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###### **COMMISSION OF THE EUROPEAN COMMUNITIES** Brussels, 30.04.1997 COM(97) 176 final

### **THE GENERAL PRINCIPLES OF FOOD LAW** **IN THE EUROPEAN UNION**

###### Commission Green Paper

**TABLE OF CONTENTS**

**Executive Summary** v

**Parti** **Introduction** 1

1. General remarks 1

2. The economic context 4

3. Development of Community activities in the foodstuffs sector 5

3.1 The Common agricultural policy and foodstuffs legislation 5

3.2 The Common Fisheries Policy 6

3.3 Development of the internal market in processed foodstuffs 7

4. The industrial policy dimension 9

5. The consumer, food safety and health protection 10

**Part II** **Simplification and Rationalisation of Community Food** Law 12

1. Introductory remarks 12

2. General considerations 13

3. General regulatory approach 13

4. Role of self-regulation in the foodstuffs sector 15

5. Horizontal or vertical approaches to food law 16

6. Subsidiarity and legislative simplification 17

7. National legislative initiatives 19

8. Need for further legislation to complete the internal market 21

**Part III** **Review** of **existing Community legislation** 22

1. Review of Community decision-making procedures 22

2. Transparency of Community legislation 22

3. Use of the regulation as an alternative to directives 23

4. Up-dating legislation to take account of technical

and scientific progress 24

5. Rationalisation of definitions used in Community

foodstuffs legislation 25

5.1 Definition of foodstuff. 25

5.2 Definition of placing on the market 26

6. Food hygiene 27

7. Food quality 30

8. Food labelling 31

**m** **-**

Part IV **Maintenance of** **a** **high level of protection** 34

1. General considerations 34

2. The role of scientific advice in the

preparation of food safety legislation 35

3. Scientific cooperation relating to food 38

4. Management of serious and urgent public health risks 39

5. Radiological emergencies 41

6. Zoonoses 41

7 Introduction of a general obligation to ensure that food 

is safe and wholesome 44

7.1 The current situation at Community level 44

7.2 Scope of the general obligation of safety and wholesomeness 45

8. Application of the principle of product liability
in the foodstuffs sector 47
9. Meeting the new aspirations of consumers 48

Part V Ensuring the effective implementation of internal market rules 50

1. General considerations 50

2. Transposition and application of Community law 50

3. Control and enforcement 51

3.1 Veterinary controls 52

3.2 Other official controls of foodstuffs 53

4. Sanctions 55

5. Management of the internal market in non-harmonized areas 55

Part VI The external dimension 57

1. General considerations 57

2. The multilateral dimension 58

2.1 The WTO Agreements 58

2.2 Developments within the Codex Alimentarius 60

2.3 The consequences of these developments for the Community :.. 61

3. The bilateral dimension 62

**Executive Summary**

**General Background**

1. Food law is **a** matter of great public concern. A high level of security and effective
public control is necessary to ensure that the food supply is safe and wholesome and
to ensure the effective protection of the other interests of consumers.

2. With every household spending on average about 20% of its disposable income on
food and drink, the sector is of vital importance to the European economy. The food
and drink processing industries alone employ some 2.3 million people, and in 1996
consumption within the Community will reach about ECU 500,000 million.

3. The volume of Community legislation relating to foodstuffs has grown substantially,
in particular as a result of the Internal market programme and the progressive
implementation of the Common Agricultural Policy. Today, the vast majority of
national food legislation has been harmonized at Community level. Even in areas
which have not been harmonized, the application of the general Treaty rules, in
particular Articles 30-36, provides a basis for the free movement of foodstuffs.

4. The new approach of the Commission on scientific advice and control, as laid down
in the Communication on Consumer Health and Food Safety, which has followed the
decision on the separation of responsibilities for the management of scientific
committees, and for control activities from the responsibilities of the legislative
departments, is not considered in this Green Paper, as it is mainly concerned with the
substantive rules of Community law applicable to the foodstuffs sector. The
Commission, as described in the above-mentioned Communication, has taken
measures to raise the performance of its control services and to strive for their
excellence by ensuring their independence, transparency and effectiveness.

**The** aims of **the Green Paper**

1. to examine the extent to which the legislation is meeting the needs and expectations
of consumers, producers, manufacturers and traders.

2. to consider how the measures to reinforce the independence and objectivity,
equivalence and effectiveness of the official control and inspection systems are
meeting their basic objectives to ensure a safe and wholesome food supply and the
protection of other interests of consumers.

3. to launch a public debate on our food legislation, and thereby,

4. to enable the Commission to propose appropriate measures for the future
development of Community food law, where necessary.

**As** a **starting point for discussion, the Green Paper** identifies six basic goals for
Community **food law:**

1. to ensure a high level of protection of public health, safety and the consumer;

2. to ensure the free movement of goods within the internal market;

3. to ensure that the legislation is primarily based on scientific evidence and risk

assessment;

4. to ensure the competitiveness of European industry and enhance its export
prospects;

5. to place the primary responsibility for safe food on industry, producers and suppliers,
using hazard analysis and critical control points (HACCP) type systems, which must
be backed up by effective official control and enforcement;

6. to ensure the legislation is coherent, rational and user friendly.

In order to achieve these goals, it is necessary to ensure that our regulatory approach
covers the whole food chain "from the stable to the table". This gives rise to two issues:

1. the extent to which primary agricultural production and the processed foodstuffs
sector should be brought within the same set of general rules;

2. the principle of producers' liability for defective products to be made obligatory for
primary agricultural production (see Directive 85/374/EEC).

Simplification and rationalisation of Community foodstuffs legislation

1. Although desirable objectives, simplification and rationalisation cannot be allowed to
result in a reduction in the level of protection of public health or consumer
protection. Since 1985, the Commission has in general limited its internal market
proposals in the foodstuffs sector to measures which are necessary for the protection
of public health and of consumers.

2. It is important to ensure that the existing legislation strikes the right balance between
general provisions and more detailed prescriptive legislation, between the use of
binding legislation and recourse to voluntary instruments and between horizontal
approaches and specific rules applicable to particular categories of foodstuffs.

3. The application of the principles of subsidiarity and legislative simplification in this
area have produced mixed results. One particular problem has been the difficulty of
ensuring that the practical application of the subsidiarity principle does not result in
the progressive dismantling of the internal market as a result of new national
legislative initiatives. In addition, the scope of Community legislation may need to be
extended to cover certain areas where the internal market does not appear to be
functioning effectively.

**VI**

Review of **existing legislation**

1. Extensive consultation of the social partners during the preparation of legislation is
an important means of ensuring that the legislation meets its goals. The social
partners could be encouraged to participate more actively in the evaluation of the
costs and benefits of proposed new legislation.

2. Greater use of Regulations instead of Directives would increase the transparency of
the legislation and avoid difficulties arising from delayed or incorrect transposition.
The Directive, should however, remain the instrument of choice for framework
legislation.

3. There are serious difficulties in adapting existing legislation to technical and scientific
progress which would be reduced by the greater use of simplified procedures.

4. The existing definitions which are contained in a variety of legal instruments should
be rationalised and completed by new definitions of foodstuffs and placing on the
market.

5. In the field of hygiene, 11 vertical veterinary hygiene directives co-exist with a
general directive on the hygiene of foodstuffs. The Commission has already begun
work on the simplification of the vertical directives, but their relationship with the
general directive must also be considered. Priority should be given to ensuring that
there is a coherent and consistent body of Community hygiene rules. This can best be
achieved by the generalised application of HACCP-type principles, and by limiting
detailed prescriptive regulations to cases where they are considered essential. The
desire for consistency must also be balanced by the need to maintain the necessary
degree of flexibility in the design and implementation of food hygiene regulations in
order to ensure a high level of protection without imposing an unnecessary burden
on business.

- 6. In the field of quality, it does not appear that the differences of approach resulting
from the different objectives of internal market and agricultural legislation give rise
to problems of incoherence or inconsistency.

7. In the field of labelling, binding labelling rules should ensure that consumers are
provided with essential information about the foodstuff in a user-friendly manner. It
is necessary to strike a balance which ensures that consumers receive all useful
information, whilst avoiding unnecessarily detailed provisions. Manufacturers should
remain free to provide additional information provided it is not misleading., although
in some cases, legislation may be necessary to govern the provision of this additional
information. In this context, the Green paper specifically invites comments on the
approach followed in Community legislation to claims and nutritional labelling.

**-** **vu** **-**

**Maintenance of a high level of protection**

1. The Treaty requires the Community to contribute to the maintenance of a high level
of protection of public health, the environment and consumers. In order to ensure a
high level of protection and coherence, protective measures should be based on risk
assessment, taking into account all relevant risk factors, including technological
aspects, the best available scientific evidence and the availability of inspection
sampling and testing methods. Where a full risk assessment is not possible, measures
should be based on the precautionary principle.

2. The importance of an independent source of advice which will command public
respect is crucial. The independence and objectivity of scientific advice and scientific
committees must be guaranteed at all levels. The Commission has taken steps to
ensure central co-ordination of the number, scope, composition and activities of
scientific committees so that a high level of competence and full consistency of its
scientific advice is ensured and the necessary resources are provided. Every effort
must be made to present scientific conclusions in a clear and cogent manner.

3. Scientific advice is of primary, but not exclusive, importance. Community legislation
has on a number of occasions recognised that other factors, in particular consumer
needs and concerns, must also be taken into consideration during the decisionmaking process.

4. The Community must have adequate means to take preventative action against
serious and urgent public health risks. The Commission has a range of safeguard
powers available, but it is important to verify that there are no gaps in the system.
There may also be a need to improve communication to the public in the event of
serious risks.

5. The Community has a variety of strategies available for the management and control
of zoonoses (eradication, reduction, removal, treatment). The Commission invites
comments on possible improvements to the arrangements for managing the risk of

zoonoses.

6. The legislation should set out clearly the responsibilities of producers, processors,
distributors and retailers to supply safe, wholesome food fit for human consumption,
of specified quality and properly identified, as well as the responsibilities of the
competent control authorities. It may be desirable to introduce general obligations
on all economic operators to take all the steps necessary to ensure that only safe and
wholesome food is placed on the market. Such obligations would be independent of
consumer rights to redress in the framework of the Directive on liability for defective
products.

7. The extension of the product liability directive to cover primary agricultural
production should improve the overall level of protection of consumers, but should

**Vlll**

not be considered,s an alternative to appropriate product safety rules and effective
official control systems.

8. Recent developments have highlighted consumer interest in food production
methods. Community food legislation [1] does not require the labelling of production
methods which do not have an impact on the food characteristics of the finished
product. However, in certain cases, mandatory labelling schemes may be considered
necessary, such as the recently adopted rules on the labelling of beef. Moreover, it
may be necessa:y to consider an appropriate framework for voluntary labelling
schemes designed to address this interest.

**Ensuring the** **effects** e **implementation of internal market rules**

1. Timely and correct implementation of Community legislation is essential for the
effective operation of the internal market. Greater use should be made of Standing
Committees to consider questions regarding the interpretation of Community
legislation, and unforeseen difficulties which may arise during its implementation.
Consideration should be given to the establishment of a forum in which
representatives of the Commission, member States and interested parties could
discuss general issues relating to the implementation of the legislation.

2. The primary role of the Community in the field of control is not to replace the
Member States, but to verify that the necessary controls are being carried out in an
effective and equivalent manner throughout the internal market. The legislation
should provide for appropriate enforcement and control measures. Whilst aimed at
achieving a high level of protection, control and enforcement measures should take
into account the principle of proportionality and should also provide for the targeting
of controls on activities presenting the greatest risk. Steps should be taken to
reinforce administrative and scientific cooperation between Member States and with
the Commission in order to ensure equivalence of enforcement throughout the
Community and to ensure effective mechanisms to prevent the marketing of unsafe
food and to trace the origins of, and factors contributing to, outbreaks of food-borne
disease. The fifth Research Framework Programme also has a role to play in this
respect. In order to reinforce consumer confidence, efforts have been made in the
Communication on Consumer Health and Food Safety to improve the transparency
of the control system at Community level, and the need for greater transparency at
national level should also be considered.

3. The sanctions for infringement of Community internal market legislation should be
equivalent to the sanctions set out in domestic legislation, effective, proportionate
and dissuasive.

**l** Directive 79/112/EEC on the labelling, presentation and advertising of foodstuffs
Regulation (EC) n° 374/97 on novel foods and novel food ingredients

**-** **IX**

4. There are mechanisms for examining new draft national legislation, principally under
Directive 83/189/EEC where it contains technical regulations; the Commission also
ensures respect for the Community rules on foodstuffs by the investigation of
complaints. The new procedure for mutual information on national measures
derogating from the principle of free movement of goods is also expected to make an
important contribution in this respect.

In non-harmonized areas, the primary instrument for the management of the internal
market remains the principle of mutual recognition, which requires that a Member
State should allow to circulate freely in its territory goods produced or marketed in
conformity with the rules, tests or standards found in another Member State which
offer an equivalent level of protection to its own rules, tests or standards.

The External Dimension

1. The Community is both a major importer and exporter of food. As an importer, the
Community is obliged to ensure that imported foods meet the same high standards as
have been laid down for Community production. As an exporter, the Community
must be able to reassure governments and consumers in third countries that food
produced within the Community may be safely marketed in their countries.

2 The legislation should be compatible with the international obligations of the
Community, in particular those arising under the WTO agreements. Equally, the
Community must work in close partnership with the Member States, producers and
industry to ensure that our major trading partners are also respecting their
obligations. The Community should be able to participate fully in international
standardisation activities relating to the foodstuffs sector. Where possible, the
Community should negotiate equivalence agreements or mutual recognition
arrangements with major trading partners to ensure in all cases, a high level of
protection of the consumer.

**X -**

**PART I**

**INTRODUCTION**

**1.** **General remarks**

Following more than 30 years of legislative activity, the great majority of national
food law has been harmonized at Community level. Recent studies, in particular the
study of the Impact and Effectiveness of the Internal market Programme on the
Processed Foodstuffs Sector, have shown that the Community's legislative
programme in the foodstuffs sector has had a generally positive impact, although
some criticisms have been expressed of overly detailed legislation, fragmentation,
difficulties of adapting the legislation to innovation, and problems in the day-to-day
functioning of the internal market. In the light of certain recent events, in particular
BSE, others have raised doubts about the capacity of the legislation to entirely fulfil
its objectives to ensure a high level of protection of public health and consumer
protection.

In contrast to legislation in most of the Member States, Community food law has
developed piecemeal, over time, and there is no central unifying text setting out the
fundamental principles of Community food law and clearly defining the obligations of
those concerned. In recent years, there have been increasing calls for such a
legislative framework, most notably from the European Parliament. In 1992, the
Commission invited three eminent food law experts to consider the need for, and
possible scope of, such a general directive. In May 1993, at the request of the
Commission, the European University Institute of Florence organised a conference on
this question bringing together the three experts and representatives from the Member
States and the Commission, from agricultural, industrial and commercial interests,
and from consumer groups.

The aim of this Green Paper is to:

examine the extent to which the legislation is meeting the needs and expectations
of consumers, producers, manufacturers and traders;

consider how the measures to reinforce the independence and objectivity,
equivalence and effectiveness of the official systems for the control and inspection
of foodstuffs are fulfilling their objectives;

invite a public debate on our food legislation to provide guidance to the
Commission in its future legislative initiative on food, and accordingly;

**-1** **-**

- enable the Commission to propose measures allowing, wherever possible, to
improve the protection of public health laid down in its measures for the internal
market and the common agricultural policy, improve the coherence of Community
food law, consolidate and simplify it, improve the operation of the internal
market, and take into account the increasingly, important external dimension,
notably the policies followed by our most advanced trading partners and the
requirements of the WTO agreements.

The new approach of the Commission on scientific advice and control, as laid down
in the Communication on Consumer Health and Food Safety, which has followed the
decision on the separation of responsibilities for the management of scientific
committees, and for control activities from the responsibilities of the legislative
departments, is not considered in this Green Paper, as it is mainly concerned with the
substantive rules of Community law applicable to the foodstuffs sector. The
Commission, as described in the above-mentioned Communication, has taken
measures to raise the performance of its control services and to strive for their
excellence by ensuring their independence, transparency and effectiveness.

