Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food (presented by the Commission)

TABLE OF CONTENTS

EXPLANATORY MEMORANDUM

PROPOSAL

CHAPTER I - Scope and Definitions

Article 1 - Aim and scope

Article 2 - Definition of "food"

Article 3 - Other Definitions

CHAPTER II - General Food Law

Article 4 - Scope

Section 1 - Principles and requirements of food law

Article 5 - General objectives

Article 6 - Protection of health

Article 7 - Precautionary principle

Article 8 - Protection of consumers' interests

Article 9 - Traceability

Article 10 - Responsibilities

Article 11 - Liability

Section 2 - Requirements of food safety

Article 12 - Food safety requirements

Article 13 - Feed safety requirements.

Article 14 - Responsibilities for food safety: food businesses

Article 15 - Responsibilities for food safety: feed businesses

Section 3 - Principles of food trade

Article 16 - Food imported into the Community

Article 17 - Food exported from the Community

Article 18 - International food standards

Section 4 - Principles of transparency

Article 19 - Public consultation

Article 20 - Public information

CHAPTER III - European Food Authority

Section 1 - Mission and Tasks

Article 21 - Mission of the Authority

Article 22 - Tasks of the Authority

Section 2 - Organisation

Article 23 - Bodies of the Authority

Article 24 - Management Board

Article 25 - Executive Director

Article 26 - Advisory Forum

Article 27- Scientific Committee and Scientific Panels

Section 3 - Operation

Article 28 - Scientific opinions

Article 29 - Conflicting scientific opinions

Article 30 - Scientific and technical assistance

Article 31 - Scientific studies

Article 32 - Collection of data

Article 33 - Identification of emerging risks.

Article 34 - Rapid Alert System

Article 35 - Networking of organisations operating in the fields within the Authority's mission

Section 4 - Independence, Transparency and Communication

Article 36 - Independence

Article 37 - Transparency

Article 38 - Confidentiality

Article 39 - Communication

Article 40 - Access to documents

Article 41 - Consumer and other interested parties

Section 5 - Financial Provisions

Article 42 - Adoption of the Authority's budget

Article 43 - Implementation of the Authority's budget

Article 44 - Fees received by the Authority

Section 6 - General Provisions

Article 45 - Legal personality and privileges

Article 46 - Liability

Article 47 - Staff

Article 48 - Participation of third countries

CHAPTER IV - Rapid Alert System, Crisis Management and Emergencies

Section 1 - Rapid Alert System

Article 49 - Rapid alert system

Article 50 - Implementing measures

Article 51 - Confidentiality rules for the rapid alert system

Section 2 - Crisis Management

Article 52 - General plan for crisis management

Article 53 - Crisis unit

Article 54 - Tasks of the crisis unit

Section 3 - Emergencies

Article 55 - Emergency measures for food of Community origin or imported from a third country

Article 56 - Other measures

CHAPTER V - Procedures and Final Provisions

Section 1 - Committee and mediation procedures

Article 57 - Committee

Article 58 - Functions asigned to the Committee

Article 59 - Mediation procedure

Section 2 - Final Provisions

Article 60 - Review clause

Article 61 - Reference to the European Food Authority and to the Committee on food safety and animal health

Article 62 - Competence of the EMEA

Article 63 - Seat

Article 64 -Relationship between the Regulation and existing food law

Article 65 - Commencement provisions

Article 66 - Entry into force

FINANCIAL STATEMENT

IMPACT ASSESSMENT

EXPLANATORY MEMORANDUM

General Introduction

The White Paper on Food Safety [1] outlined the Commission's strategic objectives, priorities and work programme in relation to food safety in particular, and food law in general. It elaborated the Commission's commitment to develop a comprehensive integrated approach to regulating the food supply chain. In particular it proposed the establishment of a European Food Authority and an overarching set of definitions, principles and measures to ensure a high level of protection and the effective functioning of the internal market in food.

[1] COM(1999) 719 final, 12 January 2000.

This proposal for a European Regulation responds to this commitment by laying down the general principles and requirements of food law, establishes procedures in matters of food safety and establishes a rapid alert system for foods and feeds. It creates a European Food Authority defining its scope, tasks and responsibilities.

European food legislation has evolved over the last forty years reflecting a blend of scientific, societal, political and economic forces. Over this period, food legislation has had different policy objectives: one has been to harmonise national measures and provide the basis for the internal market, the other, to adopt common measures within the Common Agricultural Policy. Although not always explicit, these objectives have been inextricably linked with the establishment and maintenance of a high level of protection of human health, safety and of consumer protection.

These different objectives have led to some divergence in the approach to food legislation, some inconsistencies and even some lacunae. One of the objectives of this Regulation is to establish common definitions, including a definition of food, and to lay down the overarching guiding principles and legitimate objectives for food law in order to ensure a high level of health protection and the effective functioning of the internal market.

In contrast to the relatively recent development of food law at Community level, national "food acts" have a longer history. Therefore, definitions of food and the general principles and requirements of food law have a deep-rooted basis in some Member States' legal history. Although similar in concept and principle, these national measures have some differences in approach and detail, which may cause disruption of the internal market. This Regulation seeks to harmonise at Community level existing national requirements, placing them in the European context.

One objective of this proposal is not only to harmonise national requirements, but also to provide the basic framework of principles and definitions for future European food law. Where measures are revised in the future or where proposals are drafted in new areas, this Regulation will provide the basic principles, definitions and orientation for doing so. Although some specific requirements are proposed in this Regulation, others are more generally applicable and will provide the basis for more specific provisions.

In common with other trading areas, the European Community has had a number of contamination problems in the food supply and other types of food safety emergencies, some of which have arisen as a result of contamination problems in animal feed. This Regulation will establish principles and in some cases responsibilities and obligations on businesses which will address the causes of food safety problems in a broad manner and will include requirements for food businesses at the level of primary production, and, where relevant to food safety, for feed businesses.

The White Paper identified the need to address the issue of securing the confidence of consumers and trading partners in the European food supply. There has been a reduction in the confidence of consumers and trading partners in the public authorities' ability to regulate and control the safety of the food supply, in the system under which European food law is made, and in the European institutions themselves. This has resulted in a significant reappraisal of the existing organisational arrangements at Community level.

The need for rapid, reliable and strong scientific opinions, in what is an increasingly innovative and technological sector, has placed a significant burden on the European system of obtaining scientific opinions through the work of scientific committees. More and more Community legislation requires scientific assessments to be carried out for the European population. This need is currently met by the scientific committees established under Commission Decision 97/579/EC [2] setting up the scientific committees in the field of consumer health and food safety and Decision 97/404/EC [3] setting up the scientific steering committee. This growing need has inevitably stretched the systems both in relation to the ability of the Committees to undertake safety evaluation of scientific dossiers, and in relation to the assessment of broader public health issues.

[2] OJ L 237, 28.8.1997.

[3] OJ L 169, 27.6.1997.

This proposal addresses the organisational changes needed in relation to the provision of scientific opinions and the increased collaboration with the Member States that must be fostered in order for the best use of expertise to be made.

The White Paper on Food Safety proposed that a European Food Authority be created, in particular in order to consider the scientific issues relevant, either directly or indirectly, to food safety, and to communicate openly on such matters. Public and inter-institutional consultation on the White Paper shows that the creation of a European Food Authority with scientific and technical competencies is widely considered to be the most effective mechanism to address this growing need and to re-establish public confidence. This proposed Regulation responds to the commitment in the White Paper and provides the concrete basis for the functioning of the Authority, detailing its mission, tasks, organisational arrangements and scope.

The proposal also considers the most logical and effective arrangements for the collection and analysis of scientific and other data, the identification of emerging risks to health and the role of the Food Authority in a food safety crisis. It establishes a rapid alert system for foods and feeds, which will integrate and improve the system.

It aligns procedures and responsibilities where a serious risk to health has been identified in the European food supply whether the product originates within the Community or a third country.

The following section refers to Chapters I and II of the Regulation.

Section 1

1.1 Overall aims of general Food Law

One of the aims of this proposal is to provide a common comprehensive basis for food law. This proposal establishes the common principles underlying food law, defines common terms and creates a general framework for food law.

It includes the following main provisions:

Food law must provide a high level of health protection;

The effective functioning of the internal market in safe food and feed should be assured;

Clear definitions to increase consistency and legal security including the definition of food;

Food law should be based on high quality, transparent independent scientific advice following the three interconnected components of risk analysis: risk assessment, risk management and risk communication;

The use of the precautionary principle to develop provisional measures where an unacceptable level of risk to health has been identified but further scientific data is required to arrive at a comprehensive assessment of risk to health;

Rights of consumers not to be misled and to have access to accurate information;

Traceability of food, feed, ingredients and food-producing animals;

Primary responsibility for safe food and feed rests with businesses;

Member States are responsible for the enforcement of food law;

An obligation to ensure that only safe food and feed are placed on the market;

Recognition of the Community's international obligations particularly in relation to trade;

Transparency of the development of food law and the access to information in this regard.

