The European Union’s Tacis programme for Ukraine
Establishment of an agricultural
standards certification and control
mechanism in line with WTO-SPS
Ukrainian Food Safety Draft Law
International STE Legal Expert
Author: Richard Moody
This project is funded by A project implemented by
GFA Terra Systems GmbH
the European Union and TÜV Nord
The contents of this publication is the sole responsibility of Richard Moody /
GFA Terra Systems and can in no way be taken to reflect the views
of the European Union.
Establishment of an agricultural standards certification and control mechanism
in line with WTO-SPS requirements
Project N° EuropeAid/114025/C/SV/UA
Ukrainian Food Safety Draft Law Analysis
International STE Legal Expert
Author: Richard Moody1
GFA Terra Systems GmbH
In consultation with Dr David J Jukes – Senior Lecturer in Food Regulation, The Universtiy of
1.1 The Task
1.2 The scope of the task and aim of this analysis
1.4 The Mechanism and approach of this analysis
2 The Key EU Principles in the sphere of Food Safety
2.1 “Farm to Fork approach”
2.2 Primary Responsibility
2.3 Clear definition of roles of stakeholders
2.6 Risk analysis
3 Conclusions and recommendations
Annex 1 Excerpt - The Regulation - Article 1
Annex 2 Excerpt - The Regulation - Articles 19 and 20
Annex 3 Excerpt - The 1990 Act – Regulations
Annex 4 Excerpts - Codex Alimentarius Commission - Procedural Manual
CAC Codex Alimentarius Commission
EC European Commission
EU European Union
FSA Food Standards Agency
FVO Food and Veterinary Office
GM Genetically Modified
MS Member State
NCC National Codex Committee
SPS Sanitary and Phytosanitary
UEPLAC Ukrainian European Policy and Legal
UK United Kingdom
USAID United States Agency for International
WTO World Trade Organisation
1) The Introduction
1.1) The Task
The project has been asked to review the current Ukrainian draft law2 and in
particular the key institutional issues in the light of the relevant EU legislation in the
context of the future commitment to the WTO SPS agreement3 and its principles.
Due to the limited man power and time resources available and on the basis that
considerable work has already been undertaken by the UEPLAC in preparing the
scoreboard and by the USAID WTO project on the technical detail of the law in
particular, the analysis will be limited to a number of key issues.
1.2) The scope of the task and aim of this analysis
The task of this analysis is to consider to what extent the draft law in it’s current form
succeeds in being consistent with the principles of the WTO SPS as well as the
achieving the relevant degree of harmonisation with legislation of the European
Union - both at EU and MS level - whilst at the same time remaining an effective
mechanism for protecting the food consumers and producers of Ukraine.
This brief paper should serve to highlight a number of key issues for discussion in
meetings of the working group drafting this law and for possible future project inputs.
The EU is a member of the WTO as well as each MS and where prevalent SPS
systems and standards are not challenged by other WTO members there may be a
presumption that they are compatible with the SPS agreement and other WTO
principles or at least not considered worthy of being challenged by other WTO
members. This means that taking the EU and EU member states implementation of
the SPS agreement as a model, will provide a good guideline for the law drafters of
Ukraine. It must however be borne in mind that many of the measures implemented
within the framework of the EU or by EU members are targeted specifically at
achieving the goals of the single market and must therefore being considered in this
light when assessing their relevance to the non-member status of the Ukraine.
1.4) The mechanism and approach of this analysis.
I) Each key principle of EU law in the sphere will be illustrated with text and examples
from the relevant EU legislation or preparatory document.
II) Each principle will then be applied to the relevant provisions of the Ukrainian draft
law on safety and quality of food products to illustrate where there is clear
concurrence and where there is divergence.
III) Where relevant the implementation of the principle in UK law4 will be
IV Where the above does not cover the relevant SPS principles they will be
Draft English translation passed to the project by the Veterinary service on 18 th May..
The Agreement on the Application of Sanitary and Phytosanitary Measures
The Food Standards Act 1999 and the Food Safety Act 1990
2) The Key EU Principles in the sphere of Food Safety
2.1) A comprehensive, integrated “From the farm to the fork” approach
throughout the food chain - with consumers responsible for proper handling
storage and cooking through retail, transport, processing, primary production and
feed production – leading to a coherent, effective and dynamic food policy;
Addressing shortcomings from the sectoral rigid approach
EU The scope of the Regulation 178/2002 (the Regulation) 5
Due to major developments in the sphere of food technology and well-known recent
food safety crises in Europe, there has been much discussion in recent years about
what may be considered as the ambit of food safety law. In January 2000, the
European Commission presented its White Paper on Food Safety – COM (1999) 719
(White paper). In this paper the key conceptual and practical issues were considered
in depth. The resulting regulation on food safety 178/2002 embodies these principles
and makes institutional arrangements for their implementation.
How the Regulation includes the entire food chain in its ambit
One of the key indicators as to whether the entire food chain is being considered by
food safety regulation is the express inclusion of feed.
In article 1 paragraph 2 of the Regulation, whilst the definition of food expressly
excludes feed, the scope of the law expressly includes it:
―..This regulation laws down the general principles governing food and feed in
general and food and feed safety in particular‖
On numerous subsequent occasions the scope is defined widely to incorporate the
concept feed being an integral part of the entire food chain: Article 1 paragraph 3
states that ―The regulation applies to all stages of production, processing and
distribution of food and feed. In chapter II on the section on general food law ―this
chapter applies to all stages of production, processing and distribution of food and of
feed produced for or fed to, food producing animals‖.
The above clearly demonstrates one aspect of the ―comprehensive, integrated ―From
the farm to the fork‖ approach throughout the food chain‖ as expressed in paragraph
7) of the preamble.
This is further demonstrated by institutional changes including the setting up of a
committee on the ―Food chain and animal health‖ to replace the standing veterinary
committee the standing committee for foodstuff and the standing committee for
feeding stuffs and the standing committee for plant health in certain competences.
Paragraphs 11 to 14 of the preamble to the Regulation and article 8 of the White
Paper 6 illustrate the philosophy behind the above articles.
The Food Safety Act 1990 (1990 Act) is the defining piece of legislation in the UK in
the sphere of food safety. It was conceptualised and introduced before the most
recent major food safety crises and before the publication of the EU White Paper on
Regulation 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down
the general principles and requirement s of food law, establishing the European Food Safety Authority
and laying down procedures in matters of safety.
See Annex I
food safety and the subsequent Regulation 178/2002 laying down the general
principles and requirements of food law.