Before considering the policy options which are submitted for discussion, it is
important to reaffirm the fundamental goals and achievements of EC food law, which
should in no way be put into question. These are :

the need to ensure a high level of protection of public health and safety, and of
consumer protection;

the need to ensure the free circulation of goods within the single market;

the need for legislation to be based primarily on scientific evidence and risk
assessment, in respect of our international obligations;

- the need to ensure the competitiveness of the European industry, allowing for
flexible adaptation of the legislation to incorporate new technical developments as
well as to enhance Community export prospects;

the need to place the primary responsibility for safe food with industry, producers
and suppliers, including imports from third countries, through self-checking
provisions (so-called Hazard Analysis Critical Control Points systems or HACCP)
backed up by official controls and appropriate enforcement;

the need for legislation to be coherent, rational, consistent, simpler, user-friendly
and developed in full consultation with all interested parties.

**2 -**

It is also necessary to stress that as the food chain becomes increasingly complex,
with a growing number of interventions from primary producers through the agrofood industry to distributors and retailers, so it becomes essential to ensure that our
regulatory approach covers all potential risks to the safety and wholesomeness of
food, at all stages of the food chain, including factors arising upstream, from
potentially hazardous inputs or environmental contaminants; factors arising during on
farm production and factors arising during downstream manufacturing, processing
distribution or storage.

For this reason, a further objective of this Green paper is to examine whether or to
what extent processed foodstuffs and primary agricultural production can be brought
within the scope of the general rules applicable to foodstuffs, despite their differences.
Similarly, under the product liability Directive, it is left to Member States to
determine whether to apply product liability to primary production. The extension of
Community rules on product liability to all operators in the food chain, including
primary producers is therefore also considered.

The Commission wishes to ensure that the consultation exercise covered by this
Green Paper is as broad as possible. It therefore invites any other relevant comments
and suggestions from interested parties. At the end of the consultation process the
Commission will consider what changes may be necessary. These changes may
consist of:

a proposal for a general Directive on food law;
consolidation and simplification of certain provisions, or reformulation of
existing legislation;
suggestions or proposals of a non-legislative nature, including changes in
procedures or working methods.

Comments on this Green paper should be addressed before 31 July 1997 to.

European Commission
Directorate General for Industry (Green Paper on Food Law)

200 rue de la Loi (RP 113/1)
B-1049 Brussels

**-3**

**2.** **The economic context**

Within the Community, every household spends on average about 20% of its
disposable income on food and drink. It is estimated that in 1996 consumption of
food and drink and tobacco within the Community will amount to about ECU
500,000 million, while production will amount to ECU 510,000 million. The
Community is both a major importer and a major exporter of foodstuffs. In 1994
exports from the Community reached ECU 34,250 million, while imports into the
Community were valued at ECU 24,480 million, leaving a favourable trade balance of
ECU 9,770 million, an increase of over 50% when compared with 1992. In some
food sectors, however, there is a negative trade balance. For example there is a deficit
of fisheries products in the Community which amounted to ECU 6,172 million in
1994. Over 2.3 million people are employed by the food and drink industries, nearly
50% of them in enterprises with less than 100 employees. A further 10 million people
are employed in primary agricultural production. The food and drink sector is thus
clearly of major importance for the European economy as a whole.

Between 1984 and 1992 both production and consumption of food and drink within
the EC grew at a constant real rate of about 2-2.5% a year. However, in 1992-93,
this rate of growth slowed to below 1%. Much of this growth is achieved through
higher added value, as, particularly in Northern Europe, consumers switch from fresh
foodstuffs to "convenience" processed foods. The major producers have reacted to
this long-term change by investing heavily in increasing their production capacity, in
the modernisation of equipment and in new technology. Smaller producers, on the
other hand are finding themselves under growing pressure, not only as a result of the
changing pattern of foodstuffs demand, but also because of the major changes taking
place in the retail distribution system, notably due to the increasing concentration in
food distribution and the growing role of the supermarkets' "own-brand" products in
the market place. As a result, many smaller producers face a choice of seeking a
niche in a quality market or of becoming suppliers of "own-brand" products for
supermarkets.

Across the Community as a whole, there are still substantial regional variations in the
market for foodstuffs, particularly between the northern and the Mediterranean
regions. In Southern Europe, consumption of fresh food remains relatively high and
the proportion of value added by the food processing industry is thus significantly
lower. Nevertheless, in all regions there has been considerable diversification of the
type and range of products available, and this trend is likely to continue as
manufacturers seek to use the rules of the internal market to obtain new outlets for

their products.

**- 4 -**

Against this background, it appears clear that the Community has a major role to play
by promoting a transparent and stable regulatory environment as the foundation for
further development of this vital sector. In particular, the transparency and efficient
operation of the internal market is of major importance for the survival of the large
number of smaller and medium-sized companies which must increasingly compete
with the giants of the multi-national agro-food industry.

3. **Background to the development of Community activities in the foodstuffs sector**

The primary influences on the development of the Community's food law have
resulted from the Common Agricultural Policy and the programme for the realisation
of the internal market. There is also a distinct policy for fisheries and acquaculture,
the Common Fisheries Policy.

For the future, the development of Community activities in this sector will also be
strongly influenced by the new provisions added by the Maastricht Treaty concerning
human health protection (Article 129), consumer protection (Article 129a), and the
environment (Article 13Or).

3.1 The **Common Agricultural Policy and** foodstuffs **legislation**

The common agricultural policy has had a significant impact on the development of
food law within the Community. Measures taken to achieve the objectives of the
CAP have inevitably also resulted in the development of legislation which affects the
sale of foodstuffs of agricultural origin. Three points in particular may be noted:

1. One of the main features of the CAP has been the development of common
organizations of the market for the major agricultural commodities, along with
price support and intervention measures funded by the European Agricultural
Guidance and Guarantee Fund (EAGGF). For these measures to operate
effectively and to avoid fraud, it has been necessary in some cases to establish
quality specifications to define those products eligible for support. In addition, as
a market support measure, and sometimes in the absence of price support
mechanisms, it has been considered necessary to lay down quality specifications
for products. The nature and extent of these rules vary according to the common
organization of the market concerned. In some cases the rules may have little
impact on the marketing of the finished foodstuffs. In others, for example the
common organization for wine, the rules constitute a comprehensive and selfcontained marketing code.

2. To secure free movement of primary agricultural produce within the Community,
it has been considered necessary to lay down detailed rules approximating the
laws relating to human, animal or plant health. For example, the rules on
veterinary hygiene have a profound influence on the use and marketing of
foodstuffs of animal origin. It is also necessary to ensure that the techniques
used in agricultural production do not themselves present a risk to public health.
Thus, for example, detailed provisions have been laid down establishing limits for
residues of pesticides or veterinary medicines in foodstuffs.

3. In its 1989 communication on the future of rural society, the Commission
indicated its intention to promote a product quality policy at Community level.
As a consequence, specific Community legislation has been adopted governing the
use of quality marks or labels to identify products which are subject to a special
production quality requirement (Regulation 2082/92), originate in areas known
for their traditional production (Regulation 2081/92), or can be shown to be
produced using special methods, such as organic foods.

More recently, there have been several other developments of importance for the
consumer. The Council has recently adopted binding rules on the traceability of
products of bovine origin, and consideration is being given to further measures to
improve the traceability of other animal products. Proposals are also in preparation to
extend organic labelling to cover foodstuffs of animal origin.

3.2 The Common Fisheries Policy

While the term primary agricultural production is usually taken to include fisheries
products, fishing and acquaculture are covered by a quite separate Common Fisheries
Policy (CFP). This provides specific provisions in Community food law for fishery
products. The common organisation of the market involves a set of principles and
rules dealing with common marketing standards, producers organizations, internal
market price support mechanisms and a régime for trade with non-member countries.
Structural assistance mechanisms for fisheries and acquaculture are implemented
under the financial instrument for fisheries guidance (FIFG), which includes finance
for improvement and control of quality and hygiene. Detailed rules relating to the
conservation of limited fish stocks are an integral part of the CFP. The veterinary
legislation applying to fish and shellfish is currently being reviewed as part of the
project to simplify veterinary legislation on products of animal origin.

3.3 The development of the internal market in processed foodstuffs

The foodstuffs sector is an essential part of the internal market, both from the
consumer's point of view and that of economic operators. Thus all measures taken at
Community and national level have to take full account of the general principles of
the internal market, and in particular the principle of the free movement of goods.

The Community has a variety of instruments at its disposal for the realisation of the
internal market.

application of the general principles governing the free movement of goods,
notably the principle of mutual recognition derived from the case law of the
Court of Justice (which requires that a Member state should allow to circulate
freely in its territory goods produced or marketed in conformity with the
rules, tests or standards found in another Member State which offer an
equivalent level of protection to its own rules, tests or standards)

detailed harmonization of national legislation in those cases where application of
the principle of mutual recognition does not provide a sufficient basis for the
internal market;

    - the use of framework legislation, setting out certain general principles, but leaving
Member States free to adopt stricter or more specific rules, provided these do not
create unjustified restrictions on the operation of the internal market;

    - the use of voluntary instruments, such as standardization or codes of practice.

Detailed harmonization of national foodstuffs legislation, in order to secure free
movement, began in the earliest years of the Community. From 1962 to 1985, two
approaches were followed:

    - horizontal harmonization covering all foodstuffs, either to protect public health
(e.g. additives) or for the protection of other consumer interests, such as the
provision of information or the prevention of misleading trade practices (e.g. with
regard to labelling)

    - vertical harmonization laying down detailed specifications for a specific type of
foodstuff; eight directives were adopted covering cocoa and chocolate products,
sugars, honey, fruit juices and similar products, jams, jellies and marmalades,
preserved milk, coffee extracts and natural mineral waters.

In addition, mention should be made of Council Directive 80/778/EEC on the quality
of drinking water for human consumption. This Directive is of fundamental
importance for the foodstuffs sector as all water used in a food production
undertaking for the manufacture, processing, preservation or marketing of products
or substances intended for human consumption and affecting the wholesomeness of
the foodstuff in its finished form must comply with the requirements laid down in that
Directive.

Parallel with the legislative development at Community level, the Court of Justice has
interpreted Articles 30-36 of the EC Treaty. Following the jurisprudence of the Court
in the Cassis de Dijon case, the Commission completely reviewed its policy on the
harmonization of foodstuffs legislation and in 1985 presented a communication to the
Council and the European Parliament on the completion of the internal market in the
foodstuffs sector (COM (85) 603 final). At the same time the scope of the principle of
mutual recognition was clarified.

In accordance with the communication, Community food legislation would
henceforth be limited to the harmonization of national rules justifiable in terms of the
mandatory requirements identified by the Court, namely:
the protection of public health;

- the protection of other consumer interests, notably consumer information;
fair trading;

- the need to ensure appropriate official controls.

On the other hand, the Commission indicated that in principle it would no longer put
forward proposals for the harmonization of quality specifications, such as rules
relating to the composition or manufacture of foodstuffs which are not related to the
protection of public health. Instead, the Commission believed mutual recognition
could be achieved by reinforcing the labelling rules to guarantee consumer
information and fair trading. In addition, the Commission encouraged the industry to
develop quality policies based on the use of voluntary instruments.

In a further communication of 1989 on the free movement of foodstuffs within the

Community the Commission summarized the principles in this area taking into
account the jurisprudence of the Court. In its 1991 interpretative communication on
the names under which products are sold, the Commission specified the system for
mutual recognition of foodstuffs in non-harmonized areas together with the possibility
of adopting sectoral provisions considered necessary for the implementation of other
Community policies, for example, composition requirements, definition of organic
production, quality marks for traditional foods, and designations of origin.

Virtually all the legislation set out in the Commission's 1985 programme has now
been adopted, with the exception of the proposals relating to food irradiation,
currently under consideration by the Council and the European Parliament. In
addition, further measures have been adopted to take account of problems not
foreseen in 1985, notably in respect of food hygiene, contaminants, and cooperation
between the Commission and the Member States on the examination of scientific

questions relating to food.

Since 1 January 1989, Member States have been required to communicate to the
Commission, under the procedure for the provision of information set out in Directive
83/189/EEC, draft technical regulations relating to foodstuffs. Further specific
notification procedures apply to national measures concerning food labelling,
contaminants and food hygiene. These are described in Part 2, section 7.

Finally, consideration must be given to the fact that, in areas not covered by
Community legislation, the developing case law of the Court of Justice provides a
continuing basis for the free movement of foodstuffs.

4. The industrial policy dimension

In section 2, it was noted that primary agricultural production, and the processed
food and drink sectors, are of major importance to the European economy. It is
important, therefore, to maintain the competitiveness of these sectors as a means of
achieving rising living standards and social welfare across the Community. In its
recent Communication on Benchmarking the competitiveness of European industry,
the Commission indicated that the primary responsibility for ensuring that firms
remain competitive remains with the firms themselves. Nevertheless, the public
authorities sustain competitiveness by putting in place the appropriate framework
conditions under which enterprises operate, notably by providing the necessary
infrastructure, putting in place an appropriate regulatory environment and specific
initiatives, particularly in the areas of innovation, quality, the business environment
for small and medium sized enterprises and economic cohesion. In this context, the
Commission has recently taken a series of general initiatives, such as the Green Paper
on Innovation, the working document on quality and the Multi-annual programme for
SMEs, which are equally relevant to the foodstuffs sector. Certain of these issues,
such as the need to ensure an appropriate regulatory environment, which is conducive
to innovation, are touched on at various points in this Green Paper. The Commission
considers that it is important to ensure that these industrial policy orientations are
integrated into its regulatory approach to the foodstuffs sector, and it would invite
comments on any further measures which may be necessary in this respect.

5. The consumer, food safety and health protection

As the previous sections have shown, Community rules applicable to foodstuffs have
developed from the variety of different legal bases set out in the treaty, in order to
serve different policy objectives. The legislation is also based on a complex division of
responsibilities between the Commission and the Member States. The situation is
complicated and difficult to understand, not only for the average citizen, but
sometimes also for the specialist. This has led to criticisms that the Community lacks
a coherent policy towards the foodstuffs sector as a whole, and approaches problems
piecemeal. The general remarks at the beginning of this Part have identified a number
of common goals which run all the way through Community food law.

The BSE crisis has highlighted the need for a European food policy centered on the
requirement that only foodstuffs which are safe, wholesome and fit for consumption
be placed on the market. Health protection in relation with consumption of foodstuffs
is to be an absolute priority at any time and not only something to be looked at in
emergency situations.

The Commission has already taken steps to adapt the structure of its services, so as to
make it possible to fully reach this objective.

The Commission intends to develop a true food policy which attaches fundamental
importance to the protection of the consumer and his health.

In order to build an effective food safety policy, major efforts will be deployed in
order to ensure that:

   - the most recent and complete scientific evidence is taken into account when
deciding on legislative or other measures;

   - a precautionary approach is the rule in case scientific evidence is incomplete or
unconvincing one way or the other which makes a full risk assessment impossible;

   - at all stages of the food chain, there is clear responsibility for the safety and
wholesomeness of food. This implies corresponding provisions for liability in case
of damages caused to the consumer's health by unsafe or unwholesome food;

   - control measures are taken at all critical points throughout the food chain (primary
production, processing, transport, handling and distribution, display at final point
of sale). The same applies to imported foodstuffs.

**-10**

- appropriate measures are taken to ensure the correct information of the consumer
about the nature and content of foodstuffs

- the responsibilities of the various controlling agents (eg producers, Member
States' authorities, Commission services...) as well as the nature of the control (eg
on-site inspection, audit of control systems...) are clearly defined.

In this context, account must be taken of the fact that, following the entry into force
of the Maastricht Treaty, the Commission has acquired new responsibilities to
contribute to the attainment of a high level of human health protection (Article 129)
of protection of consumers (Article 129a), and of the environment (Article 13Or). In
recent years, increasing attention has been given to issues such as nutrition and
health.The revision of Article 129 of the Treaty is currently under discussion by the
Inter-Governmental Conference.

Moreover, in recent years, increasing attention has been given to issues such as
nutrition and health, which raises questions as to the role of the Community in such

areas.