Responsibilities of feed businesses where their products or activities may have an adverse impact on food safety.

1.2 Definition of food and other definitions

Although a substantial body of food law exists at the Community level, the term 'food' has not been defined. The Green Paper on Food Law [4] and the White Paper on Food Safety both propose that in order to increase clarity and legal security the term should be defined and its use adopted in future proposals on food law. Although the term itself has not been defined at the European level, food has generally been accepted to mean substances, ingredients, raw materials, additives and nutrients ingested through the gastro-intestinal tract, including drinks but not medicines, cosmetics or tobacco. It includes residues deriving from the production and processing of foods such as veterinary medicine residues and pesticide residues. Animals that are to be eaten live (e.g. oysters) are generally considered to be food, but live animals which require slaughter prior to consumption are not, until after the slaughter step.

[4] Green Paper on Food Law, April 1997.

Most Member States have a definition of a food or foodstuff and at the international level a definition exist in Codex Alimentarius.

The proposed definition reflects the general understanding of a food as drafted in Community measures, draws from the definition in Codex Alimentarius and takes into consideration well established definitions in the legislation of the Member States.

The proposed definition includes any substance that is intended to be, or is 'reasonably expected' to be ingested by humans. The reference to 'reasonably expected' is formulated to ensure that a substance (e.g. palm oil) that may be reasonably expected to find its way into the food supply chain but may find its way into different industry sectors, is handled with the same care as a food until it is clear it will not become a food.

In addition to raw materials and ingredients, the definition includes all water intended for human consumption. This is without prejudice to the standards and requirements for water in Council Directives 80/778/EEC [5] and 98/83/EC [6]on the Quality of Water Intended for Human Consumption.

[5] OJ L 229, 30.8.1980, p. 11.

[6] OJ L 330, 5.12.1998, p. 32.

However, by contrast the term 'food law' in this proposal covers a wider range of provisions than those that relate to just food. It includes all measures relating to materials and substances in contact with food, to practices on the farm and also animal feed given to food-producing animals, where there may be a direct or indirect impact on food safety.

The objective of defining food and other concepts in this proposal is to provide legal certainty in relation to future European food law and provide an understanding at Community level for such concepts.

1.3 General objectives of food law

This proposal establishes the overarching principles of food law. It establishes the rights of consumers to safe food and to accurate and honest information from which they can choose their diet. It complements the Treaty requirements in relation to food and the Community's responsibilities to ensure a high level of human health protection in the definition and implementation of Community policies and activities.

The primary objectives of food law established in this proposal will be to ensure the effective functioning of the internal market and in this regard provide a high level of protection of human health, safety and consumer interests. Food law will be based on an integrated approach from the farm to the final consumer, including measures applicable on the farm. In addition, where directly or indirectly relevant to food safety, requirements applicable to feed businesses are established. The 'farm to table' approach has already been followed in the Commission's proposal recasting the Community's hygiene provisions. This principle will in future be considered in other areas as a general principle.

Food law will also pursue the general objectives of the protection of animal or plant health and life and the protection of the environment where this is compatible with the nature of the measure.

Food law, both at the national and Community level not only provides health protection but also protects other consumer interests in relation to the prevention of deceptive practices, including the adulteration of food and ensures consumers are provided with accurate information. This proposal broadens the more specific provisions in Community labelling and advertising legislation by providing an overall principle that consumers must not be misled.

1.4 Scientific basis for food law and the principles of risk analysis

This proposal establishes the principles of risk analysis in relation to food law and establishes the structures and mechanisms in relation to the scientific and technical evaluation which will be, in the main, undertaken by the European Food Authority. Depending on the nature of the measure, food law, and in particular, measures relating to food safety, shall be underpinned by strong science. The European Community has been at the forefront of the development of the risk analysis principles and their subsequent international acceptance. This Regulation proposes that the three inter-related components of risk analysis: risk assessment, risk management and risk communication provide the basis for food law as appropriate to the measures under consideration. Clearly not all food law has a strong scientific basis e.g. food law relating to consumer information or the prevention of misleading practices does not need a scientific foundation.

This proposal requires the scientific assessment of risk to be undertaken in an independent objective and transparent manner based on the best available science.

Risk management is the process of weighing policy alternatives in the light of the results of a risk assessment and, if required, selecting the appropriate actions necessary to prevent, reduce or eliminate the risk to ensure the high level of health protection determined as appropriate in the European Community. In the risk management phase the decision makers need to consider a range of information in addition to the scientific risk assessment, including for example, the feasibility of controlling a risk, the most effective risk reduction actions depending on the part of the food supply chain where the problem occurs, the practical arrangements needed, the socio-economic effects and environmental impact. Therefore, risk management actions are not just based on scientific assessment of risk but also take into consideration a wide range of other factors legitimate to the matter under consideration.

Risk communication is the third component of the risk analysis process, but should not be considered to be a final phase as, in fact, it encompasses all phases. It is an interactive process of exchange of information and opinions on risk between risk assessors, risk managers and other interested parties. It is required particularly during the risk assessment process between risk assessors and risk managers, to ensure, for example, the relevance of the risk assessment to the problem identified by the risk managers, and also following the risk assessment, the communication of the reasons behind a risk-management decision and the decision itself to all interested parties. This proposal lays the foundation for all elements of risk analysis in relation to matters with a direct and indirect affect on food safety.

1.5 The precautionary principle

This proposal reflects the Commission's recent position expressed in its Communication on the precautionary principle in relation to its application in food law [7]. The precautionary principle is recognised as an option open to risk managers when decisions have to be made to protect health or the environment but scientific information concerning the risk is inconclusive or incomplete in some way.

[7] COM(2000) 1 final. Communication on the precautionary principle.

The precautionary principle is relevant in those specific circumstances where risk managers have identified there are reasonable grounds for concern that an unacceptable level of risk to health exists but the supporting information and data may not be sufficiently complete to enable a comprehensive risk assessment to be made. When faced with these specific circumstances, decision makers or risk managers, may take measures or other actions to protect health based on the precautionary principle while seeking more complete scientific and other data. Such measures have to comply with the normal principles of non-discrimination and proportionality and should be considered as provisional until such time that more comprehensive information concerning the risk can be gathered and analysed. This proposal places the precautionary principle in the context of its application in the area of food law. It is also in step with the growing international acceptance of this principle as it applies in the field of food safety.

1.6 Traceability

Recent food scares (BSE and dioxin crises) have demonstrated that the identification of the origin of feed, food, including ingredients and food sources is of prime importance for the protection of consumers. In particular traceability facilitates the withdrawal of foods and enables consumers to be provided with targeted and accurate information concerning implicated products. Recent proposals from the Commission in relation to the recast of the hygiene legislation provide the general requirements in relation to hygiene problems. This proposal broadens this. This Regulation also enables derogation from the requirements for traceability in those sectors where this is impracticable, and on the other hand provides for more specific requirements where necessary.

This proposal requires all feed and food businesses to have in place systems so that they can identify the supplier of foods, feeds and food-producing animals to their businesses and also to whom they have supplied such products. This information should be made available to the competent authorities if requested. Importers are similarly affected, as they will be required to identify from whom the product was exported in the third country. This measure is limited to ensuring that businesses are at the least able to identify the one step in the food supply 'above' them and the one step 'below', unless specific provisions exist for further traceability.

1.7 Responsibilities

In some areas of European food law, notably in hygiene legislation, the primary responsibility for ensuring compliance with food law, and in particular the safety of the food, rests with the food business. To complement and support this principle there must be adequate and effective controls organised by the competent authorities of the Member States. In other areas of food law this principle is not so widely applicable. This proposal will extend this principle to all food law, and lead to a general review of food law to establish if this principle is respected or whether there are rules where Community legislation has unnecessarily taken responsibility away from the feed or food business by prescribing how a given objective has to be achieved instead of fixing the objective.

1.8 Food and feed safety requirements

This proposal seeks to define a food safety requirement. One of the lacunae identified in European food law is that there is no overarching principle for only safe food to be placed on the market. However, this principle exists in the food law of several Member States. This proposal seeks to fill this gap by establishing a food safety requirement which comprises two elements: food should not be potentially injurious to health or unfit for human consumption or contaminated in such a manner that it would not be reasonable to expect it to be used for human consumption according to its intended use.

Only one of these elements has to be in place for the food to be considered as unsafe. These concepts exist internationally in Codex Alimentarius and in the provisions of some Member States.

