(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. 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. 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 28Scientific Committee and Scientific Panels1. 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. Before 31 January each year, the Management Board shall adopt the Authority's programme of work for the coming year. 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. 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. 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. 1. 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. The conclusions of the scientific opinions delivered by the Authority relating to foreseeable health effects shall on no account be kept confidential.4. The Member State may maintain its national interim protective measures until the Community measures have been adopted. REGULAMENTUL (CE) NR. 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. 7. (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. These rules shall be made public.4. Directive as last amended by Directive 1999/34/EC of the European Parliament and of the Council (OJ L 141, 4.6.1999, p. 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. The Management Board shall adopt the Authority's internal rules on the basis of a proposal by the Executive Director. The Authority shall provide the technical and logistic support necessary for the Advisory Forum and provide the Secretariat for its meetings. The Management Board shall meet at the invitation of the Chair or at the request of at least a third of its members. 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. (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. Recent food crises have demonstrated the need to set up an improved and broadened rapid alert system covering food and feed. Regulation (EC) No 178/2002 of the European Parliament and of the Councilof 28 January 2002laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safetyTHE 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. (Regulation (EC) No 178/2002); it is not an evaluation of the entire food and feed law or of individual areas of secondary legislation. 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. (14) OJ L 221, 7.8.1986, p. 37. 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. 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,HAVE ADOPTED THIS REGULATION:CHAPTER ISCOPE AND DEFINITIONSArticle 1Aim and scope1. 4. Directive repealed by Directive 98/83/EC. (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. 4. It shall provide independent information on all matters within these fields and communicate on risks. 5. The Member State may maintain its national interim protective measures until the Community measures have been adopted.SECTION 3CRISIS MANAGEMENTArticle 55General plan for crisis management1. The Executive Director may be removed from office by a majority of the Management Board. 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. Directive as last amended by Commission Directive 2001/49/EC (OJ L 176, 29.6.2001, p. 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. (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). The members of the Scientific Committee and the Scientific Panels shall undertake to act independently of any external influence. 1. 3. This document shall be made public.Article 31Scientific and technical assistance1. 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. (22) OJ L 297, 13.10.1992, p. 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. Directive as last amended by Commission Directive 2000/57/EC (OJ L 244, 29.9.2000, p. 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. The Committee shall carry out the functions assigned to it by this Regulation and by other relevant Community provisions, in the cases and conditions provided for in those provisions. 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. 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. The Authority shall develop effective contacts with consumer representatives, producer representatives, processors and any other interested parties. 2. 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 authorities receiving information covered by professional secrecy shall ensure its protection in conformity with paragraph 1. (23) OJ L 262, 27.9.1976, p. 169. 1. Representatives of the Commission's departments may participate in the work of the Advisory Forum. Directive amended by Directive 2001/82/EC of the European Parliament and of the Council (OJ L 311, 28.11.2001, p. 1). 178/2002 amended by. 2. 3. 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. (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. 9. Every reference in Community legislation to the Standing Committee on Foodstuffs, the Standing Committee for Feedingstuffs and the Standing Veterinary Committee shall be replaced by a reference to the Standing Committee on the Food Chain and Animal Health. A European Food Safety Authority, hereinafter referred to as the "Authority", is hereby established.2. 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. 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. In other circumstances, food and feed can only be exported or re-exported if the importing country has expressly agreed. In particular, the Authority should be able to assign certain tasks to organisations in the Member States. (27) OJ L 147, 9.6.1975, p. 13. 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. Those declarations shall be made annually in writing.3. (24) OJ L 359, 8.12.1989, p. 1. (15) OJ L 221, 7.8.1986, p. 43. 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. The Authority, Commission and Member States shall cooperate to promote the effective coherence between risk assessment, risk management and risk communication functions.9. 4. 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. Skip to content. 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. In all Member States it shall enjoy the widest powers granted by law to legal persons. 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. 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. 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. 1. The Executive Director may also ask the Advisory Forum for advice on the prioritisation of requests for scientific opinions.4. The European Parliament, acting on a recommendation from the Council, shall give a discharge to the Authority's Executive Director in respect of the implementation of the budget. 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. Directive as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22). 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. 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. Those rules shall specify, in particular, 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.4. (9) OJ L 371, 30.12.1987, p. As soon as possible, and at most within 10 working days, the measures taken shall be confirmed, amended, revoked or extended in accordance with the procedure referred to in Article 58(2), and the reasons for the Commission's decision shall be made public without delay. "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. 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 36Networking of organisations operating in the fields within the Authority's mission1. DisplayLogo . In good time, before the date referred to in paragraph 5, the Executive Director shall draw up an estimate of the Authority's revenue and expenditure for the coming financial year, and shall forward it to the Management Board, accompanied by a provisional list of posts. 6. (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. 6. The Community should have access to high-quality, independent and efficient scientific and technical support. For this reason, it is vital to ensure its independence, high scientific quality, transparency and efficiency. (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. 76. 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. On the basis of that draft, the Commission shall enter the relevant estimates in the preliminary draft general budget of the European Union to be put before the Council pursuant to Article 272 of the Treaty.6. Use this menu to access essential accompanying documents and information for this legislation item. Members' term of office shall be four years, and may be renewed once. (3) Opinion delivered on 14 June 2001 (not yet published in the Official Journal). The Court of Justice shall have jurisdiction in any dispute relating to compensation for such damage. Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner.3. The Executive Director may be removed from office by a majority of the Management Board.2. The Commission shall set up a crisis unit immediately, in which the Authority shall participate, and provide scientific and technical assistance if necessary.Article 57Tasks of the crisis unit1. 1. (4) Opinion of the European Parliament of 12 June 2001 (not yet published in the Official Journal), Council Common Position of 17 September 2001 (not yet published in the Official Journal) and Decision of the European Parliament of 11 December 2001 (not yet published in the Official Journal). (44) The Authority should cooperate closely with competent bodies in the Member States if it is to operate effectively. The Protocol on the privileges and immunities of the European Communities shall apply to the Authority.Article 47Liability1. 1. Food shall be deemed to be unsafe if it is considered to be: 3. 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. This Regulation shall be without prejudice to the competence conferred on the European Agency for the Evaluation of Medicinal Products by Regulation (EEC) No 2309/93, Regulation (EEC) No 2377/90, Council Directive 75/319/EEC(27) and Council Directive 81/851/EEC(28). After the adoption of the general budget of the European Union by the budgetary authority, the Management Board shall adopt the Authority's final budget and work programme, adjusting them where necessary to the Community's contribution. 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 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. "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 3Other definitionsFor the purposes of this Regulation:1. Recent food crises have demonstrated the need to set up an improved and broadened rapid alert system covering food and feed. 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.
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