The 1990 Act does not introduce the concept of the all-inclusive food chain and
cannot claim to embody the farm to fork philosophy. The Food Standards Act 1999
(The 1999 Act) whilst not amending the 1990 Act in this respect introduces the
concept of the relevance of feeding stuffs into the food chain in terms of the
responsibility of the Food Standards Agency (The Agency):
“Article 9 General functions in relation to animal feedingstuffs
General functions in relation to animal feedingstuffs. 9. - (1) The Agency has the
same general functions in relation to matters connected with the safety of animal
feedingstuffs and other interests of users of animal feedingstuffs as it has under
sections 6(1), 7(1) and 8 in relation to matters connected with food safety and other
interests of consumers in relation to food.
(2) Section 6(2) and (3) apply in relation to the Agency's powers under this
section corresponding to those under section 6(1).
(3) Section 7(2), in its application to the Agency's function under this section
corresponding to that under section 7(1)(a), applies with the substitution, for the
words "members of the public" and "food", of the words "users of animal
feedingstuffs" and "animal feedingstuffs".
(4) In this section "safety of animal feedingstuffs" means the safety of animal
feedingstuffs in relation to risks to animal health which may arise in connection with
This is a clear recognition of the value of including feed into the remit of the food
safety concept and makes the key policy formulating and information processing
body in the sphere responsible for its inclusion.
Scope of the Draft law
The current Draft Law on Safety and Quality of Food (The Draft Law) does not begin
with a section on the scope of the law. Therefore it is not clear from the outset
whether the law is aiming to address the expanded ambit or remaining with the
restricted scope of food safety. The objectives of state regulation which in its current
form are in essence the objectives of the law are in fact given in Section IV under
article 17. For the sake of clarifying the internal logic it would make sense to start
with these defining paragraphs applying them to the whole law. It is here that any
novel concepts may also be introduced.
Definition of food
In fact the law defines its scope by expressly excluding three types of food:
i) Tobacco and tobacco products
ii) Special requirements for safety of food products containing GM organisms7
iii) Food products produced for personal consumption
Water is currently included only as an ingredient of food products (as per definition of
food). If it is to be included then it should be defined either explicitly or by reference
to any other legislation in the sphere. (See example of article 2 of the Regulation) If it
is to be excluded then reference should be made to where it is dealt with e.g. the Law
Does this exclude “food products containing GM organisms” or “special requirements”
dealing with drinking water as approved 10.01.02. The Regulation includes it in
essence where it is drinking water. (See article 6 of directive 98/83/EC)
The scope of the Sanitary Service responsibility is defined. It introduces a concept of
―food handling‖ which is defined in the text of the article but is not defined in the
glossary. It is subsequently used in the context of food handling enterprises in
connection with the power of sanitary inspectors to inspect buildings (article 8) and
with the suspension of licences (article 24).
Article 19 State Sanitary-Epidemiological Supervision of the Safety and Quality
of Food Products states that
State sanitary-epidemiological supervision shall cover all stages of food handling
from growing of plants and breeding of livestock intended for food to supply of food
products to consumers.
Whilst ―feed additives‖ are defined and to be considered in scientific studies of the
Codex Commission which also considers and monitors residue levels in feed but
―feed‖ does not appear to be considered as an integral part of the food chain and
therefore a major focus of the law. The word or concept of food chain is not
mentioned in the current text.
Consequences for the draft law of adopting this approach to the scope
Together the definition of food and the scope of the law most effectively determine to
what extent the concept of farm to fork is embodied in the law. It is possible as
demonstrated by the 1999 Act to expand the scope of the law by adding a paragraph
that effectively extends all responsibilities and rights in respect of food to include
feed. This addresses one aspect of the approach but there are many others including
for example the production, storage, transportation and use and disposal of
This extension would have a number of institutional and practical resource
consequences as well. Considering the whole of the food chain from farm to table in
the remit of food safety means that if primary responsibility for the enforcement of
regulation remains with the state, enormous resources are required. This is one of
the reasons why the farm to table approach is interlinked with the reallocation of the
2.2) Primary Responsibility lies with the feed manufacturers, farmers and
food business operators: Competent authorities monitor and enforce
The concept of primary responsibility
Where full responsibility for food safety is assumed by the state the resources
required by the state are substantial. The state is responsible for checking that
everyone is doing everything correctly all of the time. For unscrupulous producers
who are cutting corners on safety issues in order to increase profits etc, the aim is to
avoid detection. The sheer size of the country and the complexity of the food chain
these days mean that even where there is no intention to contravene the regulation,
detection of contraventions is very costly (both in time and money). The resources
required by the state increase rapidly and the number of checks and analyses
increase particularly as the internal market and international trade develop. In
addition to the increased costs to the state there is the issue of whether such high
numbers of checks and procedures may constitute a barrier to trade.
Where the trader/producer is primarily responsible to the consumer or the next link in
the food chain, then each link and eventually the consumer is the primary
enforcement - the burden for supervisory testing and monitoring is switched from
the state to the massive resources of the production chain where each link has
responsibility to ensure the safety of that stage – and the state may conserve
resources in order to intervene where it is really needed – i.e. where a risk is high or
the consequences of a breach are severe or where a real risk is identified as having
been realised and reported by a link in the chain or the final consumer. In this way
the normal processes of the majority of food business operators can continue
unhindered to the benefit of the consumer, producer and state alike.
Paragraph 30 of the preamble defines the EU approach to this issue:
―A food business operator is best placed to devise a safe system for supplying food
and ensuring that the food it supplies is safe: thus it should have primary responsibly
for ensuring food safety.‖
Articles 17, of the Regulation places the primary responsibility for ensuring the safety
of food or feeds on ―food and feed business operators:
1. Food and feed business operators at all stages of production,
processing and distribution within the businesses under their control shall ensure that
foods or feeds satisfy the requirements of food law which are relevant to their
activities and shall verify that such requirements are met.
2. Member States shall enforce food law, and monitor and verify that the
relevant requirements of food law are fulfilled by food and feed business operators at
all stages of production, processing and distribution. For that purpose, they shall
maintain a system of official controls and other activities as appropriate to the
circumstances, including public communication on food and feed safety and risk,
food and feed safety surveillance and other monitoring activities covering all stages
of production, processing and distribution. Member States shall also lay down the
rules on measures and penalties applicable to infringements of food and feed law.
The measures and penalties provided for shall be effective, proportionate and
Articles 19 and 20 specify the responsibilities and the mechanisms for achieving the
above goal. In particular they give the actions to be taken when the safety systems in
paragraph 17 fail to achieve the required standard. 8 Implicit in these articles is the
principle that the greater the delay in removing unsafe food from the food chain, the
greater the risk and therefore the greater the liability.
Essentially it means that the food and feed business operator is responsible for:
i) Monitoring the safety of what he produces imports, processes, manufactures or
ii) Taking steps to withdraw food or feed from the market when it has reason to
believe it does not comply with the safety requirements;
iii) Informing the appropriate authorities and the public where necessary of the risk.
It is clear from the structure and the text of the law that the state plays the primary
role in ensuring the safety and quality of food products. Article 3 quite clearly states
See annex II
that the state control refers directly to the food products directly rather than to the
food and feed business operators.
