6. 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. xref (http://www.color.org) /S /GTS_PDFA1 /Type /OutputIntent >> ] Food and feed exported from the Community. The Authority shall act in close collaboration with the Commission and the Member States to promote the necessary coherence in the risk communication process. (61) Recent food crises have also shown the benefits to the Commission of having properly adapted, more rapid procedures for crisis management. Without prejudice to the application of other Community provisions, where a Member State is of the opinion that a measure taken by another Member State in the field of food safety is either incompatible with this Regulation or is likely to affect the functioning of the internal market, it shall refer the matter to the Commission, which will immediately inform the other Member State concerned.2. 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.Article 45Fees received by the AuthorityWithin 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 6GENERAL PROVISIONSArticle 46Legal personality and privileges1. 1. Representatives of the Commission's departments may participate in the work of the Advisory Forum. Directive as last amended by Commission Directive 2000/41/EC (OJ L 145, 20.6.2000, p. 25). The Court of Justice shall have jurisdiction in any dispute relating to compensation for such damage.3. /Metadata 78 0 R 0000096600 00000 n In order to achieve these objectives, the Authority shall develop and disseminate information material for the general public.3. The Management Board, having received the Commission's approval and the opinion of the Court of Auditors, shall adopt the Authority's financial regulation which specifies in particular the procedure for drawing up and implementing the Authority's budget, in accordance with Article 142 of the Financial Regulation of 21 December 1977 applicable to the general budget of the European Communities(26) and with the legislative requirements concerning investigations conducted by the European Anti-Fraud Office. (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. (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. 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. 9. The Executive Director may invite representatives of the European Parliament and from other relevant bodies to take part. (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. 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. This Regulation shall apply to all stages of production, processing and distribution of food and feed. Its operational procedures shall be specified in the Authority's internal rules and shall be made public.6. 0000117060 00000 n The Scientific Panels shall be composed of independent scientific experts. Regulation (EC) N° 178/20021(hereafter “the Regulation”) was adopted on 28 January 2002. Food shall not be placed on the market if it is unsafe.2. Directive as last amended by Commission Directive 2001/57/EC. It may also examine any issue falling under those provisions, either at the initiative of the Chairman or at the written request of one of its members. Directive as last amended by Directive 1999/34/EC of the European Parliament and of the Council (OJ L 141, 4.6.1999, p. 20). 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. 1. 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. Without prejudice to its role of ensuring the application of Community law, where the Commission identifies a situation involving a serious direct or indirect risk to human health deriving from food and feed, and the risk cannot be prevented, eliminated or reduced by existing provisions or cannot adequately be managed solely by way of the application of Articles 53 and 54, it shall immediately notify the Member States and the Authority. 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. Before 1 January 2005, the Commission shall publish a report on the experience acquired from implementing Sections 1 and 2 of Chapter IV.3. 8. Before 31 January each year, the Management Board shall adopt the Authority's programme of work for the coming year. 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). 812 0 obj (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. Directive as last amended by Commission Directive 2001/57/EC (OJ L 208, 1.8.2001, p. 36). 1-24) The evaluation will take into account the views of the stakeholders, at both Community and national level.The Management Board of the Authority shall examine the conclusions of the evaluation and issue to the Commission such recommendations as may be necessary regarding changes in the Authority and its working practices. 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. 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. 3. Article 50 identifies the members of the system and sets out … Food shall be deemed to be unsafe if it is considered to be: 3. 0000039308 00000 n (14) OJ L 221, 7.8.1986, p. 37. 1. In all Member States it shall enjoy the widest powers granted by law to legal persons. "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. 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. Representatives may be replaced by alternates, appointed at the same time. 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 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 Commission shall be assisted by a Standing Committee on the Food Chain and Animal Health, hereinafter referred to as the "Committee", composed of representatives of the Member States and chaired by the representative of the Commission. (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. 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. 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. The Community should have access to high-quality, independent and efficient scientific and technical support. It sets out general principles, requirements and procedures that underpin decision making in matters of food and feed safety, covering all stages of food and feed production and distribution. The Management Board of the Authority shall examine the conclusions of the evaluation and issue to the Commission such recommendations as may be necessary regarding changes in the Authority and its working practices. 