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 
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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. 
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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 decision­
making 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 legislation1 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. 
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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; 
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- 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. 
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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 agro-
food 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 
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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. 
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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 self-
contained 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. 
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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. 
-15-
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. 
-22-
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 ever-
increasing 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 
-24-
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 intra-
Community 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 intra-
Community 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: 
-42-
- 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. 
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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 non-
member 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 Trans-
Atlantic Dialogue, and regulatory cooperation. 
63 


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