White Paper on food safety
Date: 2000-01-12
Institutions: European Commission
Subjects: agro-industry, consumer protection, foodstuffs legislation, public health, scientific research

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 12.1.2000
COM (1999) 719 final

WHITE PAPER ON FOOD SAFETY

(presented by the Commission)

TABLE OF CONTENTS

EXECUTIVE SUMMARY .................................................................................................... 3

CHAPTER 1: INTRODUCTION........................................................................................... 6

CHAPTER 2: PRINCIPLES OF FOOD SAFETY.................................................................. 8

CHAPTER 3: ESSENTIAL ELEMENTS OF FOOD SAFETY POLICY: INFORMATION
GATHERING AND ANALYSIS – SCIENTIFIC ADVICE................................................. 10

CHAPTER 4: TOWARDS ESTABLISHING A EUROPEAN FOOD AUTHORITY .......... 14

CHAPTER 5: REGULATORY ASPECTS .......................................................................... 22

CHAPTER 6: CONTROLS.................................................................................................. 29

CHAPTER 7: CONSUMER INFORMATION..................................................................... 31

CHAPTER 8: INTERNATIONAL DIMENSION ................................................................ 34

CHAPTER 9: CONCLUSIONS ........................................................................................... 36

ANNEX ............................................................................................................................... 37

2

EXECUTIVE SUMMARY

Assuring that the EU has the highest standards of food safety is a key policy priority for the
Commission. This White Paper reflects this priority. A radical new approach is proposed.
This process is driven by the need to guarantee a high level of food safety.

European Food Authority

The establishment of an independent European Food Authority is considered by the
Commission to be the most appropriate response to the need to guarantee a high level of food
safety. This Authority would be entrusted with a number of key tasks embracing independent
scientific advice on all aspects relating to food safety, operation of rapid alert systems,
communication and dialogue with consumers on food safety and health issues as well as
networking with national agencies and scientific bodies. The European Food Authority will
provide the Commission with the necessary analysis. It will be the responsibility of the
Commission to decide on the appropriate response to that analysis. A European Food
Authority could be in place by 2002 once the necessary legislation is in place. Before
finalising our proposals we are inviting all interested parties to let us have their views by end
April. A definitive legislative proposal would then be brought forward by the Commission.

Food Safety Legislation

The setting up of the independent Authority is to be accompanied by a wide range of other
measures to improve and bring coherence to the corpus of legislation covering all aspects of
food products from “farm to table”.

Already the Commission has identified a wide range of measures that are necessary to
improve food safety standards. The White Paper sets out over 80 separate actions that are
envisaged over the next few years.

There have been enormous developments in the past decades, both in the methods of food
production and processing, and the controls required to ensure that acceptable safety
standards are being met. It is clear that, in a number of areas, existing European legislation
has to be brought up to date.

Following the Commission’s Green Paper on food law (COM(97)176 final), and subsequent
consultations, a new legal framework will be proposed. This will cover the whole of the food
chain, including animal feed production, establish a high level of consumer health protection
and clearly attribute primary responsibility for safe food production to industry, producers and
suppliers. Appropriate official controls at both national and European level will be
established. The ability to trace products through the whole food chain will be a key issue.
The use of scientific advice will underpin Food Safety policy, whilst
the precautionary
principle will be used where appropriate. The ability to take rapid, effective, safeguard
measures in response to health emergencies throughout the food chain will be an important
element.

3

Proposals for the animal feed sector will ensure that only suitable materials are used in its
manufacture, and that the use of additives is more effectively controlled. Certain food quality
issues, including food additives and flavourings and health claims, will be addressed, whilst
controls over novel foods will be improved.

The risks associated with the contamination of foods have been brought into sharp focus by
the recent dioxin crisis. Steps will be taken to address those areas where the existing
legislation in this sector needs to be improved to provide adequate protection.

Food Safety Controls

The experience of the Commission’s own inspection service, which visits Member States on a
regular basis, has shown that there are wide variations in the manner in which Community
legislation is being implemented and enforced. This means that consumers cannot be sure of
receiving the same level of protection across the Community, and makes it difficult for the
effectiveness of national authority measures to be evaluated. It is proposed that, in co-
operation with the Member States, a Community framework for the development and
operation of national control systems will be developed. This would take account of existing
best practices, and the experience of the Commission’s inspection services. It will be based on
agreed criteria for the performance of these systems, and lead to clear guidelines on their
operation.

In support of Community-level controls, more rapid, easier-to-use, enforcement procedures in
addition to existing infringement actions will be developed.

Controls on imports at the borders of the Community will be extended to cover all feed and
foodstuffs, and action taken to improve co-ordination between inspection posts.

Consumer Information

If consumers are to be satisfied that the action proposed in White Paper is leading to a
genuine improvement
in Food Safety standards, they must be kept well informed. The
Commission, together with the new European Food Authority, will promote a dialogue with
consumers to encourage their involvement in the new Food Safety policy. At the same time,
consumers need to be kept better informed of emerging Food Safety concerns, and of risks to
certain groups from particular foods.

Consumers have the right to expect information on food quality and constituents that is
helpful and clearly presented, so that informed choices can be made. Proposals on the
labelling of foods, building on existing rules, will be brought forward. The importance of a
balanced diet, and its impact on health, will be presented to consumers.

International dimension

The Community is the world’s largest
importer/exporter of food products. The actions
proposed in the White Paper will need to be effectively presented and explained to our trading
partners. An active role for the Community in international bodies will be an important
element in explaining European developments in Food Safety.

4

Conclusions

The implementation of all the measures proposed in the White Paper will enable Food Safety
to be organised in a more co-ordinated and integrated manner with a view to achieving the
highest possible level of health protection.

Legislation will be reviewed and amended as necessary in order to make it more coherent,
comprehensive and up-to-date. Enforcement of this legislation at all levels will be promoted.

The Commission believes that the establishment of a new Authority, which will become the
scientific point of reference for the whole Union, will contribute to a high level of consumer
health protection, and consequently will help to restore and maintain consumer confidence.

The success of the measures proposed in this White Paper is intrinsically linked to the support
of the European Parliament and the Council. Their implementation will depend on the
commitment of the Member States. This White Paper also calls for strong involvement of the
operators, who bear the prime responsibility for the daily application of the requirements for
Food Safety.

Greater transparency at all levels of Food Safety policy is the thread running through the
whole White Paper and will contribute fundamentally to enhancing consumer confidence in
EU Food Safety policy.

5

1.

2.

3.

4.

CHAPTER 1: INTRODUCTION

The European Union's food policy must be built around high food safety standards,
which serve to protect, and promote, the health of the consumer. The production and
consumption of food is central to any society, and has economic, social and, in many
cases, environmental consequences. Although health protection must always take
priority, these issues must also be taken into account in the development of food
policy. In addition, the state and quality of the environment, in particular the eco-
systems, may affect different stages of the food chain. Environment policy therefore
plays an important role in ensuring safe food for the consumer.

€

The agro-food sector is of major importance for the European economy as a whole.
The food and drink industry is a leading industrial sector in the EU, with an annual
production worth almost 600 billion
, or about 15% of total manufacturing output.
An international comparison shows the EU as the world's largest producer of food
and drink products. The food and drink industry is the third-largest
industrial
employer of the EU with over 2.6 million employees, of which 30% are in small and
the agricultural sector has an annual
medium enterprises. On the other hand,
production of about 220 billion
and provides the equivalent of 7.5 million full-time
€
jobs. Exports of agricultural and food and drink products are worth about 50 billion
a year. The economic importance and the ubiquity of food in our life suggest that
there must be a prime interest in food safety in society as a whole, and in particular
by public authorities and producers.

€

Consumers should be offered a wide range of safe and high quality products coming
from all Member States. This is the essential role of the Internal Market. The food
production chain is becoming increasingly complex. Every link in this chain must be
as strong as the others if the health of consumers is to be adequately protected. This
principle must apply whether the food is produced within the European Community
or imported from third countries. An effective food safety policy must recognise the
inter-linked nature of food production. It requires assessment and monitoring of the
risks to consumer health associated with raw materials, farming practices and food
processing activities; it requires effective regulatory action to manage this risk; and it
requires the establishment and operation of control systems to monitor and enforce
the operation of these regulations. Each element forms part of a cycle:
thus,
developments in food processing can require changes to existing regulations, whilst
feedback from the control systems can help to identify and manage both existing and
emerging risks. Each part of the cycle must work if the highest possible food safety
standards are to be enforced.

These facts therefore demand a comprehensive and integrated approach to food
safety. This does not mean that the EU should be exclusively responsible for all
aspects of food safety. However, it demands that all aspects of food safety are
addressed at EU level. For example, EU legislation has to be enforceable in an
efficient way in the Member States in line with the principle of subsidiarity.
Responsibility for enforcement above all should remain primarily a national, regional
and local responsibility. However, the Internal Market means that these are not
exclusively national responsibilities: each Member State has a duty towards not only
to its own citizens but to all citizens of the EU and third countries for the food
produced on their territory.

6

5.

6.

7.

It is necessary to underline that the European food chain is one of the safest in the
the present system has generally functioned well. Food safety
world and that
measures have formed part of the body of European legislation since the early days
of the Community. Historically, these measures have mainly been developed on a
sectoral basis. However, the increasing integration of national economies within the
Single Market, developments in farming and food processing, and new handling and
distribution patterns require the new approach outlined in this White Paper.

Community and Member State food safety systems have been under unprecedented
pressure during recent feed and food emergencies. These emergencies have exposed
weaknesses which call for action by the responsible authorities (Commission,
Member States and the Parliament), to re-enforce, improve and further develop
existing systems.

Food safety needs to be organised in a more co-ordinated and integrated way. This
will allow existing weaknesses to be addressed, whilst at the same time creating a
genuinely world-leading food safety framework, which can deliver a high level of
public health and consumer protection in accordance with the requirements of the EC
Treaty. However, the most comprehensive system cannot function without the full
collaboration of all parties involved. The proper functioning of any system depends
decisively on the commitment of the Member States and operators, as well as third
countries.

The European Union needs to re-establish public confidence in its food supply, its
food science, its food law and its food controls. This White Paper on Food Safety
outlines a comprehensive range of actions needed to complement and modernise
existing EU food legislation, to make it more coherent, understandable and flexible,
to promote better enforcement of that legislation, and to provide greater transparency
to consumers. This will provide the response to the conclusions of the Helsinki
European Council in December 1999.

The Commission is determined to implement the actions outlined in this White Paper
as a matter of priority. A detailed Action Plan on food safety with a precise timetable
for action over the next three years is provided in the Annex. Under this timetable,
the most important proposals should be put forward by the Commission before the
end of 2000, allowing for a coherent and up-to-date body of food law supported by a
new European Food Authority to be in place by the end of 2002. The Commission
in the
looks forward to the full co-operation of the Parliament and Council
implementation of this ambitious programme.

There has already been extensive
consultation and discussion concerning
improvements to the EU’s food legislation arising from the Green Paper on the
general principles of food law (COM (97) 176 final). This White Paper presents the
changes the Commission proposes in this area. However,
the
Commission envisages the creation of a European Food Authority as a further
measure. In respect of this proposal, the Commission wishes to elicit public debate,
informed comment and broad consultation. Interested parties are therefore invited to
submit comments on Chapter 4 of this White Paper by the end of April 2000.

in addition,

7

8.

9.

10.

11.

CHAPTER 2: PRINCIPLES OF FOOD SAFETY

This White Paper makes proposals that will transform EU food policy into a pro-
active, dynamic, coherent and comprehensive instrument to ensure a high level of
human health and consumer protection.

The guiding principle throughout this White Paper is that food safety policy must be
based on a comprehensive, integrated approach. This means throughout the food
chain 1 ('farm to table'); across all food sectors; between the Member States; at the
EU external frontier and within the EU; in international and EU decision-making
fora, and at all stages of the policy-making cycle. The pillars of food safety
contained in this White Paper (scientific advice, data collection and analysis,
regulatory and control aspects as well as consumer information) must form a
seamless whole to achieve this integrated approach.

