2002R0178 — EN — 07.08.2009 — 004.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:









▼B

REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 28 January 2002

laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety







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 Article 152(4)(b) thereof, Having regard to the proposal from the Commission ( 1 ), Having regard to the opinion of the Economic and Social Committee ( 2 ), Having regard to the opinion of the Committee of the Regions ( 3 ), Acting in accordance with the procedure laid down in Article 251 of the Treaty ( 4 ), 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 and feed within the Community can be achieved only if food and feed safety requirements do not differ significantly from Member State to Member State. (4) There are important differences in relation to concepts, principles and procedures between the food laws of 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 procedures so as to form a common basis for measures governing food and feed taken in the Member States and at Community level. It is however necessary to provide for sufficient time for the adaptation of any conflicting provisions in existing legislation, both at national and Community level, and to provide that, pending such adaptation, the relevant legislation be applied in the light of the principles set out in the present Regulation. (6) Water is ingested directly or indirectly like other foods, thereby contributing to the overall exposure of a consumer to ingested substances, including chemical and microbiological contaminants. However, as the quality of water intended for human consumption is already controlled by Council Directives 80/778/EEC ( 5 ) and 98/83/EC ( 6 ), it suffices to consider water after the point of compliance referred to in Article 6 of Directive 98/83/EC. (7) Within the context of food law it is appropriate to include requirements for feed, including its production and use where that feed is intended for food-producing animals. This is without prejudice to the similar requirements which have been applied so far and which will be applied in the future in feed legislation applicable to all animals, including pets. (8) 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. (9) 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. (10) Experience has shown that it is necessary to adopt measures aimed at guaranteeing that unsafe food is not 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. Similar issues relating to feed safety should be addressed. (11) In order to take a sufficiently comprehensive and integrated approach to food safety, there should be a broad definition of food law covering a wide range of provisions with a direct or indirect effect on the safety of food and feed, including provisions on materials and articles in contact with food, animal feed and other agricultural inputs at the level of primary production. (12) In order to ensure the safety of food, it is necessary to consider all aspects of the food production chain as a continuum from and including primary production and the production of animal feed up to and including sale or supply of food to the consumer because each element may have a potential impact on food safety. (13) Experience has shown that for this reason it is necessary to consider the production, manufacture, transport and distribution of feed given to food-producing animals, including the production of animals which may be used as feed on fish farms, since the inadvertent or deliberate contamination of feed, and adulteration or fraudulent or other bad practices in relation to it, may give rise to a direct or indirect impact on food safety. (14) For the same reason, it is necessary to consider other practices and agricultural inputs at the level of primary production and their potential effect on the overall safety of food. (15) Networking of laboratories of excellence, at regional and/or interregional level, with the aim of ensuring continuous monitoring of food safety, could play an important role in the prevention of potential health risks for citizens. (16) Measures adopted by the Member States and the Community governing food and feed should generally be based on risk analysis except where this is not appropriate to the circumstances or the nature of the measure. 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. (17) Where food law is aimed at the reduction, elimination or avoidance of a risk to health, the three interconnected components of risk analysis — risk assessment, risk management, and risk communication — provide a systematic methodology for the determination of effective, proportionate and targeted measures or other actions to protect health. (18) In order for there to be confidence in the scientific basis for food law, risk assessments should be undertaken in an independent, objective and transparent manner, on the basis of the available scientific information and data. (19) 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, traditional, ethical and environmental factors and the feasibility of controls. (20) The precautionary principle has been invoked to ensure health protection in the Community, thereby giving rise to barriers to the free movement of food or feed. Therefore it is necessary to adopt a uniform basis throughout the Community for the use of this principle. (21) 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. (22) Food safety and the protection of consumer's interests 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. (23) 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 feed 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 feed and safe, wholesome food in a non-discriminatory manner, following fair and ethical trading practices. (24) It is necessary to ensure that food and feed exported or re-exported from the Community complies with Community law or the requirements set up by the importing country. In other circumstances, food and feed can only be exported or re-exported if the importing country has expressly agreed. However, it is necessary to ensure that even where there is agreement of the importing country, food injurious to health or unsafe feed is not exported or re-exported. (25) It is necessary to establish the general principles upon which food and feed may be traded and the objectives and principles for the contribution of the Community to developing international standards and trade agreements. (26) 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, these 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. Similarly such barriers may arise to trade in feed. (27) 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. (28) Experience has shown that the functioning of the internal market in food or feed can be jeopardised where it is impossible to trace food and feed. It is therefore necessary to establish a comprehensive system of traceability within food and feed businesses so that 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. (29) It is necessary to ensure that a food or feed business including an importer can identify at least the business from which 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. (30) A food business operator is best placed to devise a safe system for supplying food and ensuring that the food it supplies is safe; thus, it should have primary 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. (31) Similar requirements should apply to feed and feed business operators. (32) The scientific and technical basis of Community legislation relating to the safety of food and feed 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. (33) The scientific and technical issues in relation to food and feed safety are becoming increasingly important and complex. The establishment of a European Food Safety 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. (34) Pursuant to the general principles of food law, the Authority should take on the role of an independent scientific point of reference in risk assessment 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 the Community institutions and Member States to take informed risk management decisions necessary to ensure food and feed safety whilst helping avoid the fragmentation of the internal market through the adoption of unjustified or unnecessary obstacles to the free movement of food and feed. (35) The Authority should be an independent scientific source of advice, information and risk communication in order to improve consumer confidence; nevertheless, in order to promote coherence between the risk assessment, risk management and risk communication functions, the link between risk assessors and risk managers should be strengthened. (36) The Authority should provide a comprehensive independent scientific view of the safety and other aspects of the whole food and feed supply chains, which implies wide-ranging responsibilities for the Authority. These should include issues having a direct or indirect impact on the safety of the food and feed supply chains, animal health and welfare, and plant health. However, it is necessary to ensure that the Authority focuses on food safety, so its mission in relation to animal health, animal welfare and plant health issues that are not linked to the safety of the food supply chain should be limited to the provision of scientific opinions. The Authority's mission should also cover scientific advice and scientific and technical support on human nutrition in relation to Community legislation and assistance to the Commission at its request on communication linked to Community health programmes. (37) Since some products authorised under food law 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 also be assessed by the Authority in accordance with the relevant legislation. (38) In order to avoid duplicated scientific assessments and related scientific opinions on genetically modified organisms (GMOs), the Authority should also provide scientific opinions on products other than food and feed relating to GMOs as defined by Directive 2001/18/EC ( 7 ) and without prejudice to the procedures established therein. (39) The Authority should contribute through the provision of support on scientific matters, to the Community's and Member States' role in the development and establishment of international food safety standards and trade agreements. (40) 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 Member States is also indispensable. (41) To that effect the Management Board should be appointed in such a way as to secure the highest standard of competence, a broad range of relevant expertise, for instance in management and in public administration, and the broadest possible geographic distribution within the Union. This should be facilitated by a rotation of the different countries of origin of the members of the Management Board without any post being reserved for nationals of any specific Member State. (42) The Authority should have the means to perform all the tasks required to enable it to carry out its role. (43) 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. (44) The Authority should cooperate closely with competent bodies in the Member States if it is to operate effectively. An Advisory Forum should be created in order to advise the Executive Director, to constitute a mechanism of exchange of information, and to ensure close cooperation in particular with regard to the networking system. Cooperation and appropriate exchange of information should also minimise the potential for diverging scientific opinions. (45) 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. (46) In order to guarantee independence, members of the Scientific Committee and Panels should be independent scientists recruited on the basis of an open application procedure. (47) 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. In order to ensure the manageability and consistency of the process of scientific advice, the Authority should be able to refuse or amend a request providing justification for this and on the basis of predetermined criteria. Steps should also be taken to help avoid diverging scientific opinions and, in the event of diverging scientific opinions between scientific bodies, procedures should be in place to resolve the divergence or provide the risk managers with a transparent basis of scientific information. (48) 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. It should be done in an open and transparent fashion and the Authority should take into account existing Community expertise and structures. (49) 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. A review of Community data collection networks already existing in the fields covered by the Authority is called for. (50) 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 and providing evaluation of and information on emerging risks with a view to their prevention. (51) 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. (52) It is necessary to ensure that a balance is struck between the need to use national organisations to carry 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. 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 with the objective of taking into account the establishment of the Authority and the new facilities it offers, the evaluation procedures remaining at least as stringent as before. (53) The Commission remains fully responsible for communicating risk management measures. The appropriate information should therefore be exchanged between the Authority and the Commission. Close cooperation between the Authority, the Commission and the Member States is also necessary to ensure the coherence of the global communication process. (54) 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. (55) Appropriate cooperation with the Member States and other interested parties is necessary in the specific field of public information campaigns to take into account any regional parameters and any correlation with health policy. (56) 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. (57) The Authority should be financed by the general budget of the European Union. 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 following the entry into force of this Regulation. The Community budgetary procedure remains applicable as far as any subsidies chargeable to the general budget of the European Union are concerned. Moreover, the auditing of accounts should be undertaken by the Court of Auditors. (58) It is necessary to allow for the participation of 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. (59) A system for rapid alert already exists in the framework of Council Directive 92/59/EEC of 29 June 1992 on general product safety ( 8 ). 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 managed by the Commission and include as members of the network the Member States, the Commission and the Authority. The system should not cover the Community arrangements for the early exchange of information in the event of a radiological emergency as defined in Council Decision 87/600/Euratom ( 9 ). (60) Recent food safety incidents have demonstrated the need to establish appropriate measures in emergency situations ensuring that all foods, whatever their type and origin, and all feed should be subject to common measures in the event of a serious risk to human health, animal health or the environment. Such a comprehensive approach to emergency food safety measures should allow effective action to be taken and avoid artificial disparities in the treatment of a serious risk in relation to food or feed. (61) Recent food crises have also shown the benefits to the Commission of having properly adapted, more rapid procedures for crisis 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 form of advice in the event of a food crisis. (62) In order to ensure a more effective, comprehensive approach to the food chain, a Committee on the Food Chain and Animal Health should be established to replace the Standing Veterinary Committee, the Standing Committee for Foodstuffs and the Standing Committee for Feedingstuffs. Accordingly, Council Decisions 68/361/EEC ( 10 ), 69/414/EEC ( 11 ), and 70/372/EEC ( 12 ), should be repealed. For the same reason the Committee on the Food Chain and Animal Health should also replace the Standing Committee on Plant Health in relation to its competence (for Directives 76/895/EEC ( 13 ), 86/362/EEC ( 14 ), 86/363/EEC ( 15 ), 90/642/EEC ( 16 ) and 91/414/EEC ( 17 )) on plant protection products and the setting of maximum residue levels. (63) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ( 18 ). (64) It is necessary that operators should have sufficient time to adapt to some of the requirements established by the present Regulation and that the European Food Safety Authority should commence its operations on 1 January 2002. (65) It is important to avoid confusion between the missions of the Authority and the European Agency for the Evaluation of Medicinal Products (EMEA) established by Council Regulation (EEC) No 2309/93 ( 19 ). 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 ( 20 ). (66) It is necessary and appropriate for the achievement of the basic objectives of this Regulation to provide for the approximation of the concepts, principles and procedures forming a common basis for food law in the Community and to establish a European Food Safety Authority. In accordance with the principle of proportionality as set out in Article 5 of the Treaty, this Regulation does not go beyond what is necessary in order to achieve the objectives pursued, Whereas: 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 health and consumers' interest in relation to food, taking into account in particular the diversity in the supply of food including traditional products, whilst ensuring the effective functioning of the internal market. It establishes common principles and responsibilities, the means to provide a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food and feed safety.