Section III on the role of the producers and sellers in ensuring the safety and quality
of food products commences with their rights. Their obligations are in essence
focussed on facilitating control and supervision by the state.
Whilst article 17 paragraph 6 gives as one of the objectives of state regulation
―Establishing the liabilities of producers, importers, exporters, and those who
otherwise circulate food products for ensuring the safety and quality of such products
during their production and circulation, and also for destruction of or correction of
deficiencies of these products in case of their failure to comply with relevant food
safety sanitary measures and technical regulations.‖ This concept is not developed
further in the text of the law.
Article 58 deals with civil, administrative, and criminal liability in compliance with
Ukrainian legislation. Introduction of product liability legislation and the concept of
strict liability in line with the principles of the EU directive 85 374 strengthen the
capacity of the legal framework to deal with the concept of primary responsibility.
Whilst primary responsibility is de facto maintained by the state it is the borough
district or county council (Food Authority) which takes on the burden of enforcement
rather than central bodies. Article 6 of the 1990 Act stipulates that ―Every food
authority shall enforce and execute within their area the provisions of this Act…..‖
The Act does however provide for the Ministers to resume that responsibility‖ in
relation to cases of a particular description or a particular case.‖
This quite clearly does not constitute a transfer of primary responsibility away from
the state merely away from the central bodies of state power. The law focuses on
establishing criminal liability for activity which jeopardises the health of the UK
In the UK however, under civil law, the consumer in the UK is protected by a whole
range of tort and contractual remedies. The consumer is in addition protected from
defective products by the Consumer protection act 1987 which implements the
product liability directive (85 374) and introduced strict liability for producers and
importers, and subsequently by the (The Consumer Protection Act 1987 (Product
Liability) (Modification) Order 2000) implementing Directive 99/34 to include ―primary
agricultural products" and game. These essentially removed the need for contractual
relations and proof of fault in civil litigation cases where a defective product caused
injury or death.
Whilst it is not explicitly provided for by a single Act, in fact the system of strict liability
and the defence of due diligence together with the liability under the 1990 Act
combine to effectively impose the obligations of primary responsibility onto the food
business operators. A large proportion of medium and large enterprises in the food
production industry allocate substantial resources specifically to analyse and reduce
their own liability by preparing due diligence defences. This involves analysing the
potential risks and putting in place mechanisms to deal with eventualities if they
In order for such a system to work effectively however a culture of self regulation and
the infrastructure for enforcement of civil law principles need to be well established.
The competitive nature of the market also ensures that commercial entities working
on limited margins in a market place where there are always competitors waiting to
seize business are very wary of damaging company or brand reputations or incurring
fines or other restrictions on their trading activities. When considering methods of
transferring primary responsibility away from the state in Ukraine it is important to
consider to what extent the same situation prevails.
2.3) Clear definition of the roles of all stakeholders in the food chain (feed
manufacturers, farmers and food business operators, the Member States, the
At the EU level as considered in the White Paper there are clearly actors which do
not play a part at national level. Whilst Ukraine remains a non-member of the EU the
EC plays a limited direct role in its food chain.
The primary responsibility of the food business operators has been dealt with above
and it is the respective roles of others in the food chain which are considered here.
Foreseen in the White Paper is the scheme where the farmers, food and feed
operators essentially take on the role of self regulators with the state bodies
supervising and monitoring this self regulation through surveillance and control
systems. The EC through its own mechanisms then surveys and monitors the
member state surveillance systems. In this way the available resources at state and
EU level are used for management and supervision rather than for direct
Regulation 178/2002 establishes the European Food Safety Authority (The Authority)
as the key scientific body, advisory and information dissemination mechanism in the
sphere of food safety at the European level.
The EU model envisages a separate body dealing with Risk assessment/risk
communication and risk management (as discussed below) and so the Commission
retains the legislative powers and the Authority the policy advisory and information
dissemination. It has not really developed into a monitoring system of national
implementation systems as foreseen by the White Paper as this role has been
retained by the FVO. It remains to be seen whether the two bodies and therefore
functions will be amalgamated in the future.
The roles and responsibilities of the producers under the EU vision is the key one
and is dealt with under the chapter of primary responsibility (2 - above)
The consumer who is the object of the protection also has a key role to play. The
consumer is of course obliged to store and use the food as it is intended and
prescribed. Most importantly the consumer is a key source of pressure on the
commercial enterprises to produce safe food. Through demanding information,
expressing opinions reporting breaches and suspicions of breaches and expressing
their freedom of choice they are an integral part of the enforcement mechanism.
The respective roles of the state bodies are defined in part 1 of the Act in which the
responsibility for enforcing and executing the provisions of the act are entrusted to
the Food Authorities (see above). Articles 16, 17, 18 and 19 of the Act specify the
regulations (i.e. implementing legislation) which may be made by the ministers in
protecting the consumer in the sphere of food safety including for registration and
licensing of food premises, special provisions for particular foods and enforcement of
community provisions. Part IV specifies the powers of ministers to issue codes of
practice, to require returns and the default powers.
The main point of interest in terms of the UK law is the role of the Food Standards
Agency as introduced by the 1999 Act. Articles 6, 7 and 8 specify the general
functions in relation to food including the development of policy and provision of
advice to public authorities, the provision of advice information and assistance to
others and the collection and analysis of information relevant to the sphere. These
functions also apply as indicated above to feed stuffs. Article 26 defines the powers
passed to the agency by the relevant Ministers. In fact in respect of the 1990 Act all
functions of the Minister of Agriculture, Fisheries and Food (as was) are passed to
The second key role is that of monitoring of enforcement as described in article 12 of
the 1999 Act. This it should achieve by setting standards of performance for and
reporting on the performance of the enforcement agencies. For example in 2003 the
Agency conducted audits of 15 local authorities and 10 port health authorities to
examine the consistency and effectiveness of their approach to the formal
enforcement of food legislation. In this context the agency is also empowered to
issue guidance on the control of food borne disease.
Very importantly the act foresees the agency being empowered to make emergency
orders – a power formally reserved to the Minister.
Role of the state bodies
Article 3 specifies which state bodies will be involved in control and supervision in the
sphere of food safety. i) The Sanitary and Veterinary services as well as ii) the
Cabinet of Ministers and iii) the central body of executive power in the sphere of
technical regulation and protection of consumers rights.
The role of the Sanitary and Veterinary services is laid out in articles 4 and 5. The
roles of the other two bodies are not specified in a similar way.