**11 -**

###### PART n

**SIMPLIFICATION AND RATIONALISATION OF COMMUNITY FOOD LAW**

**1.** **Introductory remarks**

In recent years, a number of criticisms have been expressed concerning the
complexity, fragmentation and incoherence of Community food law, and of the
difficulties of adapting the legislation to innovation. In particular it has been
suggested that:

certain provisions are unnecessarily detailed or prescriptive, and fail to take
account of the development of internal control systems by industry to ensure the
quality and safety of food products;

there are instances of the duplication of legislative provisions, or of
incoherences between different vertical rules applicable to specific sectors, or
between vertical and horizontal rules;

the complexity of the legislation and the slowness of Community legislative
procedures makes it difficult to update the legislation to take account of
technical and scientific progress.

At the political level, the Internal Market Council has also called on the Commission
to consider the scope for the simplification of internal market legislation.

The objective of this Part is to consider the general approach of the Community to the
foodstuffs sector, in the light of these criticisms, and to consider the scope for
measures to simplify and rationalise Community food law.

2. **General considerations**

One of the essential responsibilities of the public authorities has been to ensure that an
adequate supply of safe and wholesome food is available to consumers. Today, all
developed countries have adopted a substantial body of legislation which seeks to
guarantee that food is safe, wholesome and fit for human consumption, that
commercial transactions are conducted fairly, and that the necessary systems of
official control and inspection are put in place.

In recent years, a new range of issues concerning foodstuffs has emerged, as a result
of increasing scientific knowledge and popular awareness of the links between
nutrition and health, and also as a result of the new aspirations of consumers who are
not only interested in "safe food" but are also increasingly concerned about the
methods used in agricultural and food production.

**-12**

As work towards the implementation of the internal market and the common
agricultural policy has progressed, national rules have increasingly been replaced by
Community legislation. Today, the vast majority of food law has been harmonised at
Community level, and in many fields the scope for unilateral initiatives by the Member
States is severely restricted. It follows that the Community must itself develop
policies which provide for a high level of protection and meet the legitimate demands
and expectations of consumers, but avoid legislation which imposes unnecessary
burdens on producers and industry, the costs of which, of course, are ultimately
passed on to consumers through higher prices.

As noted above, since 1985, the scope of Community food legislation has, in general,
been limited to measures which are necessary for the protection of public health, for
the protection of other consumer interests, and for the establishment of the necessary
control provisions. Moreover, the fact that Community legislation has resulted in the
replacement of 15 different and sometimes conflicting sets of rules with a single set of
harmonized rules has of itself made a significant contribution to the simplification of
food law.

Against this general background it should be clearly understood that there can be no
question of wholesale deregulation and the dismantling of the system of protection
which has been put in place. The objective is to provide a body of legislation which is
effective, straightforward, simpler to understand, and more user friendly for those
principally concerned, producers, industry, food businesses, enforcement authorities
and consumers.

General regulatory approach

Food law is a matter of great public concern. Only a high level of security and
effective public control can minimise the vulnerability of food to health scares which
can have a major impact on consumer demand, industry profits and employment. An
effective legislative and regulatory framework is therefore essential. Moreover, in
view of the increasing complexity of food production and distribution, it is necessary
to ensure that the entire food chain is covered. There is no point in strictly controlling
parts of the food chain if contamination can be introduced at other points.

Nevertheless this regulatory framework must be designed and implemented in'such a
way as to take full account of the fact that the primary responsibility for the

**13**

production of safe and wholesome food lies with producers and industry. Thus,
whenever possible, it should offer industry the flexibility to design and implement
appropriate internal monitoring procedures, provided these are backed up by effective
official control systems.

In some instances, specific detailed legislation may be necessary. This is particularly
important in cases where treatments which are difficult to detect could otherwise be
used to conceal the effects of unhygienic or unsound production methods.

In other cases, it is sufficient that regulatory requirements are worded in terms of
their goals and intended result, rather than in terms of prescribing how that result is to
be achieved. Once a clear legislative framework has been established setting out the
goals to be achieved, economic operators can be left to implement the legislation,
subject to the effective supervision of the control authorities, using HACCP-type
systems, codes of practice and other appropriate instruments.

The difference between the two approaches is most clearly illustrated in the field of
food hygiene, where they co-exist. For food products of animal origin, which are
sensitive from the health point of view, a series of detailed vertical directives
prescribe in some detail the hygiene requirements which must be observed. Other
foodstuffs are covered by the general directive on food hygiene. Although it contains
some prescriptive provisions, this latter directive aims at a more general approach,
defining the objectives of food hygiene and leaving a large measure of flexibility for
industry in its implementation. The area of food hygiene is considered in greater detail
in Part III, Section 6.

Both approaches offer advantages and disadvantages. Since the more prescriptive
approach requires the legislator to identify the major risk factors and the means of
managing those risks, it often makes it easier for companies to identify their
obligations and it facilitates the tasks of the control authorities. The more general
approach, on the other hand, leaves industry with greater flexibility in the
implementation of the legislation, and is thus likely to reduce compliance costs, but it
must ensure a level of protection of public health which is equivalent to the more
prescriptive approach. It is also likely to reduce the need for frequent updating of the
legislation. However, it requires both food businesses and the control authorities to
take a much more active role in analysing the hazards presented by different activities
and ensuring that effective measures may be taken to control them. This may present
particular difficulties for small businesses working in the sector, although the
elaboration of industry wide codes of practice may provide a solution to this problem.

**14-**

It should be noted that the two approaches are not necessarily mutually exclusive.
Community legislation on food additives provides an example of a field in which they
have been successfully combined. The legislation is based upon a rigorous safety
evaluation of all additives. Only those additives which have been found to be safe for
use in food may be used within the Community. Where the safety evaluation has led
to the conclusion that it is necessary to establish a total acceptable daily intake (adi)
for the protection of public health, prescriptive limits are set for the use of each
additive in each food in order to ensure that human exposure does not exceed the adi.
However, where the safety evaluation leads to the conclusion that an adi is not
necessary, the concept of "quantum satis" is applied. This means that industry is free
to use the additive in question, in accordance with good manufacturing practice, at a
level no higher than is necessary to achieve the intended purpose, and provided that
the consumer is not misled.

In these circumstances, the Commission considers that a balanced approach is
necessary between detailed prescriptive legislation, and a more general legislative
approach. It would invite comments on whether that balance is correctly reflected in
current Community legislation.

4. Role of self regulation in the foodstuffs sector

Because of the sensitivity of the foodstuffs sector, there has always been some debate
as to the extent to which the use of self-regulatory instruments, such as codes of
practice or standards, is appropriate either as an alternative to regulation or to
supplement it.

Where voluntary instruments are used, it is important that these instruments remain
genuinely voluntary and that appropriate safeguards are applied in order to ensure
that the procedures for their elaboration are transparent, open to all interested parties
and provide for the necessary quality control of the work.

Hitherto, the use of voluntary instruments as an alternative to regulation has mainly
taken place:

in the field of compositional specifications for foodstuffs. In its 1985
Communication on the realisation of the internal market for the foodstuffs

sector, the Commission announced that it would no longer bring forward
legislative proposals to harmonize compositional specifications for foodstuffs,
except where necessary for the purposes of the Common Agricultural Policy,
and would encourage instead the use of voluntary standards in this field. Since
then, the experience of standardization in this field at European level has not
been particularly successful, and virtually no European standards have been
adopted concerning quality specifications for foodstuffs, despite several
attempts. However, at the national, level, there has been an increasing use of
standards, or equivalent instruments such as codes of practice, which brings
with it the risk of new de facto barriers to intra Community trade.

**- 1 5 -**

in the field of methods of sampling and analysis, where the experience at
Community level has been much more positive, and a number of standards have
been adopted.

In the field of food hygiene, voluntary instruments are being used to compliment the
existing legislation. Article 5 of Directive 93/43/EEC encourages the development of
codes of good hygiene practices which food businesses can use on a voluntary basis,
and which can serve as guidelines for the implementation of the general principles of
food hygiene laid down in the Directive. In addition, the Directive sets out a
procedure for the recognition of the guides at Community level, and sets out certain
guarantees to ensure that they are developed by representatives of the food businesses
involved, and of other groups which are substantially affected, such as the competent
authorities and consumer groups, that they meet the hygiene requirements laid down,
that they are practicable, and that there is adequate consultation during their
preparation. In addition to a number of initiatives at national level, the Commission is
aware that a number of such guides are in preparation at the European level, notably
in the fields of edible ices, patisserie and the sale of hot and cold foods and drinks by
vending machines.

The Commission would welcome comments on the role of voluntary instruments in
the foodstuffs sector. It would also welcome comments on the possibility of widening
the scope of application of existing national voluntary instruments to cover the whole
Community.

5. Horizontal or vertical approaches to food law

Because of the great diversity of the foodstuffs sector, it is sometimes necessary to
consider whether preference should be given to a horizontal approach, which lays
down general rules applicable to foodstuffs in general, or whether a vertical approach
laying down specific rules for a particular sector should not sometimes be used.

Within the framework of the legislation adopted under the 1985 White Paper
Programme for processed foodstuffs, priority has in general been given to horizontal
measures which apply to all categories of foodstuffs (additives, flavours, extraction
solvents, labelling, nutritional labelling, hygiene etc). Nevertheless, recourse to
vertical measures has sometimes been considered necessary, notably in the case of
foodstuffs for particular nutritional purposes, and quick frozen foodstuffs.

In the case of the rules governing primary production and products of animal origin, a
more sectorally based approach has generally been used, although some general
legislation has also been adopted, notably that dealing with designations of origin and
specificities, and the use of the organic label.

**-16-**

Specific questions concerning the co-existence of horizontal and vertical texts in
existing Community legislation are dealt with in Part III. In general terms, however, it
may be noted that rather than favouring one approach over the other in every case, it
is a question of finding the appropriate balance between the two approaches, both of
which have their advantages and disadvantages. The horizontal approach makes it
possible to take a general overview of a particular situation, and facilitates
implementation, particularly for food businesses working in many sectors, including
not only manufacturers, but also for commerce and distribution. The vertical
approach, on the other hand makes it possible to adjust the legislation to the needs of
a specific sector, particularly in cases where a more targeted approach to legislation
has been judged necessary. It also makes it possible to envisage a more integrated
regulatory approach which covers all aspects of a particular sector.

The Commission would particularly welcome comments on this issue.

6. Subsidiarity and legislative simplification

Article 3b of the EC Treaty states that in areas which do not fall within its exclusive
competence, the Community shall take action, in accordance with the principle of
subsidiarity, only if and in so far as the objectives of the proposed action cannot be
sufficiently achieved by the Member States and can therefore, by reason of the scale
or effects of the proposed action, be better achieved by the Community.

For several years, it has been the practice of the Commission to include a 'Subsidiarity
statement' in all new legislative proposals, to explain why the Commission considers
that action at Community level is necessary. This statement also includes
consideration of the objectives of the measure proposed and whether recourse to less
binding provisions would be sufficient to achieve the objectives proposed. In addition,
on 16 January 1996, the Commission adopted general guidelines on regulatory policy
which are intended to promote the coherence of Commission activity, to rationalise
and modernise the evaluation of the effects of its proposals, and to reinforce external
consultations.

In response to the conclusions of the Edinburgh Summit of December 1992, the
Commission has undertaken several initiatives to simplify existing Community
legislation in the foodstuffs sector. These initiatives include a reconsideration of
whether certain items of legislation are necessary, and the removal of unnecessarily
restrictive provisions from existing legislation.

In April 1994 the Commission presented a proposal to amend Directive 89/398/EEC
on foodstuffs for particular nutritional purposes in order to reduce the number of
specific directives for particular categories of dietetic foods from 8 to 4. In effect, the

**17**

Commission proposed not to proceed with detailed directives concerning low sodium
foods, gluten free foods, foods for diabetics and foods for athletes. While there is
general agreement that there is no need for detailed directives on low sodium and
gluten-free foods, and that general labelling provisions would suffice, there has been
much controversy about the need for directives on foods for diabetics and foods for
athletes. The Commission amended its proposal to accept an amendment from
Parliament calling for a Directive on foods for diabetics. However, within the
Council, a substantial majority of Member States contest the need for such a
Directive, whilst a significant number of Member States insist on the need for a
Directive on foods for athletes.

In addition, on 17 April 1996, the Commission adopted a package of 7 proposals to
simplify the old compositional directives which were adopted in the 1970s concerning
honey, sugars, preserved milks, coffee extracts, fruit juices and nectars, jams, jellies
and marmalades and chocolate and chocolate products. Once again, this exercise has
given rise to much controversy, notably in respect of the compositional rules relating
to chocolate.

These two examples clearly show that legislative simplification is by no means an easy
task. Provisions which are considered as unnecessarily restrictive by some, may be
considered fundamentally importantly others. The potential advantages of legislative
simplification must be carefully balanced against the risks of reopening old
controversies, and of the possibility of creating a long period of uncertainty for
economic operators in the sectors concerned.

The Commission has presented proposals to consolidate, simplify and update the
drinking water directive (COM (94) 612). A further Commission initiative for
legislative simplification in the field of veterinary hygiene is examined in Part III,
Section 6.

One particular problem in the food sector is the difficulty of reconciling the practical
concepts of simplification and subsidiarity with the maintenance of a high level of
protection, as well as with the effective operation of the internal market and the
common agricultural policy. Each year, Member States take a number of legislative
measures for reasons of protection of public health or for consumer protection. Such
measures can create barriers within the internal market or problems for the
functioning of the CAP, leading to calls for Community legislation. However, what is
considered as necessary by one Member State may be considered as over-regulation
by others. Nevertheless, if they are to be fully effective, the principles of subsidiarity
and legislative simplification must be applied at national as well as at Community
level.

**-18-**

**In conclusion, it is important** to emphasise the need to ensure that the right balance is
**found between the application** of **the** principles of subsidiarity and simplification, on
**the one hand, and the needs of** the **internal market on the other. In order to** ensure a
**high level of protection of public health and** of consumers, **the** foodstuffs sector is and
**will continue to be highly regulated. In the absence** of Community legislation,
**Member States will continue to adopt new legislation which they** consider to be
**necessary tc** **protect** **health** or consumers. Unless **an** appropriate response can be
**found at** Community level, there will be a constant risk of fragmentation of the
internal **market** back **into** national markets.

7. **National legislative initiatives**

Although the volume of Community legislation relating to the foodstuffs sector has
slowed substantially, the flow of new national legislation shows no sign of abating.
Each year, the services of the Commission consider some 60-80 new national
legislative initiatives relating to the foodstuffs sector under the procedures laid down
in Directive 83/189/EEC.

In accordance with the procedure, Member States are required to notify draft
technical legislation to the Commission which circulates the draft to the other
Member States. A standstill requirement of 3 months initially applies. If the
Commission, or a Member State, considers that the new measures will give rise to
barriers to trade within the internal market, it may issue a detailed opinion, as a
consequence of which a Member State must postpone the application of its measures
for six months. In this case, the Member State must report on the action it proposes
to take in response to the detailed opinion. The procedure also enables the
Commission to defer the adoption of the national measure for up to one year to allow
time for the preparation of proposals for legislation at the Community level, or for the
adoption of pending proposals. In the CIA Security International case, the Court of
Justice has recently held that the failure of a Member state to notify draft legislation in
accordance with Directive 83/189/EEC will result in that legislation being
unenforceable against individuals.

The procedure under Directive 83/189/EEC enables the Commission to comment on
draft legislation, and to ask Member States to make changes which would minimise
the effect on intra-Community trade. In a number of cases, the Commission has
successfully persuaded a Member State to modify the draft in order to bring it into
conformity with Community law, for example by the insertion of a mutual
recognition clause into the national legislation. The application of this procedure is
also important in that it highlights areas where further Community legislation may be
needed.

However, further specific notification procedures also apply to the foodstuffs sector.
The Community rules on food labelling, on contaminants and on food hygiene permit
a Member State to adopt more specific rules than those adopted at Community level.

