The Regulation of Food Additives in the EU by rt3463df

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									EU Legislation on Food Additives

                                   by
                         Dr Michael E. Knowles
                 Director Scientific & Regulatory Affairs
                Coca-Cola Europe, Eurasia & Middle East

               IUFoST Berlin Symposium – 25/26 May 2004
“Food Ingredients – Product and Perception in a New European Environment:
       Challenges of Entering the Expanded European Market Place.‟



                                   -1-
What I will try and do in the time allotted to me is:
• Provide a brief overview of EU food additive and related legislation
• Summarize the current Commission Proposal on Food Additives
• Describe the approval procedures
• Review recent developments in risk assessment:
    – Threshold of toxicological concern
    – Probabilistic intake assessments
• Public concerns about additive safety

Actual text of legislation is available on the EU website:
http://europa.eu.int/comm/food/food/chemicalsafety/additives/index_en.htm




                                     -2-
Description of Basic Laws

The authorisation and use of food additives in the European Union are based on the
framework Directive 89/107/EEC1 on food additives. On the basis of the framework
Directive, three specific directives were adopted by the Council and European Parliament:
on sweeteners (Directive 94/35/EC2), colours (Directive 94/36/EC3) and on additives other
than colours and sweeteners (Directive 95/2/EC4). Since the adoption of the last directive
in 1995, legislation on food additives has been fully harmonised in the European Union.
After adoption by the EU community, the directives must be implemented into national
legislation in all EU member countries. However, the member states have some degree
of flexibility in how the legal text is formulated, which can differ from the way it is
presented in the directives, provided the legal content is not changed.
Besides, the 15 member states in the European Union, Iceland and Norway are also
obliged to implement the directives into their national legislation because of the EEA
agreement*.




 1. O.J. n° L40, 11.02.1989, p.27
 2. O.J. n° L237, 10.09.1994, p.1
 3. O.J. n° L237, 10.09.1994, p.13
 4. O.J. n° L61, 18.03.1995, p.1
 *: European Economic Area agreement between EU and EFTA countries (except Switzerland)
                                                     -3-
Framework Directive on Food Additives (89/107/EEC)

• Art 1: - lists categories of food additives and defines a „food additive‟ as:
           “any substance not normally consumed as a food in itself and not normally used as
           a characteristic ingredient of food whether or not it has nutritive value, the
           intentional addition of which to food for a technological purpose in the manufacture,
           processing, preparation, treatment, packaging, transport or storage of such food
           results, or may be reasonably expected to result, in it or its by-products becoming
           directly or indirectly a component of such foods.”
           It also lists substances excluded from its scope, such as processing aids.
• Art 2:   - labelling by primary function (from Annex I) and general criteria in Annex II.
• Art 3:   - mandate positive lists of additives and foodstuffs to which these
           additives may be added, together with purity criteria, methods of analysis
           and sampling.
• Art 4:   - procedure for proctecting public health as a result of new knowledge on
           additives.
• Art 5:   - procedure for approvals by individual Member States and subsequent EU
           approvals.




                                                 -4-
• Art 6:   - SCF consultation.
• Art 7:   - labelling for the trade.
• Art 8:   - sale to consumers, labelling and use information.
• Art 9:   - 14 - procedural requirements.
           Food additives are authorised at EU level for all the fifteen Member States, as well
           as for Norway and Iceland.
           The Community legislation on food additives is based on the principle that only those
           additives that are explicitly authorised may be used. Most food additives may only
           be used in limited quantities in certain foodstuffs. If no quantitative limits are
           foreseen for the use of a food additive, it must be used according to good
           manufacturing practice, i.e. Only as much as necessary to achieve the desired
           technological effect.
           Food additives may only be authorised if:
           - There is a technological need for their use,
           - They do not mislead the consumer,
           - They present no hazard to the health of the consumer.
           Note that the same requirements apply in Codex Alimentarius but not in the USA,
           where there is no requirement to demonstrate a technological case of need.



                                               -5-
Description of Additive Functions
Acids: Substances which increase the acidity of a foodstuff and/or impart a sour taste to it.
Anti-caking agents: Substances which reduce the tendency of individual particles of a
foodstuff to adhere to one another.
Anti-foaming agents: Substances which prevent or reduce foaming.
Antioxidants: Substances which prolong the shelf-life of foodstuffs by protecting the against
deterioration caused by oxidation, such as fat rancidity and colour changes.
Bulking agents: Substances which contribute to the volume of a foodstuff without contributing
significantly to its available energy value.
Carriers (including carrier solvents): Substances used to dissolve, dilute, disperse or
otherwise physically modify a food additive without altering its technological function (and
without exerting any technological effect themselves) in order to facilitate its handling,
application, or use.
Colours: Substances which add or restore colour in a food, and include natural constituents of
foodstuffs and natural sources which are normally not consumed as foodstuffs as such and
not normally used as characteristic ingredients of food.
Preparations obtained from foodstuffs and other natural source materials obtained by physical
and/or chemical extraction resulting in a selective extraction of the pigments relative to the
nutritive or aromatic constituents, are colours.