The roles of all stakeholders in the food chain (feed manufacturers, farmers and food
manufacturers/operators;
the competent authorities in Member States and third
countries; the Commission; consumers) must be clearly defined: feed manufacturers,
farmers and food operators have the primary responsibility for
food safety;
competent authorities monitor and enforce this responsibility through the operation
of national surveillance and control systems; and the Commission concentrates on
evaluating the ability of competent authorities to deliver these systems through audits
and inspections at the national level. Consumers must also recognise that they are
responsible for the proper storage, handling and cooking of food. In this way, the
farm to table policy covering all sectors of the food chain,
including feed
production, primary production, food processing, storage, transport and retail sale,
will be implemented systematically and in a consistent manner.

A successful food policy demands the traceability of feed and food and their
ingredients. Adequate procedures to facilitate such traceability must be introduced.
These include the obligation for feed and food businesses to ensure that adequate
procedures are in place to withdraw feed and food from the market where a risk to
the health of the consumer is posed. Operators should also keep adequate records of
suppliers of raw materials and ingredients so that the source of a problem can be
identified. It must be emphasised however that unambiguous tracing of feed and food
and their ingredients is a complex issue and must take into account the specificity of
different sectors and commodities.

This comprehensive, integrated, approach will lead to a more coherent, effective
and dynamic food policy. It needs to address the shortcomings which flow from the
current sectoral, rigid approach, which has limited its ability to deal rapidly and
flexibly with risks to human health. The policy needs to be kept under constant
review and, where necessary, be adapted to respond to shortcomings, to deal with
emerging risks, and to recognise new developments in the production chain. At the
same time, the development of this approach needs to be transparent, involving all
the stakeholders and allowing them to make effective contributions to new
developments. The level of transparency already achieved by making public

1

Throughout this White Paper, the term ‘food chain’ covers the whole of the feed and food chain

8

12.

13.

14.

15.

scientific opinions and inspection reports should be extended to other food safety
related areas.

Risk analysis must form the foundation on which food safety policy is based. The
EU must base its food policy on the application of the three components of risk
analysis:
risk
management (regulation and control) and risk communication.

(scientific advice and information analysis)

risk assessment

The Commission will continue to use the best available science in developing its
food safety measures. The organisation of the independent scientific advice, and the
role of a new European Food Authority in providing this advice, will be dealt with in
Chapter 4. The Commission recognises that consumers and the food industry need to
this advice is being produced to the highest standards of
be confident
independence, excellence and transparency.

that

Where appropriate, the precautionary principle will be applied in risk management
decisions. The Commission intends to present a Communication on this issue.

In the decision making process in the EU, other legitimate factors relevant for the
health protection of consumers and for the promotion of fair practices in food trade
can also be taken into account. The definition of the scope of such legitimate factors
is presently being studied at international level particularly in Codex Alimentarius.
Examples of such other legitimate factors are environmental considerations, animal
welfare, sustainable agriculture, consumers’ expectation regarding product quality,
fair information and definition of the essential characteristics of products and their
process and production methods.

9

CHAPTER 3: ESSENTIAL ELEMENTS OF FOOD SAFETY
POLICY: INFORMATION GATHERING AND ANALYSIS –
SCIENTIFIC ADVICE

16.

17.

Information gathering and analysis are essential elements of food safety policy, and
are particularly important for the identification of potential feed and food hazards.

Methods and indicators to identify problems are manifold. They may include data
derived from controls carried out along the feed and food chain, disease surveillance
networks, epidemiological investigations and laboratory analysis. Correct analysis of
data would facilitate study of the evolution of known food hazards and the
identification of new ones; it would thus become possible to better define and adapt
food safety policy as necessary. The role of Member States in information gathering
is crucial, and needs to be well defined.

Monitoring and surveillance

in the

agricultural

The Commission collects a large amount of information on issues relating to food
safety. The major sources of information are networks for public health monitoring
and surveillance (in particular communicable disease reporting systems under
Decision 2119/98), surveillance plans of zoonoses and residues, rapid alert systems,
information systems
radioactivity
monitoring and research activities and associated research networks. However, the
existing systems have been developed independently from each other and therefore
co-ordination of the different sources of information is not always done. Moreover, a
large amount of the available information is not fully exploited. Integration of data
collection systems and analysis of data should be the two guiding principles in this
area in order to draw maximum benefits from the current systems for data gathering.
The Community needs a comprehensive and effective food safety monitoring and
surveillance system integrating all the above sources of information The expertise of
the Commission Joint Research Centre could provide a useful support in this matter.

environmental

sector,

The first objective should be an on-going and day to day management of the
information to allow a real time response to potential hazards. Secondly, such a
system would enable the Commission to develop a more pro-active and forward-
looking role. It should aim at the early identification of potential hazards to prevent
crises arising rather than reacting to them. It would also facilitate long-term policy
planning and priority setting.

Alert systems

18.

In general, the Rapid Alert System for Food functions well for foodstuffs intended
for the final consumer. Various other types of notification systems exist in different
areas, such as transmissible diseases in human and animals, animal products stopped
at the external borders of the EU, movements of live animals and the ECURIE
system in case of radiological emergency. But once again, integrated use of the
information is difficult, because of the difference in objectives and scope of these
systems. In addition, certain areas are not covered at all, for example, animal feed.

10

19.

20.

21.

The creation of a comprehensive and harmonised legal framework enlarging the
scope to all food and feed of the current Rapid Alert System is necessary. It should
extend obligations of economic operators to notify food safety emergencies and
ensure appropriate information of consumers and trade organisations. Furthermore,
an appropriate link with other rapid information systems must be made. This system
should also be extended to third countries for incoming and outgoing information.

Research

Scientific excellence requires investment in R&D to expand the scientific knowledge
base with regard to food safety. Under the Fifth Framework Programme for
Research, Community R&D projects on food safety are carried out on the basis of
multi-annual work programmes. These programmes include indirect action (shared
cost actions) and direct action executed by the Commission Joint Research Centre.
Their objectives are mostly geared towards improving scientific knowledge and
contributing towards a sound scientific basis for policy and regulation. The Fifth
Framework Programme has been oriented towards a problem solving approach with
citizens and their needs at its centre. Research actions will be carried out in particular
on advanced food technologies, safer methods of food production and distribution,
new methods for assessing contamination and chemical risks and exposures, the role
of food in promoting health, harmonised systems of food analyses.

However,
in specific cases where a potential human health problem has been
identified, the initiation of ad hoc and immediate research is often necessary. At
present, these needs could be partially covered by the Commission Joint Research
Centre, but the present system must be endowed with overall flexibility and adequate
financial resources to be able to finance R&D projects in direct response to food
emergencies. Therefore, budgetary and administrative procedures,
including a
regular revision of the research work programme and dedicated and targeted calls for
proposals, must be created in order to respond to urgent challenges.

Scientific co-operation

Scientific information is compiled by national
institutions and organisations
throughout the Community on a wide range of issues relating to food safety under
the Scientific Co-operation or SCOOP system. Only in a limited number of areas has
co-ordination of scientific information been undertaken to build a European picture,
when in many cases it is precisely this EU dimension which is lacking to provide the
information necessary for an EU risk assessment. Priority setting for the collation of
scientific information must be enhanced and co-ordinated with the work programme
of the Scientific Committee(s). Scientific co-operation should also be initiated in
third countries as appropriate.

Analytical support

A system of Community Reference Laboratories has been established for products of
animal origin to give specialised analytical support
to the Commission and to
laboratories in the Member States. They develop detection methods and assist
laboratories in the Member States to apply these methods. Effective central
management needs to be provided in order to ensure that these laboratories become a
real network of Community laboratories at the service of the EU policy. Given its
scientific capabilities and infrastructures, the Joint Research Centre could perform

11

this task. In addition, the establishment of Community Reference Laboratories for
new areas should be examined.

Scientific information underpins Food Safety policy. It is clear that scientific advice
on food safety must be of the highest quality. It must be provided in a timely and
reliable manner to those responsible for taking decisions to protect consumer health.

The current system for scientific advice

The system for the provision of scientific advice to the Commission was completely
reorganised in 1997 with emphasis on the fundamental principles of excellence,
transparency and independence. Scientific opinions are currently provided by eight
sectoral Scientific Committees2, of which five cover, directly or indirectly, the feed
and food areas. In addition, a Scientific Steering Committee has been set up which
provides advice on multidisciplinary matters, BSE, harmonised risk assessment
procedures, and co-ordination of questions which cut across the mandates of more
than one of the sectoral Committees (e.g. anti-microbial resistance). This co-
ordination task is particularly important because food safety questions are
increasingly addressed as a continuum from the farm to the table. The Committee
Secretariats are provided by the Commission services.

Members of these Committees are chosen following rigorous assessment of their
scientific excellence in their field of competence. Their independence is guaranteed
through the strict application of declarations of interests.

In the field of radioactive contamination of feed and food, specific groups of
scientific experts have been established under Article 31 of the Euratom Treaty.

The nature of the questions put to the Committees

Many of the questions concern the evaluation of dossiers submitted by the industry
for Community authorisation (pesticides, novel foods, food and feed additives).
Others questions
contaminants or
microbiological risk. A third category concerns broader assessments of risk as
typified by anti-microbial resistance.

concern specific

health problems

e.g.

Obligatory consultation of the Committees

Some food safety legislation requires the Commission to consult a scientific
committee prior to making proposals which may affect public health. This situation
is not systematically reflected in other legislation in the food safety sector and will
have to be reviewed in order to ensure that all food safety legislation is adequately
based on independent scientific advice.

Limitations of the current system

Since the reform, the Committees have provided some 256 opinions, many of which
include evaluations of a large number of individual substances. It has become evident

Food, Animal Nutrition, Veterinary-Public Health, Plants, Animal Health and Animal Welfare,
Cosmetic products & non-food products, Medicinal products and medical devices, Toxicity, Eco-
toxicity and Environment

12

22.

23.

24.

25.

2

that the existing system is handicapped by a lack of capacity and has struggled to
cope with the increase in the demands placed upon it. Furthermore, the recent dioxin
crisis could only be managed by delaying work in other areas and has shown the
need to have a system which is able to respond rapidly and flexibly. This lack of
capacity has led to delays which have consequences both for the Commission's
legislative programmes, and hence its ability to respond to consumer health
problems, and for industry where commercial dossiers are involved. This situation
will be exacerbated by the increased demands that will be placed on the scientific
committees resulting, for example, from the proposed programme for reform of food
legislation as set out later in this White Paper.

The need for systematic provision of risk assessment data

26.

Risk assessment depends upon the availability of accurate, up-to-date, scientific data.
These may include, for example, epidemiological information, prevalence figures
and exposure data. Support mechanisms for the provision of such information barely
exist and need to be established. As the European Union enlarges, data covering the
new Member States will also need to be taken into consideration. The need to
develop effective information gathering systems at European and world level
requires a new approach, which will make the best use of available resources.

The need for scientific networks

27.

In many areas, the lack of capacity identified above could be addressed by reducing
the amount of time-consuming preparatory work required of Committee members
and external experts.

Community risk assessments for pesticides, biocides and chemicals are already
underpinned by networks of Member State institutes, which are established under
sectoral legislation. This has greatly enhanced the work and efficiency of the relevant
scientific committees. It allows an effective peer review system, and thereby
provides a means of making maximum use of Member States’ expertise without
being prejudicial to the independence of the Committees. Networks also have great
potential for the collection of data. This approach needs to be extended and
consideration must be given to the better exploitation of existing networks.

Concluding remarks

28.