**-19-**

In line with the principle of subsidiarity, Member States can therefore adopt more
detailed legislation to take account of the particular situation in their country.
However, in order to protect the Community interest, and notably the operation of
the internal market, the Commission is given powers to supervise the use which
Member States make of this possibility. Thus Member States are required to notify
the texts to the Commission, and allow the Commission three months to examine the
draft. If the Commission has doubts about the effect of the legislation on the internal
market, the Commission may issue a negative opinion. Subject to a favourable
opinion from the Member States within the Standing Committee for Foodstuffs, the
Commission may then require a Member State to amend or withdraw the text, or to
postpone its adoption for a period, which may exceed one year, in order to allow the
preparation of Community legislation.

In order to simplify the administrative procedures involved in notification, the
Commission has introduced arrangements whereby all notifications are submitted
initially to a single entry point. However, the later stages of the procedure differ
considerably. Under Directive 83/189/EEC, if a Member State insists on maintaining
its draft legislation, claiming it is justified under Article 36 of the Treaty, it may
proceed to the adoption of the national text once the relevant standstill period has
expired. In this case, the Commission must decide whether or not to refer the matter
to the Court of Justice for a definitive ruling on whether the national measure is
compatible with Community law. Under the specific procedures applicable to
foodstuffs, the Commission has the possibility, subject to a Committee procedure, to
require a Member State to amend or discontinue legislation which is considered
unnecessary or disproportionate.

The Commission considers that in the interests of administrative efficiency, it is
important to maintain the principle of one* entry point for all notifications. On the
other hand, during the later stages of the procedure, the extension of the powers
which are provided by the labelling, contaminants and hygiene rules to cover the
entire foodstuffs sector may provide a means for resolving the problem of reconciling
the principles of subsidiarity and simplification with the operation of the internal
market. In particular, it would enable the Commission, working closely with the
Member States, to develop clear principles for the treatment of new national
legislative initiatives, for defining the conditions under which they would be regarded
as creating difficulties for the internal market, and the circumstances under which
national initiatives would give rise to a need for new Community legislation.

On the other hand, it is clear that the development of such procedures must not be
allowed to interfere with the fulfilment of the Commission's obligation to ensure the
proper application of Articles 30-36 of the Treaty by Member States. The
Commission would invite comments on this issue.

**20-**

**8.** **Need for further Community legislation to complete the internal market**

In some non-harmonized areas, the Member States have frequently emphasised the
difficulty of using mutual recognition clauses to resolve problems of free circulation.
In areas where the protection of public health is involved, Member States may
consider that their proposed or existing national legislation is justified for the
protection of public health under Article 36, and therefore be unwilling to apply
mutual recognition. In such cases, the need for further Community legislation must be
considered in the light of the public health interests concerned, and in accordance
with the principles described above.

Following an analysis of the complaints received in recent years relating to the free
movement of foodstuffs, the Commission has identified three areas where the
principle of mutual recognition cannot by itself solve the adverse effects on the
internal market. The Commission therefore intends to initiate technical consultations

as soon as possible on the need for, and possible scope of, Community legislation in
respect of processing aids, the addition of vitamins and minerals to foodstuffs and
dietary supplements.

**-21**

**PART** **m**

**REVIEW OF EXISTING COMMUNITY LEGISLATION**

**1.** **General considerations**

The objective of this Part is to review, in the light of the general considerations
described in the previous part, various measures which might be taken to rationalise
or simplify existing Community legislation. It begins with a consideration of certain
aspects of the Community's working procedures, such as the choice of legal
instrument and the possibility to update the legislation in the light of technical and
scientific progress. It also considers the scope for improving the coherence of the
legislation through the introduction of common terms and definitions. It concludes
with a review of the three main areas of Community food law (hygiene, quality and
labelling) which have given rise to criticism that certain provisions are unnecessarily
detailed or unnecessarily restrictive, or which give rise to difficulties arising from the
co-existence of legislative texts of a horizontal and a vertical nature, including
possible problems of coherence between those texts. However, the Commission
would also invite comments on any areas which are not specifically mentioned here.

2. Transparency of Community legislation

Adequate consultation of the socio-economic interests affected by Community
legislation before and during the decision-making process is the foundation of
transparency. In order to be effective, consultation should not be limited to the
technical aspects of a proposal, but should also enable the social partners to provide
all relevant information and comment regarding the legislative approach envisaged
and the costs and benefits of the proposed measure.

The Advisory Committee on Foodstuffs was established in 1975 by the Commission
in order to provide a framework for the representation of the socio-economic groups
primarily concerned by the foodstuffs sector, agriculture, commerce, consumers,
industry and workers. It may give its opinion on any question relating to the
harmonisation of legislation in the foodstuffs sector. Analogous Committees have also
been established in the veterinary sector, and in the various agricultural product
sectors. Meetings of these Committees provide a valuable opportunity to reconcile
the various positions of the different parties on draft legislation. However, if they are
to be effective it is necessary that documents are circulated in good time before each
meeting and that the participants are able to consult fully with the various interests
which they represent.

**- 2 2 -**

The services of the Commission are currently taking a number of steps to improve the
consultation of the socio-economic partners during the preparation of Community
legislation, including publication of notices of intention to legislate in the Official
Journal, increased use of Green Papers and other consultation documents and
increased contacts with interested parties. Nevertheless, difficulties still arise when the
other institutions propose major changes to Commission proposals, the effects of
which are often difficult or impossible to evaluate within the limited time available.

**3.** Use **of the regulation as an alternative to directives**

In certain cases, the Community has undertaken the approximation of national
legislation in two stages. In the first stage, a framework text sets out the general
criteria and principles applicable to the matter. In the second stage, a series of specific
provisions are adopted to ensure the full and uniform implementation of these
principles throughout the Community. These implementing provisions are sometimes
extremely detailed, and leave little or no margin of discretion to Member States in
their implementation. Examples include the specific Community provisions relating to
additives, materials in contact with foodstuffs and extraction solvents.

In other cases, although contained in a single text, the provisions of Directives are
also extremely detailed and leave little margin of discretion to Member States.

In such circumstances, the use of the regulation as an alternative to the directive may
present several advantages:

the use of the regulation facilitates the uniform application of the legislation
throughout the internal market;

the use of the regulation increases the transparency of Community law;

since national implementing legislation is not necessary, the use of the
regulation facilitates the rapid updating of Community legislation to take
account of technical and scientific developments.

For these reasons it is suggested that consideration be given to greater use of
Regulations in appropriate cases, both in primary and in secondary Community
legislation. However, legislation which is limited in scope to the harmonisation of
general principles and criteria, such as legislation on the official control of foodstuffs,
would continue to be adopted by means of a directive.

**23**

**4.** **Updating legislation to take account of technical and scientific progress**

The ability to amend legislation rapidly to take account of technical and scientific
progress is of fundamental importance. From the point of view of innovation, and the
competitiveness of European industry, it is important that innovatory products can
gain rapid access to a continental-scale market. From the public health point of view,
also, it is important to be able to adapt the legislation quickly to take account of new
risk factors which may emerge.

However, experience suggests that the Community does not possess the instruments
which are necessary to respond to the quickening pace of innovation and the everincreasing range of scientific knowledge.

One reason for this is the unwillingness of the Council and Parliament to delegate to
the Commission the necessary powers for the technical implementation of Community
legislation. Although the Council and Parliament have delegated significant powers to
the Commission in fields such as contaminants, general food hygiene, materials in
contact with foodstuffs, foodstuffs for particular nutritional purposes and food
labelling, in other areas, such as food additives, extraction solvents and veterinary
legislation, there has been much less delegation of competence to the Commission.

For example, in the field of food additives, any amendment to add or withdraw an
additive from the positive list, or to enlarge or restrict the conditions of use of an
additive, must be adopted using the co-decision procedure. Once allowance is made
for the time necessary for an evaluation of the public health aspects by the Scientific
Committee for Food, the preparation of a Commission proposal, and the completion
of two, possibly three readings by the Council and Parliament under the co-decision
procedure, an average of about 5 years is necessary to complete the procedure at
Community level. This increases to 6-7 years if allowance is also made for the time
necessary for the adoption of national implementation measures. In contrast, in most
if not all Member States a similar decision would be taken rapidly by a ministerial
decision, on advice from the competent national scientific advisory committee, and
without the need for primary legislation.

Even if powers are delegated to the Commission, they are often subject to procedures
which are inappropriately burdensome. For example, in a declaration on the powers
of implementation of the Commission annexed to the Single European Act, the
Intergovernmental Conference requested 'the Council, to give the Advisory
Committee procedure in particular a predominant place in the interests of speed and
efficiency in the decision-making process, for the exercise of the powers of
implementation conferred on the Commission within the field of Article 100a".
However, in the foodstuffs sector, the Council has systematically rejected
Commission proposals for a type I Consultative Committee, in favour of a type III
Regulatory Committee, which requires a favourable opinion from a qualified

**- 2 4 -**

majority of Member States before the Commission can take a decision. In the fields of
veterinary hygiene, the Council systematically has recourse to a type Illb procedure
which enables a simple majority of Member States to block any action at Community
level.

The Commission considers that the adaptation of Community legislation to innovation
and technical progress in the foodstuffs sector constitutes a serious problem which
requires careful consideration. Comments received from interested parties on this
matter will be considered in the light of the outcome of the institutional and
intergovernmental discussions in progress.

5. **Rationalisation of definitions** used **in** Community foodstuffs legislation

Existing Community foodstuffs legislation already contains a series of definitions,
including definitions of food additives, food flavourings, food flavourings, processing
aids, contaminants, pesticide residues, residues of veterinary medicines, materials and
articles intended to come into contact with foodstuffs, labelling, nutrition labelling,
nutrition claims, official control of foodstuffs and hygiene of foodstuffs.

Community veterinary legislation also includes definitions of meat, red meat, poultry
meat, rabbit meat, farmed game, wild game, fishery products, bivalve molluscs, milk,
milk products, egg products, eggs, snails, frogs legs, other products of animal origin
and processed products.

In the past, doubts have sometimes arisen as to whether these definitions, apply only
to those specific pieces of legislation in which they are contained or whether they
apply more generally. To remove any further doubt, the Commission proposes to
stipulate that these definitions are generally applicable to all Community legislation on
foodstuffs.

5.1 Definition of "foodstuffs"

Although the legislation of most Member States contains a definition of "foodstuffs",
the Community does not as yet have its own definition. The European Parliament has
officially asked the Commission to make a proposal to this effect, because a
Community definition would ensure that all Community legislation on foodstuffs will
actually apply to the same products and substances in all Member States.

The following definition, based on that contained in the Codex Alimentarius, is
suggested for consideration:

_"Foodstuff_ _means any substance or product, whether processed, partially_
_processed or unprocessed, intended to be ingested by humans, with the_
_exception of tobacco as defined by Directive 89/662/EEC, medicinal products_
_as defined by Directive 65/65/EEC, and narcotic or psychotropic substances_
_controlled by Member States pursuant_ _to the relevant international_
_conventions._

**25**

This definition is deliberately wide in scope and is intended to cover all products
intended for direct human consumption, including drinks and chewing gum, and all
substances used in the manufacture, preparation and processing of foods, including
raw materials, ingredients, contaminants and residues in the broadest sense.

The concept of ingestion is intended to cover all products which pass through the
gastrointestinal tract, including products taken by mouth or nose or administered by
gastric intubation. On the other hand, the definition would not cover products
administered parenterally directly into the blood stream.

A further question concerns the application of the definition to primary production
which may be intended either for human consumption or for industrial use (e.g.
potatoes which may either be consumed as food or used for the production of
industrial starch, or chemicals which may be used as food additives or for other
industrial purposes.) Their inclusion within the scope of the definition would mean
that producers would have to fulfil all the relevant obligations. arising under
Community food legislation, which may be inappropriately restrictive. However, it is
obviously necessary to ensure that all substances used in food meet the requirements
of Community legislation. The Commission would invite comments on this question.

5.2 **Definition of** **"placing** **on the market"**

The concept of "placing on the market" is used several times in Community food
legislation, without being defined. A definition of marketing is included in the
veterinary hygiene directives, but this is not entirely suitable for the purposes of
foodstuffs legislation because it excludes retail sale. Other definitions of placing on
the market are included in the new approach directives and Directive 90/220/EEC on
the deliberate release of genetically modified organisms into the environment, but
these also are not entirely appropriate to the foodstuffs sector.

One possible definition would be:

_**"placing**_ _**on the**_ _**market"**_ _means any operation the purpose of which is to_
_supply foodstuffs to a third party, including supply for sale or any other form_
_of transfer against payment or free of charge to a third party and storage with_
_a view to supply to a third party, with the exception of supply for the purposes_
_of scientific research conducted under the supervision of the Member States._ _"_

To ensure full compliance with Community regulations on health protection, the
proposed definition covers not only commercial transactions but also charitable

**26**

operations and the provision of free samples. The definition would also apply to all
types of supply of foodstuffs, including supply by restaurants, canteens, hospitals and
the armed forces. However term "third party" has been used deliberately in order to
exclude storage or the transfer of foodstuffs to family or friends within the family
home.

**6.** **Food hygiene**

The field of food hygiene would appear to raise some of the most difficult questions
for the simplification and rationalisation of Community food legislation.

For foodstuffs of animal origin, a series of 11 vertical directives establish specific
conditions of hygiene for the categories of foodstuffs concerned: fresh meat, poultry
meat; meat products, minced meat and meat preparations; rabbit; farmed and wild
game; fish; shellfish; eggs and egg products; milk and milk products; and other
products such as frogs legs, snails and honey. Further legislation covers the
importation and control of foodstuffs from third countries. These directives set out
specific regulatory requirements for those aspects of the products concerned which
are considered particularly sensitive, while using a HACCP based approach for other
aspects.

For foodstuffs which are not covered by these specific provisions, the general
Directive on the hygiene of foodstuffs applies (Directive 93/43/EEC). This Directive
applies a more generalized approach to hazard management, based on the application
of HACCP principles and the development of voluntary codes of good hygiene
practice.

The co-existence of these different texts has resulted in numerous criticisms of

inconsistency and incoherence. Thus Article 1 (2) of the general hygiene directive
requires the Commission to establish the relationship between the specific hygiene
rules and those of the general directive and, if necessary, make proposals.

As a first step in this process, the Commission has launched a large scale consultation
exercise on the inter-relationship between the vertical veterinary hygiene rules which
apply to foodstuffs of animal origin. To this end, the services of the Commission have
prepared a Guide to certain rules governing the production, marketing and
importation of products of animal origin intended for human consumption. The guide
envisages the consolidation of the provisions of 14 separate directives relating to
animal and public health into a single text which would also covers the conditions of
imports from third countries. Certain common principles, such as HACCP would be
extended to cover all the Directives, and certain unnecessarily detailed provisions and
contradictions in the texts would be eliminated.

**27-**

At the same time the Commission has launched a consultation exercise on the

possibilities for simplification of the rules. In particular, the Commission specifically
invited comments from interested parties on the following points;

the role of voluntary instruments such as standards or codes of practice in
veterinary hygiene;
temperature control requirements;
the need and appropriateness of derogations for small and medium-sized
enterprises;
the international dimension of veterinary hygiene rules;
the role of self-control by manufacturers and the role of the public authorities;
authorization procedures and procedures for the approval of establishments;
conformity marking.

Further questions have also been raised concerning the inclusion in hygiene legislation
of quality or labelling provisions which are not directly related to food hygiene.

Once the relationship between the specific vertical hygiene directives has been
clarified, consideration must be given to the relationship between them and the
general directive on food hygiene. In this context, it would appear appropriate to give
priority to ensuring that there is a coherent and consistent body of legislation relating
to food hygiene. This can best be achieved by the application of HACCP principles
and limiting detailed prescriptive provisions to cases where they are considered
essential.

Nevertheless, it should be noted that there is scope for some flexibility in the manner
in which HACCP principles are conceived and applied. According to the Codex
Alimentarius Guidelines for the Application of the Hazard Analysis Critical Control
Point System, HACCP is a system which identifies specific hazards and preventative
measures for their control. The system consists of seven principles.

1. Identify the potential hazards associated with food production at all stages, from
growth, processing, manufacture and distribution, until the point of
consumption. Assess the likelihood of occurrence of the hazards and identify
preventative measures for their control. '

2. Determine the points/procedures/operational steps that can be controlled to
eliminate the hazards or minimize their likelihood of occurrence (Critical control
point (CCP).