2. For the purposes of paragraph 1, this Regulation lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and national level.

It establishes the European Food Safety Authority.

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

3. This Regulation shall apply to all stages of production, processing 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 private domestic consumption.

Article 2

Definition of ‘food’

For the purposes of this Regulation, ‘food’ (or ‘foodstuff’) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.

‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC and without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC.

‘Food’ shall not include:

(a) feed;

(b) live animals unless they are prepared for placing on the market for human consumption;

(c) plants prior to harvesting;

(d) medicinal products within the meaning of Council Directives 65/65/EEC ( 21 ) and 92/73/EEC ( 22 );

(e) cosmetics within the meaning of Council Directive 76/768/EEC ( 23 );

(f) tobacco and tobacco products within the meaning of Council Directive 89/622/EEC ( 24 );

(g) narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971;

(h) residues and contaminants.

Article 3

Other definitions

For the purposes of this Regulation:

1. ‘food law’ means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals;

2. ‘food business’ means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food;

3. ‘food business operator’ means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control;

4. ‘feed’ (or ‘feedingstuff’) means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;

5. ‘feed business’ means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on his own holding;

6. ‘feed business operator’ means the natural or legal persons responsible for ensuring that the requirements of food law are met within the feed business under their control;

7. ‘retail’ means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets;

8. ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves;

9. ‘risk’ means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard;

10. ‘risk analysis’ means a process consisting of three interconnected components: risk assessment, risk management and risk communication;

11. ‘risk assessment’ means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation;

12. ‘risk management’ means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options;

13. ‘risk communication’ means the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, feed and food businesses, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions;

14. ‘hazard’ means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect;

15. ‘traceability’ means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution;

16. ‘stages of production, processing and distribution’ means any stage, including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production, manufacture, storage, transport, distribution, sale and supply of feed;

17. ‘primary production’ means the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products;

18. ‘final consumer’ means the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity.