In the light of the shortcomings outlined in this Chapter, it is clear that reinforced
systems are required to respond to the overall objective of improving consumer
health protection and restoring confidence in the EU’s Food Safety policy.
Improvements will therefore be made in the areas of monitoring and surveillance, the
rapid alert system, food safety research, scientific co-operation, analytical support
and the provision of scientific advice. The setting up of a European Food Authority
responsible for, inter alia, these areas is considered in the next Chapter. The report
‘The future of scientific advice in the EU’ by Professors Pascal, James and Kemper
will be taken into account for the establishment of the Authority, as well as for the
improvement of the present system in the transitional phase.

13

CHAPTER 4: TOWARDS ESTABLISHING A EUROPEAN
FOOD AUTHORITY

The Commission envisages the establishment of an independent European Food
Safety Authority, with particular responsibilities for both risk assessment and
communication on food safety issues.

29.

A key priority for the Commission is to take effective measures to ensure a high level
of consumer protection through which consumer confidence can be restored and
maintained. This task has many facets. First there is the confidence question itself –
how is that to be achieved? Secondly, we must ensure that not only is confidence
restored but, even more importantly, that it is retained.
In other words, the system
that is implemented to restore confidence must be sufficiently durable and flexible to
ensure that consumer confidence is maintained on an ongoing basis.

In addition to the range of measures proposed in this White Paper, the Commission
also envisages the establishment of a European Food Authority. The key criteria for
establishing such an authority are considered in this Chapter. The Commission
believes that major structural changes are necessary in the way food safety issues are
handled, having regard to the experience over the last few years and the generally
accepted need functionally to separate risk assessment and risk management. The
in
establishment of a new Authority will provide the most effective instrument
achieving the changes required to protect public health and to restore consumer
confidence. It is clear therefore that the primary focus of such an Authority will be
the public interest.

This Chapter is designed to elicit public debate and informed comment. The
Commission wishes to have a broad consultation on establishing a European Food
Authority. Interested parties are therefore invited to submit comments by the end of
April 2000.

Potential scope of the Authority

30.

31.

The role of an Authority must be defined in the context of the process of risk
analysis, which
risk
communication.

risk management

assessment,

comprises

risk

and

The objective of risk assessment is the provision of scientific advice. Extensive
information gathering and analysis is a pre-requisite for sound and up-to-date
scientific advice. Networks for monitoring and surveillance in the area of public
health and animal health, information systems in the agricultural sector and rapid
alert systems, as well as R&D programmes, play an important role in the generation
of scientific knowledge.

32.

Legislation and control are the two components of risk management.

Legislation comprises primary legislation adopted by Council alone or in co-decision
with the European Parliament and implementing legislation adopted by the
Commission under conferred powers. Legislation implies a political decision and
involves judgements not only based on science but on a wider appreciation of the

14

wishes and needs of society. There must be a clear separation between risk
management and risk assessment.

The Commission, in its role of guardian of the Treaty, is responsible for ensuring that
law and properly
Community legislation is properly transposed into national
implemented and enforced by national authorities in the Member States. The control
function is carried by the Commission's Food and Veterinary Office (FVO), which
reports on its findings and makes recommendations. FVO reports are key elements
for the Commission in deciding whether to take safeguard measures within the
Community or for imports from third countries, or to take infringement proceedings
against Member States. Furthermore, the Commission, in establishing agreements
with third countries that recognise the equivalency of food safety controls under the
WTO/SPS agreement, calls on the FVO for an evaluation of the health situation in
the third countries concerned.

33.

The inclusion of risk management in the mandate of the Authority would raise three
very serious issues.

Firstly,
there is a serious concern that a transfer of regulatory powers to an
independent Authority could lead to an unwarranted dilution of democratic
accountability. The current decision-making process provides a high degree of
accountability and transparency, which could be difficult
to replicate in a
decentralised structure.

the control function must be at

Secondly,
the heart of the Commission's risk
management process if it is to act effectively on behalf of the consumer, notably in
ensuring that recommendations for action arising from control are properly followed-
up. The Commission must retain both regulation and control if it is to discharge the
responsibilities placed upon it under the Treaties.

Thirdly, an Authority with regulatory power could not be created under the current
institutional arrangements of the European Union, and would require modification of
the existing provisions of the EC Treaty.

For these reasons, it is not proposed to transfer risk management competencies to the
Authority.

34.

Risk communication is a key element in ensuring that consumers are kept informed,
and in reducing the risk of undue food safety concerns arising. It requires scientific
opinions to be made widely and rapidly available, subject only to the usual
requirements of commercial confidentiality, where
In addition,
consumers need to be provided with easily accessible and understandable
information relating not only to these opinions, but also to wider issues touching
upon consumer health protection.

applicable.

The advantage of an Authority

The broadest acceptance of scientific risk assessment is essential to ensure that action
is effective, appropriate and rapid.

35.

The responsibilities of the Authority would consist of the preparation and provision
of scientific advice, the collection and analysis of information required to underpin

15

36.

37.

both that advice and the Community’s decision making processes, the monitoring
and surveillance of developments touching upon food safety issues and the
communication of its findings to all interested parties.

Through the manner in which it discharges its functions, the Authority would have to
demonstrate the highest
levels of independence, of scientific excellence and of
transparency in its operations. In this fashion it should be in a position rapidly to
establish itself as the authoritative point of reference for consumers,
the food
industry, Member State authorities and on the wider world stage.

An Authority would be ideally placed to develop the flexible, rapid, response that the
new challenges require. It would provide a single, highly visible, point of contact for
all concerned. It would not only act as a point of scientific excellence, but would also
be available to consumers to provide advice and guidance on important food safety
developments. It would undertake information actions with a view to ensuring that
consumers can make informed choices, and are better informed on food safety issues.

The Authority needs to work in close co-operation with national scientific agencies
and institutions in charge of food safety. The creation of a network of scientific
is
contacts throughout Europe and elsewhere, with the Authority at
designed to ensure that all concerned become associated with the analytical process,
and have a clearer understanding and greater acceptance of the basis for the opinions
that are generated.

its centre,

The Commission and the other EU institutions will have a vital role to play in
supporting the Authority and ensuring that the Authority is adequately resourced and
staffed, and by taking full account of the opinions that the Authority generates.

Objectives of a European Food Authority

The principal objective of a European Food Authority will be to contribute to a high
level of consumer health protection in the area of food safety,
through which
consumer confidence can be restored and maintained.

38.

The Authority must meet the fundamental principles of independence, excellence and
transparency to be successful in its mission. As an integral part of these principles,
the Authority must demonstrate a high level of accountability to the European
institutions and citizens in its actions.

Therefore the Authority must

• be guided by the best science,

• be independent of industrial and political interests,

• be open to rigorous public scrutiny,

• be scientifically authoritative and

• work closely with national scientific bodies.

16

39.

40.

41.

42.

43.

This White Paper draws upon the Commission’s experience of operating scientific
advice, and an examination of a number of models already in place, such as the EU’s
European Medicines Evaluation Agency (EMEA) and the US’s Food and Drug
Administration (FDA). Account has also been taken of the report of Professors
James, Kemper and Pascal on the ‘Future of scientific advice in the EU’.

The Commission believes that a European Food Authority should have a legal
existence and personality separate from the current EU Institutions in order to carry
out independently its role in terms of risk assessment and risk communication, so as
to maximise its impact on consumer health protection and confidence building.

As indicated earlier,
the existing Treaty provisions impose constraints on the
activities that can be attributed to the Authority, but this should not be taken to mean
that a possible future extension of its competencies should be discounted. Such an
extension should only be considered in the light of the experience with the
functioning of the Authority and the confidence gained in its operation, including the
possible need to change the Treaty.

Independence: The existing situation where scientists involved in the provision of
advice are required to respect strict rules concerning their independence must
continue into the new Authority. If consumer confidence is to be regained, the
Authority will need not only to act independently of outside pressures, but to be
accepted as doing so by all parties concerned. Nevertheless the Authority will need
to be representative and accountable. The Commission will examine the range of
the Authority strikes the correct balance in terms of
options to ensure that
independence and accountability,
the views of the other
institutions and stakeholders. Particular attention will need to be paid to the selection
of the head of the Authority.

taking into account

Excellence: To allow the Authority to act as a point of scientific excellence and
reference, and to resolve disputes on scientific issues, it will need rapidly to establish
its international pre-eminence. In addition to ensuring the excellence of independent
scientists, this will require the identification and recruitment of the highest calibre of
personnel, and the best use of available information systems. Particular attention will
be paid to the staffing of the Authority, to ensure that it employs suitably qualified
specialists, who can provide the necessary support for the independent scientists
responsible for the generation of the scientific opinions, as well as collecting and
to its functions. In addition, systems will need to be
analysing data relevant
established so that the best scientists in the different fields can be identified and
called upon as required.

It will also be important that the Authority can respond with sufficient speed and
flexibility to deal with food safety emergencies, as well as longer term projects.

Transparency involves not only the rapid, open, presentation of the findings and
recommendations of the Authority, but also implies that the processes followed in
reaching them are as open as possible, in order to respond to the fundamental right of
access of citizens as laid down in the Treaty. This requires clear procedures, publicly
available, governing the operation of the Authority. In addition, details of the
Authority’s working programme would be made widely available.

17

issues of confidentiality,

Although the discussions by which scientific opinions are reached will need to
their presentation and explanation must be
respect
undertaken as openly as possible. These opinions will continue to be made available
to the Commission and the Parliament by the Authority as soon as they are available
and, at the same time, published on the internet so that all interested parties are kept
fully informed.

The tasks of the Authority

It is envisaged that the Authority would embrace scientific advice, the gathering and
analysis of information and the communication of risk. These issues are dealt with in
Chapters 3 and 7 of this White Paper.

Scientific advice: The scope of the Authority should be to provide scientific advice
and information to the Commission on all matters having a direct or indirect impact
on consumer health and safety arising from the consumption of food. Thus it will
industrial
cover primary food production (agricultural and veterinary aspects),
processes, storage, distribution and retailing. Its remit will encompass both risk and
nutritional issues. The Authority will also cover animal health and welfare issues,
take into consideration risk assessments in other areas, notably the
and will
environmental and chemical sectors where these overlap with risk assessment in
relation to food.

the scientific work currently undertaken by the
The Commission believes that
Scientific Committees related to food safety should be a core part of the proposed
Authority. In this context, the structure and mandates of the existing Scientific
Committees will be reviewed to ensure that scientific advice responds to the full
range of responsibilities attributed to the Authority. The Committee(s) will provide
opinions upon request by the Commission. In a proactive capacity, the Committee(s)
should also signal new health hazards or emerging health problems and the Authority
will have to follow-up such concerns.

The Authority will establish means for the rapid identification of scientific experts in
the European Union, and elsewhere. In this manner, the Authority will need to access
a world-wide network of scientific excellence, with the flexibility to respond rapidly
to changing situations.

The Authority must be able to keep up-to-date with the most recent scientific
developments and to identify gaps in on-going research or topics where it feels that
rapid targeted work is necessary. The Authority would have its own budget for the
commissioning of ad-hoc targeted and immediate research in response to unforeseen
health emergencies, in liaison with the Commission’s Joint Research Centre, national
scientific agencies and international organisations. Account should also be taken of
the work of the networks established through the Community research programmes;
mechanisms to enhance a two-way interaction between these Community research
programmes and the Authority will need to be established.

The Scientific Committee(s) must be able to concentrate on the core task of
preparing the scientific opinions. The Committee(s) will be supported by a scientific
secretariat, which will be responsible for the interface between them and the risk
managers. In addition, it will be necessary to establish in-house scientific support
which will undertake much of the preparatory work for the Committee(s).

18

44.

45.

46.

47.

48.

49.

50.

51.

52.

53.

Information gathering and analysis: There is a pressing need to identify and use
the information currently available throughout both the Community and world-wide
on food safety issues. This would be a key task for the Authority, and represents an
area where great scope for
this
improvement exists.
in ensuring that potential problems are
information can form a major element
identified as quickly as possible and that scientific advice addresses the wider health
picture.