Potentially injurious to health is further defined in this proposal as this could have a broad interpretation. In considering whether a food is potentially injurious to health it is important to consider the likely, and reasonably foreseeable use of the food and the processing or subsequent handling to which it is to be subject. For example, raw foods which are to be consumed after cooking or other processing, and have been produced in line with good hygiene practices may nevertheless contain low levels of harmful bacteria which will be destroyed by normal processing, including novel processes, irradiation or cooking. The same levels of bacteria in a food, which is to be eaten raw, would not be acceptable. However, the fact that processing may eliminate certain types of hazards, does not abrogate a business from its responsibility to ensure that food safety is considered all along the food supply and that practices are consistent with good practice and, where these exist, in line with the requirements of specific provisions.

The requirement applies to acute effects but can also apply to longer term effects where one exposure may have an adverse effect in the future, as in the case of prions or micro-organisms with a long incubation period. The cumulative effects on the health of the consumer must also be considered in relation to the term potentially injurious to health.

Certain foods are marketed for particularly sensitive consumers, and the concept of potentially injurious to health for these consumers has also to be taken into consideration when determining whether a food is unsafe. Consumers have the right to choose the types and amounts of foods they eat, and otherwise have the freedom to choose their diet. Where information is provided either on a label or otherwise, or information is generally available, and yet the consumer ignores this information in his choice of diet, or for example, consumes food at abnormal levels which may ultimately lead to detrimental health effects, this Regulation does not consider these foods to be unsafe where other requirements of food law are met.

Food unfit for human consumption or contaminated food is also considered to be unsafe in this Regulation. Food, for example, putrid food, may or may not be potentially injurious to health but it is unacceptable for human consumption and may be injurious to health. It may be almost impossible to prove injury or probable injury to health with such food, so this separate factor is proposed in relation to safety within this Regulation.

Similarly, food which is contaminated with, for example, insect parts, or beef which may be contaminated with the hairs from cattle, may not be injurious to health but it is still not reasonable to expect this to be used for human consumption, and proving that it may be potentially injurious to health should not be required to declare that it is unsafe.

Provided that a food business ensures that foods are in compliance with the specific provisions applicable to that food, then the food business shall be deemed to have met his responsibilities in relation to the food safety requirement. However, where a food complies with the relevant specific provisions for that food, but is still deemed to be unsafe by the Competent Authorities, the food may still be withdrawn by the Competent Authorities or other measures taken to impose restriction on that food.

To reinforce the primary responsibility of operators in the food sector, this proposal contains a general obligation for all food businesses to ensure within their respective sphere of influence, that food put on the market complies with the principles of safety. This proposal also makes a general requirement for food businesses to inform the Competent Authorities where a food is suspected to be unsafe and to provide the authorities with all assistance to ensure that consumer health is protected. Where a serious risk to health is identified the competent authorities shall inform the European Food Authority via the rapid alert system.

The proposal requires food businesses to withdraw food if other means of safeguarding the consumer are not sufficient, and to inform consumers of the needs for this withdrawal.

Recent experience has clearly implicated animal feed as a root cause of food safety problems. This Regulation seeks to ensure that food safety is considered at all stages that may have an impact on food safety. Therefore a feed business must ensure that feeds for which they are responsible do not have the potential to cause a food safety problem, and should ensure that practices are carried out in such a manner that food safety is not compromised. It establishes a requirement for only safe feed to be placed on the market and establishes a link with the need to ensure that food from animals fed on such feed is safe. The responsibilities of feed businesses also extend to a duty to withdraw products and to inform the Competent Authorities where they become aware that a feed may affect food safety.

1.9 International obligations and trade in foods

The proposal acknowledges the Community's commitment to its international obligations particularly in relation to the Sanitary and Phyto-Sanitary and the Technical Barriers to Trade Agreements under the auspices of the World Trade Organisation. It underscores the European Community's commitment to the development of international technical standards for foods.

It is proposed that the Community will contribute to the development of international standards and also take them into consideration in the adoption of food law. The texts of Codex Alimentarius and the Office International des Epizooties have gained particular importance under the World Trade Organisation Agreements in the context of food law.

Under the Sanitary and Phyto-Sanitary Agreement, compliance with these standards is considered as conforming to the obligations of the Agreement. Members may require a higher level of health protection, and apply measures which are based on a risk assessment. The Technical Barriers to Trade Agreement similarly acknowledges the need for member countries to use international standards on which to base their regulatory measures unless using such a standard would be an ineffective or inappropriate means for the fulfilment of its legitimate objectives. This proposal recognises the Community's obligation to consider international standards within both of these agreements but balances this with the Treaty requirement for a high level of health protection, and with the other objectives of food law established in this proposal. International standards will only be considered where the high level of health protection or the other objectives of food law are not compromised.

The agro-food sector of the European Community is a major player in the global market place being an active producer, exporter and importer of foods. The Community therefore has a vital interest in ensuring that the high standards of Community food law are widely accepted internationally and consumers are protected both within the Community and in third countries. Through the building of consumer and trading partners' confidence, food safety contributes to the competitiveness of the European food industry. The Community will also take into consideration standards which are at the final steps of adoption procedures in line with the rules of the governing international bodies.

The European Community has been active in the development of international trading rules and standards and is committed to free trade in safe and wholesome foods. This Regulation establishes the general principles upon which the international trade in food shall be based. It establishes the objective that food law will be developed in such a way that it does not arbitrarily or unjustifiably discriminate against any international trading partner and should not present a disguised barrier to trade. It underlines the Community's commitment to developing equivalency and other trade agreements in appropriate circumstances.

1.10 Principle of transparency

This proposal establishes a framework for the greater involvement of stakeholders at all stages in the development of food law and establishes the mechanisms necessary to increase consumer confidence in food law.

This confidence is an essential outcome of a successful food policy and is therefore a primary goal of Community action related to food. Transparency of legislation and effective public consultation are essential to build this greater confidence. Better communication about food safety and the relevance of potential risks, including full transparency of the scientific opinions given to the Commission by its scientific committees are essential in this respect.

The following section refers to Chapter III of the Regulation.

Section 2

2.1 The European Food Authority (EFA)

The White Paper on Food Safety presented an analysis of the scientific elements that underpin food safety policy and, on that basis, set out proposals for a European Food Authority that would meet the needs of the Community in the new millennium. It concluded that a European Food Authority (EFA) would not only contribute to a high level of consumer health protection in the area of food safety but also to the restoration and maintenance of consumer confidence in food safety. Earning consumer confidence would however require the Authority to function at the highest levels of scientific excellence, independence and transparency. The European Food Authority will give effect to the General principles and requirements of Food Law and will be a key component to improve human health protection and consumer confidence.

The White Paper considered that EFA's essential role would be to provide the Community with the independent scientific and technical advice that it requires to underpin policy and legislation in the areas of food safety, nutrition, animal health and animal welfare, plant health at both the European and international level.

It stressed that such an Authority would have to respect the principle of separation of risk assessment and risk management and should respect the existing policy and legal responsibilities of the Commission, European Parliament and Council.

In addition to its core task of providing the Community with first class, independent scientific opinions, it is proposed that the EFA will be responsible for the day-to-day operation of the rapid alert system (covering both food and feed) and that it will have a key role in the management of crisis situations under the Commission's responsibility. Central to the restoration of consumer confidence, it will give clear and publicly accessible information on all matters that fall within its mandate. Its right to communicate on its own initiative on any such matter provides an important additional safeguard to ensure consumer concerns related to food safety are not overlooked during the Community decision-making process.

The Commission also proposed that the EFA would be entrusted with the fundamentally important task of the collection and analysis of data that would allow characterisation and monitoring of food related safety issues in the Community. No such mechanism exists at present even though this information is vital for the early identification of emerging risks, for the identification of weaknesses in Community legislation and for comprehensive risk assessments in many areas.

The White Paper recognised that the current scientific advisory system is hampered by a lack of capacity which has led to serious delays in the delivery of the opinions required for both the management of important matters of consumer health and for the authorisation of products, substances and process under the Community regime. It identified the need to establish in-house scientific support that would undertake much of the preparatory work that is currently done by the scientific committees in order that their members could focus on the core problems of risk assessment.

Central to the establishment of a modern structure that will provide the Community with timely scientific and technical support in EFA's areas of competence, is the deep integration of the expertise and resources of the Member States through various networks. This support will touch all aspects of the Authority's work including preparatory work for the scientific committees, information gathering and emerging risks. An essential facet of the EFA will be to add value to what can be achieved within the existing system through the coordination and collaboration of the Member States.

