(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. (7) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 3. Regulation 178/2002 (Opens in a new window)is directly applicable EU legislation and provides the general principles of food safety and food law which food businesses must comply with: to place safe food on the market 1. for traceability of food 2. for presentation of food 3. provision of suitable food information 4. for the withdrawal or recall of unsafe food placed on the market 5. to ensure food and feed imported into, and exported from, the EU shall comply with food law. 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. Where a Member State officially informs the Commission of the need to take emergency measures, and where the Commission has not acted in accordance with Article 53, the Member State may adopt interim protective measures. The members of the Scientific Committee and the Scientific Panels shall undertake to act independently of any external influence. 2. Regulation (EC) 178/2002 of the European Parliament and of the Council, lays down the general principles and requirements of food law, establishes the European Food Safety Authority and lays down procedures in matters of food safety. 3. In all Member States it shall enjoy the widest powers granted by law to legal persons. A Scientific Committee and Permanent Scientific Panels should therefore be set up within the Authority to provide these opinions. 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. 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). (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. Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner.3. (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. 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. In such cases, it shall draw on the expertise of those working groups when establishing scientific opinions.3. (13) OJ L 340, 9.12.1976, p. 26. (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. It shall publish each year a report on the Authority's activities. 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). 1. Those declarations shall be made annually in writing.3. (4) There are important differences in relation to concepts, principles and procedures between the food laws of the Member States. 2. Directive as last amended by Commission Directive 2001/57/EC (OJ L 208, 1.8.2001, p. 36). No 178 2002 The General Evaluation Of Regulation Ec No 178 2002 The General Recognizing the pretension ways to acquire this books evaluation of regulation ec no 178 2002 the general is additionally useful. 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). 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. (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. 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 21LiabilityThe 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 IIIEUROPEAN FOOD SAFETY AUTHORITYSECTION 1MISSION AND TASKSArticle 22Mission of the Authority1. 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. 2. Therefore it is necessary to adopt a uniform basis throughout the Community for the use of this principle. 0000115883 00000 n (17) OJ L 230, 19.8.1991, p. 1. 0000004271 00000 n (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. 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. 0000116668 00000 n 10. 0000120978 00000 n 0000119604 00000 n 2. 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. The Executive Director shall, following adoption by the Management Board, forward the general report and the programmes to the European Parliament, the Council, the Commission and the Member States, and shall have them published. 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. 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. "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. 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. (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. 2. 5. Regulation (EC) No 178/2002 of the European Parliament and of the Council, 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. "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. These rules shall be made public.4. 2. 4. 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. (6) OJ L 330, 5.12.1998, p. "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. Minority opinions shall be recorded. /Filter /FlateDecode 4. 1. The conclusions of the scientific opinions delivered by the Authority relating to foreseeable health effects shall on no account be kept confidential. Feed shall not be placed on the market or fed to any food-producing animal if it is unsafe.2. 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. 1. The Protocol on the privileges and immunities of the European Communities shall apply to the Authority.Article 47Liability1. 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. 0 Competence of the European Agency for the Evaluation of Medicinal Products. (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). Some of these tasks may be eligible for financial support. 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. 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. 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. This Regulation shall be binding in its entirety and directly applicable in all Member States. This sets out … Definition of Regulation 178/2002 Regulation 178/2002 means Regulation (EC) No. The measures and penalties provided for shall be effective, proportionate and dissuasive.Article 18Traceability1. For the purpose of paragraphs 1 and 2, "Community legislation" shall mean all Community Regulations, Directives and Decisions.4. "risk assessment" means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation;12. /Metadata 78 0 R Article 118 – Amendment to Regulation (EC) No 178/2002 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 (*) . In Articles 50, 51 and 52 scope and procedures of the RASFF are defined. 2. 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. Having regard to the opinion of the Economic and Social Committee(2). 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. 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. 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. 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. Those declarations shall be made annually in writing.2. /Type /Catalog Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. Accordingly, Council Decisions 68/361/EEC(10), 69/414/EEC(11), and 70/372/EEC(12), should be repealed. It shall involve the Member States, the Commission and the Authority. The Executive Director shall implement the Authority's budget.2. 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. Similar issues relating to feed safety should be addressed. 1. (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. 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 Scientific Committee and the Scientific Panels shall each choose a Chair and two Vice-Chairs from among their members. Justifications for the refusal shall be given to the institution or Member State(s) that made the request.