CHAPTER II

GENERAL FOOD LAW

Article 4

Scope

1. This Chapter relates to all stages of the production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals.

2. The principles laid down in Articles 5 to 10 shall form a general framework of a horizontal nature to be followed when measures are taken.

3. Existing food law principles and procedures shall be adapted as soon as possible and by 1 January 2007 at the latest in order to comply with Articles 5 to 10.

4. Until then, and by way of derogation from paragraph 2, existing legislation shall be implemented taking account of the principles laid down in Articles 5 to 10.







SECTION 1

GENERAL PRINCIPLES OF FOOD LAW

Article 5

General objectives

1. Food law shall pursue one or more of the general objectives of a high level of protection of human life and health and the protection of consumers' interests, including fair practices in food trade, taking account of, where appropriate, the protection of animal health and welfare, plant health and the environment.

2. Food law shall aim to achieve the free movement in the Community of food and feed manufactured or marketed according to the general principles and requirements in this Chapter.

3. Where international standards exist or their completion is imminent, they shall be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Community.

Article 6

Risk analysis

1. In order to achieve the general objective of a high level of protection of human health and life, food law shall be based on risk analysis except where this is not appropriate to the circumstances or the nature of the measure.

2. Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner.

3. Risk management shall take into account the results of risk assessment, and in particular, the opinions of the Authority referred to in Article 22, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) are relevant, in order to achieve the general objectives of food law established in Article 5.

Article 7

Precautionary principle

1. In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.

2. Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.

Article 8

Protection of consumers' interests

1. Food law shall aim at the protection of the interests of consumers and shall provide a basis for consumers to make informed choices in relation to the foods they consume. It shall aim at the prevention of:

(a) fraudulent or deceptive practices;

(b) the adulteration of food; and

(c) any other practices which may mislead the consumer.







SECTION 2

PRINCIPLES OF TRANSPARENCY

Article 9

Public consultation

There shall be open and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it.

Article 10

Public information

Without prejudice to the applicable provisions of Community and national law on access to documents, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, then, depending on the nature, seriousness and extent of that risk, public authorities shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or feed, or type of food or feed, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk.







SECTION 3

GENERAL OBLIGATIONS OF FOOD TRADE

Article 11

Food and feed imported into the Community

Food and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognised by the Community to be at least equivalent thereto or, where a specific agreement exists between the Community and the exporting country, with requirements contained therein.

Article 12

Food and feed exported from the Community

1. Food and feed exported or re-exported from the Community for placing on the market of a third country shall comply with the relevant requirements of food law, unless otherwise requested by the authorities of the importing country or established by the laws, regulations, standards, codes of practice and other legal and administrative procedures as may be in force in the importing country.

In other circumstances, except in the case where foods are injurious to health or feeds are unsafe, food and feed can only be exported or re-exported if the competent authorities of the country of destination have expressly agreed, after having been fully informed of the reasons for which and the circumstances in which the food or feed concerned could not be placed on the market in the Community.

2. Where the provisions of a bilateral agreement concluded between the Community or one of its Member States and a third country are applicable, food and feed exported from the Community or that Member State to that third country shall comply with the said provisions.

Article 13

International standards

Without prejudice to their rights and obligations, the Community and the Member States shall:

(a) contribute to the development of international technical standards for food and feed and sanitary and phytosanitary standards;

(b) promote the coordination of work on food and feed standards undertaken by international governmental and non-governmental organisations;

(c) contribute, where relevant and appropriate, to the development of agreements on recognition of the equivalence of specific food and feed-related measures;

(d) give particular attention to the special development, financial and trade needs of developing countries, with a view to ensuring that international standards do not create unnecessary obstacles to exports from developing countries;

(e) promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Community is not reduced.







SECTION 4

GENERAL REQUIREMENTS OF FOOD LAW

Article 14

Food safety requirements

1. Food shall not be placed on the market if it is unsafe.

2. Food shall be deemed to be unsafe if it is considered to be:

(a) injurious to health;

(b) unfit for human consumption.

3. In determining whether any food is unsafe, regard shall be had:

(a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and

(b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.

4. In determining whether any food is injurious to health, regard shall be had:

(a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations;

(b) to the probable cumulative toxic effects;

(c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.

5. In determining whether any food is unfit for human consumption, regard shall be had to whether the food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay.

6. Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe.

7. Food that complies with specific Community provisions governing food safety shall be deemed to be safe insofar as the aspects covered by the specific Community provisions are concerned.

8. Conformity of a food with specific provisions applicable to that food shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the food is unsafe.

9. Where there are no specific Community provisions, food shall be deemed to be safe when it conforms to the specific provisions of national food law of the Member State in whose territory the food is marketed, such provisions being drawn up and applied without prejudice to the Treaty, in particular Articles 28 and 30 thereof.

Article 15

Feed safety requirements

1. Feed shall not be placed on the market or fed to any food-producing animal if it is unsafe.

2. Feed shall be deemed to be unsafe for its intended use if it is considered to:

— have an adverse effect on human or animal health;

— make the food derived from food-producing animals unsafe for human consumption.

3. Where a feed which has been identified as not satisfying the feed safety requirement is part of a batch, lot or consignment of feed of the same class or description, it shall be presumed that all of the feed in that batch, lot or consignment is so affected, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment fails to satisfy the feed safety requirement.

4. Feed that complies with specific Community provisions governing feed safety shall be deemed to be safe insofar as the aspects covered by the specific Community provisions are concerned.

5. Conformity of a feed with specific provisions applicable to that feed shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the feed is unsafe.

6. Where there are no specific Community provisions, feed shall be deemed to be safe when it conforms to the specific provisions of national law governing feed safety of the Member State in whose territory the feed is in circulation, such provisions being drawn up and applied without prejudice to the Treaty, in particular Articles 28 and 30 thereof.

Article 16

Presentation

Without prejudice to more specific provisions of food law, the labelling, advertising and presentation of food or feed, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, shall not mislead consumers.

Article 17

Responsibilities

1. Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met.

2. Member States shall enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution.

For that purpose, they shall maintain a system of official controls and other activities as appropriate to the circumstances, including public communication on food and feed safety and risk, food and feed safety surveillance and other monitoring activities covering all stages of production, processing and distribution.

Member States shall also lay down the rules on measures and penalties applicable to infringements of food and feed law. The measures and penalties provided for shall be effective, proportionate and dissuasive.

Article 18

Traceability

1. The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution.

2. Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed.

To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand.

3. Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand.