Finally, and fundamental to the overall success of the EFA, the White Paper recognised that consumer confidence can only be regained if the Authority acts independently of outside pressures and is accepted as doing so by all parties concerned. Its statute must therefore provide for assurances in respect of independence, transparency, representativity and accountability.

2.2 Mission and tasks

A broad mandate is essential if the EFA is to take a comprehensive view of the food chain and to provide a coherent scientific basis for the Community's policy and legislation in this area. In addition to food safety and certain aspects of nutrition it therefore also embraces plant health, animal health and animal welfare. Its competence extends to all matters having a direct or indirect impact on the safety and health of consumers arising from the consumption of food. It thus covers all stages from primary production of food and feed, processing, storage and distribution to the final consumer.

The Commission's proposal recognises that the safety assessment of products of importance for the food and feed areas cannot be made without regard to important non-food aspects. It is essential to ensure that risk assessments are both comprehensive, consistent between related industrial sectors and maintain the "one-door one-key principle" for authorisation of industrial products which fall under the Community regime. Therefore, the EFA will ensure that, where the legislation relating to the authorisation of a product or process of primary relevance to food or animal safety also requires an assessment of environmental risk and/or worker safety (notably for GM plants and seeds, pesticides and feed additives), this will continue to be dealt with by a single scientific committee or panel. For reasons of scientific coherence and administrative efficiency, it is proposed that the EFA will also provide scientific opinions on genetically modified organisms even if they are not intended for food or feed use. However as concerns Community legislation and policy relating to genetically modified organisms that are not intended for human or animal consumption, the mission of the Authority will be limited to the provision of scientific opinions in order to avoid confusion in relation to responsibilities for environmental matters in the Community. In practice this means that the Authority cannot undertake its others tasks such as the collection of data or identification of emerging risks in relation to genetically modified organisms except if these organisms are food or feed. However according to point n) of Article 22 the Commission remains free to require more scientific support in relation to all genetically modified organisms from the Authority.

The EFA will address consumer health aspects of water intended for human consumption.

It is also important to avoid risk of confusion between the role of the Authority and the European Medicinal Evaluation Agency (EMEA). The proposal therefore makes clear that its scope is without prejudice to the competences attributed to EMEA.

It is to be noted that the scope of the rapid alert system which will be operated by the Authority, and the management of crises are limited to food and feed safety.

In the area of nutrition the EFA must take account of the need to ensure that nutritional advice is only given within the framework of broad public health policy. The EFA must ensure continuity of scientific opinions in relation to the nutritional requirements of foods for particular nutritional purposes (dietetic foods marketed under Community rules such as foods for infants and young children and for sports people), the expanding area of nutritional claims and nutritional aspects of novel foods. However, it is essential that advice on nutrition and health is carefully coordinated by the Commission and Member States to avoid confusing or incomplete messages to the public.

2.3 Organisation

The proposed organisational structures will facilitate the involvement of EFA's many and diverse stakeholders, independence from external pressures, transparency and accountability to the democratic institutions. It is therefore proposed that the EFA's board includes four representatives appointed by the Council of Ministers, four by the Commission, four by the European Parliament and four representatives of consumers and industry designated by the Commission. The Commission also believes that, as a Community body, the EFA should ensure the best use of the expertise and resources of the Member States in pursuit of its mission whilst respecting the principle of separation of risk assessment and risk management and the overarching requirement for independence. It is therefore proposed that the EFA includes an Advisory Forum comprising representatives of the analogous Member States bodies to ensure the effective operation of the various information gathering networks and supporting mechanisms. It is evident that individual Member States will need to consider how they will interface with the EFA in such a Committee given that not all Member States have established "food agencies" and, even where they have, their scope is unlikely to reflect the broad remit proposed for the Authority.

The proposal foresees transfer and radical restructuring of the 6 independent scientific committees which currently advise the Commission on matters to be covered by EFA: the Scientific Steering Committee (SSC) and its sub-group as concerns BSE and TSE, the Scientific Committee on Food (SCF), the Scientific Committee on Animal Nutrition (SCAN), the Scientific Committee on Plants (SCP), the Scientific Committee on Veterinary measures relating to Public Health (SCVPH) and the Scientific Committee on Animal Health and Welfare (SCAHAW). The restructuring is necessary to both streamline the scientific advisory process and to reflect current rationales in Community policy and legislation as typified by the farm-to-table approach to the safety of the food chain. The proposed structure, which consists of 8 permanent independent panels and a scientific committee, responsible for providing scientific opinions, each within their own sphere of competence, on all matters falling within the Authority's mission. This system is also designed to ensure greater scientific coherence in related areas such as in GM products, food and feed contaminants and microbiological risk, and to anticipate future needs for example, in the area of nutritional claims and novel feed. The system also has the flexibility to handle questions not covered by the panels. For example, problems connected with natural mineral waters, food irradiation or plant health, can be managed by the scientific committee which includes the chairpersons of the permanent panels and will thereby allow maximum flexibility and best use of available scientific expertise.

The excellence of scientific opinions will continue to be ensured on the basis of the procedures introduced by the Commission in 1997 which allow individual scientists to propose themselves for consideration for membership of a committee or a panel. The executive director will be responsible for the management and for ensuring the transparency of the selection process but the decision on Membership will reside with the Management Board.

The lack of capacity of the existing scientific committees to address the increasing number and urgency of questions was highlighted in the White Paper. In addition to providing the Committee secretariat, EFA will need to have the means necessary to ensure that the Committee members enjoy sufficient administrative and scientific support to allow them to concentrate their limited time on the core issues of risk assessment. This implies substantial in-house scientific expertise which, together with the support of the Member States in the preparatory work, will allow the scientific committee and the independent panels to work primarily by peer review. Members of the scientific committee and panels will thus be very largely liberated from the detailed and time-consuming dossier preparation and evaluation that characterises the present, overloaded system.

2.4 Scientific opinions

Currently, the scientific committees are constituted under Community legislation to advise the Commission. It is proposed that the EP, the Member States or their competent bodies will also be able to address requests for scientific opinion to the EFA with the important exception of questions in areas where consultation of the EFA is obligatory under Community law. In such cases, the Commission, in accordance with its right of initiative, is solely responsible for addressing a question to the EFA. The right of EFA to initiate its own questions reflects the Authority's independence and is an additional and important safeguard that consumer safety is given pride of place in Community policy and rule making.

The extension of the right to the EP, Member States or their competent bodies to make direct requests to the EFA for scientific opinions brings with it the need to avoid overload, needless duplication, loss of coherence and distraction from priority tasks. It is also important that the right of Member States to pose questions does not lead to a reduction of the already limited national resources on which the long-term success of the EFA will depend.

These considerations imply the need to establish clear and transparent rules covering the treatment of questions including criteria by which EFA will assess the acceptability and management of questions from different sources and the guidelines governing the submission of dossiers in support of a request to include products or processes in a Community positive list. It is proposed that the Commission, after consultation of the EFA, brings forwards a proposal to define these modalities.

2.5 Conflicting scientific opinions

Differences between the scientific opinions of the Commission's scientific committees and those of other Community bodies can complicate both risk management and risk communication, especially where the issues touch on matters which are sensitive for the public or for our trading partners.

The Commission does not consider that it is practical or appropriate to empower the EFA to act as a final, scientific, arbitrator in the case of conflicting scientific opinions in a manner which is binding on the parties concerned. However, the draft Regulation foresees an important role for EFA to anticipate conflicts, to bring the parties together and to identify and agree the basis of the difference of opinion. Even if the EFA is unable to resolve the conflict, the procedure will provide the Commission with a transparent basis on which to develop its proposals for risk management with a clear understanding of the underlying scientific issues.

Where the conflicting opinions involves a Community body or one of the Commission's scientific committees, the Authority and the body or committee concerned shall be obliged to work together to resolve the conflict, or, if this is not possible, to submit a joint document to the Commission clarifying the contentious issues.

Where the conflict involves differences in scientific opinion between the Authority and a national body, a similar procedure will be followed but in consultation with the Advisory Forum. The procedure does not imply the supremacy of the Authority in the case of scientific conflict. Indeed, it is envisaged that an analogous provision will be considered for the European Medicines Evaluation Agency during its forthcoming review.

Conflicts arising from national measures are addressed in mediation procedures established under Chapter V of this proposal.

