to which poultry are susceptible,         meet the requirements of this Directive.
it may present the programme to the Commission, out-              A summary of the Directives focused on specific pro-
lining in particular: (i) the distribution of the disease in   visions – poultry – is given in Table 2.7.
its territory, (ii) the reasons for the programme, taking
into consideration the importance of the disease and
                                                               2.2.8 Specific provisions – meat and meat-based
the programme’s likely benefit in relation to its cost,
                                                                     production
(iii) the geographical area in which the programme will
be implemented, (iv) the status categories to be applied       The Directive 72/461/EEC (entry into force 31/12/
to poultry establishments, the standards which must be         1977) applies to intra-Community trade in fresh meat
attained in each category and the test procedures to be        of domestic bovine animals, swine, sheep, goats and
used, (v) the programme monitoring procedures, (vi)            solipeds. All parts of these animals which are fit for
the action to be taken if, for any reason, an establish-       human consumption shall be considered to be meat.
ment loses its status and (vii) the measures to be taken       All meat which has not undergone any preserving pro-
if the results of the tests carried out in accordance with     cess shall be considered as fresh meat; however, for the
the provisions of the programme are positive.                  purposes of this Directive chilled and frozen meat shall
    According to Directive 92/116/EEC (entry into force        be considered to be fresh meat. Only fresh meat which
1/1/1994), the model health certificate for fresh poul-         fulfils the following requirements may be sent from
try meat should contain the following points: (i) iden-        the territory of one Member State to the territory of
tification of meat, (ii) origin of meat, (iii) destination      another Member State: (a) meat obtained from domes-
of meat and (iv) attestation. Fresh poultry meat must          tic sheep, goats or solipeds must come from animals
meet the following conditions: carcases and offal must         which have stayed in the territory of the Community
(a) come from an animal inspected before slaughter             for at least 21 days immediately prior to slaughter or
and considered suitable for slaughter for the placing          from birth in the case of animals less than 21 days
on the market of fresh poultry meat, (b) have been             old, (b) the meat must not have been obtained from
obtained from an approved slaughterhouse subject to            animals which come from a holding or area which
own-checks and to checks by the competent authority,           for health reasons is subject to prohibition on animal
(c) have been treated under satisfactory hygiene con-          health problems affecting intra-Community trade in
ditions, (d) have been inspected post-mortem and not           bovine animals and swine, as a result of the outbreak
have been found unfit for human consumption, (e) be             of foot-and-mouth disease, swine fever or contagious
given a health marking on the understanding that such          swine paralysis (Teschen disease) to which the animals
marking is not necessary for carcases that are to be cut       in question are susceptible and (c) the meat must not
in the same establishment, (f) after post-mortem in-           be obtained from slaughterhouses in which cases of
                            EU, US and Canadian Legislation Relating to Safety in Foods                                        69

Table 2.7 Directives (main points and comments) with regard to specific provisions – poultry.

Title                             Main points                                       Comments

Directive 71/118/EEC (entry       r This Directive applies to trade in fresh        Amendment
into force 28/3/1971)                 meat of domestic animals of the following     r Directive 92/116/EEC (entry into force
Health problems affecting             species: hens, turkeys, guinea fowls,           15/3/1993)
trade in fresh poultry meat           ducks and geese                                  Replacement and addition of this
                                  r   All poultry meat which has not                   Directive
                                      undergone any preserving process shall be
                                      considered to be fresh meat; however,
                                      chilled and frozen poultry meat shall be
                                      considered to be fresh meat
                                  r   Provisions concerning intra-Community
                                      trade and trade within Member States
                                  r   Provisions concerning only
                                      intra-Community trade
                                  r   Hygiene requirements for slaughterhouses
Directive 89/437/EEC (entry       r   The Directive covers health problems          Amendments – Directive
into force 31/12/1991)                affecting the production and marketing of     r 89/662/EEC (entry into force 1/7/1992)
Hygiene and health problems           egg products for direct human                 r 91/684/EEC (entry into force 31/12/91)
affecting the production and          consumption or for use in the                    Replacement of Annex and Articles
the placing on the market of          manufacture of foodstuffs
egg products                      r   Member States are required to comply
                                      with a number of similar requirements
                                      with respect to the manufacture,
                                      handling, packaging, storage and
                                      transport of egg products
                                  r   Member States must draw up a list of
                                      approved establishments
Directive 90/539/EEC (entry       r   Defining the animal health conditions          Amendments – Directive
into force 1/1/1992)                  governing intra-Community trade in and        r 91/494/EEC (entry into force 1/5/1992)
Animal health conditions              imports from third countries of poultry       r 91/496/EEC (entry into force 1/7/1992)
governing intra-Community             and hatching eggs                             r 92/65/EEC (entry into force 1/1/1994)
trade in, and imports from        r   This Directive does not apply to poultry      r 92/369/EEC (entry into force 25/6/1992)
third countries of, poultry           in trade for exhibitions, shows or contests   r 93/120/EC (entry into force 1/1/1995)
and hatching eggs                 r   Definition (poultry, hatching eggs,            r 1999/90/EC (entry into force 1/7/2000)
                                      day-old chicks etc.)                          r 2000/505/EC (entry into force 29/8/2000)
                                  r   Rules for intra-Community trade               r 2001/867/EC (entry into force 1/1/2002)
                                  r   Rules for imports from third countries           Replacement in Articles and Annexes
Directive 92/116/EEC (entry       r   This Directive lays down health rules for
into force 1/1/1994)                  the production and placing on the market
Health problems affecting             of fresh poultry meat
trade in fresh poultry meat       r   This Directive does not apply to the
                                      cutting and storage of fresh poultry meat
                                      in retail shops or in premises adjacent to
                                      sales points
                                  r   Fresh poultry meat to be marketed must
                                      meet certain requirements
                                  r   Commission veterinary experts will be
                                      required to make on-the-spot checks
                                  r   Each Member State will draw up a list of
                                      its approved establishments

Adapted from Arvanitoyannis et al. (2005).


foot-and-mouth disease, swine fever or contagious                  to be contaminated forms part of intra-Community
swine paralysis (Teschen disease) have been recorded.              trade. If there is a danger that animal diseases may be
Should there be an outbreak of one of these diseases,              spread by the introduction into its territory of fresh
the Member States shall ensure that no meat suspected              meat from another Member State, take the following
70                      HACCP and ISO 22000 – Application to Foods of Animal Origin

measures: (a) in the event of an outbreak of an epi-          inspected post-mortem by an official veterinarian and
zootic disease in the other Member State, it may tem-         do not show any change except for traumatic lesions
porarily prohibit or restrict the introduction of meat        which occurred shortly before slaughter or localised
from the affected areas of that Member State and (b)          malformations or changes, provided that it is estab-
if an epizootic disease becomes widespread or if there        lished, if necessary by appropriate laboratory tests,
is an outbreak of another serious contagious or infec-        that these lesions, malformations or changes do not
tions animal disease, it may temporarily prohibit or          render the carcase and offal unfit for human consump-
restrict the introduction of meat from the entire terri-      tion or dangerous to human health, (e) bear a health
tory of that State.                                           mark, (f) are accompanied during transportation by
   The Directive 80/215/EEC (entry into force 31/12/          the health certificate issued by the official veterinar-
1980) claims that a Member State may take the follow-         ian, (g) are stored in accordance with the Annex of this
ing measures if there is a danger that animal diseases        Directive after post-mortem inspection under satisfac-
may be spread by the introduction of meat products            tory hygiene conditions in establishments approved
from another Member State into its territory: (a) in          and supervised in accordance with this Directive, (h)
the event of an outbreak of classical foot-and-mouth          are transported under satisfactory hygiene conditions.
disease, classical swine fever or Teschen disease in the      Cuts or small pieces of boned meat (a) are boned or
other Member State, the introduction of products pre-         cut in a cutting plant meeting the conditions laid down
pared from the meat of animals which are susceptible          in this Directive, (b) are boned or cut and come from
to these diseases, other than products which have un-         fresh meat from Community or from third countries,
dergone one of the treatments referred to the Directive,      (c) have been stored under conditions which comply
may be temporarily prohibited or restricted from those        with this Directive, (d) have been checked by an official
parts of the territory of the Member State in which           veterinarian and (e) meet the wrapping and packaging
the disease has appeared and (b) if an epizootic dis-         requirements. However, this Directive shall not apply
ease becomes widespread or if there is an outbreak of         to (a) fresh meat intended for uses other than human
another serious and contagious or infectious animal           consumption, (b) fresh meat intended for exhibition,
disease, the introduction from the entire territory of        special studies or analysis, provided that official con-
that State, of products prepared from the meat of an-         trol makes it possible to ensure that the meat is not
imals which are susceptible to these diseases may be          used for human consumption and that, when the exhi-
temporarily prohibited or restricted. Meat products           bition is over or when the special studies or the analy-
intended for intra-Community trade, which are pre-            sis have been carried out, the meat, with the exception
pared in whole or in part from or with fresh meat may         of that used for the purposes of analysis, is destroyed
enter intra-Community trade if they have also under-          and (c) fresh meat intended exclusively as supplies for
gone one of the following forms of treatment: (a) heat        international organisations.
treatment in a hermetically sealed container, with an            All EU Member States shall prohibit (96/22/EC, en-
Fc value of 3–7 or more and (b) where the fresh meat          try into force 23/5/1996): (a) the placing on the market
has been obtained from animals which do not come              of stilbenes, stilbene derivatives, their salts and esters
from an infected holding subject to prohibition mea-          and thyrostatic substances for administering to ani-
sures of this Directive: (i) heat treatment different from    mals of all species, (b) the placing on the market of
that referred to in (a) in which the internal temperature     beta-agonists for administering to animals the flesh
is raised to at least 70◦ C or (ii) treatment consisting in   and products of which are intended for human con-
natural fermentation and maturation of not less than          sumption, (c) the administering to a farm or aquacul-
9 months for boned or boneless hams weighing not less         ture animal, by any means whatsoever, of substances
than 5.75 kg and having the following characteristics:        having a thyrostatic, oestrogenic, androgenic or gesta-
aw value of not more than 0.793 and pH value of not           genic action and of beta-agonists, (d) the holding, ex-
more than 6.                                                  cept under official control, of animals referred to in
   According to Directive 91/497/EEC (entry into force        (c) on a farm, the placing on the market or slaughter
1/1/1993), each Member State shall ensure that car-           for human consumption of farm animals or of aqua-
cases, half carcases or half carcases cut into no more        culture animals which contain the substances referred
than three wholesale cuts, and quarters (a) have been         to in (c) or in which the presence of such substances
obtained in a slaughterhouse meeting the conditions           has been established, unless proof can be given that
laid down in this Directive, (b) come from a slaughter        the animals in question have been treated in accor-
animal inspected ante-mortem by an official veterinar-         dance with this Directive, (e) the placing on the mar-
ian, as a result of such inspection, for slaughter for        ket for human consumption of aquaculture animals
the purposes of this Directive, (c) have been treated         to which substances have been administered and of
under satisfactory hygiene conditions, (d) have been          processed products derived from such animals, (f) the
                           EU, US and Canadian Legislation Relating to Safety in Foods                               71

placing on the market of meat of the animals referred         tive. The placing on the market of live fish belonging
to in (d), (g) the processing of the meat referred to in      to the susceptible species, their eggs or gametes, shall
(f). The following may not, however, be authorised:           be subject to the following additional guarantees: (a)
(a) the following hormonal products: (i) products act-        where they are to be introduced into an approved zone,
ing as a deposit, (ii) products with a withdrawal pe-         they must be accompanied by a movement document
riod of more than 15 days after the end of treatment          corresponding or certifying that they come from an
and (iii) products which were authorised under rules,         approved zone or an approved farm. Additional guar-
whose conditions of use are not known, for which no           antees to be met for the introduction into an approved
reagents or equipment exist for use in the analytical         zone of fish coming from an approved farm situated in
techniques for detecting the presence of residues in          a non-approved zone shall be fixed. Pending that deci-
excess of the permitted limits; (b) veterinary medic-         sion, national rules shall continue to apply subject to
inal products containing beta-agonists which have a           compliance with the general provisions of the Treaty,
withdrawal period of more than 28 days after the end          (b) where they are to be introduced into a farm, al-
of treatment. Third countries whose legislation autho-        though not situated in an approved zone, they must be
rises the placing on the market and administration of         accompanied by a movement document corresponding
stilbenes, stilbene derivatives, their salts and esters, or   or certifying that they come respectively from an ap-
of thyrostatic substances for administering to animals        proved zone or from a farm of the same health status
of all species may not appear on any of the lists of          as the farm of destination. Live molluscs susceptible
countries provided for under Community legislation            to the diseases of a list must be delivered either for di-
from which Member States are authorised to import             rect human consumption or to the preserving industry
farm or aquaculture animals or meat or products ob-           and shall not be relaid unless they originate in an ap-
tained from such animals. Member States shall also            proved farm in a non-approved coastal zone or they are
prohibit the importation from third countries on any          temporarily immersed in storage ponds or sterilisation
of the lists of (a) farm or aquaculture animals: (i) to       centres which are specially equipped and approved for
which products or substances have been administered           that purpose by the competent authority and include in
by any means whatsoever and (ii) to which substances          particular a system for the treatment and disinfection
or products have been administered, unless those sub-         of residual water. The conditions for such approval
stances or products were administered in compliance           will be determined by the Commission. Aquaculture
with the provisions and requirements laid down in             animals and products must come from third countries
this Directive (96/22/EC) and the withdrawal periods          or parts thereof appearing on a list drawn up by the
allowed in international recommendations have been            Commission. In deciding whether a third country or
observed and (b) meat or products obtained from the           part thereof may appear on the list referred to in the
importation of animals.                                       Directive, particular account shall be taken of (a) the
   The titles, main points and comments of the EU             state of health of the aquaculture animals, particular
Directives about specific provisions – meat and meat-          attention being paid to exotic diseases and the envi-
based production – are summarised in Table 2.8.               ronmental health situation in the third country which
                                                              might endanger the health of livestock in the Member
                                                              States, (b) the regularity and rapidity of the informa-
2.2.9 Specific provisions – fish and fishery products
                                                              tion supplied by the country relating to the existence
According to Directive 91/67/EEC (entry into force            of infectious or contagious diseases of aquaculture an-
1/1/1993), the placing on the market of aquaculture           imals in its territory, in particular those diseases men-
animals shall be subject to the following general re-         tioned in the list of the International Office of Epi-
quirements: (a) they must show no clinical signs of           zootics, (c) the rules of the third country on the preven-
disease on the day of loading, (b) they must not be           tion and control of diseases of aquaculture animals, (d)
intended for destruction or slaughter under a scheme          the structure of the official services in the third country
for the eradication of a disease and (c) they must not        and their powers, (e) the organisation and implemen-
come from a farm which is subject to a prohibition            tation of measures to prevent and control infectious
for animal health reasons and must not have been in           or contagious diseases of aquaculture animals and (f)
contact with animals from such a farm. Aquaculture            assurances which the third country may provide con-
products being placed on the market for breeding pur-         cerning the rules laid down in this Directive.
poses (eggs and gametes) must originate from animals             Following the Directive 91/492/EEC (entry into
which satisfy the requirements laid down in this Direc-       force 14/10/1991), the placing on the market of live
tive. Aquaculture products being placed on the market         bivalve molluscs for immediate human consumption
for human consumption must originate from animals             shall be subject to the following conditions: (a) they
which satisfy the requirements laid down in this Direc-       must originate from production areas which comply
72                       HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 2.8 Directives (main points and comments) for specific provisions – meat and meat-based production.

Title                          Main points                                   Comments

Directive 72/461/EEC           r This Directive shall apply to                Amendments – Directive
(entry into force                intra-Community trade in fresh meat of      r 74/387/EEC (entry into force 18/7/1974)
31/12/1977)                      domestic bovine animals, swine, sheep,      r 75/379/EEC (entry into force 18/6/1975)
Health problems affecting        goats and solipeds                          r 77/98/EEC (entry into force 31/12/1982)
intra-Community trade in       r The animals from which the fresh meat       r 80/213/EEC (entry into force 31/12/80)
fresh meat                       is taken must have been in the              r 80/1099/EEC (entry into force 1/7/1981)
                                 Community for at least 21 days before       r 81/476/EEC (entry into force 7/7/1981)
                                 slaughter                                   r 83/646/EEC (entry into force 2/1/1984)
                               r Intra-Community trade in fresh meat of      r 84/336/EEC (entry into force 30/6/1984)
                                 animals coming from an area in which        r 84/643/EEC (entry into force 31/12/84)
                                 health restrictions apply is forbidden      r 85/332/EEC (entry into force 1/1/1986)
                               r The meat must be obtained in                r 87/64/EEC (entry into force 1/1/1988)
                                 slaughterhouses in which no disease has     r 87/231/EEC (entry into force 31/12/87)
                                 been recorded                               r 87/489/EEC (entry into force 31/12/88)
                                                                             r 89/662/EEC (entry into force 31/12/92)
                                                                             r 91/266/EEC (entry into force 21/5/1991)
                                                                             r 91/687/EEC (entry into force 1/7/1992)
                                                                             r 92/118/EEC (entry into force 30/6/1996)
                                                                             ◦ Regulation (EEC) No. 3768/85 (entry
                                                                                into force 20/1/1986)
                                                                               Measures relating to swine vesicular
                                                                                disease, classical swine fever and
                                                                                African swine fever
Directive 80/215/EEC           r Defining common rules in order to             Amendments – Directive
(entry into force                eliminate disparities between Member        r 80/215/EEC (entry into force 31/12/80)
31/12/1980)                      States concerning health rules affecting    r 80/1100/EEC (entry into force 1/7/1981)
Animal health problems           meat products                               r 81/476/EEC (entry into force 7/7/1981)
affecting intra-Community      r The rules applicable to fresh meat must     r 85/321/EEC (entry into force 1/1/1986)
trade in meat products           be applied to certain meat products in      r 87/491/EEC (entry into force 1/1/1988)
                                 case of preventing animal diseases          r 88/660/EEC (entry into force 1/4/1989)
                               r If an epizootic disease becomes             r 89/662/EEC (entry into force 31/12/92)
                                 widespread or if there is an outbreak of    r 91/687/EEC (entry into force 1/7/1992)
                                 another serious animal disease, the         ◦ Regulation (EEC) No. 3768/85 (entry
                                 introduction of products prepared from         into force 1/1/1986)
                                 the meat of animals which are                   Measures relating to swine vesicular
                                 susceptible to these diseases may be            disease, classical swine fever and
                                 prohibited or restricted                        African swine fever
Directive 91/497/EEC           r The Directive lays down the health          Amendments
(entry into force 1/1/1993)        conditions applicable to the production   r Directive 95/23/EC (entry into force
Health problems affecting          and placing on the market of fresh meat       1/12/1995)
intra-Community trade in           intended for human consumption from       ◦ Regulation (EC) No. 806/2003 (entry
fresh meat to extend it to         domestic bovine animals, pigs, sheep,         into force 5/6/2003)
the production and                 goats and domestic solipeds                    Amending a number of technical points
marketing of fresh meat        r   Definitions (meat, fresh meat, carcase,         which have caused problems of
                                   establishment etc.)                            practical application
                               r   Provisions concerning health
                                   requirements for the placing on the
                                   market of fresh meat
                               r   Provisions on meat and animal carcases
                                   declared unfit for human consumption
                                   by the official veterinarian
                               r   Provisions on residue tests carried out
                                   on animals or their meat
                              EU, US and Canadian Legislation Relating to Safety in Foods                                   73

Table 2.8 (Continued )

Title                              Main points                                      Comments

Directive 96/22/EC (entry          r The purpose of the Directive is to             Amendment
into force 23/5/1996)                regulate the use in meat of substances         r Directive EU 2003/74/EC (entry into
The prohibition on the use           having a hormonal or thyrostatic action         force 14/10/2003)
in stockfarming of certain           and of beta-agonists with a view to               Replacements in the Articles
substances having a                  protecting consumer health and                   Repeals – Directive
hormonal or thyrostatic              safeguarding the quality of foodstuffs of       ◦ 81/602/EEC from 1/7/1997
action and of beta-agonists          animal origin                                   ◦ 88/146/EEC from 1/7/1997
                                   r The Directive prohibits the placing on          ◦ 88/299/EEC from 1/7/1997
                                     the market of thyrostatic substances,
                                     stilbenes, stilbene derivatives, their salts
                                     and esters etc.
                                   r It provisionally prohibits the
                                     administration of five hormones to
                                     animals intended for human
                                     consumption: progesterone,
                                     testosterone, trenbolone acetate, zeranol
                                     and melengestrol acetate

Adapted from Arvanitoyannis et al. (2005).

with the requirements laid down in this Directive, in               location and the boundaries of production areas must
the case of Pectinidae, this provision shall apply only             be fixed by the competent authority in such a way as
to aquaculture products, (b) they must have been har-               to identify the areas from which live bivalve molluscs
vested and transported from the production area to                  (a) can be collected for direct human consumption,
a dispatch centre, sterilisation centre, relaying area or           (b) can be collected but only placed on the market for
processing plant under the conditions laid down in this             human consumption after treatment in a sterilisation
Directive, (c) where provided for in this Directive, they           centre, after relaying. Live bivalve molluscs from these
must have been relaid in suitable areas approved for                areas must not exceed the limits of a five-tube, three-
that purpose, (d) they must have been handled hygien-               dilution MPN-test of 6000 faecal coliforms per 100 g
ically, and where appropriate, they must have been                  of flesh or 4600 Escherichia coli per 100 g of flesh in
purified in establishments approved for that purpose,                90% of samples, (c) can be collected but placed on the
(e) they must comply with the criteria set out in this              market only after relaying over a long period (at least
Directive, (f) health controls must have been carried               2 months), whether or not combined with sterilisation,
out, (g) they must have been appropriately wrapped,                 or after intensive sterilisation for a period to be fixed,
(h) they must have been stored and transported under                so as to meet the requirements under (a). Live bivalve
satisfactory conditions of hygiene and (i) they must                molluscs from these areas must not exceed the limits
bear a health mark. Member States shall ensure that                 of a five-tube, three-dilution MPN-test of 60,000 fae-
persons handling live bivalve molluscs during their                 cal coliforms per 100 g of flesh. Any change in the
production and placing on the market shall adopt all                demarcation of production areas and the temporary
measures necessary to comply with the requirements                  or definitive closure thereof must be immediately an-
of this Directive. Persons responsible for dispatch and             nounced by the competent authority to those affected
sterilisation centres shall in particular ensure that (i)           by this Directive and in particular to producers and
representative numbers of samples for laboratory ex-                operators of sterilisation and dispatch centres. Centres
amination are regularly taken and analysed in order to              must have at least: (1) appropriate buildings, durable
establish an historical record on the basis of the areas            walls etc on premises where bivalve mollusks are han-
where batches come from and of the health quality of                dled or stored, (2) an appropriate number of changing
the live bivalve molluscs both before and after han-                rooms, wash basins and lavatories, (3) adequate equip-
dling at a dispatch centre or sterilisation centre and              ment for washing tools, containers and equipment,
(ii) a register is kept for the permanent record of the re-         (4) facilities for the supply and, where appropriate,
sults of the various checks and kept for presentation to            storage of exclusively potable water within the mean-
the competent authority. Provisions applied to imports              ing of Council Directive 80/778/EEC relating to the
of live bivalve molluscs from third countries shall be at           quality of water intended for human consumption or
least equivalent to those governing the production and              facilities for supply of clean sea water, (5) equipment
placing on the market of Community products. The                    and instruments or their surfaces which are intended
74                      HACCP and ISO 22000 – Application to Foods of Animal Origin

to come into contact with bivalve mollusks must be            rooms at a temperature not exceeding those laid down
made of corrosion-resistant material which is easy to         in this Directive, whatever the ambient temperature
wash and clean repeatedly.                                    may be. However, for technical reasons related to the
   According to Directive 91/493/EEC (entry into force        method of freezing and to the handling of such prod-
1/1/1993), the placing on the market of aquaculture           ucts, for whole fish frozen in brine and intended for
products shall be subject to the following conditions:        canning, higher temperatures than those laid down in
(a) they must have been slaughtered under appropri-           this Directive are acceptable although they may not
ate conditions of hygiene. They must not be soiled with       exceed −9◦ C.
earth, slime or faeces. If not processed immediately af-         The Directive 92/48/EEC (entry into force 1/1/1993)
ter having been slaughtered, they must be kept chilled        makes clear general hygiene conditions applicable to
and (b) they must have been handled and, where ap-            fishery products on board fishing vessels: (1) The sec-
propriate, packaged, prepared, processed, frozen, de-         tions of vessels or the containers reserved for the stor-
frosted or stored hygienically in establishments ap-          age of fishery products must not contain objects or
proved in accordance with this Directive and they must        products liable to transmit harmful properties or ab-
have been stored and transported under satisfactory           normal characteristics to the foodstuffs. These sections
conditions of hygiene. The placing on the market of the       or containers must be so designed as to allow them to
following products shall be forbidden: (i) poisonous          be cleaned easily and to ensure that melt water can-
fish of the following families: Tetraodontidae, Mol-           not remain in contact with the fishery products. (2)
idae, Diodontidae, Canthigasteridae and (ii) fishery           When used, the sections of vessels or the containers
products containing biotoxins such as ciguatera tox-          reserved for the storage of fishery products must be
ins or muscle-paralysing toxins. When fixing the im-           completely clean and, in particular, must not be ca-
port conditions of fishery products, particular account        pable of being contaminated by the fuel used for the
shall be taken of (a) the legislation of the third coun-      propulsion of the vessel or by bilge water. (3) As soon
try, (b) the organisation of the competent authority          as they are taken on board, the fishery products must
of the third country and of its inspection services, the      be protected from contamination and from the effects
powers of such services and the supervision to which          of the sun or any other source of heat. (4) The fishery
they are subject, as well as their facilities for effec-      products shall be handled and stored in such a way
tively verifying the implementation of their legislation      as to prevent bruising. The use of spiked instruments
in force, (c) the actual health conditions during the         shall be tolerated for the moving of large fish or fish
production, storage and dispatch of fishery products           which might injure the handler, provided the flesh of
intended for the Community and (d) the assurances             these products is not damaged. (5) Fishery products
which a third country can give on the compliance with         other than those kept alive must undergo cold treat-
the standards. Areas used for the preparation and pro-        ment as soon as possible after loading. However, in
cessing or freezing/quick-freezing of fishery products         the case of fishing vessels where cooling is not possible
must have (a) a non-slip floor that is also easy to clean      from a practicable point of view, the fishery products
and disinfect and equipped for easy drainage of water.        must not be kept on board for more than 8 hours.
Structures and fixtures must have limber holds that            (6) Ice used for the chilling of products must be made
are large enough not to be obstructed by fish waste            from drinking water or clean sea water. Before use, it
and to allow water to drain freely, (b) walls and ceil-       must be stored under conditions which prevent its con-
ings that are easy to clean, particularly where there are     tamination. (7) After the fishery products have been
pipes, chains or electricity conduits, (c) the hydraulic      unloaded, the containers, equipment and sections of
circuits must be arranged or protected in such a way          vessels which are directly in contact with the fishery
as to ensure that it is not possible for any leakage of oil   products must be cleaned with drinking water or clean
to contaminate fishery products, (d) adequate ventila-         sea water. (8) Where fish is headed and/or gutted on
tion and, where necessary, proper vapour extraction,          board, such operations must be carried out hygien-
(e) adequate lighting, (f) appliances for cleaning and        ically and the products must be washed immediately
disinfecting tools, equipment and fittings and (g) appli-      and thoroughly with drinking water or clean sea water.
ances for cleaning and disinfecting the hands with taps       The viscera and parts which may pose a threat to pub-
that are not hand-operable and with single use tow-           lic health must be removed and set apart from prod-
els. Conditions for frozen products, especially plants        ucts intended for human consumption. Livers and roes
must have (a) freezing equipment sufficiently power-           intended for human consumption must be refrigerated
ful to achieve a rapid reduction in the temperature so        or frozen. (9) Equipment used for gutting, heading and
that the temperatures laid down to in this Directive          the removal of fins, and containers and equipment in
can be obtained in the product and (b) freezing equip-        contact with the fishery products, must be made of or
ment sufficiently powerful to keep products in storage         coated with a material which is waterproof, resistant
                          EU, US and Canadian Legislation Relating to Safety in Foods                             75

to decay, smooth and easy to clean and disinfect. When      year concerned and (b) where a producer organisation
used they must be completely clean. (10) Staff assigned     has not implemented the measures provided for in its
to the handling of fishery products shall be required to     operational programme, then for the fishing year con-
maintain a high standard of cleanliness for themselves      cerned: (i) only 75% of the financial assistance shall
and their clothes.                                          be granted for intervention operations carried out un-
   According to the Decision 97/296/EC (entry into          der title for the first instance of non-implementation,
force 1/7/1997), the list of countries and territo-         (ii) only 50% of the above financial assistance shall be
ries from which importation of fishery products in           granted for the second instance and (iii) none of the
any form intended for human consumption is au-              above financial assistance shall be granted after any
thorised. The countries are United Arab Emirates,           further instance.
Antigua and Barbuda, Albania, Netherlands Antilles,            All the Directives/Regulations related to specific
Argentina, Australia, Bangladesh, Bulgaria, Brazil,         provisions – fish and fishery products – are given in
Belize, Canada, Switzerland, Ivory Coast, Chile,            Table 2.9.
China, Colombia, Costa Rica, Serbia and Montenegro,
Cuba, Cape Verde, Ecuador, Egypt, Falkland Islands,
                                                            2.2.10 Contamination from substances with
Gabon, Ghana, Greenland, Gambia, Guinea Conakry,
                                                                   hormonal action and other substances
Guatemala, Guyana, Hong Kong, Honduras, Croatia,
Indonesia, India, Iran, Jamaica, Japan, Kenya, South        According to Directive 96/22/EC (entry into force
Korea, Kazakhstan, Sri Lanka, Morocco, Madagascar,          23/5/1996), Member States shall prohibit: (a) the plac-
Mauritania, Mauritius, Maldives, Mexico, Malaysia,          ing on the market of stilbenes, stilbene derivatives,
Mozambique, Namibia, New Caledonia, Nigeria,                their salts and esters and thyrostatic substances for ad-
Nicaragua, New Zealand, Oman, Panama, Peru,                 ministering to animals of all species and (b) the plac-
Papua New Guinea, Philippines, French Polynesia,            ing on the market of beta-agonists for administering
St. Pierre and Miquelon, Pakistan, Romania, Russia,         to animals, the flesh and products of which are in-
Saudi Arabia, Seychelles, Singapore, Senegal, Suri-         tended for human consumption. They shall, also, pro-
name, El Salvador, Thailand, Tunisia, Turkey, Taiwan,       hibit (i) the administering to a farm or aquaculture
Tanzania, Uganda, Uruguay, Venezuela, Vietnam,              animal of substances having a thyrostatic, androgenic
Yemen, Mayotte, South Africa, Zimbabwe, Armenia,            or gestagenic action and of beta-agonists, (ii) the hold-
Angola, Azerbaijan, Benin, Bahamas, Belarus, Re-            ing of animals on a farm, the placing on the market or
public of Congo, Cameroon, Algeria, Eritrea, Fiji,          slaughter for human consumption of farm animals or
Grenada, Israel, Myanmar, Solomon Islands, St.              of aquaculture animals which contain the substances
Helena, Togo and the United States of America.              referred or in which the presence of such substances
   The Regulation (EC) No. 104/2000 (entry into force       has been established, (iii) the placing on the market for
2/2/2000) states for the purposes of this Regulation,       human consumption of aquaculture animals to which
producer organisation means any legal entity: (a) set       substances have been administered and of processed
up on the own initiative of a group of producers of one     products derived from such animals, (iv) the placing
or more of the products, in case of frozen, treated or      on the market of specific animals and (v) the process-
processed products, as the operations in question have      ing of specific kinds of meat. Member States may au-
been carried out on board fishing vessels, (b) estab-        thorise: (1) the administering to farm animals, for ther-
lished for the purpose of ensuring that fishing is car-      apeutic purposes, of oestradiol 17α, testosterone and
ried out along rational lines and that conditions for       progesterone and derivatives and (2) the administer-
the sale of the members’ products are improved, by          ing for therapeutic purposes of authorised veterinary
taking such measures as will encourage the planning         medicinal products containing: (i) allyl trenbolone,
of production, promote the concentration of supply,         administered orally, or beta-agonists to Equidae and
stabilise prices, encourage fishing methods and (c) the      pets and (ii) beta-agonists, in the form of an injection
rules of association of which require its producer mem-     to induce tocolysis in cows when calving. The offi-
bers, in particular to apply to fishing production and       cial checks are carried out by the competent national
marketing. Member States shall carry out appropriate        authorities without prior notice. Member States shall
checks to ensure that each producer organisation fulfils     also prohibit the importation from third countries of:
the obligations and shall apply the following penalties     (a) farm or aquaculture animals to which products
in the event that these obligations are not fulfilled: (a)   or substances referred have been administered by any
where a producer organisation has failed to draw up an      means whatsoever or to which substances or prod-
operational programme for the fishing year, it shall not     ucts referred have been administered, unless those sub-
receive any of the financial assistance granted for inter-   stances or products were administered in compliance
vention operation carried out under title for the fishing    with the provisions and requirements laid down and
76                      HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 2.9 Directives (main points and comments) focused on specific provisions – fish and fishery products.

Title                          Main points                                     Comments

Directive 91/67/EEC (entry     r This Directive creates a framework            Amendments – Directive
into force 1/1/1993)             designed to overcome obstacles to trade       r 93/54/EEC (entry into force 30/6/1994)
The animal health                in aquaculture animals while at the same      r 95/22/EC (entry into force 31/12/1995)
conditions governing the         time avoiding the spread of infectious        r 97/79/EC (entry into force 19/2/1998)
placing on the market of         diseases, particularly in disease-free        r 98/45/EC (entry into force 3/7/1998)
aquaculture animals and          regions of the European Union.                   Changes in the Articles and Annexes
products                       r Aquaculture animals and products must
                                 come from third countries or parts
                                 thereof appearing on a list

Directive 91/492/EEC           r This Directive applies to echinoderms,        Amendments – Directive
(entry into force                  tunicates and marine gastropods             r 97/61/EC (entry into force 18/11/1997)
14/10/1991)                    r   Provisions for Community production         r 97/79/EC (entry into force 19/2/1998)
Laying down the health         r   Imports of live bivalve molluscs from          Laying down the organisation of
conditions for the                 third countries                                veterinary checks
production and the placing     r   Live bivalve molluscs may not be
on the market of live              prepared for marketing except in
bivalve molluscs                   establishments meeting the standards
Directive 91/493/EEC           r   Fishery products which are to be            Amendments – Directive
(entry into force 1/1/1993)        marketed live must at all times be kept     r 95/71/EC (entry into force 30/12/1995)
Laying down the health             under the most suitable survival            r 97/79/EC (entry into force 19/2/1998)
conditions for the                 conditions                                     Laying down the organisation of
production and the placing     r   Certain species that are poisonous or          veterinary checks and adding in the
on the market of fishery            contain biotoxins may not be marketed          Articles
products                       r   Fishery products may not be handled
                                   except in factory ships or establishments
                                   conforming to the standards laid down
                                   in this Directive
Directive 92/48/EEC (entry     r   The general hygiene conditions shall
into force 1/1/1993)               apply to fishery products handled on
Laying down the minimum            board fishing vessels
hygiene rules applicable to    r   The additional hygiene conditions shall
fishery products caught on          apply to fishing vessels designed and
board certain vessels              equipped to preserve fishery products on
                                   board under satisfactory conditions for
                                   more than 24 hours
Decision 97/296/EC (entry      r   List of countries and territories from      Amendments – Decision
into force 1/7/1997)               which importation of fishery products in     r 1999/136/EC (entry into force
Drawing up the list of             any form intended for human                   8/3/1999)
third countries from which         consumption is authorised                   r 1999/244/EC (entry into force 27/4/99)
the import of fishery           r   Certification that fishery products           r 1999/277/EC (entry into force 17/5/99)
products is authorised for         exported to the Community meet the          r 1999/488/EC (entry into force 12/8/99)
human consumption                  health requirements                         r 1999/532/EC (entry into force 23/8/99)
                                                                               r 1999/814/EC (entry into force
                                                                                 29/12/99)
                                                                               r 2000/88/EC (entry into force
                                                                                 22/2/2000)
                                                                               r 2000/170/EC (entry into force 19/3/00)
                                                                               r 2000/674/EC (entry into force
                                                                                 24/11/00)
                                                                               r 2001/40/EC (entry into force 2/2/2001)
                                                                               r 2001/66/EC (entry into force
                                                                                 13/2/2001)
                                                                               r 2001/111/EC (entry into force
                                                                                 5/3/2001)
                                                                               r 2001/635/EC (entry into force
                                                                                 6/9/2001)
                                                                               r 2002/28/EC (entry into force 4/2/2002)
                             EU, US and Canadian Legislation Relating to Safety in Foods                                77

Table 2.9 (Continued )

Title                             Main points                                     Comments
                                                                                  r 2002/473/EC (entry into force 11/6/02)
                                                                                  r 2002/863/EC (entry into force
                                                                                    25/11/02)
                                                                                  r 2003/303/EC (entry into force 23/5/03)
                                                                                  r 2003/606/EC (entry into force
                                                                                    9/9/2003)
                                                                                  r 2003/764/EC (entry into force
                                                                                    14/11/03)
                                                                                  r 2004/36/EC (entry into force 3/2/2004)
                                                                                  r 2004/359/EC (entry into force 10/4/04)
                                                                                     Addition in the list of countries
Regulation (EC) No.               r A common organisation of markets in           Repeals
104/2000 (entry into force            fishery products is hereby established,      Regulation (EEC)
2/2/2000)                             comprising a price and trading system       r No. 3759/92 from 1/1/2001
The common organisation               on competition                              r No. 105/76 from 1/1/2001
of the markets in fishery          r   Marketing standards and consumer            r No. 1772/82 from 1/1/2001
and aquaculture products              information                                 r Amendments – Regulation (EC)
                                  r   Conditions for grant of and withdrawal      r No. 2065/2001 (entry into force 1/1/02)
                                      recognition of producer organisations       r No. 1767/2004 (entry into force
                                  r   Production and marketing planning             4/11/04)
                                  r   Trade of fishery products with third            Corrections in the Articles of this
                                      countries                                      Directive

Adapted from Arvanitoyannis et al. (2005).

the withdrawal periods allowed in international rec-             comply with the sampling rules and levels. Member
ommendations have been observed and (b) meat or                  States may have official random checks conducted: (i)
products obtained from animals, the importation of               during the manufacture of the substances and during
which is prohibited.                                             their handling, storage, transport, distribution and sale
   In agreement with Directive 96/23/EC (entry into              or acquisition, (ii) at any point in the animal foodstuffs
force 23/5/1996), substances having an anabolic ef-              production and distribution chain and (iii) throughout
fect and unauthorised substances are (1) stilbenes, stil-        the production chain of animals and raw materials of
bene derivatives and their salts and esters, (2) an-             animal origin covered by this Directive. Where illegal
tithyroid agents, (3) steroids and (4) resorcylic acid           treatment is established, the competent authority must
lactones including zeranol and beta-agonists. More-              ensure that the livestock is immediately placed under
over, veterinary drugs and contaminants which are                official control. Where there is evidence of residues of
to be monitored include: (a) antibacterial substances,           authorised substances or products of a level exceed-
including sulphonomides, quinolones, (b) other vet-              ing the maximum limit for residues, the competent au-
erinary drugs (anthelmintics, anticoccidials, carba-             thority shall carry out an investigation in the farm of
mates and pyrethroids, sedatives, non-steroidal anti-            origin or departure, as applicable, to determine why
inflammatory drugs, other pharmacologically active                the above limit was exceeded. In the event of repeated
substances) and (c) other substances and environmen-             infringements of maximum residue limits when ani-
tal contaminants (organochlorine compounds includ-               mals are placed on the market by a farmer or products
ing PCBs, organophosphorus compounds, chemical el-               are placed on the market by a farmer or a processing
ements, mycotoxins, dyes). The plan used to carry out            establishment, intensified checks on the animals and
the required inspections shall (a) provide for detection         products from the farm and/or establishment in ques-
of groups of residues or substances according to type            tion must be carried out by the competent authorities
of animal, (b) specify in particular the measures for de-        for a period of at least 6 months, products or carcases
tection of the presence of the substances referred in the        being impounded pending the results of analysis of the
animals, in the drinking water of the animals and in all         samples.
places where the animals are bred or kept and residues              Some representative points and comments of the Di-
of the aforementioned substances in live animals, their          rectives regarding contamination from substances with
excrement and body fluids and in animal tissues and               hormonal action and other substances are given in
products such as meat, milk, eggs and honey and (c)              Table 2.10.
78                       HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 2.10 Directives (main points and comments) for contamination from substances with hormonal action and other
substances.

Title                             Main points                                     Comments

Directive 96/22/EC (entry         r The placing on the market and the             Repeals
into force 23/5/1996)               administering to farm animals of              r Directive 81/602/EEC from 1/7/1997
The prohibition on the use          substances having a thyrostatic action or     r Directive 88/146/EEC from 1/7/1997
in stockfarming of certain          substances having an oestrogenic,             r Directive 88/299/EEC from 1/7/1997
substances having a                 androgenic or gestagenic action and of
hormonal or thyrostatic             stilbenes and beta-agonists are
action and of beta-agonists         prohibited
                                  r Certain of these substances may be used
                                    for therapeutic purposes provided their
                                    use is controlled
Directive 96/23/EC (entry         r The to be monitored substances are            Repeals
into force 23/5/1996)               divided into two groups: substances           r Directive 85/358/EEC from 1/7/1997
Measures to monitor                 having anabolic effect and unauthorised       r Directive 86/469/EEC from 1/7/1997
certain substances and              substances on the one hand, and               r Directive 89/197/EEC from 1/7/1997
residues thereof in live            veterinary drugs and contaminants on          r Directive 91/664/EEC from 1/7/1997
animals and animal                  the other. Determination of the official
products                            control measures and of those taken in
                                    the event of infringement

Adapted from Arvanitoyannis et al. (2005).



2.2.11 Biological safety                                         and caprine animals of all ages, (c) the entire head
                                                                 (excluding the tongue) of bovine animals aged over
Regulation (EC) No. 999/2001 (entry into force                   6 months, and the intestines of animals of all ages,
1/7/2001) has no application to (a) cosmetic or medic-           (d) the vertebral column of bovine animals aged over
inal products or medical devices, or to their starting           30 months and (e) the skull including the brain and
materials or intermediate products, (b) products which           eyes, the tonsils, the spinal cord of ovine and caprine
are not intended for use in human food, animal feed or           animals aged over 12 months and the spleen of ovine
fertilisers, or to their starting materials or intermedi-        and caprine animals of all ages. All these shall be re-
ate products, (c) products of animal origin intended for         moved from slaughterhouses, cutting plants, high-risk
exhibition, teaching, scientific research, special studies        processing plants or premises. Any animal suspected of
or analysis and (d) live animals used in or intended for         being infected by a TSE shall be placed under an offi-
research. Each Member State shall carry out an annual            cial movement restriction until the results of a clinical
programme for monitoring BSE and scrapie. Member                 and epidemiological examination are known. Where
States shall inform the Commission of the emergence              the competent authority decides that the possibility
of a TSE encephalopathy other than BSE. All official              of infection with a TSE cannot be ruled out, the an-
investigations and laboratory examinations shall be              imal shall be killed, if it is still alive; its brain and
recorded. Finally, Member States shall submit an an-             all other tissues as the competent authority may de-
nual report to the Commission. According to the Reg-             termine shall be removed and sent to an officially ap-
ulation, the following are prohibited: (i) the feeding to        proved laboratory. When the presence of a TSE has
any farmed animal of protein derived from mammals,               been officially confirmed, the following measures shall
(ii) the feeding to any mammal of processed animal               be applied as soon as possible: (1) all parts of the body
protein derived from mammals and (iii) the feeding to            of the animal shall be completely destroyed, (2) an
any ruminant of rendered ruminant fat. The following             enquiry shall be carried out to identify all animals at
tissues shall be designated as specified risk materials:          risk and (3) all animals and products of animal ori-
(a) the skull, including the brain and eyes, the ton-            gin that have been identified as being at risk, shall be
sils and the spinal cord of bovine animals aged over             killed and completely destroyed. The use of ruminant
12 months and the intestines of bovine animals of all            materials for the production of the following products
ages, (b) the skull including the brain and eyes, the            of animal origin is prohibited: mechanically recovered
tonsils and the spinal cord of ovine and caprine an-             meat, dicalcium phosphate intended as foodstuffs for
imals aged over 12 months and the spleen of ovine                livestock, gelatin, unless it is produced from ruminant
                            EU, US and Canadian Legislation Relating to Safety in Foods                                      79

Table 2.11 Regulations (main points and comments) with regard to biological safety.

