/Root 812 0 R (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. Justifications for the refusal shall be given to the institution or Member State(s) that made the request. (10) OJ L 255, 18.10.1968, p. The Executive Director shall be appointed by the Management Board, on the basis of a list of candidates proposed by the Commission after an open competition, following publication in the Official Journal of the European Communities and elsewhere of a call for expressions of interest, for a period of five years which shall be renewable. 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. Accordingly, Council Decisions 68/361/EEC(10), 69/414/EEC(11), and 70/372/EEC(12), should be repealed. Directive as last amended by Directive 92/41/EEC) (OJ L 158, 11.6.1992, p. 30). The Authority may entrust to these organisations certain tasks, in particular preparatory work for scientific opinions, scientific and technical assistance, collection of data and identification of emerging risks. 1. 2. The representatives of the Commission's departments shall be entitled to be present in the meetings of the Scientific Committee, the Scientific Panels and their working groups. (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. /T 346601 Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. Directive as last amended by Commission Directive 2001/57/EC. 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. 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. This document shall be made public.Article 31Scientific and technical assistance1. 1. "feed business" means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on his own holding;6. (56) In addition to its operating principles based on independence and transparency, the Authority should be an organisation open to contacts with consumers and other interested groups. Before appointment the candidate nominated by the Management Board shall be invited without delay to make a statement before the European Parliament and answer questions put by members of this institution. The latter shall be based on reciprocity and shall include confidentiality measures equivalent to those applicable in the Community. 9. The principles laid down in Articles 5 to 10 shall form a general framework of a horizontal nature to be followed when measures are taken.3. There should therefore be close cooperation between the Authority and the Member States for this purpose. 812 0 obj startxref (20) OJ L 224, 18.8.1990, p. 1. Directive as last amended by Directive 92/41/EEC) (OJ L 158, 11.6.1992, p. /OutputCondition <> /OutputConditionIdentifier (Custom) /RegistryName 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.2. Four of the members shall have their background in organisations representing consumers and other interests in the food chain. 32. This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. The Authority shall contribute to a high level of protection of human life and health, and in this respect take account of animal health and welfare, plant health and the environment, in the context of the operation of the internal market. 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. One of its objectives is to establish common definitions and to lay down overarching guiding principles and legitimate objectives for food law in order to ensure a high level of health protection and the effective functioning of the internal market. 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. 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 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. 2. "risk" means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard; 10. 4. The Authority, Commission and Member States shall cooperate to promote the effective coherence between risk assessment, risk management and risk communication functions.9. 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. Existing food law principles and procedures shall be adapted as soon as possible and by 1 January 2007 at the latest in order to comply with Articles 5 to 10.4. (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. 0000117847 00000 n 9„&ˆd#œ*ÍT"@C¾~4T,h€À•yÇ* íÄî`-¦n3&!FöJ†&†;Œ‰æ¦Œ. 0000001892 00000 n (5) OJ L 229, 30.8.1980, p. 11. 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. The evaluation and the recommendations shall be made public. The Advisory Forum shall constitute a mechanism for an exchange of information on potential risks and the pooling of knowledge. 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. (9) OJ L 371, 30.12.1987, p. 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. (28) OJ L 317, 6.11.1981, p. 1. 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. INDEPENDENCE, TRANSPARENCY, CONFIDENTIALITY AND COMMUNICATION. Until then, and by way of derogation from paragraph 2, existing legislation shall be implemented taking account of the principles laid down in Articles 5 to 10. 1. 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. stream 1. 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. Insert free text, CELEX number or descriptors. It establishes the European Food Safety Authority. 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. 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. 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. Cooperation with Member States is also indispensable. The Authority shall have legal personality. 2. (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. In this event, it shall immediately inform the other Member States and the Commission. 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.8. 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. The Management Board shall adopt its rules of procedure. 4. 7. 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. (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. 1. (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. These rules shall be made public.4. The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution. 9. Directive as last amended by Commission Directive 2000/57/EC (OJ L 244, 29.9.2000, p. 1. "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. 0000116668 00000 n 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. 1. The report, which shall be accompanied, where appropriate, by proposals, shall indicate in particular, for each system, any modifications or improvements which might be required to enable the Authority to carry out its mission, in cooperation with the Member States. (57) The Authority should be financed by the general budget of the European Union. (13) OJ L 340, 9.12.1976, p. 26. 2. Definition of Regulation 178/2002 Regulation 178/2002 means Regulation (EC) No. The European Parliament or a Member State may request the Authority to issue a scientific opinion on matters falling within its mission. 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). The Authority shall seek to avoid duplication with Member State or Community research programmes and shall foster cooperation through appropriate coordination. (14) OJ L 221, 7.8.1986, p. 37. 0000118627 00000 n (21) OJ 22, 9.2.1965, p. 369. (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. 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. 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. 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. (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. 2. "stages of production, processing and distribution" means any stage, including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production, manufacture, storage, transport, distribution, sale and supply of feed;17. 6. 0000053973 00000 n 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.For that purpose, they shall maintain a system of official controls and other activities as appropriate to the circumstances, including public communication on food and feed safety and risk, food and feed safety surveillance and other monitoring activities covering all stages of production, processing and distribution.Member States shall also lay down the rules on measures and penalties applicable to infringements of food and feed law. 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. Those declarations shall be made annually in writing.2. Recent food crises have demonstrated the need to set up an improved and broadened rapid alert system covering food and feed. 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. (15) OJ L 221, 7.8.1986, p. 43. Regulation (EC) No 178/2002 formally establishes the Precautionary Principle as an option where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures based on the precautionary principle may be made. 6. 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.3.