2.6 Scientific and technical support

In addition to the need for independent scientific opinions from the scientific committees in relation to various kinds of risks, the Commission needs substantial, on-line assistance on a wide range of scientific and technical matters that do not fall within the scope of the scientific committee and permanent scientific panels. Examples include the gathering and interpretation of scientific information to assist with policy matters, the drafting of specifications in relation to the purity criteria of food and feed additives, assistance with the technical evaluation of third country residue programmes, support to assessment of technical notifications under WTO rules, the development of technical guidelines and guides to good practice in food hygiene. It is proposed that the EFA will facilitate this support by various means including use of its in-house expertise, external contracts with industry and research bodies and Member State networks. Such support cannot however be unlimited and it will be essential to agree an annual work programme with sufficient flexibility to manage ad hoc and urgent problems. Full account must also be taken of the contribution of Joint Research Centre (JRC) expertise in specific areas of scientific and technical support to the Commission. This support should continue with appropriate coordination to ensure best use of existing expertise and resources.

2.7 Scientific studies

The White Paper identified the need for the EFA to have its own budget to undertake scientific studies where necessary in order to fill gaps in knowledge which prevent it from fulfilling its mission or to respond to crises. This ensures that the EFA has the necessary independence to investigate problems which are not examined elsewhere.

It is essential however to make best use of existing resources and to develop synergies through appropriate coordination with the JRC and with Community and national research activities. EFA scientific studies would be characterised by their relatively high degree of focus and short-term duration as necessary to ensure that it is able to react with due urgency to well defined problems which arise in its work.

2.8 Information and data collection

The absence of a centralised mechanism for gathering and analysing intelligence at Community level on matters relating to the health and safety of consumers and animals in respect to food and feed is recognised as a major weakness in current procedures. The availability of reliable, comparable and up-to-date information will provide the Community at large with an objective overview of food safety, allow the legislator to identify gaps in Community legislation concerning public health objectives and the EFA itself to identify emerging risks. Information relating to food consumption, composition and the levels of potentially harmful substances and biological agents are essential if the Authority is to evaluate nutrient intake and dietary exposure for the general population of the Community, and more importantly, for vulnerable sub-groups such as infants, children and the elderly. The lack of such information frequently prevents completion of risk assessments and is an additional weakness in the current situation which will be remedied by this task. Relevant information will be collected from all accessible sources including data-bases, scientific literature and Member State networks. Collection of data from third countries will be necessary where relevant to the health and safety of the European consumer.

The draft Regulation takes account of the many existing information gathering networks of Member States that have been established under Community legislation. In general, these networks address sectoral problems with little cross fertilisation and often lack the infrastructure and support to ensure that the data generated are comparable, fully exploited or published in a timely manner.

In those cases where the subjects are of indirect interest to the work of the Authority, the most appropriate approach will be to arrange for exchange of information of mutual interest. This is likely to be the case, for example, for the network for the epidemiological surveillance and control of communicable diseases in the Community established by European and Council Decision No 2119/98/EC.

In view of the number and complexity of the existing networks it is proposed that the Commission publishes an inventory of the Community networks that are relevant to the EFA's mission together with recommendations concerning their transfer to the EFA and an analysis of weaknesses which need to be corrected.

2.9 Identification of emerging risks

Although it is obviously not possible to prevent all problems and crises, early warning of emerging risks or newly identified concerns will allow the risk manager to take preventive rather than curative measures. In response to the broad consensus that a European Food Authority should be pro-active and not simply reacting passively to food scares and crises, it is proposed that the EFA undertakes prospective actions to identify and monitor emerging risks that are of potential concern for the Community. In addition to the use of its own intelligence gathering and analysis procedures and Member State networks to identify potentially worrying trends, it will also need to establish close contacts with international agencies and third countries. Communication of EFA's conclusions in relation to emerging risks are an inherent component of this activity. The Authority will also need to make best use of relevant information sources established at Community level, notably in the JRC and the European Environmental Agency.

2.10 The rapid alert system

It is proposed that the EFA is charged with the day-to-day operation of the enlarged rapid alert system for food and feed. Experience with a wide range and large number of alerts over the past years has shown the need for considerable scientific and technical judgment in assessing the health importance and urgency of certain notifications. The Commission considers that this can best be done within the multi-disciplinary environment of a European Authority having immediate access to food related safety data. The provisions for the operation of the rapid alert system are set out in Chapter IV.

2.11 Networks of organisations operating in the same fields as the Authority

The establishment of effective networks of organisations operating in the same fields as the Authority will provide the mechanism by which the Member States can combine their expertise in the common interests of the Community. This will give the proposed Authority an overall capacity which is comparable to much bigger national organisations such as the US FDA. The Commission's proposal in this area takes account of experience of the operation of the system of scientific cooperation with the Member States on food related issues under Directive 93/5/EEC (SCOOP). Although SCOOP has demonstrated the tremendous potential to focus Member State resources on a wide range of Community problems, it also highlighted the limitations arising from a system which depends on the voluntary support of the Member States. This has meant that important tasks that underpin Community policy and legislative development could not always be managed with the rigour necessary to ensure their adequate completion within the necessary time-limits.

The Authority will work in direct cooperation with the competent organisations in the Member States in order to closely associate them with its work in a manner which not only draws on their scientific potential but also conserves and even reinforces the capacity of their scientific institutes. It is particularly here that the Advisory Forum comprising representatives of the analogous Member States' bodies will be key to ensuring the effective operation of the various networks.

The draft Regulation provides for the Authority to draw up a list of organisations designated by the Member States (governmental bodies, university department or private institutes) that have the scientific competence in the domains covered by the EFA and which could undertake various tasks on its behalf. This procedure will be particularly important for the evaluation of industry dossiers submitted in the context of requests for Community level authorisation of products and processes. It is proposed that the Authority will enlist the expertise of the Member States for the drafting of an initial assessment report on the basis of the authorisation dossier in preparation for final evaluation by one of the specific scientific panels. This procedure draws on the successful experience of the EMEA which is able to meet strict time-limits for the evaluation of dossiers for the authorisation of medicinal products in the Community. It is therefore intended that, where appropriate, the EFA may remunerate such competent organisations for their assistance with authorisation dossiers in order to ensure time delays and common quality standards are met. Detailed procedures will need to be established by means of a subsequent Commission decision covering the criteria for inclusion of organisations on the Authority's list and the rules governing any financial support.

Community level authorisation places a clear responsibility on the legislator to ensure that the granting of an authorisation to use a process or to place a product or substance on the market does not lead to risks to human or animal health, or to the environment. It is important to note that, in the areas of concern for EFA, there are wide variations in the nature and extent of the preparatory work undertaken by the Member State Authorities in relation to dossiers submitted as part of the Community authorisation processes. For food additives, flavourings, materials in contact with food, technological aids, nutritional substances, the scientific committee undertakes the entire work apart from limited assistance through SCOOP. In the case of pesticides, novel foods, feed additives and GM plants the petitioner selects the Member State to act as Rapporteur in accordance with procedures which are specific to the sector. This has resulted in wide differences in the nature and level of involvement of the scientific committees in the risk assessment work related to Community authorisations.

To take maximum benefit from the resources of the Authority and the system of Member State support, the establishment of the EFA will need to be accompanied by a revision of existing procedures relating to the scientific support by Member States to the preparatory work particularly as concern dossiers related to requests for authorisation. It will be essential to ensure that all scientific evaluations undertaken by EFA meet the expectations of consumers and industry in terms of scientific quality and independence.

In view of the practical and legislative complexity of advancing harmonisation within the current proposal, it is proposed that, within 12 months of the Regulation entering into force, the Commission will publish an inventory of the various systems of scientific support of relevance to the work of EFA, particularly as concern Community authorisation dossiers. The report will be accompanied by appropriate proposals.

The scope of the SCOOP as currently defined will be reviewed at the same time.

2.12 Independence, transparency, confidentiality and communication

Acceptance of the advice and the objectivity of the EFA by the public and the scientific world will depend crucially on establishing a culture of independence and transparency at all levels of its operation. The proposed Regulation therefore foresees a series of obligations on the Management Board, the members of the scientific committee, scientific panels and their working groups and the Advisory Forum of Member States. These are designed to ensure that EFA's advice is both truly and visibly independent.

Provision is made for the Management Board to hold some of its meetings in public or to allow stakeholders to observe some of the Authority's activities.

The EFA will adopt the internal rules, which govern the practical and detailed application of these requirements.

2.13 Communication

The White Paper highlighted the importance of direct and open Communication with consumers relating to scientific opinions and to its monitoring and surveillance tasks. It recognised that consumer confidence would be greatly enhanced by readily accessible and easily understood information. The proposal to give the EFA a right of initiative to communicate on subjects within its competence provides an important, additional safeguard for the consumer. In line with the White Paper, the Commission will remain responsible for communication on risk-management decisions, however, it is important that there is appropriate exchange of information between EFA and the Commission to ensure that coherence of the overall message.

The work of the EFA in the area of public information campaigns on matters of food safety or nutrition will need to be carefully orchestrated with the Member States and other interested parties to take account of broader public health considerations, regional factors and the need to avoid conflicting or incomplete advice.