Title                                        Main points

Regulation (EC) No. 999/2001                 r Rules for the prevention, control and eradication of TSEs in animals
(entry into force 1/7/2001)                  r Application to the production and placing on the market of live animals and
Rules for the prevention, control                products of animal origin and in certain specific cases to exports thereof
and eradication of certain                   r Member States shall carry out an annual programme for monitoring BSE and
transmissible spongiform                       scrapie
encephalopathies (TSEs)                      r The feeding to ruminants of protein derived from mammals is prohibited
                                             r The specified risk material shall be removed and destroyed
Regulation (EC) No. 2160/2003                r Measures to detect and to control Salmonella and other zoonotic agents
(entry into force 12/12/2003)                r Application to production, processing and distribution
The control of Salmonella and                r Designation of a competent authority for each Member State and arrangement
other specified foodborne zoonotic              of responsibilities
agents                                       r Arrangement of control plans
                                             r Imports from third countries only if specific conditions are met

Adapted from Arvanitoyannis et al. (2005).

hides, derivatives made from rendered ruminant fat                   logical units, (d) the definition of the testing schemes
and rendered ruminant fat.                                           necessary to verify the achievement of the target and (e)
   The purpose of Regulation (EC) No. 2160/2003 (en-                 the definition, where relevant, of serotypes with pub-
try into force 12/12/2003) is to ensure that proper and              lic health significance or of other subtypes of zoonoses
effective measures are taken to detect and to control                or zoonotic agents. To achieve the Community tar-
salmonella and other zoonotic agents at all relevant                 gets, Member States shall establish national control
stages of production, processing and distribution, par-              programmes for each zoonosis and zoonotic agent.
ticularly at the level of primary production, includ-                National control programmes shall cover at least the
ing in feed, in order to reduce their prevalence and                 following stages of the food chain: feed production,
the risk they pose to public health. This Regulation                 primary production of animals, processing and prepa-
shall cover: (a) the adoption of targets for the reduc-              ration of food of animal origin. After a Member State
tion of the prevalence of specified zoonoses in animal                submits a national control programme, the Commis-
populations, (b) the approval of specific control pro-                sion shall have 2 months within which to request any
grammes established by Member States and food and                    further relevant and necessary information from that
feed business operators, (c) the adoption of specific                 Member State. The Member State shall provide such
rules concerning certain control methods applied in the              further information within 2 months of receiving such
reduction of the prevalence of zoonoses and zoonotic                 a request. The Commission shall, within 2 months of
agents and (d) the adoption of rules concerning intra-               receiving such further information or, if it did not re-
Community trade and imports from third countries                     quest further information, within 6 months of the sub-
of certain animals and products thereof. It shall not                mission of the control programme, establish whether it
apply to primary production: (a) for private domes-                  complies with relevant rules, including this Regulation
tic use or (b) leading to the direct supply, by the pro-             in particular.
ducer, of small quantities of primary products to the                   Some points of the EU legislation focused on bio-
final consumer or to local retail establishments directly             logical safety are stated in Table 2.11.
supplying the primary products to the final consumer.
Each Member State shall designate a competent au-
thority or competent authorities for the purpose of                  2.3 US LEGISLATION FOR FOOD OF
this Regulation and notify the Commission thereof.                       ANIMAL ORIGIN
The Community targets for the reduction of the preva-
lence of zoonoses and zoonotic agents consist at least               2.3.1 Meat, poultry and their products legislation
of a numerical expression of (a) the maximum per-                    Following the Federal Meat Inspection Act (1908),
centage of epidemiological units remaining positive                  ‘meat food product’ means any product capable of use
and/or the minimum percentage of reduction in the                    as human food which is made wholly or in part from
number of epidemiological units remaining positive,                  any meat or other portion of the carcass of any cattle,
(b) the maximum time limit within which the target                   sheep, swine or goats, excepting products which con-
must be achieved, (c) the definition of the epidemio-                 tain meat or other portions of such carcasses only in
80                      HACCP and ISO 22000 – Application to Foods of Animal Origin

a relatively small proportion or historically have not       ported into the United States unless they are healthful,
been considered by consumers as products of the meat         wholesome, fit for human food, not adulterated, and
food industry, and which are exempted from defini-            contain no dye, chemical, preservative or ingredient
tion as a meat food product by the Secretary under           which renders them unhealthful, unwholesome, adul-
such conditions as he or she may prescribe to assure         terated or unfit for human food and unless they also
that the meat or other portions of such carcasses con-       comply with the rules and regulations made by the Sec-
tained in such product are not adulterated and that          retary of Agriculture to assure that imported poultry or
such products are not represented as meat food prod-         poultry products comply with the standards provided
ucts. This term as applied to food products of equines       for in this chapter.
shall have a meaning comparable to that provided in              For the purpose of Egg Products Inspection (1970),
this paragraph with respect to cattle, sheep, swine and      ‘egg product’ means any dried, frozen or liquid eggs,
goats. For the purpose of preventing the use in com-         with or without added ingredients, excepting products
merce of meat and meat food products which are adul-         which contain eggs only in a relatively small propor-
terated, the Secretary shall cause to be made, by in-        tion or historically have not been, in the judgement
spectors appointed for that purpose, an examination          of the Secretary, considered by consumers as prod-
and inspection of all cattle, sheep, swine, goats, horses,   ucts of the egg food industry, and which may be ex-
mules and other equines before they shall be allowed         empted by the Secretary under such conditions as he
to enter into any slaughtering, packing, meat-canning,       or she may prescribe to assure that the egg ingredients
rendering or similar establishment, in which they are        are not adulterated and such products are not repre-
to be slaughtered and the meat and meat food prod-           sented as egg products and ‘egg’ means the shell egg
ucts thereof are to be used in commerce; and all cattle,     of the domesticated chicken, turkey, duck, goose or
sheep, swine, goats, horses, mules and other equines         guinea. Eggs and egg products found to be adulterated
found on such inspection to show symptoms of dis-            at official plants shall be condemned and, if no appeal
ease shall be set apart and slaughtered separately from      be taken from such determination of condemnation,
all other cattle, sheep, swine, goats, horses, mules or      such articles shall be destroyed for human food pur-
other equines, and when so slaughtered the carcasses of      poses under the supervision of an inspector: Provided
said cattle, sheep, swine, goats, horses, mules or other     that articles which may by reprocessing be made not
equines shall be subject to a careful examination and        adulterated need not be condemned and destroyed if
inspection, all as provided by the rules and regulations     so reprocessed under the supervision of an inspector
to be prescribed by the Secretary.                           and thereafter found to be not adulterated. If an ap-
   In the Poultry Products Inspection Act (1968), ‘poul-     peal be taken from such determination, the eggs or
try’ means any domesticated bird, whether live or dead       egg products shall be appropriately marked and seg-
and ‘poultry product’ means any poultry carcass, or          regated pending completion of an appeal inspection,
part thereof; or any product which is made wholly or in      which appeal shall be at the cost of the appellant if
part from any poultry carcass or part thereof, except-       the Secretary determines that the appeal is frivolous.
ing products which contain poultry ingredients only          If the determination of condemnation is sustained, the
in a relatively small proportion or historically have        eggs or egg products shall be destroyed for human food
not been considered by consumers as products of the          purposes under the supervision of an inspector.
poultry food industry, and which are exempted by the             Following meat and poultry pathogen reduction and
Secretary from definition as a poultry product under          Hazard Analysis and Critical Control Point (HACCP)
such conditions as the Secretary may prescribe to as-        systems (1996), each official establishment that slaugh-
sure that the poultry ingredients in such products are       ters cattle and/or hogs shall test for E. coli Biotype I
not adulterated and that such products are not repre-        (E. coli) and shall (i) collect samples in accordance
sented as poultry products. Each official establishment       with the sampling techniques and methodology and
slaughtering poultry or processing poultry products          (ii) obtain analytic results. An establishment’s raw
for commerce or otherwise subject to inspection un-          meat products or raw poultry products, when sampled
der this chapter shall have such premises, facilities and    and tested by Food Safety and Inspection Service (FSIS)
equipment, and be operated in accordance with such           for Salmonella, may not test positive for Salmonella
sanitary practices, as are required by regulations pro-      at a rate exceeding the applicable national pathogen
mulgated by the Secretary for the purpose of prevent-        reduction performance standard. Food safety haz-
ing the entry into or flow or movement in commerce or         ards might be expected to arise from the following:
burdensome effect upon commerce, of poultry prod-            (i) natural toxins, (ii) microbiological contamination,
ucts which are adulterated. No slaughtered poultry,          (iii) chemical contamination, (iv) pesticides, (v) drug
or parts or products thereof, of any kind shall be im-       residues, (vi) zoonotic diseases, (vii) decomposition,
                           EU, US and Canadian Legislation Relating to Safety in Foods                               81

(viii) parasites, (ix) unapproved use of direct or indirect    and smell. They conduct both ante-mortem (before
food or colour additives and (x) physical hazards. Ev-         slaughter) and post-mortem (after slaughter) inspec-
ery establishment shall develop and implement when-            tion. Inspectors look for signs of disease, contami-
ever a hazard analysis reveals one or more food safety         nation and/or other abnormal conditions. FSIS’s legal
hazards that are reasonably likely to occur includ-            inspection responsibilities do not begin until animals
ing products in the following processing categories:           arrive at slaughterhouses, and they generally end once
(a) slaughter – all species, (b) raw product – ground,         products leave processing plants. The agency has
(c) raw product – not ground, (d) thermally processed          no regulatory jurisdiction at the farm level. The US
– commercially sterile, (e) not heat treated – shelf sta-      Department of Agriculture (USDA) states that generic
ble, (f) heat treated – shelf stable, (g) fully cooked – not   E. coli was chosen because it is the best microbial in-
shelf stable, (h) heat treated but not fully cooked – not      dicator of faecal contamination, the primary vehicle
shelf stable and (i) product with secondary inhibitors –       for such potentially dangerous bacteria as Salmonella,
not shelf stable.                                              Campylobacter and E. coli O157:H7. USDA inspec-
   Meat, Poultry and Egg Products Inspection (1999):           tors conduct the Salmonella testing. Plants were re-
(i) requires that each plant develop and implement             quired to begin meeting the standards when they im-
written standard operating procedures for sanitation           plemented their HACCP plans.
to reduce the likelihood that harmful bacteria will               US legislation dealing with meat, poultry and their
contaminate the finished product, (ii) requires regu-           products are given in Table 2.12.
lar microbial testing by slaughter establishments to
verify the adequacy of their process controls for pre-
                                                               2.3.2 US legislation for fish and fishery products
venting and removing faecal contamination, (iii) estab-
lished pathogen reduction performance standards for            According to procedures for the safe and sanitary pro-
Salmonella that slaughter plants and plants producing          cessing and importing of fish and fishery products
raw ground products had to meet and (iv) required              (1995), ‘fish’ means fresh or saltwater finfish, crus-
that all meat and poultry plants develop and imple-            taceans, other forms of aquatic animal life (including,
ment HACCP systems to prevent food safety problems,            but not limited to, alligator, frog, aquatic turtle, jel-
by addressing microbial, chemical and physical haz-            lyfish, sea cucumbers, and sea urchin and the roe of
ards reasonably likely to occur. FSIS began conduct-           such animals) other than birds or mammals, and all
ing a risk assessment for E. coli O157:H7 in ground            molluscs, where such animal life is intended for hu-
beef and carcass trimmings. The risk assessment will           man consumption; ‘fishery products’ mean any human
estimate the risk of foodborne illness from E. coli            food product in which fish is a characterising ingredi-
O157:H7 both with existing programmes and prac-                ent. The HACCP plan shall at a minimum list the food
tices and with alternative mitigation strategies. FSIS         safety hazards that are reasonably likely to occur and
is exploring whether further changes are needed in its         that thus must be controlled for each fish and fishery
policy regarding E. coli O157:H7 in the light of new           product. Food safety hazards are reasonably likely to
information that is emerging about the pathogen and            occur as a result of the following: (i) natural toxins,
its relation to human health. FSIS will re-evaluate its        (ii) microbiological contamination, (iii) chemical con-
policy on E. coli O157:H7 through an open, partici-            tamination, (iv) pesticides, (v) drug residues, (vi) de-
patory process, soliciting input from all of its various       composition in scombroid toxin, (vii) parasites, (viii)
constituents.                                                  unapproved use of direct or indirect food or colour ad-
   In the Meat and Poultry Inspection Issues (2000), no        ditives and (ix) physical hazards. Every importer of fish
meat or poultry establishment can slaughter or process         and fishery products shall either obtain the fish or fish-
products for human consumption until FSIS approves             ery product from a country that has an active memo-
in advance its plans and specifications for the premises,       randum of understanding (MOU) or similar agreement
equipment and operating procedures. A key feature              that covers the fish or fishery product and documents
of the programme is that FSIS must inspect all meat            the equivalency or compliance of the inspection sys-
and poultry animals at slaughter on a continuous ba-           tem of the foreign country with the US system or have
sis; that is, no animal may be slaughtered and dressed         and implement written verification procedures for en-
unless an inspector has examined each carcass. One             suring that the fish and fishery products that they offer
or more federal inspectors are ‘on the line’ during all        for import into the United States were processed in ac-
hours the plant is operating; the appropriate number           cordance with the requirements of this part. Processors
depends upon each plant’s production level. Since the          of smoked or smoke-flavoured fishery products shall
programme’s inception, inspectors have relied mostly           include in their HACCP plans how they are controlling
on organoleptic detection procedures: sight, touch             the food safety hazard associated with the formation
82                       HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 2.12 US legislation related to meat, poultry and their products.

                          Entry into
Title                     force          Main points                                           Comments

Federal Meat              1908           r Definitions (meat food product etc.)                 Amendments
Inspection Act                           r Inspection of meat and meat food products           r 1958 (changes in slaughtering
                                         r Sanitary inspection and regulation of                 and handling methods)
                                             slaughtering and packing establishments;          r 1967 (amendments in the
                                             rejection of adulterated meat or meat food          slaughter, storage, handling
                                             products                                            and distribution of carcases)
                                         r   Marking, labelling or other identification of      r 1970 (repeal two sections of
                                             kinds of animals of articles’ derivation;           the Act)
                                             separate establishments for preparation and       r 1999 (replacements of sections)
                                             slaughtering activities
Poultry Products          1968           r   Poultry and poultry products are an
Inspection Act                               important source of the nation’s total supply
                                             of food
                                         r   Definitions (poultry, poultry products etc.)
                                         r   Federal and State cooperation in
                                             development and administration of State
                                             poultry product inspection programmes
                                         r   Sanitary practices
                                         r   Storage and handling of poultry products
Egg Products              1970           r   Eggs and egg products are an important
Inspection                                   source of the nation’s total supply of food,
                                             and are used in food in various forms
                                         r   Definitions (egg product, egg etc.)
                                         r   Inspection of egg products
                                         r   Pasteurisation and labelling of egg products
                                             at official plants
Meat and poultry          1996           r   Contamination with micro-organisms,
pathogen reduction                           pathogen reduction performance standards
and Hazard Analysis                          for Salmonella
and Critical Control                     r   Poultry products inspection regulations
Point (HACCP)                            r   Sanitation control procedures for meat and
systems                                      poultry
Meat, Poultry and         1999           r   The Food Safety and Inspection Service
Egg Products                                 (FSIS), a public health regulatory agency
Inspection                                   within the US Department of Agriculture
                                             (USDA), is responsible for ensuring that the
                                             commercial supply of meat, poultry and egg
                                             products in the United States is safe,
                                             wholesome and accurately labelled
                                         r   FSIS and FDA worked together on a Listeria
                                             monocytogenes (Listeria) risk ranking
Meat and Poultry          2000           r   The USDA’s FSIS is responsible for
Inspection Issues                            inspecting most meat, poultry and processed
                                             egg products for safety, wholesomeness and
                                             proper labelling
                                         r   No meat or poultry establishment can
                                             slaughter or process products for human
                                             consumption until FSIS approves in advance
                                             its plans and specifications for the premises,
                                             equipment and operating procedures
                                         r   FSIS’s legal inspection responsibilities do not
                                             begin until animals arrive at
                                             slaughterhouses, and they generally end
                                             once products leave processing plants

Adapted from Arvanitoyannis et al. (2006).
                          EU, US and Canadian Legislation Relating to Safety in Foods                                83

        Table 2.13 US legislation for fish and fishery products.

        Title                                                Main points

        Procedures for the safe and             1995         r Definitions (fish, fishery products etc.)
        sanitary processing and importing                    r Current good manufacturing practice
        of fish and fishery products                           r Special requirements for imported products and for
                                                               processing smoked, smoke-flavoured fishery
                                                               products, fresh and frozen molluscan shellfish
        Sustainable Fishery Act                 1996         r Fishery monitoring, research and management plans
                                                             r Fisheries financing and capacity reduction

        Adapted from Arvanitoyannis et al. (2006).


of toxin by Clostridium botulinum for at least as long          terested governmental and non-governmental parties
as the shelf life of the product under normal and mod-          and shall (1) be designed to standardise the require-
erate abuse conditions.                                         ments of vessel registration and information collec-
   For the purpose of Sustainable Fishery Act (1996),           tion systems required by this Act, the Marine Mam-
‘commercial fishing’ means fishing in which the fish               mal Protection Act and any other marine resource law
harvested, either in whole or in part, are intended to en-      implemented by the Secretary, and, with the permis-
ter commerce or enter commerce through sale, barter             sion of a State, any marine resource law implemented
or trade and ‘fishing community’ means a commu-                  by such State, (2) integrate information collection pro-
nity which is substantially dependent on or substan-            grammes under existing fishery management plans into
tially engaged in the harvest or processing of fishery           a non-duplicative information collection and manage-
resources to meet social and economic needs, and in-            ment system, (3) avoid duplication of existing State,
cludes fishing vessel owners, operators and crew and             tribal or Federal systems and shall utilise, to the max-
the US fish processors that are based in such commu-             imum extent practicable, information collected from
nity. The North Pacific Council and the Secretary shall          existing systems, (4) provide for implementation of the
establish a western Alaska community development                system through cooperative agreements with appropri-
quota programme under which a percentage of the to-             ate State, regional or tribal entities and Marine Fish-
tal allowable catch of any Bering Sea fishery is allo-           eries Commissions, (5) provide for funding (subject
cated to the programme. To be eligible to participate           to appropriations) to assist appropriate State, regional
in the western Alaska community development quota               or tribal entities and Marine Fisheries Commissions
programme under subparagraph, a community shall (i)             in implementation, (6) establish standardised units of
be located within 50 nautical miles from the baseline           measurement, nomenclature and formats for the col-
from which the breadth of the territorial sea is mea-           lection and submission of information, (7) minimise
sured along the Bering Sea coast from the Bering Strait         the paperwork required for vessels registered under
to the westernmost of the Aleutian Islands, or on an            the system, (8) include all species of fish within the
island within the Bering Sea, (ii) not be located on the        geographic areas of authority of the Councils and all
Gulf of Alaska coast of the North Pacific Ocean, (iii)           fishing vessels including charter fishing vessels, but ex-
meet criteria developed by the Governor of Alaska, ap-          cluding recreational fishing vessels and (9) require the
proved by the Secretary, and published in the Federal           US fish processors, and fish dealers and other first ex-
Register, (iv) be certified by the Secretary of the Inte-        vessel purchasers of fish that are subject to the pro-
rior pursuant to the Alaska Native Claims Settlement            posed system, to submit information (other than eco-
Act to be a Native village, (v) consist of residents who        nomic information) which may be necessary to meet
conduct more than one-half of their current commer-             the goals of the proposed system.
cial or subsistence fishing effort in the waters of the             A summary of the US legislation focused on fish and
Bering Sea or waters surrounding the Aleutian Islands           fishery products is given in Table 2.13.
and (vi) not have previously developed harvesting or
processing capability sufficient to support substantial
                                                                2.4 CANADIAN LEGISLATION FOR FOOD OF
participation in the groundfish fisheries in the Bering
                                                                    ANIMAL ORIGIN
Sea, unless the community can show that the bene-
fits from an approved Community Development Plan
                                                                2.4.1 Meat legislation
would be the only way for the community to realise
a return from previous investments. The recommen-               According to Meat Inspection Act (1985), it shall be
dations shall be developed after consultation with in-          a condition of the registration and operation of an
84                     HACCP and ISO 22000 – Application to Foods of Animal Origin

establishment as a registered establishment that the es-   connection with which the meat inspection legend is
tablishment and all animals and meat products in it are    applied or used and prescribing the fees payable there-
subject to this Act and the regulations. No person shall   fore, (i) prescribing standards for meat products that
operate a registered establishment unless that person      are prepared or stored in registered establishments,
has obtained a licence therefore in accordance with the    for meat products that enter into interprovincial or
regulations. The meat inspection legend shall be a na-     international trade and for meat products in connec-
tional trademark, and the exclusive property in and,       tion with which the meat inspection legend is applied
subject to this Act, the right to the use of that trade-   or used, (j) prescribing standards for imported meat
mark is hereby declared to be vested in Her Majesty        products, (k) governing the packaging and labelling of
in right of Canada. No person shall export a meat          meat products and prescribing the specifications for
product out of Canada unless (a) it was prepared or        the packages and labels, (l) respecting the withholding
stored in a registered establishment that was operated     from slaughter of animals and the inspection, holding,
in accordance with this Act and the regulations, (b)       treatment, condemnation, confiscation and disposal of
that person provides an inspector with evidence sat-       animals, meat products or other things in registered es-
isfactory to the Minister that the meat product meets      tablishments that are or are suspected on reasonable
the requirements of the country to which it is being ex-   grounds of being injurious to health or otherwise in
ported and (c) that person obtains a certificate from an    contravention of this Act or the regulations, (m) re-
inspector authorising the export of that meat product.     specting the inspection and disposal of imported meat
No person shall import a meat product into Canada          products and prescribing the fees payable for such in-
unless (a) at the time it was prepared for export, the     spection, (n) providing for systems for ascertaining the
country from which it originated and any country in        places of origin of the animals to be slaughtered in reg-
which it was processed had meat inspection systems,        istered establishments, (o) prescribing the manner of
those systems and the relevant establishments in those     seizing and detaining anything under this Act and pro-
countries were approved in writing by the Minister         viding for the safe-keeping and disposal of anything
before that time and the approvals were valid at that      seized, detained or forfeited under this Act, (p) respect-
time, (b) that person provides an inspector with ev-       ing the storage, handling and transportation of meat
idence satisfactory to the Minister that it meets the      products and the payment of expenses in connection
prescribed standards for imported meat products, (c)       with that storage, (q) prohibiting the transportation
it meets the prescribed standards for imported meat        of meat products unless they are properly packaged
products and (d) it is packaged and labelled in the man-   and labelled under this Act and the regulations and
ner prescribed. The Governor in Council may make           evidence satisfactory to the Minister are provided that
regulations for carrying out the purposes and provi-       they meet any other requirements of this Act and the
sions of this Act and, without limiting the generality     regulations, (r) exempting any person, establishment,
of the foregoing, may make regulations (a) prescribing     registered establishment, animal, meat product or any
the meat inspection legend and the form and manner         class thereof from the application of this Act or the
in which, terms and conditions on which, persons by        regulations or any provisions thereof, subject to such
whom and things in connection with which it may be         terms and conditions as the Governor in Council con-
applied or used, (b) governing the registration of es-     siders appropriate and (s) prescribing anything that by
tablishments and the licensing of the operators thereof,   this Act is to be prescribed. The main points of this
and prescribing the fees payable therefore, (c) provid-    Act are given in Table 2.14.
ing for the cancellation and suspension of the registra-
tion of registered establishments, (d) governing the de-
                                                           2.4.2 Fish and fishery products legislation
sign, construction and maintenance of registered estab-
lishments and of the equipment and facilities therein,     The Fish Inspection Act (1985) applies to the shipment
(e) respecting the operation and suspension of oper-       of fish or marine plants from one province to another
ation of registered establishments, (f) prescribing the    as though the shipment from a province were an export
equipment and facilities to be used, the procedures to     and the shipment into a province were an import. The
be followed and the standards to be maintained in reg-     Governor in Council may, for the purpose of regulating
istered establishments to ensure humane treatment and      the export or import of fish and containers, make reg-
slaughter of animals and hygienic processing and han-      ulations (a) prescribing grades, quality and standards
dling of meat products, (g) providing for the inspec-      of fish; (b) defining, for the purposes of section 10,
tion of establishments and registered establishments       the expressions ‘tainted’, ‘decomposed’ and ‘unwhole-
and the animals and meat products in registered estab-     some’; (c) respecting the processing, storing, grading,
lishments and prescribing the fees payable therefore,      packaging, marking, transporting and inspection of
(h) providing for the reinspection of meat products in     fish; (d) respecting the quality and specifications for
                          EU, US and Canadian Legislation Relating to Safety in Foods                               85

          Table 2.14 Canadian legislation focused on meat.

          Title                        Year        Main points

          Meat Inspection Act          1985        r Provisions for export, interprovincial trade and import
                                                   r The Governor in Council may make regulations for
                                                    carrying out the purpose of this Act
                                                   r It shall be a condition of the registration and operation of
                                                    an establishment as a registered establishment that the
                                                    establishment and all animals and meat products in it are
                                                    subject to this Act and the regulations



containers and the marking and inspection of contain-         Every person who contravenes a provision of this Act
ers; (e) requiring the registration of establishments and     or a regulation made under it is guilty of an offence
the licensing of persons engaged as principals or agents      and liable (a) on summary conviction (i) to a fine not
in the export or import of fish or containers; (f) pre-        exceeding $20,000 or to imprisonment for a term not
scribing the requirements for the equipment and sani-         exceeding 3 months or to both, or (ii) for a subsequent
tary operation of establishments, of premises operated        offence, to a fine not exceeding $50,000 or to impris-
by an importer for the purpose of importing fish, and          onment for a term not exceeding 2 years or to both;
of any boats, vehicles or other equipment used in con-        or (b) on conviction by indictment (i) in the case of
nection with an establishment or in connection with           a corporation, to a fine not exceeding $250,000, and
fishing or the import or export of fish; (g) prescribing        (ii) in the case of an individual, to a fine not exceeding
fees for registration of establishments, issue of licences    $100,000 or to imprisonment for a term not exceeding
and grading and inspection services; (h) prohibiting          5 years or to both.
the sale or offering for sale or holding in possession           In agreement with Fresh Fish Marketing Act (1985),
for sale of any fish or containers under any grade name        the Corporation is established for the purpose of mar-
or standard prescribed by regulations made under this         keting and trading in fish, fish products and fish by-
Part unless all the requirements of this Part and the         products in and outside Canada and, in addition to the
regulations thereunder with respect thereto have been         powers conferred by other provisions of this Act and
complied with, or under any name calculated to mis-           by any other Act, has for that purpose power to (a) buy
lead or deceive; (i) prescribing the manner in which          fish and dress, fillet, freeze, package or otherwise pre-
samples of any fish may be taken; (j) prohibiting or           pare fish for market; (b) buy, manufacture or produce
restricting any export or import of, or any attempt or        fish products and fish by-products and package or oth-
offer to export or import, any fish or containers unless       erwise prepare fish products and fish by-products for
all the requirements of this Part and the regulations         market; (c) store, ship, insure, import, export, market,
thereunder with respect thereto have been complied            sell or otherwise dispose of fish, fish products and fish
with and (k) establishing requirements governing the          by-products bought, prepared, manufactured or pro-
seizure and detention of fish and containers. A thing          duced by it; (d) purchase, lease or otherwise acquire
seized under this Act, or the proceeds realised from its      and hold, sell or otherwise deal with any real property;
disposition, shall not be detained after (a) an inspec-       (e) establish branches or employ agents in Canada or
tor determines that this Act and the regulations have         elsewhere; (f) invest any money in its possession or
been complied with in relation to the thing, or (b) the       under its control that in its opinion is not immediately
expiration of 180 days after the day of its seizure, or       required for the purposes of its operations, in securi-
such longer period as may be prescribed, unless before        ties of or guaranteed by the Government of Canada
that time proceedings are instituted in relation to the       and sell any securities so acquired by it and reinvest
thing seized, in which case it may be detained until          the proceeds or any part of the proceeds thereof in like
the proceedings are finally concluded. The Governor            manner; (g) borrow money from any bank on the credit
in Council may make regulations (a) prescribing stan-         of the Corporation; (h) make loans of working capi-
dards of grade, class or quality for marine plants and        tal on a seasonal basis to persons engaged in fishing
the names or marks that may be used to designate any          for commercial purposes in a participating province;
such grade, class or quality; (b) providing for inspec-       and (i) do all such other things as are necessary or
tion, grading and labelling of marine plants, the form,       incidental to the exercise of any of its powers or the
issue and use of inspection certificates, and prescrib-        carrying out of any of its functions under this Act. For
ing inspection fees; and (c) generally for carrying any       the purpose of enabling the Corporation to carry on
of the purposes or provisions of this Part into effect.       its operations under this Act, the Governor in Council
86                        HACCP and ISO 22000 – Application to Foods of Animal Origin

           Table 2.15 Canadian legislation for fish and fishery products.

           Title                          Year        Main points

           Fish Inspection Act            1985        r   Regulating the export or import of fish and containers
                                                      r   Regulating marine plants
                                                      r   This Act applies to the shipment of fish or marine plants
           Fresh Fish Marketing Act       1985        r   Export trade in fish
                                                      r   Marketing and trading in fish, fish products and fish
                                                          by-products



may authorise the Minister of Finance, on such terms               93/43/EEC
and conditions as may be agreed on (a) to guarantee                  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
repayment of loans, and interest thereon, made by any                celexplus!prod!DocNumber&1g=en&type doc=
                                                                     Directive&an doc=93&nu doc=43
bank to the Corporation; and (b) to make loans to the              93/99/EEC
Corporation. Except in accordance with the terms and                 http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
conditions set out in any licence that may be issued                 celexplus!prod!DocNumber&1g=en&type doc=
by the Corporation in that behalf, no person, other                  Directive&an doc=93&nu doc=99
than the Corporation or an agent of the Corporation,               2002/99/EC
shall (a) export fish from Canada; (b) send, convey                   http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
                                                                     celexplus!prod!DocNumber&1g=en&type doc=
or carry fish from a participating province to another
                                                                     Directive&an doc=2002&nu doc=99
participating province or to any other province; (c) in            2004/41/EC
a participating province, receive fish for conveyance                 http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
or carriage to a destination outside the province; or                celexplus!prod!DocNumber&1g=en&type doc=
(d) sell or buy, or agree to sell or buy, fish situated in            Directive&an doc=2004&nu doc=41
a participating province for delivery in another par-
ticipating province or any other province, or outside
Canada.                                                            Directives related to imports from third countries
   Some representative points and comments of the                  and intra-Community trade; general provisions
Acts regarding fish and fishery products are given in                89/662/EEC
Table 2.15.                                                          http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
                                                                     celexplus!prod!DocNumber&1g=en&type doc=
                                                                     Directive&an doc=89&nu doc=662
                                                                   90/425/EEC
REFERENCES                                                           http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
                                                                     celexplus!prod!DocNumber&1g=en&type doc=
Arvanitoyannis, I.S., Chroreftaki, S. and Tserkezou, P.              Directive&an doc=90&nu doc=425
  (2005). An update of EU legislation (directives and regu-        91/174/EEC
  lations) on food related issues (safety, hygiene, packaging,       http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  technology, additives, GMOs, radiation, labelling). Inter-         celexplus!prod!DocNumber&1g=en&type doc=
  national Journal of Food Science and Technology, 40(10),           Directive&an doc=91&nu doc=174
  1021–1112.                                                       91/496/EEC
Arvanitoyannis, I.S., Tserkezou, P., and Varzakas, T. (2006).        http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  An update of US food safety, food technology, GM food              celexplus!prod!DocNumber&1g=en&type doc=
  and water protection and management legislation. Inter-            Directive&an doc=91&nu doc=496
  national Journal of Food Science and Technology, 41(1),          92/65/EEC
  1130–1159.                                                         http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
                                                                     celexplus!prod!DocNumber&1g=en&type doc=
                                                                     Directive&an doc=92&nu doc=65
                                                                   92/118/EEC
EU legislation                                                       http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
Directives on controls and food hygiene rules                        celexplus!prod!DocNumber&1g=en&type doc=
                                                                     Directive&an doc=92&nu doc=118
85/591/EEC                                                         96/23/EEC
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!                http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  celexplus!prod!DocNumber&1g=en&type doc=                           celexplus!prod!DocNumber&1g=en&type doc=
  Directive&an doc=85&nu doc=591                                     Directive&an doc=96&nu doc=23
                           EU, US and Canadian Legislation Relating to Safety in Foods                            87

97/78/EEC                                                 89/556/EEC
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  celexplus!prod!DocNumber&1g=en&type doc=                  celexplus!prod!DocNumber&1g=en&type doc=
  Directive&an doc=97&nu doc=78                             Directive&an doc=89&nu doc=556
                                                          90/429/EEC
                                                            http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
Directives related to production and placing on the         celexplus!prod!DocNumber&1g=en&type doc=
market – milk                                               Directive&an doc=90&nu doc=429
                                                          Decision 1999/879/EC
89/384/EEC                                                  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       celexplus!prod!DocNumber&1g=en&type doc=
  celexplus!prod!DocNumber&1g=en&type doc=                  Decision&an doc=1999&nu doc=879
  Directive&an doc=89&nu doc=384
92/46/EEC
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!     Directives related to specific provision – ovine and
  celexplus!prod!DocNumber&1g=en&type doc=                caprine animals
  Directive&an doc=92&nu doc=46
                                                          72/462/EEC
                                                            http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
Directives for production and placing on the                celexplus!prod!DocNumber&1g=en&type doc=
market – meat                                               Directive&an doc=72&nu doc=462
                                                          89/361/EEC
91/495/EEC                                                  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       celexplus!prod!DocNumber&1g=en&type doc=
  celexplus!prod!DocNumber&1g=en&type doc=                  Directive&an doc=89&nu doc=361
  Directive&an doc=91&nu doc=495                          91/68/EEC
92/45/EEC                                                   http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       celexplus!prod!DocNumber&1g=en&type doc=
  celexplus!prod!DocNumber&1g=en&type doc=                  Directive&an doc=91&nu doc=68
  Directive&an doc=92&nu doc=45                           2004/68/EC
94/65/EEC                                                   http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       celexplus!prod!DocNumber&1g=en&type doc=
  celexplus!prod!DocNumber&1g=en&type doc=                  Directive&an doc=2004&nu doc=68
  Directive&an doc=94&nu doc=65

                                                          Directives with regard to specific provisions –
Directives dealing with specific provisions – bovine       poultry
and porcine animals
                                                          71/118/EEC
64/432/EEC                                                  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       celexplus!prod!DocNumber&1g=en&type doc=
  celexplus!prod!DocNumber&1g=en&type doc=                  Directive&an doc=71&nu doc=118
  Directive&an doc=64&nu doc=432                          89/437/EEC
72/462/EEC                                                  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       celexplus!prod!DocNumber&1g=en&type doc=
  celexplus!prod!DocNumber&1g=en&type doc=                  Directive&an doc=89&nu doc=437
  Directive&an doc=72&nu doc=462                          90/539/EEC
77/96/EEC                                                   http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       celexplus!prod!DocNumber&1g=en&type doc=
  celexplus!prod!DocNumber&1g=en&type doc=                  Directive&an doc=90&nu doc=539
  Directive&an doc=77&nu doc=96                           92/116/EEC
77/504/EEC                                                  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       celexplus!prod!DocNumber&1g=en&type doc=
  celexplus!prod!DocNumber&1g=en&type doc=                  Directive&an doc=92&nu doc=116
  Directive&an doc=77&nu doc=504
88/407/EEC
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!     Directives for specific provisions – meat and
  celexplus!prod!DocNumber&1g=en&type doc=                meat-based production
  Directive&an doc=88&nu doc=407
88/661/EEC                                                72/461/EEC
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!       http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  celexplus!prod!DocNumber&1g=en&type doc=                  celexplus!prod!DocNumber&1g=en&type doc=
  Directive&an doc=88&nu doc=661                            Directive&an doc=72&nu doc=461
88                      HACCP and ISO 22000 – Application to Foods of Animal Origin

80/215/EEC                                              Regulation (EC) No. 2160/2003
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!     http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  celexplus!prod!DocNumber&1g=en&type doc=                celexplus!prod!DocNumber&1g=en&type doc=
  Directive&an doc=80&nu doc=215                          Regulation&an doc=2003&nu doc=2160
91/497/EEC
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  celexplus!prod!DocNumber&1g=en&type doc=
  Directive&an doc=91&nu doc=497                        US legislation
96/22/EC
                                                        Federal Meat Inspection Act
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
                                                        http://www.fda.gov/opacom/laws/meat.htm
  celexplus!prod!DocNumber&1g=en&type doc=
                                                        Poultry Products Inspection Act
  Directive&an doc=96&nu doc=22
                                                        http://www.fda.gov/opacom/laws/pltryact.htm
                                                        Egg Products Inspection
Directives focused on specific provisions – fish and      http://www.fda.gov/opacom/laws/eggact.htm
fishery products                                         Meat and poultry pathogen reduction and Hazard Analysis
                                                           and Critical Control Point (HACCP) systems
91/67/EEC                                               http://www.govtrack.us/congress/bill.xpd?bill=s109-1357
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!   Meat and Poultry Inspection Issues
  celexplus!prod!DocNumber&1g=en&type doc=              http://www.fsis.usda.gov/Regulations & Policies/Meat
  Directive&an doc=91&nu doc=67                            Poultry Egg Inspection Directory/index.asp
91/492/EEC                                              Meat, Poultry and Egg Products Inspection
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!   http://www.law.umaryland.edu/marshall/crsreports/
  celexplus!prod!DocNumber&1g=en&type doc=                 crsdocuments/IB0082.pdf
  Directive&an doc=91&nu doc=492                        Procedures for the safe and sanitary processing and import-
91/493/EEC                                                 ing of fish and fishery products
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!   http://www.cfsan.fda.gov/∼lrd/searule3.html
  celexplus!prod!DocNumber&1g=en&type doc=              Sustainable Fishery Act
  Directive&an doc=91&nu doc=493                        http://sero.nmfs.noaa.gov/pubann/pa05/sfbulletins.htm
92/48/EEC
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  celexplus!prod!DocNumber&1g=en&type doc=
  Directive&an doc=92&nu doc=48                         Canadian legislation
Decision 97/296/EC
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!   Meat Inspection Act
  celexplus!prod!DocNumber&1g=en&type doc=              http://lois.justice.gc.ca/en/showdoc/cs/M-3.2//20070313/
  Decision&an doc=97&nu doc=296                            en?command=home&caller=SI&fragment=meat&
Regulation (EC) No. 104/2000                               search type=all&day=13&month=3&year=2007&
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!      search domain=cs&showall=L&statuteyear=all&
  celexplus!prod!DocNumber&1g=en&type doc=                 lengthannual=50&length=50
  Regulation&an doc=2000&nu doc=104                     Fish Inspection Act
                                                        http://lois.justice.gc.ca/en/showdoc/cs/F-13//20070314/en?
Directives for contamination from substances with          command=home&caller=SI&fragment=Fish&
                                                           search type=all&day=14&month=3&year=2007&
hormonal action and other substances                       search domain=cs&showall=L&statuteyear=all&
96/22/EC                                                   lengthannual=50&length=50
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!   Freshwater Fish Marketing Act
  celexplus!prod!DocNumber&1g=en&type doc=              http://laws.justice.gc.ca/en/F-13/index.html
  Directive&an doc=96&nu doc=22
96/23/EC
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!
  celexplus!prod!DocNumber&1g=en&type doc=              Electronic references
  Directive&an doc=96&nu doc=23
                                                        http://www.fst.vt.edu/undergraduate. courses.html
                                                        http://europa.eu.int/comm/food/animal products/milk/
Regulations with regard to biological safety               index en.htm
Regulation (EC) No. 999/2001                            http://www.washingtonwatchdog.org/documents/usc/
  http://europa.eu.int/smartapi/cgi/sga doc?smartapi!      index.html
  celexplus!prod!DocNumber&1g=en&type doc=              http://www.onderzoekinformatie.nl/en/oi/nod/onderzoek/
  Regulation&an doc=2001&nu doc=999                        OND1305164/
               Part II
Implementing HACCP and ISO 22000
     for Foods of Animal Origin
                                              3
                                         Dairy Foods
              Ioannis S. Arvanitoyannis, Theodoros H. Varzakas and
                     Maria Koukaliaroglou-van Houwelingen




3.1 PRODUCTION OF RAW AND PASTEURISED                           critical elements in this determination are: (1) quantita-
    MILK – POTENTIAL HAZARDS                                    tive determination of the difference between S100 and
                                                                regular dairy ingredients, (2) comparison of exposures
Pasteurised milk is the largest selling milk in most            resulting from proposed uses to background exposures
industrialised countries because the consumption of             already in the American diet and (3) corroborative re-
raw milk carries the risk of infection by milk-borne            sults of controlled clinical trials comparing safety out-
pathogens, especially Salmonella (Small and Sharp,              comes from consumption of S100 with those of con-
1979), Campylobacter (Heeschen, 1996; Potter et al.,            ventional dairy ingredients. Comparative analytical
1983; Summer, 1996) and tuberculosis (Pinto Angela              data reveal that the only difference between S100 and
et al., 2006). The International Dairy Federation has           conventional dairy ingredients is significantly higher
defined pasteurisation as, ‘A process applied to a prod-         active (undenatured) immunoglobulin G (IgG) (61–
uct with the object of minimising possible health haz-          79% versus control grade A fluid and powdered skim,
ards arising from pathogenic micro-organisms associ-            respectively, p < 0.005) with slightly altered specific
ated with milk, by heat treatment, which is consistent          antibody activity. Estimated daily intake projections
with minimal chemical, physical and sensory changes             showed that use of S100 ingredients at maximum pro-
in the product’ (EEC 92/46, 1992; EEC 93/43, 1993;              posed levels resulted in exposures to active (undena-
Mossel, 1981; Varnam and Sutherland, 1996). How-                tured) IgG below background in the present American
ever, in some countries, farms are still allowed to sell        diet in infants but above background in children and
raw milk for household use. In the UK and several               adults, whose intake of conventional dairy products is
other countries, bottled raw milk can be directly deliv-        markedly lower. Safety of this consumption level is cor-
ered to customers provided that milk-producing cows             roborated by clinical results showing no difference in
have been attested free from tuberculosis and brucel-           safety outcomes between S100 ingredients, consumed
losis (Mossel et al., 1995).                                    at exaggerated levels, and conventional dairy products,
   Bovine milk-derived ingredients (non-fat dried milk          in a variety of adult populations. There is no evidence
[NFDM], milk protein concentrate [MPC] and whey                 that demonstrates a hazard to the public when S100
protein concentrate [WPC]) from cows hyperimmu-                 ingredients are used at levels that might reasonably be
nised with a variety of antigens have been available            expected from the proposed applications.
experimentally or commercially for several decades.                Raw milk is an excellent medium for the growth of
Although the safety of milk is rarely questioned, an            micro-organisms which can be derived from the udder,
assessment of ingredients derived from the milk of              the environment, milk handling equipment and per-
cows hyperimmunised with a proprietary bacterin                 sonnel (Mossel et al., 1995). Escherichia coli, Staphy-
(S100) consisting of heat killed cultures of 26 bacte-          lococcus aureus, Corynebacterium bovis, Streptococ-
rial pathogens, originally isolated from humans, ob-            cus agalactiae, Str. dysgalactiae and Str. uberis (Hahn,
tained from the American Type Culture Collection,               1996) may cause under certain circumstances mastitis,
was made to determine that these ingredients share              leading to significant economic losses (Barkema et al.,
the human food safety profile traditionally ascribed             1998; Elbers et al., 1998). In winter months, feed and
to regular milk (Gingerich and McPhillips, 2005). The           bedding are the main sources of thermoduric spoilage

                                                           91
92                     HACCP and ISO 22000 – Application to Foods of Animal Origin

organisms, while milk handling equipment is the major       community such as unborn babies, the elderly and the
source of Gram-negative, psychotropic spoilage bacte-       immunocompromised (Bell and Kyriakides, 2005).
ria. Employees suffering from clinical symptoms of in-         Listeria monocytogenes is a widely occurring en-
fection, and faeces may contaminate milk with Campy-        vironmental contaminant whose primary means of
lobacter and Salmonella.                                    transmission to humans is through contamination of
   Milk should only be accepted at the dairy plant          foodstuffs at any point in the food chain, from source
when obtained from animals which are not suffer-            to kitchen. The total elimination of Listeria monocy-
ing from tuberculosis and brucellosis (Romero et al.,       togenes from all food is impractical and may be im-
1995); are free from contagious diseases (Heeschen,         possible. This claim comes from the ‘Conclusion and
1996; Troutt et al., 1995); are not suffering from clini-   Recommendations’ in the report of a World Health
cal mastitis (Mossel et al., 1995); have not been treated   Organization informal working group convened in
with antibiotics unless milk has been obtained after        1988 to discuss foodborne listeriosis. Listeria mono-
expiration of the retention period following veteri-        cytogenes is widespread in nature and can be found
nary treatment (Troutt et al., 1995); are subjected to      in raw fish, shellfish, meat, milk, poultry, vegetables
proper supervision and support from relevant author-        etc. (Codex Alimentarius Commission, 1996). Liste-
ities (Tschumi, 1997); and do not suffer from infec-        ria species are Gram-positive, short, non-sporing rods
tions or tissue damage of the udder (Burgess et al.,        that are motile at 20–25◦ C by means of new peritric-
1994).                                                      hous flagella that give a tumbling form of motility (Far-
   The use of antimicrobial drugs in livestock is           ber and Peterkin, 2000). Some examples of the process
suspected to contribute to bacterial antimicrobial          stages where Listeria monocytogenes may represent a
resistance (AR) development. Dairy farms experienc-         hazard in dairy products are given in Table 3.1.
ing recent outbreaks of salmonellosis involving multi-         From the 930 milk samples tested in Malaysia by
resistant (MR) Salmonella strains were compared to          Chye et al. (2004), approximately 90% were contami-
control farms with respect to AR among bovine com-          nated by coliform bacteria and 65% were E. coli posi-
mensal E. coli isolates (DeFrancesco et al., 2004).         tive, with mean counts ranging from 103 to 104 colony
For most antimicrobials tested, the percentage of AR        forming unit (cfu)/mL. S. aureus was isolated from
E. coli isolated from salmonellosis-affected farms was      more than 60% of the samples and the mean count per
significantly higher than that from control farms. Calf      millilitre was 12 × 103 . Meanwhile, E. coli O157:H7
E. coli from both case and control farms had greater        was also detected in 312 (33.5%) samples. However,
levels of AR than cow isolate. Commensal E. coli            Salmonella was only detected in 1.4% of the samples,
isolates from case farms and calves tended to more          with the Central region having the highest frequency
frequently be MR. These data are consistent with the        of isolation. Thirteen Salmonella serotypes were iden-
existence of higher antimicrobial selection pressure on     tified, including S. muenchen, S. anatum and S. agona.
farms with recent salmonellosis outbreaks; however,         A total of 47 strains of Listeria were isolated from
the directionality of the relationship remains to be elu-   4.4% Listeria-positive samples including L. monocy-
cidated.                                                    togenes (1.9%), L. innocua (2.1%) and L. welshimeri
   Pathogens that have been involved in foodborne           (0.6%). Some examples of the process stages where
outbreaks associated with the consumption of milk           Salmonella may represent a hazard in dairy products
include Listeria monocytogenes, Salmonella, Campy-          are given in Table 3.2.
lobacter, S. aureus, B. cereus and Clostridium bo-             The toxins produced by C. botulinum are among
tulinum. Most recently, E. coli O157:H7 has become          some of the most potent, naturally occurring toxic sub-
a serious threat to the dairy industry with several out-    stances known. If spores of C. botulinum are present
breaks reported in developed countries ranging from         in food and conditions are not inhibitory to germi-
mild diarrhoea to potentially fatal haemolytic uraemic      nation and growth, the organism can proliferate and
syndrome (HUS), haemorrhagic colitis and thrombotic         produce toxin. The organism is widespread in soil and
thrombocytopenic purpura (Coia et al., 2001).               aquatic sediments and also in the gastrointestinal tracts
   Levels of listeriosis in the human population have al-   of animals, fish and birds (Bell and Kyriakides, 2000).
ways been greatly overshadowed by other foodborne           The toxins produced by C. botulinum and affecting
illnesses, such as salmonellosis or campylobacteriosis,     humans are neurotoxins which attack the nervous sys-
and substantiated foodborne outbreaks of listeriosis        tem of the affected individual. They block the release
were rare. Outbreaks of foodborne listeriosis in the        of acetylcholine, a neurotransmitter at the peripheral
early 1980s, however, demonstrated the severe nature        nerve ends. Transmission of nerve impulses at the neu-
of the illness with exceptionally high levels of mortal-    romuscular junction is prevented and no muscle stimu-
ity, particularly in the most vulnerable members of the     lation occurs, resulting in flaccid paralysis. The nature
                                                        Dairy Foods                                                   93

Table 3.1 Examples of the process stages where Listeria monocytogenes may represent a hazard in dairy products.

                                                                                             Product             Consumer
                               Raw material     Reduction      Destruction   Post-process    allows      Shelf   cidal
Product                        contamination    process        process       contamination   growth      life    process

Pasteurised soft cheese        Yes              Yes            Yes           Yes             No          Yes     No
(plain cottage cheese)
Pasteurised, ripened           Yes              Yes            Yes           Yes             Yes         Yes     No
soft/semi-hard cheese
(Camembert)
Pasteurised hard cheese        Yes              Yes            Yes           Yes             No          Yes     No
(Cheddar)
Yoghurts                       Yes              Yes            Yes           No              No          Yes     No
Raw milk, ripened soft         Yes              No             No            Yes             Yes         Yes     No
cheese (category 1: highest)
Pasteurised, ripened soft      Yes              Yes            Yes           Yes             Yes         Yes     No
cheese (category 2: high)
Pasteurised hard cheese        Yes              Yes            Yes           Yes             No          Yes     No
(category 5: low)


and the properties of botulinum neurotoxins and their            also wound botulism and infant botulism. Botulism
mode of action are subjects of study in their own right          may be easily misdiagnosed because symptoms resem-
and further information may be found in Hauschild                ble other illnesses (Bell and Kyriakides, 2000). Some
(1989); Shone (1987); Smith (1997); and Sugiyama                 examples of the process stages where C. botulinum
(1980). Toxic doses for humans of all botulinum toxin            may represent a hazard in dairy products are given in
types, however, are estimated to be very low, i.e. at lev-       Table 3.3.
els of <1 µg for toxin types A and B and approximately              Since the 1920s, a great deal for more work has
10 µg for toxin types E and F (Shone, 1987; Sugiyama,            been carried out on serogrouping within E. coli and in
1980). Three categories of botulism are recognised in            the mid-1940s, a classification scheme was developed
humans; in addition to foodborne botulism, there are             that allowed E. coli to be divided into more than 170

Table 3.2 Examples of the process stages where Salmonella may represent a hazard in dairy products.

                               Raw         Raw
                               material    material                                    Process                   Consumer
                               of animal   of poultry    Reduction    Post-process     allows      Destruction   cidal
Product                        origin      origin        process      contamination    growth      process       process

Raw material ripened soft      Yes         No            No           Yes              No          Yes           No
cheese (Brie, Camembert)
Raw milk hard cheese           Yes         No            Yes          Yes              No          No            No
(Cheddar, Parmesan)
Pasteurised milk ripened       Yes         No            Yes          Yes              Yes         Yes           No
soft cheese (Brie,
Camembert)
Pasteurised milk hard          Yes         No            Yes          Yes              Yes         No            No
cheese (Edam, Cheddar,
Cheshire)
Pasteurised milk fermented     Yes         No            Yes          No               Yes         No            No
products (yoghurt,
fromage frais, cottage
cheese)
Spray dried milk powder        Yes         No            Yes          Yes              Yes         No            No
(infant dried milk)
94                       HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.3 Examples of the process stages where Clostridium botulinum may represent a hazard in dairy products.