                                               -6-
Description of Additive Functions (cont‟d)
Emulsifiers: Substances which make it possible to form or maintain a homogeneous mixture
of two or more immiscible phases, such as oil and water, in a foodstuff.
Emulsifying salts: Substances which convert proteins contained in cheese into a dispersed
form and thereby bring about a homogeneous distribution of fat and other components.
Firming agents: Substances which make or keep tissues of fruits or vegetables firm or crisp,
or intact with gelling agents to produce or strengthen a gel.
Flavour enhancers: Substances which enhance the existing taste and/or odour of a foodstuff.
Flour treatment agents: Substances other than emulsifiers which are added to flour or dough
to improve its baking quality.
Foaming agents: Substances which make it possible to form a homogeneous dispersion of a
gaseous phase in a liquid or solid foodstuff.
Gelling agents: Substances which give a foodstuff texture through formation of a gel.
Glazing agents (including lubricants): Substances which, when applied to the external surface
of a foodstuff, impart a shiny appearance or provide a protective coating.
Humectants: Substances which prevent foodstuffs from drying out, by counteracting the effect
of an atmosphere having a low degree of hymidity, or promote the dissolution of a powder in
an aqueous medium.



                                             -7-
Description of Additive Functions (cont‟d)
Modified starches: Substances obtained by one or more chemical treatments of edible
starches, which may have undergone a physical or enzymatic treatment, and may be acid or
alkali thinned or bleached.
Packaging gases: Gases other than air, introduced into a container before, during, and after
the placing of a foodstuff in that container.
Preservatives: Substances which prolong the shelf-life of foodstuffs by protecting them
against deterioration caused by micro-organisms.
Propellants: Gases other than air, which expel a foodstuff from a container.
Raising agents: Substances or combinations of substances which liberate gas and thereby
increase the volume of a dough or a batter.
Sequestrants: Substances which form chemical complexes with metal ions.
Stabilizers: Substances which make it possible to maintain the physicochemical state of a
foodstuff. Stabilizers include substances which enable the maintenance of a homogeneous
dispersion of two or more immiscible substances in a foodstuff, and include also substances
which stabilize, retain, or intensify and existing colour of a foodstuff.
Sweeteners: Substances which impart a sweet taste to foodstuffs.
Thickeners: Substances which increase the viscosity of a foodstuff.


                                              -8-
Other definitions
Processing aids: Any substance which is not consumed as a food ingredient by itself, but
which is intentionally used in the processing of raw materials, foods, or their ingredients, to
fulfil a certain technological purpose during treatment or procesiing and which may result in
the unintentional but technically unavoidable presence of residues of the substance or its
derivatives, provided that these residues do not present any health hazard and do not have
any technological effect on the finished product.
With no added sugar: Without any added mono-or disaccharides or any other foodstuff used
for its sweetening properties.
Energy-reduced: With an energy value reduced by at least 30% compared with the original
foodstuff or a similar product.
Maximum usable doses (in the Directive on Sweeteners): refer to ready-to-eat foodstuffs
prepared according to the instructions for use.
Maximum levels (in the Directive on Colours):
- Relate to ready-to-eat foodstuffs prepared according to the instructions for use,
- Refer to the quantities of active colouring principle contained in the colouring preparation.
Maximum levels (in the „Miscellaneous‟ Directive): refer to foodstuffs as marketed, unless
otherwise stated.