4. Food or feed which is placed on the market or is likely to be placed on the market in the Community shall be adequately labelled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions.

5. Provisions for the purpose of applying the requirements of this Article in respect of specific sectors may be adopted in accordance with the procedure laid down in Article 58(2).

Article 19

Responsibilities for food: food business operators

1. If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection.

2. A food business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the food shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the food-safety requirements and shall participate in contributing to the safety of the food by passing on relevant information necessary to trace a food, cooperating in the action taken by producers, processors, manufacturers and/or the competent authorities.

3. A food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health. Operators shall inform the competent authorities of the action taken to prevent risks to the final consumer and shall not prevent or discourage any person from cooperating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a food.

4. Food business operators shall collaborate with the competent authorities on action taken to avoid or reduce risks posed by a food which they supply or have supplied.

Article 20

Responsibilities for feed: feed business operators

1. If a feed business operator considers or has reason to believe that a feed which it has imported, produced, processed, manufactured or distributed does not satisfy the feed safety requirements, it shall immediately initiate procedures to withdraw the feed in question from the market and inform the competent authorities thereof. In these circumstances or, in the case of Article 15(3), where the batch, lot or consignment does not satisfy the feed safety requirement, that feed shall be destroyed, unless the competent authority is satisfied otherwise. The operator shall effectively and accurately inform users of the feed of the reason for its withdrawal, and if necessary, recall from them products already supplied when other measures are not sufficient to achieve a high level of health protection.

2. A feed business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the feed shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the feed-safety requirements and shall participate in contributing to the safety of food by passing on relevant information necessary to trace a feed, cooperating in the action taken by producers, processors, manufacturers and/or the competent authorities.

3. A feed business operator shall immediately inform the competent authorities if it considers or has reason to believe that a feed which it placed on the market may not satisfy the feed safety requirements. It shall inform the competent authorities of the action taken to prevent risk arising from the use of that feed and shall not prevent or discourage any person from cooperating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a feed.

4. Feed business operators shall collaborate with the competent authorities on action taken in order to avoid risks posed by a feed which they supply or have supplied.

Article 21

Liability

The provisions of this Chapter shall be without prejudice to Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products ( 25 ).







CHAPTER III

EUROPEAN FOOD SAFETY AUTHORITY







SECTION 1

MISSION AND TASKS

Article 22

Mission of the Authority

1. A European Food Safety Authority, hereinafter referred to as the ‘Authority’, is hereby established.

2. The Authority shall provide scientific advice and scientific and technical support for the Community's legislation and policies in all fields which have a direct or indirect impact on food and feed safety. It shall provide independent information on all matters within these fields and communicate on risks.

3. The Authority shall contribute to a high level of protection of human life and health, and in this respect take account of animal health and welfare, plant health and the environment, in the context of the operation of the internal market.

4. The Authority shall collect and analyse data to allow the characterisation and monitoring of risks which have a direct or indirect impact on food and feed safety.

5. The mission of the Authority shall also include the provision of:

(a) scientific advice and scientific and technical support on human nutrition in relation to Community legislation and, at the request of the Commission, assistance concerning communication on nutritional issues within the framework of the Community health programme;

(b) scientific opinions on other matters relating to animal health and welfare and plant health;

(c) scientific opinions on products other than food and feed relating to genetically modified organisms as defined by Directive 2001/18/EC and without prejudice to the procedures established therein.

6. The Authority shall provide scientific opinions which will serve as the scientific basis for the drafting and adoption of Community measures in the fields falling within its mission.

7. The Authority shall carry out its tasks in conditions which enable it to serve as a point of reference by virtue of its independence, the scientific and technical quality of the opinions it issues and the information it disseminates, the transparency of its procedures and methods of operation, and its diligence in performing the tasks assigned to it.

It shall act in close cooperation with the competent bodies in the Member States carrying out similar tasks to these of the Authority.

8. The Authority, Commission and Member States shall cooperate to promote the effective coherence between risk assessment, risk management and risk communication functions.

9. The Member States shall cooperate with the Authority to ensure the accomplishment of its mission.

Article 23

Tasks of the Authority

The tasks of the Authority shall be the following:

(a) to provide the Community institutions and the Member States with the best possible scientific opinions in all cases provided for by Community legislation and on any question within its mission;

(b) to promote and coordinate the development of uniform risk assessment methodologies in the fields falling within its mission;

(c) to provide scientific and technical support to the Commission in the areas within its mission and, when so requested, in the interpretation and consideration of risk assessment opinions;

(d) to commission scientific studies necessary for the accomplishment of its mission;

(e) to search for, collect, collate, analyse and summarise scientific and technical data in the fields within its mission;

(f) to undertake action to identify and characterise emerging risks, in the fields within its mission;

(g) to establish a system of networks of organisations operating in the fields within its mission and be responsible for their operation;

(h) to provide scientific and technical assistance, when requested to do so by the Commission, in the crisis management procedures implemented by the Commission with regard to the safety of food and feed;

(i) to provide scientific and technical assistance, when requested to do so by the Commission, with a view to improving cooperation between the Community, applicant countries, international organisations and third countries, in the fields within its mission;

(j) to ensure that the public and interested parties receive rapid, reliable, objective and comprehensible information in the fields within its mission;

(k) to express independently its own conclusions and orientations on matters within its mission;

(l) to undertake any other task assigned to it by the Commission within its mission.







SECTION 2

ORGANISATION

Article 24

Bodies of the Authority

The Authority shall comprise:

(a) a Management Board;

(b) an Executive Director and his staff;

(c) an Advisory Forum;

(d) a Scientific Committee and Scientific Panels.

Article 25

Management Board

1. The Management Board shall be composed of 14 members appointed by the Council in consultation with the European Parliament from a list drawn up by the Commission which includes a number of candidates substantially higher than the number of members to be appointed, plus a representative of the Commission. Four of the members shall have their background in organisations representing consumers and other interests in the food chain.

The list drawn up by the Commission, accompanied by the relevant documentation, shall be forwarded to the European Parliament. As soon as possible and within three months of such communication, the European Parliament may make its views available for consideration by the Council, which will then appoint the Management Board.

The members of the Board shall be appointed in such a way as to secure the highest standards of competence, a broad range of relevant expertise and, consistent with these, the broadest possible geographic distribution within the Union.

2. Members' term of office shall be four years, and may be renewed once. However, for the first mandate, this period shall be six years for half of the members.

3. The Management Board shall adopt the Authority's internal rules on the basis of a proposal by the Executive Director. These rules shall be made public.

4. The Management Board shall elect one of its members as its Chair for a two-year period, which shall be renewable.

5. The Management Board shall adopt its rules of procedure.

Unless otherwise provided, the Management Board shall act by a majority of its members.