                                                                                                             Storage
                                             Product                                                         restrictions
                             Raw             formulation     Destruction                   Process           required
                             material        allows          process       Post-process    allows    Shelf   to prevent
Product                      contamination   growth (NP/P)   (NP/P)        contamination   growth    life    growth

Soft ripened cheese (Brie,   Yes             Yes/yes         No/no         Yes             No        Yes     Yes
Camembert)
Hard cheese (Cheddar,        Yes             No/no           No/no         Yes             No        Yes     No
Parmesan)
Acid fermented milk          Yes             No/no           No/no         Yes             No        Yes     No
products (pH <4.7,
yoghurt, clotted cream)
Low acid                     Yes             Yes/yes         No/no         Yes             No        Yes     Yes
fermented/acidified milk
products (pH >5,
mascarpone, cream
cheese)
Processed cheese, chilled    Yes             Yes/no          Yes/no        Yes             No        Yes     Yes
storage (cheese spread)
Processed cheese, ambient    Yes             No/no           Yes/no        Yes             No        Yes     No
storage (processed cheese)
Heat processed, extended     Yes             Yes/yes         Yes/no        Yes             No        Yes     No
life, chilled dessert
(mousse)


different serogroups based on the somatic (O) antigens       can obviously be limited by appropriate animal hus-
(Kauffmann, 1947). In addition, over 50 flagella (H)          bandry practices that monitor the health of the animals
antigens and approximately 100 capsular (K) antigens         and provide conditions under which such sources of
(previously divided into L, A and B antigens) are now        infection can be reduced (Bell and Kyriakides, 1998).
also recognised and these are used to further subdi-            Many manufacturers of raw milk cheese operate in-
vide E. coli into serotypes (Linton and Hinton, 1988).       centive payment schemes for their farmers based on
The main raw material of concern in relation to E. coli      the results of monitoring the hygienic status of the in-
O157 and other verocytotoxin-producing Escherichia           coming raw milk. Indicators of contamination such as
coli (VTEC) is the raw milk itself. The key factors con-     Enterobacteriaceae or E. coli may be monitored at fre-
trolling the likelihood of contamination at this stage       quent intervals in samples from each farm and from
include the health of the animals and the hygienic pre-      bulk milk tanks, and payment increased where good
cautions taken during milking (Beutin et al., 1993).         control is demonstrated and reduced for poor control
Padhey and Doyle (1991) reported a 10% (11/115)              (Bramley and McKinnon, 1990). Studies to date of
incidence of E. coli O157:H7 in raw milk, although a         the incidence of E. coli O157 rarely found evidence
large study of raw milk, dairy and associated samples        of extensive contamination in raw milk. This is not
in the UK failed to detect the organism (Neaves et al.,      surprising as tests for pathogens that are likely to be
1994). A recently published survey of unpasteurised          intermittent contaminants, present at low levels and a
milk on sale in the UK found E. coli O157 in 3/1097          low frequency, will rarely yield a positive result (Bell
(de Louvois and Rampling, 1998).                             and Kyriakides, 1998).
   Contamination from the animal is most likely to              A survey published by the Public Health Laboratory
arise in two areas: first, from infection in the udder        Service of England and Wales (Nichols et al., 1996)
and shedding of organisms into the milk and second,          found high levels of coliforms and E. coli in a num-
from faecal contamination of the external surfaces of        ber of cheeses. The type of E. coli found was not re-
the udder. Although it is possible for E. coli to cause      ported as tests for specific pathogenic strains were not
mastitis (Bramley and McKinnon, 1990), this is un-           carried out. In a study of 60 cheeses on retail sale in
likely to be a frequent occurrence in relation to human      Iraq, Abbar (1988) reported the presence of E. coli in
pathogenic types such as VTEC. Mastitis of this nature       43 samples with coliform counts ranging from 500 to
                                                       Dairy Foods                                                   95

Table 3.4 Examples of the process stages where Escherichia coli may represent a hazard in dairy products.

                           Raw
                           material        Raw                                       Post-process    Process   Consumer
                           contamination   material    Restructuring   Destruction   contamination   allows    cidal
Product                    origin          of bovine   process         process       growth          growth    process

Raw milk ripened soft      Yes             Yes         No              No            Yes             Yes       No
cheese
Raw milk hard cheese       Yes             Yes         Yes             No            Yes             No        No
Pasteurised milk ripened   Yes             Yes         Yes             Yes           Yes             Yes       No
cheese, Brie
Pasteurised milk hard      Yes             Yes         Yes             Yes           Yes             No        No
cheese (Cheddar, Edam)


26,000 per gram. In addition, four of the E. coli strains     spreading to other, more harmful species and genera.
were identified as pathogenic serotypes (O119:K69,             The transmissible enterococcal resistance against gly-
O125:K70, O86:K61 and O111:K58). The fact that                copeptide antibiotics (vancomycin and teicoplanin) is
E. coli is such a common contaminant in raw milk              particularly noteworthy as reported by Salminen et al.
cheese and occasionally present at very high levels gives     (1998), as vancomycin is one of the last effective antibi-
clear warning that the processes used do not elimi-           otics left in the treatment of certain multidrug-resistant
nate the hazard, if present, in raw milk. In fact, it         pathogens. New species and more specific strains of
is clear that with levels of E. coli in raw milk usu-         probiotic bacteria are continuously identified. Prior to
ally at <100/mL and more frequently, at <10/mL, lev-          incorporating new strains into products their efficacy
els in excess of 100–1000/mL in the finished cheese            should be carefully assessed, and a case by case eval-
products must be representative of growth and con-            uation as to whether they share the safety status of
centration or excessive contamination during process-         traditional food-grade organisms should be made.
ing (Bell and Kyriakides, 1998). Some examples of the            These micro-organisms can produce a wide vari-
process stages where Escherichia coli may represent a         ety of antagonistic primary and secondary metabolites
hazard in dairy products are given in Table 3.4.              including organic acids, diacetyl, CO2 and even an-
   Finally, probiotics, commonly defined as viable             tibiotics such as reutericyclin produced by Lactobacil-
micro-organisms (bacteria or yeasts) that exhibit a           lus reuteri. Moreover, members of the group can also
beneficial effect on the health of the host when they          produce a wide range of bacteriocins, some of which
are ingested, are used in foods, especially in fermented      have activity against food pathogens such as Listeria
dairy products, but also in pharmaceutical prepara-           monocytogenes and C. botulinum. Indeed, the bacte-
tions. The development of new probiotic strains aims          riocin nisin has been used as an effective biopreserva-
at more active beneficial organisms. In the case of            tive in some dairy products for decades, while a num-
novel micro-organisms and modified organisms, the              ber of more recently discovered bacteriocins, such as
question of their safety and the risk to benefit ra-           lacticin 3147, demonstrate increasing potential in a
tio have to be assessed. Lactic acid bacteria (LAB) in        number of food applications. Both of these lactococ-
foods have a long history of safe use. Members of the         cal bacteriocins belong to the lantibiotic family of post-
genera Lactococcus and Lactobacillus are most com-            translationally modified bacteriocins that contain lan-
monly given generally-recognised-as-safe (GRAS) sta-          thionine, β-methyllanthionine and dehydrated amino
tus whilst members of the genera Streptococcus and            acids. The exploitation of such naturally produced an-
Enterococcus and some other genera of LAB contain             tagonists holds tremendous potential for extension of
some opportunistic pathogens. LAB are intrinsically           shelf life and improvement of safety of a variety of
resistant to many antibiotics. In many cases resistances      foods (Ross et al., 2002).
are not, however, transmissible, and the species are             Ln. mesenteroides subsp. cremoris or Ln. lactis
also sensitive to many clinically used antibiotics even in    strains are of classical use in butter and cream or fresh
the case of an LAB-associated opportunistic infection.        cheese production and some fermented fresh dairy
Therefore, no particular safety concern is associated         products (Vedamuthu, 1994). The presence of Leu-
with intrinsic type of resistance. Plasmid-associated         conostoc in numerous cheese varieties made without
antibiotic resistance, which occasionally occurs, is an-      addition of Leuconostoc starter is regular, in particular
other matter because of the possibility of the resistance     in raw milk cheeses. Previous data have confirmed the
96                      HACCP and ISO 22000 – Application to Foods of Animal Origin

presence of Leuconostoc in the majority of raw milk          finally add to their confidence and safety. The intelli-
French cheeses and other European cheeses (Devoyod           gent, responsible development and use of genetically
and Poullain, 1988).                                         improved micro-organisms led us to the new millen-
   The role of Ln. mesenteroides subsp. cremoris             nium bringing exciting new products to the consumer
in aroma production has been well described by               (Mollet, 1999).
Vedamuthu (1994). In pressed ripened Dutch cheeses              Exposure to mycotoxins through food is widely
such as Edam, Gouda and other brine salted cheese va-        recognised as a human health hazard (Bhat and Vasan-
rieties, small and shiny openings are due to CO2 pro-        thi, 1999). Of all the mycotoxins, Aflatoxin B1 (AFB1)
duced by Leuconostoc present in the starter. The major       is considered to be the most toxic/carcinogenic com-
compound related to the utilisation of Leuconostoc           pound (IARC, 1993). It is biotransformed by hep-
in the dairy field is diacetyl, acetate for thioester         atic microsomal cytochrome P450 to Aflatoxin M1
and ethanol for ester production (Crow et al., 2002)         (AFM1) which possesses ten times lower carcinogenic
contributing also to aroma formation (Vedamuthu,             potential with respect to the parent molecule (Cullen
1994) in cheeses in which methane thiol is present           et al., 1987) and has been listed as class 2B carcino-
(Hemme and Foucaud-Scheunemann, 2004). Alterna-              gen (Smith et al., 1994). AFM1 has been shown to
tively, Leuconostoc could be used in the conversion of       be excreted in milk following exposure to AFB1 con-
acetaldehyde to ethanol and acetate (Liu et al., 1997).      taminated feed (Heathcoate and Hibbert, 1978). The
   Genetic modifications such as one-step genetic             consumption of milk and milk products by the hu-
events like deletions, gene amplifications, plasmid in-       man population is quite high, particularly among in-
sertions or losses; multi-step genetic rearrangements        fants and young children thereby increasing the risk
with DNA of a same species; and trans-species genetic        of exposure to AFM1. Since milk is a major com-
modifications illustrate the vast potential LAB have for      modity for introducing aflatoxins in the human diet,
present and future applications in various domains of        the occurrence of AFM1 in this product is of concern
the dairy industry (Mollet, 1999). They will continue        (Stoloff, 1980). Evidence of hazardous human expo-
to play an important role in the fermentation processes      sure to AFM1 through dairy products has been shown
of a variety of different food products by contribut-        by several investigators (Galvano et al., 1996).
ing to their conservation, flavour development, tex-             Regulatory limits throughout the world are greatly
ture and health beneficial properties. Increasingly, they     influenced by economic considerations and may vary
will also be used as a natural source of food ingredi-       from one country to another (Stoloff et al., 1991).
ents and additives to non-fermented products to attain,      The European Community and Codex Alimentarius
for example organoleptic, texturing or probiotic aims.       prescribe that the maximum level of AFM1 in liquid
The progress in molecular biology and genetic engi-          milk and dried or processed milk products should not
neering will broaden the possibilities for using LAB in      exceed 50 ng/kg (Codex Alimentarius Commission,
food and may also allow the improvement of existing          2001). This limit has been established in compliance
products and the development of novel products and           with the ALARA (as low as reasonably achievable)
applications.                                                principle.
   LAB have a long history of safe use in fermented             The occurrence of AFM1 contamination in Indian
food products. They are considered non-toxic and             infant milk products and liquid milk samples was in-
were not reported as the causative agents in disease         vestigated by competitive ELISA technique (Rastogi
or infection. Nevertheless, all newly isolated or ge-        et al., 2004). A total of 87 samples in categories of
netically altered LAB and their resultant fermented          infant milk food (18), infant formula (17), and milk-
foods have to be carefully evaluated for their safety        based cereal weaning food (40) and liquid milk sam-
to the consumer and environment. They are subjected          ples (12) showed that the incidence of contamination
to stringent safety and regulatory procedures in the         of AFM1 was of the magnitude of 87.3%. The range
same way as do all new food products which are com-          of contamination of AFM1 was comparatively higher
mercialised and sold to the consumer. In fact, it was        in infant milk products (65–1012 ng/L) than liquid
only with the help of molecular biology that it became       milk (28–164 ng/L). Almost 99% of the contaminated
possible to correctly classify and differentiate the di-     samples exceeded the European Communities/Codex
verse species of the LAB to better identify their origins,   Alimentarius recommended limits (50 ng/L), while 9%
natural habitats and dissemination in nature and in          samples of exceeded the prescribed limit of US regu-
the intestines of humans and animals. This knowledge         lations (500 ng/L). The extrapolation of AFM1 data
and the possibility to trace individual strains along the    to estimate the AFB1 contamination in dairy cattle
food chain and the digestive tract further contribute        feedstuffs indicated that the contamination may range
to the better evaluation of potential risk factors and       from 1.4 to 63.3 µg/kg with a mean of 18 µg/kg which
                                                      Dairy Foods                                                  97

is substantially higher than the directive of European           Enterococci commonly occur in milk and milk prod-
Communities Regulation (5 µg/kg).                             ucts, especially in artisan cheeses from the Mediter-
   More than two million metric tonnes of ewe’s milk          ranean area. They may be present in high numbers in
is produced in the European Union (EU), with Italy,           a variety of such cheeses at the end of the ripening
Greece and Spain being the largest producers (Her-            period and contribute to ripening and aroma develop-
rero, 1999). Cheese making is one of the main uses            ment (Franz et al., 1999a; Giraffa, 2002). This has led
of ewe’s milk, as is demonstrated by the fact that in         to the suggestion that enterococci might have been in-
Spain ewe milk cheeses account for 40% of total cheese        cluded in starter culture preparations for the manufac-
consumption (ILE, 1999). Many of these cheeses are            ture of certain Mediterranean cheeses (Centeno et al.,
manufactured from raw milk at small, artisan cottage          1996; Parente et al., 1989). Furthermore, they have
cheeseries in accordance with regulations established         been isolated from Spanish-style green olive fermenta-
and supervised by a Designation of Origin.                                ´
                                                              tions (Fernandez-Diaz, 1983), in which E. faecalis is a
   The microbial quality of cheeses made from raw             frequent contaminant.
ewe’s milk will depend both on the quality of the raw            One special benefit of the presence of enterococci
material and on the cheese-making process. The mi-            in food is that such strains may also produce bacteri-
crobiological characteristics of ovine milk differ from       ocins (the enterocins). Some enterococci of dairy origin
bovine milk in certain respects. Such factors as the          have also been reported to produce bacteriocins (ente-
larger number of head per volume of milk produc-              rocins) inhibitory against food spoilage or pathogenic
tion, the seasonality of production, the large number         bacteria, such as Listeria monocytogenes, S. aureus,
of head per flock, feeding, the milking process, etc.,         Vibrio cholerae, Clostridium spp. and Bacillus spp.
all increase the difficulty of establishing good sanitary      The technological application of enterocins, shown to
practices during milk production.                             be produced during cheese manufacture, led to pro-
   The microbiological standard set by the Direc-             pose enterococci as adjunct starters or protective cul-
tive 71/96/EC indicated a maximum permissible total           tures in cheeses. There is evidence that enterococci,
count of 5 × 105 cfu/mL for raw ewe milk intended             either added as adjunct starters or present as non-
for direct use in cheese making. For milk that does not       starter NSLAB, could find potential applications in the
comply with that standard, pasteurisation is the pri-         processing of some fermented dairy products. Litera-
mary means of ensuring that the cheeses will not repre-       ture suggests that the complex biochemical and eco-
sent a health risk. Still, industrial pasteurisation cannot   logical phenomena explaining the technological func-
guarantee the absence of pathogenic micro-organisms,          tionality of the enterococci in dairy products are still
either because they are present in large numbers in           to be fully understood. Clearly, the clinical research
the raw milk, or because of post-pasteurisation recon-        on enterococci underlines also that the safety of dairy
tamination. In addition, pasteurisation reduces a large       products containing enterococci is an issue that the
proportion of the lactic acid flora and secondary flora         industry must carefully address before proceeding to
that may play an important role in the development of         their application (Giraffa, 2003).
many desirable characteristics in cheeses.                       Most enterococcal bacteriocins belong to class II of
   Counts of micro-organisms with health and tech-            the Klaenhammer classification (Klaenhammer, 1993),
nological implications (total aerobic mesophiles, En-         although they exhibit a considerable diversity. In
terobacteriaceae, total coliforms, faecal coliforms,          addition, enterocins other than those which belong to
E. coli, Enterococcus, Staphylococcus, Lactobacil-            the class II bacteriocins are also produced and these
lus, Leuconostoc, Pseudomonas, Clostridium tyrobu-            include the class I lantibiotic cytolysin, as well as
tyricum, moulds and yeasts) in raw and pasteurised                                           ´
                                                              cyclic enterocin AS-48 (Gonzalez et al., 2000). Many
ewe’s milk were performed over the course of one lac-         enterococcal bacteriocins are active against the food-
tation period (winter, spring and summer) by Salmeron         borne pathogen Listeria monocytogenes, while oth-
et al. (2002). Seasonal differences in the counts were        ers (like enterocin AS-48) show a much broader in-
recorded for ten of the micro-organism groups consid-         hibitory spectrum, including pathogenic, toxigenic and
ered, the highest counts being in spring. In contrast, the                                ´
                                                              food spoilage bacteria (Galvez et al., 1989). Conse-
highest counts in the pasteurised milk were recorded in       quently, the enterocins have become attractive in re-
summer, because of lower effectiveness of pasteurisa-         cent years as natural additives for food preservation
tion at that time of the year. Reductions in the counts       and safety. Although they occur as commensals of the
of the different micro-organism groups were likewise          gastrointestinal tract of warm-blooded animals, ente-
variable. The presence of micro-organisms that may            rococci may also display subtle virulence traits (Mundy
pose a health threat in the pasteurised milk highlights       et al., 2000) and certain strains of enterococci have
the need for post-pasteurisation controls.                    emerged as leading causes of nosocomial infection,
98                      HACCP and ISO 22000 – Application to Foods of Animal Origin

including urinary tract infections, wound infections         strategies for Listeria control in raw milk vary between
and bacteraemia.                                             plants, as a function of the number of farms to be moni-
   The role of enterococci in disease has raised ques-       tored, cost of analytical method and corrective strategy
tions regarding their use in foods or as probiotics. Re-     in case of pathogen detection. Monitoring can be made
cent studies on the incidence of virulence traits among      in different ways: (i) on each farm (bulk tank) at each
food strains showed that food isolates can also har-         raw milk collection, (ii) on each milk tanker, with sub-
bour such traits (Franz et al., 2001).                       sequent examination of bulk tanks in case of contam-
   The results presented by Omar and his co-workers          ination or (iii) with more elaborate sampling schemes
(2004) suggested that the presence of enterococci in         designed for a global quality evaluation of each farm.
Spanish foods does not represent a threat to human           Strategies (i) and (ii) are very expensive, but make it
health. The large differences reported on the incidence      possible to target corrective actions to contaminated
of virulence factors among isolates from foods and the       farms. The last strategy (iii) is used mainly by plants
reports on clinical isolates clearly indicate that the en-   with large pool of farms, in which the best sanitary sta-
vironment plays a critical role in selection of the best     tus farms are selected for raw milk cheese production
suited strains. Accordingly, enterococcal strains iso-       (Meyer-Broset et al., 2003). These authors confirmed
lated from foods seem to be equipped with biochem-           that farm milk contamination is, most often, a sporadic
ical traits that allow them survival and proliferation       event. In addition to this prevalence study, contamina-
in foods and (probably) to displace virulent and food        tion levels were quantified by enumerating L. monocy-
spoilage strains. Nevertheless, the safety of enterococci    togenes using direct plating of small volumes of farm
in foods may be compromised by the acquisition of an-        milk previously tested positive. Most often, these lev-
tibiotic resistance traits, and further studies should be    els were extremely low. A simple simulation model
carried out to determine the traffic of antibiotic re-        showed that, when milk tankers were found positive,
sistance genes and movable genetic elements between          contamination levels in the corresponding bulk-tank
strains from food and clinical environments.                 milk were themselves very low (typically, below 3 L.
   L. monocytogenes is widely distributed in the farm        monocytogenes per millilitre with most probable con-
(soil, manure, plants and water) and in the indus-           centration 0.1cfu/mL and median ranging from 5 ×
trial and human food chain environment. Since the            10−2 to 0.1 cfu/mL). Such low levels are very likely to
early 1980s, outbreaks have been associated with a           be due to environmental contamination.
lot of ready-to-eat foods, including coleslaw, milk and         Hassan et al. (2001) carried out a cross-sectional
cheese (pasteurised or not), pate and pork tongue in         study to identify farm factors associated with isola-
jelly.                                                       tion of L. monocytogenes from on-farm in-line milk fil-
   Estimates of the yearly incidence of human liste-         ters. Logistic regression was used to find that a bucket
riosis range from <2–12 per 106 persons (Low and             system had higher odds of L. monocytogenes com-
Donachie, 1997) and display a decreasing trend over          pared to farms using a round-the-barn pipeline milk-
the past decade, both in North America (Tappero              ing system or milking parlour. Among modern tech-
et al., 1995) and in Europe (Goulet et al., 2001; PHLS,      niques, the Petrifilm system (3M, Microbiology Prod-
1998). Public warnings enabling susceptible numbers          ucts), for enumerating total aerobic mesophilic micro-
of the population to avoid high-risk foods may have          organisms, has been proposed as a substitute to stan-
contributed to reduce the number of reported cases, es-      dard plate count. These plates consist of two rehy-
pecially in the pregnant female population. Host sus-        dratable films that contain the necessary nutrients for
ceptibility remains, however, an important factor in         bacterial growth, a soluble gel, and, to facilitate colony
infection (Goulet et al., 2001). The fall in numbers of      enumeration, tetrazolium as an indicator.
reported cases of human listeriosis has demonstrated            The direct epifluorescent filter technique (DEFT)
the efficacy of both veterinary inspection procedures         for micro-organism enumeration combines staining of
and corrective measures based on the Hazard Anal-            micro-organisms with fluorochromes and observation
ysis Critical Control Point (HACCP) approach taken           using epifluorescence microscopy. Pettipher and Ro-
on production lines and stores since the early 1990s         driguez (1982) described it, and it rapidly gained the
(Goulet et al., 2001).                                       acceptance of the scientific community (Fung, 1994;
   In France, absence of L. monocytogenes in 25 g is         Patel, 1994; Pettipher, 1986). Among its advantages
compulsory for the finished product (raw milk cheese)         the most important are: speed (full analysis within
but not for the raw milk on reception at the plant.          25–30 minutes), sensitivity (it detects three or four
However, French cheese plants must have HACCP                higher magnitude ranges than direct microbiologi-
monitoring and must communicate internal control             cal observation), accuracy (results showed good cor-
results regularly to public health services. Sampling        relation coefficient compared to standard methods)
                                                     Dairy Foods                                                  99

and possibility of distinction between dead and living       19.2% of all sampled cattle were truly exposed to the
bacteria.                                                    agents of BVD, EBL, JD and neosporosis, respectively.
   Rosmini et al. (2004) evaluated the advantages of         For EBL, because bovine leukaemia virus is primar-
two microbiological rapid techniques (Petrifilm plates        ily horizontally transmitted by blood (virus-infected
and DEFT), applied to enumerating total aerobic              lymphocytes), vaccination is like a surrogate measure
mesophilic micro-organisms in refrigerated raw milk          of good management where needles are not reused
supplied by dairy farms, compared to the reference           (thereby reducing other sources of blood transfer).
technique (standard plate count) considering results         Tobit regression analyses determined that vaccination
correlation, costs and needed time for results to be         practices were associated with reduced prevalence of
available.                                                   exposure for BVD and EBL. Also, farms that tended
   The two alternative techniques under study showed         to purchase their dairy animals were associated with
good correlation levels with the standard in plate tech-     higher seroprevalence for JD.
nique. The dry rehydratable film technique had higher            Kan and Meijer (2007) reported that toxic sub-
costs but this technique allows the analysis of twice the    stances such as dioxins, mycotoxins, heavy metals, pes-
quantity of samples in the same unit of time compared        ticides, veterinary drugs and polycyclic aromatic hy-
to the standard plate technique. This compensates for        drocarbons are also present in ingredients for animal
the higher costs. The epifluorescent technique gave the       feed. Adequate risk management depends on knowl-
results in shorter time but it is necessary to use sophis-   edge of absorption, metabolism, carry-over and toxi-
ticated equipment and trained personnel. Therefore, it       cological profile of these substances and on practical
is preferred when having the appropriate infrastruc-         measures to reduce especially the latter two. Gener-
ture. The most important risk factors are antibiotics        ally, toxic substances are metabolised before or af-
and dioxin for chemical food safety, and Salmonella,         ter absorption through the intestinal tract. Depend-
E. coli, S. aureus and Mycobacterium paratubercu-            ing on their physicochemical characteristics, some sub-
losis for microbiological food safety (Valeeva et al.,       stances such as veterinary drugs and feed additives
2005).                                                       are metabolised into naturally occurring and generally
   Valeeva et al. (2005) assessed the relative impor-        harmless constituents. Other substances like dioxins
tance of 30 preventive measures for chemical and mi-         are persistent and remain in the animal and in ani-
crobiological food safety at farm level. On the basis of     mal products. Heavy metals are not metabolised at all.
these assessments indices for chemical and microbio-         Some metals are irreversibly bound to body tissues, e.g.
logical food safety were calculated by van Calker et al.     lead to bone or cadmium to kidneys.
(2006). The workers’ physical health and societal sus-          Exposure prevention is by far the preferred risk
tainability indicators were successfully included in a       management tool. Known contaminants from known
dairy farm LP model. The model offers the opportunity        sources can be handled effectively in this way, an exam-
to analyse differences between and within dairy farm-        ple being the reduction in organochlorine and heavy
ing systems with respect to the level of economic and        metal residue levels in poultry. Use of adsorbents has
social sustainability. They concluded therefore that the     been tested extensively both for organochlorine com-
societal sustainability performance of conventional as       pounds and for mycotoxins. Heavy metal and drug
well as organic dairy farming systems can be improved        contamination of feeds are also to be controlled at the
by applying additional management measures.                  feed mill, by selection of feed ingredients and through
   Bovine viral-diarrhoea (BVD), enzootic bovine leu-        proper manufacturing practices. Mycotoxin control
cosis (EBL), Johne’s disease (JD) and neosporosis are        is quite hard to be executed as weather conditions
common infectious diseases on dairy farms in Canada          play a pivotal role in fungal growth and mycotoxin
and elsewhere. A more recent survey found that 37.6,         formation. Absorbents added to the feed may some-
20.8, 2.6 and 20.3% of a random sample of dairy cat-         times alleviate the problem. Withdrawal times should
tle in the Maritimes provinces of Canada were seropos-       be followed if prescribed legally and may in some in-
itive to the agents that cause BVD (in cattle not vacci-     stances provide a solution. In the case of milk and
nated for BVD), EBL, JD and neosporosis, respectively        eggs, produced on a daily basis, the animal products
(VanLeeuwen et al., 2001).                                   are most likely to show increased residue levels during
   Chi et al. (2002) determined the relationship be-         prolonged exposure (Kan and Meijer, 2007).
tween various control practices and herd-level preva-           Reduction in contamination levels due to dilution as
lence of exposure with the agents causing four               a result of growth will also help to obtain a product in
production-limiting diseases in dairy cattle (BVD, EBL,      compliance with legal residue limits. On-farm HACCP
JD, neosporosis) in 90 dairy herds in the Maritimes          programmes for monitoring antibiotic residues are
provinces of Canada. Overall, 37.8, 20.4, 3.4 and            costly to implement as reported by Gardner (1997).
100                      HACCP and ISO 22000 – Application to Foods of Animal Origin


                                                               CCP decision tree



                                                Q1.
                                                                                              Modify step,
                           Do preventive measure(s) exist for the identified
                                                                                           process or product
                                             hazard?

                                                                        Is
                                                  No           control at this step
                                                                                                  Yes
                   Yes                                            necessary for
                                                                    safety?

                                                                         No           Not a CCP         Stop*
                                                  Q2.
                             Does this step eliminate or reduce the likely
                              occurrence of a hazard to an acceptable
                                                level?


                   No                                               Yes                    CCP

                                                    Q3.
                                       Could contamination with
                           identified hazard(s) occur in excess of acceptable
                                    level(s) or could these increase to
                                         unacceptable level(s)?


                   Yes                                         No                     Not a CCP         Stop*

                                                 Q4.
                              Will a subsequent step eliminate identified
                            hazard(s) or reduce the likely occurrence to an
                                          acceptable level?

                   Yes
                                                        No           CCP

                         Not a CCP           Stop*



                                                     * Proceed to the next step in the described process

Fig. 3.1 Tree diagram for CCP determination.



The estimated annual cost of testing to detect β-lactam             of new research funding. Validation of tests is essen-
antibiotic residues in tanker truck milk in the United              tial for selection of the most appropriate testing strate-
States is between $8 and $35 million. Extension of test-            gies, to estimate predictive values and for appropriate
ing to other drugs, chemicals and pathogens in bulk-                test interpretation. The determination of the numbers
tank milk stretch the dairy industry resources. The                 of samples to be tested in HACCP monitoring pro-
lack of field-validated tests for most of the chemical               grammes depends on the specific purpose of the test
and infectious agents of concern makes it difficult to               and the likely prevalence of the agent or residue at
ensure that stated goals of HACCP programmes are                    the critical control point (CCP). The tree diagram for
consistently achieved. Much basic and field research                 CCP detection is given in Fig. 3.1 and the raw materials
is needed to develop and validate these tests, which                and hazard analysis of raw materials are summarised
can only be achieved through a substantial infusion                 in Tables 3.5 and 3.6, respectively.
                                                     Dairy Foods                                                     101

   Plant-associated toxins can enter the human food           Table 3.5 Raw materials.
supply as endogenous components of the food hu-
                                                              Raw materials                     Description
mans eat, as contaminants in foods such as grain prod-
ucts and honey, or as contaminant residues in animal-         Milk                              Fresh
derived food such as meat, dairy products and eggs.           Cow
Animals are exposed to these toxins via normal graz-          Goat
ing and browsing, or being supplied with otherwise            Sheep
healthy feed contaminated by toxin-producing plants           Other raw materials               Packaged/suitable for food
or plant-associated micro-organisms.                          Salt
   To protect animal health, welfare and productiv-           Cultures
ity there is an ongoing need to elucidate the factors         Rennet
                                                              Calcium chloride
associated with intoxication, chemically identify the
causative toxins and then develop assay methodology           Water                             Potable water
to allow the assessment of animal feed for potential          Packaging materials               Food grade
toxicity. Three classes of plant-associated toxins, i.e.      Tin cans
                                                              Bags
the phomopsins, corynetoxins and pyrrolizidine alka-          Paraffin
loids have been detected and quantified by Than et al.
(2005).
   A risk-factor study was performed by Rugbjerg et al.
                                                              grain or molasses had a higher risk of excreting VTEC
(2003) in eight dairy herds found to excrete Verocy-
                                                              O157.
totoxigenic E. Coli 0157 (VTEC O157) in a former
prevalence study. Associations between excretion of
VTEC O157 and management factors such as hous-                3.2 INTRODUCTION TO DAIRY INDUSTRY
ing and feeding were analysed in a generalised linear
mixed model. The animals were stratified in three age          The HACCP system was developed to help manufac-
groups and sampled four times during 1 year. The risk         turers produce safe food. It is designed to identify
of excreting VTEC O157 was higher among weaned                hazards and to establish and monitor controls. An
calves than non-weaned calves.                                HACCP plan proves that the controls are in place
   Among the calves aged 1–4 months, the risk was             and that the system is functioning effectively (FAO,
reduced if the calf had suckled colostrum from the            1998). The dairy industry presents a unique and com-
mother or if the calf had stayed >2 days with the             plex problem for the implementation of HACCP. The
mother after calving. Calves aged 5–24 months that            starting point is raw milk collected from a living animal
had been moved within the last 2 weeks had a higher           with all the hazards associated with such working con-
risk, but risk was reduced if fed barley silage. Cows fed     ditions; however, the problem then widens as a result

Table 3.6 Hazard Analysis of raw materials.

Raw materials          Biological hazard                                  Chemical hazard                Physical hazard

Milk                   Presence of pathogenic micro-organisms:            Antibiotic residues            Foreign matter
                       Listeria monocytogenes, Yersinia
                       enterocolitica, Campylobacter jejuni, Bacillus     Detergent remnants
                       cereus, Salmonella spp., Staphylococcus
                       aureus, E. coli (O157:H7)
                       Shigella spp., Mycobacterium spp., Brucella        Presence of
                       spp., Bacillus anthracis, Streptococcus,           mycotoxins
                       Clostridium botulinum, Clostridium
                       perfringens
                       Viruses
                       Increased temperature during receipt of milk       Increase in pesticide
                       (>6◦ C):                                           residues, dioxins, PCBs
                       This means danger for microbial growth and
                       multiplication of pathogenic micro-organisms
Salt                   Increased moisture, contamination                  Heavy metals                   Foreign matter
Enzymes/               Contamination, genetically modified
micro-organisms        organisms
102                     HACCP and ISO 22000 – Application to Foods of Animal Origin

of subsequent treatment. In some cases the milk may          cheeses constitutes a health risk (Meyer-Broseta et al.,
be pasteurised or sterilised or subjected to ultra-high-     2003).
temperature (UHT) treatments, each of which brings              The microbial quality of raw milk is crucial for
a different combination of challenges to the food sci-       the production of quality dairy foods. Spoilage is a
entist. In other cases, the milk may be used in its raw      term used to describe the deterioration of a food’s
state thereby giving rise to different challenges asso-      texture, colour, odour or flavour to the point where
ciated with the microflora and bacterial contaminants         it is unappetising or unsuitable for human consump-
found in the milk. Further to this, the use of milk in       tion. Microbial spoilage of food often involves the
various modified forms, cheese, cream, butter, yoghurt        degradation of protein, carbohydrates and fats by the
etc. results in yet further processing and a range of dif-   micro-organisms or their enzymes. In milk, the micro-
ferent scenarios for the food technologist implement-        organisms that are principally involved in spoilage
ing HACCP. To further complicate the problems the            are psychotropic organisms. Most psychrotrophs are
production of certain milk-based foods involves fer-         destroyed by pasteurisation temperatures; however,
mentation, storage under precise conditions and the          some like Pseudomonas fluorescens and Pseudomonas
deliberate addition of a range of bacteria or moulds         fragi can produce proteolytic and lipolytic extracel-
on which the flavour and quality of the final product          lular enzymes which are heat stable and capable
are dependent. In this chapter, an attempt is made to        of causing spoilage (http://www.foodsci.uoguelph.ca/
describe the planning needed in the various industries       dairyedu/micro.html#micro3).
associated with the production of the wide range of             Some species and strains of Bacillus, Clostridium,
dairy products.                                              Corynebacterium, Arthrobacter, Lactobacillus, Mi-
   Numerous micro-organisms, including bacteria,             crobacterium, Micrococcus and Streptococcus can sur-
yeasts and moulds, constitute the complex ecosystem          vive pasteurisation and grow at refrigeration tempera-
present in milk and fermented dairy products. Bac-           tures which can cause spoilage problems. The follow-
teria in the unknown ecosystems were assigned an             ing bacterial pathogens are still of concern today in raw
identity by comparison with a comprehensive bacterial        milk and other dairy products: Bacillus cereus, Liste-
reference database of approximately 150 species that         ria monocytogenes, Yersinia enterocolitica, Salmonella
includes useful dairy micro-organisms (lactic acid bac-      spp., E. coli O157:H7 and Campylobacter jejuni. It
teria), spoilage bacteria (e.g. Pseudomonas and Enter-       should also be noted that moulds, mainly of species
obacteriaceae) and pathogenic bacteria (e.g. Listeria        of Aspergillus, Fusarium and Penicillium, can grow in
monocytogenes and S. aureus) (Ogier et al., 2004).           milk and dairy products. Under favourable conditions,
Numerous dairy products are home to a complex mi-            these moulds may produce mycotoxins which can
crobial ecosystem, which is responsible for the broad        be a health hazard (http://www.foodsci.uoguelph.ca/
diversity of tastes, aromas and textures that are as-        dairyedu/micro.html#micro4).
sociated with them. Many bacteria make a positive               With the exception of soft cheese and pasteurised
contribution to the organoleptic qualities of cheeses        milk products, processed dairy products have an ex-
or fermented milk, while others may have adverse ef-         cellent history of safety with regard to listeriosis. The
fects or even constitute a health risk. Cheese process-      only reported incident to date associated with other
ing is largely based on fermentation by LAB, which           dairy products occurred in Belgium, where listerio-
are both deliberately added as starter cultures or ad-       sis was said to be associated with the consumption
ventitiously present in the biotope and selected dur-        of ice cream made with fresh cream in a restaurant
ing the fermentation process. Furthermore, raw milk          (McLauchin, 1996). Like ready-meals, this low asso-
bacteria, including non-starter LAB, reportedly en-          ciation with listeriosis probably relates to the fact that
hance cheese flavour and diversity (Martley and Crow,         fresh dairy desserts usually have an extremely short
1993). Ripened cheeses are characterised by a succes-        shelf life of less than 5 days because of the spoilage of
sion of largely undefined microbial communities on            the product that could occur by other contaminating
their surface. These aerobic micro-organisms have a          micro-organisms if the shelf life was much longer (Bell
strong impact on the appearance, odour, flavour and           and Kyriakides, 2005).
texture development of the respective cheese prod-              Indeed, it is believed that the sharp rise in cases in the
ucts (Brennan et al., 2002). Non-desirable micro-            period between 1987 and 1989 was due to a foodborne
organisms, such as the psychotropic Pseudomonas              outbreak associated with contaminated pat´ from aˆ e
fluorescens (Stevenson et al., 2003) or certain pro-          single Belgian manufacturer (McLauchin et al., 1991).
teolytic LAB may cause flavour defects (e.g. bitter-          Listeria monocytogenes is widespread in the environ-
ness and putrid flavours) in milks and cheeses (Ce-           ment and, consequently, can be found in a wide vari-
lestino et al., 1996). The presence of E. coli, Liste-       ety of raw foods (Table 3.7). The organism is trans-
ria monocytogenes and S. aureus in raw milks and             mitted to humans via three main routes: contact with
                                                    Dairy Foods                                                   103

Table 3.7 Incidence of micro-organisms reported in dairy products.

Food                          Country          Micro-organism              Incidence     Reference

Raw cows’ milk from farm      USA              Listeria monocytogenes      12            Rohrbach et al. (1992)
bulk tanks
Raw cows’ milk from farm      UK               Listeria monocytogenes      102           O’Donnell (1995)
bulk tanks
Raw cows’ drinking milk       UK               Listeria monocytogenes      32            Bell and Kyriakides (2005)
Raw caprine milk              Spain            Listeria monocytogenes      37            Gaya et al. (1996)
Soft and semi-soft cheeses    Sweden           Listeria monocytogenes      20            Loncarevic et al. (1995)
Cheeses                       USA              Listeria monocytogenes      42            Gombas et al. (2003)
Prepared retail foods         Denmark          Listeria monocytogenes      760           Norrung et al. (1999)
including cheese products                      (present at >10 per gram)
1997
Prepared retail foods         Denmark          Listeria monocytogenes      670           Norrung et al. (1999)
including cheese products                      (present at >10 per gram)
1998
Ice cream imported            Korea            Listeria monocytogenes      8             Baek et al. (2000)
Pasteurised milk              USA              Listeria monocytogenes      49            Fleming et al. (1985)
                                                                           (14 deaths)
Vacherin cheese               Switzerland      Listeria monocytogenes      122           Bula et al. (1995)
                                                                           (34 deaths)
Chocolate milk                USA              Listeria monocytogenes      45            Dalton et al. (1997)
Raw milk soft cheese          France           Listeria monocytogenes      20            Goulet et al. (1995)
                                                                           (4 deaths)
Butter                        Finland          Listeria monocytogenes      25            Maijala et al. (2001)
                                                                           (6 deaths)
Butter                        UK               Listeria monocytogenes      14            Bell and Kyriakides (2005)
Pasteurised flavoured milk     USA              Listeria monocytogenes      45            Bell and Kyriakides (2005)
Hazelnut yoghurt              UK               Clostridium botulinum       27            Critchley et al. (1989);
(contaminated and toxic                                                    (1 death)     O’Mahony et al. (1990)
canned hazelnut conserve
component)
Canned cheese sauce           USA              Clostridium botulinum       8             Townes et al. (1996)
                                                                           (1 death)
Mascarpone cheese             Italy            Clostridium botulinum       8             Aureli et al. (1996)
(acidified dairy cream)                                                     (1 death)
Cheddar cheese                USA              Salmonella                  339           Fontaine et al. (1980);
                                                                                         D’Aoust (1989)
Raw milk                      Scotland         Salmonella                  654           Cohen et al. (1983)
Cheddar cheese                Canada           Salmonella                  1500          D’Aoust et al. (1985)
Pasteurised milk              USA              Salmonella                  16,284        Lecos (1986); Ryan et al.
                                                                                         (1987)
Vacherin Mont d’Or cheese     Switzerland      Salmonella                  >40           Sadik et al. (1986)
Infant dried milk             UK               Salmonella                  76            Rowe et al. (1987)
Mozzarella                    USA              Salmonella                  164           Hedberg et al. (1992)
Unpasteurised milk soft       UK               Salmonella                  42            Maguire et al. (1992)
cheese
Goat’s milk cheese,           France           Salmonella                  273           Desenclos et al. (1996);
unpasteurised                                                                            Threlfall et al. (1999)
Unpasteurised milk soft       Canada           Salmonella                  35            Ellis et al. (1998)
cheese product
French cheese                 France and       Salmonella                  25            Vaillant et al. (1996)
                              Switzerland
                                                                                                         (Continues )
104                        HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.7 (Continued )

Food                            Country            Micro-organism          Incidence       Reference

Raw milk soft cheese –          France             Salmonella              113             De Valk et al. (2000)
Morbier
Pasteurised milk                UK                 Salmonella              86              Bell and Kyriakides (2002)
Spray dried milk powder         UK                 Salmonella              76              Bell and Kyriakides (2002)
used for infant formula                                                    (1 death)
French Brie cheese              USA, Denmark,      Escherichia coli        169             Padhey and Doyle (1991);
                                the Netherlands                                            MacDonald et al. (1985)
                                and Sweden
French Brie cheese and          USA                Escherichia coli        387             Marier et al. (1973)
Camembert cheese
Yoghurt                         UK                 Escherichia coli        16              Morgan et al. (1993)
Dairy herds                     UK                 Escherichia coli        13              Zhao et al. (1995)
Fresh pasteurised liquid        Scotland           Escherichia coli        69              Bell and Kyriakides (1998)
milk


animals, cross-infection of newborn babies in hospital      probiotic species applied in dairy products, displayed
and foods. Listeria monocytogenes is found within the       strong inhibitory effect against B. linens when tested
normal human intestinal flora as part of the transient       using the spot-on-lawn assay (Knox et al., 2005).
or resident population. Two to six per cent of healthy
people are reported to be asymptomatic carriers of L.
monocytogenes. In a study of 147 healthy pregnant           3.3 ENZYMES IN DAIRY PRODUCTS
women, a faecal carriage rate of 2.7% was found over
the time of the study (Gray et al., 1993). Wild and         It is well known that a part of the world population
domestic animals are known to carry L. monocyto-            suffers from lactose intolerance (Kretchmer, 1972).
genes, and many can become infected and suffer lis-         These people cannot benefit from the nutritional qual-
teriosis. Most farm-associated incidents occur in the       ity of milk and milk-derived products without having
form of skin infections of farmers and veterinarians ac-    serious intestinal problems. Pre-treatment of the milk
quired by direct contact with infected animals (Bell and    with the enzyme lactase (β-galactosidase) converts lac-
Kyriakides, 2005).                                          tose into galactose and glucose. These mono-sugars
   The properties and the significance of the princi-        can be consumed without any problem even by hu-
pal indigenous enzymes in milk, milk coagulants, en-        mans with lactose intolerance.
zymes from dairy micro-organisms participating in              The US Food and Drug Administration (FDA) af-
cheese ripening, and spoilage enzymes such as li-           firmed lactase preparations, produced by Kluyveromy-
pases, phosphatases, enzymes from somatic cells, en-        ces lactis (formerly known as Saccharomyces lactis)
zymes involved in antimicrobial and antiviral sys-          as Generally Recognised As Safe (GRAS) in 1984
tems in milk, enzymes from LAB, propionibacteria            (FDA, 1984). Maxilact, the DSM brand name of a
and micro-organisms involved in smear- and mould-           lactase preparation produced by the classical strain of
ripened cheese were reviewed by Stepaniak (2004).           K. lactis, has already been on the market for decades
Brevibacterium linens is an important species in dairy      and has a history of safe use (AMFEP, 1997). Its safety
products rendering a specific taste and aroma to nu-         evaluation was based on an LD50, a 14-day subacute
merous smear ripened and blue-veined cheeses due to         and a 90-day subchronic toxicity study in rats.
proteolysis. However, the presence of the species in           Neutralact, the DSM brand name of a lactase en-
South African blue-veined cheeses is undesirable and        zyme preparation, obtained from a homologous rDNA
consumers require a product void of the species. Ac-        strain of Kluyveromyces lactis, was subjected to a se-
cordingly, numerous methods including microbial in-         ries of toxicological tests to document the safety for
hibition using fungi and bacterial probiotic cultures       use as a processing aid in the dairy industry (Coenen
with possible inhibitory effects were applied in an at-     et al., 2000). The enzyme preparation was examined
tempt to inhibit the species. None of the fungi, how-       for subacute oral toxicity and mutagenic potential. As
ever, proved to be successful, whereas Lactobacillus        a result of these tests, no evidence of oral toxicity, mu-
rhamnosus and Bifidobacterium lactis, two typical            tagenicity or clastogenicity was found. Administration
                                                      Dairy Foods                                                   105

Table 3.8 Feta cheese description, properties and shelf      Table 3.10 Batzos description, properties and shelf life.
life.
                                                             Product             Batzos
Product             Feta cheese
                                                             General             Derived from goat’s and sheep’s milk. It
General             Derived from goat’s and sheep’s milk     characteristics     has been ripened. Fat on dry matter at
characteristics     (up to 30% goat’s milk). It has been                         least 25%. Humidity 38% maximum.
                    ripened. Fat on dry matter                                   Does not contain additives
                    approximately 43%, humidity 56%          Packaging           Tin cans with brine
                    maximum. Does not contain additives
                                                             Use                 Sales to stores
Packaging           Tin cans with brine
                                                             Shelf life          18 months
Use                 Sales to stores
                                                             Instructions for    In the fridge between 0 and 4◦ C
Shelf life          18 months                                storage and         Consumed with no further thermal
Instructions for    In the fridge between 0 and 4◦ C         distribution        processing
storage and         Consumed with no further thermal         General             Regulations: 852/2004; 853/2004;
distribution        processing                               specifications       854/2004
General             Regulations: 852/2004; 853/2004;
specifications       854/2004
                                                             Anthotyros, Manouri), Table 3.16 (butter whey),
                                                             Table 3.17 (hard Italian cheese), Table 3.18 (Cheddar
of the lactase enzyme preparation at doses of 500,           cheese), Table 3.19 (Swiss-type cheese) and Table 3.20
3000 and 10,000 mg/kg body weight per day for                (Camembert cheese).
28 days did not induce noticeable signs of toxicity.
The no-observed-adverse-effect level (NOAEL) of the
enzyme preparation in the acute toxicity study was           3.4.1 Feta cheese
10,000 mg/kg body weight per day (equivalent to              Feta is a traditional white soft Greek cheese and rep-
114,000 NL units/kg body weight per day). It can be          resentative of the cheeses that are ripened and kept in
concluded that no safety concerns were identified in          brine (Abou-Donia, 1991; Anifantakis, 1991a; Tamine
the studies conducted with this lactase enzyme prepa-        and Kirkegaard, 1991). The distinguishing character-
ration derived from Kluyveromyces lactis under con-          istics of Feta are the creamy and rich flavour, the soft
trolled fermentation conditions.                             texture with some irregular small mechanical open-
                                                             ings, the white colour and the rectangular shape (Tsot-
3.4 CHEESES                                                  sanis, 1996; Zerfiridis, 1994).
                                                                It is produced from sheep’s milk or mixed sheep’s
The percentage composition, properties and shelf             and goat’s milk in a ratio up to 7:3, respectively (Greek
life of various cheeses are given in Table 3.8 (Feta         Codex of Foods and Drinks, 1998). Moisture content
cheese), Table 3.9 (Telemes), Table 3.10 (Batzos),           and minimum fat in dry matter of Feta should be 52–
Table 3.11 (Kasseri), Table 3.12 (semi-hard cheese),         56 and 43%, respectively (Abd El-Salam et al., 1993;
Table 3.13 (hard cheese), Table 3.14 (Graviera,              Vastardis and Anifantakis, 1992).
Kefalograviera, Kefalotyri), Table 3.15 (Mizithra,
                                                             Table 3.11 Kasseri description, properties and shelf life.
Table 3.9 Telemes description, properties and shelf life.
                                                             Product             Kasseri
Product             Telemes
                                                             General             Derived from sheep’s milk. It has been
General             Derived from cow’s, goat’s or sheep’s    characteristics     ripened. Fat on dry matter at least
characteristics     milk or their mixtures. It has been                          43%. Humidity 56% maximum. No
                    ripened. Does not contain additives                          additives
Packaging           Tin cans with brine                      Packaging           Paraffin or vacuum
Use                 Sales to stores                          Use                 Sales to stores
Shelf life          18 months                                Shelf life          18 months
Instructions for    In the fridge between 0 and 4◦ C         Instructions for    In the fridge between 0 and 4◦ C
storage and         Consumed with no further thermal         storage and         Consumed with no further thermal
distribution        processing                               distribution        processing
General             Regulations: 852/2004; 853/2004;         General             Regulations: 852/2004; 853/2004;
specifications       854/2004                                 specifications       854/2004
106                     HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.12 Semi-hard cheese description, properties and    Table 3.15 Mizithra/Anthotyros/Manouri description,
shelf life.                                                properties and shelf life.