If properly exploited,

The Authority will be expected to take a proactive role in developing and operating
food safety monitoring and surveillance programmes. It will need to establish a
network of contacts with similar agencies, laboratories and consumer groups across
the European Union and in third countries.

The Authority must be able to guarantee a real-time evaluation and response of the
outcome of these programmes, ensuring that real or potential hazards are rapidly
identified. In addition, the Authority will need to develop a predictive system that
will allow the early identification of emerging hazards, so that crises can be avoided
where possible.

Communication: The ability to communicate directly and openly with consumers on
food issues will give the Authority a high public profile. The Authority will need to
make special provision for informing all interested parties of its findings, not only in
respect of the scientific opinions, but also in relation to the results of its monitoring
and surveillance programmes.

The Authority must become the automatic first port of call when scientific
information on food safety and nutritional issues is sought or problems have been
identified. It will also need to ensure that appropriate information on these issues is
published, as part of its commitment to re-establishing consumer confidence. Clearly
the Commission will continue to be responsible for communicating risk management
decisions.

Reacting to crises

Where a food safety emergency occurs, the Authority will collect, analyse and
distribute relevant information to the Commission and Member States, and will
mobilise the necessary scientific resources to provide the best possible scientific
advice. The Authority will have to respond rapidly and effectively to crises, and will
take a key role in supporting the EU response. This will promote improved planning
and handling of crisis situations at the European level, and will demonstrate to
consumers that a pro-active approach is being taken to deal with problems.

The Authority will operate the Rapid Alert System, which allows the identification
and rapid notification of urgent food safety problems. The Commission will be part
of the network and will therefore be informed on a real-time basis. Depending on the
the Authority may be requested carry out follow-up tasks,
nature of a crisis,
including monitoring and epidemiological surveillance.

Networking with national agencies and scientific bodies

54.

The European Food Authority must be a value-added structure: it should work in
close co-operation with national scientific agencies and institutions in charge of food

19

55.

56.

57.

safety and build upon their expertise. This would result in the creation of a network,
designed to ensure the best and most effective use of existing structures and
resources. One of the tasks of the European Food Authority will, therefore, be to link
centres of excellence, allowing its in-house scientific staff to draw from the leading-
edge scientific expertise in all the relevant disciplines across the European Union and
at international level. Similarly, national bodies will be able to have access to a
scientific base of the highest possible calibre. Through their dynamic two-way
exchange, the role of the Authority will be progressively enhanced. This will lead,
over time, to reliance on the Authority as the most authoritative source of knowledge
on food safety matters in the EU.

Within the network system, best use of the existing scientific and technical
capabilities and infrastructures of the Commission Joint Research Centre (JRC)
should be ensured.

Interface with Commission services

The Authority and the Commission services must work very closely together from
the moment that the Authority assumes its functions. This will concern, in particular,
those charged with the preparation of legislation, law enforcement and the operation
of controls and inspections (FVO), as well as the Joint Research Centre and those in
charge of Community R&D. This will ensure that the Authority’s findings can be
used to the best effect possible, and that it is kept informed of issues of direct
consequence for its own activities. At the same time, it will allow the Authority to be
responsive to the needs of the Commission services. This interface should of course
not blur the distinctive role assigned to the Authority.

Resources

The resource implications of setting up and operating the scientific advisory systems,
information collection and analysis, and effective networks with scientific bodies in
Member States should not be underestimated. In addition to its scientific and
communication tasks, the Authority will have to carry a heavy workload in terms of
administrative and financial management. The Authority will make extensive use of
information and communication technologies; and promote their use by national
agencies and institutions in charge of food safety. The efficacy of the Authority will
ultimately depend on the adequacy, in terms of both size and quality, of the human,
financial and physical resources allocated. It will only be possible to define the
resources needed in the light of decisions taken after the consultation process and
detailed feasibility studies. The detailed figures in this regard will be presented with
the Commission’s definitive proposal for the establishment of the Authority and take
account of the forthcoming Commission debates concerning political priorities and
the related allocation for operational and human resources.

Location of the Authority

58.

The Authority will need to develop very close working links with the Commission’s
services involved in food safety issues, and with the other EU institutions if it is to
carry out its functions effectively and to be available for rapid consultation in crises
situations. The Authority also needs to be easily accessible, not only for the scientists
called upon to develop the scientific opinions, but also for all other stakeholders who
need to seek the views of the Authority. This is not only important for the best use of

20

resources, but also to demonstrate the openness and availability of the Authority, in
the
particular
Commission considers that the Authority must be established in an easily accessible
location.

In light of these considerations,

in its role in communication.

Candidate countries

59.

The candidate countries will be associated to the work of the Authority in line with
the conclusions of
the Luxembourg European Council which underlined the
importance for these countries to become familiar with the working methods and
policies of the Union. Specific arrangements will be developed in the up-coming
work on the establishment of the Authority.

Implementation Timetable

The Commission believes that it is essential to have a very rapid implementation
schedule for the establishment of the Authority.

60.

The following timetable is foreseen for the formal establishment of the new
Authority:

• White Paper published : January 2000

• Consultation period : end of April 2000

• Commission proposal : September 2000

• Enabling legislation : December 2001

• Authority starting operations : 2002

61.

62.

While the timetable set out is ambitious, particularly given the scale of the task, the
Commission considers that it is achievable given its experience in establishing the
EMEA. Not alone will it be necessary to have a rapid start up schedule for the new
Authority, but it will also be necessary, in parallel, to improve the functioning of the
existing system. The Commission will establish a dedicated team to ensure that there
is rapid action on the range of issues identified in this Chapter of the White Paper.

The reinforcement of the present system of risk assessment and communication will
be a key part of the range of measures necessary to ensure that the Authority can
really become operational within two years. Having regard to the availability of
resources over the next two years, the Commission will evaluate the possibility of
reinforcing the existing scientific support and advice structures in the lead-in phase
to the establishment of the Authority.

21

63.

64.

65.

66.

67.

CHAPTER 5: REGULATORY ASPECTS

In Chapter 4, the Commission has highlighted why risk management must be left to
an institutional framework with full political accountability. Notwithstanding the
proposed creation of a European Food Authority,
the drafting and making of
legislation will remain the responsibility of the Commission, the Parliament and the
Council.

The European Union has a broad body of legislation which covers primary
production of agricultural products and industrial production of processed food. The
legislation has evolved over the last thirty years, reflecting a blend of scientific,
societal, political and economic forces, in particular in the framework of creating the
Internal Market, but no overall coherence has been guiding this development. For
this reason, the Green Paper on the general principles of food law in the European
Union (COM(97) 176 final) already foresaw the need for a major review of food
legislation.

Food production is extremely complex. Products of animal and plant origin present
intrinsic hazards, due to microbiological and chemical contamination. Nevertheless,
the current legal framework and operational set-up has in general afforded the EU
consumer a high level of health protection. The real problem is not necessarily due to
a lack of legal instruments, but the broad disparity in the means to respond to
situations in specific sectors, or the multiplicity of actions which need to be triggered
in the case where a problems spills over from one sector to another. One of the
weakest links in the system is the lack of a clear commitment from all interested
parties to give an early warning about a potential risk, so that the necessary scientific
evaluation and protective measures can be triggered early enough to ensure a pro-
active rather than reactive response at EU level.

The full range of measures proposed is presented in the Annex with an indication of
the priority measures and likely timing, though resource constraints may affect the
finalisation of some initiatives.

New legal framework for food safety

There is a need to create a coherent and transparent set of food safety rules.

The Commission intends to make proposals for a new legal framework laying down
the principles to ensure a coherent approach and to fix the principles, obligations and
definitions that apply in this field. The aim of these proposals will be to reflect the
outcome of the extensive consultation which the Commission initiated in 1997 with
the publication of its Green Paper on food law, to lay down the common principles
underlying food legislation and to establish food safety as the primary objective of
EU food law.

The Commission will make proposals including a General Food Law, which will
embody the principles of food safety referred to in Chapter 2. These proposals will
be subject to the fullest consultation with all interest groups at the earliest possible
stage in their development and impact analysis of legislative proposals will be
undertaken as appropriate. Individual legislation needs to be clear, simple and

22

68.

69.

understandable for all operators to put into effect. There also needs to be close co-
operation with the competent authorities at the appropriate levels in the Member
States to ensure proper and consistent compliance and enforcement and to avoid
unnecessary administrative procedures.

These proposals will also provide the general frame for those areas not covered by
specific harmonised rules but where the functioning of the Internal Market is ensured
by mutual recognition, as developed by the European Court of Justice in its “Cassis
in the absence of Community
de Dijon” jurisprudence. Under this principle,
harmonisation, Member States may only restrict
the placing on the market of
products lawfully marketed in another Member State when and to the extent that this
can be justified by a legitimate interest such as the protection of public health and
that the measures taken are proportionate. In this context, the Commission will
continue to use all means at its disposal, either formal (infringement procedures) or
informal (networks of Member States representatives and meetings, etc) in order to
resolve disputes on obstacles to trade. Action for measures at Community level will
be envisaged where a barrier to trade is found to be justified on food safety grounds.

New legal framework for animal feed

The safety of food from animal origin begins with safe animal feed.

Although legislation cannot prevent all incidents affecting the feed and food chain, it
can set up appropriate requirements and controls allowing for early detection of
problems and speedy corrective action. In this respect, the action needed in the
animal feed sector is illustrative. The principles of food safety mentioned in Chapter
2 should become applicable to the feed sector, in particular to clarify responsibilities
of
feed producers and to provide a comprehensive safeguard clause. More
specifically, the materials which may or may not be used in animal feed production,
including animal by-products, need to be clearly defined. A positive list of feed
materials would give the clearest response to the current lack of definition of feed
materials but this task is complex and time-consuming. In the short term, the current
negative list needs to be rapidly expanded. However the Commission is committed to
working towards a positive list over the medium term. In addition, a revision of
Community legislation will be proposed in order to exclude fallen animals (cadavers)
and condemned material from the feed chain. The only material allowed to be used in
animal feed would then be material derived from animals declared fit for human
consumption.

A legislative proposal for the evaluation, authorisation and labelling of novel feed, in
particular of genetically modified organisms and feeding stuffs derived therefrom,
will be put forward.

Clarification between the different categories of products used in animal nutrition
(additives, medicinal products, supplements) is necessary in order to avoid grey
zones and to clarify which requirements apply in each case. The Commission will
also pursue the prohibition or phasing-out of antibiotics used as growth promoters in
the EU depending on their potential use in human and veterinary medicine as part of
its broad strategy to control and contain antibiotic resistance.

Now that the origins and consequences of the dioxin crisis are becoming clearer, it
has become obvious that the feed manufacturing industry should be subjected to the

23

70.

71.

same rigorous requirements and controls as the food producing sector. Lack of
internal controls (good manufacturing practice, own-checks, contingency plans) and
lack of mechanisms for traceability allowed the dioxin crisis to develop and expand
throughout the whole food chain. Legislation will be proposed in order to correct
these anomalies, including official approval of all feed producing plants as well as
official controls at national and EU level. To align the framework for the feed sector
with that of the food sector, a rapid alert system for feed shall be integrated into the
rapid alert system for food.

Animal health and welfare

The health and welfare of food producing animals is essential for public health and
consumer protection.

Animal health is also an important factor in food safety. Some diseases, the so-
called zoonoses, such as tuberculosis, salmonellosis and listeriosis can be transmitted
to humans through contaminated food. These diseases can be particularly serious for
certain categories of
the population. Listeriosis may cause encephalitis and
spontaneous abortions; salmonellosis is an emerging public health problem. The
availability of a correct picture of the situation is a pre-requisite for action. Therefore
Community monitoring for
food borne diseases and zoonoses is needed and
harmonised reporting requirements need to be introduced. The information derived
therefrom will facilitate the Commission in setting targets and in taking more
effective measures to reduce the prevalence of zoonotic diseases.