The Cabinet of Ministers has a number of varied functions including:
i) Approving the statute of the National Codex Alimentarius Commission of Ukraine
ii) The Cabinet of Ministers shall issue the regulations and guidelines necessary to
carry out the provisions of this Article (article 11) upon the approval of the Chief `
Doctor of the recommendation of the National Codex Alimentarius Commission of
iii) Establishing a number of procedures in respect of article 11
iv) Food additives that may be used in food products that are produced or circulated
in Ukraine shall be allowed for use by the Cabinet of Ministers of Ukraine.
v Food additives shall be allowed to be produced and circulated in Ukraine by the
Cabinet of Ministers on the basis of approved maximum inclusion levels of such food
additive in specified food products approved by the central body of executive power
in the sphere of health care upon submission of the National Codex Alimentarius
Commission of Ukraine.9
vi) The procedure for including food products in the category of food for special
dietary uses and functional food shall be established by the Cabinet of Ministers of
vii) The description of specific symbols, their utilization and labelling of food products
with bar codes shall be in accordance with the procedure established by the Cabinet
of Ministers of Ukraine.
Mention of the Cabinet of Ministers is limited to the English text in iv and v
viii) Laboratory evaluation, regular radiological analysis, examination for trichinosis,
and other mandatory laboratory analysis [approved by the Cabinet of Ministers] of
food products of animal origin, are financed from the appropriate budgets.
ix) (5) Before (date) the Cabinet of Ministers of Ukraine shall:
1) submit to the Verkhovna Rada of Ukraine proposals on amending the laws of
Ukraine resulting from the present Law;
2) bring its normative legal acts in compliance with the present Law;
3) ensure adoption of normative legal acts set forth by the present Law, within
competence of the Cabinet of Ministers of Ukraine;
4) ensure revision and annulment of normative legal acts inconsistent with the
present Law by ministries and other central bodies of executive power of Ukraine.
(2) The Cabinet of Ministers of Ukraine shall prepare and submit to the
Verkhovna Rada of Ukraine the following draft regulations of Ukraine:
Whilst it is clear that the Cabinet of Ministers has a number of statutory functions
according to the Constitution and other fundamental laws, its functions in the above
scheme are somewhat haphazard. There is a variety of approvals, procedures,
permissions some of which are quite technical e.g. food additives approval. There is
no clear picture of its role in the system of food safety.
The “Central body of executive power in the sphere of technical regulation and
protection of consumer’s rights‖ is also responsible as per article 3 but again no
overall role is specified. In fact in the text of the law this body is not referred to in
these terms at all;
Article 7. Laboratories
The paragraph dealing with evaluating the Safety and Quality of Food Products
refers to ―Laboratories of the bodies of technical regulations and consumer rights
The National Codex Alimentarius Commission has a number of responsibilities
specified in article 6 but has no role as specified in article 3.
In many respects it has a scientific advisory role as one would expect but it is also
expected to ―coordinate activities on harmonisation of international and national
legislation‖ which is not what one would expect.
Paragraph 22 suggests that it should perform functions of ―information enquiry
service‖ – this presumably refers to the Codex Contact Point but this should be
clarified as there may be some confusion with the SPS Enquiry Point.
It has the power to propose the programme for random extended control for food
(and feed) products produced and circulated in Ukraine but not for those imported
food products – it is not clear from the law who will do this.
The draft guidelines10 for the establishment of National Codex Committee (NCC)
state that it ―would serve a most useful service in supporting the work of the Contact
Point (see annex 4) and ensuring that all ministries, non-governmental
organizations, consumers and industry would have ample opportunity to present their
views on various Codex matters, including aspects related to food control matters.
The primary terms of reference of such a Committee should be to advise
governments on the implications of various food standardization and food control
Draft Guidelines for Codex Contact Points and National Codex Committees (Asian Regional
issues which have arisen and are related to the work undertaken by the CAC.‖ In the
UK the Codex Contact point is subsumed within the FSA.
In many respects, The National Codex Commission would seem to have been
allocated a number of the functions of a food safety agency i.e. greater than those
normally foreseen merely in the context of the Codex. These expanded functions
would enable it to perform a lead role in the sphere, however the status of this
commission in the current law and most likely its limited resources would not enable
it to perform such a pivotal coordinating role. Whilst it is authorised to coordinate
legislative approximation activities it is not clear what role the codex plays in drafting
or approving laws and therefore to what extent it may play a risk management or
merely a risk assessment role.
In fact from the law it is not clear which body if any will have the central coordinating
role in terms of science, policy advice, legislative initiative and information
dissemination. From the text of the current draft law it is clear that the sanitary
service will undertake the largest number of functions. From the current draft the
input of the Veterinary Service into policy making appears to be only possible through
the Codex Alimentarius Commission and is relatively limited. Overall responsibility for
the coordination of food safety of Ukraine is not clear.
Role of non-state entities
i) As there is no scope section to the law only reference to the text of the law reveals
that feed and fertilizer manufacturers are not covered by the law
ii) Transport and storage are considered in the law and operating permits are
foreseen for those involved in storage and transportation of food products. Those
involved in these activities are however not seen as an integral part of the food chain.
The role of the Consumer is not expanded upon apart from the fact that he has the
right to compensation under Article 15.Obligations of Producers and Sellers
(Suppliers) of Food Products
―To compensate consumers for damages caused by consumption of adulterated or
misbranded food products and consumption of food products that were proven to be
unsafe when handled and/or consumed according to instructions provided by the
The clear definition of the respective roles of the key stakeholders in the food safety
sphere, which should be one of the main aims of this law, is currently not achieved.
2.4) Transparency - measures based on science and open consultation
Transparency is the key for public confidence. If it can be seen that good science is
being used without political or commercial interference, then the consumer but also
third countries will be more willing to trust the judgement and recommendations of
any body making decisions in the field of food safety.
In the preamble of the 178/2002 Regulation, the principle of transparency in science
and in particular of risk assessment is addressed:
18) In order for there to be confidence in the scientific basis for food law, risk
assessments should be undertaken in an independent, objective and transparent
manner, on the basis of the available scientific information and data.
46) In order to guarantee independence, members of the Scientific Committee and
Panels should be independent scientists recruited on the basis of an open application
In the text of the regulation itself, articles 9 and 10 deal with public consultation and
There shall be open and transparent public consultation,
directly or through representative bodies, during the
preparation, evaluation and revision of food law, except
where the urgency of the matter does not allow it.
Without prejudice to the applicable provisions of
Community and national law on access to documents, where there are
reasonable grounds to suspect that a food or feed may present
a risk for human or animal health, then, depending on the
nature, seriousness and extent of that risk, public
authorities shall take appropriate steps to inform the general
public of the nature of the risk to health, identifying to the
fullest extent possible the food or feed, or type of food or
feed, the risk that it may present, and the measures which are
taken or about to be taken to prevent, reduce or eliminate
Indeed the Authority is committed in Article 30 of the regulation 178/2002 to
publishing divergences in scientific opinions with member state bodies.