                                                -9-
Other definitions (cont‟d)
Quantum satis (q.s.): No maximum level is specified. However, food additives shall be used
in accordance with good manufacturing practice, at a level not higher than is necessary to
achieve the intended purpose and provided that they do not mislead the consumer.
Unprocessed foodstuffs: Foodstuffs which have not undergone any treatment resulting in a
substantial change in the original state of the foodstuffs; however, the foodstuffs may have
been, for example, divided, parted, severed, boned, minced, pared, peeled, ground, cut,
cleaned, trimmed, deep-frozen or frozen, chilled, milled or husked, packed or unpacked.
Carry-over (in the Directive on Colours): The presence of a colour in a foodstuff is
permissible:
- In a compound foodstuff other than one mentioned in Annex II in the Directive, to the extent
that the colour is permitted in one of the ingredients of the compound foodstuff, or
- If the foodstuff is destined to be used solely in the preparation of a compound foodstuff and
to such an extent that the compound foodstuff conforms to the provisions of the directive.
Carry-over (in the „Miscellaneous‟ Directive): The presence of a food additive in a foodstuff
is permissible:
- In a compound foodstuff other than one mentioned in Art. 2 (3), to the extent that the food
additive is permitted in one of the ingredients of the compound foodstuff, or
- If the foodstuff is destined to be used solely in the preparation of a compound foodstuff and
to an extent such that the compound foodstuff conforms to the provisions of the directive.
The above does not apply to infant formulae, follow-on forumulae, and weaning foods, except
where specially provided for.

                                              - 10 -
Directive on Sweeteners (94/35/EC), as Amended by
Directives 96/83/EC and 2003/115/EC

• Art 1:   - specific Directive under the Framework Directive, 89/107/EEC.
           - defines „with no added sugar‟ and „energy reduced‟.
           - exclusion for foods with sweetening properties.


• Art 2:   - specific uses as detailed in the Annex.


• Art 5:   - specific warning labelling requirements for polyols and aspartame.

• Art 7:   - Standing Committee for Foodstuffs procedures.




                                               - 11 -
Directive on Colours for use in Foodstuffs (94/36/EC)

• Art 1:   - a specific Directive under the Framework Directive, 89/107/EEC.
           - definition of colour and exclusion criteria for certain coloured foodstuffs.

• Art 2:   - describes the specific authorizations in the Annexes.
           - explains „quantum satis‟ (see earlier definitions) as applied to colours.
           - lists which colours may be sold directly to consumers and definition of
           „unprocessed‟.


• Art 3:   - presence of colours in compound foodstuffs.

• Art 5:   - Standing Committee for Foodstuffs procedures.




                                                - 12 -
Directive of Food Additives other than Colours and
Sweeteners (95/2/EC)
– „Miscellaneous Additives Directive‟.
Amended by 96/85/EC, 98/72/EC, 2001/5/EC.
• Art 1:   - specific Directive under the Framework Directive, 89/107/EEC.
           - defines the additive functions (see earlier definitions)
           - explains flour treatment agents.

• Art 2:   - explains the Annexes in relation to the specific uses of additives.
           - gives exclusions for foodstuffs from addition of additives.


• Art 5:   - „q.s.‟ reference

• Art 6:   - Standing Committee for Foodstuffs procedure.




                                               - 13 -
Directives on Purity Criteria for the Additives


They are adopted by the Directives:

• Commission Directive 95/31/EC laying down specific criteria of purity concerning
  sweeteners for use in foodstuffs

• Commission Directive 95/45/EC laying down specific purity criteria concerning colours for
  use in foodstuffs

• Commission Directive 96/77/EC laying down specific purity criteria on food additives other
  than colours and sweeteners




                                            - 14 -
The following amendments have also been adopted:

• Commission Directive 98/66/EC amending Directive 95/31/EC laying down specific
  criteria of purity concerning sweeteners for use in foodstuffs
• Commission Directive 98/86/EC amending Directive 96/77/EC laying down specific
  purity criteria on food additives other than colours and sweeteners
• Commission Directive 1999/75/EC amending Directive 95/45/EC laying down specific
  purity criteria concerning colours for use in foodstuffs
• Commission Directive 2000/63/EC amending Directive 96/77/EC laying down specific
  purity criteria on food additives other than colours and sweeteners
• Commission Directive 2001/30/EC amending Directive 96/77/EC laying down specific
  purity criteria on food additives other than colours and sweeteners
• Commission Directive 2001/50/EC amending Directive 95/45/EC laying down specific
  purity criteria concerning colours for use in foodstuffs
      • Corrigendum to Commission Directive 2001/50/EC amending Directive 95/45/EC
      laying down specific purity criteria concerning colours for use in foodstuffs
• Commission Directive 2001/52/EC amending amending Directive 95/31/EC laying
  down specific criteria of purity concerning sweeteners for use in foodstuffs




                                        - 15 -
Related EU Legislation


• General Food Law Regulation (178/2002): definition of food includes „additives‟ (Art 2); risk
  analysis (Art 6), safety (Art 14), traceability (Art 18);
• Labelling (2000/13/EC): ingredients definition and listing (Art 6);
• Genetically Modified Food and Feed (1829/2003): definitions includes additives (Art 2);
• Traceability and Labelling of Genetically Modified Organisms ... (1830/2003): definitions of
  „food‟ and „ingredient‟ (Art 3), traceability requirements throughout food chain (Art 5).