Product            Semi-hard cheese                        Product            Mizithra/Anthotyros/Manouri

General            Derived from cow’s milk. It has been    General            Derived from cow’s and sheep’s whey
characteristics    ripened. Minimum fat in dry matter      characteristics    (Mizithra), goat’s and sheep’s whey
                   20–50% (partially skimmed up to                            (Anthotyros, Manouri) and from
                   excellent quality)/moisture 38–46%.                        mixing of whey with milk or cream
                   No additives                                               milk. Raw materials have been
Packaging          Vacuum in bags                                             pasteurised. No ripening. Minimum fat
                                                                              on dry matter 50, 65 and 70% for
Use                Sales to stores
                                                                              Mizithra, Anthotyros and Manouri,
Shelf life         18 months                                                  respectively. Maximum moisture 70%.
Instructions for   In the fridge between 0 and 4◦ C                           No additives
storage and        Consumed with no further thermal        Packaging          Vacuum in bags
distribution       processing
                                                           Use                Sales to stores
General            Regulations: 852/2004; 853/2004;
                                                           Shelf life         3 months
specifications      854/2004
                                                           Instructions for   In the fridge between 0 and 4◦ C
                                                           storage and        Consumed with no further thermal
Table 3.13 Hard cheese description, properties and shelf   distribution       processing
life.                                                      General            Regulations: 852/2004; 853/2004;
                                                           specifications      854/2004
Product            Hard cheese

General            Derived from cow’s milk. It has been       All stages upstream of cooling of heated milk should
characteristics    ripened. Minimum fat in dry matter      comply with the prescribed requirements for pas-
                   20–47% (partially skimmed up to
                   excellent quality)/moisture 32–38%.     teurised milk except for a few differences. It should
                   No additives                            be stressed that the performed controls at the re-
Packaging          Paraffin or vacuum                       ceipt of raw milk are (Mauropoulos and Arvanitoy-
Use                Sales to stores
                                                           annis, 1999): (1) acidity, (2) aerobic mesophilic count,
                                                           (3) freezing point and (4) antibiotic and metabo-
Shelf life         18 months
                                                           lite residues. The used sheep milk for the produc-
Instructions for   In the fridge between 0 and 4◦ C
                                                           tion of good-quality Feta should have lower acidity
storage and        Consumed with no further thermal
distribution       processing                              than 0.23% and pH higher than 6.55 (Anifantakis,
General            Regulations: 852/2004; 853/2004;
                                                           1991b). Sheep milk should also be standardised to a
specifications      854/2004                                fat and casein content of 5.8 and 4.6%, respectively
                                                           (Greek Codex of Foods and Drinks, 1998). The lactic
                                                           cultures used for Feta are Lactobacillus bulgaricus–
Table 3.14 Graviera/Kefalograviera/Kefalotyri              Streptococcus thermophilus (1:1) (Pappas and Zer-
description, properties and shelf life.                    firidis, 1989), Lactobacillus bulgaricus–Lactococcus

Product            Graviera/Kefalograviera/Kefalotyri      Table 3.16 Butter whey description, properties and shelf
                                                           life.
General            Derived from cow’s, goat’s or sheep’s
characteristics    milk or their mixtures. It has been     Product            Butter whey
                   ripened. Minimum fat in dry matter
                   40%. Maximum moisture 38%. No           General            Derived from pasteurised whey cream,
                   additives                               characteristics    maximum moisture 18%, no additives
Packaging          Paraffin or vacuum                       Packaging          Tin cans
Use                Sales to stores                         Use                Sales to stores
Shelf life         18 months                               Shelf life         12 months
Instructions for   In the fridge between 0 and 4◦ C        Instructions for   In the fridge between 0 and 4◦ C
storage and        Consumed with no further thermal        storage and        Consumed with no further thermal
distribution       processing                              distribution       processing
General            Regulations: 852/2004; 853/2004;        General            Regulations: 852/2004; 853/2004;
specifications      854/2004                                specifications      854/2004
                                                      Dairy Foods                                                  107

Table 3.17 Hard Italian cheeses description, properties      Table 3.19 Swiss-type cheese description, properties and
and shelf life.                                              shelf life.

                   Hard Italian cheeses (Provolone,                                                    e
                                                                                Swiss-type cheese (Gruy` re and
Product            Romano and Parmesan)                      Product            Emmental)

General            Provolone: moisture <45% and fat in       General                 e
                                                                                Gruy` re: moisture 38% and fat in dry
characteristics    dry matter 46–47%, Romano:                characteristics    matter 49% and Emmental: moisture
                   moisture <34% and fat in dry matter                          40% and fat in dry matter 45%. The
                   >38% and Parmesan: moisture <32%                             characteristic eye formation in these
                   and fat in dry matter >32%. Provolone                        cheeses is related to propionic acid
                   and Romano cheeses are manufactured                          fermentation and to CO2 release. Raw
                   from either raw or HTST pasteurised                          milk used for these cheeses should be a
                   standardised milk, while Parmesan                            premium microbiological quality
                   cheese is produced only from HTST         Packaging          Vacuum and in Emmental wax
                   pasteurised standardised milk
                                                             Use                Sales to stores
Packaging          Vacuum or different types of wax
                                                             Shelf life         3 months
Use                Sales to stores
                                                             Instructions for   In the fridge between 0 and 4◦ C
Shelf life         6 months                                  storage and        Consumed with no further thermal
Instructions for   In the fridge between 0 and 4◦ C          distribution       processing
storage and        Consumed with no further thermal          General            Regulations: 852/2004; 853/2004;
distribution       processing                                specifications      854/2004
General            Regulations: 852/2004; 853/2004;
specifications      854/2004
                                                             and the temperature of milk before rennet addition
                                                             (Mehanna et al., 1998).
lactis (3:1) and Lactobacillus casei–Lactococcus lac-           Many European cheeses are characterised by com-
tis (1:1) (Abd El-Salam et al., 1993). Starter culture       plex bacterial surface flora. This so-called ‘red smear’
should be inoculated at 1% and should be left at 32–         consists of yeasts, coryneform bacteria and (micro-/)
34◦ C for 15–30 minutes (milk ripening). The activ-          staphylococci (Kammerlehner, 1995). The smear layer
ity of the lactic culture should be verified by monitor-      protects cheeses from drying and contaminations with
ing the acidity development in milk. Contamination           undesirable bacteria and moulds. The composition of
with bacteriophages can alter the activity of the cul-       the surface flora depends largely on the specific house
ture, while phage inhibitory media for starter growth        microflora of the cheese manufacturer.
can be used to minimise the hazard of bacteriophages            Traditionally, growth of the surface microflora is
(Cogan and Hill, 1993). The acidity of milk should           initiated with the help of mature cheeses, which re-
be measured in order to control the quantity of rennet       lease part of their surface microflora into the smear
                                                             tank. Thus, all necessary micro-organisms have been
                                                             transferred to the smear tank, from where smearing
Table 3.18 Cheddar cheese description, properties and
shelf life.
                                                             Table 3.20 Camembert cheese description, properties
Product            Cheddar cheese                            and shelf life.

General            Cheddar cheese has moisture content       Product            Camembert cheese
characteristics    lower than 39% and fat –in –dry
                   matter higher than 50%. Cheddar           General            The typical composition of Camembert
                   cheese is manufactured from               characteristics    cheese found commercially is 50%
                   pasteurised milk. The pH value of the                        moisture content, 28% fat content, and
                   fresh product should be 5.2–5.3                              2% salt and minerals
Packaging          Vacuum or wax                             Packaging          Different types of wax or vacuum
Use                Sales to stores                           Use                Sales to stores
Shelf life         4 months                                  Shelf life         6 months
Instructions for   In the fridge between 0 and 4◦ C          Instructions for   In the fridge between 0 and 4◦ C
storage and        Consumed with no further thermal          storage and        Consumed with no further thermal
distribution       processing                                distribution       processing
General            Regulations: 852/2004; 853/2004;          General            Regulations: 852/2004; 853/2004;
specifications      854/2004                                  specifications      854/2004
108                    HACCP and ISO 22000 – Application to Foods of Animal Origin

of young cheeses is started (old–young smearing). Al-       increased shelf life. It is also well known that HP ap-
though this process is rather inexpensive, the disadvan-    plications on milk and dairy products have shown to
tage is that pathogens (e.g. Listeria monocytogenes) or     be an effective method to inactivate micro-organisms
other contaminants like moulds are also transferred         including most infectious foodborne pathogens.
to the smear/spray tank and are spread to all cheeses          In milk, HP produces casein micelles disintegration
in the factory (Bockelmann et al., 1997). Apart from        into casein particles of smaller diameter, with a de-
Listeria, enterobacteria with transferable antibiotic re-   crease in milk turbidity and lightness, and an increase
sistances are matters of concern in this respect as well    of viscosity of the milk (Johnston et al., 1992). Fur-
(Teuber, 1999).                                             thermore, the pressure-induced dissociation of the col-
   Since the microbial ecology of smear cheese surfaces     loidal calcium phosphate and denaturation of serum
is still not understood in detail, no surface ripening      proteins in milk may change and/or improve its tech-
cultures of adequate composition are commercially           nological properties (Lopez Fandino et al., 1996).
available. However, such cultures will be necessary            Dry-salting of Feta requires the use of corn-sized
for cheese factories (often small and medium enter-         granular salt, which is slowly dissolved and con-
prises) to meet the continuously increasing hygienic        tributes to the drainage of the curd (Anifantakis,
demands of European guidelines and regulations. Gen-        1991a, b). Salt should be evenly distributed in the mass
erally, only a few species like Debaryomyces hansenii       of cheese. Within the first 24 hours, salt-in-moisture
and Brevibacterium linens are used as smear adjuncts,       should be 2.5% and pH 5.2 to ensure the safe preser-
which do not reflect the microbial complexity found          vation and normal ripening of Feta (Mehanna et al.,
on the surface of smear cheeses.                            1998; Pappas et al., 1996). During salting, Feta should
   Bockelmann (2002) reported on growth on cheese           also be protected from flies because they lay their eggs
(lab scale) of the five strain minimal starter devel-        on the cheese surface causing its spoilage within a few
oped comparable to that of a typical old–young              days (Zerfiridis, 1994). Further ripening is completed
smear ‘starter’. A complete smear layer was devel-          at 5◦ C after two months (Tsotsanis, 1996). Ripening
oped within 4–7 days. It consisted of the yeast De-         usually lasts for two weeks at 16◦ C and 85% relative
baryomyces hansenii, and the bacteria Brevibacterium        humidity and is crucial to the development of the char-
linens, Arthrobacter nicotianae, Corynebacterium am-        acteristic physicochemical and organoleptic properties
moniagenes and Staphylococcus equorum. When de-             of Feta. Ripening rooms should be separated from the
fined starters were tested on a pilot scale, a too weak      rest of the plant, be equipped with an air filtration
sulphury volatile flavour was observed compared to           system and thoroughly cleaned (Mauropoulos and Ar-
the old–young smeared control cheeses. Some of the          vanitoyannis, 1999). By the end of the first ripening
key sulphur components (methanethiol and deriva-            stage, the pH should be 4.0–4.6 because lower values
tives), some alcohols and aldehydes were produced           result in moisture loss, acidic taste and limited com-
at lower levels by the defined starters. The develop-        pactness, while higher values lead to reduced shelf life
ment of typical light-brown cheese colour (so-called        (Anifantakis, 1991a).
‘red smear’) was attributed to the interactions between        After milking, the raw milk is chilled to below 4◦ C
yellow-pigmented Arthrobacter spp. and proteolytic          and kept at this temperature during its transportation
bacteria. The orange pigments of B. linens and staphy-      to the dairy factory. Following reception, milk is fil-
lococci were found to be of lesser importance. The role     tered and stored in large silo tanks and is sampled
of Corynebacterium species which show fast growth is        for analyses. The milk is standardised (casein/fat 0.7–
still not clear. An impact of this predominant part of      0.8), pasteurised (72◦ C/15 seconds) and cooled down
the smear flora on aroma and colour development can          to 32◦ C. At this temperature, a starter culture is added
be expected. However, clear effects were not observed       and after 30 minutes, rennet is also added and the milk
in experiments with model systems.                          is coagulated in 50–60 minutes. The coagulum is cut by
   It has been reported that high pressure (HP) (pres-      using a 2-cm wire knife; it stays for ten minutes and is
sures between 300 and 600 MPa) improves rennet or           then transferred in thin layers into perforated moulds.
acid coagulation of milk without detrimental effects on     The moulds are rectangular of dimensions 23 × 23 ×
important quality characteristics, such as taste, flavour,   35 mm3 . The curd is drained without pressing, until it
vitamins and nutrients (Trujillo et al., 2002). These       is firm enough to remove the moulds. The cheese is cut
characteristics offer the dairy industry numerous prac-     into four blocks of 11 × 11 × 8 cm3 . These blocks are
tical applications to produce microbiologically safe,       dry-salted on the surface. After 12 hours, the blocks
minimally processed dairy products with improved            are reversed and salted again. This is repeated until
performances, and to develop novel dairy products of        the salt content of cheese reaches 4%. After the cheese
high nutritional and sensory quality, novel texture and     blocks have thus remained on the cheese tables for a
                                                     Dairy Foods                                                 109

few more days, the cheeses are packed into tin cans,         than the caseins contained in the cheese curd. The
containing 6–8% salt solution and kept at 14–16◦ C           composition of Mizithra cheese from cow’s whey is
for about 15 days until they attain pH 4.6 and mois-         70% moisture content and 11% fat content, while the
ture content 55%. The cheeses are then transferred           composition of low-fat Mizithra cheese is 80 ± 2.8%
to new containers where more brine is added and the          moisture content and 1.4 ± 0.9% fat content.
containers are sealed and stored at 4◦ C (Mauropoulos           Raw milk should comply with the prescribed re-
and Arvanitoyannis, 1999).                                   quirements for the safety of raw milk used for Feta
   Packaging of Feta is traditionally carried out in bar-    cheese. Milk should be standardised to 3% fat content
rels, although nowadays tins are mostly used. Tins           by means of a separator to meet the legal requirements
are filled with 6% brine to cover the surface of the          for the composition of Teleme cheese.
cheese, are hermetically sealed, and transferred to the         Lactic culture of Streptococcus lactis and Lacto-
refrigerator. Other types of conventional wrapping for       bacillus bulgaricus (1:3) should be added at 0.5% and
soft cheeses can consist of waxed paper board (both          left at 32◦ C for 35 minutes to lower the pH value
sides)/regenerated cellulose or high-density polyethy-       to 6.5 (milk ripening). Unsuccessful milk ripening re-
lene (HDPE) or polyethylene terephthalate (PET)              veals that the lactic culture is inactive and requires
coated with hydrosorbent coating (Mathlouthi et al.,         an additional quantity of the starter in order to avoid
1994). Feta should not be packaged and cooled unless         growth of undesirable micro-organisms and degraded
it has reached a pH value of at least 4.6, otherwise the     organoleptic characteristics. Rennet should be added
cheese will convert into a soft, creamy mass similar to      at the appropriate proportion, depending on the tem-
mud. Moreover, the destruction of pathogens, such as         perature and acidity of the milk. If cheese milk was
coliforms, Salmonella and Brucella is not feasible dur-      stored for an extended time and has high acidity, the
ing ripening. Killing of Mycobacterium requires ade-         rennet quantity should increase, while milk temper-
quate pasteurisation of milk and is not affected by pH       ature should be lower than 32◦ C to complete curd
value or salt concentration in cheese (Hammer et al.,        formation rapidly and to prevent the growth of any
1998). In the refrigerator, tins can swell if temperature    undesirable microflora. At this stage, CaCl2 should be
exceeds 5◦ C or psychrotrophs continue cheese fermen-        added to compensate for Ca2+ losses during pasteuri-
tation. To prevent tin swelling, the temperature should      sation, while chlorophyll should be added to change
be constantly monitored and a small, easily covered          the yellowish colour of cow’s milk into white. When
hole should be made at the surface of the tins to release    the curd formation is completed, the coagulum should
the produced gases. The relative humidity in the refrig-     be cut to avoid excessive fat losses. Curd pieces should
erator should also be controlled to prevent tin rusting.     be uniform and of proper size to ensure adequate mois-
Feta is safe for consumption only after 2 months ripen-      ture expulsion. Then, the curd should be transferred
ing at 5◦ C (Sandrou and Arvanitoyannis, 2000a).             into moulds to drain and the next day the pH value
                                                             of the curd should be 4.8–4.9. Insufficient acidity de-
                                                             velopment is detrimental to Teleme cheese quality, be-
3.4.2 Teleme and Mizithra cheeses
                                                             cause it can lead to growth of E. coli and gas formation
Teleme cheese is a soft white cheese, ripened and kept       by coliforms (Sandrou and Arvanitoyannis, 2000a).
in brine. The technology of this cheese was first intro-         Teleme cheese should be salted into brine of 18◦ B´  e
duced in Greece by refugees who came from Romania            and at 16◦ C, while its surface should be dry-salted with
and was quickly spread, because it was easier than           high-grade salt. The following morning, the cheese
the technology for Feta cheese. Teleme cheese is made        temperature should be 20◦ C, the pH value should be
only from cow’s milk, is salted directly into brine, lacks   lower than 5.2, the moisture content should be 65%
the characteristic slime that develops on the surface of     and the salt concentration should be higher than 2.5%.
Feta cheese, and is packaged into tins. The distinguish-     After two days, the cheese should be dry-salted, trans-
ing characteristics of Teleme cheese are the piquant         ferred into sealed tins and left for 2 weeks to ripen. At
flavour, the white yellowish colour and the hard and          the beginning of ripening (16◦ C), the pH value should
friable texture. Its usual composition is less than 70%      be 4.8, the salt concentration should be higher than
moisture content and less than 10% fat content and           3% and the moisture content should be 57%. Ripening
it is widely preferred for its low-fat content (Sandrou      is crucial to the destruction of pathogens and contam-
and Arvanitoyannis, 2000a).                                  ination with coliforms and yeasts should be avoided
   Mizithra cheese can be made from both cow’s and           to prevent blowing of Teleme cheese. When the salt
sheep’s whey used for the manufacture of Teleme or           concentration has reached 5%, the moisture content
Feta cheese and is characterised by the presence of          is 54% and the pH value is lower than 4.8, the tins
whey proteins, which have higher nutritional value           should be placed into the refrigerator at 4–5◦ C for
110                    HACCP and ISO 22000 – Application to Foods of Animal Origin

2 months to complete cheese ripening (Arvanitoyan-          EU (Regulation 1017/1996/EU). Kasseri cheese is pro-
nis and Mavropoulos, 2000).                                 duced from sheep’s milk or from a mixture of sheep’s
   The whey removed during Teleme cheese produc-            and up to 20% goat’s milk. The addition of goat’s milk
tion can be successfully used for the production            leads to harder cheeses. The major advantage of this
of Mizithra cheese. The characteristics of the whey         cheese is that it can be produced from milk with high
should be a pH value of 6.38 and acidity of 9–11◦ D         acidity (Zerfiridis, 1997). The annual manufacture
(degree Dornic), a fat content of 0.3–0.4%, and a tem-      in Greece is approximately 21,000 tonnes (Zerfiridis,
perature of 32–35◦ C. Low acidity of the whey permits       1994).
the denaturation and coagulation of whey proteins              The typical form of Kasseri cheese is flat, cylindrical
and increases cheese yield. Whey should be heated at        and its typical size is : diameter, 25–30 cm; height, 7–10
88–90◦ C for 5–7 minutes and the pH value should            cm; and weight, 7–8 kg. Its texture is firm and the few
be adjusted to the isoelectric point of the whey pro-       holes, if any, are uniformly distributed. The cheese has
teins. The temperature should rise progressively (1–        a white-yellow colour and a rind of the same colour.
1.5◦ C/minute) and heating should be completed within       It is packaged in Cryovac plastic bags, at the age of
45–50 minutes. The optimum pH value varies within           three weeks, and its ripening time is of duration of at
the range 5.5–5.8 and depends on the physicochem-           least three months. The cheese is distinguished for its
ical condition of the whey and on the calcium con-          pleasant taste and flavour and is consumed as table
centration. The pH adjustment is usually done with          cheese or used for pizza production like Mozzarella
a solution of citric acid and the protein coagulum          cheese (Rudan and Barbano, 1998). Kasseri is a semi-
formed is collected and placed into moulds, where the       hard cheese with maximum moisture 40% and mini-
temperature decreases progressively. Since, after heat-     mum fat –in –dry matter 40%. The determination of
ing, there are few competitive microflora, the danger        CCPs and the flow diagram for Kasseri and semi-hard
of undesirable fermentations caused by coliforms and        cheese are given in Table 3.22 and Fig. 3.3, respectively.
yeasts is high. A combination of dry-salting and the
use of proper cultures can contribute to a sufficient
                                                            3.4.4 Kefalotyri cheese
decrease in pH value and to the development of better
organoleptic characteristics. Finally, Mizithra cheese is   Kefalotyri is a traditional Greek cheese made from
packaged into tins and can be safely kept in refrigera-     sheep’s or goat’s milk or a mixture of them (Ani-
tors for 3–4 months.                                        fantakis, 1991b). Since 1996, Kefalotyri is of ‘pro-
   Mizithra, Anthotyros and Manouri are whey                tected name of origin’ in the EU (Regulation (EC)
cheeses traditionally produced in Greece from whey          No. 1017/1996). The name is supposed to refer to
derived from cheeses made from mixtures of ewe’s            the ‘head-shaped’ appearance of the cheese (Kalant-
and goat’s milk. Whey from Feta cheese is mostly            zopoulos, 1993). Around 3600 tonnes of Kefalotyri
used for preparation of these whey cheeses. Govaris         cheese are annually consumed in Greece (Zerfiridis,
et al. (2001) studied the behaviour of E. coli O157:H7      1994). The main characteristics of Kefalotyri cheese
in Mizithra, Anthotyros and Manouri whey cheeses.           are its hard texture, salty taste and strong flavour. It
Results showed that E. coli O157:H7 can grow at             is a hard rind cheese of white-yellow colour. Small gas
12◦ C and survive at 2◦ C storage in Mizithra, Antho-       holes and bigger slit holes exist in the mass of cheese.
tyros and Manouri whey cheeses, and therefore post-         Kefalotyri has a flat cylindrical shape, diameter of 32–
manufacturing contamination with this pathogen must         34 cm, height of 12–14 cm and weight of 8–10 kg. The
be avoided by employing hygienic control programmes         chemical constituents of the final product are: moisture
such as HACCP accompanied by good manufacturing             36%, fat 28%, fat –in –dry matter 45%, pH 5.6 and
practices (GMPs).                                           salt content 4%.
   The determination of CCPs and the flow diagram               The thermophilic starters used consist of Str. ther-
for Feta cheese, Batzos and Telemes are given in Table      mophilus and Lb. bulgaricus (2:1) (Robinson, 1995),
3.21 and Fig. 3.2, respectively.                            or Str. thermophilus and Lb. casei (8:2) (Pappas and
                                                            Zerfiridis, 1989), or Str. thermophilus, Str. diacetylac-
                                                            tis and Str. durans (4:4:2) (Tzanetaki, 1993). After dry-
3.4.3 Kasseri cheese
                                                            salting, the cheeses are waxed or coated with plastic
Kashkaval is a typical Balkan pasta filata cheese, which     films and curing continues for three months at 15◦ C.
is traditionally made from sheep’s milk (Robinson,          Cured cheeses are stored at 4–5◦ C, thereafter. Ripen-
1995). Its Greek relative is Kasseri cheese, which is       ing for 3 months makes a cheese ready for consump-
very popular in Greece. Since 1996, Kasseri belongs         tion. Kefalotyri is consumed as table or grated cheese.
to the products with ‘protected name of origin’ in the      The determination of CCPs and the flow diagram for
Table 3.21 Determination of critical control points (CCPs) for Feta cheese/Batzos/Telemes.

                                                                                                                                                     α/α
S/n       Processing step    Hazard        Description of hazards            Q1     Preventive action                           Q2    Q3    Q4       CCP

1         Water              Biological    Polluted water with high          Yes    Annual microbiological and chemical         No    Yes   No
                                           microbial load and other                 control
                                           chemical substances
                             Chemical                                        Yes    Monthly routine control                     No    Yes   No
3         Milk receipt       Biological    Milk with high microbial load     Yes    Periodical control of milk sample           No    Yes   Yes      CCP 1a
                                                                             Yes    Determination of pH                         Yes                  1b
                                           Distribution under non-hygienic   Yes    Control of temperature of receipt and       Yes
                                           conditions                               cleaning of the vehicle
                             Physical      Foreign matter, hair and other    Yes    Filtration, macroscopic control             No    Yes   Yes      1c
                                           material
                             Chemical      Antibiotics, pesticide residues          Periodical control of milk for antibiotic   No    Yes   No       1d
                                                                                    residues
                                           Adulterated milk (with water or   Yes    Determination of specific gravity            Yes
                                           cheaper milk)                            Instructions to producers and sign of
                                                                                    agreements for standard specifications
                                                                                    (TPC, somatic cells, antibiotics, fat
                                                                                    concentration)
2, 4, 5   Receipt of other   Biological    Contaminated raw materials,       Yes    Reliable suppliers, raw materials’          No    Yes   Yes
                                                                                                                                                                 Dairy Foods




          raw materials                    Use after expiry date                    specifications according to legislation
          Salt                                                                      Implementation of FIFO
          Starter cultures   Physical      Presence of foreign matter        Yes    Macroscopic control before use              No    Yes   Yes
          Rennet             Chemical      Presence of heavy metals          Yes    Reliable suppliers, raw materials’          No    No
                                                                                    specifications according to legislation
6, 9      Receipt–storage    Biological    Presence of contaminants and      Yes    Macroscopic control. Ideal storage          No    Yes   Yes
          of packaging                     foreign matter                           conditions/cleaning
          materials          Physical      Moisture uptake                   Yes    Conformity certificates for the use of       No    Yes   Yes
                             Chemical      Packaging materials               Yes    packaging materials in the food industry    No    No
                                           non-conforming to come into
                                           contact with food
7         Pasteurisation     Biological    Survival of pathogenic            Yes    Control of time and temperature of          No    Yes   Yes
                                           micro-organisms, weakness of             pasteurisation
                                           satisfactory reduction of the
                                           initial microbial load
8         Starter culture    Biological    Lower quantity of culture         Yes    Use according to suppliers’ instructions    No    No
          preparation
                                           Weak culture                      Yes    Use before expiry date                      No    No
                                                                                                                                                  (Continues )
                                                                                                                                                                 111
                                                                                                                                                   112




Table 3.21 (Continued )

                                                                                                                                            α/α
S/n      Processing step      Hazard        Description of hazards            Q1    Preventive action                     Q2    Q3    Q4    CCP

10       Brine formation      Biological    Weak brine, weakness of           Yes                        e
                                                                                    Determination of Baum´ degrees        Yes               CCP2
                                            antimicrobial action
11       Curd formation       Biological    Weakness of fast multiplication   Yes   Weigh rennet                          Yes               CCP3
                                            of good micro-organisms,                Monitoring of temperature of cheese
                                            prevailing of undesirable and           boiler
                                            harmful ones                            Monitoring of curdling time
                                                                                    Control of milk temperature
12–19    Curd cut–            Biological/   Contamination from equipment      Yes   Regular cleaning and disinfection,    No    Yes   Yes   CCP4
         moulding             physical      and personnel. Uneven pieces.           GMPs
                                            Uneven draining
20, 21   Dry-salting/         Biological    Lowering of pH and removal of     Yes   pH monitoring                         Yes               CCP5
         ripening in cheese                 moisture                                Temperature control and check of
         tables and in                      Early stop of ripening                  ripening area
         open containers                                                            Macroscopic control
22       Cooling              Biological    Growth of micro-organisms         Yes   Temperature control of cooling        Yes               CCP6
                                                                                    chambers
                                            Release before the end of         Yes   Control of pH, production dates
                                            ripening
23       Distribution         Biological    Growth of undesirable             Yes   Control of temperature of vehicles    Yes               CCP7
                                            micro-organisms
                                                                                                                                                   HACCP and ISO 22000 – Application to Foods of Animal Origin
                                                                      Dairy Foods                                                   113


                                                                                                                        6.
                                                          3. Milk                 4. Starter                        Packaging
            1. Water                2. Salt                                                          5. Rennet
                                                          receipt                  culture                          material `
                                                                                                                     receipt

                                                                  CCP1 P, C, M

                                                          8. Cool                                                 11. Packaging
                        7. Brine                          storage                                                    material
                        formation                                                                                    storage
                        (6–8%)
                                              48 hours
                CCP2

           10. Cream                                      9. Cream
           collection                                    separation
                                                                                  13. Starter
                                                                                    culture
                                                          12.                    preparation
                                                    Pasteurisation


                                                          14. Curd
                                                         formation
                                                                          CCP3
          Other usage
                                                     15. Curd cut


                                                     16. Moulding


           18. Whey
                                                     17. Draining          16–18°C, 3–6 hours
           collection


                                                         19. Salting             pH 5.2


                                                          20.
                                                                            CCP4
                                                     Preripening
                                                                                                                 Metal containers
                                                     Does it float?                No           Reject


                                       16–18°C              Yes
                                    min RH = 85%
                                      7–15 days
                                                         Ripening           CCP5



                                                    21. Packaging


                                       0–2°C
                                                          22. Cool
                                     RH = 85%                               CCP6
                                     2 months             storage




                                                          23.
                                                                            CCP7
                                                     Distribution



Fig. 3.2 Feta cheese/Batzos/Telemes flow diagram production.
Table 3.22 Determination of critical control points (CCPs) for Kasseri/semi-hard cheese.                                                                   114
                                                                                                                                                    α/α
S/n       Processing step     Hazard        Description of hazards             Q1     Preventive action                           Q2    Q3    Q4    CCP

1         Water               Biological    Polluted water with high           Yes    Annual microbiological and chemical         No    Yes   No    SSM1
                                            microbial load and other                  control
                                            chemical substances
                              Chemical                                         Yes    Monthly routine control                     No    Yes   No
3         Milk receipt        Biological    Milk with high microbial load      Yes    Periodical control of milk sample           No    Yes   Yes   1a
                                                                                      Determination of pH                         Yes   Yes   Yes   1b
                                            Distribution under non-hygienic    Yes    Control of temperature of receipt and       Yes   Yes   No    1c
                                            conditions                                cleaning of the vehicle                     No                1d
                              Physical      Foreign matter, hair and other     Yes    Filtration, macroscopic control             No
                                            material                                                                              Yes
                              Chemical      Antibiotics, pesticide residues    Yes    Periodical control of milk for antibiotic
                                            Adulterated milk (with water or    Yes    residues
                                            cheaper milk)                             Determination of specific gravity
                                                                                      Instructions to producers and sign of
                                                                                      agreements for standard specifications
                                                                                      (TPC, somatic cells, antibiotics, fat
                                                                                      concentration)
2, 4, 5   Receipt of other    Biological    Contaminated raw materials,        Yes    Reliable suppliers, raw materials’          No    Yes   Yes
          raw materials                     Use after expiry date                     specifications according to legislation      No    Yes   Yes
          Salt                                                                        Implementation of FIFO                      No    No
          Starter cultures    Physical      Presence of foreign matter         Yes    Macroscopic control before use
          Calcium chloride    Chemical      Presence of heavy metals           Yes    Reliable suppliers, raw materials’
                                                                                      specifications according to legislation
6         Receipt–storage     Biological    Presence of contaminants and       Yes    Macroscopic control. Ideal storage          No    Yes   Yes
          of packaging                      foreign matter                     Yes    conditions/cleaning                         No    Yes   Yes
          materials           Physical      Moisture uptake                    Yes    Conformity certificates for the use of       No    No
                              Chemical      Packaging materials                       packaging materials in the food industry
                                            non-conforming to come into
                                            contact with food
9         Pasteurisation      Biological    Survival of pathogenic             Yes    Control of time and temperature of          No    Yes   Yes
                                            micro-organisms, weakness of              pasteurisation
                                            satisfactory reduction of the
                                                                                                                                                           HACCP and ISO 22000 – Application to Foods of Animal Origin




                                            initial microbial load
12        Curd formation      Biological    Weak growth of good                Yes    Weigh rennet                                Yes               CCP2
                                            micro-organisms, prevailing of            Monitoring of temperature of cheese
                                            undesirable and harmful ones              boiler
                                                                                      Monitoring of curdling time
                                                                                      Control of milk temperature
13, 18    Curd                Biological/   Contamination from equipment       Yes    Regular cleaning and disinfection,          No    Yes   Yes   SSM2
          cut–moulding        physical      and personnel. Uneven pieces.             GMPs
                                            Uneven draining
14   Stirring/            Biological/   Contamination from equipment       Yes   Regular cleaning and disinfection,       No    Yes   Yes
     reheating/           physical      and personnel                            GMPs
     precipitation
15   Curd removal/        Biological/   Contamination from equipment       Yes   Regular cleaning and disinfection,       No    Yes   Yes
     curd extraction      physical      and personnel                            GMPs
16   Cutting/ mixing      Biological/   Contamination from equipment       Yes   Regular cleaning and disinfection,       No    Yes   Yes
                          physical      and personnel                            GMPs
17   Pressing of cheese   Biological/   Contamination from equipment       Yes   Regular cleaning and disinfection,       No    Yes   Yes
     mass                 physical      and personnel                            GMPs. Use of appropriate weights,        No    No
                                        Unable to remove the required      Yes   adjustment of room temperature
                                        quantity of whey
21   Ripening of          Biological    Failure of prevailing of good      Yes   Adjustment of temperature and            No    Yes   Yes
     cheese mass                        micro-organisms and drop of              humidity, filtering test, control of pH
                                        pH
     Cutting/             Biological/   Clotted, unstrained kasseri mass   Yes   GMPs, regular cleaning and               No    Yes   Yes
     immersion in hot     physical      Contamination from equipment       Yes   disinfection,                            Yes               CCP3
     water/               Biological    and personnel                            Time and temperature control
     fermentation                       Failure to kill micro-organisms
     Moulding/            Biological/   Contamination from equipment       Yes   Regular cleaning and disinfection,       No    Yes   Yes
                                                                                                                                                   Dairy Foods




     hardening of         physical      and personnel                            GMPs
     cheese heads
20   Mould removal        Biological/   Contamination from equipment       Yes   Regular cleaning and disinfection,       No    Yes   Yes
                          physical      and personnel                            GMPs
     Salting/ ripening    Biological    Failure to remove moisture         Yes   Regular salting                          Yes               CCP4
                                        Growth of undesirable                    Temperature control and adjustment of
                                        micro-organisms                          moisture in the chamber of ripening
     Drying               Biological    Moisture points on the surface     Yes   Macroscopic control before packaging     No    No
                                        of the cheese, mould growth
22   Paraffin/             Biological/   Contamination from equipment
     packaging            physical      and personnel
23   Cooling              Biological    Growth of micro-organisms          Yes   Temperature control of cooling           Yes               CCP5
                                        Release before the end of          Yes   chambers
                                        ripening                                 Control of pH, production dates
     Distribution         Biological    Growth of undesirable              Yes   Control of temperature of vehicles       Yes               CCP6
                                        micro-organisms
                                                                                                                                                   115
116                   HACCP and ISO 22000 – Application to Foods of Animal Origin


                                                                                                               6.
                                                                          4.
                                              3. Milk                                       5. Rennet      Packaging
          1. Water       2. Salt                                     Streptococci
                                              receipt                                       CaCl2           material
                                                                    bulgaricus L.
                                                                                                            receipt
                                                            CCP1
                                              7. Cool
                                              storage                                                     8. Packaging
                                                              48 hours                                       material
                                              9.                                                             storage
                                                                                            0.02% CaCl2
                                        Pasteurisation

                                             10.                      11. Starter
                         Cream         Standardisation               preparation         CCP2
                                                                        (1.5%)
                                      32°C
                                              12. Curd
                                             formation


                                         13. Curd cut/
                                              rest

                                                                CCP3
                                         14. Stirring/
                                          Reheating/                 <48°C, 30 minutes
                                        Sedimentation

                                          15. Whey                    pH = 5.1–5.2,
        Other
                         Whey            removal/ `                    60–70°D,
        uses                                                            3 hours
                                         Warm hold


                                         16. Cut/Stir

                                                              CCP4
                                         17. Hot water
                         Water               bath/                       70–80°C
                                          Kneading

                                        18. Moulding/
                                         Preripening

                                             19. Salting/
                                                              CCP5
                                             Capsizing

                                             20. Mould
                                              removal


                                         21. Ripening

                                                                   <18°C, 70 days
                                             22.
                                        Paraffination/
                                         Packaging


                                         23. Ripening



                                              24. Cool
                                                              CCP6
                                              storage


Fig. 3.3 Kasseri/semi-hard cheese flow diagram.
                                                  Dairy Foods                                                117

Graviera, hard cheese and Kefalotyri are given in Table   ing runs and inspection of appropriate removal of salt
3.23 and Fig. 3.4, respectively.                          residues. The pressure difference between pasteurised
                                                          and untreated milk should be tested and calibrated
                                                          at 0.5 bar, to avoid the cross-contamination of pas-
3.5 CCPs IN THE PRODUCTION LINE OF                        teurised milk (Dijkers et al., 1995). Thorough records
    KASSERI AND KEFALOTYRI                                of pasteurisation temperatures, deviations and under-
                                                          taken corrective actions should be kept.
3.5.1 Storage in silo tanks                                  Pasteurisation constitutes a CCP, because some
                                                          pathogens and bacteria such as Mycobacterium can
The raw milk should be cooled down to temperatures        survive under the ripening conditions (pH, % NaCl)
below 6◦ C (Directive 92/46/EEC). Silo tanks must be      and is of high risk for public health (Hammer et al.,
provided with a stirring system for the uniform cool-     1998). At least one CCP must proceed pasteurisation
ing of milk. Mixing stored raw milk with recently re-     (e.g. reception of raw milk), because bacterial agglom-
ceived raw milk should be discouraged. To avoid the       erations, toxins and spores are not easily destroyed and
risk of further growth of micro-organisms potentially     antibiotics, aflatoxins or other chemical substances
dangerous to human health (e.g. Bacillus cereus), milk    cannot be eliminated with pasteurisation.
should be kept at the lowest possible temperature (e.g.      Cross-contamination of milk after pasteurisation is
4◦ C) and treated within 72 hours. Milk to be stored      of major importance and has to be avoided for produc-
for longer periods is usually subjected to a mild heat    ing cheeses that are both safe and of desirable storage
treatment (‘thermisation’) (van den Berg, 1984). Daily    life (Varnam and Sutherland, 1996). The main con-
cleaning schedules for the silo tanks should be set up,   tamination sources are: air, water, equipment, peo-
documented and updated.                                   ple, utensils, starter cultures, rennet and packaging.
                                                          The most common micro-organisms contaminating
                                                          the product after pasteurisation are: Staphylococcus,
3.5.2 Pasteurisation
                                                          Salmonella, Campylobacter, coliforms and Yersinia.
The pasteurisation process is carried as a continuous     The presence of E. coli indicates potential contami-
operation with the milk heated in a heat exchanger        nation with pathogenic micro-organisms which may
and then held in a holding tube for a prescribed time.    grow at ripening conditions of cheese with potential
In an HTST (high-temperature short time) system,          problems for public health.
the minimum temperature–time conditions are 72◦ C            Faeces are the primary source of pathogenic E.
for 15 seconds. The heat treatment aims at limiting       coli contamination of agricultural commodities and,
public health hazards arising from pathogenic micro-      as there is no definitive assay for faecal contamina-
organisms (e.g. Coxiella burnetii) associated with milk   tion, FDA (1995) and FSIS (1990) use the presence
(Jervis, 1992).                                           of generic E. coli as an indicator for faecal contam-
   Moreover, HTST extends the quality of cheese by        ination. The adverse health risks of E. coli in foods
reducing the number of spoilage micro-organisms. Af-      are well documented (Armstrong et al., 1996; Hui,
ter heat treatment, milk gives a negative phosphatase     2001; Mead et al., 1999). Faeces can also be the source
test. The surviving micro-organisms are thermoresis-      of many other types of pathogenic organisms, includ-
tant (Micrococcus, Streptococcus, Lactobacillus), sur-    ing parasites (Blackburn and McClure, 2002; Hui,
viving without any further growth, and thermophilic       2001). The authors have demonstrated that fluores-
bacteria (Micrococcus, Coryneform), able to survive       cence can be a very sensitive method for detecting fae-
and grow (Hull et al., 1992). Although not all of         ces (Kim et al., 2002, 2003; Lefcourt et al., 2003),
them are pathogens, a critical limit should be esta-      and that fluorescence responses of faeces from differ-
blished.                                                  ent animal species are similar. Lefcourt et al. (2005)
   Pasteurisation equipment should be properly de-        describe a transportable imaging system for detect-
signed and meticulously operated to ensure that the       ing faecal contamination. The primary components
entire amount of milk is heated to the appropriate        of the system are a UV light source, an intensified
temperature and that the flow diversion valve (leading     camera with a six-position filter wheel, and software
to repasteurisation) is properly operated. The holding    for controlling the system and automatically analysing
tube should be of uniform diameter and the holding        images.
time must be very accurately determined. Preventative        Cleaning and disinfection procedures of the heating
measures include an automatic safety system to pre-       equipment are optimised and programmed. Duration,
vent too low or too high temperatures, extra cleaning     temperature and concentration of the cleaning solution
if more than three days have elapsed between process-     are checked and records are kept.
     Table 3.23 Determination of critical control points (CCPs) for Graviera/hard cheese/Kefalotyri
                                                                                                                                                                 118
                                                                                                                                                       α/α CCP
S/n         Processing step      Hazard        Description of hazards             Q1     Preventive action                           Q2    Q3    Q4

1           Water                Biological    Polluted water with high           Yes    Annual microbiological and chemical         No    Yes   No
                                               microbial load and other                  control
                                               chemical substances
                                 Chemical                                         Yes    Monthly routine control                     No    Yes   No    CCP 1a
3           Milk receipt         Biological    Milk with high microbial load      Yes    Periodical control of milk sample           No    Yes   Yes   1b
                                                                                  Yes    Determination of pH                         Yes   Yes   Yes   1c
                                               Distribution under non-hygienic    Yes    Control of temperature of receipt and       Yes   Yes   No    1d
                                               conditions                                cleaning of the vehicle                     No
                                 Physical      Foreign matter, hair and other     Yes    Filtration, macroscopic control             No
                                               material                           Yes    Periodical control of milk for antibiotic   Yes
                                 Chemical      Antibiotics, pesticide residues           residues
                                               Adulterated milk (with water or           Determination of specific gravity
                                               cheaper milk)                             Instructions to producers and sign of
                                                                                         agreements for standard specifications
                                                                                         (TPC, somatic cells, antibiotics, fat
                                                                                         concentration)
2, 4, 5     Receipt of other     Biological    Contaminated raw materials         Yes    Reliable suppliers, raw materials           No    Yes   Yes
            raw materials                      Use after expiry date                     conforming to the legislation
            Salt                                                                         Implementation of FIFO
            Rennet               Physical      Presence of foreign matter         Yes    Macroscopic control before use              No    Yes   Yes
                                 Chemical      Presence of heavy metals           Yes    Reliable suppliers, raw materials           No    No
                                                                                         conforming to the legislation
6           Receipt–storage      Biological    Presence of contaminants and       Yes    Macroscopic control. Ideal storage          No    Yes   Yes
            of packaging         Physical      foreign matter                     Yes    conditions/cleaning                         No    Yes   Yes
            materials            Chemical      Moisture uptake                    Yes    Conformity certificates for the use of       No    No
                                               Packaging materials                       packaging materials in the food industry
                                               non-conforming to come into
                                               contact with food
            Brine formation      Biological    Weak brine, weakness of            Yes                         e
                                                                                         Determination of Baum´ degrees              Yes               CCP2
                                               antimicrobial action
10          Pasteurisation       Biological    Survival of pathogenic             Yes    Control of time and temperature of          No    Yes   Yes
                                               micro-organisms, weakness of              pasteurisation
                                                                                                                                                                 HACCP and ISO 22000 – Application to Foods of Animal Origin




                                               satisfactory reduction of the
                                               initial microbial load
12          Curd formation       Biological    Slow growth of “good”              Yes    Weigh rennet                                Yes               CCP3
                                               micro-organisms, prevailing of            Monitoring of temperature of cheese
                                               undesirable and harmful ones              boiler
                                                                                         Monitoring of curdling time
                                                                                         Control of milk temperature
13          Curd                 Biological/   Contamination from equipment       Yes    Regular cleaning and disinfection,          No    Yes   Yes
            cut–moulding         physical      and personnel. Uneven pieces.             GMPs
                                               Uneven draining
14   Stirring/          Biological/   Contamination from equipment     Yes   Regular cleaning and disinfection,       No    Yes   Yes   SSM2
     reheating/         physical      and personnel                          GMPs                                                       SSM3
     precipitation
15   Curd removal/      Biological/   Contamination from equipment     Yes   Regular cleaning and disinfection,       No    Yes   Yes   SSM2
     curd extraction    physical      and personnel                          GMPs                                                       SSM3
16   Moulding           Biological/   Contamination from equipment     Yes   Regular cleaning and disinfection,       No    Yes   Yes   SSM2
                        physical      and personnel                          GMPs                                                       SSM3
17   Pressing/ change   Biological/   Contamination from equipment     Yes   Regular cleaning and disinfection,       No    Yes   Yes   SSM2
     of paddy/          physical      and personnel                    Yes   GMPs                                     No    Yes   Yes   SSM3
     reversing          Biological    Inability to remove moisture,          Control of room temperature conditions   Yes               CCP4
                                      prevailing of good                     Control of pH
                                      micro-organisms
19   Mould removal/     Biological/   Contamination from equipment     Yes   Regular cleaning and disinfection,       No    Yes   Yes   SSM2
     placement in       physical      and personnel                    Yes   GMPs                                     No    No          SSM3
     brine                            Growth of undesirable                  Adjustment of room temperature
                                      micro-organisms
     Dry-salting/       Biological/   Contamination from equipment     Yes   Regular cleaning and disinfection,       No    Yes   Yes   SSM3
     surface abrasion   physical      and personnel                    Yes   GMPs                                     No    No
                                      Growth of undesirable                  Adjustment of room temperature
                                      micro-organisms, insufficient
                                                                                                                                               Dairy Foods




                                      quantity of salt
18   Ripening           Biological    Failure to remove moisture       Yes   Regular salting                          Yes               CCP5
                                      Growth of undesirable                  Temperature control and adjustment of
                                      micro-organisms                        moisture in the chamber of ripening
22   Washing/           Biological    Presence of pollutants and       Yes   GMPs                                     No    No
     drying                           points of contamination on the         Macroscopic control before packaging
                                      surface
                                      Moisture points on the surface
                                      of kasseri, mould growth
24   Paraffin            None
     formation/
     packaging
25   Cooling            Biological    Growth of micro-organisms        Yes   Temperature control of cooling           Yes               CCP6
                                      Release before the end of        Yes   chambers
                                      ripening                               Control of pH, production dates
                                                                                                                                               119
120                      HACCP and ISO 22000 – Application to Foods of Animal Origin