Further articles 37 and 38 define the independence and transparency with which the
Authority should operate. There are mechanisms to ensure the independence of the
management board and of the scientific committee through annual declarations of
interests. Transparency is ensured through the publishing of almost all documents
produced by the authority including the agendas and minute of meetings, the
opinions of the scientific committee and panels, the results of scientific studies and
the annual report etc.
Transparency is a vital element of the enforcement process – i.e. justice is seen to be
done. Article 11 paragraph 5 of the 1990 Act provides for a copy of any prohibition
order issued under paragraph 1 of the article to be affixed ―in a conspicuous position
on such premises used for the purposes of the business.‖
Key to the legitimacy of the Agency is its independence. The public trust in its
independence is supported by transparency in all its actions:
Under the 1999 Act the Agency is empowered to publish advice given in its policy
advice and its general advisory capacity, any information obtained through
observations and any other information in its possession. There are also wide
ranging obligations for consultation and notification.
On its own website11 the FSA explains:
How is the FSA independent?
Although the FSA is a Government agency, it works at 'arm's length' from
Government because it doesn't report to a specific minister and is free to publish any
advice it issues.
How is the FSA structured?
The Agency is led by a Board that has been appointed to act in the public interest
and not to represent particular sectors. Board members have a wide range of
relevant skills and experience.
Further they have a code of practice of openness, the introduction of which states:
Openness is one of the core values of the Food Standards Agency. This means that
we will use plain language & communicate in a timely way, that we will explain the
reasons for our decisions and advice, and that we will publish our targets and our
achievements against them.
There are several articles which deal with transparency issues in the draft law:
Publication of results
The draft law12 applies the principle of transparency in Article 24 by providing that
―the suspension and/or revocation of an operating permit for a subject of economic
activity shall be announced publicly to protect consumer health.‖
Scientific basis of measures
For credibility it is important to be perceived to be beyond political and commercial
pressures. This can be achieved by demonstrating openly that decisions are based
on objective scientific analysis. The principles governing the preparation, adoption,
application and review of food safety measures are given in article 11 of the draft law
―All food safety sanitary measures shall be based on scientific principles and
available scientific evidence except as provided in item 4 of this paragraph;
There is however little development of the concept of transparency in the reaching of
scientific decisions in the body of the law and as indicated above, this has
consequences not only for national public confidence but for the building of trust in
2.5) Traceability of feed and food and their ingredients - 'the ability to follow a
food, feed, food-producing animal or substance... through all stages of production,
processing and distribution'.
Paragraph 28 introduces the concept in to the Regulation. ―Experience has shown
that the functioning of the internal market in food or feed can be jeopardised where it
is impossible to trace food and feed. It is therefore necessary to establish a
comprehensive system of traceability within food and feed businesses so that
Currently only in the English version
targeted and accurate withdrawals can be undertaken or information given to
consumers or control officials, thereby avoiding the potential for unnecessary wider
disruption in the event of food safety problems.‖
1. The traceability of food, feed, food-producing animals, and
any other substance intended to be, or expected to be,
incorporated into a food or feed shall be established at all
stages of production, processing and distribution.
2. Food and feed business operators shall be able to identify
any person from whom they have been supplied with a food, a
feed, a food-producing animal, or any substance intended to
be, or expected to be, incorporated into a food or feed.
To this end, such operators shall have in place systems and
procedures which allow for this information to be made
available to the competent authorities on demand.
3. Food and feed business operators shall have in place
systems and procedures to identify the other businesses to
which their products have been supplied. This information
shall be made available to the competent authorities on demand.
The article goes on to stipulate the traceability labelling requirements for products
intended for the EU.
The burdens imposed by strict liability and the due diligence defence as well as other
civil and criminal liability mechanisms have ensured that traceability is a standard
part of many substantial food business operators systems. The emphasis now is on
standardising the approach and the mechanisms to ensure uniformity. Following the
FSA Board July 2002 paper on traceability in the food chain, the food chain strategy
division of the food standards agency has begun consultations with key stakeholders
on the issue. The Board decided that the Agency will:
provide clear guidelines on the legal requirements for traceability
explore with industry the scope for strengthening current traceability
arrangements, and identifying and spreading good practice
In article 4 Role of the State Sanitary Epidemiological Service, paragraph 18 provides
for them to ―Specify records to be maintained by subjects of economic activity
producing and selling food products to enable traceability of such products‖
Article 15 Obligations of producers and sellers defines the reverse side of the above
article. Keep records on the receipt and use of raw food products and other
components of food products they produce, according to lot number, or sell for three
years to enable traceability of such products.
Whilst the records and the subjects of the requirement in Article 4 are defined in
general terms, they are quite specific in article 15. The issue is to what extent such a
universally applicable highly demanding requirement at this stage is realistic and
2.6) Risk analysis - comprising risk assessment, management and communication
– allocation of assessment and management. Application of the precautionary
principle in risk management
Article 16 of the preamble states in line with the SPS principles that ―measures
adopted by the member states and the community governing food and feed should
generally be based on risk analysis except where this is not appropriate to the
circumstances of the measure.‖ Article 17 further elaborates that ―where food law is
aimed at the reduction, elimination or avoidance of risk to health, the three
interconnected components of risk analysis – risk assessment, risk management and
risk communication – provide a systematic methodology for the determination of
effective proportionate and targeted measures or other actions to protect health’
In the White Paper there is a relatively detailed analysis and discussion of the
appropriate allocation of the various aspects of the risk analysis to bodies of differing
status. Essentially it is maintained that risk management involves the twin
components of legislation and control. Legislation can legitimately only be allocated
to an accountable body – control is considered to be linked to the legislative function
(not in the traditional separation of powers) and therefore this role should be
performed by the Commission. The risk assessment function should be objective and
independent and may best be performed by a body not subject to political or
commercial pressures. Such a body best has the resources to perform the risk
The Authority was therefore set up to perform the risk assessment and
communication functions - as per article 22 of the regulation ―the authority shall
provide scientific advice and technical support for the Communities legislation and
policies in all fields which have a direct or indirect impact on food safety. It shall
provide independent information on all matters within these fields and communicate
on risks. ―
Under article 35 it is also the recipient of any messages forwarded via the rapid alert
Article 20 states that ―the precautionary principle has been invoked to ensure health
protection in the Community, thereby giving rise to barriers to the free movement of
food or feed. Therefore it is necessary to adopt a uniform basis throughout the
community for the use of this principle.‖ A decision on the validity of this concept in
international law has not been finally reached and in fact in the Regulation it is
defined in paragraph I of article 7 in terms taken from the SPS agreement.
Whilst it is not expressed in these terms in the relevant law the risk analysis i.e.
assessment, key management functions and the communication are all assumed by
the FSA. The UK Government asked the FSA in 2001 to undertake review of risk
procedures used by the Government's Advisory Committees dealing with food safety.