                                               - 16 -
 Current Commission Proposal on Food Additives
 (WGA/OO4/03 rev 6)

• Consolidates existing food additive legislation
• Confers implementing power on the Commission to update list of additives
• Consultation of EFSA for safety evaluation
• Sets up re-evaluation programme for existing authorisations of food additives within 10 year
  (EFSA)
• Requires authorizations of „GMO-derived additives‟
Chapter I -          General Provisions (scope, definitions, functional claims, risk
                     assessment, purity criteria)
Chapter II -         Placing on the Market of a food additive (authorisations -10 years &
                     conditions, application – EFSA via MS, renewal)
Chapter III -        Labelling (to manufacturers, consumers)
Chapter IV -         Placing on the market (conditions of use) (principle for use, compliance,
                     intake, traditional foods)
Chapter V -          Other Provisions (public access, confidentiality, data protection


                                               - 17 -
Current Commission Proposal on Food Additives
(WGA/OO4/03 rev 6) - cont‟d
Re-evaluations by EFSA: start in 2005 with:
•   Colours
•   Miscellaneous
•   Sweeteners


a) Screening stage:             - original SCF Opinion
                                - comments of Nordic Report (2000), JECFA
                                - consider new data since 2000


b) EFSA decides on full or partial re-evaluation on grounds of:
•   critical data gaps
•   uncertainties in existing data
•   new evidence of potentially harmful effects



                                              - 18 -
 Application for Authorisation of an Additive

In 1980 the Scientific Committee for Food (SCF) issued its first guidelines for the safety
assessment of food additives (Tenth Report Series, 1980). When the work on the present
report started, these guidelines were still the official guidelines for the toxicological
assessment of food additives, but simultaneaously with the work on the present report the
SCF started the updating of its 1980 report. In 2001 the SCF adopted its new guidelines:
“Guidance on Submissions for Food Additive Evaluations by the Scientific Committee on
Food” (Opinion expressed on 11 July 2001).
This opinion explains in detail the important elements of a dossier: Administrative data,
Technical data, Toxicological data, and References and reports. In an annex the SCF
describes in detail, which studies it considers to be the core toxicological studies for the
establishment of the Acceptable Daily Intake (ADI) and which studies are supportive for
reaching the most correct ADI seen from a human health point of view. The section on
toxicological data in the Guidance document describes very well, how SCF performs the
safety evaluation of the individual food additives and thus how the SCF might handle the
type of information delivered by the monographs in this report.




                                               - 19 -
General Criteria for the Use of Food Additives

•   There can be demonstrated reasonable technological need (i.e. demonstrate benefit to
    the consumer) and the purpose cannot be achieved by other means which are
    economically and technologically practicable;
•   They present no hazard to health of the consumer at the level of use proposed, so far
    as can be judged on the scientific evidence available,
•   They do not mislead the consumer.




                                            - 20 -
TECHNICAL DATA:

1. Identity of substance
2. Microbiological characteristics
3. Proposed chemical and microbiological specifications
4. Manufacturing process
5. Methods of analysis in food
6. Reaction and fate in food
7. Case of need and proposed uses
8. Exposure
9. Additives produced by microbiological processes
10. Additives produced from genetically modified organisms
11. Information on national authorisations




                                         - 21 -
TOXICOLOGICAL DATA
1. General framework for the toxicological evaluation of food additives
2. Study protocols
3. Toxicological section of the dossier
     3.1 Core studies
         a) Metabolism / Toxicokinetics
         b) Subchronic toxicity
         c) Genetic toxicity
         d) Chronic toxicity and carcinogenicity
         e) Reproduction and developmental toxicity
     3.2 Other studies
                         a) Immunotoxicity
                         b) Allergenicity
                         c) Food intolerance
                         d) Neurotoxicity
                         e) Human volunteer studies
                         f) In vitro studies as alternatives to in vivo studies
                         g) Special studies
                         h) Acute toxicity
                         I) Skin and eye irritation and skin sensitisation
                     4. Data reporting
5. Review of results and conclusions
                                            - 22 -
- 23 -
- 24 -
    Intake of Food Additives – Report from the
    Commission (COM(2001) 542 final
BACKGROUND
In 1996, under Council Directive 93/5/EEC on assistance to the Commission and cooperation
  by the Member States in the scientific examination of questions relating to food5, a task was
  set up on “Methodologies for monitoring of food additive intakes” (SCOOP Task 4.2). The
  objectives of the task were:
• to identify data that can be used to assess likely additive intakes,
• to review methodologies currently used for monitoring additive usage and estimating
  intakes,
• to consider the need for different approaches to different types of additives,
• to establish systematic procedures for the identification of additives for which potential
  dietary intake gives most cause for concern
• and to develop a strategy that matches the complexity and cost of intake estimation to the
  level of concern posed by the potential intake of an additive.
The following Member States participated in the scientific co-operation task: Austria, Denmark,
  Greece, Finland, France, Ireland, the Netherlands, Spain, Sweden and the United Kingdom.
  In addition, Norway participated in the task. The report was produced in January 19986.