2.14 Access to information

Although the policy of transparency demands easy public access to information held by the EFA, there are inevitable constraints arising from legitimate commercial confidentiality and from legislation governing the protection of personal information. The Management Board will adopt any additional internal rules that it considers appropriate to respect confidentiality where it considers it justified.

2.15 Contact with consumers and other interested parties

The Commission's proposal recognises the need for the Authority to have contact with consumer representatives and other interested parties. This would serve to increase confidence in its work and would be consistent with its broad communication mandate.

2.16 Fees

Unlike the EMEA system, it is not intended to levy fees for the work of the EFA, at least, not in its initial period of operation. It is to be noted however that Community legislation relating to the Community approval of plant protection products and on the authorisation of feed additives provides for the charging of fees by the Member State that undertakes the initial assessments. The Commission proposes that the possibility of charging fees, particularly in regard to the work relating to Community authorisation of commercial products, should be the subject of a reflection. It therefore proposes to review the situation within 3 years of operation of EFA and to issue a report on the matter.

2.17 Participation of third countries

Appropriate provisions will be established in relation to the participation of EEA and candidate countries.

The following section refers to Chapter IV.

Section 3

3. Rapid alert system, management of crises and emergency situations

The Authority will be responsible for ensuring the operation of a broadened rapid alert system for food and feed. A system for rapid alert already exists in the framework of the General Product Safety Directive under which the Member States must notify the Commission of measures taken which restrict the placing on the market, or require the withdrawal of a product or a product batch. In the case of products posing a serious and immediate risk, the information on such measures taken or decided by a Member State must be rapidly transmitted by the Commission to all Member States including EEA and EFTA countries through the Community rapid alert system. The scope of the existing rapid alert system is limited to consumer products (food and industrial products) and does not cover animal feed. However, in the food sector the rapid alert system has evolved on a voluntary basis to cover other circumstances where it is useful for Member States to be informed about risks to health, in particular, in relation to the rejections of consignments of product at the external borders of the European Union.

The Commission considers that there is an urgent need to separate food from other consumer goods and to set up an improved and broadened rapid alert system which covers the entire food chain. The new system will therefore specifically address products intended for human consumption and for animal feed in a network that will include the Commission, the Member States and the Authority. The Authority will ensure the operation of the network, namely, the immediate transmission of the notifications received through the rapid alert system to all the members of the network and the analysis of the data generated by the system, the Commission and Member States remaining responsible for management measures in their own domains of competence. The revised system provides for the following types of mandatory notifications in relation to food and feed: notification of a serious direct or indirect risk for health, notification of measures taken in relation to food or feed and notification of rejections at the EU borders. In case of notification of a serious direct or indirect risk for health, the Authority can assess the risk and complement the notification with scientific or technical information thereby facilitating rapid and appropriate action by the Member States.

This new system takes into account the improvements made in proposal for amendment of the General Product Safety Directive. In particular, the measures or actions to be notified by the Member States are those related to a serious direct and indirect risk to human health which require rapid intervention including the notification of voluntary action initiated by business operators or agreed with the authorities. The proposal foresees the possibility to open the rapid alert system to non-EU countries or international organisations on the basis of reciprocity, under appropriate conditions.

3.2 Crisis management

Recent events have demonstrated the importance of establishing clearly defined operational procedures which allow the Commission to manage food crises efficiently especially where there are specific needs for coordination and/or close interaction with scientists. New modalities are envisaged by this proposal to ensure optimum coordination and to strengthen the Community's overall capacity to identify the most effective measures to prevent, reduce or eliminate a risk for human health. These modalities are consistent with a global approach of the safety of the food chain, encompassing products for both human consumption and for animal feed.

These new tools include the definition of a crisis management plan and provide for the Commission to establish, where necessary, a crisis unit in which the Authority will participate. The Authority will give scientific and technical support to the crisis unit, the Commission remaining responsible for the management measures. The crisis unit will be responsible for communication during the time of crisis.

3.3 Emergency situations

Under current Community legislation, measures to be taken in the event of emergencies differ according to the type and origin of the product. This source of confusion and inefficiency is addressed by this Chapter in relation to all foods. These emergency measures do not cover products intended for animal feed because analogous provisions to deal with emergencies in this area are in the process of adoption by Parliament and Council.

This Section refers to Chapter V.

Section 4

4.1 Establishment of the Committee

This Chapter provides for the introduction of a Committee for Food Safety and Animal Health covering all relevant regulatory activities with a direct or indirect impact on the food chain. The establishment of a single, overarching Committee, will foster greater harmony of approach and provide flexibility to manage problems which affect several sectors, for example dioxin contamination of food and feed.

4.2 Mediation

This Chapter establishes a mediation procedure enabling the Commission, without prejudice of other applicable procedures, to ask for the opinion of the Authority on contentious scientific issues if a Member State considers that another Member State has taken measures which are either incompatible with the proposed Regulation or likely to affect the operation of the internal market. This mediation procedure will be of particular value in case of a conflict involving differences of scientific opinions.

4.3 Commencement of the Authority

It is proposed that the Authority takes up its responsibilities after entry into force of the Regulation, at a date to be decided, so as to ensure continuity of existing functions, in particular, as concerns the provision of scientific opinions. The existing scientific committees will continue to exercise their functions until the nomination of the scientific committee and 8 panels by the administrative board. This process requires the establishment of the management board, appointment of the Executive Director and completion of a call for expressions of interests from scientists who wish to be considered for membership of a scientific committee or panels.

This Section refers to miscellaneous matters.

Section 5

5.1 Personnel

For carrying out the tasks described above, the Authority needs to have a sufficient number of high-quality and specialised staff. The staff will provide extensive, scientific and organisational support to ensure the efficient work of the independent scientific committee and the eight panels and manage the various Member State networks that underpin the Authority's work, prepare the communication strategy for a food safety crisis. Personnel are also required for information gathering networks, technical support to the Commission, communication and the administrative support necessary for a stand-alone body.

The analysis leads to an estimated number of staff for the Authority of around 339 when fully functional in the year n + 5 (n being the year of adoption of the regulation). However the current personnel estimates attached to this Regulation cover the period n + 3 where it is estimated that 255 persons will be required.This will be reviewed during the third year to ensure that there are sufficient personnel to enable the EFA to function effectively in subsequent years. By way of comparison, the newly established United Kingdom Food Standards Agency has 570 staff to carry out tasks relevant to food safety only. The most comparable organisation to the EFA in terms of the population it covers is the CFSAN part of the United States Food and Drug Administration which employs approximately 850 people. The European Medicines Evaluation Agency, which operates in the field of human and animal medicine evaluation, and has a more limited remit than is envisaged for EFA, has 210 staff.

The personnel of the Authority will be subject to the Staff Regulations applicable to Officials of the European Communities and the Conditions of Employment of Other Servants. It is envisaged that a relatively small number of these will be seconded from the Commission in order to ensure efficient transfer of expertise and continuity of the work concerning the secretariats of the independent scientific advisory system, the operation of the rapid alert system, the management of certain existing Member State information collection networks and to set up the administrative and informatics systems. It is envisaged that staffing will be primarily on the basis of temporary renewable contracts and will take account of the need to ensure that the personnel keep abreast of scientific developments.

5.2 Budget

The Authority needs a budget allocation large enough to hire its personnel as described above; to organise and host the meetings of the scientific committees; to refund the Member States for evaluation work on authorisation dossiers and to commission scientific studies. For the first year this budget can be valued at roughly EUR 9 000 000. When fully operational it is estimated that the Authority will need a budget of circa EUR 67 200 000 in year n + 5 (n being the year of the adoption of the Regulation). However, the present financial assessment attached to this Regulation covers the period from n until year n + 3 when it is estimated that EUR 44 400 000 will be required. In the third year and in light of the experience gained this will be reviewed to ensure the continued effective functioning of EFA.

By way of comparison the United Kingdom Food Standards Agency has a budget of EUR 136 500 000 for the year April 1999 to April 2000. The European Medicines Evaluation Agency which has a more limited scope and remit than EFA has a budget of approximately EUR 50 000 000 for the year 2000, a proportion of which it is able to retrieve from charges it levies in relation to its main work of evaluation of dossiers for proprietary medicines.

The Authority's budget will be financed by a subsidy from the Community. It is not generally accepted to levy fees on petitioners, however, the Commission will review this area. Consequently, the Community contribution will be EUR 9 000 000 the first year and increase progressively to EUR 44 400 000 in the third year and reviewed for subsequent years.