                                                                                                                    6.
                                                                                                  5. Rennet
                                                3. Milk                 4. Starter                              Packaging
          1. Water               2. Salt                                                        40% solution
                                                receipt                  culture                                 material
                                                                                                    CaCl2
                                                                                                                 receipt

                                                        CCP1

                       Brine                    7. Cool              11. Starter
                                                storage                                                        8. Packaging
                     formation                                       preparation                                  material
                        18°Be                                           (1%)                                      storage
                                                  9.
                             Cream          Standardisation
                                                                48 hours
                                                  10.
                                             Pasteurisation
                                                                 32°C
                                                12. Curd
                                               formation
                                                              CCP2
                                             13. Curd cut/
                                                  rest
                                                                CCP3
                                              14. Stirring/
                                                                     <45°C, pH 2 = 6.2
                                               Reheating

           Other                               15. Whey
                             Whey
           usage                                removal

                                              16. Shaping/
                                               Moulding

                                              17. Press/         CCP4
                                               Change
                            Residues                                       1st day
                                            draining cloth/
                                              Capsizing

                                                                         2nd day
                                            18. Preripening          14–16°C, pH 2 = 4.8


                                               19. Mould
                                                removal

                                              20. Insertion
                                                in brine

                                              21. Removal               Room: 14–16°C, RH = 85%,
                                               from brine                  Duration 24 hours


                                            22. Dry salting/            Room: 14–16°C, RH = 85%,
                                     CCP5   Surface rubbing                Duration 48 hours


                                              23. Ripening                  Duration 3 months



                                            24. Paraffination


                                                   25.
                                     CCP6         Cool                        2–5°C, RH = 85%
                                                storage

Fig. 3.4 Graviera/hard cheese/Kefalotyri flow diagram.
                                                     Dairy Foods                                                 121

3.5.3 Starter culture                                        distinct and firm rind, free of visible openings, which
                                                             can constitute pollution sites for mould strains. The
The product standardisation is assured with the addi-
                                                             main hazards consist of contamination from pressing
tion of a thermophilic starter culture. The thermophilic
                                                             and the salting environment, the quality of salt and wa-
cultures usually contain Str. salivarius subsp. bulgari-
                                                             ter and the growth of moulds during salting. The envi-
cus and various strains of lactobacilli, such as Lb. del-
                                                             ronment is monitored for the absence of mould spores
brueckii subsp. bulgaricus and Lb. delbrueckii subsp.
                                                             and records are kept. Air quality should be controlled
lactis (Caric, 1993). Formation of lactic acid by the
                                                             by means of air filters and the critical limit is <100
starter bacteria is very important for the appropriate
                                                             moulds and yeasts per cubic metre (Hocking, 1997).
ripening and preservation of the cheese. The percent-
                                                                Kefalotyri cheese is pressed for 3–4 hours at 15◦ C
age of added culture is approximately 1.5% (Zerfiridis,
                                                             and after pressing is placed immediately in brine
1997).
                                                             (18◦ B´ ) at 15◦ C. The pressure increases progressively
                                                                   e
                                                             until the pressure value reaches 12 times of cheese
3.5.4 Rennet addition                                        weight. During cheese salting, pH and salt content
                                                             should be inspected and records should be kept. The
Rennet is added to milk at 32◦ C after 30 minutes have       presence of salt in moisture helps to control the growth
elapsed from the starter culture addition. The rennet        of micro-organisms especially coliforms, staphylococci
must be obtained from a certified supplier. The liquid        and clostridia. If weaker brines are used, growth of salt
rennet 1:10,000 gives the best quality of cheese. Incu-      tolerant lactobacilli in the brine may be observed and
bation at 32◦ C continues until the formation of curd        flavour defects in cheese quality may occur. Placement
(35–40 minutes). The curd formation must follow a            of brined cheese under UV irradiation bulbs aims at
correct pattern. Curd formation time, temperature and        inactivating the spores of moulds thus resulting in su-
acidity of milk are regarded as the monitoring parame-       perficial disinfection.
ters at this stage. Verification includes the inspection of      Brine temperature and pH should be regularly
plant records and the control of coagulum properties.        checked and recorded. These parameters can be used as
                                                             indicators for ensuring the desirable ripening process.
3.5.5 Ripening                                               Every six ± eight months, the brine should be changed
                                                             and regular cleaning of the equipment is conducted.
The curd remains in the vat, dipped in the whey, at             Before the beginning of dry-salting, pH value is
38–42◦ C. The starter culture continues to reduce the        checked (4.8). Dry-salting is completed within 20–25
pH of coagulum. Ripening is completed within 3–6             days. Control measures include the degree and distri-
hours, when the pH reaches 5.1–5.2 or the acidity            bution of salt, time and number of dry-salting, pH
of whey attains 60–70◦ D. The end of curd ripening           values and humidity. The temperature and RH (%)
should be checked by experienced personnel. Poten-           are held at 15◦ C and 80%, respectively. At higher RH
tial cross-contamination of the curd from personnel          (%) moulds may grow.
and environment may favour the growth of pathogens
in the final product.
                                                             3.5.8 Dry-salting

3.5.6 Kneading                                               The hazards include potential growth of undesirable
                                                             micro-organisms, the quality of salt which may contain
The curd is cut into slices which are transferred to a       metals (physical hazard) or chemical substances at high
machine for mechanical kneading thus avoiding any            concentrations and microbial contamination from the
microbial contamination. Kneading is carried out in          environment, water and personnel.
hot water (80◦ C) for 15 minutes. The kneaded cheese            The salt concentration and its uniform distribution
at 57◦ C is filled in the moulds in a room without            throughout the curd are important for ensuring a stan-
draught. The microbial and the chemical quality of           dard cheese quality. The control measures include de-
water should be checked.                                     gree and distribution of salt, duration and number of
                                                             dry-salting for every cheese surface and titratable acid-
                                                             ity. Dry-salting is completed within 15–30 days.
3.5.7 Pressing/salting (Kefalotyri cheese)
                                                                Verification includes monitoring of the quality of
At Kefalotyri cheese production the cheese is trans-         the end product and the inspection of plant records.
ferred in plastic moulds, wrapped in clean cloths,           During ripening the surface of the cheese is washed
pressed and salted in brine in contrast to Kasseri           1–2 times with lukewarm water, brushed and ap-
cheese. With pressing the cheese develops a very             plied with brine. Ripening storage premises must be
122                     HACCP and ISO 22000 – Application to Foods of Animal Origin

free from draughts and insects. The temperature and          should be of controlled quality and purchased only
the RH (%) are held at 15◦ C and 80%, respectively.          from reputable suppliers. Acidification of whey is re-
At higher temperatures the fat may come out of the           quired to pH 5.8, before or during heating, when the
cheese.                                                      pH value is high (pH > 6.0) in order to avoid the
                                                             growth of C. botulinum. The added acids are citric,
                                                             lactic and acetic acid. The heating rate must be con-
3.5.9 Packaging
                                                             trolled in order to reach the final temperature of 88–
After ripening the cheeses are removed by the first in        90◦ C within 40–45 minutes (Kalantzopoulos, 1993;
first out (FIFO) method and are prepared for packag-          Veinoglou et al., 1984). The heat treatment aims at
ing. The hazards are that the cheeses can be cross-          the separation of proteins and fat as curd and at the
contaminated by the packaging material (Cryovac)             destruction of the vegetative forms of bacteria. Cross-
and the environment. If the packages happen to be            contamination of product after production leads to
sealed non-hermetically, moulds can grow at the sur-         the growth of a high number of micro-organisms (co-
face of the cheese. The preventative measures consist        liforms, yeasts and moulds), due to the high moisture
of measuring the vacuum in packaged cheese and con-          content.
trolling the prescriptions for packaging material. The          If the hygienic conditions are not strictly adhered
latter must be kept under strict hygienic conditions and     to after heat treatment, the addition of a starter cul-
the temperature should be held at 12◦ C.                     ture (1%) is recommended, when the curd tempera-
                                                             ture is below 50◦ C. Recording of temperature during
                                                             heat treatment should be carried out by experienced
3.5.10 Storage
                                                             personnel using temperature recording charts. When
When the cheeses are transferred to the storage room         the temperature increases, the ingredients must be
their uniform cooling should be checked. During stor-        added at 70–75◦ C (Greek Codex of Foods and Drinks,
age the product temperature must be maintained at            1998). For the purpose of drainage, moulds and/or
5◦ C or less in order to ensure the microbiological safety   cloth bags are used. Potassium sorbate solution (15%)
of this product. The product must be kept at least for       is added to the cheeses for a few seconds to avoid the
three months before consumption. The shelf life of this      growth of moulds later during storage. The cheese, in
product is approximately one year. The control mea-          its final form, has the shape of a cylinder (diameter,
sures include pH of cheeses, duration of ripening (3         10–12 cm; length, 20–30 cm). Manouri cheeses are
months), temperature and RH (%) of the storage room          vacuum packed in plastic bags and can be consumed
(Arvanitoyannis and Mavropoulos, 2000).                      right after production, without ripening. The high
                                                             moisture and lactose content make the product very
                                                             vulnerable to micro-organisms. Therefore, it should
3.6 MANOURI CHEESE                                           be stored at cooling temperatures (<4◦ C) and con-
                                                             sumed within 10–15 days. The shelf life of the product
Manouri cheese is one of the most popular white              made from ultra-filtrated whey can be extended even
soft whey cheeses produced in Macedonia (northern            for up to six months, without any alteration of the
Greece). It is produced from the whey derived from           desirable organoleptic characteristics (Veinoglou and
full-cream goat’s milk or from mixtures of sheep’s           Kandarakis, 1984). If the temperature exceeds 4◦ C,
and goat’s milk during the production of hard cheeses        there is a great risk of toxin growth producing moulds
(Anifantakis, 1991b). Cream and/or milk may also be          (Mauropoulos and Arvanitoyannis, 1999). The deter-
added. It is in the shape of a cylinder and does not have    mination of CCPs and the flow diagram for Mizithra,
any holes. It is considered the highest quality whey         Anthotyros and Manouri are given in Table 3.24 and
cheese. The moisture, the fat and the salt content are       Fig. 3.5, respectively.
48, 37 and 0.8%, respectively. Furthermore, it has a
high nutritional value due to its high biological value
proteins content, higher than the biological value of        3.7 ICE CREAM
caseins of which most cheeses consist. Since the whey
cheeses are characterised by a great variety in their        Ice cream still retains a reputation as a high-risk food,
composition, special concern is required for maintain-       although its safety record in developed countries has
ing the appropriate hygienic conditions in the produc-       been very good over many years. This record can be
tion line in order to avoid the uncontrolled growth of       attributed to the use of high-quality ingredients, the
microflora.                                                   strict control of pasteurisation of the mix and the high
   All the ingredients used, such as whey, milk, cream       level of hygiene during subsequent operations up to
and salt constitute potential hazards. Therefore, they       the point of sale.
     Table 3.24 Determination of critical control points (CCPs) for Mizithra/Anthotyros/Manouri.

                                                                                                                                                       α/α CCP
S/n         Processing step     Hazard        Description of hazards              Q1     Preventive action                           Q2    Q3    Q4

2           Milk receipt        Biological    Milk with high microbial load       Yes    Periodical control of milk sample           No    Yes   Yes   CCP 1a
                                              Distribution under non-hygienic     Yes    Determination of pH                         Yes   Yes   Yes   1b
                                              conditions                                                                                               1c
                                Physical      Foreign matter, hair and other      Yes    Control of temperature of receipt and       Yes   Yes   No    1d
                                              material                                   cleaning of the vehicle                     No
                                Chemical      Antibiotics, pesticide residues     Yes    Filtration, macroscopic control             No
                                              Adulterated milk (with water or     Yes    Periodical control of milk for antibiotic   Yes
                                              cheaper milk)                              residues
                                                                                         Determination of specific gravity
                                                                                         Instructions to producers and sign of
                                                                                         agreements for standard specifications
                                                                                         (TPC, somatic cells, antibiotics, fat
                                                                                         concentration)
4, 10       Receipt of whey/    Biological    Whey loaded with                    Yes    Control of acidity, use of fresh whey       No    Yes   Yes   CCP2
            filtration                         micro-organisms, low yield                 Filtration
                                Physical      Residence of cheese crumbs,         Yes                                                Yes
                                              burning during pasteurisation
1           Salt                Biological    Contaminated raw materials          Yes    Reliable suppliers, raw materials           No    No    Yes
                                              Use after expiry date                      conforming to the legislation
                                                                                         Implementation of FIFO
                                Physical      Presence of foreign matter          Yes    Macroscopic control before use              No    No
                                                                                                                                                                      Dairy Foods




                                Chemical      Presence of heavy metals            Yes    Reliable suppliers, raw materials           No    Yes
                                                                                         conforming to the legislation
12, 13      Receipt–storage     Biological    Presence of contaminants and        Yes    Macroscopic control. Ideal storage          No    Yes   Yes
            of packaging                      foreign matter                             conditions/cleaning                         No    Yes   Yes
            materials           Physical      Moisture uptake                     Yes    Conformity certificates for the use of       No    No
                                Chemical      Packaging materials                 Yes    packaging materials in the food industry
                                              non-conforming to come into
                                              contact with food
15          Pasteurisation/     Biological    Survival of pathogenic              Yes    Control of time and temperature of          Yes               CCP3
            baking of cheese                  micro-organisms, weakness of               pasteurisation
            curd                              satisfactory reduction of the
                                              initial microbial load
18          Collection/         Biological/   Contamination from equipment        Yes    Regular cleaning and disinfection,          No    Yes   No
            moulding            physical      and personnel                              GMPs
19          Draining            Biological/   Contamination from equipment        Yes    Regular cleaning and disinfection,          No    Yes   No
                                physical      and personnel                              GMPs
                                Biological    Inability to remove moisture,       Yes    Control of room’s conditions                Yes
                                              prevailing of good
                                              micro-organisms
                                                                                                                                                       (Continues )
                                                                                                                                                                      123
                                                                                                                                              124




Table 3.24 (Continued )

                                                                                                                                       α/α
S/n      Processing step   Hazard        Description of hazards         Q1    Preventive action                       Q2    Q3    Q4   CCP

20       Mould removal     Biological/   Contamination from equipment   Yes   Regular cleaning and disinfection,      No    Yes   No
                           physical      and personnel                        GMPs
21       Stay on the       Biological/   Contamination from equipment   Yes   Regular cleaning and disinfection,      No    Yes   No
         cheese table      physical      and personnel                        GMPs
                                         Growth of undesirable          Yes   Adjustment of room temperature          No    Yes   No
                                         micro-organisms
22       Packaging         Biological/   Contamination from equipment   Yes   Regular cleaning and disinfection,      No    Yes   No
                           physical      and personnel                        GMPs                                    Yes
                           Biological    Failure of vacuum operation          Operation control, control of closure                    CCP4
23       Cooling           Biological    Growth of micro-organisms      Yes   Temperature control of cooling          Yes              CCP5
                                         Release before the end of      Yes   chambers
                                         ripening                             Control of pH, production dates
         Distribution      Biological    Growth of undesirable          Yes   Control of temperature of vehicles      Yes              CCP6
                                         micro-organisms
                                                                                                                                              HACCP and ISO 22000 – Application to Foods of Animal Origin
                                                            Dairy Foods                                                            125



                                                                                                                    7. Potassium
                                                                           5. Citric acid         6. Starter
       2. Milk           3. NaOH                      4. Whey milk                                                     sorbate
                                                                               10%                 culture
                                                                                                                    solution 15%

                                                                    CCP1
                                                         Direct
                                                      processing?
 1. Salt                                                                                                                    12.
                                                           No                                                            Packaging
                                                                                                                          material
                                          Yes        9. Milk storage                                                      receipt


                                                      10. Filtering     CCP2

                                                                                                                       13. Packaging
                            11.                        14. Acidity                                                        material
                                        pH < 6.3
                       Neutralisation                   control                                                            storage
   Up to 10% at 70°C
                                                         pH > 6.3
                                                                        CCP3                  17. Starter culture
                                                       15. Heating                               preparation
                                                                                                     (1%)

                                                    16. Coagulation


                                                      18. Transfer      CCP4
                                                       to moulds


                                                      19. Draining      CCP5



                                                    20. Mould removal

                                                                              <22°C, RH = 80–85%, 5 days

                                                    21. Rest on table



                                                     22. Packaging



                                                           23.
                                             CCP6         Cool             8°C for 2 months
                                                         storage


Fig. 3.5 Mizithra/Anthotyros/Manouri flow diagram.
126                       HACCP and ISO 22000 – Application to Foods of Animal Origin

   Nevertheless, even if ice cream has not been the ve-          Roughly speaking, ice cream manufacture involves
hicle of major food poisoning outbreaks, complacency          the following steps: blending, pasteurisation, homoge-
should be avoided. The isolation of Listeria monocyto-        nisation, ageing of the mix, freezing, packaging and
genes from ice cream in the USA (Varnam and Suther-           hardening.
land) underlines the necessity of re-evaluating the pro-
cess with respect to this micro-organism. Salmonella
                                                              3.7.1 Blending
and Listeria are in practice of the greatest concern and
should be tested for by standard cultural techniques or       The liquid and dry ingredients are weighed and
rapid tests. Moreover, additions made to ice cream af-        blended together by means of rapid agitation in high-
ter pasteurisation are potential sources of hazard and        speed blenders. It is of key importance that the dry
under some circumstances microbiological examina-             ingredients disperse fully in the mix; therefore, blend-
tion should be considered.                                    ing tanks should be fitted with highly efficient turbine
   To conclude, micro-organisms are unable to grow in         agitators. Dispersion can also be aided by introducing
ice cream if stored at adequate temperatures. Pasteuri-       solid ingredients into the liquid in the pipe feeding the
sation of the mix involves elimination just of the vege-      blending tank.
tative pathogens; therefore, it is of paramount impor-
tance to: prevent recontamination after pasteurisation,
                                                              3.7.2 Pasteurisation
assure the microbiological status of ingredients with
particular reference to thermoduric micro-organisms           The mix should be heated to a level sufficient to destroy
and the preformed toxins, prevent microbial growth            vegetative pathogens and especially Listeria mono-
before freezing and ensure the continuity of the freez-       cytogenes. Moreover, pasteurisation also reduces the
ing chain up to consumption. The ice cream descrip-           number of spoilage organisms such as psychrotrophs
tion, determination of CCPs, the HACCP plan, haz-             and helps to hydrate some of the components (proteins
ards identification and the flow diagram for ice cream          and stabilisers). Both batch pasteurisers and continu-
are given in Tables 3.25–3.28 and Fig. 3.6, respectively.     ous (HTST) methods are used.


      Table 3.25 Ice cream product description.

      Product                      Ice cream

      General characteristics      Pasteurised
                                   Deep frozen
                                   aw > 0.95
                                   No preservatives
                                   Contains nuts or may contain traces of nuts
                                   Sizes: stick 80 g, cone 78 g, cup 150 g,
                                   family size 500 and 1000 g
      Packaging/size               Wooden stick, laminated foil/pp film
                                   Cone sleeves                                   Cardboard
                                   Plasticised paper cups, paper lids
                                   PE containers, PE lids
      Usage                        Ready to eat
      Shelf life                   18 months
      Storage and transport        −20 to −26◦ C
      requirements
                                   Ferrous 1.5–2.0 mm
      Foreign materials            Non-ferrous 2.5 mm
                                   Stainless steel 316 (2.5–3.0 mm)
      Microbiological              APC                                            1 × 105
      standards                    Coliform or Enterobacteria                     0/0.1 mL
                                   Salmonella spp.                                0/25 mL
                                   Staphylococcus aureus                          As coagulase positive, 0/0.1 mL
                                   Yeasts                                         1 × 102
                                   Moulds                                         1 × 102
                                   Yeasts and Moulds                              1 × 102
Table 3.26 Determination of critical control points (CCPs) for ice cream.

S/n      Process                    Hazard        Hazard description                                             PP     Q1    Q2    Q3    Q4        CCP

1        Water supply               Biological    Water not meeting potable water criteria                       1
                                    Chemical      Heavy metals, pesticides
                                    Physical      Extraneous matter
2        Raw material receipt       Biological    Pathogen growth/toxin production due to accepting              7      Yes   No    Yes   Yes
                                                  temperature/time abused product
                                    Chemical      Pathogen contamination from receiving equipment                4
                                                  Veterinary drug residues, heavy metals, pesticides             7
                                                  Cross-contamination from non-food chemicals (cleaners,
                                                  sanitisers, lubricants)
                                                  Not food grade
                                    Physical      Extraneous matter                                              7
3        Packaging material         Biological    Soiled packaging                                               7
         receipt                    Chemical      Not food grade
                                    Physical      Extraneous matter
4, 5     Raw and packaging          Biological    Pathogen growth due to temperature and/or humidity abuse       3      Yes   Yes                   1
         material storage                         Contamination from unclean storage rooms                       4
                                    Chemical      Contamination from chemicals present in food storage           4
                                                  rooms
                                    Physical      Contamination from extraneous matter                           4
6        Recipe calculation/        Biological    Contamination from personnel and equipment                     4, 5
         weighing                   Chemical      Exceed acceptable quantity of additive (i.e. of stabilisers)   4, 5
                                                                                                                                                               Dairy Foods




                                    Physical      Contamination from extraneous matter                           5
7        Blending                   Biological/   Contamination from personnel and equipment                     4, 5
                                    chemical
                                    Physical      Contamination from extraneous matter                           5
8–10     Pasteurisation/            Biological    Pathogen survival due to improper time/ temperature                   Yes   Yes                   2–3
         homogenisation/                          Pathogen recontamination due to improper pressure              2
         cooling                                  differential
                                                  Pathogen recontamination from raw product (product             4, 5
                                                  accumulation)
                                    Chemical      Cross-contamination from non-food chemicals (cleaners,         4, 5
                                                  sanitisers)
                                                  Cross-contamination from heating and/or cooling media          2
                                                  (pinholes)
                                    Physical      Contamination from hazardous extraneous material (metal,       2
                                                  gaskets)
11       Flavour and colourant      Biological    Contamination from personnel and equipment                     4, 5
         addition                   Chemical      Cross-contamination from non-food chemicals (cleaners,         4, 5
                                                  sanitisers)
                                    Physical      Contamination from extraneous matter                           5
                                                                                                                                                (Continues )
                                                                                                                                                               127
                                                                                                                                                128




Table 3.26 (Continued )

S/n      Process                 Hazard       Hazard description                                            PP     Q1    Q2    Q3    Q4   CCP

12       Ageing                  Biological   Pathogen growth if temperature rises above 5◦ C.                     Yes   No    Yes   No   4
                                              Contamination from unclean tanks                              4, 5
                                 Chemical     Cross-contamination from non-food chemicals (cleaners,        4, 5
                                              sanitisers)
                                 Physical     Contamination from extraneous matter                          2, 5
13       Freezing with air       Biological   Contamination from air                                        2
         incorporation                        Contamination from unclean equipment                          2, 4
                                 Chemical     Cross-contamination from non-food chemicals (cleaners,        4, 5
                                              sanitisers)
                                 Physical     Contamination from extraneous matter                          2, 5
14       Chocolate melting       Biological   Contamination from unclean equipment                          2, 4
                                 Chemical     Cross-contamination from non-food chemicals (cleaners,        4, 5
                                              sanitisers)
                                 Physical     Contamination from extraneous matter                          2, 5
15, 20   Metal detection         Physical     Risk of releasing contaminated end product from hazardous     2      Yes   Yes              5
                                              metal material due to improper functioning/calibration of
                                              metal detector
16–22    Mould filling-coating/   Biological   Contamination from unclean equipment                          2, 4
         decoration              Chemical     Cross-contamination from non-food chemicals (cleaners,        4, 5
                                              sanitisers)
                                 Physical     Contamination from extraneous matter                          2, 5
23       Packaging/labelling     Biological   Pathogen contamination from physical damage to the            2, 5
                                              container
24       Hardening               Biological   Inability to prevent microbial growth and achieve desirable          Yes   No    No
                                              shelf life
                                                                                                                                                HACCP and ISO 22000 – Application to Foods of Animal Origin




                                              Contamination from unclean equipment                          2, 4
25       Storage/distribution    Biological   Pathogen growth due to abuse                                  3
Table 3.27 HACCP plan for ice cream.

                     Hazard           Preventive       Monitoring                      Critical          Verification          Corrective      HACCP
CCP    Process       description      actions          procedures        Responsible   control limits    procedures           actions         records

1      4. Milk       Pathogen         Equipment        Trained           Storage       Storage           Maintenance          Hold affected   Raw milk
       storage       growth/toxin     maintenance/     personnel to      personnel     temperature       supervisor will      storage tanks   storage
                     production       calibration      monitor the                     <5◦ C             verify accuracy of   (not to be      temperature
                     from time        Training–        storage                         Maximum           the room             directed in     and time
                     and              critical         temperature                     storage period    temperature log      production)     monitoring
                     temperature      control limits   and time of                     see expiry date   once per shift       Inform          records and
                     abuse            observance       every raw milk                                    and observe plant    quality         action taken
                                                       storage tank                                      employee             control         records
                                                       and record on                                     performing           supervisor      Thermometer
                                                       daily log                                         monitoring           and he/she to   calibration
                                                                                                         QA will check all    decide on       records
                                                                                                         thermometers         disposition     Quality
                                                                                                         used for             Quality         control audit
                                                                                                         monitoring           control to      records
                                                                                                         devices for their    investigate,    Affected load
                                                                                                         accuracy on a        identify and    history
                                                                                                         daily basis          correct cause
                                                                                                                              of problem
2      8. Milk       Pathogen         Equipment        Operator          Pasteuriser   Pasteurisation    Specialist           Activate        Calibration
       pasteurisa-   survival due     maintenance/     monitors          operator      temperature       auditing and         manual divert   record
       tion          to improper      calibration      cut-in/cut-out                  not less than     plate                and hold all    Corrective
                                                                                                                                                               Dairy Foods




                     time and/or      Training–        temperature at                  80◦ C for a       maintenance          product         action records
                     temperature      critical         start up for                    holding time      should be carried    processed       Recording
                     of pasteurisa-   control limits   each batch                      of not less       out twice a          since last      charts
                     tion             observance       Operator                        than 25           month                satisfactory    Quality
                                                       checks the                      seconds or        Ensure correct       check           control
                                                       indicating                      69◦ C/30          operations at        Inform          pasteurisation
                                                       thermometer                     minutes           start of each run    quality         verification
                                                       reading is                                        Twice a week         control         records
                                                       equal to                                          examination of       supervisor      Quality
                                                       critical limits                                   thermograph          and he/she to   control audit
                                                       and is                                            records              decide on       records
                                                       recorded on                                       Monthly              disposition     Product
                                                       the pasteuriser                                   microbiological      Quality         deviation
                                                       chart                                             tests meeting        control to      records
                                                       Operator                                          standards            investigate,    Records of
                                                       checks                                                                 identify and    discussions
                                                       everyday that                                                          correct cause   Equipment
                                                       the seal is                                                            of problem      and control
                                                       intact on flow                                                                          test records
                                                       control device
                                                                                                                                                (Continues )
                                                                                                                                                               129
                                                                                                                                                                  130




Table 3.27 (Continued )

                    Hazard         Preventive       Monitoring                      Critical         Verification               Corrective        HACCP
CCP    Process      description    actions          procedures        Responsible   control limits   procedures                actions           records

3      10.          Inability to   Equipment        Operator          Pasteuriser   Rapid cooling    If a deviation is         A recall may      The
       Cooling      inactivate     maintenance/     monitors          operator      under 4◦ C       found on                  be initiated if   deviation and
                    pathogen       calibration      cut-in/cut-out                  within 1.5       verification the           the product       corrective
                    spores         Training–        temperature at                  hours            HACCP                     has left the      action will be
                                   critical         start up for                    Hold at this     coordinator               facility          recorded.
                                   control limits   each batch                      temperature      assesses whether
                                   observance       Operator                        not more than    food safety has
                                                    checks the                      24 hours         been affected and
                                                    indicating                                       if it has will treat it
                                                    thermometer                                      as in the deviation
                                                    reading is                                       procedure and
                                                    equal to                                         retrain the
                                                    critical limits                                  employee
                                                    and is                                           responsible for the
                                                    recorded on                                      deviation.
                                                    the pasteuriser
                                                    chart
4      12. Ageing   Pathogen       Equipment        Trained           Pasteuriser   Temperature      Quality of end
                    growth/toxin   maintenance/     personnel to      operator      <5◦ C Time       product
                    production     calibration      monitor the                     <24 hours        Number of
                    from time      Training–        storage                                          psychotropic
                    and            critical         temperature                                      micro-organisms
                    temperature    control limits   and time of                                      (twice a month)
                    abuse          observance       every raw milk                                   Twice a week
                                                    storage tank                                     inspection of
                                                                                                                                                                  HACCP and ISO 22000 – Application to Foods of Animal Origin




                                                    and record on                                    records
                                                    daily log
5   15/20.      Release      Routine       Function and      Shift        Ferrous           QA, outside the      Reject          Calibration
    Metal       product      equipment     sensitivity       supervisor   1.5–2.0 mm        packaging unit,      Activate        record
    detection   containing   check/        confirmation                    Non-ferrous       will verify that     manual divert   Corrective
                ferrous      calibration   Packaging line                 2.5 mm            the metal            and hold all    action records
                fragments                  supervisor will                Stainless steel   detector is          product         Quality
                                           check the                      316 (2.5–3.0      functioning as       processed       Control audit
                                           metal detector                 mm)               intended by          since last      records
                                           using a seeded                 All               running the          satisfactory    Product
                                           sample every 2                 contaminated      seeded sample        check           deviation
                                           hours to                       product is        through the metal    Quality         records
                                           determine                      removed from      detector twice       control to      Equipment
                                           limits are not                 system by         per shift (once      investigate,    and control
                                                                                                                                                  Dairy Foods




                                           exceeded                       triggering kick   AM, once PM).        identify and    test records
                                                                          out               QA will observe      correct cause
                                                                          mechanism         monitoring to        of problem
                                                                                            assure that
                                                                                            product from
                                                                                            kick out is placed
                                                                                            on hold
                                                                                                                                                  131
132                     HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.28 Hazards identification in incoming materials.

Incoming materials      Biological                                 Chemical                 Physical

Packaging material      Pathogen contamination from                Not food grade           Hazardous extraneous
                        soiled/damaged packaging materials                                  material (glass, metal, wood)
Water                   Water not meeting the drinking water       Heavy metals,            Hazardous extraneous
                        criteria                                   pesticides               material (metal)
Dairy                   Pathogens:                                 Veterinary drug          Hazardous extraneous
                        Listeria monocytogenes, Yersinia           residues, mycotoxins,    material (glass, metal, wood)
                        enterocolitica, Campylobacter jejuni,      pesticide residues,
                        Bacillus cereus, Salmonella spp.,          dioxins, PCBs
                        Staphylococcus aureus,
                        E. coli (O157:H7), Shigella spp.
Eggs                    Pathogens:                                 Veterinary drug          Hazardous extraneous
                        Salmonella typhimurium, Salmonella         residues, furans,        material (glass, metal, wood),
                        enteritidis, Campylobacter jejuni,         dioxins, PCBs            egg shells
                        Yersinia enterocolitica, S. aureus,
                        E. coli
Chocolate               Pathogens:                                 Pesticide residues,      Hazardous extraneous
                        Enterobacteriaceae, Salmonella             ochratoxin A             material (glass, metal, wood)
                        Spoilage from:
                        Bacillus coagulans and Bacillus
                        stearothermophilus
Isoglucose/glucose/     Spoilage from:                             Pesticide residues,      Hazardous extraneous
sugar                   Bacillus coagulans, Bacillus               heavy metals             material (glass)
                        stearothermophilus, Clostridium
                        thermosaccharolyticum,
                        Desulfotomaculum nigrificans
Additives                                                          Not food grade           Hazardous extraneous
                                                                                            material (glass, metal, wood)
Fruit pieces            Pathogens:                                 Pesticide residues       Hazardous extraneous
                        Salmonella spp., Listeria                                           material (glass, metal, wood)
                        monocytogenes, Shigella spp.,
                        B. cereus, S. aureus
                        Spoilage from:
                        Yeasts, fungi, Erwinia
Dry nuts                Aspergillus flavus, Aspergillus             Pesticide residues,      Hazardous extraneous
                        parasiticus                                aflatoxins                material (glass)
Cones/waffles                                                                                Hazardous extraneous
                                                                                            material (glass, metal, wood)



   Low temperature–long time pasteurisation, which              cooling the mix to refrigerated temperatures (4◦ C).
takes place in a steam or water jacketed vat, results           Batch tanks are usually operated in tandem so that one
in more whey protein denaturation, giving a better              is holding while the other is being prepared. Automatic
body to the ice cream. The product is heated in the             timers and valves ensure the proper holding time has
vat to at least 69◦ C and held for 30 minutes to sat-           been met.
isfy legal requirements for pasteurisation, necessary for          Plate heat exchangers are commonly used for HTST
the destruction of pathogenic bacteria. Various time            processing, although tubular heaters may be preferred
and temperature combinations can be used. The heat              where space is limited. Some preheating, 30–40◦ C, is
treatment must be severe enough to ensure destruc-              necessary for the components to dissolve easily. The
tion of pathogens and to reduce the bacterial count             HTST system is equipped with a heating section, a
to a maximum of 100,000 per gram. Following pas-                cooling section and a regeneration section. Cooling
teurisation, the mix is homogenised by means of HPs             sections of ice cream mix HTST presses are usually
and then is passed across some type of heat exchanger           larger than milk HTST presses. Because of the preheat-
(plate or double or triple tube) for the purpose of             ing of the mix, regeneration is lost and mix entering the
                                                                  Dairy Foods                                                                   133


                                                2. Raw                                          3.
                                                material                                    Packaging
                                                receipt                                      material
                                      No                                                     receipt
                                                  4. Is
          1.                               raw material storage                          5. Packaging
        Water                                  adequate?
                                                                                        material storage
        supply
                                                   Yes
                                       6. Recipe calculation/                CCP1
                                             Weighing

                                               7. Blending
                                       No
                                                     8.
                                             Is pasteurisation                69°C/30 minutes
                                                                               80°C/25 s                                          Sticks
                                                 adequate?

                         Flavours,                 Yes
                        colourants
                                        9. Homogenisation                    CCP2
                                       No
                                               10. Is cooling
                                                adequate?                    3-4°C

                                                   Yes

                                           11. Flavour, colour
                                                                             CCP3
                                                addition
                                      No
                                               12. Is ageing               <5°C/
                                                adequate?                overnight
         14. Chocolate
            melting                                Yes                                                            Sticks
                                             13. Continuous                   –6°C
                              CCP4          freezing with air                          15. Metal detection   16. Mould filling
                                              incorporation
                                                                  Dry nuts,
                                                                                                    CCP5
                                                                   fruits                                    17. Immersion in
                                            Plain ice cream?
                                                                                                               freezing tank
                                                    No                                                                     < –30°C/15 minutes

                                             19. Particulate       Cones,                                    18. Immersion in
                                                addition                             CCP5
                                                                   waffles                                     warm glycole
                               Yes
           Chocolate,                                                                                                      42°C/instantly
                                           20. Metal detection
             syrup,
                                                                                  Cups,
            dry nuts
                                                                              containers, lids
                                               21. Filling/
                                               Packaging

                                              22. Coating/
                                              Decoration

                                                                          Cardboards,
                                             23. Packaging               laminated foil

                              –40°C          24. Hardening          CP


                                                   25.
                                                Storage/
                              –20°C                                 CP
                                              Distribution



Fig. 3.6 Ice cream manufacturing flow diagram.
134                     HACCP and ISO 22000 – Application to Foods of Animal Origin

cooling section is still quite warm. Fouling is a serious     case of batch freezers) with about 50% of its water
potential problem during HTST pasteurisation but can          frozen. Inside the barrel, there are rotating blades that
be minimised by taking rigorous precautions against           keep the ice scraped off the surface of the freezer and
the incorporation of excess air into the mix.                 also dashers inside the machine which help to whip the
                                                              mix and incorporate air.
3.7.3 Homogenisation                                             The crystallisation stage is of major importance as
                                                              the texture of ice cream is largely determined by the size
The reduction of the size of fat globules is required         of the ice crystals. Fast freezing rates decrease the size
during ice cream manufacture to prevent churning and          of crystals rendering the mundetectable in the mouth.
to improve whipping properties and air incorporation             Flavouring, colouring and finely chopped fruit and
by allowing proteins to absorb onto the surface of fat        nuts may be added to the mix directly before freezing,
globules. This is accomplished by means of homogeni-          whereas larger pieces must be added as the ice cream
sation, a process that reduces the size of the fat globules   leaves the freezer.
found in milk or cream to less than 1 µm. Two-stage              After the particulates have been added, ice cream
homogenisation (15 MPa in the first and 4 MPa in the           is packaged and placed into a blast freezer at −30 to
second stage) is usually preferred for ice cream mix.         −40◦ C where most of the remainder of the water is
Clumping or clustering of the fat is reduced thereby          frozen. Below −25◦ C, ice cream is stable for indefinite
producing a thinner, more rapidly whipped mix. Melt-          periods without danger of ice crystal growth; however,
down is also improved. Homogenisation of the mix              above this temperature, ice crystal growth is possible
should take place at the pasteurising temperature. The        and the rate of crystal growth is dependent upon the
high temperature produces more efficient breaking up           temperature of storage, limiting the shelf life. Harden-
of the fat globules at any given pressure and also re-        ing is the static (still, quiescent) freezing of the pack-
duces fat clumping and the tendency to thick, heavy-          aged products in blast freezers. Freezing rate must still
bodied mixes. The higher the fat and total solids in the      be rapid, so freezing techniques involve low tempera-
mix, the lower the pressure should be.                        ture (−40◦ C) with either enhanced convection (freez-
                                                              ing tunnels with forced air fans) or enhanced conduc-
3.7.4 Ageing                                                  tion (plate freezers).
The mix is then aged for at least four hours and usu-
ally overnight. This allows time for the fat to cool
down and crystallise and for the proteins and polysac-        3.8 HARD ITALIAN CHEESES (PROVOLONE,
charides to fully hydrate. Ageing improves whipping               ROMANO AND PARMESAN)
qualities of mix and body and texture of ice cream.
Ageing is performed in insulated or refrigerated stor-        Provolone cheese belongs to the pasta filata class of
age tanks, silos etc. Mix temperature should be main-         Italian cheeses, characterised by the working of curd
tained as low as possible without freezing, at or below       in hot water until it becomes a close-knit, elastic mass
5◦ C. The longer the ageing time, the better the results      followed by moulding of curb into the desired shape
under average plant conditions. A ‘green’ or unaged           (Wilster, 1997). Provolone cheese is used as a table
mix is usually quickly detected at the freezer.               cheese and is preferred for its piquant flavour, due to
                                                              the action of several bacteria and a lipase and is en-
                                                              hanced by a light smoking. Romano cheese is a very
3.7.5 Freezing and hardening
                                                              hard cheese, has a sharp, piquant taste, granular tex-
Traditionally, ice cream freezing is a two-stage process.     ture and a few holes, and is usually consumed as grat-
In the first stage, the temperature is reduced under stir-     ing cheese. Parmesan cheese is also a very hard grating
ring, air being incorporated to give an aerated product.      cheese and has sensory properties similar to Romano
The second stage, which is much slower, involves no           cheese. The typical compositions of these cheeses are (i)
air incorporation and takes place under quiescent con-        Provolone: moisture <45% and fat in dry matter 46–
ditions in a hardening room or tunnel. The process is         47%, (ii) Romano: <34% and fat in dry matter >38%
not complete and even at very low temperatures some           and (iii) Parmesan: moisture <32% and fat in dry mat-
water remains unfrozen.                                       ter >32% (Sandrou and Arvanitoyannis, 2000b).
   Freezing takes place in a ‘barrel’ freezer; a scraped-        The flow diagram for the production of these hard
surface, tubular heat exchanger, which is jacketed with       cheeses is outlined in Fig. 3.7. Although there is not
a boiling refrigerant such as ammonia or Freon. Mix is        just one manufacturing process applied in this indus-
pumped through this freezer and is drawn off the other        try, Provolone and Romano cheeses are manufactured
end in a matter of 30 seconds (or 10–15 minutes in the        from either raw or HTST pasteurised standardised
                                                    Dairy Foods                                        135


                                                         1. Milk
                                                         (raw or
                                                     pasteurised and     CCP1
                                                     standardised)



                                                     2. Temper milk
                                                                         CCP2
                                                         to 32°C

                                                      3. Addition of
                                                                         CCP3
                                                     starter to 1–2%

                                                      4. Addition of
                                                     rennet and curd     CCP4
                                                        formation

                                                      5. Cutting of
                                                          curd
                                              No
                                                            6.
                                                    Is cooking of curd
                                                        adequate?

                                                            Yes
           No
                         7.                                                     No
                Is draining of curd
                                                                                           19.
                    adequate?
                                                    8. Dipping of curd               Is draining and
                                                                                     dipping of curd
                       Yes                     No                                       adequate?
                10. Acid ripening
                 of curd patties                           11.
                                                                                          Yes
                                                       Is pressing              No
          No
                                                       adequate?
                         13.
                Is milling and heat                                                        12.
                processing of curd                                                     Is pressing
                   satisfactory?                                                       adequate?

                       Yes                                  Yes
                 14. Moulding of                                                          Yes
                      curd



                                                       15. Salting       CCP5


                   16. Smoking


                                                      17. Ripening       CCP6



                                                             18.
                                                                         CCP7
                                                           Storage


Fig. 3.7 Hard Italian cheeses manufacturing flow diagram.
136                     HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.29 Strains, cooking conditions, acidity, salting and ripening conditions of hard Italian cheeses.

Hard Italian                                  Cooking conditions                      Salting (% brine      Ripening
cheese           % Strain                     (◦ C, time)              % Acidity      salt, ◦ C, time)      (◦ C, time)

Provolone        1–1.5 Lb. delbrueckii        48◦ C × 45 minutes       0.14–0.16      23%                   13◦ C × 4 weeks
                 bulgaricus                                                           7◦ C × 1–3 days
Romano           1–1.5 Str. thermophilus      47◦ C × 45 minutes       0.2            23%                   10–13◦ C × 5–12
                 and Lb. delbrueckii                                                  2–5 days              months
                 bulgaricus (1:1)
Parmesan         0.7 Lb. delbrueckii          50◦ C × 60 minutes       0.14–0.16      24%                   16◦ C until 15%
                 bulgaricus, 0.75 Str.                                                14–15 days            weight reduction
                 thermophilus and 0.5 LAB



milk, while Parmesan cheese is produced only from               tion should be monitored to avoid excessive smoking,
HTST pasteurised standardised milk. Cheese milk                 which degrades the flavour of the end product (San-
should be a premium quality and should comply                   drou and Arvanitoyannis, 2000b).
with the prescribed requirements for the milk used in              During ripening, it is important to monitor tempera-
Feta cheese. Starters for each cheese consist of dif-           ture, RH and hygienic condition of the ripening room.
ferent strains and are used at different proportions            After ripening, Provolone should be stored at 4◦ C for
(Table 3.29). Starters are usually incubated in whey            2–12 months, Romano should be vacuum packaged
until 0.8% acidity is reached at 43–46◦ C. Whey used            and stored at 4◦ C for 10 months and Parmesan should
for culture incubation should be first heated at least           be stored at 2◦ C for 10 months. During storage, the
at 82◦ C for 30 minutes, in order to minimise the po-           temperature should be constantly monitored and ade-
tential problems caused by bacteriophages present in            quacy of vacuum and seam integrity should be period-
the whey obtained from cheese vats (Wilster, 1997).             ically checked (Sandrou and Arvanitoyannis, 2000a).
Two or three strain cultures should be used with or             A tentative determination of CCPs for hard Italian
without rotation and phage-sensitivity should be mon-           cheeses is given in Table 3.30.
itored on a daily basis. Phage-sensitive strains should
be removed from use and should be replaced with re-
sistant strains (Varnam and Sutherland, 1996). Ren-             3.9 CHEDDAR CHEESE
net addition and curd formation should be carried
out at 32◦ C and should be supervised by experienced            Cheddar cheese is one of the most important varieties
personnel.                                                      of hard cheeses and is characterised by the salting of
   When the acidity of Provolone curd reaches 0.14–             the cheese mass prior to moulding and pressing of the
0.16%, the curd should be drained, cut into patties and         cheese, causing retardation of the rate of acid devel-
left on the vat floor for 2 hours to obtain the optimum          opment. Acidity is produced in the cheese vat by the
acidity of 0.6–0.8% (pH of 5.1–5.2). After acid ripen-          starter culture, which is characterised by the absence
ing of curd, Provolone should be milled to the correct          of lactobacilli. Cheddar cheese has a pleasant taste,
size and curd strips should be left for 15 minutes in           compact texture and few mechanical holes (Zerfiridis,
the vat containing 77–82◦ C hot water. During knead-            1994). The typical composition of Cheddar cheese has
ing, potential cross-contamination of curd should be            moisture content lower than 39% and fat –in –dry
avoided and water of potable quality should be used.            matter higher than 50% (Sandrou and Arvanitoyan-
Romano curd is drained, partly salted and placed in             nis, 2000b).
cloth-lined hoops. The initial whey draining from the              Preparation of equipment refers to cleaning and
hoops should have a titratable acidity of 0.25–0.3%.            sanitisation of cheese-making equipment and acces-
The curd is pressed at 69 kPa for 20 minutes, removed           sories. Cheese milk should be received and processed
from the moulds, reversed, replaced into moulds, and            only in thoroughly cleaned and properly sanitised
re-pressed for 60 minutes or even longer. Parmesan              equipment. Non-hygienic conditions during manufac-
curd, on the other hand, is partially drained, stirred          ture will cause contamination, thereby impairing the
gently for 15–20 minutes and dipped into cloth-lined            quality of the finished cheese. All cheese-making equip-
metal hoops. Afterwards, the curd is pressed at 69 kPa          ment and accessories should be sterilised just before
for 30 minutes at room temperature and re-pressed               use by contact with hot water (at 82◦ C/180◦ F) or chlo-
at 138 kPa overnight. After salting, smoking of Pro-            rine solution (having 100 ppm available chlorine) for
volone cheese follows. Smoking temperature and dura-            at least 2 minutes (De, 2000).
    Table 3.30 Determination of critical control points (CCPs) for hard Italian cheeses (Provolone, Romano and Parmesan).