In general the Board concluded that risk analysis in food safety was in general
operating well but commented that various committees should communicate better
with each other and that a range of management options should be presented to
Risk analysis is referred to in particular in two articles of the draft law: Article 30
Food Additives for Producing Food Products states:
―Upon request of a producer or seller (supplier), food additives approved for use by
the relevant international organisations shall be approved for use in Ukraine within
six months of approval by the relevant international organisations unless the results
of a risk analysis are that use of the food additive, due to characteristics or
circumstances specific to the population of Ukraine, will result in less than the
appropriate level of human health protection.‖
Article 51: Import Restrictions due to Zoonoses
(1) The Chief Veterinary Inspector may, when so recommended by the relevant
international organisations or necessary, as determined by a risk analysis, to achieve
the appropriate level of human health protection, restrict or prohibit imports of food
products of animal origin from certain countries or zones within certain countries due
to a confirmed outbreak of zoonoses that can render food products of animal origin
unsafe. Such restrictions or prohibitions shall be repealed upon confirmation of the
end of the outbreak and subsequent safety of food products of animal origin.
Article 11 introduces the concept of risk assessment as the basis for measures
adopted in the absence of appropriate international standards. This article also
addresses the major principles of the WTO SPS agreement including harmonisation,
adequacy, transparency equivalence and non-discrimination.
2.7) Structure and drafting of the law
i) In order to avoid subsequent problems with implementation and interpretation the
Draft Law should be clear in its objectives, logical and consistent in its structure and
appropriately precise in its definition. Whilst it is acknowledged that it is still in draft, it
currently does not achieve this. One of the reasons is that it attempts to include much
of what could more effectively be included in subordinate legislation into the primary
law and does not elaborate sufficiently on the basic principles. By way of illustrative
example the 1990 Act deals with the subordinate legislation in Article 16 and 17 by
specifying the implementing regulations to be made ―The ministers may make
ii) The definitions and concepts of ―misbranded‖ and ―adulterated‖ are not directly
comparable with the terminology and approach used within the EU. This has
consequences for equivalence assessment and for contradictions with other EU
principles, concepts and terminology which may be used in the law.
iii) The status of dietary supplements is not clear. In general they are defined as
being added to food (i.e. not food) and references to them being food have been
deleted e.g. Article 33 but Article 22 paragraph 2 ―The procedure for keeping the
Register of Food for Special Dietary Uses and Functional Food Dietary Supplements‖
would seem to treat them as food – in any event it is not clear. EU law treats dietary
supplements as food.
iv) The concept of HACCP is introduced in Article 8 Powers of Sanitary Inspectors
through ―Assessing the application of HACCP principles‖; and in Article 15 one of the
Obligations of Producers and Sellers (Suppliers) of Food Products is to ―Implement a
Hazard Analysis and Critical Control Points (hereinafter: HACCP) or other safety
assurance system for production and circulation of food products;‖
In article 18 State Regulation of the Safety and Quality of Food Products it is stated
that it shall be carried out by means of ―Requiring the use by producers and those
who circulation food products of safety and quality assurance systems for production
of food products, in particular HACCP (Hazard Analysis and Critical Control Point);‖
See Annex III
There is however no elaboration on how, when and by whom this massive task will
be undertaken – according to the text of the law it applies at all levels of production.
By including unrealistic requirements the value of the law is undermined.
iv) Article 29 Requirements for Producing Food Products specifies that ―It shall be
prohibited to use food additives that are not approved for use in Ukraine, unless such
food additives are approved for use by the relevant international organisations and
concurrently approved for use by at least [one-third] of interested trading partners of
Ukraine‖; The last part of this paragraph is not scientifically based but appears to be
founded on a commercial justification. The rationale for this should be re-examined
and if not otherwise justified should be removed.
v) The definition of Novel foods being ―produced from, but not containing genetically
modified organisms‖ which is questioned in the current draft accords with the EU
vi) Article 4 paragraph 17 gives the Sanitary Service the right to ―issue operating
permits for production, storage, transportation, sale and processing of food products..
which as it currently stands is vague and therefore arbitrary with no reference to
vii) Article 9 in the English version lacks provision for procedures which appears to
have been addressed in the Ukrainian text.
viii) Article 13 appears to deal with the functions of an enquiry point under the SPS
agreement. Currently the intergovernmental obligations of notification and enquiry
responses are combined with the general information dissemination activaties under
the auspices of one as yet undesignated authority. Whilst these functions may be
undertaken by the same body this is not necessarily the case.
3) Conclusions and recommendations
i) Whilst there are areas of divergence with EU principles as demonstrated above,
the most pressing issue to be considered currently is the extent to which
harmonisation is relevant to ensure the compatibility with the WTO principles as well
as with the EU trading regime rather than that required for direct integration into the
Whilst there is clearly currently no obligation on Ukraine to implement measures that
go beyond the WTO SPS requirements,, this is a great opportunity for Ukraine to be
at the forefront of a movement to drive food safety forward. As a major agricultural
nation, as a future WTO member and as a neighbour of the EU where this philosophy
will define the development of production and trade in agricultural produce in the
coming years, it is essential that where it is feasible these approaches be adopted
into the general approach of the government bodies and agencies involved and that
this be reflected in the draft law being considered. The example of the UK
demonstrates that whilst it is possible to introduce these concepts and mechanisms
piecemeal it is a long and complicated process. This inevitable process would be
greatly facilitated by at least foreseeing the key principles in the current draft law.
ii) One of the issues which is unavoidable in the context of WTO accession and
future trade negotiations is the need for a unified approach and a fully coordinated
system of implementation of food safety regulation. As the final question regards the
health of the Ukrainian population it is of course vital that the sanitary service plays a
key role. Recent EU experience and practice has demonstrated the vital role that the
veterinary service has to play. There is a need for a clear leading and coordinating
role in the sphere of policy formulation, regulation, scientific research and information
The tendency in the EU, as illustrated by the UK, is the formation of an independent
body to take on these key functions. Independence, scientific excellence and
transparency are the key elements of this as illustrated in the EU White Paper in
order to ensure domestic public and third country trust in such a body. There are
various models for this body. There are those which combine risk assessment and
risk management (e.g. UK) and those which separate these functions (e.g. France).
Whichever model is adopted, EU experience is showing that the creation of such a
body, facilitates the coordination of policy on a national and regional level, that its
high visibility and transparency contributes substantially to a much needed trust
building process, and its interaction with all stakeholders in the food safety sphere
invigorates the enforcement mechanisms.