Existing eradication and disease control programmes, such as those for tuberculosis
and brucellosis, should be continued and where possible re-enforced; in particular, in
those Member States whose status with regard to these diseases remains problematic.
Particular attention should be devoted to the control of hydatidosis and Brucella
militensis in Mediterranean regions. Information on zoonoses monitoring needs to be
better exploited in order better to define programmes at EU level.

This White Paper makes proposals specifically designed to promote the health and
welfare of animals only in so far as Food Safety policy is directly concerned. The
Commission acknowledges that animal health and welfare issues in a broader context
are important. In the context of this White Paper, it
is recognised that animal
welfare questions need to be integrated more fully with regard to food policy. In
particular the impact on the quality and safety of products of animal origin intended
for human consumption needs to be reflected in the legislation.

Most of the legislation relating to BSE/TSE has been adopted in the form of
safeguard measures, taken on an ad hoc basis. By definition, the adoption of such
measures does not involve all Community institutions. They also do not provide for a
fully consistent approach. The Commission has addressed this problem in proposing
to the Council and the European Parliament a comprehensive proposal based on
Article 152 of the Treaty, which covers all measures to control BSE and other
transmissible spongiform encephalopathies (TSEs). Until
this
proposal, emergency measures will be taken to ensure a high level of protection
during the interim period. The most important measures will be rules on removal of
specified risk materials in combination with a provisional classification according to
BSE status, reinforcement of the epidemiosurveillance system on the basis of testing

the adoption of

24

certain higher risk animals (fallen stock, emergency slaughtered cattle), updating of
the feed ban and embargoes in the light of recent scientific advice.

In addition the Commission takes the view that further testing to establish the
incidence of BSE across the Union is desirable. This will of course depend upon the
availability of suitable post mortem tests. The Commission will keep this under
active review and will make proposals for a suitable testing programme in the light
of developments.

Hygiene

A co-ordinated and holistic approach towards hygiene is an essential element of food
safety.

Over time, the Community has developed extensive requirements relating to hygiene
of food. These include over twenty legal texts, which are designed to ensure the
safety of food produced and placed on the market. However, these requirements were
adopted as a scattered response to the needs of the Internal Market, taking into
account a high level of protection. This has resulted in a series of different hygiene
regimes according to whether the food is of animal or plant origin, which can only be
justified for historical reasons. It has also left some areas out of the scope of the
requirements, such as production of food of plant origin at the level of the farm
(primary production). A new comprehensive Regulation will be proposed recasting
the existing legal requirements to introduce consistency and clarity throughout the
food production chain. The guiding principle throughout will be that food operators
bear full responsibility for the safety of the food they produce. The implementation
of hazard analysis and control principles and the observance of hygiene rules, to be
applied at all levels of the food chain, must ensure this safety. The Commission shall
examine how best to assist small and medium enterprises in implementing these
requirements, in particular by supporting the development of guidance documents. In
addition, a procedure for laying down microbiological criteria and, where necessary,
food safety objectives will be introduced.

Contaminants and residues

Limits of contaminants and residues must be set and controlled.

The term “contaminants” traditionally covers substances which are not intentionally
added to food. They can be the result of environmental contamination; they also can
result
from agricultural practices, production, processing, storage, packaging,
transport or from fraudulent practices. Specific EU requirements only exist for a few
contaminants, although many measures exist at national level. This is de facto
leading to disparity in consumer health protection throughout the EU, but also to
practical difficulties for control authorities and industry. The serious nature of this
gap was highlighted during the dioxin crisis, where ad hoc limits, only valid for
products of Belgian origin, were set in the framework of a safeguard measure. There
is therefore an obvious need to define standards for contaminants throughout the
chain leading from feed to food. The scientific basis for setting these limits needs to
be addressed as a matter of priority.

72.

73.

74.

Some substances are found in food as a result of intentional use. This concerns
residues of pesticides in food of plant and animal origin and veterinary medicines

25

in food of animal origin. Community legislation has laid down rules for the
establishment of maximum residue limits of these substances in food and agricultural
products. Member States have an obligation to monitor compliance with these limits
but there are no harmonised requirements and the monitoring activities varies among
them. Moreover there is a limited number of accredited laboratories capable of
carrying out monitoring in the Member States. As far as pesticides are concerned, the
Commission aims at progressively setting limits for all pesticide/commodity
combinations. Action to correct deficiencies with regard to monitoring and
laboratory testing will be taken.

At present, there is a large number of pesticides on the market that have not yet been
evaluated at Community level. In the meantime, new pesticides are being presented
for obtaining a market authorisation. The approval procedure of new pesticides needs
to be accelerated. In parallel, the review of the approval of existing pesticides needs
to be streamlined so as to eliminate very rapidly products for which safety data are
lacking or for which safety concerns have been identified. This will therefore
promote the use of safer pesticides.

However, the performing of risk assessments for approving pesticides and setting
maximum residue limits is hampered by the absence of sufficient accurate data about
diets. In order to fill this gap, a major study to establish a database on diets will be
carried out; this database will also be an essential tool for risk assessment of any
other contaminant, additive, etc.

Legislation on the radioactive contamination of food and feed is taken on the basis
of Article 31 of the Euratom Treaty, and in case of imports, on the basis of Article
133 of the Treaty. In this context, the post-Chernobyl legislation will be kept under
constant review.

Novel Food

The Community provisions governing novel foods have to be tightened and
streamlined.

The procedure for authorising the placing on the market of novel foods (i.e. foods
and food ingredients which have not yet been used for human consumption, in
particular those containing or derived from genetically modified organisms) should
be clarified and made more transparent. Exemptions from these provisions need to be
reviewed. Therefore, the Commission will adopt an implementing regulation to
clarify the procedures laid down in the Novel Food Regulation (EC) N° 258/97 and
will in due course also present a proposal to improve this Regulation in accordance
with the revised regulatory framework for the deliberate release of GMOs under
Directive 90/220/EEC. Furthermore, the labelling provisions have to be completed
and harmonised.

Additives, flavourings, packaging and irradiation

There is a need to up-date and complete existing Community legislation with regard
to additives, flavourings, packaging and irradiation.

75.

76.

77.

The provisions relating to food additives and flavourings need to be amended in
implementing powers should be conferred on the
several

respects. Firstly,

26

78.

79.

80.

Commission to maintain the Community lists of authorised additives and the status
of enzymes should be clarified. Secondly, the Community lists of colouring matters,
sweeteners and other additives need to be updated. Thirdly, the purity criteria for
sweeteners, colours and other additives have to amended and appropriate purity
criteria for food additives made from novel sources have to be laid down. The
Commission will further publish a report on the intake of food additives. Specific
action concerning flavourings has so far concentrated on chemically defined
substances. More work is needed to reflect innovation in this field and new insight in
toxicological effects of substances naturally present in flavourings. The Commission
will update the register of flavouring substances, establish a programme for their
evaluation and lay down a list of additives authorised for use in flavourings.

The Commission will also consider changing the Community framework for
materials that come into contact with food in order to enhance the administration
of this sector and to improve the labelling requirements. The structure and
the Directives on plastic materials will be improved and
transparency of
consideration will be given to an extension of these provisions to surface coatings.
As regards the materials not yet under harmonisation (paper, rubber, metals, wood,
cork), the Commission will continue to collaborate with the other European bodies
active in this field (CEN, Council of Europe).

The Commission will further propose a Directive to complete the list of foodstuffs
authorised for irradiation treatment, and publish the details of the irradiation
facilities operating in the Member States, as well a list of third countries’ facilities
which are approved as equivalent. It will also elaborate a Directive on constituents of
natural mineral waters and on the conditions of use for the treatment of certain
natural mineral waters with ozone enriched air.

Emergency measures

The possibility for taking safeguard measures is an essential tool for managing food
safety emergencies.

The dioxin crisis has demonstrated the lack of consistency of the present framework
for the adoption of safeguard measures in response to an identified risk to consumer
health. The Commission does not at present have a legal instrument to adopt a
safeguard measure upon its own initiative either for feed or for a processed food of
non-animal origin originating from one of the Member States. According to the
sector,
the mechanisms for adoption of safeguard measures are different. The
adoption of a single emergency procedure applicable to all types of food and feed,
whatever their geographical origin, is the only means to remove the disparities and
close the loopholes. In this regard, the Commission will be making a comprehensive
legislative proposal.

Decision making process

The decision making process needs to be streamlined and simplified in order to
ensure efficacy, transparency and rapidity.

81.

The EU food legislation can be based on various provisions of the EC Treaty: Article
95 in the case of measures for the completion of or the functioning of the Internal
Market (taking as a basis a high level of consumer and health protection), Article 152

27

for measures in the veterinary and phyto-sanitary fields which have as their direct
objective the protection of public health, Article 153 relating to consumer protection
and Article 37 where agricultural aspects are preponderant. Depending on the legal
basis, measures are adopted by the Council
in co-decision with the European
Parliament or after consultation of the European Parliament on proposal by the
Commission.

Article 202 of the EC Treaty provides that in the instruments which it adopts, the
Council shall confer on the Commission powers for the implementation of the rules
which the Council lays down, save in specific cases where it may reserve the right to
exercise directly implementing powers itself. Such transfer of competence should
normally allow the Commission to transform rapidly the scientific advice it receives
by amending the appropriate legislation or adopting appropriate decisions. In some
cases however (in particular for food additives) implementing powers have not yet
been conferred on the Commission with the undesirable result that updating positive
lists of authorised substances (whether this is necessary to authorise a new substance,
to ban the use of an authorised substance, or to modify the conditions of use of an
authorised substance) can take several years after the formulation of the scientific
advice.

Where implementing powers have been conferred on the Commission (for example
flavourings, extraction solvents, contaminants, pesticide residues, materials in
contact with food, diet foods, irradiated foods or quick-frozen foods), the current
transforming scientific advice into legislation or
decision-making process for
decision is in some cases not satisfactory: the procedures applicable are disparate and
cumbersome; different committees are involved; different modalities apply;
resources are scarce and scattered.

All the procedures laid down by the EU food legislation for its implementation and
its adaptation to technical and scientific progress need to be reviewed. In this respect
the number of committees dealing with delegated legislation and the adoption of
individual decisions should be reduced and streamlined. Better co-ordination should
be introduced to ensure that food safety issues are addressed as a continuum from
farm to fork through the application of a single regulatory procedure for delegated
legislation, a single management procedure for the adoption of individual decisions
and an emergency procedure for all urgent matters of food safety. The new
procedures should be in conformity with the recent Decision on comitology.

Clear and strict deadlines should be fixed for the Commission to prepare an
amendment or decision, for the Standing Committee to reach an opinion and for the
Commission to finalise an amendment or decision. Greater transparency should be
considered at all stages of the regulatory process. Information and communication
technologies should be used extensively to automate the production and tracking of
amendments and decisions and to accelerate their circulation between all the parties
involved.

82.

83.

84.

28

CHAPTER 6: CONTROLS

A comprehensive piece of legislation will be proposed in order to recast the different
control requirements. This will take into account the general principle that all parts of
the food production chain must be subject to official controls.

Development of EU legislation

Legislative requirements setting out official controls at both national and EU level
have been established in different pieces of Community legislation over a period of
more than 30 years. Although these legislative acts have the same objective, their
approach to the operation of these controls is different. They also contain anomalies,
resulting in an incomplete legal basis for carrying out official controls in both
Member States and third countries. There is a need to clarify and update existing
food control legislation and to ensure that it covers all steps in the production.
Furthermore, certain detailed meat inspection requirements need to be reviewed as
they are no longer in line with modern food safety management practices.