6. The Management Board shall meet at the invitation of the Chair or at the request of at least a third of its members.

7. The Management Board shall ensure that the Authority carries out its mission and performs the tasks assigned to it under the conditions laid down in this Regulation.

8. Before 31 January each year, the Management Board shall adopt the Authority's programme of work for the coming year. It shall also adopt a revisable multi-annual programme. The Management Board shall ensure that these programmes are consistent with the Community's legislative and policy priorities in the area of food safety.

Before 30 March each year, the Management Board shall adopt the general report on the Authority's activities for the previous year.

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9. The financial rules applicable to the Authority shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities ( 26 ) unless such departure is specifically required for the Authority's operation and the Commission has given its prior consent.

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10. The Executive Director shall take part in the meetings of the Management Board, without voting rights, and shall provide the Secretariat. The Management Board shall invite the Chair of the Scientific Committee to attend its meetings without voting rights.

Article 26

Executive Director

1. The Executive Director shall be appointed by the Management Board, on the basis of a list of candidates proposed by the Commission after an open competition, following publication in the Official Journal of the European Communities and elsewhere of a call for expressions of interest, for a period of five years which shall be renewable. Before appointment the candidate nominated by the Management Board shall be invited without delay to make a statement before the European Parliament and answer questions put by members of this institution. The Executive Director may be removed from office by a majority of the Management Board.

2. The Executive Director shall be the legal representative of the Authority and shall be responsible for:

(a) the day-to-day administration of the Authority;

(b) drawing up a proposal for the Authority's work programmes in consultation with the Commission;

(c) implementing the work programmes and the decisions adopted by the Management Board;

(d) ensuring the provision of appropriate scientific, technical and administrative support for the Scientific Committee and the Scientific Panels;

(e) ensuring that the Authority carries out its tasks in accordance with the requirements of its users, in particular with regard to the adequacy of the services provided and the time taken;

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(f) the preparation of the Authority's draft statement of estimates of revenue and expenditure, and the execution of its budget;

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(g) all staff matters;

(h) developing and maintaining contact with the European Parliament, and for ensuring a regular dialogue with its relevant committees.

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3. Each year, the Executive Director shall submit to the Management Board for approval:

(a) a draft general report covering all the activities of the Authority in the previous year;

(b) draft programmes of work.

The Executive Director shall, following adoption by the Management Board, forward the programmes of work to the European Parliament, the Council, the Commission and the Member States, and shall have them published.

The Executive Director shall, following adoption by the Management Board and by 15 June, forward the Authority's general report to the European Parliament, the Council, the Commission, the Court of Auditors, the European Economic and Social Committee and the Committee of the Regions, and shall have it published.

The Executive Director shall forward annually to the budgetary authority all information relevant to the outcome of the evaluation procedures.

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Article 27

Advisory Forum

1. The Advisory Forum shall be composed of representatives from competent bodies in the Member States which undertake tasks similar to those of the Authority, on the basis of one representative designated by each Member State. Representatives may be replaced by alternates, appointed at the same time.

2. Members of the Advisory Forum may not be members of the Management Board.

3. The Advisory Forum shall advise the Executive Director in the performance of his duties under this Regulation, in particular in drawing up a proposal for the Authority's work programme. The Executive Director may also ask the Advisory Forum for advice on the prioritisation of requests for scientific opinions.

4. The Advisory Forum shall constitute a mechanism for an exchange of information on potential risks and the pooling of knowledge. It shall ensure close cooperation between the Authority and the competent bodies in the Member States in particular on the following items:

(a) avoidance of duplication of the Authority's scientific studies with Member States, in accordance with Article 32;

(b) in those circumstances identified in Article 30(4), where the Authority and a national body are obliged to cooperate;

(c) in the promoting of the European networking of organisations operating within the fields of the Authority's mission, in accordance with Article 36(1);

(d) where the Authority or a Member State identifies an emerging risk.

5. The Advisory Forum shall be chaired by the Executive Director. It shall meet regularly at the invitation of the Chair or at the request of at least a third of its members, and not less than four times per year. Its operational procedures shall be specified in the Authority's internal rules and shall be made public.

6. The Authority shall provide the technical and logistic support necessary for the Advisory Forum and provide the Secretariat for its meetings.

7. Representatives of the Commission's departments may participate in the work of the Advisory Forum. The Executive Director may invite representatives of the European Parliament and from other relevant bodies to take part.

Where the Advisory Forum discusses the matters referred to in Article 22(5)(b), representatives from competent bodies in the Member States which undertake tasks similar to those referred to in Article 22(5)(b) may participate in the work of the Advisory Forum, on the basis of one representative designated by each Member State.

Article 28

Scientific Committee and Scientific Panels

1. The Scientific Committee and permanent Scientific Panels shall be responsible for providing the scientific opinions of the Authority, each within their own spheres of competence, and shall have the possibility, where necessary, of organising public hearings.

2. The Scientific Committee shall be responsible for the general coordination necessary to ensure the consistency of the scientific opinion procedure, in particular with regard to the adoption of working procedures and harmonisation of working methods. It shall provide opinions on multisectoral issues falling within the competence of more than one Scientific Panel, and on issues which do not fall within the competence of any of the Scientific Panels.

Where necessary, and particularly in the case of subjects which do not fall within the competence of any of the Scientific Panels, the Scientific Committee shall set up working groups. In such cases, it shall draw on the expertise of those working groups when establishing scientific opinions.

3. The Scientific Committee shall be composed of the Chairs of the Scientific Panels and six independent scientific experts who do not belong to any of the Scientific Panels.

4. The Scientific Panels shall be composed of independent scientific experts. When the Authority is established, the following Scientific Panels shall be set up:

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(a) the Panel on food additives and nutrient sources added to food;

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(b) the Panel on additives and products or substances used in animal feed;

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(c) the Panel on plant protection products and their residues;

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(d) the Panel on genetically modified organisms;

(e) the Panel on dietetic products, nutrition and allergies;

(f) the Panel on biological hazards;

(g) the Panel on contaminants in the food chain;

(h) the Panel on animal health and welfare;

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(i) the Panel on plant health;

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(j) the Panel on food contact materials, enzymes, flavourings, and processing aids.

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The number and names of the Scientific Panels may be adapted in the light of technical and scientific development by the Commission, at the Authority’s request. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 58(3).

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5. The members of the Scientific Committee who are not members of Scientific Panels and the members of the Scientific Panels shall be appointed by the Management Board, acting upon a proposal from the Executive Director, for a three-year term of office, which shall be renewable, following publication in the Official Journal of the European Communities, in relevant leading scientific publications and on the Authority's website of a call for expressions of interest.

6. The Scientific Committee and the Scientific Panels shall each choose a Chair and two Vice-Chairs from among their members.