Another key issue is that of transfer of primary responsibility. Whilst a high degree of
state control may be required to ensure that standards are met for export, EU
experience has shown that allowing careful and well organised producers to go about
their business without interference promotes trade and frees up resources to deal
with less careful or rogue producers or with natural food safety disasters. It must be
said that this should not mean a reduction in resources for such tasks but merely a
iii) The law would reduce scope for delay in consensus and for misinterpretation by
restricting itself to defining the key principles, roles and powers and providing for
subordinate legislation (which may be drafted concurrently). With the combined use
of EU and US principles, concepts and definitions, there is increased potential for
duplication, lacunae and contradiction.
i) That the key principles driving food safety reform in the EU as highlighted above
are integrated where feasible or at least foreseen in the current law. That those
measures which are currently practicable are explicitly included in the law e.g. the
establishment of a Food Safety Coordination Body, the first realistic traceability and
HACCP measures and that where they are not feasible for immediate introduction,
that the long term wider objectives including primary responsibility transfer could be
formulated as objectives of any Food Safety Coordination body and/or the National
Codex Alimentarius Commission.
ii) In particular that serious consideration be given to the creation or development of a
Food Safety Coordination Body (perhaps on the basis of or incorporating the National
Codex Alimentarius Commission) which could take on the risk assessment and
communication and possibly risk management tasks as discussed above and above
all the coordinating role.
iii) Consideration should be given to reorganising the law into a primary law dealing
with the key principles, creation of a coordinating body, allocating roles and powers
and providing for subordinate legislation. The text of the current law can be used as
the basis for concurrently drafted implementing legislation. Care should be taken to
ensure that the combination of the EU and US systems does not produce internal
contradictions and compatibility problems.
The Regulation Article 11
(11) In order to take a sufficiently comprehensive and integrated approach to food
safety, there should be a broad definition of food law covering a wide range of
provisions with a direct or indirect effect on the safety of food and feed, including
provisions on materials and articles in
contact with food, animal feed and other agricultural inputs
at the level of primary production.
(12) In order to ensure the safety of food, it is necessary to
consider all aspects of the food production chain as a
continuum from and including primary production and the
production of animal feed up to and including sale or supply
of food to the consumer because each element may have a
potential impact on food safety.
(13) Experience has shown that for this reason it is necessary
to consider the production, manufacture, transport and
distribution of feed given to food-producing animals,
including the production of animals which may be used as feed
on fish farms, since the inadvertent or deliberate
contamination of feed, and adulteration or fraudulent or other
bad practices in relation to it, may give rise to a direct or
indirect impact on food safety.
(14) For the same reason, it is necessary to consider other
practices and agricultural inputs at the level of primary
production and their potential effect on the overall safety of food.
The White Paper paragraph 8
8 The guiding principle throughout this white paper is that food safety must be based
on a comprehensive integrated approach. This means throughout the food chain
(whole of food and feed chain) (farm to table) across all food sectors between the
members states and the eu external frontier and within the EU in international and eu
decision making for a and at all stages of the policy making cycle.
The Regulation Articles 19 and 20
Responsibilities for food: food business operators
1. If a food business operator considers or has reason to
believe that a food which it has imported, produced,
processed, manufactured or distributed is not in compliance
with the food safety requirements, it shall immediately
initiate procedures to withdraw the food in question from the
market where the food has left the immediate control of that
initial food business operator and inform the competent
authorities thereof. Where the product may have reached the
consumer, the operator shall effectively and accurately inform
the consumers of the reason for its withdrawal, and if
necessary, recall from consumers products already supplied to
them when other measures are not sufficient to achieve a high
level of health protection.
2. A food business operator responsible for retail or
distribution activities which do not affect the packaging,
labelling, safety or integrity of the food shall, within the
limits of its respective activities, initiate procedures to
withdraw from the market products not in compliance with the
food-safety requirements and shall participate in contributing
to the safety of the food by passing on relevant information
necessary to trace a food, cooperating in the action taken by
producers, processors, manufacturers and/or the competent
3. A food business operator shall immediately inform the
competent authorities if it considers or has reason to believe
that a food which it has placed on the market may be injurious
to human health. Operators shall inform the competent
authorities of the action taken to prevent risks to the final
consumer and shall not prevent or discourage any person from
cooperating, in accordance with national law and legal
practice, with the competent authorities, where this may
prevent, reduce or eliminate a risk arising from a food.
4. Food business operators shall collaborate with the
competent authorities on action taken to avoid or reduce risks
posed by a food which they supply or have supplied.
Responsibilities for feed: feed business operators
1. If a feed business operator considers or has reason to
believe that a feed which it has imported, produced,
processed, manufactured or distributed does not satisfy the
feed safety requirements, it shall immediately initiate
procedures to withdraw the feed in question from the market
and inform the competent authorities thereof. In these
circumstances or, in the case of Article 15(3), where the
batch, lot or consignment does not satisfy the feed safety
requirement, that feed shall be destroyed, unless the
competent authority is satisfied otherwise. The operator shall
effectively and accurately inform users of the feed of the
reason for its withdrawal, and if necessary, recall from them
products already supplied when other measures are not
sufficient to achieve a high level of health protection.
2. A feed business operator responsible for retail or
distribution activities which do not affect the packaging,
labelling, safety or integrity of the feed shall, within the
limits of its respective activities, initiate procedures to
withdraw from the market products not in compliance with the
feed-safety requirements and shall participate in contributing
to the safety of food by passing on relevant information
necessary to trace a feed, cooperating in the action taken by
producers, processors, manufacturers and/or the competent
3. A feed business operator shall immediately inform the
competent authorities if it considers or has reason to believe
that a feed which it placed on the market may not satisfy the
feed safety requirements. It shall inform the competent
authorities of the action taken to prevent risk arising from
the use of that feed and shall not prevent or discourage any
person from cooperating, in accordance with national law and
legal practice, with the competent authorities, where this may
prevent, reduce or eliminate a risk arising from a feed.
4. Feed business operators shall collaborate with the
competent authorities on action taken in order to avoid risks
posed by a feed which they supply or have supplied.
The 1990 Act Regulations
Food safety and consumer protection.
16.—(1) The Ministers may by regulations make—
(a) provision for requiring, prohibiting or regulating the presence in food or food
sources of any specified substance, or any substance of any specified class, and
generally for regulating the composition of food;
(b) provision for securing that food is fit for human consumption and meets such
microbiological standards (whether going to the fitness of the food or otherwise) as
may be specified by or under the regulations;
(c) provision for requiring, prohibiting or regulating the use of any process or
treatment in the preparation of food;
(d) provision for securing the observance of hygienic conditions and practices in
connection with the carrying out of commercial operations with respect to food or
(e) provision for imposing requirements or prohibitions as to, or otherwise regulating,
the labelling, marking, presenting or advertising of food, and the descriptions which
may be applied to food; and
(f) such other provision with respect to food or food sources, including in particular
provision for prohibiting or regulating the carrying out of commercial operations with
respect to food or food sources, as appears to them to be necessary or expedient—
(i) for the purpose of securing that food complies with food safety requirements or in
the interests of the public health; or
(ii) for the purpose of protecting or promoting the interests of consumers.