5   O.J. n° L 052, 04.03.1993, p. 18
6   The scientific co-operation report on development of methodologies for the monitoring of food additive intake across the
    European Union (SCOOP/INT/REPORT/2)
                                                             - 25 -
The participants of the SCOOP task reviewed the relevant methods for estimating the
intake of food additives and proposed a tiered approach, which could be used by the
Member States to meet the monitoring requirements set out in EC directives. According to
the report, “monitoring of additive intake should concentrate on discovering whether the
exposure of consumers to any food additives regularly exceeds the acceptable daily intake
(ADI)”. This information can then be used by the Community regulator to determine what
action (if any) is required to ensure that safety advice is being followed.

The definition of a number of key terms used throughout the report is given in box 1 (see
next slide)




                                            - 26 -
Box 1:

Scientific Committee on Food (SCF) = A scientific advisory body to the European
Commission on any problem relating to the protection of the health and safety of persons
arising or likely to arise from the consumption of food.

Scientific co-operation (SCOOP) = Assistance to the European Commission and
cooperation by the Member States in the scientific examination of questions relating to food.

Intake = The amount of food additive ingested in the diet (calculated as food consumption x
food additive concentration).

Acceptable daily intake (ADI) = The amount of a food additive, expressed as mg/kg
body weight, that can be ingested daily over a lifetime without incurring any appreciable
health risk. The ADI is based on an evaluation of available toxicological data and
established by identifying the No-Observed-Adverse-Effect-Level (NOAEL) in the most
sensitive experiment among a battery of studies in test animals performed with the test
compound and extrapolating to man by dividing the NOAEL with a safety factor of
usually 100.



                                             - 27 -
Box 1 (cont‟d):

ADI “not specified” = A term used when, on the basis of the available toxicological,
biochemical and clinical data, the total intake of the substance, arising from its natural
occurrence and/or its present use or uses in food at the levels necessary to achieve the
desired technological effect, will not represent a hazard to health. For this reason, the
establishment of a numerical limit for the ADI is not considered necessary for the
substance.

Maximum usage level = Highest level of a food additive permitted in foodstuff to
achieve an intended technological effect. The levels are set in the specific directives: for
sweeteners in Directive 94/35/EC, for colours in Directive 94/36/EC and for additives
other than colours and sweeteners in Directive 95/2/EC.

Quantum satis = no maximum level is specified for the additive in question. However,
the additive shall be used in accordance with good manufacturing practice, at a level not
higher than necessary to achieve the intended purpose and provided that it does not
mislead the consumer (Article 2(8) of Directive 95/2/EC).




                                              - 28 -
In the tiered approach (see box 2), tier 1 is based on theoretical food consumption data7
and maximum usage levels for additives as permitted by relevant Community legislation.
The second and third tiers refer to assessment at the level of individual Member States,
combining national data on food consumption with the maximum permitted usage levels
for the additive (tier 2) and with its actual usage patterns (tier 3).
The SCF has recommended that special attention should be given to intake by children, since
there is evidence suggesting that their dietary behaviour means that their intake of some
additives, expressed on a bodyweight basis, may be markedly higher than that of adults.
Therefore, in the SCOOP task, it was concluded that adults and children should be covered
by a separate assessment.
   Box 2:

   TIER 1 = theoretical food consumption data combined with the maximum permitted
   usage levels for the additive

   TIER 2 = actual national food consumption data combined with the maximum
   permitted usage levels for the additive

   TIER 3 = actual national food consumption data combined with the actual usage
   levels of the additive