7. The Scientific Committee and the Scientific Panels shall act by a majority of their members. Minority opinions shall be recorded.

8. The representatives of the Commission's departments shall be entitled to be present in the meetings of the Scientific Committee, the Scientific Panels and their working groups. If invited to do so, they may assist for the purposes of clarification or information but shall not seek to influence discussions.

9. The procedures for the operation and cooperation of the Scientific Committee and the Scientific Panels shall be laid down in the Authority's internal rules.

These procedures shall relate in particular to:

(a) the number of times that a member can serve consecutively on a Scientific Committee or Scientific Panel;

(b) the number of members in each Scientific Panel;

(c) the procedure for reimbursing the expenses of members of the Scientific Committee and the Scientific Panels;

(d) the manner in which tasks and requests for scientific opinions are assigned to the Scientific Committee and the Scientific Panels;

(e) the creation and organisation of the working groups of the Scientific Committee and the Scientific Panels, and the possibility of external experts being included in those working groups;

(f) the possibility of observers being invited to meetings of the Scientific Committee and the Scientific Panels;

(g) the possibility of organising public hearings.







SECTION 3

OPERATION

Article 29

Scientific opinions

1. The Authority shall issue a scientific opinion:

(a) at the request of the Commission, in respect of any matter within its mission, and in all cases where Community legislation makes provision for the Authority to be consulted;

(b) on its own initiative, on matters falling within its mission.

The European Parliament or a Member State may request the Authority to issue a scientific opinion on matters falling within its mission.

2. Requests referred to in paragraph 1 shall be accompanied by background information explaining the scientific issue to be addressed and the Community interest.

3. Where Community legislation does not already specify a time limit for the delivery of a scientific opinion, the Authority shall issue scientific opinions within the time limit specified in the requests for opinions, except in duly justified circumstances.

4. Where different requests are made on the same issues or where the request is not in accordance with paragraph 2, or is unclear, the Authority may either refuse, or propose amendments to a request for an opinion in consultation with the institution or Member State(s) that made the request. Justifications for the refusal shall be given to the institution or Member State(s) that made the request.

5. Where the Authority has already delivered a scientific opinion on the specific topic in a request, it may refuse the request if it concludes there are no new scientific elements justifying the re-examination. Justifications for the refusal shall be given to the institution or Member State(s) that made the request.

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6. The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority. Those rules shall specify in particular:

(a) the procedure to be applied by the Authority to the requests referred to it;

(b) the guidelines governing the scientific evaluation of substances, products or processes which are subject under Community legislation to a system of prior authorisation or entry on a positive list, in particular where Community legislation makes provision for, or authorises, a dossier to be presented for this purpose by the applicant.

The measure referred to in point (a), designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 58(3).

The guidelines referred to in point (b) shall be adopted in accordance with the regulatory procedure referred to in Article 58(2).

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7. The Authority's internal rules shall specify requirements in regard to format, explanatory background and publication of a scientific opinion.

Article 30

Diverging scientific opinions

1. The Authority shall exercise vigilance in order to identify at an early stage any potential source of divergence between its scientific opinions and the scientific opinions issued by other bodies carrying out similar tasks.

2. Where the Authority identifies a potential source of divergence, it shall contact the body in question to ensure that all relevant scientific information is shared and in order to identify potentially contentious scientific issues.

3. Where a substantive divergence over scientific issues has been identified and the body in question is a Community agency or one of the Commission's Scientific Committees, the Authority and the body concerned shall be obliged to cooperate with a view to either resolving the divergence or presenting a joint document to the Commission clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. This document shall be made public.

4. Where a substantive divergence over scientific issues has been identified and the body in question is a Member State body, the Authority and the national body shall be obliged to cooperate with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. This document shall be made public.

Article 31

Scientific and technical assistance

1. The Authority may be requested by the Commission to provide scientific or technical assistance in any field within its mission. The tasks of providing scientific and technical assistance shall consist of scientific or technical work involving the application of well-established scientific or technical principles which does not require scientific evaluation by the Scientific Committee or a Scientific Panel. Such tasks may include in particular assistance to the Commission for the establishment or evaluation of technical criteria and also assistance to the Commission in the development of technical guidelines.

2. Where the Commission refers a request for scientific or technical assistance to the Authority, it shall specify, in agreement with the Authority, the time limit within which the task must be completed.

Article 32

Scientific studies

1. Using the best independent scientific resources available, the Authority shall commission scientific studies necessary for the performance of its mission. Such studies shall be commissioned in an open and transparent fashion. The Authority shall seek to avoid duplication with Member State or Community research programmes and shall foster cooperation through appropriate coordination.

2. The Authority shall inform the European Parliament, the Commission and the Member States of the results of its scientific studies.

Article 33

Collection of data

1. The Authority shall search for, collect, collate, analyse and summarise relevant scientific and technical data in the fields within its mission. This shall involve in particular the collection of data relating to:

(a) food consumption and the exposure of individuals to risks related to the consumption of food;

(b) incidence and prevalence of biological risk;

(c) contaminants in food and feed;

(d) residues.

2. For the purposes of paragraph 1, the Authority shall work in close cooperation with all organisations operating in the field of data collection, including those from applicant countries, third countries or international bodies.

3. The Member States shall take the necessary measures to enable the data they collect in the fields referred to in paragraphs 1 and 2 to be transmitted to the Authority.

4. The Authority shall forward to the Member States and the Commission appropriate recommendations which might improve the technical comparability of the data it receives and analyses, in order to facilitate consolidation at Community level.

5. Within one year following the date of entry into force of this Regulation, the Commission shall publish an inventory of data collection systems existing at Community level in the fields within the mission of the Authority.

The report, which shall be accompanied, where appropriate, by proposals, shall indicate in particular:

(a) for each system, the role which should be assigned to the Authority, and any modifications or improvements which might be required to enable the Authority to carry out its mission, in cooperation with the Member States;

(b) the shortcomings which should be remedied to enable the Authority to collect and summarise at Community level relevant scientific and technical data in the fields within its mission.

6. The Authority shall forward the results of its work in the field of data collection to the European Parliament, the Commission and the Member States.

Article 34

Identification of emerging risks

1. The Authority shall establish monitoring procedures for systematically searching for, collecting, collating and analysing information and data with a view to the identification of emerging risks in the fields within its mission.

2. Where the Authority has information leading it to suspect an emerging serious risk, it shall request additional information from the Member States, other Community agencies and the Commission. The Member States, the Community agencies concerned and the Commission shall reply as a matter of urgency and forward any relevant information in their possession.

3. The Authority shall use all the information it receives in the performance of its mission to identify an emerging risk.

4. The Authority shall forward the evaluation and information collected on emerging risks to the European Parliament, the Commission and the Member States.