Existing legislation includes a system whereby Member States can collect fees to
cover the costs of controls for products of animal origin. Member States may levy
charges on importers for the control of a certain number of products of animal and
legislation. There are
non-animal origin for compliance with post-Chernobyl
differences in the level of fees charged between, and within, the Member States. In
addition, there is no legal basis for a similar system to be applied to controls of feed
and food of non-animal origin.

The lack of uniformity in setting and charging control fees, and the extension of this
principle to the areas not presently covered, will be included in this legislative
review. Common objectives should be fixed at EU level with regard to the staff and
equipment requirements, whilst guarantees should be introduced to ensure that fees
are used only for the financing of controls.

Controls over the operation of EU legislation

Responsibility for safe food production is shared between operators, national
authorities and the European Commission. Operators are responsible for compliance
with legislative provisions, and for minimising risk on their own initiative. National
authorities are responsible for ensuring food safety standards are respected by
operators. They need to establish control systems to ensure that Community rules are
being respected and, where necessary, enforced.
These systems need to be
developed at Community level, so that a harmonised approach is followed.

To ensure that these control systems are effective, the Commission, through the Food
and Veterinary Office (FVO), carries out a programme of audits and inspections.
These controls evaluate the performance of national authorities against their ability to
deliver and operate effective control systems, and are supported by visits to
individual premises to verify that acceptable standards are actually being met.

Recent food safety crises have highlighted deficiencies in national systems of
control. At the heart of the problem is the lack of harmonised Community approach
to the design and development of national control systems.

29

85.

86.

87.

88.

89.

90.

91.

There is therefore a clear need for a Community framework of national control
improve the quality of controls at Community level, and
systems, which will
consequently raise food safety standards across the European Union. The operation
of such control systems would remain a national responsibility. This Community
framework would have three core elements.

• The first element would be operational criteria set up at Community level,
which national authorities would be expected to meet. These criteria would form
the key reference points against which the competent authorities would be audited
by the FVO, thereby allowing it to develop a consistent, complete, approach to the
audit of national systems.

• The second element would be the development of Community control
guidelines. These would promote coherent national strategies, and identify risk-
based priorities and the most effective control procedures. A Community strategy
would take a comprehensive, integrated, approach to the operation of controls.
These guidelines would also provide advice on the development of systems to
record the performance and results of control actions, as well as setting
Community indicators of performance.

• The third element of the framework would be enhanced administrative co-
operation in the development and operation of control systems. There would be a
reinforced Community dimension to the exchange of best practice between
national authorities. This would also include promoting mutual assistance between
the Member States by integrating and completing the existing legal framework.
Furthermore, this would cover issues such as training, information exchange and
longer term strategic thinking at Community level.

Development of this overall Community framework for national control systems
would clearly be a task for the Commission and the Member States working together.
The experience of the FVO will be an essential element in its development.

Since the establishment of the Single Market, the importance of having effective and
harmonised
health controls at the external borders of the European Union has
become very clear. The current system, based on border inspection posts (BIPs)
under the control of individual Member State authorities, only covers products of
animal origin. Furthermore it fails to provide a sufficiently well co-ordinated
approach to border checks. The legal basis for border checks needs to cover all
products, and to identify a more effective Community-level control system.

It is necessary to consider whether the Commission needs to be given additional
in support of existing infringement procedures, where controls reveal
powers,
significant non-compliance with EU rules. This must allow,
in particular, rapid
action to be taken in the face of immediate consumer health risks, and be based upon
an effective and transparent follow-up of FVO inspection reports. As appropriate, it
should also be possible to withhold Community financial support, or to reclaim
funding already allocated.

92.

93.

94.

30

CHAPTER 7: CONSUMER INFORMATION

Risk communication

Risk communication should not be a passive transmission of information, but should
be interactive, involving a dialogue with and feedback from all stakeholders.

95.

Risk communication consists of information exchange between concerned parties on
the nature of the risk and the measures to control this risk. This is a fundamental
responsibility for public authorities when managing public health risks. This can only
function correctly if risk assessments and risk management decisions are transparent
and public. Since 1997, the Commission has implemented a new approach to ensure
transparency by making available to the public all information on scientific advice
and on inspections and controls. This policy is a key element in risk communication
and public confidence and has therefore to be actively pursued.

96.

In all aspects related to food safety, it is essential that the consumer is a fully
recognised stakeholder and that consumer concerns are taken into account by

97.

98.

99.

• consulting the public on all aspects of food safety

• providing a framework for discussions (public hearings) between scientific

experts and consumers

• facilitating trans-national consumer dialogue both at European and at global level.

It is important that all steps in policy making are taken in full openess. However
good a new system may be, without this transparency the consumers will not be able
to follow the development of
the new measures and fully appreciate the
improvements which they bring. Transparency will result in the necessary public
scrutiny and ensure democratic control and accountability.

Finally, a more pro-active approach needs to be introduced concerning the
communication of unavoidable risks for certain parts of the population. For instance
women of childbearing age, pregnant women, infants, the elderly and immuno-
deficient people should be warned more actively about the possible risks of certain
foods.

Labelling and advertising

Consumers are to be provided with essential and accurate information so that they
can make informed choices.

Binding labelling rules must, therefore, ensure that the consumer has the information
on the product characteristics that determines choice, composition and storage and
use of a product. Operators should be free to provide more information on the label,
provided this information is correct and not misleading.

Within the WTO, labelling has become a trade policy issue in many different fields,
including food safety, in relation to both the TBT and the SPS agreements. The
Community has therefore indicated that it will pursue multilateral guidelines on

31

100.

101.

102.

103.

labelling. The guidelines should serve to avoid unnecessary disputes. This is of
particular interest for the Community given our position on the consumer’s right to
know.

Further to the ongoing codification of the Labelling Directive, the Commission
intends to propose a new amendment which would remove the current possibility not
to indicate the components of compound ingredients, where they form less than 25%
of the final product. Full ingredient labelling will not only ensure optimal consumer
information as to the composition of a food product but will at the same time ensure
the necessary information for those consumers who for health or ethical reasons have
to, or want to, avoid certain ingredients. In this context, the problem of carry-over of
additives still needs to be considered. Furthermore, for ingredients that are known
allergens, but where only the name of the category needs to be indicated, an
indication as to the presence of such allergens will be considered in order to enable
susceptible consumers to avoid such products.

The Labelling Directive prohibits the attribution to any foodstuff of the property of
preventing, treating or curing a human disease or reference to such properties. The
Commission continues to consider that
labelling and advertising of a foodstuff
should not contain such health claims. It is indeed true that a good balanced diet is a
prerequisite for good health, but claims that the intake of food can prevent, treat or
cure one disease or another could in fact lead consumers to unbalanced dietary
choices. The Commission will however consider whether specific provisions should
be introduced in EU law to govern “functional claims “ (for example claims related
to beneficial effects of a nutrient on certain normal bodily functions) and “nutritional
claims” (such as claims which describe the presence, absence or the level of a
nutrient, as the case may be, contained in a foodstuff or its value compared to similar
foodstuffs). Furthermore, the Commission will consider the need of bringing the
requirements of the Nutrition Labelling Directive into line with consumer needs and
expectations.

Complementary to the approach to labelling of foodstuffs, the means of redress that
consumers and competitors enjoy against misleading advertising messages should
be extended to allegations related to the above-mentioned types of claims. The
to amend the Misleading
Commission will make a proposal
Advertising Directive and will ensure that advertising and labelling provisions in
respect of claims provide for a coherent legislative framework.

in this respect

The Commission will further consider the opportunity to revise or introduce specific
labelling provisions for certain categories of foods. Specific rules, such as the
obligatory indication of place of origin for
fresh fruit, which provide better
information to the consumer on these products, are not in contradiction with the
general rules. The Commission will also clarify the provisions governing the
labelling of novel food, and,
in particular, products derived from genetically
modified organisms, and will take an initiative with regard to the labelling of
additives produced through genetic engineering and to the labelling of food and food
ingredients produced without genetic engineering (so-called “GMO-free food”).

32

104.

105.

106.

107.

Nutrition

Consumers show a rising interest in the nutritional value of the food they purchase,
and there is a growing need to avail consumers of correct information about the food
they consume.

Ensuring the protection of public health is not restricted to chemical, biological and
physical safety of food.
It should also aim at ensuring the intake of essential
nutrients while limiting intake of other elements in order to avoid adverse health
effects, including anti-nutritional effects. Scientific information has shown that an
adequate and varied diet are very important factors in maintaining good health and
overall well being. This may be particularly true now that new types of products are
appearing on the market with modified nutritional value, which can influence the
behaviour and well being of consumers either favourably or unfavourably. In
addition, the information which would allow the consumer to make the correct
choices is not systematically available in a clear and accessible way.

In respect of dietetic foods (i.e. foods intended to satisfy the particular nutritional
requirements of specific groups of the population), the Commission will elaborate a
the needs resulting from intense
specific Directive on foods intended to meet
muscular effort. It will also prepare a report on foods intended for persons suffering
from diabetes, and define the conditions for making the claims “low-sodium” or
“sodium-free” and “gluten-free”. The Commission will also submit to Council and
Parliament two proposals for Directives on food supplements (i.e. concentrated
sources of nutrients such as vitamins and minerals) and fortified foods (i.e. and
foods to which nutrients have been added). Finally, purity criteria will have to be laid
down for nutritional substances which are added to food for particular nutritional use
or which are present in food supplements and foods to which nutrients are added.

A number of actions at Community level have been organised in the context of the
“Fourth and Fifth Research and Development Framework Programme”. These
actions provide some of the components which should be relevant to a nutritional
policy. The Commission is considering the development of a comprehensive and
coherent nutritional policy and will present an action plan for that purpose.

A number of aspects that have already been raised in this White Paper also apply to
the establishment of a policy in this field. Successful implementation of a nutritional
policy requires in particular efficient monitoring, data collection and data analysis.
Information on food intake, diets and nutritional status should therefore be included
in national and Community data collection systems. In addition, research and studies
on nutrition should be promoted, scientific advice should be actively sought and the
results thereof be made available in full transparency. Another important aspect of a
nutritional policy is efficient and correct consumer information; in this respect, the
Nutrition Labelling Directive plays a role. A special effort to establish appropriate
information tools, including nutritional labelling but also information campaigns,
should be put in place. Council Recommendations for dietary guidelines will be
proposed. Appropriate communication to consumers will have to be ensured.

33

108.

109.

110.

CHAPTER 8: INTERNATIONAL DIMENSION

The key principle for imported foodstuffs and animal feed is that they must meet
health requirements at least equivalent to those set by the Community for its own
production.

The Community is the world’s largest importer/exporter of food products, and trades
with countries all over the world in an increasing diversity of food products. With
this extensive trade in food products, food safety cannot be seen as solely an internal
policy question. Exactly the same concerns as regards zoonoses, contaminants and
other concerns apply to food products in international trade, whether these products
are to be imported into the Community or exported from the Community. In order to
ensure that these requirements are met, our WTO obligations require either that we
base those measures on international standards or in so far as they are not based on
international standards, that the measures are scientifically warranted. In cases where
scientific evidence is insufficient, provisional measures may be adopted on the basis
of available pertinent information.

The international framework as regards food safety has developed significantly
through the enhanced role of certain international organisations such as the Codex
Alimentarius and the International Office of Epizootics (OIE) under the World Trade
Organisation Agreement on the Application of Sanitary and Phytosanitary Measures
(the SPS Agreement), the World Health Organisation (WHO) and the Food and
Agriculture Organisation (FAO).

The Community plays an active role in the SPS Committee, and in other WTO
committees, to ensure that the international framework encourages and defends the
rights of countries to maintain high public health standards for food safety. In this
context, the Community has the objective to clarify and strengthen the existing WTO
framework for the use of the precautionary principle in the area of food safety, in
particular with a view to finding an agreed methodology for the scope of action
under that principle. The adoption of a global approach towards food safety as set out
in the present White Paper will contribute to re-enforce the role of the Community in
WTO.