3. Establish critical limits which must be met to ensure the CCP is under control.

4. Establish a system to monitor control of the CCP by scheduled testing or
observations.

**28**

5. Establish the corrective action to be taken when monitoring indicates that a
particular CCP is not under control.

6. Establish procedures for verification which include supplementary tests and
procedures to confirm that the HACCP system is working effectively.

7. Establish documentation concerning all procedures and records appropriate to
these principles and their application.

In the general hygiene directive, the first five of these principles are implemented into
Community legislation. However, it was not considered necessary to lay down formal
requirements regarding verification and documentation. Each food business is left
with the flexibility to decide what requirements are necessary, subject to the
supervision of the competent authority. On the other hand, because of the nature of
the foodstuffs concerned, the basic principles for own checks set out in the veterinary
hygiene directives include detailed rules on keeping a written record for presentation
to the competent authority. This example illustrates the need to maintain a degree of
flexibility in the design and implementation of food hygiene regulations to ensure the
maintenance of a high level of protection, whilst keeping the regulatory burden for
business to a minimum. The search for consistency and coherence should not result in
the imposition of a uniform system where it is inappropriate.

It is generally recognised that in order to be effective, any system of food hygiene
legislation must cover the entire food chain, from primary production until the point
of consumption. The general food hygiene directive covers all stages of food
production and distribution after primary agricultural production. However, there is
no general Community legislation covering the hygiene of products of non-animal
origin at the primary agricultural production stage. The Commission would invite
comments on whether the existing rules to ensure the safety and hygiene of primary
products of non-animal origin, such as the rules on pesticide residues, and
contaminants are sufficient.

In the case of foodstuffs of animal origin, the primary production stage is covered by
the veterinary hygiene rules. These directives cover all stages from primary
production to distribution. However, retail sale is, in general, excluded from the
scope of the veterinary hygiene rules, and the general hygiene directive therefore
applies. The Commission would invite comments on whether the retail supply of
products of animal origin should continue to be covered by the general directive, or
whether it should be brought within the scope of the veterinary hygiene directives.

**-29**

**7.** **Food quality**

In its 1985 communication on the completion of the Internal Market in the foodstuffs
sector, the Commission indicated that it would no longer bring forward proposals for
vertical legislation imposing qualitative specifications for particular categories of
product. Instead, the Commission indicated that it would rely on the use of labelling,
together with the application of voluntary instruments, to provide the basis for mutual
recognition of national rules in accordance with the principles laid down by the Court
of Justice.

In accordance with this approach, the question of quality standards and certification
within the internal market (relating to products or companies) is left to the voluntary
initiative of operators. Obviously, however, these instruments should be used in
compliance with the rules on misleading information and should not create barriers to
trade. Moreover, to ensure that these instruments are reliable, operators should be
encouraged to adhere to the standards recognized at international and European level,
in particular the ISO 9000 and EN 29 000 series. Subsequently, the Commission has
taken a series of general initiatives designed to encourage the development of a
European quality policy.

A rather different approach has been followed in the agricultural sector. It is not
possible, given the specific objectives of the CAP, to envisage removing all possibility
of laying down qualitative specifications concerning product composition. Within the
framework of the common organisations of the market, quality specifications are
necessary for example where financial support is provided under the Community
budget.

Where quality promotion and certification policy is concerned, specific measures have
been introduced, particularly with regard to rural development. These instruments
relate to organic farming products, certificates of specific character relating to
traditional products and protected geographical indications.

Generally, the Commission does not consider that the differences of approach
followed under internal market and agricultural legislation give rise to inconsistencies
or distortions of competition. Nevertheless, in the context of the simplification of the
veterinary hygiene rules, it may be worth reviewing the quality provisions contained
in the legislation. In principle it would appear that where they are necessary, quality
provisions should have their place in specific quality legislation, and be removed from
veterinary legislation, unless a health link is established. The Commission would
welcome comments on this point.

**30**

8. Food labelling

Council Directive 79/112/EEC on the labelling, presentation and advertising of
foodstuffs was explicitly designed to constitute a single legislative framework for the
compulsory rules on the labelling of foodstuffs. The Directive has been now been
amended many times. The most recent amendments, adopted by the European
Parliament and the Council in 1996, introduce the principle of quantitative declaration
of ingredients (QUID) and makes changes to the rules on the labelling of the sales
name of the product to take account of recent case law of the Court of Justice. The
Commission intends to present a proposal for the formal consolidation of the
Directive as soon as possible.

Directive 79/112/EEC is based upon the principle of functional labelling. The
objective of the Directive is to ensure that consumers are provided with the essential
information as regards the composition of the product, its manufacturer, and its
methods of storage and preparation which are necessary to ensure consumer safety
and fair competition. Producers and manufacturers are free to provide whatever
additional information they wish, provided that this is accurate and does not mislead
the consumer.

In addition to the rules laid down in Directive 79/112/EEC, a number of vertical texts
contain specific mandatory labelling provisions, such as the Community rules on wine,
fresh fruit and vegetables, eggs, and the specific directives on foodstuffs for particular
nutritional purposes. The Commission would invite comment on whether it would be
desirable to consolidate these separate provisions into a single labelling text, or
whether in the interests of flexibility, it is preferable that these requirements should
continue to be set out in specific texts.

Recently, some concern has been expressed that certain aspects of the labelling rules
have become unnecessarily detailed. In particular, there have been occasions, both at
Community and at national level, where legislation has required information which is
already included on the label, for example in the list of ingredients, to be repeated
more prominently elsewhere on the label. In the Sauce Béarnaise case, however, the
Court recognises that the inclusion of information in the list of ingredients is in many
instances sufficient information for the consumer.

**-31**

However, concern has also been expressed that other aspects of the labelling rules
may not always provide sufficient information for the consumer. For example, the
Commission has recently been asked to consider amending the labelling rules to
provide for more information about the possible presence of known allergens in
foodstuffs, even in cases where the allergens are present at very low levels, including
trace levels. Likewise, criticism has also been expressed of the current rules regarding
the labelling of compound ingredients of foodstuffs. Under current legislation, it is not
necessary to list the ingredients of a compound ingredient separately, if the compound
ingredient makes up less than 25% of the finished product. Thus, for example, in the
case of a tart which contains less than 25% of pastry, it is sufficient to include the
mention "pastry" on the list of ingredients, and it is not necessary to list all the
ingredients of the pastry separately. It has been suggested that this upper limit of 25%
is too high, and should be reduced to, perhaps, 5%.

In addition to the core mandatory labelling requirements, certain Community
legislation has been adopted to govern the provision of additional information by
producers or manufacturers on a voluntary basis. For example, within the Community
nutritional labelling is not obligatory. However, if manufacturers wish to make
nutritional claims or to provide nutritional information they must do so in accordance
with a standardised format. Similarly, Council Regulation (EEC) 2092/91 sets out
rules governing the use of the organic label on vegetables and vegetable products, and
the Commission has recently proposed rules for the use of the organic label on
products of animal origin.

It is important that Community labelling legislation should strike the right balance
between mandatory core labelling requirements and the use of voluntary instruments.
The Commission would invite comments on whether the legislation does strike the
correct balance.

As noted above, producers or manufacturers are currently free to make whatever
statements or claims they like on the labelling of foodstuffs, provided those claims are
correct and not misleading. The responsibility for verifying such claims lies with
Member States. In recent years the range of claims being made on food labels and in
the advertising of foodstuffs has increased dramatically. Health claims present
particular difficulties because the alleged beneficial effects of a particular foodstuff
may be the subject of scientific discussion, making it difficult for the competent

**32**

authorities to verify the claim made. The Commission is aware of certain cases where
the Member States have adopted different positions on the acceptability of certain
claims, leading to problems for the free movement of the foodstuffs concerned. At
one stage, the Commission had envisaged bringing forward specific legislation to
cover food claims, by defining the circumstances under which certain claims may be
made. However, this work encountered a number of technical difficulties, and has
been shelved, at least for the time-being. Instead consideration is being given to
reinforcing the provisions of the misleading advertising directive. The Commission
would specifically invite comments on the approach which should be followed at
Community level to the regulation of claims, including not only compositional claims
such as 'light' and 'low-fat', but also health and similar types of claims which are
increasingly being made on so-called 'functional foods'.

In addition, during 1997 the Commission intends to undertake a review of the
nutritional labelling directive, in particular, in order to up-date certain provisions of
the Directive to take account of new scientific information. In this context, the
Commission would specifically invite comments on whether nutrional labelling should
be made compulsory and whether the nutritional information required is sufficient to
guarantee proper information for the consumer. This will provide the occasion for the
Commission to consider other comments relating to that Directive. At the
international level, the relevant Codex Alimentarius standards are also under review.

Finally, the regulation on novel foods, which include inter alia foods containing
GMOs or produced from GMOs has been adopted recently. This regulation contains
labelling requirements on the presence of certain materials such as GMOs. The
Commission attaches great importance to the correct implementation of these
labelling rules.

**33**

**PART IV**

**MAINTENANCE OF** **A** **HIGH LEVEL OF PROTECTION**

**1.** **General considerations**

Article 100a (3) of the Treaty requires the Commission, in its internal market
proposals concerning health, safety, environmental and consumer protection to take
as a base a high level of protection. Article 129 of the Treaty provides that health
protection requirements shall form a constituent part of the Community's other
policies. Moreover, Article 129a requires the Community to contribute to the
attainment of a high level of consumer protection through the internal market
measures adopted pursuant to Article 100a and by specific action which supplements
and supports the policies of the Member States to protect the health, safety and
economic interests of consumers and to provide adequate information to consumers.

In his speech to the European Parliament on 18 February 1997, the President of the
Commission made a plea for the gradual establishment of a proper food policy giving
pride of place to consumer protection and consumer health. In this spirit, the Union
must provide itself with the necessary means of action, identifying two imperatives:

the closer involvement of the Parliament in the decision-making process; to this
end the Commission will make more use of Article 100a for proposals in the
veterinary and phytosanitary field having as their principal objective the health of
the consumer, whilst trying to persuade the Intergovernmental Conference to
accept that all legislative decisions should be taken by co-decision:

the need to give the Community true powers in the field of health.; thus the
Commission has presented a concrete proposal to the IGC for a substantially
revised Article 129, involving three major improvements:

     - an improved procedure for coordinating the policies pursued by Member
States

     - the possibility, where necessary for harmonization at Community level in the
field of human health;

     - co-decision on health matters.

**34**

So far **as** food safety is concerned, there -can be no scope for compromise. The Treaty
requires **the** Commission **to take as a base a high level of protection in** its proposals
**and to ensure that public health requirements are fully integrated into its** policies. This
level of protection must **be kept** under constant review, **and** where necessary **it** must
be adjusted **to take account** of **new information,** or of **a re-evaluation** of existing
information. **The aim** of this Part is **to** review how these objectives **are** integrated into
the Community's policies for the management of **the internal market and** the common
agricultural policy, **and** to invite suggestions for possible improvements.

2. **The role of scientific advice in the preparation of food safety** **legislation.**

In principle, the Commission considers that the prior consultation of independent
scientific experts is the best means of guaranteeing scientific objectivity and
consistency of hazard analysis during the preparation of rules relating to public health.
To be effective, the process of risk assessment must cover the entire food chain. For
example, in assessing the safety of a chemical found in food, all sources of human
exposure to the chemical must be considered, including its presence as a contaminant
in food or drinking water, and human exposure resulting from its use as a food
additive, a pesticide or a veterinary medicine. A number of scientific committees have
responsibilities which relate to the foodstuffs sector, including the Scientific
Committee for Food (SCF), the Scientific Veterinary Committee, the Scientific
Committee for Pesticides, the Scientific Committee for Animal Nutrition, and the
Scientific Committee for Toxicity and Eco-toxicity. An integrated approach to risk
assessment may require consultation of several of these Committees. Each
Committee's risk assessment will include particular features not covered by the other
committees, for example good veterinary or agricultural practices. The involvement
of several committees is therefore necessary, but coordination is essential in order to
avoid repeated evaluation of the same risk or unnecessary duplication of effort.

In addition, it should be noted that the Committee for Veterinary Medicinal Products,
which is attached to the European Medicines Evaluation Agency in London, is
responsible for the evaluation of the safety of residues of veterinary medicines in
foodstuffs of animal origin.

A number of existing Community legislative texts provide for the compulsory
consultation of the SCF before the adoption of legislation which may have an effect
on public health, for example in the fields of additives, contaminants, food hygiene,
materials in contact and novel foods.

**35-**

If the scientific assessment process is to be credible and command public confidence,
sufficient guarantees must be provided of the objectivity and independence of the
scientific advice received. With this objective in mind, the Commission has
developed a new approach on the scientific advice which is laid down in the
Communication on Consumer Health and Food safety recently presented to the
Council and European Parliament. This new approach will reinforce the three main
principles of scientific excellence, independence and transparency of the Scientific
Committees by:

ensuring that the scientific qualification and competence are the criteria for
selecting members of the scientific Committees and that the selection process is
transparent vis à vis the European Parliament, Members States, economic
operators and consumers.

ensuring that members of the Scientific Committees are free from interests which
may be in conflict with the requirement to give independent advice. In this
respect requirements and procedures for declaration of interests will be extended.

operating an overall policy of transparency in the whole process of scientific
advice. In particular European Institutions and national authorities as well as
well all interested parties, including consumers, both individuals and associations,
will have access to information on the working procedures of the Committees
and to their advice.

Furthermore the regrouping of all Scientific Committees under the same Commission
Directorate General will ensure a greater synergy and a better co-ordination of their
work.

The Commission will also continue its efforts to:

consolidate the principle of obtaining Community scientific advice before
drafting Community foodstuffs provisions that could affect public health
(although certain exceptions will be necessary, in particular in the case of urgent
safeguard measures).

apply a single procedure to assess all relevant risks (the 'one door, one key"
principle)

**36**

On the other hand, it is important to note the limits of the role of the scientific
committees. At both the Community level and the global level, a clear distinction is
drawn between the concepts of risk assessment and risk management. According to
definitions which are under consideration by Codex Alimentarius, risk assessment is a
scientifically based process consisting of the identification and characterization of
hazards, the assessment of exposure and the characterization of the risk. Risk
management, on the other hand, is the process of weighing policy alternatives in the
light of the results of risk assessment and, if required, selecting and implementing
appropriate control options, including regulatory measures. While the task of risk
assessment may be delegated to scientific advisory bodies, the task of risk
management remains the responsibility of the regulatory authorities, and at
Community level of Council, Commission and the European Parliament.

Particular difficulties may arise in those cases where, because of scientific uncertainty
or an absence of data, the Scientific Committees are unable to undertake a
comprehensive risk assessment. In such cases, in accordance with the obligation to
provide a high level of protection, it would appear necessary to take a conservative
approach to risk management through the application of the precautionary principle.

Likewise, the Community's framework research programme should make particular
efforts in respect of research and applications intended to improve knowledge and
techniques making it possible to improve the assessment of epidiemiological and food
risks, and of the means of reducing such risks.

A further problem concerns the collection of the data which" is necessary for the
evaluation of risk. In the case of new substances, the applicant is clearly responsible
for collecting and submitting the data necessary for review. In order to assistant
applicants, guidelines and similar documents are used to describe the information
which will be necessary for evaluation. However, in the case of contaminants, or new
risk factors arising for existing substances there may be difficulties in obtaining the
necessary data. In order to meet this problem, the Community has established
procedures for scientific cooperation between Member States and the Commission
for the examination of scientific questions relating to food.

**-37**

**3.** **Scientific cooperation relating to food**

The principles of the scientific cooperation process were formalised in Directive
93/5/EEC, on assistance to the Commission and cooperation by the Member States in
the scientific examination of questions relating to food, adopted on 25 February 1993.
The Directive sets out the principle that Member States shall take the necessary
measures to enable their competent authorities and bodies to co-operate with the
Commission and lend it the assistance it needs in the scientific examination of

questions of public interest relating to food, particularly in the field of public health,
through disciplines such as those associated with medicine, nutrition, toxicology,
biology, hygiene, food technology, biotechnology, novel foods and processes, risk
assessment techniques, physics and chemistry.