Article 35

Rapid alert system

To enable it to perform its task of monitoring the health and nutritional risks of foods as effectively as possible, the Authority shall be the recipient of any messages forwarded via the rapid alert system. It shall analyse the content of such messages with a view to providing the Commission and the Member States with any information required for the purposes of risk analysis.

Article 36

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

1. The Authority shall promote the European networking of organisations operating in the fields within the Authority's mission. The aim of such networking is, in particular, to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices in the fields within the Authority's mission.

2. The Management Board, acting on a proposal from the Executive Director, shall draw up a list to be made public of competent organisations designated by the Member States which may assist the Authority, either individually or in networks, with its mission. The Authority may entrust to these organisations certain tasks, in particular preparatory work for scientific opinions, scientific and technical assistance, collection of data and identification of emerging risks. Some of these tasks may be eligible for financial support.

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3. The Commission, after consulting the Authority, shall lay down rules establishing the criteria for inclusion of an institute on the list of competent organisations designated by the Member States, arrangements for setting out harmonised quality requirements and the financial rules governing any financial support. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 58(3).

Other implementing rules for the application of paragraphs 1 and 2 shall be laid down by the Commission, after consulting the Authority, in accordance with the regulatory procedure referred to in Article 58(2).

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4. Within one year following the entry into force of this Regulation, the Commission shall publish an inventory of Community systems existing in the fields within the mission of the Authority which make provision for Member States to carry out certain tasks in the field of scientific evaluation, in particular the examination of authorisation dossiers. The report, which shall be accompanied, where appropriate, by proposals, shall indicate in particular, for each system, any modifications or improvements which might be required to enable the Authority to carry out its mission, in cooperation with the Member States.







SECTION 4

INDEPENDENCE, TRANSPARENCY, CONFIDENTIALITY AND COMMUNICATION

Article 37

Independence

1. The members of the Management Board, the members of the Advisory Forum and the Executive Director shall undertake to act independently in the public interest.

For this purpose, they shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be considered prejudicial to their independence. Those declarations shall be made annually in writing.

2. The members of the Scientific Committee and the Scientific Panels shall undertake to act independently of any external influence.

For this purpose, they shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be considered prejudicial to their independence. Those declarations shall be made annually in writing.

3. The members of the Management Board, the Executive Director, the members of the Advisory Forum, the members of the Scientific Committee and the Scientific Panels, as well as external experts participating in their working groups shall declare at each meeting any interests which might be considered prejudicial to their independence in relation to the items on the agenda.

Article 38

Transparency

1. The Authority shall ensure that it carries out its activities with a high level of transparency. It shall in particular make public without delay:

(a) agendas and minutes of the Scientific Committee and the Scientific Panels;

(b) the opinions of the Scientific Committee and the Scientific Panels immediately after adoption, minority opinions always being included;

(c) without prejudice to Articles 39 and 41, the information on which its opinions are based;

(d) the annual declarations of interest made by members of the Management Board, the Executive Director, members of the Advisory Forum and members of the Scientific Committee and Scientific Panels, as well as the declarations of interest made in relation to items on the agendas of meetings;

(e) the results of its scientific studies;

(f) the annual report of its activities;

(g) requests from the European Parliament, the Commission or a Member State for scientific opinions which have been refused or modified and the justifications for the refusal or modification.

2. The Management Board shall hold its meetings in public unless, acting on a proposal from the Executive Director, it decides otherwise for specific administrative points of its agenda, and may authorise consumer representatives or other interested parties to observe the proceedings of some of the Authority's activities.

3. The Authority shall lay down in its internal rules the practical arrangements for implementing the transparency rules referred to in paragraphs 1 and 2.

Article 39

Confidentiality

1. By way of derogation from Article 38, the Authority shall not divulge to third parties confidential information that it receives for which confidential treatment has been requested and justified, except for information which must be made public if circumstances so require, in order to protect public health.

2. Members of the Management Board, the Executive Director, members of the Scientific Committee and Scientific Panels as well as external experts participating in their working groups, members of the Advisory Forum and members of the staff of the Authority, even after their duties have ceased, shall be subject to the requirements of confidentiality pursuant to Article 287 of the Treaty.

3. The conclusions of the scientific opinions delivered by the Authority relating to foreseeable health effects shall on no account be kept confidential.

4. The Authority shall lay down in its internal rules the practical arrangements for implementing the confidentiality rules referred to in paragraphs 1 and 2.

Article 40

Communications from the Authority

1. The Authority shall communicate on its own initiative in the fields within its mission without prejudice to the Commission's competence to communicate its risk management decisions.

2. The Authority shall ensure that the public and any interested parties are rapidly given objective, reliable and easily accessible information, in particular with regard to the results of its work. In order to achieve these objectives, the Authority shall develop and disseminate information material for the general public.

3. The Authority shall act in close collaboration with the Commission and the Member States to promote the necessary coherence in the risk communication process.

The Authority shall publish all opinions issued by it in accordance with Article 38.

4. The Authority shall ensure appropriate cooperation with the competent bodies in the Member States and other interested parties with regard to public information campaigns.

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Article 41

Access to documents

1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding access to European Parliament, Council and Commission documents ( 27 ) shall apply to documents held by the Authority.

2. The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001 within six months after the entry into force of Regulation (EC) No 1642/2003 of the European Parliament and of the Council of 22 July 2003 amending Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( 28 ).

3. Decisions taken by the Authority pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman or of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the EC Treaty respectively.

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Article 42

Consumers, producers and other interested parties

The Authority shall develop effective contacts with consumer representatives, producer representatives, processors and any other interested parties.







SECTION 5

FINANCIAL PROVISIONS

Article 43

Adoption of the Authority's budget

1. The revenues of the Authority shall consist of a contribution from the Community and, from any State with which the Community has concluded the agreements referred to in Article 49, and charges for publications, conferences, training and any other similar activities provided by the Authority.

2. The expenditure of the Authority shall include the staff, administrative, infrastructure and operational expenses, and expenses resulting from contracts entered into with third parties or resulting from the financial support referred to in Article 36.

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3. The Executive Director shall draw up, in good time before the date referred to in paragraph 5, a draft statement of estimates of the Authority's revenue and expenditure for the following financial year and shall forward it to the Management Board, together with the establishment plan.

4. Revenue and expenditure shall be in balance.

5. Each year the Management Board, on the basis of a draft statement of estimates of revenue and expenditure, shall produce a statement of estimates of revenue and expenditure of the Authority for the following financial year. This statement of estimates, which shall include a draft establishment plan together with the provisional work programmes, shall be forwarded by 31 March at the latest by the Management Board to the Commission and to the countries with which the Community has concluded agreements in accordance with Article 49.