                                                                                                                                               α/α
S/N        Processing step     Hazard        Description of hazards               Q1    Preventive action                    Q2    Q3    Q4    CCP

1, 2       Milk receipt/       Biological    Milk with high microbial load        Yes   Periodical control of milk sample    No    Yes   Yes   CCP 1a
           temper milk                                                            Yes   Determination of pH                  Yes               1b
                                             Distribution under non-hygienic      Yes   Control of temperature of receipt    Yes               1c
                                             conditions                                 and cleaning of the vehicle                            1d
                               Physical      Foreign matter, hair and other       Yes   Filtration, macroscopic control      No    Yes   Yes
                                             material                                   Periodical control of milk for       No    Yes   No
                               Chemical      Antibiotics, pesticide residues      Yes   antibiotic residues                  Yes
                                             Adulterated milk (with water or            Determination of specific gravity
                                             cheaper milk)                              Instructions to producers and sign
                                                                                        of agreements for standard
                                                                                        specifications (TPC, somatic cells,
                                                                                        antibiotics, fat concentration)
3          Addition of         Biological    Whey loaded with                     Yes   Acidity control, use of fresh whey   No    Yes   Yes   CCP2
           starter                           micro-organisms, low yield
                               Physical      Stay of cheese crumbs, burning       Yes   Filtration                           No    Yes   Yes
                                             during pasteurisation
6          Rennet              Physical      Presence of foreign matter           Yes   Macroscopic control before use       No    Yes   Yes   CCP3
                                                                                                                                                              Dairy Foods




           Curd formation      Chemical      Presence of heavy metals             Yes   Reliable suppliers, raw materials    No    No
                                                                                        conforming to the legislation
                               Biological    Slow growth of “good”                Yes   Weigh rennet                         Yes
                                             micro-organisms, prevailing of             Monitoring of temperature of
                                             undesirable and harmful ones               cheese boiler
                                                                                        Monitoring of curdling time
                                                                                        Control of milk temperature
7, 8, 9    Draining/           Biological/   Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   No
           dipping of curd     physical      and personnel                              GMPs
                               Biological    Inability to remove moisture,        Yes   Control of room’s conditions         Yes
                                             prevailing of good micro-organisms
10         Ripening            Biological    Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   Yes
                                             and personnel                              GMPs
11, 12     Pressing            Biological/   Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   Yes
                               physical      and personnel                              GMPs. Use of appropriate weights,
                                             Unable to remove the required        Yes   adjustment of room temperature       No    No
                                             quantity of whey
                                                                                                                                               (Continues )
                                                                                                                                                              137
                                                                                                                                                  138




Table 3.30 (Continued )

                                                                                                                                           α/α
S/N      Processing step   Hazard        Description of hazards               Q1    Preventive action                    Q2    Q3    Q4    CCP

13       Milling           Biological/   Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   Yes
                           physical      and personnel                              GMPs
15       Salting           Biological/   Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   Yes
                           physical      and personnel                        Yes   GMPs                                 No    No
                                         Growth of undesirable                      Adjustment of room temperature
                                         micro-organisms, insufficient
                                         quantity of salt
17       Ripening          Biological    Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   Yes
                                         and personnel                              GMPs
18       Storage           Biological    Growth of micro-organisms            Yes   Temperature control of cooling       Yes               CCP4
                                         Release before the end of ripening   Yes   chambers
                                                                                    Control of pH, production dates
                                                                                                                                                  HACCP and ISO 22000 – Application to Foods of Animal Origin
                                                    Dairy Foods                                                                           139

   The microbiological safety of Cheddar cheese
mainly depends on the proportion, quantity and type                       1. Raw                                 35–40°C
                                                                  CCP1     milk               2. Preheating
of acid produced during the lactic fermentation. Pas-                    receiving                               CCP2
teurisation of raw milk and prevention of recon-                                              3. Filtration
tamination of pasteurised milk should be ensured to                                     No

avoid growth of S. aureus and Salmonella and pro-                                                   4. Is
                                                                                                                    63°C for 30 minutes
                                                                                              pasteurisation
duction of enterotoxins by S. aureus (Hendricks et al.,                                        satisfactory?
1959; Zehren and Zehren, 1968). The conditions that
                                                                                                   Yes
flavour the growth of pathogens and enterotoxins pro-                                    No

duction in Cheddar cheese have been extensively stud-                                               5.
                                                                                               Is ripening
ied (Geopfert and Biggie, 1968; Hargrove et al., 1969a;                                         effective?
                                                                           6.
Ibrahim et al., 1981; Park et al., 1970; Reiter et al.,           31°C
                                                                         Rennet                    Yes
1964; Tatini et al., 1971; Tuckey et al., 1964; Walker
                                                                                                7. Setting         CCP3
et al., 1961; White and Custer, 1976). The tradi-
tional process for making Cheddar cheese is outlined in                                        8. Cutting
                                                                                        No
Fig. 3.8. All stages prior to scalding of the curd should
comply with the prescribed requirements for Feta                                               9. Is cooking
                                                                                                                        Up to 37–39°C
                                                                                                adequate?
cheese, apart from the differences that originate from
the use of sheep’s milk. Milk should be standardised                                               Yes
to a casein/fat ratio of 0.69–0.71 before pasteurisa-                                   No

tion. After cooling of the pasteurised milk to 30◦ C, a                                        9. Is cooking
                                                                                                adequate?
lactic culture of Lactococcus lactis or L. cremoris is
added. Starters should begin acid production within                                     No
                                                                                                   Yes

30–45 minutes, should be free of bacteriophages
                                                                                             10. Is cheddaring
(Canteri, 1997; Chopin, 1997) and should exhibit sta-                                            adequate?
bility to ageing (Haque et al., 1997). The lactic culture                                          Yes
plays a determining role for Cheddar manufacture be-                                           12. Milling
cause it produces sufficient acid, inhibits growth of
pathogens, and improves the texture, consistency and                                           13. Salting          CCP4

flavour of the cheese (Litopoulou-Tzanetaki, 1993).
                                                                                              14. Hooping
The determination of CCPs for Cheddar cheese is given
in Table 3.31.                                                                                15. Dressing
   The milk grader in a cheese factory has to perform                                   No

his task conscientiously from day to day. He should                                           16. Is pressing
                                                                                                adequate?
intercept any can/tanker of inferior milk and not al-
low it to get mixed up with high-grade milk. Success-                                              Yes
ful cheese factories follow a system of daily, efficient
                                                                                               17. Drying           CCP5
grading of all milk received. This consists of:
                                                                                                   18.
  (i) Determining the odour of the milk in each                                               Paraffination

      can/tanker. No off-flavour should be accepted.               CCP7
                                                                              20.
                                                                                               19. Storage          CCP6
                                                                         Distribution
 (ii) Inspecting the appearance of the milk, this should
      be free from all extraneous matter.
(iii) Determining sediment, either once a week or every     Fig. 3.8 Cheddar cheese manufacturing flow diagram.
      10 days, in each can of milk (a minimum amount
      of sediment is desirable).
(iv) Performing MBR, Resazurin and Rennet-curd                 Throughout Cheddar manufacture, pH, acidity,
      tests on the milk once a fortnight or so for each     moisture content and consistency of the product
      producer/supplier and more frequently (weekly or      should be constantly monitored to verify that all stages
      even daily) on milk of doubtful quality.              are performed correctly. The equipment used should
 (v) Determining the percentage of titratable acidity       be well maintained and disinfected to avoid both dam-
      (there should be as little developed acidity as       age and contamination of curd (IDF, 1997; Parmentier,
      possible).                                            1997). Heating at 38◦ C leads to curd shrinking and
(vi) Examining milk for bacteriophages, antibiotics         whey expulsion and it should be terminated when the
      and inhibitory substances (De, 2000).                 titratable acidity of the whey reaches 0.14–0.16% and
Table 3.31 Determination of critical control points (CCPs) for Cheddar cheese production.

S/N    Processing step    Hazard        Description of hazards               Q1     Preventive action                    Q2    Q3    Q4    α/α CCP
                                                                                                                                                     140
1      Milk receipt       Biological    Milk with high microbial load        Yes    Periodical control of milk sample    No    Yes   Yes   CCP 1a
                                                                             Yes    Determination of pH                  Yes   Yes   Yes   1b
                                        Distribution under non-hygienic      Yes    Control of temperature of receipt    Yes   Yes   No    1c
                                        conditions                                  and cleaning of the vehicle                            1d
                          Physical      Foreign matter, hair and other       Yes    Filtration, macroscopic control      No
                                        material
                          Chemical      Antibiotics, pesticide residues      Yes    Periodical control of milk for       No
                                        Adulterated milk (with water or             antibiotic residues
                                        cheaper milk)                               Determination of specific gravity     Yes
                                                                                    Instructions to producers and sign
                                                                                    of agreements for standard
                                                                                    specifications (TPC, somatic cells,
                                                                                    antibiotics, fat concentration)
4      Preheating         Biological    Survival of pathogenic               Yes    Control of time and temperature of   Yes               CCP2
                                        micro-organisms, unsatisfactory             pasteurisation
                                        reduction of the initial microbial
                                        load
5      Ripening           Biological    Contamination from equipment         Yes    Regular cleaning and disinfection,   No    Yes   Yes
                                        and personnel                               GMPs
6      Rennet             Physical      Presence of foreign matter           Yes    Macroscopic control before use       No    Yes   Yes   CCP3

9      Cooking            Biological    Growth of micro-organisms            Yes    Temperature control of cooking       Yes   Yes   Yes
                                        Contamination from equipment         Yes    Regular cleaning and disinfection,   No
                                        and personnel                               GMPs
10     Draining           Biological/   Contamination from equipment         Yes    Regular cleaning and disinfection,   No    Yes   No
                          physical      and personnel                        Yes    GMPs                                 Yes
                          Biological    Inability to remove moisture,               Control of room’s conditions
                                        prevailing of good micro-organisms
12     Milling            Biological/   Contamination from equipment         Yes    Regular cleaning and disinfection,   No    Yes   Yes
                          physical      and personnel                               GMPs
13     Salting            Biological/   Contamination from equipment         Yes    Regular cleaning and disinfection,   No    Yes   Yes   CCP4
                          physical      and personnel                        Yes    GMPs                                 No    No
                                        Growth of undesirable                       Adjustment of room temperature
                                        micro-organisms, insufficient
                                                                                                                                                     HACCP and ISO 22000 – Application to Foods of Animal Origin




                                        quantity of salt
16     Drying             Biological/   Contamination from equipment         Yes    Regular cleaning and disinfection,   No    Yes   Yes   CCP5
                          physical      and personnel                        Yes    GMPs Use of appropriate weights,     No    No
                                        Unable to remove the required               adjustment of room temperature
                                        quantity of whey
19     Storage            Biological    Growth of micro-organisms            Yes    Temperature control of cooling       Yes               CCP6
                                        Release before the end of ripening   Yes    chambers
                                                                                    Control of pH, production dates
20     Distribution       Biological    Growth of undesirable                Yes    Control of temperature of vehicles   Yes               CCP7
                                        micro-organisms
                                                    Dairy Foods                                                   141

the pH value reaches 6.0–6.1 (ICMSF, 1988). Draining        micro-organisms, (iii) to produce a more uniform
and texturisation of the curd should be performed at        product of high quality and (iv) to increase the yield.
the correct time, to the proper extent, and at the appro-      The main limitations of pasteurisation are: (i) it de-
priate temperature by experienced personnel (Varnam         stroys the typical flavour and body of cheese; (ii) it
and Sutherland, 1996). The characteristic process of        entails a longer ripening period; (iii) it encourages the
‘cheddaring’ should start when the curd pieces are still    use of low-quality milk; and (iv) it increases the overall
hot and it should be completed when curd pieces be-         cost of cheese making. The advantages of pasteurisa-
come one mass. Salting of the curd affects ripening,        tion heavily outweigh its disadvantages.
flavour development, preservation and rind formation
of Cheddar cheese and is considered as a CCP because
it affects the growth of S. aureus and death rate of        3.9.2 Homogenisation
Salmonella. Salt concentration should be around 2%,
                                                            The advantages of homogenisation are: (i) lower fat
unless there is a deviation from the normal rate of acid-
                                                            losses in whey and thereby a higher yield of cheese;
ity development. Gradual pressing (maximum 1.7 atm)
                                                            (ii) reduced fat leakage of cheese at elevated tempera-
makes the curd more compact by completing whey
                                                            tures; and (iii) increased rate of fat hydrolysis in some
removal. After pressing, vacuum packaging in plastic
                                                            cheeses, such as blue cheese. The disadvantage is: a
film or Cryovac and cooling of the Cheddar should fol-
                                                            softer curd is formed, which necessitates modifications
low in order to prevent deformation of the Cheddar
                                                            in the cheese-making process. Because of the disadvan-
blocks. Ageing contributes to the development of the
                                                            tage, cheese milk is normally not homogenised.
desired organoleptic characteristics and to the destruc-
                                                               Excessive heat-treatment causes the precipitation of
tion of contaminating pathogens. The pH value of the
                                                            a part of the calcium salts in milk. This results in slower
fresh product should be 5.2–5.3, otherwise it is pos-
                                                            renneting action and a weaker curd, which can be cor-
sible that the fermentation has failed and the product
                                                            rected by the addition of 0.01–0.03% calcium chloride
should be checked for Salmonella and S. aureus, when
                                                            to milk.
ageing is completed after 6–12 months at 4–10◦ C
                                                               Ripening or souring of milk refers to the develop-
(ICMSF, 1988). Packages of Cheddar cheese should
                                                            ment of acidity in milk from the time it is received in
be stored at refrigerator temperatures and should be
                                                            the cheese vat until renneting. In cheese milk, ripening
kept undamaged and protected from mould growth to
                                                            is done by the addition of starter.
extend the shelf life of the product.

3.9.1 Cheddar cheese manufacture                            3.9.3 Starter culture
After the milk has been examined for quality and ac-        The starter is the ‘heart’ of cheese. A bad starter is
cepted, it is weighed; then a representative sample is      almost certain to produce low-quality cheese. A good
taken for determination of fat and casein contents.         starter may make up for other defects, such as contami-
   The main object of the filtration/clarification step is    nated milk. There are different kinds of cheese starters,
to remove any visible dirt in milk so as to improve the     such as those producing acids, aroma, special effects
aesthetic quality of the cheese. The milk is usually pre-   (such as ‘eyes’) etc. A Cheddar cheese starter usually
heated to 35–40◦ C for efficient filtration/clarification.     contains Str. lactis and/or Str. cremoris.
   In cheese making, standardisation refers to adjust-         The usual time to add the starter is before all the milk
ment of the casein/fat ratio in cheese milk to 0.68–0.70.   has been received in the vat. The amount of starter
The objects are:                                            added is to the extent of 0.5–1% of the milk, and
                                                            the temperature of addition is 30–31◦ C. Before be-
 (i) to regulate the fat in the dry matter of cheese        ing added to the milk, the starter should be examined
(ii) to produce the maximum amount of cheese per            for its quality; it should then be stirred until smooth
     kilogram of fat in cheese milk. Standardisation        and creamy in consistency; then strained and added
     should either be done correctly, or avoided alto-      in the required quantity, and mixed thoroughly and
     gether.                                                uniformly into the milk.
                                                               Ripening (or addition of starter) aids in: (i) the for-
The usual temperature–time employed for pasteurisa-         mation of desirable curd; (ii) establishing a favourable
tion of cheese milk is: (i) holder –63◦ C for 30 min-       bacterial flora (and checking the growth of undesir-
utes and (ii) HTST – 71◦ C for 15 seconds. The objects      able micro-organisms); and (iii) controlling moisture.
or advantages of pasteurising cheese milk are: (i) to       Ripeness in milk is measured by titration (for acidity),
destroy all pathogens, (ii) to destroy fault-producing      rennet test and pH meter.
142                     HACCP and ISO 22000 – Application to Foods of Animal Origin

   When a colourant is used, it is added just before         coagulation of milk (second stage) is very sensitive to
renneting. The usual amount is 30–200 mL or more             changes in concentration of calcium ions. It is common
(for buffalo milk) for 1000 kg milk. The colourant           practice to add calcium chloride to milk which has
is diluted with approximately 20 times its volume of         been severely pasteurised, e.g. at 80◦ C for 30 seconds.
(potable) water for even distribution. It is vigorously      This acts in three ways, by lowering the pH value,
agitated to ensure uniform and rapid distribution. The       increasing the calcium ion concentration and raising
colour of cheese is usually an alkaline solution of an-      the colloidal calcium phosphate content.
natto. Rennet and colour should not be mixed together           Many colloidal substances interfere with rennin co-
before being added to the milk.                              agulation, e.g. albumin, serum peptone etc. Albumin
                                                             and globulin retard coagulation. Boiling, resulting in
                                                             denaturation of the proteins, removes the inhibitory ef-
3.9.4 Rennet
                                                             fect. Five per cent ‘peptone’ almost prevents clotting.
Adding rennet to milk in cheese making is commonly           Homogenisation has an accelerating effect on rennet
known as renneting or setting. Rennet is the crude           clotting, but decreases the curd tension. Heat not only
preparation or extract from the abomasum. Rennet             destroys rennin but also makes clotting of the milk by
contains two principal enzymes: rennin and pepsin.           the enzyme less easy. The major reason for this is the
Rennin is an extremely powerful clotting enzyme,             removal or precipitation of calcium ions.
which causes rapid clotting without much proteolysis.           Rennet is added when it has been determined that
On the other hand, pepsin induces proteolysis, leading       the acid is developing at the desired rate. Thus, when
to bitterness in cheese. Rennet is available as a liquid     making cheese from ripened milk, rennet is added
or powder or as tablets.                                     when the acidity has increased from the initial level
   Rennet is the preparation obtained commercially           by 0.02%. The ideal temperature for setting raw milk
from the fourth or true stomach (abomasum) of the            under normal conditions is 30◦ C, and for pasteurised
young calf, known as the vell. The lining of the stom-       milk, 31◦ C. The amount of rennet extract used should
ach is washed, dried, cut into small pieces and mac-         be such as to form curd that is firm enough to be cut
erated into water containing about 4% rennet. Alter-         in 25–30 minutes after the addition rennet.
natively, a brine extract at 15–20◦ C may be prepared.          The amount of rennet which should be added de-
A common method is to dry the vells by inflation and          pends on the: (i) strength of the rennet, (ii) temperature
afterwards cut them into strips and extract with brine,      of the milk, (iii) acidity of the milk and (iv) composi-
i.e. sodium chloride solution (up to 10%) for a few          tion of the milk. Usually, liquid rennet is added 15–25
days. Preservatives such as boric acid are commonly          mL per 100 L of milk. The rennet is diluted with 20–40
added.                                                       times its volume of (potable) water before it is added
   The essential properties of commercial rennet are         to ensure proper distribution for uniform coagulation.
high activity, stability (constant strength) and a reason-   The milk is thoroughly stirred during the addition of
able bacteriological purity. Rennet is commonly sup-         the rennet and also for 3–5 minutes afterwards. The
plied in barrels, stone jars or plastic containers. Com-     vat is covered as soon as the stirring is over, to keep
mercial rennet should be stored in a closed vessel, in       the surface warm and protect it from contaminating
a dark room at below 10◦ C. It should not lose more          dust particles.
than 1–2% of its strength per month.                            Cutting refers to the cutting of the ‘firm’ coagulum
   Rennin is a sulphur-containing protein. One part          into cubes of a specific size. When a (sanitised) glass
can clot about 5 million parts of milk. In cheese mak-       rod is inserted at a 45◦ C angle and lifted straight up
ing, one part of liquid rennet (about 2% protein) is         makes a clean break in the curd, it is ready for cutting.
used for about 5000 parts of milk. Being an enzyme, it       If the curd is cut too soon, there will be a lower yield
is easily destroyed by heat, many chemical substances        of cheese; if cut too late, cutting will be difficult and
and some physical conditions. It is very sensitive to al-    moisture expulsion delayed.
kali. Heating to 70◦ C at pH 6.8–7.0 will destroy it in
14 minutes.
                                                             3.9.5 Draining
   Below 20◦ C, rennin is almost inactive. From 30–
48◦ C, it is almost equally active, the optimum being        Drainage of whey refers to the removal of whey from
41◦ C. Above 50◦ C, the activity falls off rapidly. The      the curd. When the curd cubes have been reduced to
rate of clotting increases rapidly with small increases      about one-half of their size at cutting, the acidity ap-
in acidity. Alkalis considerably retard the clotting of      proaches a desirable value and the cubes attain a desir-
milk by rennet. Calcium ions have little, if any, effect     able consistency (elastic feel when squeezed), stirring
on the first enzymic stage of rennin action, while the        is stopped and the cubes are ‘pitched’. The curd cubes
                                                     Dairy Foods                                                 143

are pushed away from the gate of the vat. In actual                                       `
                                                             3.10 SWISS-TYPE CHEESES (GRUYERE
practice, especially with large vats, it is quite ready           AND EMMENTAL)
so as to make quick removal of the remaining whey
possible at the proper time.                                       e
                                                             Gruy` re and Emmental are hard or semi-hard cheeses
                                                             and they are characterised as ‘cheese with eyes’. They
3.9.6 Cheddaring                                             were originally manufactured in Switzerland, although
                                                             nowadays they are also produced in considerable
Cheddaring refers to the combined operations of pack-        quantities in France. The typical composition on these
ing, turning, piling and re-piling the curd cubes. After                          e
                                                             cheeses is (i) Gruy` re: moisture 38% and fat in dry
the bulk drainage of whey, the curd cubes are kept           matter 49% and (ii) Emmental: moisture 40% and fat
closely together in two heaps with a channel in be-          in dry matter 45%.
tween. This is known as packing, and takes 5–15 min-            The main differences between these Swiss cheeses
utes after dipping. It results in the formation of two       are that Emmental has a round shape, a sweet taste
long slabs of curd. These are cut with a cheese knife        and pleasant flavour, and big, thick, and internally
into blocks or strips 15–20 minutes wide. As soon as                                  e
                                                             shiny eyes, while Gruy` re is half the size of Emmen-
the blocks of curd can be handled without breaking,          tal, contains smaller and fewer eyes, and is charac-
there are rolled bottom-side up in the vat. This is called                                                     e
                                                             terised by intense flavour. The flavour of Gruy` re can
turning and is carried out every 15 minutes till the curd    be attributed to the growth of micro-organisms on
is ready for milling and salting. The vat is kept cov-       its surface and to penetration of their enzymes into
ered and the temperature of the curd maintained at           the cheese mass, while Emmental is cleaned everyday
about 32◦ C. The cheddaring operation usually lasts          to minimise the presence of micro-organisms on its
for two hours or more and is very important not only         surface (Zerfiridis, 1994). The characteristic eye for-
for moisture control but also for improving body and         mation in these cheeses is related to propionic acid fer-
texture.                                                     mentation and to CO2 release. Eye formation is a pro-
                                                             longed procedure, which is retarded when the cheese
                                                             body becomes hard and CO2 production decreases.
3.9.7 Storage
                                                             The stages of this process have been schematised by
Natural cheeses should be stored at low temperatures,        Steffen et al. (1993) and depend mainly on the follow-
preferably at 0–1◦ C, to ensure good quality. A high         ing factors: (a) use of proper starter culture, including
temperature leads to evaporation of moisture, growth         Propionibacterium; (b) timely and adequate produc-
of unwanted moulds and taint-producing bacteria, and         tion and diffusion of CO2 and accumulation of CO2
other faults. A very low temperature also leads to           in uniformly distributed centres; (c) correct adjustment
mould growth (because of the relatively high humidity        of temperature; and (d) prevention of butyric acid fer-
usually associated with it) and may result in damaged        mentation, due to the activity of Coliforms, Clostridia
texture. Processed cheese may be stored at 5–10◦ C.          and yeasts.
   The ‘ideal’ requirements for high-grade cheddar              The flow diagram for the manufacture of Swiss
cheese are:                                                  cheeses is outlined in Fig. 3.9. Raw milk used for these
                                                             cheeses should be of premium microbial quality and
  (i) Colour: uniform, light amber to ivory, not artifi-      Clostridia free. Clarification of milk is usually car-
      cially coloured.                                       ried out at approximately 30◦ C, and contributes to
 (ii) Finish and appearance: smooth, unbroken rind           the removal of foreign material. The milk should be
      and a neat, clean, attractive appearance.              standardised to a casein/fat ratio of 0.7–0.8 in order
(iii) Body: slightly elastic, breaks slowly when plug is     to produce cheese of the desired quality. The mixture
      bent, firm but not hard when crushed between the        of starters that is commonly used for Swiss cheeses
      fingers.                                                is (Zerfiridis, 1994): (a) 0.6% Lactococcus cremori
(iv) Texture: compact, continuous and homogeneous,           and Lactococcus lactis (active at 32◦ C), (b) 0.1–0.2%
      free from openings, holes, breaks, cracks or fis-       Streptococcus thermophilus, which is active at high
      sures.                                                 scalding temperatures, (c) 0.1–0.2% Lactobacillus hel-
 (v) Flavour: clean, pleasing aroma, mildly salted in        veticus (high acidity and ripening) and (d) a few drops
      taste, when fully aged, causes a pleasant tingling     of Propionibacterium shermanii (releases of propionic
      sensation within the mouth after cheese is swal-       acid and CO2 ).
      lowed, leaves pleasing after-taste resembling the         After rennet addition, the milk should be left undis-
      flavour of sweet nuts. The defects in cheddar           turbed at 32◦ C for 30 minutes. Curd formation is
      cheese are given in Table 3.32.                        critical to the correct manufacture of these cheeses,
144                       HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.32 Defects in cheddar cheese, their causes and prevention.

Name of defect                Causes                                        Prevention

Colour
Acid cut/bleached/faded       Excessive acid development in cheese curd     Optimum acid development in cheese curd
High/unnatural                Excessive addition of colour to cheese milk   Optimum addition of colour to cheese milk
Mottled                       (i) Combining cheese curd from two            (i) Not combining cheese curd from two
                              vat-lots                                      vat-lots
                              (ii) Uneven acid development in cheese curd   (ii) Even acid development in cheese curd
Seamy                         (i) Incorrect method of addition of salt to   (i) Correct method of addition of salt to
                              curd cubes                                    curd cubes
                              (ii) Pressing curd cubes too soon after       (ii) Pressing curd cubes with sufficient
                              salting                                       time-gap after salting
Uneven/wavy                   Pressing layers of curd cubes from two        Not pressing layers of curd cubes from two
                              different vat-lots                            different vat-lots
Finish and appearance
Cracked paraffin               Excessive thickness of paraffin coating on     Optimum thickness of paraffin coating on
                              cheese                                        cheese
Scaly paraffin                 Insufficient thickness of paraffin coating on   Correct thickness of paraffin coating on
                              cheese                                        cheese
Lopsided/misshapen            Incorrect filling and pressing of curd cubes   Correct filling and pressing of curd cubes
Cracked rind                  (i) Incorrect cheddaring of cheese curd       (i) Correct cheddaring of cheese curd
                              (ii) Incorrect drying of cheese               (ii) Correct drying of cheese
Rind rot                      Excessive acidity and/or moisture in cheese   Optimum acidity and/or moisture in cheese
                              before curing                                 before curing
Mouldy surface                (i) Excessive high humidity during curing     (i) Optimum high humidity during curing
                              and storage                                   and storage
                              (ii) Excessive high temperature of curing     (ii) Correct temperature of curing and
                              and storage                                   storage
                              (iii) Unsanitary conditions of curing and     (iii) Sanitary condition of curing and
                              storage rooms                                 storage rooms
                              (iv) Delayed turning and inspection of        (iv) Frequent turning and inspection of
                              cheese blocks during curing and storage       cheese blocks during curing and storage
Huffed                        Excessive gassy fermentation in cheese        Avoiding gassy contamination in cheese
Body
Corky/dry/hard                (i) Insufficient fat content in cheese         (i) Optimum fat content in cheese
                              (ii) Excessively slow acid development in     (ii) Optimum acid development in cheese
                              cheese curd                                   curd
                              (iii) Insufficient moisture in cheese before   (iii) Optimum moisture in cheese before
                              curing                                        curing
Crumbly                       Excessive acid development in cheese curd     Optimum acid development in cheese curd
Curdy/rubbery                 (i) Low moisture content in cheese before     (i) Optimum moisture content in cheese
                              curing                                        before curing
                              (ii) Low acid development in cheese curd      (ii) Optimum acid development in cheese
                              (iii) Insufficient cheddaring of cheese curd   curd
                              (iv) Over-salting of cheese                   (iii) Proper cheddaring of cheese curd
                              (v) Excessively low temperature of curing     (iv) Optimum salting of cheese
                              cheese                                        (v) Optimum temperature of curing cheese
Greasy                        High-fat content in cheese                    Optimum fat content in cheese
Mealy/salvy                   Excessive acid development in cheese curd     Optimum acid development in cheese curd
Pasty/watery/wet              Excessive moisture content in cheese          Optimum moisture content in cheese
Weak/soft                     (i) High-fat content in cheese                (i) Optimum fat content in cheese
                              (ii) High moisture content in cheese          (ii) Optimum moisture content in cheese
                                                       Dairy Foods                                                    145

Table 3.32 (Continued )

Name of defect                Causes                                             Prevention

Texture
Fish eyes/yeast holes         Contamination with yeast                           Avoiding contamination with yeast
Pin holes/gassy               Contamination with gas-producing                   Avoiding contamination with
                              micro-organisms                                    gas-producing micro-organisms
Mechanical holes              Incorrect cheddaring of cheese curd                Correct cheddaring of cheese curd
(openings)
Swiss holes/shot holes        Contamination with propionic Bacterium             Avoiding contamination with propionic
                              shermanii                                          Bacterium shermanii
Flavour
High acid/sour                High-acid development in cheese curd               Optimum acid development in cheese curd
Bitter                        (i) Low-quality milk                               (i) Good-quality milk
                              (ii) Low-quality starter                           (ii) Good-quality starter
                              (iii) Excessive acid and/or moisture in            (iii) Optimum acid and/or moisture in
                              cheese                                             cheese
                              (iv) Unsanitary condition of equipment and         (iv) Sanitary condition of equipment and
                              surroundings                                       surroundings
                              (v) Excessive amount of rennet                     (v) Optimum amount of rennet
Mouldy                        (i) Selection of wrong cheese for curing           (i) Selection of right cheese for curing
                              (ii) Adopting warm curing conditions               (ii) Adopting cold curing conditions
                              (iii) Unsanitary conditions of curing and          (iii) Sanitary conditions of curing and
                              storage rooms                                      storage rooms
                              (iv) Inadequate supervision during curing          (iv) Proper supervision during curing and
                              and storage                                        storage

Adapted from De (2000); Mackie and Elsaesser (1991); http://www.dairyscience.info/cheese model.htm.



because if the temperature is too low and coagulation            cooking duration and moisture losses from the curd
is prolonged, the curd will become soft and friable,             particles.
thus resulting in considerable fat losses in whey and               Once the curd has been placed into hoops, pressure
many small holes in the final product. On the con-                should be gradually applied by means of a screw or a
trary, if the temperature is too high, the curd will be          lever press and the pH value should be adjusted to 5.2
hard and whey will not be sufficiently released dur-              or even lower to ensure the completion of lactic acid
ing scalding, leading to cheese blowing. When the                fermentation, the prevention of undesirable fermenta-
curd is firm enough, it should be cut in uniform small            tion and the normal course of propionic acid fermen-
cubes, about the size of rice or wheat grains. Dif-              tation. Salting is usually performed at 12◦ C and at a
ferent sizes of curd particles promote insufficient or            RH of 85–90%. The main difference between the salt-
excessive moisture and fat losses in whey degrading                                                        e
                                                                 ing of Emmental and the salting of Gruy` re is that the
the final product. At this point, whey acidity should             brine droplets should be smeared over the surface of
be 1–2◦ D higher than half of the milk acidity during                  e
                                                                 Gruy` re. The final salt content of Swiss cheeses is rela-
rennet addition. Stirring of the curd without heating            tively low, about 1.5% in order to enhance the growth
aims at whey expulsion. Cooking of the curd is car-              of Propionibacterium, eye formation and flavour de-
ried out in two stages and is crucial to whey expul-             velopment (Steffen et al., 1993). After salting, cheeses
sion, to the firmness of the cheese mass, and to eye              are transferred into the warm room, where higher tem-
formation. At the beginning, the temperature should              peratures of about 18◦ C activate Propionibacterium
slowly rise to 42◦ C and afterwards faster up to 52◦ C.          allowing eye formation. When the cheese mass swells
Under no circumstances should the temperature reach              slightly, cheeses should be transferred back to the cold
56◦ C because Propionibacterium will be killed and               chamber of 12◦ C. Both the rates of lipolysis and pro-
fermentation will fail. After cooking, the curd should           teolysis are maximised; thanks to the activity of Propi-
be intensively stirred in order to avoid precipitation           onibacterium and the production of proper enzymes.
of curd particles. Although stirring usually lasts for           Ripening of Swiss cheeses is usually completed within
30 minutes, its duration depends on titratable acid-             3–6 months and it is greatly influenced by water ac-
ity, fat content of milk, curd firmness during cutting,           tivity (aw ), which varies between 5.75 and 5.95 and
146                           HACCP and ISO 22000 – Application to Foods of Animal Origin

                                                                   3.11 CAMEMBERT CHEESE
                   1.
      CCP1    Clarification
                                       2. Standardisation          Camembert cheese was first manufactured in France
                                             of milk
                  milk                                             in 1791 and is characterised by the presence of multi-
                                           3. Starter              coloured mould and yeast areas on its surface. The typ-
                                4.
                                            culture                ical composition of Camembert cheese found commer-
                              Rennet                               cially is 50% moisture content, 28% fat content, and
                                            5. Curd
                                                            CCP2
                                                                   2% salt and minerals. Ideal Camembert cheese should
                                           formation
                                                                   have an attractive aroma, mild and sweet flavour,
                                           6. Cutting       CCP3
                                                                   medium-soft mellowy body, and reddish-yellow colour
                                                                   interspersed with blue-grey patches (Wilster, 1997).
                                        7. Foreworking             To ensure the safe contamination with pathogens, es-
                                 No                                pecially E. coli and Listeria monocytogenes, during
                                          8. Is cooking
                                                                   ripening and distribution, the pH value of the end
                                           adequate?               product should be risen to 6 or even higher. Tempera-
                                                                   ture and relative humidity controls in the dairy plant
                                               Yes
                                                                   are essential throughout the manufacturing process.
                                          9. Stirring       CCP4   Moreover, excessive acidity development during drain-
                                                                   ing is undesirable and the moisture content of Camem-
                                          10. Dipping              bert cheese should reach the predetermined level to
                                                                   enhance growth of superficial microflora, which is im-
                                          11. Pressing      CCP5
                                                                   portant to the successful manufacture of this cheese.
                                                                      The flow diagram for the production of Camembert
                                       12. Dressing and
                                       turning of cheese           cheese is shown in Fig. 3.10. Raw milk should be stan-
                                                                   dardised to a casein/fat ratio of 0.7, in order to meet the
                                          13. Salting              legal requirements for its composition and to prevent
                                 No                                potential failures of its texture. Then, milk should be
                                                                   pasteurised and cooled down to 34◦ C prior to the ad-
                                          14. Is cooling
                                            effective?             dition of 2% of the active lactic culture. Use of colour-
                                                                   ings, in particular β-carotene or annatto, is optional
                                 No
                                               Yes                 and should be carried out with care. When titratable
                                                                   acidity of the milk has increased to 0.2–0.22%, rennet
                                          14. Is cooling
                                            effective?
                                                                   should be added and left for 90 minutes until curd for-
                                                                   mation is completed. Cutting, cooking and dipping of
                                               Yes                 the curd should comply with the requirements already
                                                                   described for cheese, altering only the technological
                                          16. Curing
                                                                   conditions under which they are performed. The cook-
                                                                   ing temperature should not exceed 34◦ C and dipping
                                          17. Salting       CCP6   should be carried out by breaking the curd, by leav-
                                                                   ing the curd undamaged, or by dipping a mixture of
                                       18. Packaging of            curd and whey into the moulds. Draining of the curd
                                                                   should be performed at 21◦ C and at 85–90% RH. The
                                        cheese blocks

                                                                   pH value of the final whey should be 5.5, and after
                  20.                   19. Warm room
       CCP7
               Ripening                    treatment               that the cheese mass becomes pliable and strong curds
                                                                   should be placed into a cane-bottom container or open
                                                                   board, both of which are favourable to the develop-
Fig. 3.9 Swiss-type cheeses manufacturing flow diagram.             ment of Camembert mould.
                                                                      Prior to mould spore inoculation, the cheese should
cheeses should be cold-stored to prevent any further               be dry-salted on all parts of its surface in order to
fermentation. Coating the surface of Emmental cheese               control the growth of undesirable micro-organisms,
with wax after ripening is characteristic of this cheese           to enhance the development of the desired Camem-
and is not applicable to Gruy` re cheese. The deter-
                               e                                   bert mould, and to help rind formation by removing
mination of CCPs for Swiss-type cheeses is given in                moisture from the cheese surface. If salting is delayed
Table 3.33.                                                        and the temperature is raised, growth of Geotrichum
                                                                                        `
 Table 3.33 Determination of critical control points (CCPs) for Swiss-type cheeses (Gruyere and Emmental).

S/N     Processing step   Hazard        Description of hazards               Q1     Preventive action                    Q2    Q3    Q4    α/α CCP

1       Milk receipt      Biological    Milk with high microbial load        Yes    Periodical control of milk sample    No    Yes   Yes   CCP1a
                                                                             Yes    Determination of pH                  Yes               1b
                                        Distribution under non-hygienic      Yes    Control of temperature of receipt    Yes               1c
                                        conditions                                  and cleaning of the vehicle                            1d
                          Physical      Foreign matter, hair and other       Yes    Filtration, macroscopic control      No    Yes   Yes
                                        material
                          Chemical      Antibiotics, pesticide residues      Yes    Periodical control of milk for       No    Yes   No
                                        Adulterated milk (with water or             antibiotic residues
                                        cheaper milk)                               Determination of specific gravity     Yes
                                                                                    Instructions to producers and sign
                                                                                    of agreements for standard
                                                                                    specifications (TPC, somatic cells,
                                                                                    antibiotics, fat concentration)
3       Addition of       Biological    Whey loaded with                     Yes    Acidity control, use of fresh whey   No    Yes   Yes   CCP2
        starter                         micro-organisms, low yield
                          Physical      Stay of cheese crumbs, burning       Yes    Filtration                           No    Yes   Yes
                                        during pasteurisation
4, 5    Rennet            Physical      Presence of foreign matter           Yes    Macroscopic control before use       No    Yes   Yes
                                                                                                                                                          Dairy Foods




        Curd formation    Chemical      Presence of heavy metals             Yes    Reliable suppliers, raw materials    No    No
                          Biological    Slow growth of “good”                Yes    conforming to the legislation        Yes
                                        micro-organisms, prevailing of              Weigh rennet
                                        undesirable and harmful ones                Monitoring of temperature of
                                                                                    cheese boiler
                                                                                    Monitoring of curdling time
                                                                                    Control of milk temperature
6       Cutting           Biological/   Contamination from equipment         Yes    Regular cleaning and disinfection,   No    Yes   Yes   CCP3
                          physical      and personnel, uneven pieces,               GMPs
                                        uneven draining
8       Cooking           Biological    Growth of micro-organisms            Yes    Temperature control of cooking       Yes   Yes   Yes
                                        Contamination from equipment         Yes    Regular cleaning and disinfection,   No
                                        and personnel                               GMPs
10      Stirring          Biological/   Contamination from equipment         Yes    Regular cleaning and disinfection,   No    Yes   No    CCP4
                          physical      and personnel                               GMPs
                          Biological    Inability to remove moisture,        Yes    Control of room’s conditions         Yes
                                        prevailing of good micro-organisms
                                                                                                                                           (Continues )
                                                                                                                                                          147
                                                                                                                                                    148




Table 3.33 (Continued )

S/N     Processing step   Hazard        Description of hazards               Q1    Preventive action                    Q2    Q3    Q4    α/α CCP

11      Pressing          Biological/   Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   Yes   CCP5
                          physical      and personnel                              GMPs
                                        Unable to remove the required        Yes   Use of appropriate weights,          No    No
                                        quantity of whey                           adjustment of room temperature
13      Salting           Biological/   Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   Yes
                          physical      and personnel                              GMPs                                 No    No
                                        Growth of undesirable                Yes   Adjustment of room temperature
                                        micro-organisms, not enough
                                        quantity of salt
14,     Cool/warm         Biological    Growth of micro-organisms            Yes   Temperature control of cooling       Yes
15,     room treatment                                                             chambers
19                                      Release before the end of ripening   Yes   Control of pH, production dates
18      Salting           Biological    Growth of micro-organisms            Yes   Temperature control of cooling       Yes               CCP6
                                                                                   chambers
                                        Release before the end of ripening   Yes   Control of pH, production dates
20      Ripening          Biological    Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   Yes   CCP7
                                        and personnel                              GMPs
                                                                                                                                                    HACCP and ISO 22000 – Application to Foods of Animal Origin
                                                          Dairy Foods                                                149

                                                                 reputable suppliers at regular intervals and should be
                                                                 kept under proper conditions. The required time to
             CCP1            1. Milk                             spread the slime over the cheese surface is usually
                                                                 two weeks and depends mainly on the manufactur-
                       2. Standardisation                        ing process and temperature. Ripening of Camembert
                             of milk                             cheese is crucial to the development of the desired
                 No                                              flavour, texture and appearance. Ripening should be
                                 3.                              performed at 10◦ C and relative humidity that varies
                         Is pasteurisation                       according to the moisture content of cheese and to
                             adequate?
                                                                 the ripening stage, in order to create favourable condi-
                               Yes                               tions for the growth of P. camemberti. As ripening pro-
                 No
                                                                 ceeds, Camembert’s appearance should become greasy
                                 4.                              and yeasty. The temperature of the ripening chamber
                       Is cooling adequate?        34°C
                                                                 should be gradually lowered. After two weeks, the
                                                                 cheese is usually placed into tin foil to maintain the
                               Yes
                                                                 shape of the cheese and conceal potential cheese im-
                         5. Starter and                          perfections. Before wrapping the cheese, it should be
                            colouring                            ensured that it is dry enough, otherwise whey will be
          6.
        Rennet                                                   released and the Camembert may develop an undesired
                             7. Curd
                                                CCP2             flavour and appearance. The wrapped cheese can be
                            formation
                                                                 placed into chambers of higher temperature than the
                                                                 ripening chamber, since fermentation continues more
                           8. Cutting
                                                                 rapidly and the mould becomes inactive. The enzymes
                                                                 produced by P. camemberti play an important role in
                         9. Cooking and                          further cheese ripening and development of Camem-
                                                CCP3
                         holding of curd
                                                                 bert characteristics. The determination of CCPs for
                                                                 Camembert cheese is given in Table 3.34.
                           10. Dipping


                         11. Dry-salting                         3.12 RISK ASSESSMENT – HACCP
                 No
                                                                 Risk assessment is defined as ‘a process of evaluation
                                  4.
                      Is inoculation of mould
                                                                 including the identification of the attendant uncertain-
                          spores adequate?                       ties, of the likelihood and severity of an adverse ef-
                                                                 fect(s)/event(s) occurring to man or the environment
                                                                 following exposure under defined conditions to a risk
                               Yes
                                                CCP4             source(s)’ (EC, 2000). Risk assessment consists of haz-
                           13. Drying
                                                                 ard identification, hazard characterisation, exposure
                                                                 assessment and risk characterisation (Notermans et al.,
                         14. Wrapping
                                                                 1996).
                                                                    Risk assessment of food products has been inter-
                                                                 woven with risk analysis system and HACCP. The
                              15.
                                                                 HACCP system refers to physical, chemical and mi-
                                                CCP5             crobiological hazards occurring in raw materials/
                             Curing
                                                                 processes of food production (Mortimore and Wal-
                                                                 lace, 1995). However, some hazards or risks may es-
Fig. 3.10 Camembert cheese manufacturing flow
                                                                 cape from the HACCP system because this risk covers
diagram.
                                                                 a wider range than that of the food product process.
                                                                 Such an example is the risk of a characteristic that does
candidum can be enhanced thus causing flavour dete-               not have an obvious relationship with physical, chem-
rioration. An effective method to inoculate the cheese           ical and microbiological hazards. This risk mainly
with Penicillium camemberti spores is by spraying the            refers to the acceptance of the product by the public,
cheese daily with a water mould culture by means of              particularly negatively predisposed towards GMOs.
an atomiser. Mould spores should be obtained from                Its assessment could be part of the recently introduced
                                                                                                                                                       150




 Table 3.34 Determination of critical control points (CCPs) for Camembert cheese

S/N     Processing step   Hazard        Description of hazards                  Q1    Preventive action                    Q2    Q3    Q4    α/α CCP

1       Milk receipt      Biological    Milk with high microbial load           Yes   Periodical control of milk sample    No    Yes   Yes   CCP1a
                                                                                Yes   Determination of pH                  Yes               1b
                                        Distribution under non-hygienic         Yes   Control of temperature of receipt    Yes               1c
                                        conditions                                    and cleaning of the vehicle                            1d
                          Physical      Foreign matter, hair and other          Yes   Filtration, macroscopic control      No    Yes   Yes
                                        material                                      Periodical control of milk for       No    Yes   No
                          Chemical      Antibiotics, pesticide residues         Yes   antibiotic residues
                                        Adulterated milk (with water or               Determination of specific gravity     Yes
                                        cheaper milk)                                 Instructions to producers and sign
                                                                                      of agreements for standard
                                                                                      specifications (TPC, somatic cells,
                                                                                      antibiotics, fat concentration)
3       Pasteurisation    Biological    Survival of pathogenic                  Yes   Control of time and temperature of   Yes               CCP1
                                        micro-organisms, weakness of                  pasteurisation
                                        satisfactory reduction of the initial
                                        microbial load
5       Starter           Biological    Whey loaded with                        Yes   Acidity control, use of fresh whey   No    Yes   Yes   CCP2
                                        micro-organisms, low yield
                          Physical      Stay of cheese crumbs, burning          Yes   Filtration                           No    Yes   Yes
                                        during pasteurisation
6, 7    Rennet            Physical      Presence of foreign matter              Yes   Macroscopic control before use       No    Yes   Yes   CCP3
        Curd formation    Chemical      Presence of heavy metals                Yes   Reliable suppliers, raw materials    No    No
                          Biological    Slow growth of “good”                   Yes   conforming to the legislation        Yes
                                        micro-organisms, prevailing of                Weigh rennet
                                        undesirable and harmful ones                  Monitoring of temperature of
                                                                                      cheese boiler
                                                                                      Monitoring of curdling time
                                                                                                                                                       HACCP and ISO 22000 – Application to Foods of Animal Origin




                                                                                      Control of milk temperature
8       Cutting           Biological/   Contamination from equipment            Yes   Regular cleaning and disinfection,   No    Yes   Yes
                          physical      and personnel, uneven pieces,                 GMPs
                                        uneven draining
9     Cooking       Biological    Growth of micro-organisms            Yes   Temperature control of cooking       Yes   Yes   Yes   CCP4
                                  Contamination from equipment         Yes   Regular cleaning and disinfection,   No
                                  and personnel                              GMPs
10    Dipping       Biological/   Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   No
                    physical      and personnel                        Yes   GMPs                                 Yes
                    Biological    Inability to remove moisture,              Control of room’s conditions
                                  prevailing of good micro-organisms
11,   Dry-salting   Biological/   Contamination from equipment         Yes   Regular cleaning and disinfection,   No    Yes   Yes
13                  physical      and personnel                        Yes   GMPs                                 No    No
                                  Growth of undesirable                      Adjustment of room temperature
                                  micro-organisms, insufficient
                                                                                                                                           Dairy Foods




                                  quantity of salt
14    Wrapping      Biological    Growth of micro-organisms            Yes   Temperature control of cooling       Yes               CCP5
                                  Release before the end of ripening   Yes   chambers
                                                                             Control of pH, production dates
15    Storage       Biological    Growth of micro-organisms            Yes   Temperature control of cooling       Yes               CCP6
                                  Release before the end of ripening   Yes   chambers
                                                                             Control of pH, production dates
                                                                                                                                           151
152                    HACCP and ISO 22000 – Application to Foods of Animal Origin

ISO 22000 but could not be included in the processes        identified and were related to firm size and type of
of the HACCP system. The supplementary operations           manufactured products.
are summarised in Table 3.35 and a synoptical HACCP            Consumer concern about livestock production
monitoring system for dairy products is given in Table      methodologies has increased over recent decades due
3.36. In Table 3.37 (Feta cheese, Batzos and Telemes),      to various outbreaks of foodborne zoonoses and an-
Table 3.38 (Kasseri and semi-hard cheese), Table 3.39       imal diseases. Quality assurance programmes in the
(Graviera, hard cheese and Kefalotyri), Table 3.40          different production chains have been installed by in-
(Mizithra, Anthotyros and Manouri), Table 3.41 (Pro-        dustry to counteract the problems occurring. The pri-
volone, Romano and Parmesan), Table 3.42 (Ched-             mary producers, like the dairy farms, are not formally
                                e
dar cheese), Table 3.43 (Gruy` re and Emmental) and         comprised in such programmes. Yet, quality control
Table 3.44 (Camembert cheese) are given ISO 22000           at dairy farm level goes beyond the quality control
analysis worksheets for the determination of prereq-        of the product milk alone (Noordhuizen and Metz,
uisite programmes. The prerequisite programmes are          2005). For better safeguarding of food safety and pub-
also summarised in Table 3.45.                              lic health, as well as animal health and welfare, the
   The production of safe food is based on the use          whole production process on the dairy farm should be
of good-quality raw materials and the application of        addressed. Health and welfare were addressed, while
GMP and the HACCP system. In addition, risk anal-           the approach of the Dutch dairy sector was used as an
ysis is becoming the new cornerstone in producing           example.
acceptable, safe food. According to the agreements             A well-known welfare report regards the Tierges
of the World Trade Organization (WTO), especially           und Heits Index (Animal Health Index), TGI, applied
the agreement on the application of sanitary and            in Germany and Austria, mostly in organic farms. The
phytosanitary measures – the SPS agreement, the set-        TGI addresses categories like movement possibilities,
ting of control criteria should have a scientific basis.     opportunities for social contacts, floor design of hous-
For this purpose, quantitative risk analysis is con-        ing facilities, climatic conditions in the barns and in-
sidered to be a logical approach that can provide           tensity of care by the farmer. Disadvantage of an index
the necessary insight into the process of setting such      is that good categories may cover up for deficient cat-
criteria.                                                   egories. The TGI has features which are comparable
   Elements of quantitative risk analysis can also be       to those in good farming practice codes; hence, TGI
introduced into the HACCP system, for example, in           might be called a good welfare practice code. The em-
setting criteria at CCPs (Notermans and Mead, 1996).        phasis in welfare monitoring in general is on deviant
Notermans et al. (1998) outlined a risk assessment ap-      animals as well as on risky environmental conditions
proach to food safety evaluation, based on testing a        on the farm (Von Borell, 2000).
particular type of food, the risk assessment of Bacil-         In the case of cattle welfare, the focus should
lus cereus in pasteurised milk. The results obtained are    be on those areas which contribute significantly to
related to possible adverse effects on the health of con-   the occurrence of welfare disorders. Examples are
sumers. This chapter also gave an example of the way        housing (space per cow, floor design for locomotion,
the risk assessment approach may be used in practice.       cubicle design for resting and lying, maintenance
The proposed system seemed to provide information           standards, space for social interaction), barn climate
on the exposure of consumers to microbial pathogens         (humidity, temperature, ventilation, draughts), feed
when the food is consumed. It reflected the success-         and water availability, ration composition and qual-
ful application of GMPs and HACCP principles on             ity of feedstuffs.
the part of the producer; as well as the effect of con-        Therefore, any inspection focusing on welfare issues
sumer handling of the product, on the exposure rate.        should address both the animals and the risk condi-
The information obtained on factors affecting expo-         tions in the cow’s environment. In addition, several
sure to microbial hazards and their impact on con-          countries have started with the stepwise implementa-
sumers would allow risk management and communi-             tion of, either voluntary or compulsory, quality con-
cation to be carried out effectively.                       trol programmes on dairy farms. Monitoring of cows
   Henson and Holt (1999) explored incentives for           (prevalence and incidences) and farm conditions (risk
the adoption of food safety controls by businesses in       factors) is part of the Dairy Chain Quality programme
the UK dairy sector. Four key factors were found to         (KKM) in the Netherlands. The information gathered
have motivated the adoption of HACCP and these              is currently also used for on-farm consultancies by the
were internal efficiency, commercial pressure, external      veterinary practitioners in herd health programmes.
requirements and good practice. Four clusters were          It can be expected that the KKM programme will
Table 3.35 Supplementary operations.

