regulation 178 2002 ec

Directive as last amended by Commission Directive 2001/57/EC. 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. The Advisory Forum shall constitute a mechanism for an exchange of information on potential risks and the pooling of knowledge. 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. The Advisory Forum shall be composed of representatives from competent bodies in the Member States which undertake tasks similar to those of the Authority, on the basis of one representative designated by each Member State. "risk analysis" means a process consisting of three interconnected components: risk assessment, risk management and risk communication;11. 0000039308 00000 n 3. 0000117650 00000 n The revenues of the Authority shall consist of a contribution from the Community and, from any State with which the Community has concluded the agreements referred to in Article 49, and charges for publications, conferences, training and any other similar activities provided by the Authority. The Commission shall set up a crisis unit immediately, in which the Authority shall participate, and provide scientific and technical assistance if necessary. The Executive Director shall implement the Authority's budget.2. 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 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.5. 0000003699 00000 n 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. Cooperation with Member States is also indispensable. 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. These organisational procedures should make it possible to improve coordination of effort and to determine the most effective measures on the basis of the best scientific information. The evaluation and the recommendations shall be made public.2. 1. 0000122156 00000 n Directive amended by Directive 2001/83/EC of the European Parliament and of the Council (OJ L 311, 28.11.2001, p. This Regulation shall be binding in its entirety and directly applicable in all Member States. startxref In all Member States it shall enjoy the widest powers granted by law to legal persons. Representatives of the Commission's departments may participate in the work of the Advisory Forum. "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. 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.2. 3. The Authority shall use all the information it receives in the performance of its mission to identify an emerging risk. 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. Scientific Committee and Scientific Panels. The number and names of the Scientific Panels may be adapted in the light of technical and scientific development by the Commission, at the Authority's request, in accordance with the procedure referred to in Article 58(2). For the purpose of paragraphs 1 and 2, "Community legislation" shall mean all Community Regulations, Directives and Decisions. Directive as last amended by Commission Directive 2000/41/EC (OJ L 145, 20.6.2000, p. When Member States adopt measures governing food, these differences may impede the free movement of food, create unequal conditions of competition, and may thereby directly affect the functioning of the internal market. Risk management shall take into account the results of risk assessment, and in particular, the opinions of the Authority referred to in Article 22, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) are relevant, in order to achieve the general objectives of food law established in Article 5.Article 7Precautionary principle1. (4) There are important differences in relation to concepts, principles and procedures between the food laws of the Member States. (49) The lack of an effective system of collection and analysis at Community level of data on the food supply chain is recognised as a major shortcoming. Arrangements shall be made under the relevant provisions of those agreements, specifying in particular the nature, extent and manner in which these countries will participate in the Authority's work, including provisions relating to participation in the networks operated by the Authority, inclusion in the list of competent organisations to which certain tasks may be entrusted by the Authority, financial contributions and staff. 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. 0000004271 00000 n Where the Authority has already delivered a scientific opinion on the specific topic in a request, it may refuse the request if it concludes there are no new scientific elements justifying the re-examination. 7). This Regulation shall apply to all stages of production, processing and distribution of food and feed. 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). 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 crisis unit shall be responsible for collecting and evaluating all relevant information and identifying the options available to prevent, eliminate or reduce to an acceptable level the risk to human health as effectively and rapidly as possible.2. Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner. "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. (3) The free movement of food and feed within the Community can be achieved only if food and feed safety requirements do not differ significantly from Member State to Member State. 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. 1. It shall provide independent information on all matters within these fields and communicate on risks.3. Control of commitment and payment of all expenditure and control of the existence and recovery of all the Authority's revenue shall be carried out by the Commission's financial controller. 2. The crisis unit shall keep the public informed of the risks involved and the measures taken.CHAPTER VPROCEDURES AND FINAL PROVISIONSSECTION 1COMMITTEE AND MEDIATION PROCEDURESArticle 58Committee1. (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. 7. Representatives may be replaced by alternates, appointed at the same time. 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. "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. The Authority shall forward the evaluation and information collected on emerging risks to the European Parliament, the Commission and the Member States.Article 35Rapid alert systemTo enable it to perform its task of monitoring the health and nutritional risks of foods as effectively as possible, the Authority shall be the recipient of any messages forwarded via the rapid alert system. The Authority shall forward the results of its work in the field of data collection to the European Parliament, the Commission and the Member States. 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. 0000116473 00000 n (17) OJ L 230, 19.8.1991, p. 1. xœc```b`à8ÎÀÎÀÀéÏ È€ ‚¬@QŽ¼à…hÃõ;x(ÈLa»À’Çø’aŸÃâ„ÀZüüÌÚLïí&+„=P7cEÃú® ª¼&ì˜ý˜Õ€F±©F&MÙؓÌHH3ìLŠ8¦¢Â±±Ù‘™SH'ñð A„G,]`Á$× ‡…ÍB”ŽñÊØ4 (31) Similar requirements should apply to feed and feed business operators. (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. 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. 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. 2. (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. The Authority shall ensure that it carries out its activities with a high level of transparency. (12) In order to ensure the safety of food, it is necessary to consider all aspects of the food production chain as a continuum from and including primary production and the production of animal feed up to and including sale or supply of food to the consumer because each element may have a potential impact on food safety. Those rules shall specify, in particular, the criteria for inclusion of an institute on the list of competent organisations designated by the Member States, arrangements for setting out harmonised quality requirements and the financial rules governing any financial support.4. Risk management shall take into account the results of risk assessment, and in particular, the opinions of the Authority referred to in Article 22, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) are relevant, in order to achieve the general objectives of food law established in Article 5. 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. Directive as last amended by Commission Directive 2001/49/EC (OJ L 176, 29.6.2001, p. 61). The Advisory Forum shall be chaired by the Executive Director. Directive as last amended by Commission Directive 2001/49/EC (OJ L 176, 29.6.2001, p. "risk communication" means the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, feed and food businesses, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions; 14. It shall forward them without delay to the Commission and the budgetary authority. 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. /Metadata 78 0 R (16) OJ L 350, 14.12.1990, p. 71. 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. (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. (45) The Authority should take over the role of the Scientific Committees attached to the Commission in issuing scientific opinions in its field of competence. (25) OJ L 210, 7.8.1985, p. 29. It shall aim at the prevention of: (c) any other practices which may mislead the consumer. Official Journal L 031 , 01/02/2002 P. 0001 - 0024. The Member States shall cooperate with the Authority to ensure the accomplishment of its mission. The Authority shall communicate on its own initiative in the fields within its mission without prejudice to the Commission's competence to communicate its risk management decisions.2. In such cases, it shall draw on the expertise of those working groups when establishing scientific opinions. It establishes the European Food Safety Authority. Within one year following the date of entry into force of this Regulation, the Commission shall publish an inventory of data collection systems existing at Community level in the fields within the mission of the Authority.The report, which shall be accompanied, where appropriate, by proposals, shall indicate in particular:(a) for each system, the role which should be assigned to the Authority, and any modifications or improvements which might be required to enable the Authority to carry out its mission, in cooperation with the Member States;(b) the shortcomings which should be remedied to enable the Authority to collect and summarise at Community level relevant scientific and technical data in the fields within its mission.6. The Community budgetary procedure remains applicable as far as any subsidies chargeable to the general budget of the European Union are concerned. 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.4.

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