Some third countries use sanitary and phyto-sanitary arguments without scientific
justification in order to refuse the access of Community food products to their
market. The SPS Agreement provides the right to obtain the risk assessment on
which a third country measure is based. Such risk assessment should be carefully
analysed in due time, in order to detect inconsistencies and weaknesses and to open
the procedure of consultation foreseen by the SPS Agreement.

111. Work on the accession of the European Community to the Codex Alimentarius and

the International Office of Epizootics will be pursued rapidly.

112.

Consumers all over the world have the right to expect exported Community products
to meet the same high standards that apply within the Community. The level of food
safety required for products exported from the Community should therefore be at
least that required for products placed on the market within the Community. The

34

113.

114.

115.

need to establish Community export certification arrangements to ensure this will be
examined.

The Community has already negotiated a number of bilateral
international
agreements on sanitary measures, which include the recognition of the equivalence
of the sanitary measures applied by third countries. The possibility of negotiating
further agreements will be explored. This includes the need for technical co-
operation as well as co-operation on RTD with third countries. In order to meet the
obligations laid down in the SPS agreement, the Community must ensure that all
legislation concerning SPS measures provides for the possibility to recognise
equivalency also on a case-by-case basis.

The process of negotiating agreements with neighbouring countries and territories,
for example Norway, Switzerland, Andorra, under which they take on the
Community ‘acquis’
sanitary and phyto-sanitary
requirements, shall be continued.

food safety and other

for

As regards the future enlargement of the Community, it is essential that the candidate
countries have implemented the basic principles of the Treaty, food safety legislation
to those in place within the Community. This
and control systems equivalent
represents a significant challenge to those countries, both in terms of the upgrading
of their production and processing facilities, and the implementation of the necessary
legislation and control arrangements. The existing framework of Community
assistance will assist, where necessary, the candidate countries to adopt the necessary
legislation, including the establishment of relevant institutions to implement and
enforce this legislation, in accordance with the priorities identified in the Accession
Partnerships.

35

CHAPTER 9: CONCLUSIONS

116.

The implementation of all the measures proposed in this White Paper will enable
Food Safety to be organised in a more co-ordinated and integrated manner with a
view to achieving the highest possible level of health protection.

Legislation will be reviewed and amended as necessary in order to make it more
coherent, comprehensive and up-to-date. Enforcement of this legislation at all levels
will be promoted.

The Commission believes that the establishment of a new Authority, which will
become the scientific point of reference for the whole Union, will contribute to a
high level of consumer health protection, and consequently will help to restore
consumer confidence.

117.

The success of the measures proposed in this White Paper is intrinsically linked to
the support of the European Parliament and the Council. Their implementation will
depend on the commitment of the Member States. This White Paper also calls for
strong involvement of the operators, who bear the prime responsibility for the daily
application of the requirements for food safety.

Greater transparency at all
levels of Food Safety policy is the golden thread
throughout the whole White Paper and it will contribute fundamentally to enhancing
consumer confidence in EU Food Safety policy.

36

ANNEX

Action Plan on Food Safety3

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

I. Priority measures

1.

2.

Proposal for setting up a European
Food Authority

To set up an independent European Food Authority.

29

September
2000

December 2001

Proposal for laying down procedures
in matters of food safety

To introduce a comprehensive safeguard measure covering the
whole food chain, including feed.

80

September 2000

December 2001

To establish a comprehensive Rapid Alert System covering all
feed and food emergencies with harmonised requirements and
procedures,
including third countries on the basis of
reciprocity.

18

3.

Proposal for a General Food Law
Directive

To establish food safety as the primary objective of EU food
law.

67

September 2000

December 2001

To lay down the common principles underlying food
legislation (in particular: scientific basis, responsibility of
producers and suppliers,
traceability along the food chain,
efficient controls and effective enforcement).

3 This action plan does not include all of the on-going actions resulting from the obligations in EU legislation.

37

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

To increase transparency, consistency and legal security.

4.

Proposal for a Regulation on official
food and feed safety controls

To establish a Community framework for official controls on
all food and feed safety aspects along the feed and food chain
by:

Ch. 6

December 2000

December 2001

-merging and completing existing rules for national controls
and Community controls and inspections within the EU, at the
borders and in third countries.

-integrating existing monitoring and surveillance systems so as
to establish a comprehensive and effective food safety
monitoring and surveillance system from farm to table.

-establishing a framework for organising consolidated annual
programs for controls of foodstuffs.

-merging existing Community rules on mutual assistance and
administrative co-operation.

-creating a Community approach towards a financial support
for official controls.

5.

Proposal for a Regulation on feed

To establish animal and public health as the primary objective
of EU feed legislation

69

December 2001

December 2002

To lay down common principles underlying feed legislation (in
particular: scientific basis, responsibility of producers and
suppliers, systematic implementation of hazard analysis and

38

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

critical control points (HACCP), traceability, efficient controls
and enforcement).

To recast all existing measures on feedingstuffs so as to create
increasing transparency,
a comprehensive legislative tool
consistency and legal security.

Proposal for a Regulation on novel
feed

To put into plan a centralised system for the authorisation of
in
use in animal nutrition of non conventional products,
particular of GMOs and GMO derived feedstuffs.

69

September 2000

December 2001

to

Amendment
of
Directive 96/25/EC on the circulation
of feed materials

the Annex

To amend the definitions of feed materials listed in the Annex
to Decision 96/25/EC, particularly with regard to oils and fats
and animal products

69

September 2000

-

6.

7.

8.

Proposal for a Regulation on hygiene To recast horizontal and vertical Directives on hygiene of food

72

June 2000

June 2002

of plant and animal origin.

To clarify responsibility of food operators and to introduce the
systematic implementation of HACCP.

To apply hygiene rules at all levels of the food chain, including
primary production.

9.

Amendment to Decision 98/272/EC
on epidemio-surveillance of
transmissible spongiform
encephalopathies (TSEs)

To reinforce TSE surveillance including a study on mandatory
testing (rapid post-mortem test) on targeted groups of cattle.

71

March 2000

To reinforce TSE surveillance in small ruminants

September 2000

10. Decision on the Member State and To ensure efficacy of residue testing in Member States and

74

December 2000

-

-

-

39

NO

11.

12.

13.

14.

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

third country residue programmes

third countries.

Proposal
89/107/EEC on food additives

amending Directive

for

To confer implementing powers for maintaining the lists of
permitted food additives and to lay down specific provisions in
respect of enzymes

77

December 2000

December 2001

for

Proposal
amending Directive
95/2/EC on food additives other than
colours and sweeteners

To update and revise the list of food additives other than
colours and sweeteners

77

December 2000

December 2001

for

Proposal
amending Directive
88/388/EEC on flavourings for use in
foodstuffs

To clarify the scope and update definitions, to set maximum
limits for toxic substances and to confer implementing powers
to the Commission

77

December 2000

December 2001

Proposal
for amending Regulation
258/97 on novel foods and novel
food ingredients

the
To make the necessary adaptations in the light of
conclusions of
the
the report on the implementation of
Regulation and in accordance with the new regulatory
framework of Directive 90/220/EEC

76

December 2001

December 2002

15. Regulation on the labelling of GMO-

free foodstuffs

To give operators the possibility to use labelling claims
referring to the absence of use of genetic engineering
techniques for the production of foodstuffs

76

September 2000

-

103

16.

for

Proposal
79/112/EEC
presentation
foodstuffs

amending Directive
labelling,
on
of
and

the
advertising

To remove the possibility not to indicate the components of
compound ingredients forming less than 25 % of the final
product and lay down a list of allergenic substances

100

December 2000

December 2001

40

NO

17.

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

Proposals for Commission Directives
to fix maximum residue
levels
(MRLs) of pesticides in food and
agricultural commodities

To fix MRLs for pesticides residues for, inter alia:

74

36 pesticides with existing open positions in the residues
directives that will automatically go to zero in July 2000 unless
the Commission adopts other values

June 2000

To set MRLs at zero for 8 pesticides that were excluded from
Annex I to Directive 91/414/EEC

September 2000

To set MRLs for new active substances included in Annex I to
Directive 91/414/EEC

Continuous
process

18. Communication on an action plan on

To develop a comprehensive and coherent nutrition policy

106

December 2000

nutrition policy

II. Feedingstuffs

-

-

19.

for

Proposal
amending Directive
70/524/EEC concerning additives in
feedingstuffs

To consolidate the Directive. To fix maximum residue limits
for additives. To clarify certain aspects of the procedure
(evaluation reports) and the authorisation (generic versus
specific).

69

July 2001

December 2002

20. Amendment to Decision 91/516/EEC
on the list of ingredients the use of
which is
forbidden in compound
feedingstuffs

To introduce the changes deemed necessary to the list of feed
materials the use of which must be prohibited in compound
feedingstuffs, with particular reference to certain by-products
from fat processing.

69

June 2000

21. Amendment

to

of
Directive
the
1999/29/EC
undesirable substances and products

the Annex

on

To fix the maximum limits of dioxins for oils and fats, and for
other or all
information on
background contamination of PCB and dioxin-like PCB,

feed materials. To collect

69

December 2000

41

-

-

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

22.

23.

24.

25.

in animal nutrition

MRLs for other potential contaminants of feedingstuffs will
also be fixed.

for

Proposal
amending Directive
96/25/EEC on the circulation of feed
materials

Following reflection to decide whether an exclusive positive
list of authorised feed materials should be established

69

December 2002

December 2003

for

Proposal
amending Directive
principles
95/53/EEC fixing
governing the organisation of official
inspections in the field of animal
nutrition

the

To foresee a legal basis for a safeguard clause in case of
appearing or spreading hazards related to feedingstuffs likely
to pose a risk to human health.

To introduce an obligation for Member States to carry out a
monitoring programme for contaminants in feedingstuffs.
To introduce a Rapid Alert System for feed to be integrated in
the Rapid Alert System for food. (to be integrated in action 4)

69

March 2000

March 2001

for

amending Directive
Proposal
79/373/EEC on the marketing of
compound feedingstuffs

To review current provisions for the labelling of compound
feedingstuffs

69

January 2000

March 2001

for

amending Directive
Proposal
the
down
laying
95/69/EEC
conditions
for
approving and registration of certain
intermediaries
and
establishments
operating in the feedingstuffs sector

and arrangements

To introduce provisions for:

69

December 2000

December 2001

– Approval or registration of manufacturers of compound

feedingstuffs

– Approval of manufacturers of certain feed materials

– Improving traceability of feed materials and identification

of critical points

– Establishing a code for good manufacturing practice for

42

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

III. Zoonoses

animal feeding

26.

for
Proposal
92/117/EEC on zoonoses

amending Directive

To improve monitoring and reporting system for diseases
transmissible from animals to man and to reduce prevalence of
specified zoonoses (e.g. salmonella)

70

June 2000

June 2002

27. Decision on Member State and third
country programmes for the control
of
animal
agents
products exported to the Community

zoonotic

on

To ensure that Member States implement adequate measures to
control zoonotic agents
To ensure that third country products are controlled to the
same level as Community products

70

December 2002

-

IV. Animal health

28.

29.

Proposal for a Regulation on animal
health requirements for products of
animal origin

To recast existing animal health rules for products of animal
origin

70

June 2000

June 2002

Increase budgetary allocation for
actions provided for
in Council
Decision 90/424/EEC on expenditure
in the veterinary field

To enable actions necessary to improve animal disease
eradication (brucellosis, tuberculosis etc)
To create a task force for monitoring disease eradication in the
Member States

70

May 2000

December 2000

V. Animal by-products

30.