         Processing   Description of      Preventive                                                              Corrective
No.      stage        possible dangers    action             Controls          Critical limits     Responsible    action           Records

SSM1     General      Contamination       Microbiological    Microbiological   Characterisation    Production     Stop service     Lab control
         control of   or spoilage of      analysis once      and chemical      of water as         supervisor     Demand for
         water        water quality       per 2 months       analysis of       potable             External       water
                      Excess chlorine     and                water every 2     according to the    approved lab   rechlorination
                      concentration       physicochemical    months            legislation                        and check
                                          results once per                     (98/83/EC)
                                          year
SSM2     General      Contamination       According to       Continuous        According to        Production     Direct           Cleaning and
         hygienic     of product from     Reg. 852/2004,     control of        Reg. 852/2004       supervisor     withdrawal of    disinfection
         conditions   insects and mice    GMP principles     hygienic          Disinfection        Cleaning       every non-       Weekly audit
         in the       or other pests      Personnel          conditions of     Negative test for   operator       conformance      of places,
         dairy        Contamination       training           places,           indicator           Production     Repetition of    installation
         industry     due to inadequate   Implementation     equipment,        Absence of skin,    supervisor     personnel        and equipment
                      hygienic            of working         personnel and     gastroenteric                      training         Programme of
                      conditions of       instruction        programme for     and respiratory                    Full recovery    cleaning and
                      production areas,   ‘Cleaning,         pest control      diseases                           of sick          disinfection
                      equipment and       disinfection,      Weekly audits                                        personnel        Personnel
                      personnel           pest control’      of places and                                        Repetition of    records
                                                                                                                                                   Dairy Foods




                      Contamination       Issue of valid     personnel                                            disinfection
                      of product from     health books       Swab test,
                      chemical                               residue control
                      materials used in                      using
                      the production                         phenolphthalein
                      area                                   indicators once
                      Product                                a month
                      contamination                          Health books
                      from infectious
                      diseases carried
                      by personnel
SSM3     Keeping of   Cross-              GMP                Control every     Absolute            Production     Direct
         working      contamination       implementation     hour during       conformance         supervisor     withdrawal of
         instruc-     Transfer of         Hand washing       work                                                 every non-
         tions by     foreign matter      Cleaning of                                                             conformance
         personnel                        gloves and
                                          overalls
                                                                                                                                                   153
154                    HACCP and ISO 22000 – Application to Foods of Animal Origin



                                                      Q1.
                                   Is the technical infrastructure and the
                                   preventative maintenance programme
                                                 adequate?


                      Yes                                            No                  Corrective actions



                                                       Q2.
                                         Is it feasible to evaluate it?



                     Yes                                                          No



                                                    Q3.
                             Do they contribute in the control of recognisable
                                          food safety hazards?
                                                                                                 Included in
                                                                                                     the
                                                                          Yes                    prerequisite
                      No
                                                                                                programmes


                                                       Q4.
                                 Is control at this step necessary to prevent,
                                eliminate or reduce the risk of the hazard to
                                                  consumers?
                      No
                                                                                   Yes


                    To be
                 included in
                HACCP plan as
                  a control
                   measure


Fig. 3.11 Recognition of prerequisite programmes.



ultimately result in a HACCP-based quality man-                     with more certainty about the quality of products of
agement programme including good farming practice                   animal origin.
codes, where risk identification, risk management and
prevention will play a paramount role.
   Noordhuizen and Metz (2005) concluded that based                 3.13 HYGIENE MONITORING AND
on developments within the dairy sector as well as at                    PREREQUISITE PROGRAMMES
the EU political level, it can be expected that the ap-
plication of HACCP-compatible programmes on the                     In a typical dairy operation, relative light unit (RLU)
dairy farms will be conducted in the near future. This              data, reflecting the ATP bioluminescence technique for
application will help in identifying and managing the               rapid hygiene testing, were collected over a period of
quality hazards and risks occurring in the production               three months from a control point (CP) of a milk fill-
process on dairy farms, and in providing the consumer               ing machine and analysed in retrospect (Hayes et al.,
Table 3.36 Synoptical HACCP monitoring system for reprentating cheese and dairy products.

               Processing      Description of
Product        stage           possible dangers       Controls             Critical limits      Responsible   Corrective action     Records

All            Milk receipt    Milk with high         Determination of     6.4–6.6              Receipts      Return of             Non-conformance
products                       microbial load         pH                   T < 7◦ C             supervisor    non-conforming        sheet, corrective
                               Milk                   Control of receipt   According to                       lot                   and preventive
                               contaminated with      temperature and      legislation                        Recommendations       action
                               pathogenic             cleaning of          1.029–1.045 in                     to suppliers          Non-conforming
                               micro-organisms        transportation       15◦ C                                                    book
                               Transportation         vehicle                                                                       Incoming
                               under                  Antibiotics kits                                                              materials sheet
                               non-hygienic           Specific gravity
                               conditions
                               Antibiotics
                               Adulterated milk
                               (with water or
                               cheaper milk)
               Curd            Slow growth of         Weigh quantity       According to         Production    Increase or           Production log
               formation       “good”                 of rennet            milk condition       supervisor    decrease
                               micro-organisms        Monitoring of        and type of                        temperature of
                               in starter cultures,   temperature of       cheese                             cheese making and
                               prevailing of          cheese boiler        approximately                      milk
                               harmful                Monitoring of        32–33◦ C                           Increase or
                               micro-organisms        curding time         Rennet according                   decrease quantity
                                                      Control of milk      to instructions of                 of rennet based on
                                                                                                                                                          Dairy Foods




                                                      temperature          use                                experience
                                                                           Entrance
                                                                           temperature in
                                                                           the boiler of
                                                                           32◦ C
Feta/Batzos/   Brine           Low strength           Salt content         pH when the          Production    Addition of extra     Production log
Telemes        formation       Low strength of                             cheese curd gets     supervisor    salt
                               antimicrobial                               into brine of
                               action                                      approximately
                                                                           6.2
                                                                           16◦ B´e
               Dry-salting/    Failure to increase    pH monitoring        At the end of        Production    Extension of          Production log
               ripening in     salt coefficient        Control of room      salting (1 day       supervisor    ripening outside
               cheese tables   Drop in pH and         temperature          cheese) pH <5.2                    the fridge
               and in open     moisture removal                            At the end of                      Adaptation of
               containers      Immature stop of                            prematuration                      expiry date/fast
                               fermentation                                (before entrance                   distribution and
                                                                           to the fridge) pH                  consumption 2
                                                                           <4.8                               months after in the
                                                                           Minimum 16◦ C                      fridges
                                                                                                              Air conditioning
                                                                                                                                                          155




                                                                                                                                           (Continues )
                                                                                                                                              156
Table 3.36 (Continued )

              Processing       Description of
Product       stage            possible dangers     Controls          Critical limits      Responsible   Corrective action   Records

Kasseri       Cutting/         Failure to kill      Control of        Minimum              Production    Adjustment of       Production log
              immersion/       micro-organisms      temperature of    70◦ C/15 minutes     supervisor    temperature, time
              fermentation                          hot water, time                                      extension
              Salting/         Failure to remove    Control and       15–16◦ C             Production    Air conditioning/   Production log
              ripening         moisture             adjustment of     RH = 80–90%          supervisor    adjustment of
                               Growth of            temperature and                                      temperature
                               undesirable          moisture in the
                               micro-organisms      maturation
                                                    chamber
Graviera/     Pressing/        Failure to remove    Control of room   15–16◦ C             Production    Air conditioning/   Production log
Kefalotyri    change of        moisture,            temperature       End of pressing      supervisor    adjustment of
              paddy/           prevailing of good   conditions        pH <4.8                            temperature
              reversing        micro-organisms
              Brine            Weak brine/          Salt content                   e
                                                                      Minimum 16◦ B´       Production    Addition of extra   Production log
              formation        weakness of                                                 supervisor    salt
                               antimicrobial
                               action
              Ripening         Failure to remove    Control and       Graviera:            Production    Airconditioning/    Production log
                               moisture             adjustment of     2 weeks at           supervisor    adjustment of
                               Growth of            temperature and   12–14◦ C, 4                        temperature
                               undesirable          moisture in the   weeks at 18◦ C,
                               micro-organisms      maturation        6 weeks at
                                                    chamber           12–14◦ C
                                                                      RH = 85%
                                                                      Kefalotyri:
                                                                      3 months at
                                                                      12–16◦ C
                                                                      RH = 85%
Mizithra/     Receipt of       Remaining of         Macroscopic       pH >6.3              Production    Addition of NaOH    Production log
Manouri/      whey/            cheese crumbs,       control of raw    No visible piece     supervisor    Rejection
Anthotyros    filtration        burning during       materials                                            Refiltration
                                                                                                                                              HACCP and ISO 22000 – Application to Foods of Animal Origin




                               thermal processing   Control of pH
              Pasteurisation   Survival of          Temperature and   Increase from        Production    Extension of        Production log
                               pathogenic           time control      30 to 75◦ C in 30    supervisor    pasteurisation/
                               micro-organisms,                       minutes and from                   adjustment of
                               weakness to                            75 to 90◦ C in                     temperature
                               reduce the initial                     15 minutes
                               microbial load                         Total thermal
                               satisfactorily                         processing time is
                                                                      45 minutes
             Packaging        Vacuum failure,      Control of           Hermetic sealing   Production   Repetition        Production log
                              hermetic sealing,    parameters of        No                 supervisor
                              growth of            device, sealing      non-conformance
                              micro-organisms      control
Butter       Pasteurisation   Survival of          Control of           63◦ C/30 minutes   Production   Extension of      Production log
                              pathogenic           temperature and                         supervisor   pasteurisation/
                              micro-organisms,     time                                                 adjustment of
                              Unsatisfactory                                                            temperature
                              reduction of
                              microbial load
Provolone/   Starter          Weakness to start    Control of           82◦ C/30 minutes   Production   Adjustment of     Production log
Romano/      culture          the culture          temperature          Acidity 0.8%       supervisor   temperature
Parmesan                                           Control of acidity
             Pressing         Failure to control   Control the          69 kPa/30          Production   Increase of       Production log
                              the pressure         pressure             minutes at room    supervisor   pressure/
                                                                        temperature                     repetition
                                                                        138 kPa
                                                                        overnights
Cheddar      Heating          Growth of            Control of           38◦ C              Production   Adjustment of     Production log
cheese                        undesirable          temperature          pH = 6.0–6.1       supervisor   temperature
                              micro-organisms
                                                                                                                                                Dairy Foods




    e
Gruy` re/    Cooking          Growth of            Control of           Rising slowly      Production   Adjustment of     Production log
Emmental                      undesirable          temperature          from 42–52◦ C      supervisor   temperature
                              micro-organisms                           for 30 minutes
                              Destroy of useful                         Avoiding ≥56◦ C
                              micro-organisms
                              for ripening
             Salting          Failure to remove    Control and          pH = 5.2           Production   Adjustment of     Production log
                              moisture             adjustment of        12◦ C              supervisor   temperature/
                              Growth of            temperature and      RH = 85–90%                     humidity
                              undesirable          moisture
                              micro-organisms
Camembert    Draining         Failure to remove    Control and          pH = 5.5           Production   Adjustment of     Production log
cheese                        moisture             adjustment of        21◦ C              supervisor   temperature/
                              Growth of            temperature and      RH = 85–90%                     humidity
                              undesirable          moisture
                              micro-organisms
                                                                                                                                 (Continues )
                                                                                                                                                157
                                                                                                                                                  158




Table 3.36 (Continued )

              Processing     Description of
Product       stage          possible dangers     Controls            Critical limits   Responsible   Corrective action     Records
                                                                          ◦
All           Cooling        Growth of            Control of          0–4 C             Production    Adjustment of         Temperature
products                     undesirable          temperature of      RH = 85–95%       supervisor    temperature/          recording meters
                             micro-organisms      refrigeration                                       humidity              Lab control results
                             Release before the   chambers                                            Repairing of
                             end of ripening      Control of date     Depending on                    malfunction
                                                  of entrance/ exit   product and                     Rejection
                                                  Periodical checks   legislation                     1st distribution/
                                                  of the final                                         adaptation of shelf
                                                  product in an                                       life
                                                  external lab
              Distribution   Growth of            Temperature         0–4 ◦ C           Driver        Adjustment of         Recording meters
                             undesirable          control of the                                      temperature/
                             micro-organisms      cooling chambers                                    repairing of
                                                  in the vehicles                                     malfunction
                                                                                                      Reject
                                                                                                                                                  HACCP and ISO 22000 – Application to Foods of Animal Origin
                                                   Dairy Foods                                                  159

Table 3.37 ISO 22000 analysis worksheet for the determination of prerequisite programmes for Feta cheese/
Batzos/Telemes.

                          Are the technical                       Do they             Does the
                          infrastructure and                      contribute to       effectiveness of
                          the preventative       Is it            the control of      the remaining      Is it a
                          maintenance            feasible to      recognisable food   control measures   prerequisite
Processing step           programme adequate?    evaluate them?   safety hazards?     depend on them?    programme?

Water                     Yes                    Yes              No                  Yes                Yes
Milk receipt              Yes                    Yes              No                  No                 No
Receipt of other raw      Yes                    Yes              No                  Yes                Yes
materials
Salt
Starter cultures
Rennet
Receipt–storage of        Yes                    Yes              No                  Yes                Yes
packaging materials
Pasteurisation            Yes                    Yes              No                  Yes                Yes
Starter culture           Yes                    Yes              No                  Yes                Yes
preparation
Brine formation           Yes                    Yes              No                  No                 No
Curd formation            Yes                    Yes              No                  No                 No
Curd cut–moulding         Yes                    Yes              No                  Yes                Yes
Dry-salting/ripening in   Yes                    Yes              No                  No                 No
cheese tables and in
open containers
Cooling                   Yes                    Yes              No                  No                 No
Distribution              Yes                    Yes              No                  No                 No


1997) to assess the hygiene status of various CPs in        allowing the conversion of stimuli to responses attribu-
any HACCP system. The measurement in RLU is used            tive, so that they translate mathematically the appro-
to give a pass/fail status to the CP tested.                priate actions for sanitary hygienic control.
   The analysis showed that the Cusum and Individ-             Those abaci are the ‘fuzzy numbers’ that translate
ual charts established a proper trend analysis of the       the criteria of HACCP, for instance, the levels of con-
RLU data. Advance warning signs signifying potential        tamination risks at different stages of the productive
out of control (fail) and CP status were clearly shown      process. Fuzzy logic does not require an analysis of
in the charts. The findings highlighted the fact that        hazards as in HACCPs, because it spares the determi-
by employing statistical process control (SPC) tools,       nation of sample sizes based on the presuppositions of
it was possible to prevent CPs from failing the hy-         the statistical inference. The fuzzy logic bases on the
giene test. Furthermore, if the SPC technique of iden-      postulates of the theory of possibility, where there is
tifying assignable and unassignable causes of failure       not a necessity to assist the axioms of probability, such
was adopted, the total number of failed CPs should          as no negativity and unity (Braga et al., 1995).
decrease. This would, in the long run, lead to more            The results reached by the application of the method
effective hygiene management and more efficient pro-         of analysis based on fuzzy logic for the CCPs revealed
duction.                                                    that none of the schools of the sample got to reach
   Moreover, Bactoscan analysis and ATP could be ap-        the hygienic–sanitary quality pattern according to the
plied as emergency brakes by food firms as explained         rules of gold of the ‘OMS’. The methodology revealed
by Giffel et al. (2001). They reported that the main        rates lower than 0.35; an exception was the item stock-
problem is the sensitivity of the techniques. In the fu-    ing in one of the full-time-type schools, which reached
ture, process control systems can be developed by inte-     quality pertinence of 0.72. Food processing designs
grating microbiological results and predictive models       to comply with the desired sanitary–hygienic patterns
into process control software. IT, neural networks and      must have quality pertinence levels higher than 0.70
fuzzy logic could help in this direction.                   in all macro-events.
   In practice, the fuzzy logic allows computing with          The results lead to the conclusion that the employ-
words – fuzzification. The architecture of the food          ment of ‘fuzzy cognitive maps’ is feasible and can be a
system is codified through ‘fuzzy’ cognitive maps by         facilitating alternative technique, mainly in samples of
160                       HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.38 ISO 22000 analysis worksheet for the determination of prerequisite programmes for Kasseri/semi-hard cheese

                           Are the technical                      Do they             Does the
                           infrastructure and                     contribute to       effectiveness of
                           the preventative      Is it            the control of      the remaining      Is it a
                           maintenance           feasible to      recognisable food   control measures   prerequisite
Processing step            programme adequate?   evaluate them?   safety hazards?     depend on them?    programme?

Water                      Yes                   Yes              No                  Yes                Yes
Milk receipt               Yes                   Yes              No                  No                 No
Receipt of other raw       Yes                   Yes              No                  Yes                Yes
materials
Salt
Starter cultures
Calcium chloride
Receipt–storage of         Yes                   Yes              No                  Yes                Yes
packaging materials
Pasteurisation             Yes                   Yes              No                  Yes                Yes
Curd formation             Yes                   Yes              No                  No                 No
Curd cut–moulding          Yes                   Yes              No                  Yes                Yes
Stirring/reheating/        Yes                   Yes              No                  Yes                Yes
precipitation
Curd removal/curd          Yes                   Yes              No                  Yes                Yes
extraction
Cutting/mixing             Yes                   Yes              No                  Yes                Yes
Pressing of cheese mass    Yes                   Yes              No                  Yes                Yes
Ripening of cheese mass    Yes                   Yes              No                  No                 No
Cutting/immersion in       Yes                   Yes              No                  No                 No
hot water/fermentation
Moulding/hardening of      Yes                   Yes              No                  Yes                Yes
cheese heads
Mould removal              Yes                   Yes              No                  Yes                Yes
Salting/ripening           Yes                   Yes              No                  No                 No
Drying                     Yes                   Yes              No                  Yes                Yes
Paraffin/packaging          Yes                   Yes              No                  Yes                Yes
Cooling                    Yes                   Yes              No                  No                 No
Distribution               Yes                   Yes              No                  No                 No


reduced dimensions. The fuzzy method has been ap-           fish and bakery). The employees’ attitudes towards
plied in quality control, when the parameters used do       various surveyed risk management practices were ex-
not allow rigid limits. This is the peculiar case of the    clusively positive, regardless of job category or indus-
controls in the hot and cold chains in collective feed-     try sector. All 30 companies that responded to the
ing. The abaci fuzzy are easy and agile instruments         survey had a functioning own-checking plan (OCP),
to evaluate the conditions of temperature of the food       while other quality management programmes were less
supply and to determine the quality of the productive       prevalent. When asked what had caused most difficul-
process.                                                    ties in devising the OCP/HACCP plan, the most com-
   Attitudes towards food hygiene management strate-        mon answers were choosing the CCPs, committing the
gies in their companies were measured by a mail survey      firm’s entire workforce and organising the documen-
designed and distributed to 87 Finnish food manufac-        tation of monitoring results. According to the respon-
turing companies in order to be distributed to 870 em-      dents, the biggest benefits of the OCP/HACCP plan
ployees representing both workers and managers by           were product safety and quality.
Hielm et al. (2006). The final response rates for compa-        In Finland, as in the other Nordic countries, the pre-
nies and individual employees were 34.9 and 21.2%,          ventive risk management strategy in the food industry
respectively. Answers were stratified according to four      is based on good hygiene practices (GHPs or hygiene
job categories and four industry sectors (meat, dairy,      prerequisites) and HACCP plans when appropriate.
                                                    Dairy Foods                                                  161

Table 3.39 ISO 22000 analysis worksheet for the determination of prerequisite programmes for Graviera/hard
cheese/Kefalotyri.

                         Are the technical                        Do they             Does the
                         infrastructure and                       contribute to       effectiveness of
                         the preventative        Is it            the control of      the remaining      Is it a
                         maintenance             feasible to      recognisable food   control measures   prerequisite
Processing step          programme adequate?     evaluate them?   safety hazards?     depend on them?    programme?

Water                    Yes                     Yes              No                  Yes                Yes
Milk receipt             Yes                     Yes              No                  No                 No
Receipt of other raw     Yes                     Yes              No                  Yes                Yes
materials
Salt
Rennet
Receipt–storage of       Yes                     Yes              No                  Yes                Yes
packaging materials
Brine formation          Yes                     Yes              No                  No                 No
Pasteurisation           Yes                     Yes              No                  Yes                Yes
Curd formation           Yes                     Yes              No                  No                 No
Curd cut–moulding        Yes                     Yes              No                  Yes                Yes
Stirring/reheating/      Yes                     Yes              No                  Yes                Yes
precipitation
Curd removal/curd        Yes                     Yes              No                  Yes                Yes
extraction
Moulding                 Yes                     Yes              No                  Yes                Yes
Pressing/change of       Yes                     Yes              No                  No                 No
paddy/reversing
Mould removal/           Yes                     Yes              No                  Yes                Yes
placement in brine
Dry-salting/surface      Yes                     Yes              No                  Yes                Yes
abrasion
Ripening                 Yes                     Yes              No                  No                 No
Washing/drying           Yes                     Yes              No                  Yes                Yes
Paraffin formation/       Yes                     Yes              No                  Yes                Yes
packaging
Cooling                  Yes                     Yes              No                  No                 No
Distribution             Yes                     Yes              No                  No                 No


This approach, termed own-checking, became manda-           standing and proper and effective implementation of
tory for Finnish food operators, caterers and retailers     the HACCP principles (Panisello and Quantick, 2001).
in 1995.                                                    Recent behavioural studies from the United Kingdom
   Because of difficulties in implementing HACCP,            (Taylor and Taylor, 2004), Italy (Angelillo et al., 2001),
the hygiene prerequisites have until now formed a           the United States (Henroid and Sneed, 2004), Poland
substantial part of the own-checking system in Fin-         (Konecka-Matyjek et al., 2005) and the Philippines
land. Panisello and Quantick (2001) have categorised        (Azanza and Zamora-Luna, 2005) assert that such bar-
requirements for successful HACCP implementation            riers are of a universal nature.
into four ‘segments’: management commitment, edu-              Although own-checking/HACCP is in widespread
cation and training, availability of resources and ex-      use in the EU, few surveys have been published on at-
ternal pressures; shortcomings are explained by three       titudes towards the systems among food company em-
‘technical barriers’ (1) prior to, (2) during the process   ployees, such as a UK survey polling attitudes among
of and (3) after HACCP implementation. The tech-            food business managers towards food hygiene prac-
nical barriers seem a far more formidable hurdle to         tices and HACCP, in which the authors found that
overcome, as these encompass all those practices, atti-     positive attitudes towards HACCP correlated signif-
tudes and perceptions that negatively affect the under-     icantly with company size and previously received
162                        HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.40 ISO 22000 analysis worksheet for the determination of prerequisite programmes for Mizithra/Anthotyros/
Manouri.

                            Are the technical                      Do they             Does the
                            infrastructure and                     contribute to       effectiveness of
                            the preventative      Is it            the control of      the remaining      Is it a
                            maintenance           feasible to      recognisable food   control measures   prerequisite
Processing step             programme adequate?   evaluate them?   safety hazards?     depend on them?    programme?

Milk receipt                Yes                   Yes              No                  No                 No
Receipt of whey/            Yes                   Yes              No                  No                 No
filtration
Salt                        Yes                   Yes              No                  Yes                Yes
Receipt–storage of          Yes                   Yes              No                  Yes                Yes
packaging materials
Pasteurisation/baking of    Yes                   Yes              No                  No                 No
cheese curd
Collection/moulding         Yes                   Yes              No                  Yes                Yes
Straining                   Yes                   Yes              No                  Yes                Yes
Mould removal               Yes                   Yes              No                  Yes                Yes
Stay on the cheese table    Yes                   Yes              No                  Yes                Yes
Packaging                   Yes                   Yes              No                  No                 No
Cooling                     Yes                   Yes              No                  No                 No
Distribution                Yes                   Yes              No                  No                 No


training on HACCP (Mortlock et al., 1999). Also              study regarding perceived barriers to the implemen-
in the UK, Panisello et al. (1999) surveyed food             tation of HACCP, focused on attitudes of company
companies to establish the level of, and barriers to,        quality managers and external consultants (Vela and
HACCP implementation. While HACCP was imple-                 Fernandez, 2003). Whereas important results were
mented in 73% of the responding companies, the au-           generated in these studies, perhaps too little em-
thors recognised several barriers to the penetration of      phasis was placed on the attitudes of the company
HACCP, especially in SMEs: lack of knowledge, ex-            labourers. It is largely accepted that risk management
pertise and adequate resources. Similarly, a Spanish         strategies work only if they are internalised by all

Table 3.41 ISO 22000 analysis worksheet for the determination of prerequisite programmes for Provolone/Romano/
Parmesan.

                            Are the technical                      Do they             Does the
                            infrastructure and                     contribute to       effectiveness of
                            the preventative      Is it            the control of      the remaining      Is it a
                            maintenance           feasible to      recognisable food   control measures   prerequisite
Processing step             programme adequate?   evaluate them?   safety hazards?     depend on them?    programme?

Milk receipt/temper         Yes                   Yes              No                  No                 No
milk
Addition of starter         Yes                   Yes              No                  Yes                Yes
Rennet                      Yes                   Yes              No                  Yes                Yes
Curd formation
Draining/dipping of         Yes                   Yes              No                  Yes                Yes
curd
Ripening                    Yes                   Yes              No                  Yes                Yes
Pressing                    Yes                   Yes              No                  No                 No
Milling                     Yes                   Yes              No                  No                 No
Salting                     Yes                   Yes              No                  No                 No
Ripening                    Yes                   Yes              No                  Yes                Yes
Storage                     Yes                   Yes              No                  No                 No
                                                   Dairy Foods                                                   163

Table 3.42 ISO 22000 analysis worksheet for the determination of prerequisite programmes for Cheddar cheese.

                        Are the technical                        Do they             Does the
                        infrastructure and                       contribute to       effectiveness of
                        the preventative        Is it            the control of      the remaining      Is it a
                        maintenance             feasible to      recognisable food   control measures   prerequisite
Processing step         programme adequate?     evaluate them?   safety hazards?     depend on them?    programme?

Milk receipt            Yes                     Yes              No                  No                 No
Pasteurisation          Yes                     Yes              No                  No                 No
Ripening                Yes                     Yes              No                  No                 No
Rennet                  Yes                     Yes              No                  Yes                Yes
Cooking                 Yes                     Yes              No                  Yes                Yes
Draining                Yes                     Yes              No                  Yes                Yes
Milling                 Yes                     Yes              No                  No                 No
Salting                 Yes                     Yes              No                  No                 No
Pressing                Yes                     Yes              No                  No                 No
Storage                 Yes                     Yes              No                  No                 No
Distribution            Yes                     Yes              No                  No                 No


company employees, and that a successful implemen-             Biofilm status of different segments of pasteurisation
tation of HACCP demands commitment by the whole             lines of commercial plant (CP) and an experimental
personnel (Mortimore, 2001; Panisello and Quantick,         dairy plant (EDP) was evaluated by Sharma and Anand
2001).                                                      (2002). Biochemical differentiation of organisms in
   The prevalence of biofilms in dairy processing is an      biofilms revealed the predominance of genus Bacil-
important reservoir of both spoilage and pathogenic         lus (37 and 44%, respectively) in both the plants. The
microflora which can lead to spoilage of finished prod-       other microflora of CP included Lactobacillus, Strep-
uct and transmission of diseases. It is recommended         tococcus, Lactococcus and Staphylococcus, while mi-
that each and every plant should be evaluated for the       croflora of EDP additionally had Micrococcus sp. The
prevalence of biofilms. An effective sanitation pro-         Gram-negative genera in the constitutive microflora
gramme should then be devised based on in vitro stud-       of biofilms were mainly Shigella, E. coli, Enterobac-
ies that could be invariably repeated under in situ         ter aerogenes, Citrobacter, Flavobacterium and Pro-
conditions in order to control the biofilms prevalent        teus in CP, while EDP additionally had Klebsiella sp.
in dairy/food processing areas.                             A sanitiser, iodophore, at a concentration of 10 ppm

                                                                                                 `
Table 3.43 ISO 22000 analysis worksheet for the determination of prerequisite programmes for Gruyere/Emmental.

                        Are the technical                        Do they             Does the
                        infrastructure and                       contribute to       effectiveness of
                        the preventative        Is it            the control of      the remaining      Is it a
                        maintenance             feasible to      recognisable food   control measures   prerequisite
Processing step         programme adequate?     evaluate them?   safety hazards?     depend on them?    programme?

Milk receipt            Yes                     Yes              No                  No                 No
Addition of starter     Yes                     Yes              No                  Yes                Yes
Rennet                  Yes                     Yes              No                  Yes                Yes
Curd formation
Cutting                 Yes                     Yes              No                  No                 No
Cooking                 Yes                     Yes              No                  Yes                Yes
Dipping                 Yes                     Yes              No                  Yes                Yes
Pressing                Yes                     Yes              No                  No                 No
Salting                 Yes                     Yes              No                  No                 No
Cool/warm room          Yes                     Yes              No                  No                 No
treatment
Packaging of cheese     Yes                     Yes              No                  Yes                Yes
blocks
Ripening                Yes                     Yes              No                  Yes                Yes
164                     HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.44 ISO 22000 analysis worksheet for the determination of prerequisite programmes for Camembert cheese.

                         Are the technical                       Do they             Does the
                         infrastructure and                      contribute to       effectiveness of
                         the preventative       Is it            the control of      the remaining      Is it a
                         maintenance            feasible to      recognisable food   control measures   prerequisite
Processing step          programme adequate?    evaluate them?   safety hazards?     depend on them?    programme?

Milk receipt             Yes                    Yes              No                  No                 No
Pasteurisation           Yes                    Yes              No                  No                 No
Starter                  Yes                    Yes              No                  Yes                Yes
Rennet Curd formation    Yes                    Yes              No                  Yes                Yes
Cutting                  Yes                    Yes              No                  No                 No
Cooking                  Yes                    Yes              No                  Yes                Yes
Dipping                  Yes                    Yes              No                  Yes                Yes
Dry-salting              Yes                    Yes              No                  No                 No
Wrapping                 Yes                    Yes              No                  Yes                Yes
Storage                  Yes                    Yes              No                  No                 No


with a contact time of 20 minutes was found to be          packaging is sterilised before dispensing, a low con-
most effective to control mixed species biofilms of CP      tamination rate in the delivered packaging materials is
under in vitro and in situ conditions. Therefore, evalu-   demanded by the food producer.
ation of biofilm status and development of an effective        Common sterilisation techniques such as UV steril-
sanitation plan should be part of the HACCP plan in        isation can be reduced in effectiveness by dust. The
conjunction with ISO 9000 specifications for the dairy      application of sterilisation by heat or steam is lim-
processing industry.                                       ited by possible thermal deformation of plastic cups.
   Results of a marketing study associated with the im-    Thus, a sterilisation method for plastic cups needs to be
plementation and maintenance of HACCP in a pas-            found that ensures excellent hygienic conditions and
teurised milk plant are presented by Roberto et al.        does not influence the mechanical characteristics of the
(2006). The GMP/SSOP prerequisites were evaluated          cups. Electron beam irradiation is a simple and easily
in the plant. Two HACCP plans were proposed:               applicable method to decontaminate plastics without
the first plan was developed under the actual op-           changing the mechanical characteristics. The method
erating conditions, without previous compliance of         has been used for the sterilisation of medical dispos-
GMP/SSOP prerequisites, and a second plan in compli-       able products such as Petri dishes or catheters for
ance with GMP/SSOP. The cost estimation for imple-         many years. The principle is that electrons are ac-
mentation and maintenance of HACCP, with or with-          celerated in an electric field and then focused into a
out previous adoption of the prerequisite programmes,      beam. The accelerated electrons interact with the prod-
was performed and a comparative analysis of the esti-      uct and deposit their energy in the form of ionising
mated values was carried out.                              radiation, thus irreversibly damaging large molecules
   The results suggested that a previous compliance        such as DNA and micro-organisms, resulting in sterile
of GMP/SSOP prerequisites is essential for developing      products.
an effective HACCP plan with low number of CCPs,              Tacker et al. (2002) compared a specially adapted
leading to lower costs and investments for implemen-       coating method, impedance method, direct inocula-
tation and maintenance of HACCP. For the HACCP             tion and membrane filter technique to determine con-
plan with eight CCPs, the implementation cost for the      tamination with yeasts, moulds, coliforms and to-
first year amounted to R$177,538. With the compli-          tal bacterial counts using the appropriate agar in
ance of the prerequisite programmes (GMP/SSOP), it         each case. The coating method is recommended for
was possible to reduce these costs approximately by        determining yeasts, moulds and coliforms as it al-
24.2%. This fact emphasised the importance of a solid      lows the localisation of the micro-organisms as well
prerequisite programme to improve economic viability       as the determination of single micro-organisms. For
for HACCP implementation.                                  total bacterial count, a direct inoculation technique
   Packaging materials are often considered as CCP in      is proposed. The employing of simple measures in
HACCP systems of food companies. Methods for the           the production and during transport of packaging
determination of the microbial contamination rate of       materials, such as dust prevention or tight sealing
plastic cups, especially for dairy products, must reli-    in polyethylene bags, heavily reduces microbial con-
ably detect single moulds, yeasts or coliforms. Even if    tamination rates of packaging material. To reduce
                                                       Dairy Foods                                                    165

Table 3.45 Representative prerequisite programmes.

1. Water supply (PP1)
Hazards                 Biological
                        Pathogen recontamination (not meeting criteria for potable water)
                        Chemical
                        Cross-contamination – non-food chemicals (chlorine, water treatment chemicals, agricultural
                        chemicals)
                        Physical
                        Hazardous extraneous material
HACCP                   r Periodical microbiological and chemical control
prerequisite            r Chlorination
criteria                r Filtering
                        r Distinct separation of potable and non-potable water circulation systems
Corrective actions      r   Cease the use of problematic source, find alternative
                        r   Destroy contaminated products
                        r   Chlorination
Responsibility          r   HACCP coordinator
                        r   Technician
2. Premises/equipment (PP2)
Hazards                 Biological
                        Pathogen recontamination/pathogen growth
                        Pathogen survival due to inadequate maintenance and/or calibration
                        Chemical
                        Cross-contamination – non-food chemicals (chemicals, agricultural chemicals)
                        Physical
                        Hazardous extraneous material
HACCP                   r Building structure, adequate materials used (permit cleaning, minimise risk of contamination,
prerequisite              provide adequate working space)
criteria                r Sanitary facilities (lavatories, washbasins)
                        r Ventilation: environmental air quality
                        r Air: intake air source well located; filtered (specifications)
                        r Drains: well located; adequate size
                        r Lighting
                        r Provide temperature-controlled handling
                        r Written, implemented and effective preventative maintenance programme (calibration, servicing,
                          replacement)
                           designated responsibilities
                           complete
                           specifies procedures and frequency
                           verified and updated

Corrective actions      r Change, repair so as to adhere to legal requirements
                        r Head of each department
Responsibility          r Technician/engineer
3. Transport and storage (PP3)
Hazards                  Biological
                         Pathogen contamination and/or recontamination from damaged packaging
                         Microbial growth due to temperature abuse or to excess humidity
                         Chemical
                         Cross-contamination – non-food chemicals
                         Physical
                         Hazardous extraneous material from damaged packaging
HACCP                    r Food carrier suitability to transport food
prerequisite             r Product separation during transport and storage
criteria                 r Temperature control for ingredients and finished product (monitored and recorded)
                         r Storage and handling requirements for incoming materials
                         r Receiving and storage requirements for non-food chemicals
                         r Finished product storage/shelf life observation/FIFO
                         r Distribution: truck suitability/temperature requirements/FIFO

                                                                                                              (Continues )
166                       HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.45 (Continued )

Corrective actions        r   Reject all expired, contaminated and affected products
                          r   Restore desirable storage conditions
Responsible               r   Storage manager
                          r   Production manager
                          r   HACCP coordinator
4. Sanitation and pest control (PP4)
Hazards                   Biological
                          Pathogen contamination and/or recontamination from unclean areas/equipment
                          Pathogen contamination from rodents, insects etc.
                          Chemical
                          Cross-contamination – non-food chemicals
                          Cross-contamination – ingredients (allergy sensitivities)
                          Cross-contamination – pest control products
                          Physical
                          Hazardous extraneous material from unclean areas/equipment
HACCP prerequi-           r Written, implemented and effective sanitation and pest control programmes
site criteria                designated responsibilities
                             complete
                             specifies procedures and frequency
                             verified and updated
                          r Use of effective cleaners and sanitisers, periodical verification (swab tests etc.)
                          r Quick removal of food waste
                          r Pest control: incoming materials receiving; incoming materials storage; exposed processing areas
Corrective actions        r Repeat cleaning procedure
                          r Repeat rinsing
                          r Change detergents and cleaning agents and review sanitation programme
                          r Hold and reject all contaminated products
Responsible               r Sanitation manager
                          r HACCP coordinator
5. Personnel conduct and hygiene (PP5)
Hazards                  Biological
                         Pathogen recontamination from employee handling
                         Pathogen recontamination from incorrect practices
                         Pathogen recontamination from damaged containers
                         Chemical
                         Cross-contamination – non-food chemicals (incorrect practices)
                         Allergenic residues due to incorrect practices
                         Physical
                         Hazardous extraneous material
HACCP                    r Good manufacturing and hygiene practices
prerequisite             r Maintain high degree of personal cleanliness
criteria                 r Wear clean, protective clothing
                         r Not a carrier of contagious diseases
                         r Adhere to working instructions and standard operating procedures
                         r Written, implemented and effective training programme
                         r Technical training
                            HACCP and monitoring
                            prerequisite programmes and monitoring
                            specific duties

Corrective actions        r   Reprimand for not complying with the rules
                          r   Keep off duty
                          r   Repeat training
Responsibility            r   Production manager
                                                           Dairy Foods                                              167

Table 3.45 (Continued )

6. Recall programme (PP6)
Hazards                 Biological
                        Pathogen contamination
                        Microbial toxins
                        Chemical
                        Cross-contamination – non-food chemicals
                        Antibiotics
                        Allergenic residues
                        Physical
                        Hazardous extraneous material
HACCP                   r Written, implemented and effective recall programme
prerequisite               designated responsibilities
criteria                   specifies methods and controls
                           effectiveness procedure
                        r Documentation for product code system
                        r Production records
                        r Distribution records
                        r Complaint file
                        r Recall procedure trial
Corrective actions          r Review and test recall programme
Responsible                 r HACCP coordinator
7. Company’s receiving programme/supplier evaluation and approval (PP7)
Hazards                  Biological
                         Pathogens
                         Microbial toxins due to temperature abuse
                         Chemical
                         Cross-contamination – non-food chemicals
                         Antibiotics
                         Pesticides
                         Allergenic residues
                         Physical
                         Hazardous extraneous material (metal, glass, wood)
HACCP prerequi-          r List all incoming material
site criteria            r Define specifications for incoming material (e.g. proper use of sanitisers, proper control of
                           antibiotics etc.)
                         r Define their specifications (B, C, P, acceptable food grade)
                         r Define receiving requirements, verify product is acceptable type, examine for damaged packages
                         r Design a monitoring programme for receiving, check specifications
                         r Evaluate suppliers (questionnaires, on site, quality certificates etc.)
                         r Packaging materials, acceptable material specifications, handling (damage)
Corrective actions          r   Reject and formally complain to the supplier
                            r   Find and recall all products containing unacceptable raw materials
Responsible                 r   Storage manager
                            r   HACCP coordinator


B, biological; C, chemical; P, physical.




contamination rates further, electron beam irradiation              3.14 YOGHURT
was applied: plastic cups sealed in polyethylene bags
were treated with 4–5 kGy, a dose that already leads to             Acoustical measurements have advantages over other
sterile polystyrene and polypropylene cups without in-              measurements in food monitoring because they
fluencing mechanical characteristics of the packaging                make it possible to measure with non-contact
material.                                                           and non-destructive surfaces and contribute to the
168                     HACCP and ISO 22000 – Application to Foods of Animal Origin

hygienisation of the food manufacturing industry.            damage to fat globules. Cream separated at temper-
Ogasawara et al. (2006) tried to monitor lactic fer-         atures below 45◦ C, however, contains active milk-
mentation of yoghurt by a probing sensor using a             derived lipases (Alan and Jane, 1994) that can initiate
pair of acoustic transducers. Temperature of the so-         the development of rancidity during the short interval
lution changed because of the reaction heat of fermen-       between separation and pasteurisation.
tation. Consequently, the sound velocity propagated             The skim milk is pasteurised at 72◦ C for at least 15
through the solution also changed depending on the           seconds for low heat and 93◦ C/3 minutes for high-heat
temperature. At the same time, the solution changed          condensed milk followed by cooling at 32◦ C regard-
its phase from liquid to gel. The transducer’s usage in      ing high-temperature short time (HTST) pasteurisa-
the solution indicates the change of the temperature as      tion and concentrated by evaporation to the desired
the change of the phase difference between two trans-        solids level. The condensed skim is then cooled to
ducers. The acoustic method has advantages of non-           <5◦ C and stored in a silo, ready for dispatch. For the
destructive measurement that reduces contamination           manufacture of bulk whole condensed milk, the pro-
of food products by measuring instruments.                   cess is identical except the separation step is eliminated
   The sensor was inserted into milk with a lactic acid      (Ali and Fisher, 2002).
bacterial stain of 19◦ C and monitored phase retarda-           Concentration after heat treatment takes place un-
tion of propagated acoustic wave and its temperature         der vacuum in multiple-effect evaporators. The de-
with thermocouples in the milk. The monitoring result        gree of concentration depends on the product end
of fermentation from milk to Caspian Sea yoghurt             use. The product leaving the evaporator is not ster-
by the acoustic transducers with the frequency of 3.7        ile and further opportunities for contamination occur
MHz started to show gradient changes in temperature          during post-evaporation handling. A high standard of
caused by reaction heat of fermentation but stopped          hygiene together with rapid and efficient cooling is
the gradient change at the end although the temper-          seen as an integral part of processing. After evapo-
ature still changed. The gradient change stopped its         ration, the product is normally cooled to 20–25◦ C.
change because of phase change from liquid to gel.           The CCPs at the evaporation step are the examination
The present method measured indirectly by setting            of plant records for chemical, physical, bacteriolog-
transducers outside of the measuring object. This non-       ical and temperature standards. The bulk-condensed
contact sensing method will have the great advantage         whole and skim milk HACCP control chart is given in
of reducing the risk of food contamination from mea-         Table 3.46.
suring instruments because the measurement probes
are set out of fermentation reactor or food containers.
The flow diagram for yoghurt is given in Fig. 3.12.           3.16 QUALITY CONTROL METHODOLOGY
                                                                  (QCM) FOR DETECTION OF MILK AND
                                                                  DAIRY PRODUCTS’ AUTHENTICITY
3.15 CONDENSED MILK
                                                             The two most preferred methods for detecting mix-
Condensed or concentrated milk is the liquid food ob-        tures of milk from different species in raw and further
tained by partial removal of water from milk. Bulk-          processed milk products are immunology (sandwich
condensed milk is usually made by evaporation of             ELISA) and electrophoresis (PAGE, isoelectric focus-
manufacturing-grade milk without addition of sugar           ing [IEF] and radial immunodiffusion). Hewedy and
or any other preservative material. The primary use          Smith (1989) found fast protein liquid chromatogra-
of the product is as a source of milk solids in confec-      phy (FPLC) the best method for detecting soy ‘milk’
tionery, bakery and other manufactured foods. Heat           in pasteurised bovine milk. Electrical conductivity and
treatments vary, but begin with pasteurisation.              GLC (graphite-like carbon) can be used for the detec-
   After milking, the raw milk is chilled to below 48◦ C     tion and estimation of cow’s milk admixtures in buf-
and kept at this temperature during its transportation       falo’s milk (El-Shabrawy and Hagag, 1980).
to the dairy plant. At the plant, the receiver grades each      In products like cheese, the adulteration of milk fat
milk load for odour, temperature, and foreign matter         with pure and partially hydrogenated soybean oils and
and antibiotics. After receipt, the milk is mechanically     other similar vegetable oils, such as cottonseed oil and
filtered and stored in silo tanks. For the manufacture        corn oil, can be detected by GLC analysis of potassium
of bulk skim condensed milk, the milk is preheated to        salts of fatty acids, obtained after saponification of the
50–55◦ C and skimmed (0.5% fat) in a separator.              fat (Luf et al., 1987a,b).
   Milk is usually separated at temperatures between            A method for detecting and quantifying bovine,
38 and 62◦ C to facilitate separation and minimise           ovine and caprine milk mixtures in milk and cheeses
                                                             Dairy Foods                                                        169



         1. Packaging
                                              2. Milk                               3. Skimmed             4. Starter
            material                                          CCP1
                                              receipt                               milk powder             culture
            receipt



                                          6. Cool storage      <6°C for <24 hours
         5. Packaging                                                                                      7. Starter
        material storage     No                                                                           preparation

                                                  8.
                                         Is heat treatment
                                             adequate?        92°C for 30 minutes


                                                Yes

                           Cups            9. Cup filling         CCP2


                                           10. Balance
                                         temperature till
                                            42–45°C


                                         11. Fermentation
                                                                                                  No
                              No
                                                 12.                                                          13.
                    41–42°C                                                   Strained
                     for 3 hours
                                           Is incubation        Yes                           Yes        Is draining
                                                                              yoghurt?
                                             adequate?                                                  satisfactory?
                                                                                                                   <4°C for
                                                                No                                                   24 hours


                                            14. Balance
                     t = 30 minutes                            CCP3
                                           temperature


                                          15. Packaging/       CCP4
                           Lids                                                                   Yes
                                            Labelling


                            θ < 24°C     16. Cool storage      CCP5




                                               17.
                              θ < 24°C
                                             Delivery


Fig. 3.12 Yoghurt flow diagram.


by means of reversed phase high-performance liquid                     classification of dairy products, either in terms of ge-
chromatography (RP-HPLC) of β-lactoglobulins is de-                    ographic origin or variety. The most promising and
scribed by Ferreira and Cacote (2003).                                 effective multivariate analysis leading to the accurate
   The implementation of multivariate methods to                       separation of samples based on their attributes proved
milk and dairy products revealed the emergence of sev-                 to be the principal component analysis, cluster analysis
eral important parameters, such as mineral content,                    and canonical analysis (Arvanitoyannis and Tzouros,
volatile analysis and sensory analysis, for the proper                 2005).
170                      HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 3.46 Bulk-condensed whole and skim milk HACCP control chart.