The Authority must put in place an appropriate set of rules and controls assuring the highest level of financial control. The Management Board will be entitled to adopt, after having achieved the approval of the European Commission, the necessary measures and rules, but the Authority will ultimately be subject to the supervision of the Court of Auditors. The Authority will make use of existing Commissions expertise and resources when it carries out or commands audits and evaluations.

2000/0286 (COD)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37, 95, 133 and 152(4)(b) thereof,

Having regard to the proposal from the Commission [8],

[8] OJ C

Having regard to the opinion of the Economic and Social Committee [9],

[9] OJ C

Having regard to the opinion of the Committee of the Regions [10],

[10] OJ C

Acting in accordance with the procedure laid down in Article 251 of the Treaty [11],

[11] OJ C

Whereas:

(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2) A high level of protection of human life and health should be assured in the pursuit of Community policies.

(3) The free movement of food within the Community can be achieved only if food safety requirements do not differ significantly from Member State to Member State.

(4) There are important differences in relation to concepts, principles and definitions of food in the Member States. When Member States adopt measures governing food, these differences may impede the free movement of food, create unequal conditions of competition, and may thereby directly affect the functioning of the internal market.

(5) Accordingly, it is necessary to approximate these concepts, principles and definitions of food in the Member States so that they form a common basis for measures governing food taken in the Member States and at Community level.

(6) In this regard, water is ingested as other foods, thereby contributing to the overall exposure of a consumer to ingested substances, including chemical and microbiological contaminants. It should therefore be considered to be food, without prejudice to the requirements established in Council Directives 80/778/EEC [12] and 98/83/EC [13] on the quality of water intended for human consumption.

[12] OJ L 229, 30.8.1980, p. 11; Directive as last amended by the Act of Accession of Austria, Finland and Sweden.

[13] OJ L 330, 5.12.1998, p. 32.

(7) The Community has chosen a high level of health protection as appropriate in the development of food law which it applies in a non-discriminatory manner whether food or feed is traded on the internal market or internationally.

(8) It is necessary to ensure that consumers, other stakeholders and trading partners have confidence in the decision-making processes underpinning food law, its scientific basis and the structures and independence of the institutions protecting health and other interests.

(9) Experience has shown that it is necessary to adopt measures aimed at guaranteeing that only safe food is placed on the market and at ensuring that systems exist to identify and respond to food safety problems in order to ensure the proper functioning of the internal market and to protect human health.

(10) In order to take a sufficiently comprehensive and integrated approach to food safety, there should be a broad definition of food law covering a wide range of provisions with a direct or indirect effect on the safety of food and feed, including provisions on materials and articles in contact with food, animal feed and other agricultural inputs at the level of primary production.

(11) In order to ensure the safety of food, it is necessary to consider all aspects of the food production chain as a continuum because each element may have a potential impact on food safety.

(12) Experience has shown that for this reason it is necessary to consider the production, manufacture and distribution of feed given to food-producing animals, since the inadvertent or deliberate contamination of feed, and adulteration or fraudulent or other bad practices in relation to it, may give rise to a direct or indirect impact on food safety.

(13) For the same reason, it is necessary to consider other practices and agricultural inputs at the level of primary production and their potential effect on the overall safety of food.

(14) Measures adopted by the Member States and the Community governing food safety should not be based on the yardstick of general conjecture but on the basis of a risk analysis. Recourse to a risk analysis prior to the adoption of such measures should facilitate the avoidance of unjustified barriers to the free movement of foodstuffs.

(15) Where food law is aimed at the reduction, elimination or avoidance of a risk to health, the three interconnected principles of risk analysis: risk assessment, risk management, and risk communication, provide a systematic methodology for the determination of effective, proportionate and targeted measures or other actions to protect health.

(16) In order for there to be confidence in the scientific basis for food law, risk assessments should be undertaken in an independent, objective and transparent manner, on the basis of the available scientific information and data.

(17) It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk-management decision should be based, and that other factors relevant to the matter under consideration should legitimately be taken into account including societal, economic, ethical and environmental factors and the feasibility of controls.

(18) The precautionary principle has been invoked to ensure health protection in the Community, thereby giving rise to barriers to the free movement of food. By adopting a uniform basis throughout the Community, the possibility of an improper use of this principle is diminished.

(19) In those specific circumstances where a risk to life or health exists but scientific uncertainty persists, the precautionary principle provides a mechanism for determining risk management measures or other actions in order to ensure the high level of health protection chosen in the Community.

(20) Experience has shown that the functioning of the internal market in food can be jeopardised where it is impossible to trace food and feed. It is therefore necessary to establish a comprehensive system of traceability within feed and food businesses so that targeted and accurate withdrawals can be undertaken or information given to consumers or control officials, thereby avoiding the potential for unnecessary wider disruption in the event of food safety problems.

(21) It is necessary to ensure that a food or feed business including an importer can identify at least the business from whom the food, feed, animal or substance that may be incorporated into a food or feed has been supplied, to ensure that on investigation, traceability can be assured at all stages.

(22) A food business operator is best placed to devise a safe system for supplying food and ensuring that the food it supplies is safe; thus, he should have primary legal responsibility for ensuring food safety. Although this principle exists in some Member States and areas of food law, in other areas, this is either not explicit or else responsibility is assumed by the competent authorities of the Member State, through the control activities they carry out. Such disparities are liable to create barriers to trade and distort competition between food business operators in different Member States.

(23) Similar requirements should apply to feed and feed business operators.

(24) Some Member States have adopted horizontal legislation on food safety imposing, in particular, a general obligation on economic operators to market only food that is safe. However, such Member States apply different basic criteria for establishing whether a food is safe. Given these different approaches, and in the absence of horizontal legislation in other Member States, barriers to trade in foods are liable to arise.

(25) It is therefore necessary to establish general requirements for only safe food and feed to be placed on the market, to ensure that the internal market in such products functions effectively.

(26) The safety and confidence of consumers within the Community, and in third countries, are of paramount importance. The Community is a major global trader in food and in this context, it has entered into international trade agreements, it contributes to the development of international standards which underpin food law, and it supports the principles of free trade in safe and wholesome foods in a non-discriminatory manner, following fair and ethical trading practices.

(27) It is necessary to establish the general principles upon which food may be traded and the objectives and principles for the contribution of the Community to developing international standards and trade agreements.

(28) Food safety is of increasing concern to the general public, non-governmental organisations, professional associations, international trading partners and trade organisations. It is necessary to ensure that consumer confidence and the confidence of trading partners is secured through the open and transparent development of food law and through public authorities taking the appropriate steps to inform the public where there are reasonable grounds to suspect that a food may present a risk to health.

(29) The scientific and technical basis of Community legislation relating to the safety of food should contribute to the achievement of a high level of health protection within the Community. The Community should have access to high-quality, independent and efficient scientific and technical support.

(30) The scientific and technical issues in relation to food safety are becoming increasingly important and complex. The establishment of a European Food Authority, hereinafter referred to as "the Authority", should reinforce the present system of scientific and technical support which is no longer able to respond to increasing demands on it.

(31) It is therefore necessary to establish the Authority to serve as a mechanism for applying the general principles of food law, in particular by carrying out the risk assessments necessary for the adoption of Community measures governing food safety, in an independent, objective and transparent manner.

(32) The Authority should take on the role of an independent scientific point of reference and in so doing should assist in ensuring the smooth functioning of the internal market. It may be called upon to give opinions on contentious scientific issues, thereby enabling Member States to take informed risk-management decisions necessary to ensure food safety whilst helping avoid the fragmentation of the internal market through the adoption of unjustified or unnecessary obstacles to the free movement of food.

(33) The Authority's role as an independent scientific point of reference means that a scientific opinion may be requested not only by the Commission, but also by the European Parliament and the Member States or a competent national body. Steps should also be taken to help avoid conflicting scientific opinions and, in the event of conflicting scientific opinions between several scientific bodies, procedures should be in place to solve the conflict or provide the risk managers with a transparent basis of scientific information.

(34) The Authority should be an independent source of information and risk communication in order to improve consumer confidence.

(35) A system for rapid alert already exists in the framework of Council Directive 92/59/EEC of 29 June 1992 [14] on general product safety. The scope of the existing system includes food and industrial products but not feed. Recent food crises have demonstrated the need to set up an improved and broadened rapid alert system covering food and feed. This revised system should be operated by the Authority. The system should not cover the early exchange of information in the event of a radiological emergency established in Council Decision 87/600/Euratom [15].

[14] OJ L 228, 11.8.1992, p. 24.

[15] OJ L 371, 30.12.1987, p. 76.

(36) The Authority should provide a comprehensive independent scientific view of the safety and other aspects of the whole food supply chain, which implies wide-ranging responsibilities for the Authority. These should include issues having a direct or indirect impact on the safety of the food supply chain, animal health and welfare, plant health and nutrition.