Proposal
for amending Directives
90/667/EEC and 92/118/EEC on
animal waste and derived products

To recast existing measures of animal by-products not destined
for human consumption (meat and bone meal, rendered fats,
manure etc.)
To ensure that only animal by-products derived from animals
declared fit for human consumption can enter the animal feed

43

69

June 2000

December 2001

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

chain.
To clarify responsibility of animal by-products operators
To tighten up official control and to improve traceability

VI. BSE/TSE

31. Decision on classification according

to BSE status

Classification of individual countries in view of changes in
BSE status (post-mortem tests)

71

June 2000

32. Amendment to Decision 94/381 (feed

To amend the Decision in the light of recent scientific opinions

71

March 2000

ban)

Decision on the removal of specified
risk materials
replacing
Decision 97/534/EC.

(SRMs)

33. Decision on the harmonisation of
BSE rules for imports of live animals
and products from third countries

VII. Hygiene

To replace Decision 97/534/EC laying down the rules on the
prohibition of the use of materials that present risks as regards
TSEs. Amendment
proposal
accordingly.

the TSE framework

of

To harmonise the BSE import rules for other third countries

71

September 2000

34. Report on the testing of residues in

Member States and third countries

To evaluate the performance of national and third country
residue programmes.

74

December 2000

35. Modification

of

Council Directive
residue monitoring

the Annex

to
96/23/EC on

To re-enforce the monitoring and detection of PCBs and
dioxines in food of animal origin.

74

June 2000

44

-

-

-

-

-

NO

36.

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

Proposal for a Decision to review the
ante-and post -mortem procedures for
animals and meat

To make ante- and post-mortem inspections risk based, and to
review inspection methods applied at present

72

September 2001

December 2002

37. Decision

on

microbiological

standards on certain foods

To fix the maximum limits of undesirable micro-organisms in
foodstuffs, after risk assessment.

72

December 2001

VIII. Contaminants

38. Amendment to Regulation No 194/97
setting maximum limits for certain
contaminants

IX. Food additives and flavourings

To set up limits for several contaminants : ochratoxin A,
cadmium, lead, 3-MCPD, dioxin and, possibly, PCBs.

73

December 2000

39. Report

on the

intake of

food

additives

To provide an overview of the intake of food additives in the
European Union

77

June 2000

-

-

-

40.

Proposal
for
94/35/EC on sweeteners

amending Directive

41. Amendment to Directives 95/31/EC,
95/45/EC and 96/77/EC on purity
criteria for food additives (including
sweeteners and colours)

Directive
42. Amendment
81/712/EEC
down
Community methods of analysis for

to
laying

To update and revise the list of sweeteners for use in foodstuffs

77

December 2000

December 2001

To update and complete existing provisions.

77

September 2000

To introduce a general requirement for a new safety evaluation
for permitted additives made from new sources or with new
methods.

To replace existing provisions with a set of general principles
and a reference to other similar provisions

77

June 2001

-

-

45

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

the respect of purity criteria

43. Decision amending the Community
register of flavouring substances used
in or on foodstuffs

44. Regulation establishing a programme
flavouring

evaluation of

the

for
substances

To update the register

77

December 2000

To set priorities and time limits for evaluation

77

June 2000

-

-

45.

46.

Proposal
additives used in flavourings

a Regulation

for

on

To lay down a list of additives authorised for
flavourings

use in

77

June 2001

December 2002

Proposal for a Regulation on smoke
flavourings

To lay down the conditions for the production
flavourings

of smoke

77

June 2001

December 2002

X. Materials in contact with food

47.

for

Proposal
89/109/EEC
materials

amending Directive
contact
on

food

To allow the update of specific Directives through regulatory
procedure and to change or add provisions on the labelling of
contact materials

78

December 2000

December 2001

48. Amendment

Directive
90/128/EEC on food contact plastics

to

To update the list of authorised food contact plastics

78

December 2000

49.

Practical guide on food contact
materials

To provide guidance on the application of Community
provisions relating to contact materials

78

December 2000

46

-

-

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

XI. Novel foods/Genetically modified organisms

50. Regulation

the
authorisation procedure for novel
foods and novel food ingredients

clarifying

To clarify and make more transparent the procedure laid down
in Regulation 258/97 for the authorisation of novel foods and
novel food ingredients

76

September 2000

51. Report on the implementation of
Regulation 258/97 on novel foods
and novel foods ingredients

To examine the application of the “novel food” legislation and
assess its impact on public health, consumer protection and
information, and the functioning of the internal market

76

December 2001

52. Regulation on the labelling of food
from
or
containing
genetically modified organisms

derived

To further harmonise the provisions governing the labelling of
food, additives and flavourings containing or derived from
GMO material

76

September 2000

103

XII. Irradiation of food

-

-

-

53.

for

Proposal
1999/3/EC on
ingredients treated by irradiation

amending Directive
food

foods

and

To complete the Community list of foods and food ingredients
which may be treated with ionising radiation

79

December 2000

June 2002

54. Decision establishing the list of

irradiation facilities

Publication of the list of irradiation facilities authorised in the
Member States and those in third countries which have been
approved by the EU

79

December 2000

XIII. Dietetic foods/food supplements/fortified foods

55. Directive on foods

intended for

intense muscular effort

To lay down specific provisions for foods intended to meet the
expenditure of intense muscular effort, especially by sportsmen

105

December 2001

-

-

47

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

56. Report on foods intended for persons

suffering from diabetes

To assess the need for specific provisions for food for people
with carbohydrate-metabolism disorders

105

December 2001

-

57.

Proposal
89/398/EEC on dietetic foods

amending Directive

for

To define the conditions for making the claims “low-sodium”
or “sodium-free”, and “gluten-free”.

105

December 2001

December 2002

58. Directive on purity criteria

for
nutritional substances in food for
particular nutritional use

To lay down purity criteria for nutritional substances which are
added to food for particular nutritional use or which are present
in food supplements and foods to which nutrients are added

105

December 2002

59. Directive on substances added for
for

in foods

nutritional purposes
particular nutritional uses

To establish a positive list of the various substances which may
be added for nutritional purposes in foods for particular
nutritional uses

105

June 2000

-

-

60.

61.

Proposal
supplements

for a Directive on food

To lay down common criteria for marketing concentrated
source of nutrients (vitamins and minerals)

105

March 2000

March 2001

Proposal for a Directive on fortified
foods

To lay down provisions for marketing foods to which nutrients
such as vitamins and minerals have been added

105

September 2000

September 2001

62. Amendment

Directive
91/321/EEC on infant formulae and
follow-on formulae

to

To set up a list of pesticides not to be used in agricultural
products intended for use in these formulae

105

November 2000

63. Amendment

to Directive 96/5/EEC

on processed baby foods

To set up a list of pesticides not to be used in agricultural
products intended for infants and young children

105

November 2000

64. Amendment

to

Directive

80/777/EEC on mineral waters

To lay down a list of constituents of mineral waters and the
conditions of use for the treatment of certain mineral waters
with ozone enriched air

79

September 2000

48

-

-

-

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

XIV. Labelling of food

65.

66.

67.

for

Proposal
79/112/EEC
presentation
foodstuffs

amending Directive
labelling,
on
of
and

the
advertising

To specify the conditions under which “functional claims” and
“nutritional claims” may be made

101

July 2001

July 2002

Proposal
on nutrition labelling

for

amending Directive

To bring the provisions on nutrition labelling into line with
consumer needs and expectations

101

July 2001

July 2002

Proposal for amending Directive on
misleading advertising

To clarify the scope of the Directive with regard to claims
concerning in particular food, health and the environment

102

December 2000

July 2002

XV. Pesticides

68. Regulation

on

monitoring

of

pesticide residues in food

To improve co-ordination and quality of monitoring of
pesticides in foods

74

March 2000

69. Recommendation for a co-ordinated
Community Monitoring Programme
for pesticides residues in Foods for
the year 2001

70. Commission Decisions for pesticide
active substances
including in or
excluding from Annex I to Directive
91/414/EEC

Recommendation for a co-ordinated Community Monitoring
Programme for pesticides residues in Foods for the year 2001

74

December 2000

Pesticides active substances evaluated in the framework of
Directive 91/414/EEC need, after the evaluation to be either
included in Annex I or withdrawn from the market.

74

Continuous
process

71. Regulation on the evaluation of

existing pesticides active substances

To fix a priority list of substances for evaluation at Community
level; to introduce a notification procedure for all remaining

74

December 2000

-

-

-

-

49

NO

Action

Objective

substances
To lay out
Community evaluation of active substances

the ground rules for

the final stage of

72.

Proposal
91/414/EEC

for

amending Directive

Inter alia, to

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

the

September 2001

74

June 2002

June 2003

– extend competence

to

include

genetically modifies

organisms,

– allow a harmonised Community regime to charge fees for

the evaluation of new pesticides active substances

– develop a fast-track procedure for low-risk substances,

– clarify problems relating to data protection, work-sharing,
imports, classification and labelling, borderlines

parallel
with biocides legislation etc.

73. Directive to develop and adopt the
Annexes to Directive 91/414/EEC

XVI. Nutrition

74.

Proposal
Recommendations
dietary guidelines

for

on

Council
European

To develop Community data requirements for non-GMO
products
microbial
To develop a harmonised set of risk and safety phrases
To establish uniform principles for assessment of safety of
micro-organisms as plant protection products

protection

plant

To support the Member States in their development of nutrition
level
policy
To streamline the flow of information to enable consumers to
make informed choices

national

the

at

74

December 2000

-

December 2001

December 2001

107

December 2000

December 2001

50

NO

Action

Objective

XVII. Seeds

75.

Proposal for a Regulation concerning
in
environmental
respect of genetically modified plant
varieties

risk assessment

To lay down the specific conditions for the conduct of the risk
assessment applicable to genetically modified varieties of
agricultural and vegetable plant species, as required under
Council Directive 98/95/EC, as
required under Council
Directive 98/95/EC.

76. Directives on environmental

risk
assessment
assessment
principles laid down in Regulation
in respect of genetically
258/97,
modified plant varieties

and

the

77. Directives amending the Annexes of
the Directives on the marketing of
seeds

78.

Proposal for a Directive amending
the
68/193/EEC
Directive
marketing
the
of material
vegetative propagation of the vine.

on
for

XVIII. Supporting measures

To provide for
the
conduct of the assessment applicable to genetically modified
varieties of agricultural and vegetable plant species.

technical and scientific guidance for

To lay down the details of the labelling requirement as
established by Council Directive 98/95/EC for seeds of
genetically modified plant varieties of agricultural and
vegetable plant species.
To lay down the growing conditions and other requirements for
purity concerning the adventitious presence of genetically
modified seeds in seed lots of traditional plant varieties

To lay down assessment procedures and labelling requirements
for propagating material of genetically modified varieties of
the vine

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

March 2001

March 2002

June 2001

December 2000

-

-

January 2000

June 2001

69

76

69

76

69

76

69

76

79.

Proposal

for a Regulation on the To provide for a uniform legal basis to ensure adequate Ch. 3

December 2000

December 2001

51

NO

Action

Objective

REF. IN
WP

Adoption by
Commission

Adoption by
Council/
Parliament

support
financial
actions at Community level

for

food safety

80.

Proposal for a Decision establishing
a data base of dietary intakes across
the whole EU population.

81. Decision on an Advisory Committee

on Food Safety

Community financial support of actions necessary to enhance
food safety (liaison and reference laboratories, exchange of
officials, training of officials etc.)

To create a basis of exposure data used in risk assessments and
nutrition

74

December 2000

December 2001

To improve involvement of all stakeholders in the Community
food safety policy by streamlining the existing Advisory
Committees.

11

December 2000

82.

83.

84.

XIX. Third country policy/ international relations

Proposals for agreements with third
countries

To establish further agreements with third countries on
veterinary and/or phyto-sanitary issues

113

Continuous
process

Proposal
for
European Community
Alimentarius

accession

of

the
to Codex

To reinforce the participation of the European Union in the
elaboration of international food standards

111

May 2000

December 2000

Proposal
European Community to OIE

accession

for

of

the

To reinforce the participation of the European Union in the
elaboration of international animal health standards.

111

December 2000

December 2001

52

-

-