Processing                               Critical                                          Corrective
step            Hazard CCP               limit      Monitoring Records      Responsibility action       Verification

Raw milk        M, C      Temperature    <5◦ C     Every        Receiving   Receiving     Reject          Thermometer
receiving                 β-lactam       Absence   tanker       log         operator                      Drug test
                                            ◦
Raw milk        M         Temperature,   <5   C    Continuous   Recording   Production    Hold product, Recording
storage                   time           <72 hours              chart       supervisors   investigate     versus
                                                                                          cause and       indicating
                                                                                          adjust          thermometer
Pasteurisation M          Temperature, >83◦ C       Continuous Recording Production       Flow divert     Recording
                          time         >25                     chart     supervisors      recirculate and versus
                                       seconds                                            heat            indicating
                                                                                                          thermometer

Adapted from Ali and Fischer (2002).
C, chemical; M, microbiological.



3.17 QCM FOR OTHER FERMENTED                                 ous phase is decanted and the curd is called klila, which
     DAIRY PRODUCTS                                          is then consumed as white fresh cheese. Raw butter is
                                                             obtained after churning the fermented milk (rayeb).
Lben is a refreshing cultured product obtained by               A typical traditional procedure for jben making,
spontaneous fermentation of cow’s milk. Occasionally,        known in other Arab countries as jibneh baida, which
goat’s milk alone or in combination with cow’s milk          means ‘white’ cheese involves collection of raw milk
is used; however, the same product is made in differ-        (cow’s, goat’s or a blend of both) in an earthenware
ent Arab countries and it is known as lben or leben          vessel and its fermentation spontaneously at ambient
(in North African countries) and laban (in the Middle        temperature until coagulation. At this stage, the curd
East; Benkerrouma and Tamime, 2004).                         (rayeb) is obtained in a similar manner as for lben, ex-
   The traditional stages of manufacture of lben or          cept that a larger volume of milk is needed and, hence,
other related products involve souring of milk at am-        the period of filling the moulds extends over a period
bient temperature until coagulation occurs which may         of 3–4 days. The curd is then transferred to a muslin
take up to 24–72 hours depending on the temperature          cloth bag that is tied and hung to drain for an addi-
during the summer and winter seasons, respectively.          tional 2–3 days.
On gelation, the product is called rayeb, and may be            The cheese is then emptied from the cloth bag, cut
consumed as such; however, by churning the fermen-           into pieces (ca. 250 g), salted on the surface and con-
tate, the product is separated into lben and raw but-        ditioned for further draining.
ter called zebda beldia literally meaning ‘butter of the        Nowadays, rennet (addition of a freshly prepared
county’ (in other Middle Eastern countries, the same         infusion of dry calf stomach or by commercially made
product is known as zibdeh baladieh, samna and in            rennet [e.g. dry as a tablet or as liquid solution])
some instances, mutton fat dripping is also samen or         has been added to accelerate milk coagulation. These
samneh).                                                     changes aim either at reducing the production time or
   The churning is achieved by hanging the checoua           at enhancing the safety and the keeping quality of the
filled with rayeb (ca. 10 L) to a wooden tripod or            product.
to a cottage roof and vigorously shaking it back and            Fermentation is achieved by the addition of yoghurt
forth until fluidisation of the contents and coalescence      starter culture (ca. 1 g/100 mL) along with rennet.
of the fat globules (ca. 45–60 minutes). The end of          After the coagulation of the milk, the curd is dis-
churning is discerned by the sound of the butter lumps       pensed into small-perforated plastic moulds where it is
when shaking. Nowadays, the traditional churning is          allowed to drain and later condition (Benkerrouma
being gradually replaced by the use of electric mixers.      and Tamime, 2004).
These are metal containers, with different capacities,
equipped with an agitator and a motor on the top.
   Upon storage, lben sours and its acidity reaches high     3.18 UPDATED EU LEGISLATION
levels after 2–3 days. To avoid wastage culturally re-
garded as a sin, the product is excessively heated until     From 1 January 2006, new food hygiene legislation
separation of the curd and the whey occurs. The aque-        came into force throughout the EU. The legislation
                                                        Dairy Foods                                                       171

affects all food businesses, including caterers, primary        Regulation 852/2004
producers (such as farmers), manufacturers, distribu-           The key requirements are:
tors and retailers.
   For the dairy industry, the legislation replaces the re-     1. Primary responsibility for food safety rests with the
quirements of the Dairy Hygiene Directive 92/46/EEC.               food business operator
This directive contained many detailed prescriptive             2. Food safety throughout the food chain starts with
requirements, some of which were not consistent                    primary production
across the directives applying to other foods. The              3. Maintenance of the cold chain is important for food
new legislation achieves consistency by applying to                that cannot be stored safely at ambient tempera-
all foods, but with additional requirements apply-                 tures, particularly frozen food
ing to foods of animal origin such as dairy prod-               4. HACCP principles, together with the application
ucts. Although the result is a simplification of the re-            of GHP, should reinforce food business operators’
quirements, unfortunately the task of achieving this               responsibility
has turned out to be more complicated than ini-                 5. Guides to good practice are to be encouraged
tially envisaged. The directives are being replaced by          6. Microbiological criteria and temperature control
two main regulations together with subsidiary regula-              requirements will be established based on a scien-
tions and guidance documents. Underpinning the new                 tific risk assessment
hygiene package is Regulation 178/2002. This lays               7. Imported foods must be of the same hygiene stan-
down the general principles and requirements of food               dard or an equivalent standard as food produced in
law, and also establishes the European Food Safety                 the community.
Authority.
   The main legislations in the new package are:                Primary producers will need to follow good practice
                                                                and manage their operations as set out in Annex 1 of
r Regulation 852/2004 on the hygiene of foodstuffs. This        Regulation 852/2004.
                                                                   Primary producers must ensure that hazards are ac-
    applies to all foods, and begins at primary production
                                                                ceptably controlled and respect other existing legisla-
    and continues through processing, distribution and re-
                                                                tion but primary producers are not required to apply
    tail. Finally, Regulation 852/2004 encourages national
                                                                HACCP-based procedures.
    and community guides to the legislation, and it is ex-
                                                                   Primary producers will have to be registered with
    pected that a number of these will be produced over the
                                                                competent authorities, although existing forms of reg-
    next year.
r                                                               istration may be used for this purpose.
    Regulation 853/2004 laying down specific hygiene rules
    for food of animal origin.                                  Hazard analysis and critical control points
r   This gives additional requirements for foods of animal        “Regulation 852/2004 requires food business op-
    origin. There is a definition of such foods, the aim be-       erators to put in place, implement and maintain a
    ing to exclude composite products such as pizzas from         permanent procedure or procedures based on the
    the scope while applying the additional requirements to       following HACCP principles:
    dairy and other foods of animal origin.
r   Regulation 854/2004 laying down specific rules for the         r   Identifying all hazards
                                                                  r   Identifying CCPs
    organisation of official controls on products of animal
                                                                  r   Establishing critical limits at CCPs
    origin intended for human consumption.                        r
r   Regulation 882/2004 on official controls performed to              Establishing and implementing effective monitoring proce-
                                                                      dures at CCPs
    ensure the verification of compliance with feed and food       r   Establishing corrective actions when monitoring indicates
    law, animal health and welfare rules.                             that a CCP is not under control
r   There are also regulations giving transition measures,        r   Establishing procedures to verify that the above measures
    implementing measures and microbiological criteria. As            are working effectively
    well as this, the European Commission is issuing guid-        r   Establishing documents and records commensurate with
    ance on the interpretation of certain aspects of the leg-         the nature and size of the food business.”
    islation.
r   The new legislation requires food business operators        General requirements for heat treatment
    (except primary producers) to put in place, implement       General requirements include the following (Regula-
    and maintain a permanent procedure, or procedures,          tion 852/2004):
    based on the HACCP principles. The legislation is struc-
    tured this way so that it can be applied flexibly in all       1. Any heat-treatment process must (i) raise every part of
    food businesses regardless of their type or size.                the product treated to a given temperature for a given
172                       HACCP and ISO 22000 – Application to Foods of Animal Origin

     period of time and (ii) prevent the product from becoming     Specific requirements of Regulation 853/2004
     contaminated during the process.                              There are specific additional dairy requirements in
  2. Food business operators must check regularly the main         Regulation 853/2004 applying to primary production.
     relevant parameters (particularly temperature, pressure,      In the main, these are similar or more flexible than the
     sealing and microbiology), and the use of automatic de-
                                                                   requirements of the Directive 92/46/EEC, but the fol-
     vices.
  3. The process used should conform to an internationally
                                                                   lowing small differences are worth noting:
     recognised standard (e.g. pasteurisation, UHT or sterilisa-
                                                                   r Raw milk from any animal showing individually a pos-
     tion).
                                                                       itive reaction for tuberculosis or brucellosis must not
                                                                       be used for human consumption.
Specific requirements of Annex I of 852/2004                        r   The inspection requirements for milk from each ani-
Specific requirements include the following:                            mal have been modified to permit automatic milking.
                                                                       The new wording requires that milk from each animal
r Primary products are to be protected against contami-                be checked for organoleptic or physicochemical abnor-
 nation.                                                               malities by the milker or by a method achieving similar
r The cleanliness as far as possible of production animals             results and that milk presenting such abnormalities is
 is to be ensured.                                                     not used for human consumption.
r To keep clean any facilities used to store and handle            r   Milk from animals showing clinical signs of udder dis-
 feed.                                                                 ease must not be used for human consumption other-
r To ensure that staff handling foodstuffs are in good                 wise than in accordance with the instructions of a vet-
 health and undergo training on health risks.                          erinarian.
r To store and handle waste and hazardous substances so            r   Teat dips or sprays are to be used only after authorisa-
 as to prevent contamination.                                          tion or registration.
r To prevent the introduction and spread of contagious             r   Food business operators must initiate procedures to en-
  diseases transmissible to humans through food, includ-               sure that raw milk is not placed on the market if it con-
  ing taking precautionary measures when introducing                   tains antibiotic residues above permitted limits.
                                                                   r   When raw milk fails to comply with the standards for
  new animals and reporting suspected outbreaks of such
  diseases to the competent authority.                                 antibiotic residues, plate count or somatic cell count,
r To take account of the results of any relevant analyses              the food business operator must inform the competent
  carried out on samples taken from animals or other                   authority and take measures to correct the situation.
  samples that have importance to human health.
r To use feed additives and veterinary medicinal products             Regulation 853/2004 does not include additional
  correctly, as required by relevant legislation.                  heat-treatment requirements for dairy products but
r To keep and retain records relating to measures to con-          the Commission’s regulation laying down implement-
  trol hazards in an appropriate manner and for an ap-             ing measures (Regulation 2074/2005) has reintro-
  propriate period. These records include:                         duced definitions for pasteurisation and UHT as
                                                                   follows:
   (i) The nature and the origin of feed fed to animals.
  (ii) Veterinary medicinal products or other treat-                   1. Pasteurisation is achieved by a treatment involv-
       ments administered to the animals, dates of ad-                    ing (i) a high temperature for a short time (at least
       ministration and withdrawal periods.                               72◦ C for 15 seconds); (ii) a low temperature for
 (iii) The occurrence of diseases that may affect the                     a long time (at least 63◦ C for 30 minutes); or
       safety of the products.                                            (iii) any other combination of time and temper-
 (iv) The results of any analyses carried out on sam-                     ature conditions to obtain an equivalent effect,
       ples taken from animals or other samples taken                     such that the products show, where applicable, a
       for diagnostic purposes that have importance                       negative reaction to an alkaline phosphatase test
       for human health.                                                  immediately after such treatment.
  (v) Any relevant reports on checks carried out on                    2. UHT treatment is achieved by a treatment (i) in-
       animals or products of animal origin.                              volving a continuous flow of heat at a high tem-
                                                                          perature for a short time (not less than 135◦ C
                                                                          in combination with a suitable holding time)
Food business operators are to take appropriate re-                       such that there are no viable micro-organisms or
medial action when informed of problems identified                         spores capable of growing in the treated prod-
during official controls.                                                  uct when kept in an aseptic-closed container at
                                                       Dairy Foods                                                        173

      ambient temperature; and (ii) sufficient to ensure        Abd El-Salam, M.E., Alichanidis, E. and Zerfiridis, G.K.
      that the products remain microbiologically sta-             (1993) Domiati and Feta type cheeses. In: Fox, P.F. (ed)
      ble after incubating for 15 days at 30◦ C in closed         Cheese: Chemistry, Physics and Microbiology, 2nd edn,
                                                                  Vol. 2, London: Chapman and Hall, pp. 301–335.
      containers, or for 7 days at 55◦ C in closed con-        Abou-Donia, S.A. (1991) Manufacture of Egyptian, soft,
      tainers, or after any other method demonstrating            pickled cheeses. In: Robinson, R.K. and Tamine, A.Y. (eds)
      that the appropriate heat treatment has been ap-            Feta and Related Cheeses, London: Ellis Horwood.
      plied.                                                   Alan, H.V. and Jane, P.S. (1994) Milk and Milk Products
                                                                  Technology, Chemistry and Microbiology, London: Chap-
                                                                  man and Hall.
                                                               Ali, A.A. and Fischer, R.M. (2002) Implementation of
                                                                  HACCP to bulk condensed milk production line. Food
3.19 CONCLUSIONS                                                  Reviews International, 18(2–3), 177–190.
                                                               AMFEP (1997) Regulatory Aspects of Enzymes, Brussels:
Raw milk is normally stored at 4◦ C or below, at which            Association of Manufacturers of Fermentation Enzyme
temperature only psychrotropic organisms will grow.               Products.
Subsequent pasteurisation will eliminate almost all the        Angelillo, I.F., Viggiani, N.M., Greco, R.M. and Rito, D. for
                                                                  Collaborative Group. (2001) HACCP and food hygiene
psychrotropic organisms. However, they frequently                 in hospitals: Knowledge, attitudes, and practices of food
produce lipases and proteases that are markedly more              services staff in Calabria, Italy. Infection Control and Hos-
thermoresistant than the organisms themselves. These              pital Epidemiology, 22(6), 363–369.
enzymes may continue to function in pasteurised and            Anifantakis, E.M. (1991a) Traditional Feta cheese. In:
otherwise heat-treated milk or products derived from              Robinson, R.K. and Tamine, A.Y. (eds) Feta and Related
it, particularly in so-called UHT-sterilised milk (Chris-         Cheeses, London: Ellis Horwood.
                                                               Anifantakis, E.M. (1991b) Greek Cheeses, Athens, Greece:
ten et al., 1986; Dunkley and Stevenson, 1987; Mossel             National Committee of Milk of Greece.
et al., 1995).                                                 Armstrong, G.L., Hollingsworth, J. and Morris, J.G., Jr.
    It is well established that milk can be a potential car-      (1996) Emerging food-borne pathogens: Escherichia coli
rier of disease-producing organisms. Milk-borne epi-              O157:H7 as a model of entry of a new pathogen into the
demics have occurred in the past throughout the world.            food supply of the developed world. Epidemiologic Re-
Unless proper precautions are taken, such outbreaks               view, 18, 29–51.
                                                               Arvanitoyannis, I.S. and Mavropoulos, A.A. (2000) Im-
of milk-borne diseases can occur anywhere, any time,
                                                                  plementation of the hazard analysis critical control
especially if raw milk is consumed. Diseases, which               point (HACCP) system to Kasseri/Kefalotyri and Anevato
are known to be transmissible through milk, are listed            cheese production lines. Food Control, 11, 31–40.
below, together with the manner in which they may              Arvanitoyannis, I.S. and Tzouros, N.E. (2005) Implemen-
enter the milk: (i) infection of milk directly from the           tation of quality control methods in conjunction with
cow, (ii) infection from man to cow and then to milk,             chemometrics toward authentication of dairy products.
(iii) direct contamination of milk by human beings and            Critical Reviews in Food Science and Nutrition, 45, 231–
                                                                  249.
(iv) indirect contamination of milk by human beings            Aureli, P., Franciosa, G. and Pourshaban, M. (1996) Food-
(De, 2000).                                                       borne botulism in Italy. The Lancet, 348, 1594.
    A total of 193 outbreaks and 6053 illnesses from           Azanza, M.P.V. and Zamora-Luna, M.B.V. (2005) Barriers
1990 to 2005 were linked to such dairy products as                of HACCP team members to guideline adherence. Food
cheese, milk and ice cream. Milk was the vehicle in 67            Control, 16, 15–22.
outbreaks with 1788 illnesses, cheese was identified in         Baek, S.Y., Lim, S.Y. Lee, D.H. et al. (2000) Incidence and
                                                                  characterization of Listeria monocytogenes from domestic
57 outbreaks with 1850 illnesses and ice cream was                and imported foods in Korea. Journal of Food Protection,
identified in 49 outbreaks with 1879 illnesses. Dairy              63(2), 186–189.
products identified as unpasteurised were associated            Barkema, H.M., Schukken, Y.H. Lam, T.G.M. et al. (1998)
with 30% of the dairy-related outbreaks, including                Incidence of clinical mastitis in dairy herds grouped in
nearly 70% of milk outbreaks. In outbreaks associ-                three categories by bulk milk somatic cell counts. Journal
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                                                               Bell, C. and Kyriakides, A. (1998) E. coli: A Practical Ap-
were the most common hazards (CSPI, 2007).
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                                                               Bell, C. and Kyriakides, A. (2000) Clostridium botulinum:
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                                                          Dairy Foods                                                        175

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                                   4
                         Meat and Meat Products
                 Ioannis S. Arvanitoyannis, Theodoros H. Varzakas
                              and Persefoni Tserkezou




4.1 INTRODUCTION                                                 infections. Hermetic packaging of raw materials and
                                                                 ingredients maintains the majority of their hygienic
As a general rule, slaughterhouses and meat establish-           and physicochemical properties, some of which are
ments must fulfil two requirements:                               important for the final quality of the packaged prod-
                                                                 uct (Mossel and Stuijk, 1992; Put et al., 1980). The
1. The protection of products from external contami-             controls that should be carried out at the receiving of
   nation and to follow high-hygienic standards.                 raw materials and ingredients in order to minimise or
2. The facilitating of the slaughter and butchering of           prevent hazards, which might reduce their quality and
   animals so as to economically and efficiently pro-             pose danger to public health, are (i) identification of the
   duce meat for the market (Havas, 1995).                       product, (ii) presence of health mark or labels, (iii) cer-
                                                                 tifications for guarantees, (iv) meat freshness/freezing
   The Hazard Analysis and Critical Control Point                date, (v) inspection of the product with respect to the
(HACCP) concept provides a systematic approach to                physical state, surface colour and cleanliness, presence
improve the preparation and handling of meat and                 of abnormalities and extraneous materials, contami-
poultry products, so as to reduce significantly food-             nation by water or pests, and integrity of any wrap-
borne illness (Tompkin, 1980). Salmonella infection is           ping or packaging, (vi) internal temperature of meat
spread among animals or poultry through the use of               in relation to its physical state, upon receipt, it is im-
contaminated feed and the incidence tends to reach a             portant that raw materials be free from evidence of
peak where intensive stock raising is practised (Cross-          previous temperature abuse, (vii) microbial load and
land, 1997). To eliminate the presence of Salmonella             pH and (viii) temperature and hygienic conditions of
in meat and poultry, it is necessary to maintain strict          the transporting vehicle (Severini and Trevisani, 1996).
hygiene regimes and implement the HACCP concept                     Cooking is an important CCP and must be well con-
(Simonsen et al., 1987). To monitor the effect of these          trolled both for quality and for product safety reasons.
measures, it is necessary to screen raw materials, end           The applied cooking process depends mainly on the
products and materials in process for the presence of            required shelf life of the product. To achieve the maxi-
the pathogen (Morris, 1985).                                     mum shelf-life extension for a product, it is particularly
   Campylobacter jejuni/E. coli are found in the intes-          important to control the uniformity of heat distribu-
tine of farm and domestic animals, in the intestine of           tion and the reproducibility of heating conditions. The
poultry and in farm wastes. A strong relationship has            critical limits that should be established for cooking
been identified between poultry and food poisoning                and serving as safety boundaries are (i) the minimum
due to Campylobacter and there is some evidence that             internal temperature of the product, (ii) the composi-
illness can be caused by infection with a small number           tion and thickness of the product, (iii) time and rate
of Campylobacter (Shapton and Shapton, 1994).                    of heating and cooling and (iv) oven temperature and
   The separation of cooked and raw material is an               humidity (NACMCF, 1992).
essential prerequisite for food safety and thus the ar-             Cooling must also be strictly controlled, since germi-
rival of incoming raw materials is a significant critical         nation and outgrowth of surviving spores (especially of
control point (CCP) for the prevention of foodborne              C. perfringens) should be prevented (Hatheway et al.,

                                                           181
182                     HACCP and ISO 22000 – Application to Foods of Animal Origin

1980). The final temperature and the rate of cooling          primarily in the Adelaide region (Cameron et al.,
determine the effectiveness of this process (Tavris et       1995a). Examples of food-associated outbreaks of ill-
al., 1985). It is important that manual handling is min-     ness caused by micro-organisms are given in Table 4.1
imised and that the conveyor belts and the slicing ma-       and the general characteristics of cattle, pork and goat
chines are cleaned and disinfected frequently (ICMSF,        meat are summarised in Table 4.2.
1988).
   Canned, cured, shelf-stable meats have one of the
most enviable safety records of most food products in        4.2 NEW COMMUNITY LEGAL BASIS
relation to outbreaks of botulism. The principal micro-
biological hazard for pasteurised in-pack chilled meat       The evolution of the European Community legislation
products is foodborne botulism (Peck and Stringer,           on food hygiene and safety will affect the situation
2005). Canned, cured meats are considered in most            in the meat industry from the stage of primary pro-
markets to be standard commodity items with little           duction to the final product on the retail market.
premium attraction and they are consumed by most             The recent Community legislation was developed as
sectors of the community. Products include canned            a consequence of the adoption of the White Paper
whole meats such as ham and meat emulsions includ-           on Food Safety. The White Paper sets out over 80
ing luncheon meat. Pork luncheon meat is replaced            separate actions that are envisaged over the period
by beef luncheon meat in Jewish and Islamic commu-           ahead and intends to close identified loopholes in cur-
nities. The products are sold under ambient storage          rent legislation (EC, 2000). On 23 July 2007, the
conditions and have extensive shelf lives allocated to       member states of the European Union (EU) launched
them. They are predominantly consumed without any            an Intergovernmental Conference (IGC) to draw up
further processing by the consumer and it is common          a new Reform White Paper for an EU of 27 mem-
for canned ham to be used as sandwich filling (Bell and       ber states (http://www.fco.gov.uk/Files/kfile/CM7174
Kyriakides, 2000a).                                          Reform Treaty.pdf). Regulation (EC) No. 178/2002,
   Products in this category, whether whole meat or          laying down the general principles and requirements
emulsion based, are made under similar conditions and        of food law, establishing the European Food Safety
common to all is the absence of a process, e.g. a ‘bo-       Authority and defining procedures in matters of food
tulinum cook’, which, in isolation, could prevent any        safety, was considered as the foundation of the new
hazard relating to Clostridium botulinum. The safety         legislation Regulation (EC) No. 178/2002.
of these products is controlled by a combination of             The European Committee adopted a uniform legal
processing conditions and preservation factors which         policy applicable to the entire food chain from ‘farm
together reduce the number of spores and prevent the         to fork’ in order to protect public health and main-
growth of C.botulinum during product shelf life.             tain high food safety standards. As a result, the Eu-
   Animals used for food, including cattle, pigs, sheep,     ropean Parliament and the Council issued four Reg-
and the young of these animals, all carry Escherichia        ulations that merged, harmonised and simplified the
coli as commensal flora, often different from the ‘nor-       EU hygiene legislation that had previously been scat-
mal’ strains in humans. They may also be infected by         tered over 17 separate Directives, composing the new
specific strains, again often different from those infect-    food hygiene package. In general, this package includes
ing humans. Strains pathogenic to humans carried in          rules and procedures related to the responsibilities of
the ‘normal’ gut flora of food animals clearly pose a         all food business operators for the hygienic produc-
potential risk of infection to humans via a number of        tion and safe disposal of food products as well as the
routes: (i) faecal–oral route from animals to humans         responsibilities of the competent authorities in the con-
during rearing processes, (ii) faecal contamination of       trol of foodstuffs for the implementation of the struc-
food crops when untreated or poorly treated manure           tural, operational and hygiene requirements. The four
is used for fertiliser, (iii) faecal contamination of car-   Regulations that entered into force on 1 January 2006
casses via poor hygienic practices during slaughter and      are:
evisceration processes and (iv) consumption of faecally
contaminated raw milk, E. coli mastitic milk or prod-        r Regulation (EC) No. 852/2004 on the hygiene of food-
ucts made from such milk.                                      stuffs.
   South Australia experienced a large outbreak of           r Regulation (EC) No. 853/2004 laying down specific hy-
E. coli food poisoning between December 1994 and               giene rules for food of animal origin.
February 1995 (Cameron et al., 1995b). A total of            r Regulation (EC) No. 854/2004 laying down specific
23 cases of haemolytic–uraemic syndrome (HUS) were             rules for the organisation of official controls on prod-
reported among children less than 16 years of age,             ucts of animal origin intended for human consumption.
                                             Meat and Meat Products                                                183

Table 4.1 Examples of food-associated outbreaks of illness caused by micro-organisms.

Food                   Country              Micro-organism            Incidence          Reference

Raw pork               UK                   Clostridium botulinum        14              Dodds (1993)
Vacuum-packed          UK                   Clostridium botulinum        73              Dodds (1993)
bacon
Raw meats              North America        Clostridium botulinum         1              Dodds (1993)
Raw meats              Europe               Clostridium botulinum        36              Dodds (1993)
Manufactured frozen    USA                  Clostridium botulinum         1              Bell and Kyriakides (2000)
meat pie
Raw sausage            UK                   Salmonella                 988               Bell and Kyriakides (2002)
Raw meat               UK                   Salmonella                 830               Bell and Kyriakides (2002)
Offal                  UK                   Salmonella                 458               Bell and Kyriakides (2002)
Raw meat               Sweden               Salmonella                8845               Lundbeck et al. (1955)
Corned beef            Scotland             Salmonella                 507               Walker (1965)
Salami                 Australia            Salmonella                 279               Taplin (1982)
Pate                   France               Salmonella                 506               Bouvet et al. (1986)
Ham                    England and Wales    Salmonella                 274               Bell and Kyriakides (2002)
Salami sticks          UK                   Salmonella                 101               Cowden et al. (1989)
Cooked meat            UK                   Salmonella                 545               Sockett et al. (1993)
Salami                 Italy                Salmonella                  83               Pontello et al. (1998)
Raw beef               Malaysia             Listeria monocytogenes       6               Arumugaswamy et al. (1994)
Fresh ground beef,     Italy                Listeria monocytogenes      65               Comi et al. (1992)
fresh pork and
sausages
Raw meat               Denmark              Listeria monocytogenes     106               Norrung et al. (1999)
Ground beef and        USA                  Listeria monocytogenes       6               Amoril and Bhunia (1999)
steak
Ground pork            USA                  Listeria monocytogenes     171               Kanuganti et al. (2002)
Ready-to-eat meat      UK                   Listeria monocytogenes      61               Elson et al. (2004)
Sliced meat            UK                   Listeria monocytogenes      22               Elson et al. (2004)
Luncheon meats         USA                  Listeria monocytogenes      82               Gombas et al. (2003)
Preserved meat         Denmark              Listeria monocytogenes      77               Norrung et al. (1999)
products – not heat
treated
Pork tongue in aspic   France               Listeria monocytogenes     279 (63 deaths) Goulet et al. (1993)
Hot dogs and           USA                  Listeria monocytogenes     100 (21 deaths) Bell and Kyriakides (2005)
delicatessen meats
Pork tongue in jelly   France               Listeria monocytogenes       26 (7 deaths)   Bell and Kyriakides (2005)
Ham and corned beef    New Zealand          Listeria monocytogenes       31              Sim et al. (2002)
Hamburger patties in   Oregon and           Escherichia coli             47              Riley et al. (1983)
sandwiches             Michigan
Undercooked beef       Canada               Escherichia coli             73 (17 deaths) Chapman (1995)
patties
Hamburgers             USA                  Escherichia coli           732 (4 deaths)    Bell and Kyriakides (1998)
Uncooked, semi-dry     South Australia      Escherichia coli            23 (1 death)     Cameron et al. (1995a)
fermented sausage
(mettwurst)
Meat products          Scotland             Escherichia coli           490 (20 deaths) Pennington (1997)
Minced mixed beef      Netherlands          Escherichia coli             2             Heuvelink et al. (1996)
and pork
184                     HACCP and ISO 22000 – Application to Foods of Animal Origin

Table 4.2 General characteristics of cattle, pork and        prevention of the introduction and spread of conta-
goats meat.                                                  gious diseases transmissible to humans through food
                                                             is an essential consideration for the safe production
Products                Half-parts, quadric-parts cattle,
                        pork half-parts, goats half-parts,   of meat. Control of sources of contamination and the
                        offal, tongues, head meat            application of hygienic rules in terms of facilities, herd
General characteristics Fresh meat kept in cool chambers     management and transport of animals influence the
                                                             safety of meat for human consumption. In addition,
Packing                 Plastic packing of pork and cattle
                        livers and offal from lambs/heads    herd owners should keep records of the nature and
                                                             origin of animal feed used, veterinary medicinal prod-
Usage                   Promotion in the retail sector,
                        further treatment for the            ucts or other treatments administered to the animals,
                        preparation of various               the occurrence of diseases that may affect the safety
                        meat-based products                  of products of animal origin and the results of any
Shelf life              7 days at 0–2◦ C                     analyses carried out on samples taken from animals
Storage and transport Stored in controlled conservation      for diagnostic purposes especially those with public
instruction             conditions (temperature 0–2◦ C,      health significance. This information should be avail-
                        humidity 85–90%)                     able to the competent authorities when animals enter
                        Transport in refrigerated trucks     the slaughterhouse.
General specification    Products complied with the EEC          A wide variety of veterinary drugs are used in ani-
                        directives 93/43, PD410/1994(91/     mal production. Table 4.3 lists the major classes and
                        497/EEC, 91/498/EEC, 92/120/         gives the use of veterinary drugs. Essentially, veteri-
                        EEC), 1760/2000, 72/461/EEC          nary drugs are most likely to occur in animal-derived
                        and the Code of Foods and            food products, although drug residue in animal waste
                        Beverages                            is a growing concern (Lehotay and Mastovska, 2005).
                                                             Among the actual measures required for ensuring
                                                             hygiene in primary production are (i) cleaning of
r Regulation (EC) No. 882/2004 on official controls per-      animal udders before and after milking, (ii) cleanliness
                                                             in the farmyard, (iii) combating pests and preventing
  formed to ensure the verification of compliance with
                                                             wild birds and pets from gaining access to production
  feed and food law, animal health and animal welfare
                                                             areas, (iv) prevention of contamination when handling
  rules.

   Regulation (EC) No. 852/2004 applies to all stages        Table 4.3 Classification of veterinary drugs.
of production, processing and distribution of food and
                                                             Class                    Uses
to exports and lays down general rules for food busi-
ness operators on the hygiene of foodstuffs. This regu-      Antibacterial drugs      Treatment and prophylaxis of
lation takes into account the fact that primary respon-                               diseases caused by bacteria
sibility for food safety rests within the food business      Antihelminthic drugs     Treatment and prophylaxis of
operator. The operator should implement procedures                                    parasitic infestations
based on the HACCP principles, apply good hygiene            Anticoccidial and        Treatment of protozoal
practice (GHP), apply hygienic measures to maintain          other antiprotozoal      infections
the cold chain, establish microbiological criteria and       drugs
temperature control requirements based on a scientific        Antimicrobial growth     At subtherapeutic dosages for
risk assessment and carry out laboratory checks fol-         promoters                improved feed for an extended
lowing a proper sampling plan.                                                        period of time
                                                             Anabolic                 Use of different types of steroids.
                                                             hormonal-type growth     Not permitted in the EU
4.2.1 General hygienic provisions for primary                promoters
      production                                             Antifungal drugs         Treatment and prophylaxis of
                                                                                      diseases caused by fungi
Part A of Annex I of Regulation (EC) No. 854/2004
refers to the general hygienic provisions for primary        Corticosteroids          Prohibited for growth-promoting
                                                                                      purposes in many countries
production. This Regulation lays down specific rules                                   (including the USA and EU)
for the organisation of official controls on products of
                                                             Thyreostatic drugs       Prohibited in animal breeding
animal origin. The implementation of measures relat-                                  worldwide
ing to animal health and welfare and especially for the
                                            Meat and Meat Products                                               185

waste or dangerous substances and disposing of dead       with micro-organisms or germs, or by toxic sub-
animals and (v) protective measures to prevent the        stances produced by these germs. These illnesses are
introduction and spread of contagious diseases and        often accompanied by fever, muscle aches, shivering
epidemic animal diseases (http://eur-lex.europa.eu/       and feeling exhausted (http://www.bbc.co.uk/health/
LexUriServ/site/en/oj/2003/ce180/ce18020030731en          conditions/foodpoisoning1.shtml).
02780280.pdf).                                               The food business operators should ensure that food
                                                          handlers are supervised and instructed and/or trained
                                                          in food hygiene matters and have received adequate
4.2.2 General hygienic provisions for
                                                          training in the application of HACCP principles.
      food establishments
Food premises, including slaughterhouses, should          4.2.3 Registration and approval of food
comply with the general and special requirements de-            establishments
fined in Annex II of Regulation (EC) No. 854/2004
laying down specific rules for the organisation of offi-    All food establishments fulfilling the above require-
cial controls on products of animal origin intended for   ments are registered by the competent authority. Food
human consumption. The layout, design, construction       business operators should only place products in
and size of food premises should allow for good hy-       the market originating from an approved establish-
gienic practices, including protection against contam-    ment. The competent authority may grant approval
ination between and during operations, permit ade-        to an establishment if it meets the relevant require-
quate maintenance, cleaning and/or disinfection. They     ments of Regulations (EC) No. 852/2004 and (EC)
should also provide suitable temperature-controlled       No. 853/2004 and other relevant requirements of food
handling and storage conditions of sufficient capac-       law, following an on-site visit. An establishment re-
ity for maintaining foodstuffs at appropriate temper-     ceives a complete or conditional approval by the com-
atures, have suitable and sufficient means of lighting     petent authority under the terms defined in Regula-
and ventilation and have adequate drainage facilities     tion (EC) No. 854/2004. Products of animal origin
suitably designed and constructed. In particular, the     are also placed in the market if they have an identi-
floor and wall surfaces, the ceilings, the windows and     fication mark applied in accordance with Regulation
doors should be maintained in a sound condition and       (EC) No. 854/2004, indicating that the product has
be easy to clean and disinfect, when necessary. The use   been manufactured according to the provisional legal
of impermeable, non-absorbent, washable and non-          requirements. The mark should indicate the approval
toxic materials is required as well as conditions to      number of the establishment.
prevent food-handling areas from any sources of con-
tamination. The same requirements are defined for sur-     4.2.4 Application of a HACCP system
faces, utensils, fittings and equipment with which food    The implementation of a HACCP system in the slaugh-
comes into contact. Adequate provision is to be made      terhouse is an essential management tool, as animals
for the storage and disposal of waste in a hygienic and   accepted there originate from herds of different quality
environmentally friendly way. Potable water must be       and ante-mortem and post-mortem veterinary inspec-
used to ensure that foodstuffs are not contaminated by    tion cannot completely eliminate or reduce effectively
waterborne bacteria and non-potable water, if used,       contamination hazards for the production of safe meat
should circulate in a separate duly identified system      (Mortimore and Wallace, 1998). According to Annex
to avoid both mixing with potable water and contact       II of Regulation (EC) No. 853/2004, food business op-
with food-handling areas.                                 erators operating slaughterhouses should ensure that
   Personal hygiene is a fundamental issue and no per-    they have put in place procedures based on the princi-
son suffering from, or carrying a disease likely to be    ples of a HACCP system.
transmitted through food, is to be permitted to han-         The procedures guarantee that:
dle food or enter any food-handling area. The most
commonly recognised infections are those caused by        r each animal accepted onto the slaughterhouse premises
the bacteria Campylobacter, Salmonella and E. coli         is properly identified
O157:H7. It is estimated there are more than 9 mil-       r accompanied by the relevant information from the
lion cases of gastroenteritis each year in England.         holding of origin and is healthy and in satisfactory state
Gastroenteritis describes symptoms affecting diges-         regarding welfare
tion, such as nausea, vomiting, diarrhoea and stomach     r the animal does not come from a holding or area subject
pain. Food poisoning is the type of gastroenteritis         to a movement prohibition or restrictions for health
caused by eating or drinking something contaminated         purposes or public health
186                     HACCP and ISO 22000 – Application to Foods of Animal Origin

r rules on the use of veterinary medicinal products have     There must be appropriate facilities for disinfecting
  been complied with                                           tools and washing hands.
r no other condition which might adversely affect human      There must also be separate lockable facilities for the
  or animal health is present.                                 refrigerated storage of detained meat and of meat
                                                               declared unfit for human consumption.
   This information should be provided no less than          There should be predetermined procedures for the
24 hours before the arrival of animals at the slaugh-          slaughter of sick and suspect animals.
terhouse, except in special circumstances (e.g. animal
subject to emergency slaughter).
                                                             4.2.6 Role of the official veterinarian
   Data collected should cover:
                                                             Ante-mortem inspection of every animal to be slaugh-
r the health status of the holding of origin and of the      tered should be carried out under suitable conditions.
 animals                                                     Hygiene rules must be respected during the slaugh-
r the veterinary medicinal products or other treatments      ter operations and handling of the carcass. Slaugh-
 administered to the animals                                 terhouse workers must follow the hygiene procedures
r the occurrence of diseases that may affect the safety of   for those parts of the carcass which must be removed,
 meat                                                        or need special handling in order to avoid contam-
r the results of any laboratory analysis to diagnose dis-    ination of the meat. Post-mortem inspection should
 eases and any other report submitted by the official vet-    be followed immediately by chilling in the slaughter-
 erinarian.                                                  house. The chilling temperature must also be main-
                                                             tained during transport. These temperature provisions
  Food business operators should only accept animals         may be unnecessary when the competent authority al-
onto the slaughterhouse premises following the eval-         lows meat to leave the slaughterhouse immediately to
uation of the relevant food chain information by the         be supplied as fresh meat at outlets within two hours
official veterinarian. Slaughter of the animal should         travelling time of the slaughterhouse.
take place only when the official veterinarian has given         The ante-mortem and post-mortem inspections of
approval.                                                    meat, which have been implemented for over 30 years
                                                             without major changes, are modified within the frame
                                                             of the new hygienic package. These changes are in-
4.2.5 Slaughterhouse hygienic requirements
                                                             tended to protect human health from food crises and
In accordance with Annex III of Regulation (EC) No.          new emerging diseases of animals and from hazards
853/2004, slaughterhouses should have adequate and           linked to methods of meat production especially those
hygienic waiting pens with a drainage system that            which have been introduced in the last 30 years.
does not compromise food safety, pens for sick or               Annex I of Regulation (EC) No. 854/2004 defines
suspect animals with separate drainage, sited in such        the auditing and inspection tasks for fresh meat which
a way as to avoid contamination of other animals.            the official veterinarian should undertake. The initial
The layout of the pens must facilitate ante-mortem           task of inspection is the checking of the food chain
inspections.                                                 information as listed above. The official veterinarian
   The slaughterhouse should have also a sufficient           should verify that animals are not slaughtered unless
number of rooms, appropriate to the operations be-           the slaughterhouse operator has been provided with
ing carried out and a separate room for the emp-             the relevant checked food chain information. The ante-
tying out and cleaning of stomachs and intestines.           mortem inspection should determine whether rules on
They should ensure separation in space or time of            animal welfare have been obeyed or whether there are
stunning and bleeding, evisceration and further dress-       signs of any condition likely to affect human or animal
ing, handling of clean guts and tripe, preparation and       health, paying particular attention to the detection of
cleaning of other offal, particularly the handling of        zoonotic diseases and diseases on Office International
skinned heads if it does not take place at the slaugh-       Epizooties (OIE) listed diseases (e.g. foot-and-mouth
ter line, packaging of offal and dispatching of pack-        diseases, vesicular stomatitis etc.).
aged meat. Installations must prevent contact between           When relevant food chain information is not avail-
the meat and the floors, walls and fixtures. Slaughter         able within 24 hours of an animal’s arrival at the
lines (where operated) must be designed to allow con-        slaughterhouse, all meat from the animal should be
stant progress of the slaughter process and to avoid         declared unfit for human consumption. Based on the
cross-contamination between the different parts of the       results of the ante-mortem inspection, the official vet-
slaughter line:                                              erinarian decides whether the normal slaughter process
                                             Meat and Meat Products                                            187

will be followed, or if the animals are slaughtered or     for controlling specific hazards, such as zoonoses and
killed separately, or at the end of normal slaughtering,   TSEs, with the aim of protecting public health.
or under special conditions, taking, where necessary,
precautions to avoid contamination of other carcasses
                                                           4.2.7 Recording of ante-mortem and post-mortem
and meat. The official veterinarian is also responsi-
                                                                 inspection results
ble for taking the necessary corrective measures, if the
rules concerning the protection of animals at the time     The results of inspection activities are recorded, evalu-
of slaughter or killing are not respected.                 ated and communicated to the food business operator
   Post-mortem inspection must be carried out with-        if the presence of any disease or condition that might
out delay with minimal handling of the carcass and         affect public or animal health or compromise animal
offal or special technical facilities and there should     welfare is revealed. If the problem identified has arisen
be minimal special technical facilities for the detec-     during primary production, the herd owner and the
tion of zoonotic diseases and diseases on list A and,      veterinarian responsible for the holding of origin are
where appropriate, list B of OIE. Additional exami-        informed and if the presence of an infectious agent
nations should take place, such as palpation and in-       mentioned in OIE list A or list B is suspected, the com-
cision of parts of the carcass and offal and labora-       petent authority must be notified so as to allow the
tory tests, whenever considered necessary, to reach a      necessary measures in accordance with the applica-
definitive diagnosis and to detect the presence of an       ble Community legislation to be taken. The results of
animal disease or residues in excess of the levels laid    the inspections and tests are to be included in relevant
down under Community legislation, or to show non-          databases.
compliance with microbiological criteria or other fac-
tors that might require the meat to be declared unfit
                                                           4.2.8 Professional qualifications of inspectors
for human consumption. During the inspection, pre-
cautions should be taken to ensure that contamination      The inspection process, either ante-mortem or post-
of the meat by actions such as palpation, cutting or       mortem, is a task of special responsibility requiring
incision is kept to a minimum. In addition to the gen-     the continuous presence of an experienced veterinarian
eral requirements concerning audits of good hygiene        in the slaughterhouse. Regulation (EC) No. 854/2004
practices, the official veterinarian verifies the handling   refers to the necessary background and professional
and disposal of animal by-products including specified      qualifications of the official veterinarian. The vet-
risk material, e.g. spinal cord and brain. Moreover,       erinary should have knowledge of relevant aspects
besides audits of HACCP-based principles, the offi-         of good farming, manufacturing and hygiene prac-
cial veterinarian checks that the operators’ procedures    tices; quality management; principles, and methods of
guarantee that meat does not contain specified risk         HACCP, auditing and regulatory assessment of food
material and has been produced in accordance with          safety management systems; aspects concerning TSEs;
Community legislation on Transmitted Spongiform            and zoonoses and foodborne diseases. Candidates may
Encephalopathies (TSEs). If necessary, samples may be      acquire the necessary knowledge as part of their ba-
taken for the monitoring and control of zoonoses and       sic veterinary training, or through specialist training,
zoonotic agents, for the diagnosis of TSEs in accor-       or professional experience acquired, after qualifying
dance with Regulation (EC) No. 999/2001 of the Eu-         as veterinarians. Each official veterinarian should un-
ropean Parliament and of the Council, the detection of     dergo practical training for a probation period be-
unauthorised substances within the framework of the        fore starting to work independently. Since the inspec-
National Residue Plans and the detection of OIE list       tion procedure is complicated and time-consuming, the
A and list B diseases (Regulation (EC) No. 999/2001).      present regulation allows the competent authority to
Based on the post-mortem inspection, the official vet-      appoint official auxiliaries only if they have undergone
erinarian determines the cases and the conditions un-      sufficient special training, theoretical and practical, to
der which the meat is to be declared fit or unfit for        assist the official veterinarian.
human consumption. Finally, the official veterinarian
has to supervise the health marking and the use of the
                                                           4.2.9 Official control of slaughterhouses
appropriate marks, only applied to animals having un-
dergone ante-mortem and post-mortem inspection in          The official control of the slaughter establishments, the
accordance with this Regulation. In the same Annex,        operational procedures and the level of hygiene prac-
special requirements for post-mortem inspection pro-       tice in compliance with the relevant legislation are the
cedures for carcasses and offal of bovine, porcine and     responsibility of the competent authority of each mem-
ovine/caprine animals are included as well as actions      ber state according to Regulation (EC) No. 882/2004.
188                     HACCP and ISO 22000 – Application to Foods of Animal Origin

This regulation contains rules underpinning the inte-          r the cleanliness of the raw materials including live ani-
grated and horizontal approach necessary to imple-               mals
ment a coherent control policy on feed and food safety,        r ensuring that all detergents, sanitisers and other non-
animal health and animal welfare. The requirements of            food chemicals are properly packaged and labelled,
the competent authority to organise the official control          comply with their specifications and are stored cor-
and the obligations to perform it are determined. Of-            rectly.
ficial controls are performed with impartiality, quality
and in accordance with documented procedures. The
staff performing official controls must receive appro-
priate training enabling them to undertake their duties        4.5 STANDARD OPERATING PROCEDURES
competently and in a consistent manner.
                                                               The standard operating procedures (SOPs) are estab-
                                                               lished or prescribed methods to be allowed routinely
4.3 GOOD MANUFACTURING PRACTICES                               for the performance of designated operations or in des-
                                                               ignated situations. These may simply be referred to as
Good manufacturing practices (GMPs) are sometimes              ‘procedures’ as they include procedures for each step
referred to as ‘control points’ and are defined as the          during routine slaughter, procedures telling how each
correct processes and procedures to be followed in             GMP and GHP is to be carried out and procedures to
the preparation of food to prevent microbial, chem-            be followed at each CCP. In other words exact pro-
ical and physical contamination of the finished prod-           cedures for carrying out specific tasks are detailed as
uct. In other words, GMPs define what has to be done            SOPs.
to prevent contamination, when it has to be done and
by whom. GMPs do not address specific hazards, and
loss of control would not necessarily result in an ac-
ceptable health hazard to the consumer. Areas covered          4.6 APPLICATION OF HACCP IN BOVINE
by the GMP programme include:                                      FATLING
r personnel, including task and hygiene training, job de-
                                                               Receipt of animals is the first CCP and sorting of an-
 scription and organisational structure
r premises, including location and structure                   imals is the second one. All animals need to be la-
r equipment, including design, maintenance and calibra-        belled once the veterinary tests are completed. Animals
                                                               that might contain antibiotic residues or other chemi-
 tion
r services, including sanitary services, disposal of waste     cal substances should be removed at this point before
                                                               entering the butchering process.
  materials, the provision of electricity, water, refrigera-
                                                                  Careful attention is needed during exsanguination
  tion and steam
r raw materials, including live animals, packaging, food       as there is a danger of cross-contamination if the wrong
                                                               techniques are used. Knives should be washed in cold
  ingredients and chemicals
r product traceability                                         water and then disinfected by heating at 85◦ C, under
r documentation.                                               pressure, 7–13 Pa for at least 20 seconds. Hygiene rules
                                                               which are required from the legislation should also be
                                                               applied.
4.4 GENERAL HYGIENE PRACTICES                                     During processing the skin of the carcass is
                                                               removed. At this stage, there is the danger of cross-
Within the GMP ‘umbrella’, cleaning and hygiene are            contamination because pathogenic micro-organisms
given their own subsection referred to as GHP. This            can be transferred from the animal’s skin to the meat
may be defined as those operations involved in provid-          or the head. For this reason workers should apply hy-
ing a clean sanitary environment for the preparation,          gienic rules and always sterilise tools before slaughter-
handling and storage of fresh meat. In other words, the        ing the next animal. The process of skin removal must
GHPs define what has to be done in relation to clean-           always be checked to ensure its effectiveness.
ing and hygiene, when it has to be done and by whom.              Following skinning, the animal is transferred to the
Areas covered by the GHP programme include:                    clean area where the head is removed, front legs and
                                                               chest are cut and the offal removed. Full removal of
r the cleaning of plant and equipment                          the intestines including faeces and undigested food
r staff health in relation to food handling and staff clean-   should be carried out carefully to avoid an