In order to enable the cooperation process to operate effectively, each Member State
is required to designate a single authority which is responsible for cooperation with
the Commission and distribution of work to the appropriate institute. The principal
tasks to be carried out in the scientific cooperation process include matters relating

to;

the drawing up of protocols for the assessment of risks relating to food
components and elaborating methods of nutritional evaluation;
assessing the nutritional adequacy of the diet;
examining test data submitted to the Community and the production of a
monograph for the SCF;
carrying out food intake surveys;
conducting investigations relating to the components of diets in various Member
States or of biological or chemical food contaminants;
helping the Commission honour the Community's international commitments by
providing expertise on food safety questions.

On the basis of suggestions received from Member States, and of its own priorities,
the Commission is required to prepare and update an inventory of tasks for scientific
cooperation. The inventory includes a summary description of the task, the name of
the co-ordinating country, the name of the other countries participating in the task
and the time limit for its completion. The current inventory includes a series of tasks
relating to the collection of information about chemical and microbiological
contaminants of foods, flavours, dietary intake and exposure assessments and
examination of scientific aspects of nutrition.

**38-**

The management of each task is the responsibility of the coordinating institute. The
Commission undertakes the overall management of the scientific co-operation
process. The costs of the tasks are primarily met by the Member states concerned.
The Commission provides limited additional financial support to cover the extra costs
of coordinating and convening meetings with experts from Member States. Although
it is still too soon to make a definitive judgement, the preliminary results suggest that
scientific cooperation is a useful and very cost effective method of pooling
information and resources on certain issues.

On the other hand it is important to recognise the cornplementary nature of the role of
the scientific cooperation process and the role of the SCF. In the area of risk
assessment, the role of scientific cooperation is to collect and collate the best
available information available to Member States on a particular problem. This
information is then transmitted to the SCF in order to provide a firm basis for the
evaluation of risk by the SCF, which retains its role as the primary source of advice to
the Commission on scientific questions relating to food. As a centre of independent
scientific expertise, the Joint Research Centre can also contribute towards this policy.

4. Management of serious and urgent public health risks

Safeguard clauses are included in all Community legislation for the protection of
public health. They allow Member States to apply restrictions to the marketing of a
product or substance if there is good reason to suppose that it constitutes a danger,
even though it conforms to existing Community regulations. A rapid alert system was
formally established in 1984 for the exchange of information about serious and
immediate risks to the health and safety of consumers, and subsequently incorporated
into Directive 92/59/EEC. If necessary, the Commission can convene meetings of the
relevant scientific committees at very short notice to consider the risk.

Moreover, with the completion of the single market the Community received
important powers, in particular under Directive 92/59/EEC on general product safety,
to intervene and remove from the internal market products which present serious and
immediate risks to consumers. However, in accordance with Directive 92/59/EC, the
Commission can only intervene on the basis of information which is received from a
Member State.

In addition, the Commission has adopted a communication on the handling of urgent
situations in the context of the implementation of Community rules (COM(93) 430
final of 16 December 1993), It describes the machinery already in place in various
areas and proposes topics for consideration and discussion.

**39**

In addition, in the context of the veterinary health directives and Directive 93/43/EEC
on hygiene, the Commission may in certain cases adopt provisional emergency
measures, which are effective immediately, subject to ratification by a committee
procedure within a very short period. In its order of 12 July 1996 in the application
for interim relief brought by the United Kingdom against the emergency measures
against BSE imposed by the Commission, the Court of Justice recognised that in the
application of these procedures, paramount importance must be accorded to the
protection of public health, even at the expense of serious, and possibly irreparable,
damage to commercial and social interests.

There is however an important difference between the scope of the powers of the
Commission under the safeguard clauses in the veterinary directives and in the general
hygiene directive. The safeguard clauses in the veterinary directives apply both to
risks arising from products imported from third countries and from products in intraCommunity trade. The safeguard clause contained in Article 10 of the general hygiene
directive, on the other hand, is limited to risks arising from products imported from
third countries. The Commission would therefore invite comments on the desirability
of extending the scope of the latter safeguard clause to include products in intraCommunity trade.

Where a serious risk applies to several categories of products and thus triggers
several emergency procedures, there must be adequate coordination to ensure the
consistency of the various measures which are taken. It is also essential to ensure that
the procedures are clearly understood by all those concerned in managing serious
risks, including the competent authorities of the Member States, consumers and
industry.

Finally experience suggests there may be a need to improve arrangements for the
management of and responsibility for communication to the public in the event of
serious risks. The operation of rapid alert and safeguard procedures requires
cooperation and mutual confidence between Member States and full consideration of
the needs of consumers and industry. Whilst reliable information about serious health
risks arising from foodstuffs must be made available to the public as quickly as
possible, it is important to avoid false alerts and alarmist messages. In some cases in
the past, actions have been taken affecting a whole product category, when only one
particular product was involved. Whenever possible, public information and warnings
should be targeted at specific products and be commensurate with the nature of the
hazard.

The Commission would invite comments on measures which might be taken to
improve the capacity of the Community to deal with serious and urgent risks to public
health relating to foodstuffs.

**-40**

**5.** **Radiological Emergencies**

In normal situations, (i.e. a non-accidental situation), protection against
contamination of foodstuffs by radio-active substances is ensured by Council
Directive 80/836/EURATOM, which will be repealed with effect from 13 May 2000.
This Directive is replaced by Directive 96/29/EURATOM.

Following the Chernobyl accident, a number of provisions dealing with accidental
situations have also been adopted. The provisions currently in force following the
Chernobyl accident are set out in Council Regulation 737/90 of 22 March 1990
which supplemented and adjusted the regulations adopted hitherto. This 'Regulation
will remain in force until the end of March 2000.

The system that will be applicable in case of future accidents is laid down by
Regulation 3954/87 of 22 December 1987, which provides that in the event of an
accident, the Commission may impose predetermined maximum permitted
contamination levels. This emergency action may then be adjusted according to the
exact nature and scope of the incident concerned.

Council Regulation 89/2219/EEC of 18 July 1989 prohibits the export of foodstuffs
with a contamination level exceeding the maximum levels permissible within the
Community.

On 14 December 1987, the Council adopted Decision 87/600/EURATOM on
Community arrangements for the exchange of information in the event of a
radiological emergency. According to this mechanism, the information exchange also
covers activity levels measured in foodstuffs and drinking water.

Zoonoses

As defined in existing Community legislation, zoonoses are any disease and/or
infection which is likely to be naturally transmitted from animals to man. The most
important zoonoses which may be transmitted by food include:

viral contaminations, eg. Norwalk virus and hepatitis, type A, in shellfish;

bacterial infections, eg. Salmonella, Campylobacter, E. coli, B melitensis, bovine
tuberculosis;

bacterial intoxications, eg. Staphylococcal enterotoxaemia, botulism;

protozoal parasites, eg Cryptosporidium, Toxoplasmosis;

cestode infections, eg. Cysticercus bovis, cysticercus cellulosae;

nematode infections, eg Trichinellosis.

**41**

Specific Community rules have been adopted in respect of a number of the bacterial
infections, eg bovine tuberculosis, bovine, ovine and caprine brucellosis, with a view
to their control and eradication in the animal population (and thereby their elimination
from the human population). These programmes are based on the principle of testing
live animals and the slaughter of any giving a positive reaction. In some cases,
vaccination is also employed as a means of reducing infection levels in the animal
population. Considerable success has been achieved in respect of bovine tuberculosis
and brucellosis, although matters are less well advanced for ovine/caprine brucellosis.

All of the Community legislation concerning the hygiene of products of animal origin
intended for human consumption includes provisions which will serve to control the
risk of spread of zoonoses from the animal to the human population. These range
from the specific, eg ante and post mortem inspection of animals in abattoirs, through
to the general, eg requirements for hygienic construction and operation of food
processing premises and provisions for minimum processing conditions and storage/
transport temperatures.

In addition to these vertical Directives which provide directly or indirectly for the
control of zoonoses, the Council has adopted Directive 92/117/EEC concerning
measures for protection against specified zoonoses and specified zoonotic agents in
animals and products of animal origin in order to prevent outbreaks of food-borne
infections and intoxications. The requirements of the Directive are, in essence, aimed
at the monitoring and control of a series of zoonoses. Member States are required to
report yearly on the occurrence, trends and sources of zoonotic infections (in the
human population, domestic animals, animal feedingstuffs and wildlife) recorded
during the previous year. The Directive also provides for actions to monitor, control
and ultimately to eradicate some invasive salmonella serotypes in poultry breeding
flocks.

Experience suggests that some of the time limits for Member States to take certain
measures were over-optimistic and that certain technical provisions of the Directive
need to be reviewed.

The Commission therefore invites comments on possible improvements to this
Directive.

Options For Control Of Zoonoses

By their very nature, zoonotic agents can be found in at least two host species. In
many cases, eg Salmonella, a wide range of different hosts may be infected, with
clinical disease not necessarily being evident in all affected animals. It follows that
control and eradication programmes can intervene at a number of different points in
the infective cycle, and that it may be necessary to use more than one approach. In
addition to the general principles of good hygiene at all stages of the food chain, as
dealt with elsewhere in this Paper, specific strategies include:

**- 4 2 -**

**-** **eradication** of the agent from the animal population or the environment

- **reduction** in the level of infection in the animal population to a point where it no
longer poses a threat to human health, eg processing of animal feedingstuffs,
vaccination programmes, treatment of infected animals and destruction of
clinically infected animals

- **removal** of the agent from the food chain, eg by specific treatment during the
processing of the raw material, such that any agent is destroyed

**Eradication** is an expensive option, not only because of the need to organise labour
and resource intensive testing programmes, but also to destroy infected animals. It is
dependent upon the existence of an adequately sensitive and specific live animal test,
as well as support from the farming community. Furthermore, success can only be
anticipated where the disease has a limited host range (with no significant wildlife
involvement). This approach can be justified where significant public health, animal
health or economic problems are posed by the disease, eg bovine tuberuclosis,
brucellosis.

**Reduction** involves a series of different measures aimed at different points in the live
animal production cycle. It is often used as a precursor to a full eradication
programme. Even where this is not the intention, a coordinated programme to reduce
disease levels in the animal population can have a significant impact on the degree to
which the consumer is exposed to risk of infection. Such programmes generally
require a high degree of cooperation between farmers, suppliers, processors and the
official services.

Removal of the agent from the food chain generally involves the treatment of the
food by a specific method, irrespective of whether the agent is present. It is
particularly useful where the detection of the infective agent is either too expensive or
unreliable. It can include heat treatment, drying, curing, pickling, freezing etc.
Although effective, this approach does not generally preclude the possibility of
reinfection, eg cooked meat stored with raw meat is often implicated in food
poisoning outbreaks."

**43**

**7.** **Introduction of** **a** **general obligation to ensure that food** is safe **and wholesome**

Existing Community legislation imposes a series of specific obligations on food
producers to ensure that foodstuffs meet the requirements laid down in the
Community rules. At national level, however, certain Member States have gone a step
further. In addition to transposing existing Community legislation, they have also
introduced into their domestic legislation a general obligation of food safety. Thus
food businesses are required to ensure that only food which is safe, wholesome and fit
for human consumption is placed on the market. Any food business which markets a
food which is not safe, wholesome and fit for human consumption will commit an
offence under the law of the Member State concerned, and will be liable to a criminal
or administrative penalty.

The objective of this section is to invite comments on whether it would be appropriate
to introduce at Community level a similar general obligation on food businesses to
ensure that food is safe, wholesome and fit for human consumption. It is important to
emphasise that such a general obligation of safety and wholesomeness would be an
obligation owed by food businesses directly to the competent authorities under the
penal or administrative law of the Member State concerned. It would thus be totally
separate from the question of the liability of producers to consumers for defective
products, which is covered in the following section. Moreover, the introduction of
such a general obligation would not entail the introduction of new prior approval or
notification systems by Member States.

7.1 **The current situation** at Community **level**

Although Community food legislation sets out a series of specific obligations on food
businesses, with the exception of the general Product Safety Directive, it does not
currently contain a general legal obligation that only food which is safe, wholesome
and fit for human consumption should be placed on the market. Individual Directives
approach the question in different ways: there is an explicit requirement in some
vertical hygiene Directives for certain products to be fit for human consumption; an
implicit requirement for this in other vertical Directives; and a requirement in the
general hygiene Directive that the "preparation, processing, manufacturing,
packaging, storing, transportation, handling and offering for sale or supply of
foodstuffs shall be carried out in a hygienic way".

**-44**

Article 3(1) Directive 92/59/EEC on general product safety imposes on
manufacturers the obligation to place only safe products on the market. However,
doubts have been expressed as to whether the concept of product safety which is laid
down by Directive 92/59/EEC is rather different from the requirement that foodstuffs
should be safe, wholesome and fit for human consumption. For example, food may be
adulterated with substances which do not of themselves present a health risk, and
would not make the foodstuff unsafe within the meaning of Directive 92/59/EEC.
Nevertheless, such foodstuffs would not normally be considered as fit for human
consumption.

The introduction of a general obligation of food safety and wholesomeness would
thus serve to reinforce the overall level of consumer protection within the
Community, by encouraging all food businesses to introduce their own internal safety
and supervision procedures. This obligation of safety may also help simplify overall
Community food legislation, since it would avoid the need for more specific
regulations in areas where the general provisions would be sufficient to guarantee
product safety. However, it would also be necessary to ensure that the introduction of
a new obligation of safety and wholesomeness does not result in the creation of
barriers to trade within the internal market. Thus, all measures should be compatible
with the principles of the internal market, and particular the Treaty rules on the free
movement of goods.

7.2 Scope of the general obligation of safety and wholesomeness

In order to be effective, any new general obligation of safety and wholesomeness
should in principle apply to the whole food chain from primary production to the final
sale of the foodstuff to the consumer. It must also take account of the fact that

interactions between producers, manufacturers and distributors are becoming
increasingly complex. Thus for example, in many cases primary producers have
contractual obligations to manufacturers or distributors to meet specifications which
cover quality or safety. Distributors increasingly have products produced under their
own brand-name and play a key role in product conception and design.

This new situation should result in greater joint responsibility throughout the food
chain, rather than dispersed individual responsibilities. Each link in the food chain
should take the measures necessary to ensure food safety within the context of its
own specific activities, applying HACCP-type principles, and other similar
instruments. Where a product is found to be not up to standard, the liability of each
link in the chain should be reviewed according to whether or hot it has properly

**-45**

fulfilled its own specific responsibilities. For example, it would appear wrong in
principle to hold a food retailer responsible for the presence of an excessive quantity
of food additives in a canned product over which the retailer has no control.
However, where cooked sliced cold meats are found to be microbiologically
contaminated at the point of sale, further investigation will be required to determine
whether the contamination arose as a result of poor hygiene during manufacture, a
failure to respect the cold chain during distribution or poor handling and storage at
the point of sale.

This raises the question of the so-called "due diligence" defence. When a food
business markets a foodstuff which does not conform to the safety requirements
prescribed by Community or national law, that business may be liable to criminal or
administrative penalties undef the law of the Member State concerned. However, in
some Member States the business will not be liable if it can demonstrate that it has

taken all the steps which could reasonably be expected of it to ensure that the food
meets the legal requirements ("due diligence"). Thus, compliance with the due
diligence obligation constitutes an absolute means of defence in any subsequent
judicial or administrative procedure. In other Member States however, the operator
will still be liable, although the fact that the company has exercised due diligence will
be taken into account in order to reduce the severity of the penalties imposed.

During preliminary consultations, the Commission received a number of requests that
the introduction of a general obligation of food safety into Community legislation
should be accompanied by the introduction of a "due diligence" defence.

The Commission is aware that determining the facts and circumstances which may
render an operator liable to criminal or administrative penalties is a complex matter
which depends very much on the structure of the different national legal systems.

However, it also considers that taking account of the obligation to take all reasonable
care to ensure food safety in the sanctions system is an important means of
recognizing the responsibility of companies to ensure that their products conform to
the regulations. Accordingly, failure to fulfil the obligation should result in tougher
penalties where products do not conform to the regulations, while fulfilment of the
obligation should result either in application of the defence of due diligence or at least
in less severe penalties.

The question of the "due diligence" defence should also be considered in connection
with the possibility of extending the scope of the obligation of safety to primary
production.