6. The statement of estimates shall be forwarded by the Commission to the European Parliament and the Council (hereinafter referred to as the budgetary authority) together with the preliminary draft general budget of the European Union.

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7. On the basis of the statement of estimates, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.

8. The budgetary authority shall authorise the appropriations for the subsidy to the Authority.

The budgetary authority shall adopt the establishment plan for the Authority.

9. The budget shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly.

10. The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of the budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof.

Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.

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Article 44

Implementation of the Authority's budget

1. The Executive Director shall implement the Authority's budget.

2. By 1 March at the latest following each financial year, the Authority's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the general Financial Regulation.

3. By 31 March at the latest following each financial year, the Commission's accounting officer shall forward the Authority's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded to the European Parliament and the Council.

4. On receipt of the Court of Auditors' observations on the Authority's provisional accounts under Article 129 of the general Financial Regulation, the Executive Director shall draw up the Authority's final accounts under his own responsibility and submit them to the Management Board for an opinion.

5. The Management Board shall deliver an opinion on the Authority's final accounts.

6. The Executive Director shall, by 1 July at the latest following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion.

7. The final accounts shall be published.

8. The Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board.

9. The Executive Director shall submit to the European Parliament, at the latter's request, all information necessary for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of the general Financial Regulation.

10. The European Parliament, on a recommendation from the Council acting by a qualified majority, shall, before 30 April of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.

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Article 45

Fees received by the Authority

Within three years following the date of entry into force of this Regulation and after consulting the Authority, the Member States and the interested parties, the Commission shall publish a report on the feasibility and advisability of presenting a legislative proposal under the co-decision procedure and in accordance with the Treaty and for other services provided by the Authority.







SECTION 6

GENERAL PROVISIONS

Article 46

Legal personality and privileges

1. The Authority shall have legal personality. In all Member States it shall enjoy the widest powers granted by law to legal persons. In particular, it may acquire and dispose of movable and immovable property and institute legal proceedings.

2. The Protocol on the privileges and immunities of the European Communities shall apply to the Authority.

Article 47

Liability

1. The contractual liability of the Authority shall be governed by the law applicable to the contract in question. The Court of Justice of the European Communities shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by the Authority.

2. In the case of non-contractual liability, the Authority shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or its servants in the performance of their duties. The Court of Justice shall have jurisdiction in any dispute relating to compensation for such damage.

3. The personal liability of its servants towards the Authority shall be governed by the relevant provisions applying to the staff of the Authority.

Article 48

Staff

1. The staff of the Authority shall be subject to the rules and regulations applicable to officials and other staff of the European Communities.

2. In respect of its staff, the Authority shall exercise the powers which have been devolved to the appointing authority.

Article 49

Participation of third countries

The Authority shall be open to the participation of countries which have concluded agreements with the European Community by virtue of which they have adopted and apply Community legislation in the field covered by this Regulation.

Arrangements shall be made under the relevant provisions of those agreements, specifying in particular the nature, extent and manner in which these countries will participate in the Authority's work, including provisions relating to participation in the networks operated by the Authority, inclusion in the list of competent organisations to which certain tasks may be entrusted by the Authority, financial contributions and staff.







CHAPTER IV

RAPID ALERT SYSTEM, CRISIS MANAGEMENT AND EMERGENCIES







SECTION 1

RAPID ALERT SYSTEM

Article 50

Rapid alert system

1. A rapid alert system for the notification of a direct or indirect risk to human health deriving from food or feed is hereby established as a network. It shall involve the Member States, the Commission and the Authority. The Member States, the Commission and the Authority shall each designate a contact point, which shall be a member of the network. The Commission shall be responsible for managing the network.

2. Where a member of the network has any information relating to the existence of a serious direct or indirect risk to human health deriving from food or feed, this information shall be immediately notified to the Commission under the rapid alert system. The Commission shall transmit this information immediately to the members of the network.

The Authority may supplement the notification with any scientific or technical information, which will facilitate rapid, appropriate risk management action by the Member States.

3. Without prejudice to other Community legislation, the Member States shall immediately notify the Commission under the rapid alert system of:

(a) any measure they adopt which is aimed at restricting the placing on the market or forcing the withdrawal from the market or the recall of food or feed in order to protect human health and requiring rapid action;

(b) any recommendation or agreement with professional operators which is aimed, on a voluntary or obligatory basis, at preventing, limiting or imposing specific conditions on the placing on the market or the eventual use of food or feed on account of a serious risk to human health requiring rapid action;

(c) any rejection, related to a direct or indirect risk to human health, of a batch, container or cargo of food or feed by a competent authority at a border post within the European Union.

The notification shall be accompanied by a detailed explanation of the reasons for the action taken by the competent authorities of the Member State in which the notification was issued. It shall be followed, in good time, by supplementary information, in particular where the measures on which the notification is based are modified or withdrawn.

The Commission shall immediately transmit to members of the network the notification and supplementary information received under the first and second subparagraphs.

Where a batch, container or cargo is rejected by a competent authority at a border post within the European Union, the Commission shall immediately notify all the border posts within the European Union, as well as the third country of origin.

4. Where a food or feed which has been the subject of a notification under the rapid alert system has been dispatched to a third country, the Commission shall provide the latter with the appropriate information.

5. The Member States shall immediately inform the Commission of the action implemented or measures taken following receipt of the notifications and supplementary information transmitted under the rapid alert system. The Commission shall immediately transmit this information to the members of the network.

6. Participation in the rapid alert system may be opened up to applicant countries, third countries or international organisations, on the basis of agreements between the Community and those countries or international organisations, in accordance with the procedures defined in those agreements. The latter shall be based on reciprocity and shall include confidentiality measures equivalent to those applicable in the Community.

Article 51

Implementing measures

The measures for implementing Article 50 shall be adopted by the Commission, after discussion with the Authority, in accordance with the procedure referred to in Article 58(2). These measures shall specify, in particular, the specific conditions and procedures applicable to the transmission of notifications and supplementary information.

Article 52

Confidentiality rules for the rapid alert system

1. Information, available to the members of the network, relating to a risk to human health posed by food and feed shall in general be available to the public in accordance with the information principle provided for in Article 10. In general, the public shall have access to information on product identification, the nature of the risk and the measure taken.

However, the members of the network shall take steps to ensure that members of their staff are required not to disclose information obtained for the purposes of this Section which by its nature is covered by professional secrecy in duly justified cases, except for information which must be made public, if circumstances so require, in order to protect human health.

2. Protection of professional secrecy shall not prevent the dissemination to the competent authorities of information relevant to the effectiveness of market surveillance and enforcement activities in the field of food and feed. The authorities receiving information covered by professional secrecy shall ensure its pr