(2) The Ministers may also by regulations make provision—
(a) for securing the observance of hygienic conditions and practices in connection
with the carrying out of commercial operations with respect to contact materials
which are intended to come into contact with food intended for human consumption;
(b) for imposing requirements or prohibitions as to, or otherwise regulating, the
labelling, marking or advertising of such materials, and the descriptions which may
be applied to them; and
(c) otherwise for prohibiting or regulating the carrying out of commercial operations
with respect to such materials.
(3) Without prejudice to the generality of subsection (1) above, regulations under
that subsection may make any such provision as is mentioned in Schedule 1 to this
(4) In making regulations under subsection (1) above, the Ministers shall have
regard to the desirability of restricting, so far as practicable, the use of substances of
no nutritional value as foods or as ingredients of foods.
(5) In subsection (1) above and Schedule 1 to this Act, unless the context
(a) references to food shall be construed as references to food intended for sale for
human consumption; and
(b) references to food sources shall be construed as references to food sources
from which such food is intended to be derived.
Enforcement of Community provisions.
17.—(1) The Ministers may by regulations make such provision with respect to
food, food sources or contact materials, including in particular provision for
prohibiting or regulating the carrying out of commercial operations with respect to
food, food sources or contact materials, as appears to them to be called for by any
(2) As respects any directly applicable Community provision which relates to food,
food sources or contact materials and for which, in their opinion, it is appropriate to
provide under this Act, the Ministers may by regulations—
(a) make such provision as they consider necessary or expedient for the purpose of
securing that the Community provision is administered, executed and enforced under
this Act; and
(b) apply such of the provisions of this Act as may be specified in the regulations in
relation to the Community provision with such modifications, if any, as may be so
(3) In subsections (1) and (2) above references to food or food sources shall be
construed in accordance with section 16(5) above.
Special provisions for particular foods etc.
18.—(1) The Ministers may by regulations make provision—
(a) for prohibiting the carrying out of commercial operations with respect to novel
foods, or food sources from which such foods are intended to be derived, of any
class specified in the regulations;
(b) for prohibiting the carrying out of such operations with respect to genetically
modified food sources, or foods derived from such food sources, of any class so
(c) for prohibiting the importation of any food of a class so specified,
and (in each case) for excluding from the prohibition any food or food source which is
of a description specified by or under the regulations and, in the case of a prohibition
on importation, is imported at an authorised place of entry.
(2) The Ministers may also by regulations—
(a) prescribe, in relation to milk of any description, such a designation (in this
subsection referred to as a "special designation") as the Ministers consider
(b) provide for the issue by enforcement authorities of licences to producers and
sellers of milk authorising the use of a special designation; and
(c) prohibit, without the use of a special designation, all sales of milk for human
consumption, other than sales made with the Minister's consent.
(3) In this section—
"authorised place of entry" means any port, aerodrome or other place of entry
authorised by or under the regulations and, in relation to food in a particular
consignment, includes any place of entry so authorised for the importation of that
"description", in relation to food, includes any description of its origin or of the manner
in which it is packed;
"novel food" means any food which has not previously been used for human
consumption in Great Britain, or has been so used only to a very limited extent.
(4) For the purposes of this section a food source is genetically modified if any of
the genes or other genetic material in the food source—
(a) has been modified by means of an artificial technique; or
(b) is inherited or otherwise derived, through any number of replications, from
genetic material which was so modified;
and in this subsection "artificial technique" does not include any technique which
involves no more than, or no more than the assistance of, naturally occurring
processes of reproduction (including selective breeding techniques or in vitro
Registration and licensing of food premises.
19.—(1) The Ministers may by regulations make provision—
(a) for the registration by enforcement authorities of premises used or proposed to
be used for the purposes of a food business, and for prohibiting the use for those
purposes of any premises which are not registered in accordance with the
(b) subject to subsection (2) below, for the issue by such authorities of licences in
respect of the use of premises for the purposes of a food business, and for
prohibiting the use for those purposes of any premises except in accordance with a
licence issued under the regulations.
(2) The Ministers shall exercise the power conferred by subsection (1)(b) above
only where it appears to them to be necessary or expedient to do so—
(a) for the purpose of securing that food complies with food safety requirements or in
the interests of the public health; or
(b) for the purpose of protecting or promoting the interests of consumers.
Annex 4 Codex Alimentarius Commission - Procedural Manual
RISK ANALYSIS - GENERAL ASPECTS
The risk analysis used in Codex should be:
open, transparent and documented;
conducted in accordance with both the Statements of Principle Concerning the Role
of Science in the Codex Decision-Making Process and the Extent to Which Other
Factors are Taken into Account and the Statements of Principle Relating to the Role
of Food Safety Risk Assessment; and evaluated and reviewed as appropriate in the
light of newly generated scientific data.
The risk analysis should follow a structured approach comprising the three distinct
but closely linked components of risk analysis (risk assessment, risk management
and risk communication) as defined by the Codex Alimentarius Commission6, each
component being integral to the overall risk analysis. 6 See Definitions of Risk
Analysis Terms Related to Food Safety, page 51.
Risk analysis terminology
Risk - a function of the probability of an adverse health effect and the severity of that
effect, consequential to a hazard in food; Hazard -a biological, chemical or physical
agent in, or condition of, food with the potential to cause an adverse health effect.
Risk Assessment - a scientifically based process consisting of: - hazard
identification; - hazard characterisation - exposure assessment; and - risk
characterisation Risk Management - the process distinct from risk assessment, of
weighing policy alternatives, in consultation with all interested parties, considering
risk assessment and other factors relevant for the health protection of consumers
and for the promotion of fair trade practices, and, if needed selecting appropriate
prevention and control options. Risk Communication is the interactive exchange of
information and opinions throughout the risk analysis process concerning risks, risk
related factors and risk perceptions, among risk assessor, risk managers,
consumers, industry, the academic community and other interested parties, including
the explanation of risk assessment findings and the basis of risk management
CODEX CONTACT POINTS:
1. Act as the link between the Codex Secretariat and Member countries;
2. Coordinate all relevant Codex activities within their own countries;
3. Receive all Codex final texts (standards, codes of practice, guidelines and
other advisory texts) and working documents of Codex sessions and ensure that
they are circulated to those concerned within their own countries;
4. Send comments on Codex documents or proposals to the Codex
Alimentarius Commission or its subsidiary bodies and/or the Codex Secretariat;
5. Work in close cooperation with the national Codex committee, where such
a committee has been established. The Codex Contact Point acts as the liaison
point with the food industry, consumers, traders and all other concerned to
ensure that the government is provided with an appropriate balance of policy
and technical advice upon which to base decisions relating to issues raised in
the context of the Codex work;
6. Act as a channel for the exchange of information and coordination of
activities with other Codex Members;
7. Receive the invitation to Codex sessions and inform the relevant
chairpersons and the Codex Secretariat of the names of participants from their
8. Maintain a library of Codex final texts; and
9. Promote Codex activities throughout their own countries.