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. There should therefore be close cooperation between the Authority and the Member States for this purpose. 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. 0000116473 00000 n 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; (f) the preparation of the statement of revenue and expenditure and the execution of the budget of the Authority; (h) developing and maintaining contact with the European Parliament, and for ensuring a regular dialogue with its relevant committees. Before 1 January 2005 and every six years thereafter, the Authority, in collaboration with the Commission, shall commission an independent external evaluation of its achievements on the basis of the terms of reference issued by the Management Board in agreement with the Commission. Some of these tasks may be eligible for financial support. It lays down procedures for matters with a direct or indirect impact on food and feed safety. endobj "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. The General Food Law Regulation is the foundation of food and feed law. 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. 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. (26) OJ L 356, 31.12.1977, p. 1. 3. "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. Regulation (EC) No 178/2002 (General Food Law Regulation) is the foundation of EU food and feed law. 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. These rules shall be made public.4. >> 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. (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. (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 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 2Definition 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. 1. "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. In all Member States it shall enjoy the widest powers granted by law to legal persons. N° L 31 of 1 February 2002). 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. 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. 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. (d) a Scientific Committee and Scientific Panels. 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. The Authority shall forward the evaluation and information collected on emerging risks to the European Parliament, the Commission and the Member States. Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. 7. ¹dæ1(drÑb‰8¸ ±¥SÌ ààN‘€‚ÉlGº%šÛ'(yÌ ØÄ&¤qЙ]@%Ðik´N‚Ã!V‡‰®\b9‘-Ú¨tŒ…GááŽIjÁÅ 3ç ©Ä-8C!QɵÅñ\Jíü We have produced guidance note… 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. 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. 1. 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. 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. This document shall be made public. It came into force on 21 February 2002, although certain key (23) OJ L 262, 27.9.1976, p. 169. 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. 25). Decisions 68/361/EEC, 69/414/EEC and 70/372/EEC are hereby repealed.Article 63Competence of the European Agency for the Evaluation of Medicinal ProductsThis 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).Article 64Commencement of the Authority's operationThe Authority shall commence its operations on 1 January 2002.Article 65Entry into forceThis Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Articles 11 and 12 and Articles 14 to 20 shall apply from 1 January 2005.Articles 29, 56, 57 and 60 and Article 62(1) shall apply as from the date of appointment of the members of the Scientific Committee and of the Scientific Panels which shall be announced by means of a notice in the "C" series of the Official Journal.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 28 January 2002.For the European ParliamentThe PresidentP. 1. 1. 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. Every reference in Community legislation to the Scientific Committee on Food, the Scientific Committee on Animal Nutrition, the Scientific Veterinary Committee, the Scientific Committee on Pesticides, the Scientific Committee on Plants and the Scientific Steering Committee shall be replaced by a reference to the European Food Safety Authority. In such cases, it shall draw on the expertise of those working groups when establishing scientific opinions. The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority, in accordance with the procedure provided for in Article 58(2). 6. The Committee shall be organised in sections to deal with all relevant matters.2. Regulation as last amended by Regulation (EC, ECSC, Euratom) No 762/2001 (OJ L 111, 20.4.2001, p. 1). This revised system should be managed by the Commission and include as members of the network the Member States, the Commission and the Authority. 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. 0 1. 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 19Responsibilities for food: food business operators1. 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. Those declarations shall be made annually in writing. (11) OJ L 291, 19.11.1969, p. (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. 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. 67). 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. 1. 2. 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. (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. 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 39Confidentiality1. 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. 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 20Responsibilities for feed: feed business operators1. 0000053973 00000 n Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. (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. 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.