Such studies shall be commissioned in an open and transparent fashion. "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. 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. If agreement cannot be reached, the Commission may request an opinion on any relevant contentious scientific issue from the Authority. Title: 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. This document is an excerpt from the EUR-Lex website, 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, OJ L 31, 1.2.2002, p. 1–24 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)Special edition in Czech: Chapter 15 Volume 006 P. 463 - 486Special edition in Estonian: Chapter 15 Volume 006 P. 463 - 486Special edition in Latvian: Chapter 15 Volume 006 P. 463 - 486Special edition in Lithuanian: Chapter 15 Volume 006 P. 463 - 486Special edition in Hungarian Chapter 15 Volume 006 P. 463 - 486Special edition in Maltese: Chapter 15 Volume 006 P. 463 - 486Special edition in Polish: Chapter 15 Volume 006 P. 463 - 486Special edition in Slovak: Chapter 15 Volume 006 P. 463 - 486Special edition in Slovene: Chapter 15 Volume 006 P. 463 - 486Special edition in Bulgarian: Chapter 15 Volume 008 P. 68 - 91Special edition in Romanian: Chapter 15 Volume 008 P. 68 - 91Special edition in Croatian: Chapter 15 Volume 007 P. 91 - 114, In force: This act has been changed. 8. 0000119801 00000 n The reports and recommendations referred to in paragraphs 1 and 2 shall be forwarded to the Council and the European Parliament. 2. 0000122352 00000 n Where it is evident that food or feed originating in the Community or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, the Commission, acting in accordance with the procedure provided for in Article 58(2) on its own initiative or at the request of a Member State, shall immediately adopt one or more of the following measures, depending on the gravity of the situation: (a) in the case of food or feed of Community origin: (i) suspension of the placing on the market or use of the food in question; (ii) suspension of the placing on the market or use of the feed in question; (iii) laying down special conditions for the food or feed in question; (iv) any other appropriate interim measure; (b) in the case of food or feed imported from a third country: (i) suspension of imports of the food or feed in question from all or part of the third country concerned and, where applicable, from the third country of transit; (ii) laying down special conditions for the food or feed in question from all or part of the third country concerned; (iii) any other appropriate interim measure. This information shall be made available to the competent authorities on demand.4. 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. The Community budgetary procedure remains applicable as far as any subsidies chargeable to the general budget of the European Union are concerned. The crisis unit may request the assistance of any public or private person whose expertise it deems necessary to manage the crisis effectively.3. A Scientific Committee and Permanent Scientific Panels should therefore be set up within the Authority to provide these opinions. 0000120978 00000 n 1. Some of these tasks may be eligible for financial support.3. Such disparities are liable to create barriers to trade and distort competition between food business operators in different Member States. 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. Directive as last amended by Commission Directive 2001/49/EC (OJ L 176, 29.6.2001, p. 0000120782 00000 n (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. (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. N° L 31 of 1 February 2002). 2. In particular, the Authority should be able to assign certain tasks to organisations in the Member States. (17) OJ L 230, 19.8.1991, p. 1. 5. 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. 1. The personal liability of its servants towards the Authority shall be governed by the relevant provisions applying to the staff of the Authority. 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. ¹dæ1(drÑb‰8¸ ±¥SÌ ààN‘€‚ÉlGº%šÛ'(yÌ ØÄ&¤qЙ]@%Ðik´N‚Ã!V‡‰®\b9‘-Ú¨tŒ…GááŽIjÁÅ 3ç ©Ä-8C!QɵÅñ\Jíü 1. 1. The Authority shall inform the European Parliament, the Commission and the Member States of the results of its scientific studies.Article 33Collection of data1. 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. 3. Competence of the European Agency for the Evaluation of Medicinal Products. 4. The reports and recommendations referred to in paragraphs 1 and 2 shall be forwarded to the Council and the European Parliament.Article 62References to the European Food Safety Authority and to the Standing Committee on the Food Chain and Animal Health1. 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. It should be done in an open and transparent fashion and the Authority should take into account existing Community expertise and structures. The Management Board shall elect one of its members as its Chair for a two-year period, which shall be renewable. These rules shall be made public.4. The Executive Director shall approve all financial expenditure of the Authority and report on the Authority's activities to the Management Board.Article 27Advisory Forum1. 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 Protocol on the privileges and immunities of the European Communities shall apply to the Authority.Article 47Liability1. In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added: ‘(i) medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (*). Having regard to the opinion of the Economic and Social Committee(2). 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. (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. 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. (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). It shall act in close cooperation with the competent bodies in the Member States carrying out similar tasks to these of the Authority. Directive as last amended by Commission Directive 2001/57/EC. The Executive Director shall approve all financial expenditure of the Authority and report on the Authority's activities to the Management Board. Directive as last amended by Commission Directive 2001/57/EC. Moreover, the auditing of accounts should be undertaken by the Court of Auditors. 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. 0000039308 00000 n (4) There are important differences in relation to concepts, principles and procedures between the food laws of the Member States. The authorities receiving information covered by professional secrecy shall ensure its protection in conformity with paragraph 1. 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 particular, it may acquire and dispose of movable and immovable property and institute legal proceedings. 1. 2. (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. INDEPENDENCE, TRANSPARENCY, CONFIDENTIALITY AND COMMUNICATION. (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. 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. 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. (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. Amendment to Regulation (EC) No 178/2002. (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. 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. 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. 0000121959 00000 n (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. 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 (OJ L 31, 1.2.2002, pp. 2. (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. 3. (24) OJ L 359, 8.12.1989, p. 1. Those declarations shall be made annually in writing. (18) OJ L 184, 17.7.1999, p. 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. This document shall be made public. (33) The scientific and technical issues in relation to food and feed safety are becoming increasingly important and complex. 0000121372 00000 n (3) Opinion delivered on 14 June 2001 (not yet published in the Official Journal). Four of the members shall have their background in organisations representing consumers and other interests in the food chain. 2. 2.