The Commission would welcome detailed comments on these matters.

**46-**

**8.** **Application of the principle of product liability in the** foodstuffs sector

Council Directive 85/374/EEC on liability for defective products establishes the
principle that a producer will be liable for a defect in his product. The Directive
applies to foodstuffs as well as to other products. However, the definition of a
product in Article 2 of the Directive excludes primary agricultural products and game.
For the purposes of the directive, primary agricultural products means the products of
the soil, of stock-farming and of fisheries, excluding products which have undergone
initial processing. In principle, therefore, unprocessed agricultural products and game
are excluded from the scope of the product liability directive, although Member
States may choose to provide that these products are covered. So far, only Greece,
Luxembourg, Finland and Sweden have availed themselves of this option.

In recent years, increasing demands have been heard, in particular from consumer
organisations, for the inclusion of unprocessed primary agricultural production within
the scope of the product liability directive. These demands have increased recently, as
a result of the BSE scare.

In principle, the inclusion of unprocessed primary agricultural production within the
scope of the product liability directive would constitute an important step in the
protection of consumers under Community legislation. Nevertheless, it should not be
thought that such an extension would constitute a solution to all the problems which
may arise. Article 4 of the Directive provides that the injured person shall be required
to prove the damage, the defect and the causal relationship between the defect and
the damage. Experience has shown that it is very difficult to trace the precise source
of outbreaks of food-borne disease. The longer the period between exposure to the
contaminated foodstuff and the onset of symptoms, the greater these difficulties
become. In the specific case of BSE, even if a link is proved with the new variant of
_Creutzfeldt Jakob_ Disease, the very long incubation period involved means that it will
probably be impossible to prove that a particular product is responsible for the
damage caused.

A further question concerns the difficulty of tracing the origin of the foodstuff from
the point of sale to the consumer back to the point of production. The Community
has recently adopted measures to ensure the traceability of products of bovine origin
back to the point of production and it has been suggested that these rules might be
extended to other products of animal origin. Consideration is also needed of whether
further rules on traceability should be laid down in legally binding instruments, or
whether these would better be covered by voluntary instruments. A number of major
food retailers and distributors are known to be developing systems to improve the
traceability of foodstuffs. In this context it should be noted that Article 1(3) of the
product liability directive provides that "where the producer of the product cannot be
identified, each supplier shall be treated as its producer..."

**47**

In these circumstances, it would appear that the extension of the scope of the product
liability directive to cover unprocessed primary agricultural production should not be
considered as an alternative to the development of appropriate product safety rules
and effective official control systems but as an additional measure in its own right.
The Commission would invite comments on this question.

9 **Meeting the new aspirations of consumers**

The principal concern of Community food law until now has been to ensure the free
circulation of foodstuffs in the Community, largely through harmonized food
legislation. In contrast, Community food law has not dealt to any great extent either
with nutritional issues or with finding ways of meeting public concerns. This Green
Paper, coming as it does at a time when public concerns about food and health are
high, provides an opportunity to launch a debate about new approaches to these
issues, both within general food policy and specific legislation.

Food law constitutes one of the main components of a policy on food and nutrition. It
could play a role in increasing the awareness of Community citizens about their food
purchases, diets and meal preparation, and could help encourage them to make
healthy choices which would lead to improved health and the reduction of morbidity
and premature mortality. In this process, a collaborative effort of the health sector,
consumers, governments, industry and the Community itself would benefit all parties.

The Commission invites comments on what approach should be followed at
Community level with regard to nutrition and health, which initiatives should be
pursued and where this would require adaptations of Community food law.

In addition, consumers have become increasingly concerned about the methods by
which their foods are produced. Increasing numbers of consumers wish to ensure that
the foods which they eat are produced in a manner which is environmentally friendly
and which meet the welfare needs of farm animals. Recent events, and in particular
fears about the possible transmission of BSE to humans, have highlighted concerns
that certain production methods may also have an impact on food safety.

Other discussions have focussed on the ethical and environmental impact of new
scientific developments such as GMOs in foodstuffs and the application of cloning
techniques.

**48**

Community legislation already contains many provisions which are intended to meet
these concerns. Strict rules govern the use of pesticides and veterinary medicines in
food production, in order to ensure that such use is kept to the minimum which is
compatible with good agricultural or veterinary practice. Limits are being established
to ensure that residues of pesticides and veterinary medicines, and contaminants of
agricultural or environmental origin do not present a risk to the health of consumers.
The Community has also adopted rules relating to the welfare of farm animals. The
details of such rules fall outside the scope of this Green Paper. Nevertheless, they
give rise to two important issues of direct relevance to food law: the safety issue and
the question of consumer information.

So far as food safety is concerned, there is no scope for compromise. The previous
sections of this part have described how risk assessment and risk management
techniques are integrated into the Community's policies for the foodstuffs sector. The
maintenance of a high level of protection implies that it would not, however, be
appropriate to authorize unsafe foods or food production methods subject to a
labelling requirement. If they are not safe, they cannot be permitted.

So far as labelling is concerned, at present, Directive 79/112/EEC only requires
information on processes or treatments to be provided on food labels in cases where
the omission of such information is likely to create confusion in the mind of the
consumer, for example where products are powdered, freeze dried, deep-frozen,
concentrated or smoked. In addition irradiated foodstuffs must always be labelled.
However, Community legislation does not require the labelling of production
methods or processes which do not have an impact on the food characteristics of the
finished product. There have recently been extensive discussions between the
Parliament, Council and Commission on the extent to which a systematic labelling
requirement should be imposed on foodstuffs produced by modern biotechnology
during the examination of the Commission's proposal for a Regulation on Novel
Foods and Novel Food Ingredients.

In general, experience suggests that where there is a genuine consumer demand for
more information about certain aspects of a foodstuff, this demand will frequently be
met by producers and distributors on a voluntary basis, for example through labelling,
telephone information lines or the Internet. It may be necessary to consider the need
for new Community measures to encourage the development of such voluntary
initiatives. Moreover, in certain cases, such as the recent beef labelling scheme,
further mandatory measures may be appropriate. The Commission would invite
comments on this question.

**49**

**PART V**

**ENSURING THE EFFECTIVE IMPLEMENTATION OF**

**INTERNAL MARKET RULES**

**1.** **General considerations**

Now that the harmonization of national foodstuffs legislation has largely been
completed, it is necessary to ensure that the internal market operates effectively in
order to provide the benefits anticipated for producers and consumers.

The need to ensure efficient management of the internal market has been recognised
by the Sutherland Report of October 1992: "The Internal Market after 1992;
Meeting the Challenge" and by the European Council. A series of Commission
communications to the Council have also emphasised the need for efficient operation
of the internal market:

Management of the mutual recognition of national rules after 1992 (COM (93)

669 final, 15 December 1993)
Development of administrative cooperation for the implementation and

application of Community legislation in the framework of the internal market
(COM (94) 29 final, 16 February 1994)
Making the most of the internal market (COM (93) 632 final, 22 December

1993).
the action plan for the Internal Market (COM (97) 184)

More recently, the Internal market Council has adopted a series of resolutions which
are intended to ensure that the rules governing the operation of the internal market
are as simple and straightforward as possible. The possibilities for the simplification
of Community food law have been extensively considered in Part II, and will not be
repeated here.

The objective of this Part is to review the current arrangements for ensuring the
effective implementation of Community legislation within the internal market, and to
invite suggestions for improvements.

2. Transposition and application of Community law

In order to ensure the proper functioning of the internal market, it is clearly necessary
to monitor of the transposition of Community directives by Member States and to
verify that the Community rules are applied correctly. The Commission has arranged
for a series of specific studies on the implementation of the foodstuffs directives, and
the results of these studies are being analysed. Cases of incorrect implementation will
be pursued with the Member States concerned.

**50-**

In addition to national legislation transposing Community legislation, it is common
practice for the national authorities to issue implementing instructions or guidelines
for enforcement for official control bodies, especially when the legislation is very
broad in scope. Such guidelines are intended to ensure that the legislation is applied
uniformly throughout the Member State concerned, and to resolve practical
implementation problems.

Nevertheless, such guidelines may cause problems for management of the internal
market when Member States adopt different interpretations of the legislation, with the
result that provisions are not applied uniformly throughout the internal market. It is
important therefore that transparency be maintained at Community level* and that
these differences be resolved wherever there is divergence.

For several years, the Commission has followed an informal working practice of
submitting questions concerning the implementation of Community legislation to the
Standing Committees. A similar approach has been followed when unforeseen
difficulties have arisen during the implementation of the legislation. In many instances,
these discussions have resulted in agreement between the competent authorities of the
Member States and the Commission about the manner in which the legislation is to be
interpreted or applied. The Commission considers that this is a useful procedure
which should continue, and that the conclusions of the Committee should be made
more widely available to interested parties, it being understood that such conclusions
have no formal legal status, and that in the event of a dispute, ultimate responsibility
for the interpretation of Community law lies with the Court of Justice.

Finally, in the interests of transparency, all parties concerned should be encouraged to
discuss the implementation and application of Community legislation openly in a
forum where Member States can be consulted and where different socio-economic

interests can express an opinion. To this end the Commission would invite comments
on the desirability of convening periodic meetings with representatives from Member
States, producers, industry, commerce and consumers to discuss general issues
relating to the implementation of Community legislation. However, matters relating to
the non-compliance of national legislation with Community law would be excluded
from the scope of such meetings, and would continue to be dealt with in accordance
with established Commission procedures.

3. Control and enforcement

In accordance with the Treaty, responsibility for control and enforcement of EC rules
primarily rests with the competent authorities of the Member States. Community
legislation has followed the traditional practice in the Member States which lays down
specific rules for the inspection of foods of animal origin and more general principles
for the inspection of other foods.

**-51**

The main role of the Community in the field of control is not to replace the control
and enforcement activities of the competent authorities of the Member States, but to
control the manner in which they are implementing the relevant legislation in their
own countries.

In order to guarantee the independence and effectiveness of control activities
undertaken at Community level, the Commission has reviewed the organisation of its
inspection and control services and has submitted to the Council and the European
Parliament a Communication on its future policy in this field. In view of the important
contribution of control activities to effective implementation of Community
legislation, which is a matter of common effort between the Commission and national
authorities, the Commission is willing to receive comments from interested parties on
its new policy.

3.1 **Veterinary controls**

Legislation on controls in the veterinary sector, on foods of animal origin, is fully
harmonized at Community level by vertical Directives which lay down the control
provisions for each product or class of products (fresh meat, poultry meat, meat
products, fish and fishery products, milk and milk products, etc). These rules are
currently being reviewed with the aim of producing a codified, simplified, version (see
part II, paragraph 8.1).

In the existing hierarchy of controls, the producer is responsible in the first place for
producing food which is fit for human consumption; the national control authorities
are responsible for the day-to-day enforcement of the Community rules for the
specific products concerned; and the Commission is responsible for checking that the
national authorities are applying the Community rules effectively and uniformly. It
will be necessary to examine this present division of responsibilities for control of
food. This question will need to be addressed as part of the ongoing simplification
exercise for veterinary legislation, as well as in the light of the Commission's internal
review of its inspection and control services.

The Commission sponsors regular training courses which bring together veterinary
inspectors from several Member States to coordinate their approach to the
application of Community legislation

**52**

The Commission's Community Office of Veterinary and Phytosanitary Inspection and
Control has been responsible for carrying out on-the-spot checks in Member States,
and in third countries exporting animals or animal products to the Community. The
Office has recently been transferred to Directorate General XXIV "Consumer Policy
and Health Protection, and in recognition of its new functions, if has been entitled
"EC Office for Product Quality Control and Audit. The role of the Office is to
monitor the performance of national control authorities in checking the
implementation of relevant Community legislation, rather than to substitute for them,
rather than to substitute for them. The office is presently able to cover only a part of
its duties as specified in Community legislation.

The Commission has reviewed the role, responsibilities and manner of operation of
this Office, and has submitted to the Council and the European Parliament a
Communication on this matter.

3.2 Other Official Controls of Foodstuffs

Community legislation has laid down the general principles of the official control of
foodstuffs. Control consists of inspection, sampling and analysis, inspection of staff
hygiene, examination of written and documentary material and examination of
verification systems set up by undertakings. Inspections shall cover all stages of
production, manufacture, import into the Community, processing, storage, transport,
distribution and trade. Products which "are intended for consignment to another EC
Member State must be controlled with the same care as products intended for
marketing in the Member State concerned, and a product must not be excluded from
control simply because it is intended for export from the Community.

In addition, procedures have been developed for administrative cooperation between
the Member States on matters relating to control and enforcement in order to ensure
that the necessary controls are being carried out effectively and equivalently across
the Community. Thus, each year the Commission establishes a coordinated
programme for the control of foodstuffs. The Member States exchange statistical
information about the operation of the control systems, the number of inspections
carried out and the nature of the infringements found. The competent authorities of
the Member States are required to afford each other administrative assistance in all
supervisory procedures relating to the legal provisions and quality standards
applicable to foodstuffs and in all proceedings for the infringement of foodstuffs
legislation. Exchanges of national food inspectors are taking place within the Karolus
programme. In addition, a small centralized Community food control unit has been
established to verify the equivalence and efficiency of the national control systems.
These inspectors are currently completing their programme of first visits to each of
the Member States.

**- 5 3 -**

The objective of these activities is to facilitate the operation of the internal market by
establishing mutual confidence between the national inspectors, thus removing the
need to repeat controls for products produced in other Member States.

Nevertheless, it should be emphasised that the official inspectorates of the Member
States have limited resources and cannot inspect every batch of every product on a
market where the consumption of foodstuffs is evaluated at some ECU 500,000
million.

Moreover, systematic official inspections would not be appropriate in view of the
quality and safety control procedures developed in the industry in recent years.

For this reason, official inspections in all industrialized countries are focusing
increasingly on the suitability and reliability of companies' own internal control
procedures for meeting product conformity objectives. This means that public
resources are used more efficiently, since inspection authorities can concentrate their
efforts on those companies whose activities give grounds for concern, and reduce the
frequency of official inspections of those companies which have introduced reliable
and suitable control systems.

It would therefore seem appropriate, if a safety obligation is to be imposed on food
companies, to include in Community provisions a general requirement that the official
inspectorates should determine the intensity and frequency of inspections not only in
accordance with the level of risk presented by foodstuffs and the operations
concerned, but also as a function of the suitability and reliability of internal
procedures introduced by companies for ensuring and verifying that foodstuffs
conform to the required standards. Applying this principle would bring the general
provisions on the inspection of foodstuffs into line with Article 8 of the general
directive on food hygiene, which states that all food premises should be inspected at a
frequency which has regard to the risk associated with the premises. In addition, due
account should be taken, in the operation of the control systems of new tools which
are being developed by the industry such as indicators of freshness which may be used
to indicate whether there has been a break in the cold chain during the distribution of
a product.

Finally, concerns have been expressed about the lack of transparency of certain
aspects of food inspection and control activities, and the lack of consumer access to
the work of the inspection systems. These questions have been addressed in the
Commission's Communication on Consumer Health and Food Safety.

**54**

**4.** **Sanctions**

**In its Communication on the role of sanctions in the implementation of Community**
**legislation in the field of the internal market (COM (95) 162 final), the** Commission
**concluded that the sanctions laid down by Member States for the infringement** of
**internal market legislation should be equivalent to the sanctions set out in** the
**corresponding provisions of national legislation, effective, proportionate** and
**dissuasive. These general principles were endorsed by the Internal Market Council** in
**its resolution of 6 June 1996. It would therefore appear that** these principles should
be **introduced into Community** food legislation. The Commission would invite
comments on **this** question.

5. **Management of the Internal Market in non-harmonized areas**

In sectors which have not been harmonized at Community level, the jurisprudence of
the Court of Justice provides a basis for ensuring the free movement of foodstuffs.
The primary instrument for the management of the internal market remains the
application of the principle of mutual recognition, as it results from the case law of
the Court of Justice following the Cassis de Dijon judgement.