(37) Since some products authorised under food legislation such as pesticides or additives in animal feed may involve risks to the environment or to the safety of workers, some environmental and worker protection aspects should be covered by the Authority.

(38) The Authority should provide scientific opinions concerning all genetically modified organisms within the meaning of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms [16] whether or not intended for human of animal consumption, including the scientific assessment of their environmental impact in order to avoid duplicated scientific assessments and related scientific opinions on these organisms. However, it is necessary to avoid confusion of competence with the environmental fields as concerns genetically modified organisms that are not food or feed. therefore the Authority should be restricted in its mission in relation to genetically modified organisms that are not food or feed to scientific opinions.

[16] OJ L 117, 8.5.1990, p. 15; Directive as last amended by Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).

(39) The confidence of the Community institutions, the general public and interested parties in the Authority is essential. For this reason, it is vital to ensure its independence, high scientific quality, transparency and efficiency; cooperation with the Member States is also indispensable.

(40) The Authority should have the means to perform all the tasks required to enable it to carry out its role.

(41) It is necessary to ensure that there is effective monitoring of the Authority by the various Community institutions involved, and for this purpose its Management Board should include four representatives appointed by the European Parliament, four by the Council, and four by the Commission. The Management Board should have the necessary powers to establish the budget, check its implementation, draw up internal rules, adopt financial regulations, appoint members of the Scientific Committee and Scientific Panels and appoint the Executive Director.

(42) It is necessary to build up a relationship of confidence and transparency with the general public, and therefore the Management Board should include four representatives of consumers and industry.

(43) The Authority should cooperate closely with competent bodies in the Member States if it is to operate effectively, in particular with regard to the networking system, and an Advisory Forum should be created for this purpose.

(44) The Authority should take over the role of the Scientific Committees attached to the Commission in issuing scientific opinions in its field of competence. It is necessary to reorganise these Committees to ensure greater scientific consistency in relation to the food supply chain and to enable them to work more effectively. A Scientific Committee and Permanent Scientific Panels should therefore be set up within the Authority to provide these opinions.

(45) In order to guarantee independence, members of the Scientific Committee and Panels should be independent scientists recruited on the basis of an open application procedure.

(46) The Authority should also be able to commission scientific studies necessary for the accomplishment of its duties, while ensuring that the links established by it with the Commission and the Member States prevent duplication of effort. The Authority should take into account existing Community expertise and structures notably as concerns networks of scientific experts established under Community programmes for research and technological development (RTD) and by the Joint Research Centre. In addition, the Authority when planning its work should take due note of relevant actions undertaken by the Joint Research Centre and under Community RTD programmes.

(47) The lack of an effective system of collection and analysis at Community level of data on the food supply chain is recognised as a major shortcoming. a system for the collection and analysis of relevant data in the fields covered by the Authority should therefore be set up, in the form of a network coordinated by the Authority. Specific provisions for the adaptation of Community data collection networks already existing in the fields covered by the Authority are called for.

(48) Improved identification of emerging risks may in the long term be a major preventive instrument at the disposal of the Member States and the Community in the exercise of its policies. It is therefore necessary to assign to the Authority an anticipatory task of collecting information and exercising vigilance.

(49) The establishment of the Authority should enable Member States to become more closely involved in scientific procedures; there should therefore be close cooperation between the Authority and the Member States for this purpose. In particular, the Authority should be able to assign certain tasks to organisations in the Member States.

(50) It is necessary to ensure that a balance is struck between the use of national organisations carrying out tasks for the Authority and the need to ensure for the purposes of overall consistency that such tasks are carried out in line with the criteria established for such tasks for the Authority. Existing procedures for the allocation of scientific tasks to the Member States, in particular with regard to the evaluation of dossiers presented by industry for the authorisation of certain substances, products or procedures, should be re-examined within a year to take into account the establishment of the Authority and the new facilities it offers.

(51) The independence of the Authority and its role in informing the public mean that it should be able to communicate autonomously in the fields falling within its competence, its purpose being to provide objective, reliable and easily understandable information. However, the Commission remains fully responsible for communicating risk management measures; the appropriate information should therefore be exchanged between the Authority and the Commission.

(52) Appropriate cooperation with the Member States is necessary in the specific field of public information campaigns to take into account any regional parameters and any correlation with health policy.

(53) In addition to its operating principles based on independence and transparency, the Authority should be an organisation open to contacts with consumers and other interested groups and should be able to arrange their involvement in some of its work, in accordance with its own rules.

(54) The Authority should be financed by the Community budget. however, in the light of experience acquired, in particular with regard to the processing of authorisation dossiers presented by industry, the possibility of fees should be examined within three years after the entry into force of the Regulation. The Community budgetary procedure remains applicable as far as any subsidies chargeable to the general budget of the Communities are concerned; moreover, the auditing of accounts should be undertaken by the Court of Auditors.

(55) It is necessary to allow for the participation by European countries which are not members of the European Union and which have concluded agreements obliging them to transpose and implement the body of Community law in the field covered by this Regulation.

(56) Recent food safety incidents have demonstrated the need to establish appropriate measures in emergency situations ensuring that all foods, whatever their type and origin, should be subject to common measures in the event of a serious risk to human health. such a comprehensive approach to emergency food safety measures should allow effective action to be taken and avoid artificial disparities in the treatment of food representing a serious risk to human health.

(57) Recent food crises have also shown the benefits to the Commission of having properly adapted, more rapid procedures for crises management. These organisational procedures should make it possible to improve coordination of effort and to determine the most effective measures on the basis of the best scientific information; therefore, revised procedures should take into account the Authority's responsibilities and should provide for its scientific and technical assistance in the event of a food crisis.

(58) In order to ensure a more effective, comprehensive approach to the food chain, a Committee on Food Safety and Animal Health should be established to replace the Standing Veterinary Committee, the Standing Committee for Foodstuffs, the Standing Committee for Feedingstuffs and the Standing Committee on Plant Health. Accordingly, Council Decisions 68/361/EEC [17], 69/414/EEC [18], 70/372/EEC [19] and 76/894/EEC [20], should be repealed.

[17] OJ L 255, 18.10.1968, p. 23.

[18] OJ L 291, 19.11.1969, p. 9.

[19] OJ L 170, 3.8.1970, p. 1.

[20] OJ L 340, 9.12.1976, p. 25.

(59) Since the measures necessary for the implementation of this Regulation are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [21], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision.

[21] OJ L 184, 17.7.1999, p. 23.

(60) Without prejudice to the obligation of the Member States to ensure compliance with the requirements laid down in this Regulation, a provision should be established to avoid creating legal uncertainty as to existing Community and national measures governing food.

(61) It is important to avoid confusion between the missions of the Authority and the European Medicinal Evaluation Agency (EMEA) established by Council Regulation (EEC) No 2309/93 [22]. Consequently, it is necessary to establish that this Regulation is without prejudice to the competence conferred on the EMEA by Community legislation, including powers conferred by Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin [23].

[22] OJ L 214, 24.8.1993, p. 1; Regulation as amended by Regulation (EC) No 649/1998 (OJ L 88, 24.3.1998, p. 7).

[23] OJ L 224, 18.8.1990, p. 1; Regulation as last amended by Commission Regulation (EC) No 2391/2000 (OJ L 276, 28.10.2000, p. 5).

(62) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objectives of this Regulation to provide for definitions, principles and measures for food legislation in the Community and to establish a European Food Authority. This Regulation confines itself to what is necessary in order to achieve the objectives pursued, in accordance with the third paragraph of Article 5 of the Treaty,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SCOPE AND DEFINITIONS

Article 1 Aim and scope

1. This Regulation provides the basis for the assurance of a high level of protection of human life and health and consumers' interest in relation to food, whilst ensuring the effective functioning of the internal market. It establishes common principles, definitions and responsibilities, a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food safety.

2. For the purposes of pararaph 1, this Regulation lays down the general definitions and principles governing food and feed in general, and food and feed safety in particular, in the Community.

It establishes the European Food Authority.

It lays down procedures for matters with a direct or indirect impact on food safety.

3. This Regulation shall apply to all stages of production and distribution of food and feed. It shall not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for domestic consumption.

Article 2 Definition of "food"

'Food' (or 'foodstuff') means any substance or product, whether processed, partially processed or unprocessed, intended to be, or expected to be ingested by humans.

It includes drink, chewing gum and any substance intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water, without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC.

It shall not include:

(a) feed;

(b) live animals unless they are prepared, packaged and/or served for human consumption;

(c) plants prior to harvesting;

(d) medicinal products within the meaning of Council Directive 65/65/EEC [24];

[24] OJ 22, 9.2.1965, p