7 Hansen, S. (1979). Conditions for Use of Food Additives Based on a Budget for an Acceptable Daily Intake. Journal of
  Food Protection 42 5, 429-434.
                                                           - 29 -
CONCLUSIONS
• The Member States should follow up the SCOOP task on methodologies for the monitoring
  of food additives in order to achieve harmonisation of intake studies of additives in the
  European Union. In addition, better food consumption data should be gathered in order to
  estimate dietary food additive intake more accurately.
• The preliminary results with limited data available indicate that for the majority of food
  additives the dietary intake is below the acceptable daily intake.
• For the additives that were moved to tier 3 (see Annex V) and certain additives that are
  permitted at quantum satis (see Annex IV), intake estimations should be carried out using
  actual food consumption data combined with the actual usage levels of the additive. The
  examination should be carried out by all the Member States without delay and the results
  should be reported to the Commission with a view to initiating necessary action, if any.
• Intake of additives that did not exceed the ADI in tier 2 should, nevertheless, be re-
  examined in the light of the more detailed food consumption data (see Annex V).
• Intake studies should be carried out in respect of the additives which, at the time of this
  exercise, had only recently been approved.
• Co-operation with the food industry should be developed with a view to obtaining better
  information on food additive usage.
• A new report on the overall situation on food additive intake in the European Union should
  be compiled in three years time. It is essential that efforts are made by all the Member
  States to participate fully in the next monitoring task on dietary intake of food additives.


                                              - 30 -
Because the current procedures for estimating intake of additives (and other chemicals in
food) results in worst-case point estimates rather than distributions of intakes, an EU-funded
project, the „Monte-Carlo Project‟, coordinated by Prof. Gibney, Trinity College, Dublin, was
funded; This project will validate the use of probabilistic modelling to permit distributions of
intakes, variabilities and uncertainties to be made. Such distributions represent a more
realistic picture of the intake of food additives. This methodology will be combined with the
work of the International Life Science Institute (ILSI) on risk assessment.

Links:
http://www.tchpc.tcd.ie/projects/montecarlo/
http://www.ilsi.org/misc/fosie/index.html
Codex Alimentarius Commission main website http://www.codexalimentarius.net




                                               - 31 -
- 32 -
                                                                                         A brief description of the situation
                                              Risk Management                            Product or commodity involved
                                                                                         The values expected to be placed at risk, (e.g.
1. Assessment of effectiveness of measures
taken                                                                                    human health, economic concerns)
2. Review risk management and / or                                                       Potential consequences
assessment as necessary                                                                  Consumer perception of the risks
                                              A. Risk Evaluation                         The distribution of risks and benefits


                                                     1. Identification of a food safety problem
                                                     2. Establishment of a risk profile
           D. Monitoring and review                  3. Ranking of the hazard for risk assessment
                                                       and risk management priority
                                                     4. Establishment of risk assessment policy                  Value judgements and
                                                       for conduct of risk assessment                            policy choices for the
                                                     5. Commitment of resources                                  risk assessment process
           C. Implementation of                      6. Commissioning of risk assessment
               management decision                   7. Consideration of risk assessment result

                                                                                                           •   Hazard identification
                                             Risk Communication                                            •   Hazard characterization
               B. Risk management                                                                          •   Exposure assessment
                                                                                                           •   Risk characterization
                    option assessment
                                                                 •    Risk perception
                                                                                                Risk Assessment
1. Identification of available management                        •    Value judgement
options                                                          •    Precautionary principle
2. Selection of preferred management                             •    Benefits/costs
option, including consideration of an                            •    Other technical factors
appropriate safety standard
3. Final management decision                  Regulatory or other control measures
                                                             - 33 -
    EC Concerted Action


      •(FOSIE)
  • Food Safety in Europe:
Risk Assessment of Chemicals
       in Food and Diet



             - 34 -
                       The Risk Assessment Paradigm

                                    Problem formulation


Exposure Assessment                             Hazard Identification
• Levels of substance in food and diet          • Identification of adverse health effects
• Amounts of food consumed                           human studies
• Intake in individuals (max/min,                    animal-based toxicology studies
  regularly/occasionally)                            in vitro toxicology studies
• Intake in special population groups                structure-activity considerations


                                                Hazard Characterisation
                                                •    Selection of critical data set
                                                •    Mode/mechanism of action
                                                •    Kinetic variability
                                                •    Dynamic variability
Risk Characterisation                           •    Dose-response for critical effect
                                                •    Identification of starting point

  Advice to Risk Managers                       Reconsideration due to unexpected
                                                  data on exposure or hazard
                                            - 35 -
                           FOSIE – Objectives