In its interpretative communications, the Commission has presented its interpretation
of the principles concerning the free movement of foodstuffs in the light of the case
law of the Court. For example, in its 1989 Communication on the free movement of
foodstuffs within the Community, the Commission set out its interpretation of the
rules applicable in the absence of Community legislation. The Member States are
required to admit to their territory foodstuffs lawfully produced and marketed in the
other Member States. The importation and marketing of such foodstuffs may be
restricted, in the absence of harmonized rules at Community level, only where such a

measure

can be demonstrated to be necessary in order to satisfy mandatory requirements
(public health, protection of consumers, fairness of commercial transactions,
environmental protection);

is proportionate to the desired objective, and

is the means of achieving that objective which least hinders trade.

In these communications, the Commission also described the major specific problems
which concerned the free movement of foodstuffs, namely:

trade description (i.e. the name under which imported foodstuffs can be sold);

the presence of additives in foodstuffs.

**-55**

Subsequently, the major problems described in the Communications appear to have
been largely resolved, either as a result of the harmonisation of legislation or as a
result of developments in the case law of the Court. However, other problem areas
have emerged, such as those mentioned in Part II, Section 8.

Hitherto, the Commission has disposed of two main mechanisms for managing the
internal market in non-harmonised sectors;

the examination of draft national technical regulations which have been notified
in accordance with Directive 83/189/EEC (considered in Part II section 7)

the investigation of complaints that Member States are infringing the rules on
the free movement of goods laid down by Articles 30-36 of the Treaty. Despite
a certain reticence on the part of industry to bring forward formal complaints to
the Commission, the foodstuffs sector still accounts for the largest number of
complaints received by the Commission under Arts 30-36 of the Treaty. The
Commission has taken a number of initiatives to rationalise and expedite the
complaints procedures. In addition, the possibility of pursuing a complaint
before the national courts, and if necessary obtaining a preliminary ruling from
the Court of Justice in accordance with Article 177, constitutes an alternative
means of redress

From 1 January 1997, the Commission has had available an important new mechanism
for the management of the internal market. In accordance with the provisions of the
Decision of the European Parliament and the Council establishing a procedure for
mutual information on national measures derogating from the principle of the free
movement of goods within the Community, Member States are required to inform the
Commission of any measure which impedes the free circulation of a type of product
or model of a product which is legally produced or marketed in another Member
State, subject to the conditions laid down in the decision. The progressive
implementation of this new procedure is providing the Commission with a much more
accurate over-view of the true situation within the internal market, enabling it to take
appropriate remedial action where necessary.

The Commission would invite comments on the free movement of foodstuffs in non
harmonized areas, and particularly on whether the principles described above have
been fully implemented at national level, and are still valid.

**56**

##### **`PART VI`** **`THE EXTERNAL DIMENSION`**

**1.** **General considerations**

The effects of the Community's food legislation are not confined to the Community
alone. In accordance with the EEA agreement, Community food legislation is applied
in Norway and Iceland, and it will shortly be applied in Liechtenstein. _T\\e_ applicant
countries in central and eastern Europe and Cyprus are in the process of adjusting
their legislation to apply Community rules in preparation for their accession to the
Community. The customs union agreement between the Community and Turkey
provides for the harmonization of legislation, legislation and negotiations with
Switzerland are also at an advanced stage. A number of other third countries are also
using Community legislation, which often closely reflects the relevant international
standards established by Codex Alimentarius, as a model for their own legislation.

The principles of the internal market also apply to goods from non-member countries
which have been put into free circulation. Such products must meet all the
requirements which are laid down in Community legislation for products produced
within the Community. For foodstuffs of animal or plant origin, there are specific
veterinary and phytosanitary inspection and certification procedures which are
undertaken at the point of entry into the Community, and specific controls relating to
quality standards for unprocessed fruits and vegetables for export and import. The
Community also carries out inspections in non-Community countries.

In other cases, there are no special procedures for the inspection or certification of
imports and exports. Controls on products are undertaken on a random basis, at the
point of entry, or at the point of destination, and the activities of importers may also
be subject to control. Consideration may need to be given to better coordination of
controls on imports. It is also worth recalling that foodstuffs are part of the list of
products which are more specifically covered by controls performed under Council
Regulation (EEC) 339/93 on checks for conformity with the rules on product safety
in the case of products imported from third countries.

In addition, to being a major food importer, the Community is also a major food
exporter. Indeed it is estimated that in 1996 the Community will have a favourable
trade balance in excess of ECU 10,000 million in food and drink products. In these
circumstances, it is important to ensure that the Community's own internal legislation
provides adequate reassurances for our major trading partners, and that our exports
do not encounter unjustified restrictions in gaining access to markets outside of the
Community.

**57-**

Recent years have seen important changes in the multilateral trading system applicable
to foodstuffs, and in the bilateral relationships between the Community and its major
trading **partners.**

**2.** **The multilateral dimension**

Both the recent changes introduced by the WTO Agreements and those relating to
- the Codex Alimentarius have an impact on food law.

2.1 **The WTO Agreements**

Several of the agreements concluded at the end of the Uruguay round have had
important effects on the foodstuffs sector. The Agreement on Agriculture is having
significant effects on the conditions of international trade in foodstuffs. The
implementation of the Agreement on Trade-Related Aspects of Intellectual Property
Rights will facilitate the international recognition of denominations of origin and
certificates of specificity which have been granted in accordance with the relevant
Community regulations. However, it is the amendment of the Agreement on
Technical Barriers to Trade (TBT) and the new Agreement on Sanitary and
Phytosanitary Measures (SPS) which will have the most important consequences for
Community foodstuffs legislation.

These two Agreements are designed to prevent technical legislation which is intended
for the protection of the human health or safety, the protection of the health or life of
humans animals or plants, consumer protection against deceptive practices and
environmental protection being used to create or resulting in unjustified barriers to
international trade. The Community is a full party to both agreements, which
therefore apply both to Community legislation and to legislation adopted by the
Member States.

The Agreements encourage WTO members to participate fully in the development of
harmonised international standards with a view to reducing the barriers to trade
arising from conflicting national rules. If a member observes the standards, guidelines
and recommendations prepared by the relevant international organizations when
adopting a measure, the measure in question is presumed to comply with the
provisions of the Agreements. However, both Agreements also recognise the right of
members, as Sovereign entities, to lay down measures which provide a greater level
of protection than that provided for by the relevant international standards, providing
that these measures do not result in unjustifiable restrictions on international trade.

**58**

In order to encourage transparency,, both Agreements provide for the prior
notification of draft measures which could affect international trade, thus giving the
other WTO members an opportunity to comment on them.

The TBT Agreement applies to all products, including agricultural products, and
covers all measures which could affect international trade. It does not, however,
apply to sanitary and phytosanitary measures as defined in the SPS Agreement.

In order to achieve its objectives, the Agreement lays down a number of principles:
the measures of the contracting countries should have a legitimate objective; the
measures adopted should be appropriate or proportionate to those objectives, there
should be no alternatives which cause less disruption to international trade and there
should be no discrimination.

In the food sector, the aims which, under the TBT Agreement, might justify measures
taken by a contracting party which diverge from the relevant international standards
include: prevention of practices which might be misleading (misleading information),
protection of human health or safety, protection of animal life or health, and
protection of the environment.

Justification for measures taken to achieve these legitimate objectives might include
scientific and technical data, related processing methods or the end-use of products.

The SPS Agreement applies to measures;

to protect animal or plant life or health from risks arising from the entry,
establishment or spread of pests, diseases, disease-carrying organisms or
disease-causing organisms;
to protect human or animal life or health from risks arising from additives,
contaminants, toxins or disease-causing organisms in foods;
to protect human life or health from risks arising from diseases carried by
animals, plants or products thereof, or from the entry, establishment or spread
of pests;
to prevent or limit other damage from the entry, establishment or spread of
pests.

The basic aim of the SPS Agreement is to maintain the sovereign right of any member
to provide the level of health protection it deems appropriate, but to ensure that these
sovereign rights are not misused for protectionist purposes and do not result in
unnecessary barriers to international trade.

**-59**

**The measures which members adopt to achieve their chosen level of protection must**
**be based on an assessment of risks to health, taking into account available scientific**
**evidence, processes and production methods, inspection, sampling and testing**
**methods and, in the case of animal and plant life and health, relevant economic**
**factors.**

**Measures must not arbitrarily or unjustifiably discriminate between members where**
**identical or similar conditions prevail. They must be not more trade-restrictive than**
**required to achieve the appropriate level of protection, taking into account technical**
**and economic feasibility. Members may introduce or maintain measures which result**
**in a higher level of protection than would be achieved by measures based on**
**international standards, guidelines or recommendations** **-if** **there is a scientific**
**justification or as a consequence of the level of protection the member determines to**
**be appropriate.**

**Unlike the TBT Agreement, the SPS Agreement refers specifically to some of the**
**international organizations whose standards, guidelines and recommendations it**
**considers to be relevant. These are, for food safety the Codex Alimentarius**
**Commission,** **for animal health and zoonoses the International Office of Epizootics**
**and for plant health the International Plant Protection Convention.**

**WTO members failing to comply with the relevant international standards may be**
**challenged in several** **ways:**

**WTO Members considering that the national measures notified to them under**
**the notification procedures conflict with the SPS and TBT Agreements may ask**
**for justification;**

**the national measures may be brought before the committees responsible for**
**managing the Agreements; for example the SPS Agreement states that in the**
**case of legislation having a major impact on international trade, a list of which is**
**to be drawn up by the management committee, a Member which fails to apply**
**an international standard will have to explain its reasons to the committee;**

**disputes may be settled by special panels set up within the framework of the**
**WTO.**

**2.2 Developments within the Codex Alimentarius**

**In 1962 the Food and Agriculture Organization and the World Health Organization**
**set up** **a** **joint** **FAO/WHO** **committee on the Codex Alimentarius to prepare standards,**
**recommendations and guidelines with a view to protecting consumer health, ensuring**
**fair trading practices and facilitating international trade. By 1994, Codex had 146**
**member countries. It had established 237 commodity food standards, 41 codes of**

**60**

practice covering hygiene and food technology. 185 pesticides had been evaluated
leading to the establishment of 3,274 maximum residue limits for pesticides. 760 food
additives and 25 contaminants had also been evaluated together with 54 veterinary
drugs.

In March 1991 a conference on food standards, chemicals in food and international
trade organized by the FAO and the WHO, in cooperation with GATT, built on the
experience gained by GATT to plan future progress on the Codex Alimentarius and a
new SPS Agreement.

The SPS Agreement gives international reference status to the standards,
recommendations, guidelines and codes of good hygiene practice adopted by the
Codex.

The Codex has started a radical overhaul of its approaches and procedures so that it
can perform the role assigned to it under the SPS. This has resulted in a number of
reforms to improve the efficiency of procedures for preparing and adopting standards.
In addition, the content of a large number of Codex standards is being reviewed to
take account of the new WTO Agreements. However, the relationship of Codex with
the SPS Agreement needs to be clarified and refined further.

The Community is determined to play a constructive part in devising and
implementing these new approaches, and to seek a high level of health and consumer
protection, and must make sure it has the necessary resources to do this.

2.3 The consequences of these developments for the Community

These developments have several consequences for Community activities in the food

sector.

1. The Community will increasingly be required to provide scientific justification
for its measures at international level. The suggestions set out above for prior
consultation of scientific committees should also be considered as proposals in
connection with changes required of the Community at international level.

2. Since the Community must be able to justify measures which diverge from the
relevant international standards, it is important to take account of the
international dimension in the Community's scientific assessment work. The
members of Community scientific committees must be able to cooperate with
their other colleagues, particularly within the context of international
committees of scientific experts like the Joint Expert Committee on Food
Additives (JECFA) and the Joint Meeting on Pesticide Residues (JMPR), which
are responsible for preparing the scientific assessments of hazards which form
the scientific basis for preparation of Codex standards. International assessments
of specific hazards should, where they exist, be taken into account as far as
possible, without, however compromising the Community's level of protection.

**61**

3. The new situation provides the Community not only with a challenge, but also
with an opportunity to ensure that new measures adopted by our major trading
partners are also in accordance with their international obligations. In order to
take the best advantage of this opportunity, the Community must be prepared to
mobilise the resources necessary to scrutinise the measures which are prepared
by our trading partners. This can only be achieved through a close partnership
between the Commission, Member States and those whose interests are directly
at stake, in particular Community producers and industry.

4. The Community must also be capable of playing a full role during the
' negotiations within Codex Alimentarius and other fora which lead to the
adoption and acceptance of international standards. Full Community
participation is essential in order to ensure that the Community interest is taken
into consideration during the preparation of international standards which will
be used as a reference point for judging the legitimacy of the Community's own
legislation. The current situation where the Community is a full party to the
WTO agreements, but is accorded only the status of an observer during the
elaboration of international standards by Codex, constitutes an unacceptable
anomaly, which must be remedied as soon as possible by the accession of the
Community to full membership of Codex Alimentarius. A proposal to this effect
has been presented to the Council; the latter has granted the Commission a
mandate and negotiations have begun with the Codex Secretariat.

Likewise, given the competences of the Community in the field of plant
protection, and taking account of the objectives of the International Plant
Protection Convention (IPPC), the Community is participating in the review of
the IPPC and intends subsequently to adhere to it.

As a corollary, Community participation in international scientific efforts to
assess existing hazards should be increased. Directive 93/5/EEC on scientific
cooperation already provides the basis for Community bodies to take part in
international scientific cooperation. The proposal for a 5th framework
programme also foresees such reinforced participation.

3. The bilateral dimension

Developments at global level also provide a general framework within which
individual countries may also sign their own bilateral equivalence agreements. Article
4 of the SPS Agreement encourages the development of bilateral equivalence
agreements, and the Codex Alimentarius Committee on Food Import/Export
Certification and Inspection Systems is also preparing guidelines to encourage the
development of bilateral agreements. These agreements make it possible to evaluate
in practical terms those sectors where the regulations and guarantees provided by
official inspection and certification schemes are recognized as equivalent, i.e. which,
although they may be different, are considered to provide the same level of
protection. Recognition of equivalence helps facilitate trade by simplifying the
conditions of trade between the signatory countries.

**62**

Such agreements are particularly necessary when systems of legislation are based on
the implementation during production or processing of prevention measures such as
those based on HACCP principles. Proof that the system is being applied can be
provided only by carrying out inspections in the companies themselves and not solely
by inspecting the finished product.

These agreements also make it possible to manage public official inspection resources
more efficiently without reducing the level of consumer protection by avoiding
unnecessary repetition of inspections which have been properly carried out by the
exporting country. In addition, they could facilitate technical cooperation between
various countries in the area of scientific research, and the preparation of food
regulations, and controls and certification.

In this context, it should be recalled that on 21 September 1992 the Council adopted
a Decision authorizing the Commission to negotiate agreements between the
Community and certain non-member countries on mutual recognition with a view to
conformity assessment. In addition, on the basis of other Council mandates, the
Commission has opened negotiations with a view to bilateral veterinary and
phytosanitary equivalence agreements. An agreement with New Zealand has been
agreed by the Council and signed. A proposal for an agreement with the Czech
Republic has been completed and submitted to the Council. Negotiations are
continuing with other trading partners, including Australia, Canada and the United
States; South American countries, in particular Argentina, Chile and Uruguay and the
associated countries of Central and Eastern Europe.

In order to facilitate the development of equivalence agreements outside the
veterinary and phytosanitary sectors, consideration should be given to completing the
existing provisions on official control with measures designed to:

ensure that inspections of imported and exported products comply with
international rules, particularly by taking account of proportionality in relation
to hazards as proposed above and allowing agreements recognizing equivalence
to be taken into consideration;

allow the specific team of Community officials responsible for assessing and
checking the equivalence and effectiveness of official food control systems in
Member States as referred to in Directive 93/99/EEC also to cooperate with
Member States in assessing and inspecting the official control systems of nonmember countries within the framework of negotiating and managing an
agreement recognizing equivalence.

In addition, the Community maintains a variety of bilateral contacts with its major
trading partners on regulatory issues relating to the food sector, including the TransAtlantic Dialogue, and regulatory cooperation.

**63**

##### ISSN 0254-1475

## COM(97) 176 final

# DOCUMENTS

#### EN 03 06 01 10 Catalogue number : CB-CO-97-196-EN-C ISBN 92-78-19509-X

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