2. REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 January2002 ... Having regard to the Treaty establishing the European Community,andinparticularArticles37,95,133andArticle 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), (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. Eu Regulation 178/2002 - posted in Food Safety Talk: Hi Saferpakers, I think most of you are packaging manufacturers. 1. (28) OJ L 317, 6.11.1981, p. 1. (6) OJ L 330, 5.12.1998, p. 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 6Risk analysis1. (31) Similar requirements should apply to feed and feed business operators. /Prev 346589 3. The Commission shall draw up, in close cooperation with the Authority and the Member States, a general plan for crisis management in the field of the safety of food and feed (hereinafter referred to as "the general plan"). However, these Member States apply different basic criteria for establishing whether a food is safe. (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. 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. (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. 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 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. 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. 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. It shall involve the Member States, the Commission and the Authority. It should be done in an open and transparent fashion and the Authority should take into account existing Community expertise and structures. Moreover, the auditing of accounts should be undertaken by the Court of Auditors. 0000003603 00000 n 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. 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; (c) the draft annual accounts for the previous year; (d) the draft budget for the coming year. (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. 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. 0000039480 00000 n Directive as last amended by Commission Directive 2000/41/EC (OJ L 145, 20.6.2000, p. 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 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. If invited to do so, they may assist for the purposes of clarification or information but shall not seek to influence discussions.9. INDEPENDENCE, TRANSPARENCY, CONFIDENTIALITY AND COMMUNICATION. 3. (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. 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. 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. 0000119998 00000 n 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. 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). 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. Directive as last amended by Commission Directive 2001/49/EC (OJ L 176, 29.6.2001, p. 61). Before 31 January each year, the Management Board shall adopt the Authority's programme of work for the coming year. 4. (4) There are important differences in relation to concepts, principles and procedures between the food laws of the Member States. Responsibilities for food: food business operators. The Management Board shall adopt the Authority's internal rules on the basis of a proposal by the Executive Director. "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 IIGENERAL FOOD LAWArticle 4Scope1. 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 terms of that request and the time limit within which the Authority is requested to give its opinion shall be established by mutual agreement between the Commission and the Authority, after consulting the two Member States concerned. 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. 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). The appropriate information should therefore be exchanged between the Authority and the Commission. The Authority shall seek to avoid duplication with Member State or Community research programmes and shall foster cooperation through appropriate coordination. %âãÏÓ In this event, it shall immediately inform the other Member States and the Commission.2. 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. 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. Amendment to Regulation (EC) No 178/2002. 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. 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. 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. 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. 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. (23) The safety and confidence of consumers within the Community, and in third countries, are of paramount importance. (51) The establishment of the Authority should enable Member States to become more closely involved in scientific procedures. Those declarations shall be made annually in writing. Feed shall not be placed on the market or fed to any food-producing animal if it is unsafe. 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. It lays down procedures for matters with a direct or indirect impact on food and feed safety. (16) OJ L 350, 14.12.1990, p. 71. 1. 0000109705 00000 n (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. (13) OJ L 340, 9.12.1976, p. 26. 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. (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. 0000040137 00000 n 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. The Court of Auditors shall examine the accounts in accordance with Article 248 of the Treaty. The Commission shall draw up, in close cooperation with the Authority and the Member States, a general plan for crisis management in the field of the safety of food and feed (hereinafter referred to as "the general plan").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 Those declarations shall be made annually in writing.3. The Authority shall ensure that it carries out its activities with a high level of transparency. /OutputCondition <> /OutputConditionIdentifier (Custom) /RegistryName 9. 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. 3. Justifications for the refusal shall be given to the institution or Member State(s) that made the request.6. Explanation. 0000003699 00000 n 2. 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. (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. The two Member States concerned and the Commission shall make every effort to solve the problem. 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 13International standardsWithout 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 4GENERAL REQUIREMENTS OF FOOD LAWArticle 14Food safety requirements1. In order to achieve these objectives, the Authority shall develop and disseminate information material for the general public.3. 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. /O 813 These rules shall be made public.4. (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. 1. 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. (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. (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. Directive as last amended by Commission Directive 2001/57/EC (OJ L 208, 1.8.2001, p. It shall aim at the prevention of: (c) any other practices which may mislead the consumer. /L 362949 %PDF-1.4 61). 1. (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. 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. 2. 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. 6. 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). Therefore it is necessary to adopt a uniform basis throughout the Community for the use of this principle. 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. This document shall be made public.Article 31Scientific and technical assistance1. 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 32Scientific studies1. (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. The crisis unit may request the assistance of any public or private person whose expertise it deems necessary to manage the crisis effectively. 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.