1.   Strengthen and develop science base and general understanding of RA of
     chemicals in food
2.   Identify gaps in knowledge leading to differences in interpretation of
     toxicological and exposure data, and research needs to reduce these
3.   Determine the nature and level of testing, relevant to the nature of the
     chemical, and its level of human exposure
4.   European contribution to international initiative
5.   Contribute towards international harmonisation
6.   To explore means of improving the principles applied to, and scientific basis
     of, risk assessment with respect to food additives and contaminants,
     micronutrients and nutritional supplements, macronutrients and whole foods;
7.   To consider possible interactions between individual chemicals and effects
     of the food matrix;



                                        - 36 -
                           FOSIE – Objectives

8.    To identify the gaps in knowledge that might lead to differences in
      interpretation of toxicological and exposure data, and the research needs to
      reduce these;
9.    To determine the nature and level of testing needed for safety evaluation
      relevant to the nature of the chemical, level of use/occurrence in the diet and
      human exposure;
10.   To add a European contribution to international initiatives to harmonise
      principles, terminology and methodology for risk assessment;
11.   To contribute towards a consensus on risk assessment issues that is
      scientifically transparent and justifiable;
12.   To assist risk managers in developing appropriate, defensible food
      standards that adequately protect the safety of the consumer while allowing
      for innovation in food production and processing.




                                        - 37 -
                 FOSIE - ITG E Intake Assessment

• Main outcome
   • Intake assessment to be seen in context of a tiered system, e.g. crude
     screening may conclude:
       • No significant intake (TTC)
       • Expected exposure does not exceed Health Based Guidance Values (ADI)
• Research needs
   • Pan-European food composition database taking into account e.g.
       • Harmonisation of methods
       • Significant local differences
   • Harmonisation of food survey methods taking into account e.g.
       • Food habit trends
       • Determination of reasonable extremes
       • Options for corrections for underreporting
   • Evaluation of probabilistic models for intake assessment
   • Aggregate and cumulative exposure assessment methodology
                                         - 38 -
Probabilistic assessments can produce more meaningful outputs that quantify the
type, magnitude and frequency of effects. They can express risk in terms of the probability
that unacceptable effects will occur, and have more ecological meaning than other
measures of risk (e.g. Toxicity-exposure ratios). Therefore, they may contribute to
providing a better basis for deciding what is ecologically acceptable. If communicated well,
they should also be more meaningful to decision-makers and the public.

• Can quantify variability
• Can quantify uncertainty
• Can make better use of the available information
• Can help identify which factors have most influence on risk
• Promote better science




                                            - 39 -
- 40 -
         Integrated Document on Risk Characterisation

• Risk characterisation
    Introduction
        Prior use/exposure; Future use/exposure
    Integrating exposure assessment and hazard characterisation into
     risk characterisation
        Matching the exposure assessment with the hazard characterisation;
        Considerations related to exposure assessment;
        Matching the duration of intake measurement to the toxicity of concern;
        The use of biomarkers to define the relationship between external and
         internal dose, and to bridge the gap between exposure assessment and
         hazard characterisation;
        The influence of the nature of the hazard and hazard characterisation on
         risk characterisation.


                                       - 41 -
The iterative nature of risk characterisation:
examples of questions/information that can effect the outcome

               HAZARD                                  EXPOSURE
           CHARACTERISATION                           ASSESSMENT



                                   RISK
                             CHARACTERISATION



   Is the exposure sufficient to warrant full hazard characterisation?
   Is the hazard relevant to the exposed individuals?
   Do the hazard characterisation data match the human exposure?
   Integration of new data on hazard identification or characterisation
   Integration of new data on the nature of the distribution within food


                                       - 42 -
       Integrated Document on Risk Characterisation


 The nature of advice to risk managers
     Advice concerning individuals at increased risk; simultaneous exposure to
      different chemicals in food; different duration and patterns of human
      exposure; exposure exceeds the health-based guidance value;
      uncertainties and sensitivity analyses; very low risks for irreversible
      hazards such as cancer; when data are sparse but indicate serious
      hazard.
 Special considerations for particular food categories
     Defined single chemical entities of low molecular weight
     Micronutrients
     Macronutrients
     Whole foods
     Food processing



                                     - 43 -
Decision tree for consideration of all classes of food chemicals




                                   - 44 -
Public Concerns About the Safety of Food Additives

•   The public believes „chemical‟ food additives can represent a significant
    health risk - media dossier
•   BUT: Food is comprised of „chemicals‟
•   „Exposure isn‟t toxicity‟ – paraphrase of Paracelsus
•   Safety evaluations are very conservative, no known health issues with
    additives, except occassional hypersensitivity – not hyperactivity!


THEREFORE:
Need to provide independent, factual advice to reassure the public -> EFSA ?




                                        - 45 -
Soft drinks 'full of chemicals'
By Jonathan Prynn and Jack Doyle, Evening Standard
10 May 2004
The hidden hazards in children's favourite soft drinks are exposed today.
An Evening Standard investigation reveals that the top 10 bestsellers contain more than 70
additives, many linked to potential health problems.
Although all the ingredients have been certified safe in small quantities, almost no research
has been done on how they react with each other. As a result, Britain's children are being
exposed to an "additive cocktail", experts say.
Dr Vyvyan Howard, a senior toxicologist at Liverpool University, said: "All the additives are
tested one at a time. Little or nothing is known about how they interact in mixtures."
Six of the 10 top drinks contain the controversial sweetener aspartame, a factory-made
product 200 times stronger than sugar. Linked to brain cancer, it has been called a
"neurotoxin" by some critics.
Every drink in the top 10 contains several artificial colours, flavours or preservatives. At least
four of the additives used in many of the drinks have been linked to cancer, while others are
associated with behavioural problems, asthma and diabetes.
The analysis found that although manufacturers have to disclose some of the additives, there
is no requirement to list the hundreds of "flavourings" authorised for use.
The survey also uncovered loopholes in the rules on additives which "improve" taste or
appearance. For example, the size of the dose does not have to be revealed.
Toxicologist Adam Woolley said: "Dose is a vital component. One paracetamol clears a
headache but too many will kill you."


                                                - 46 -
Robinson's Orange Fruit Squash, Fanta, Tango, Panda Pops, Robinson's Fruit Shoot and
Sunny Delight all contain either saccharin or acesulfame k, linked to cancer in some
research.
Panda Pops contains carmoisine (E122), an artificial colouring banned in Sweden, America,
Austria and Norway over fears it can trigger asthma attacks.
Dr Howard said: "Many of the flavour enhancers are related to transmitter substances in the
brain. It is not surprising very that they have been linked with behaviour problems." Procter
& Gamble, maker of Sunny Delight, which has at least 10 artificial colours, flavourings,
stabilisers and preservatives, insists it is sold chilled, creating the impression it is fresh.
Given the Food Commission's Additive Nightmare Award in 2002, "Sunny D" contains
artificial thickeners, giving a false impression it contains a lot of fruit.
A spokesman for the British Soft Drinks Association said: "There is a wide range of soft
drinks available from which consumers can choose. All ingredients are approved as safe for
the purpose by the Food Standards Agency. The ingredients list on the label enables
consumers to choose which drinks they prefer."
Coca-Cola, Britvic, which makes Tango and owns the Robinson's brand, GlaxoSmithKline,
which makes Lucozade, and Procter &Gamble all refused to disclose what artificial
flavourings are in their products - citing "commercial confidentiality".




                                             - 47 -
Side effects
By Evening Standard Reporters
10 May 2004
Phosphoric acid - tooth erosion, weakens bones
Citric acid - tooth erosion
Sunset yellow - hyperactivity, may exacerbate asthma
Carmoisine - as above
Sodium Benzoate (E211) - may exacerbate asthma
Aspartame - brain cancer, migraines, dizziness, blurred vision
Saccharin - bladder cancer
Glucose fructose syrup - obesity and diabetes
Acesulfame k - cancer links
Caffeine - behavioural problems, insomnia
Sodium metabisulphate - intestinal irritation
Caramel colour - behavioural problems
What the drinks contain
By Jonathan Prynn and Jack Doyle, Evening Standard
10 May 2004
1. Robinson's Orange Squash 89p/1 litre
Calories 53
Sugar *
Additives: Glucose-fructose syrup, citric acid, trisodium citrate, potassium sorbate,
sodium metabisulphate, aspartame, saccharin, flavourings, stabiliser E466, beta
carotene
2. Tango £1.28p/2 litres
Calories 29                                  - 48 -
Public Concerns About the Safety of Food Additives

•   The public believes „chemical‟ food additives can represent a significant health risk -
    media dossier
•   BUT: Food is comprised of „chemicals‟
•   „Exposure isn‟t toxicity‟ – paraphrase of Paracelsus
•   Safety evaluations are very conservative, no known health issues with additives, except
    occassional hypersensitivity – not hyperactivity!


THEREFORE:
Need to provide independent, factual advice to reassure the public -> EFSA ?




                                             - 49 -

								
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