regulation 178 2002 ec

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. 0000119408 00000 n 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. 1. 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 evaluation will take into account the views of the stakeholders, at both Community and national level. The Authority shall exercise vigilance in order to identify at an early stage any potential source of divergence between its scientific opinions and the scientific opinions issued by other bodies carrying out similar tasks. If a feed business operator considers or has reason to believe that a feed which it has imported, produced, processed, manufactured or distributed does not satisfy the feed safety requirements, it shall immediately initiate procedures to withdraw the feed in question from the market and inform the competent authorities thereof. 0000123726 00000 n 0000121569 00000 n /S 1271 Having regard to the opinion of the Economic and Social Committee(2). The 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). 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. It shall analyse the content of such messages with a view to providing the Commission and the Member States with any information required for the purposes of risk analysis. 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. (44) The Authority should cooperate closely with competent bodies in the Member States if it is to operate effectively. (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. 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. "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. 0000115489 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. "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. Steps should also be taken to help avoid diverging scientific opinions and, in the event of diverging scientific opinions between scientific bodies, procedures should be in place to resolve the divergence or provide the risk managers with a transparent basis of scientific information. 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. 1). (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. These measures shall specify, in particular, the specific conditions and procedures applicable to the transmission of notifications and supplementary information. The notification shall be accompanied by a detailed explanation of the reasons for the action taken by the competent authorities of the Member State in which the notification was issued. 811 0 obj Food and feed imported into the Community. On the 28th of January 2002 the European Parliament and the Council adopted Regulation (EC) 178/2002 laying down the General Principles and requirements of Food Law. 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. Directive as last amended by Commission Directive 2001/49/EC (OJ L 176, 29.6.2001, p. On the basis of that draft, the Commission shall enter the relevant estimates in the preliminary draft general budget of the European Union to be put before the Council pursuant to Article 272 of the Treaty. 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. After the adoption of the general budget of the European Union by the budgetary authority, the Management Board shall adopt the Authority's final budget and work programme, adjusting them where necessary to the Community's contribution. (20) OJ L 224, 18.8.1990, p. 1. 10. (55) Appropriate cooperation with the Member States and other interested parties is necessary in the specific field of public information campaigns to take into account any regional parameters and any correlation with health policy. 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. DisplayLogo. The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.Article 59Functions assigned to the CommitteeThe Committee shall carry out the functions assigned to it by this Regulation and by other relevant Community provisions, in the cases and conditions provided for in those provisions. "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. 5. "placing on the market" means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves;9. 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.2. It came into force on 21 February 2002, although certain key Those declarations shall be made annually in writing. In such cases, it shall draw on the expertise of those working groups when establishing scientific opinions.3. To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand. 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.6. This Chapter relates to all stages of the production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals.2. In particular, it may acquire and dispose of movable and immovable property and institute legal proceedings. The Executive Director shall be the legal representative of the Authority and shall be responsible for: (a) the day-to-day administration of the Authority; (b) drawing up a proposal for the Authority's work programmes in consultation with the Commission; (c) implementing the work programmes and the decisions adopted by the Management Board; (d) ensuring the provision of appropriate scientific, technical and administrative support for the Scientific Committee and the Scientific Panels; (e) ensuring that the Authority carries out its tasks in accordance with the requirements of its users, in particular with regard to the adequacy of the services provided and the time taken; (f) the preparation of the statement of revenue and expenditure and the execution of the budget of the Authority; (h) developing and maintaining contact with the European Parliament, and for ensuring a regular dialogue with its relevant committees. 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. (8) OJ L 228, 11.8.1992, p. 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. "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 ensure close cooperation between the Authority and the competent bodies in the Member States in particular on the following items: (a) avoidance of duplication of the Authority's scientific studies with Member States, in accordance with Article 32; (b) in those circumstances identified in Article 30(4), where the Authority and a national body are obliged to cooperate; (c) in the promoting of the European networking of organisations operating within the fields of the Authority's mission, in accordance with Article 36(1); (d) where the Authority or a Member State identifies an emerging risk. /Info 76 0 R The Protocol on the privileges and immunities of the European Communities shall apply to the Authority.Article 47Liability1. This Regulation shall be binding in its entirety and directly applicable in all Member States. The Authority shall lay down in its internal rules the practical arrangements for implementing the transparency rules referred to in paragraphs 1 and 2. The tasks of the Authority shall be the following: (a) to provide the Community institutions and the Member States with the best possible scientific opinions in all cases provided for by Community legislation and on any question within its mission; (b) to promote and coordinate the development of uniform risk assessment methodologies in the fields falling within its mission; (c) to provide scientific and technical support to the Commission in the areas within its mission and, when so requested, in the interpretation and consideration of risk assessment opinions; (d) to commission scientific studies necessary for the accomplishment of its mission; (e) to search for, collect, collate, analyse and summarise scientific and technical data in the fields within its mission; (f) to undertake action to identify and characterise emerging risks, in the fields within its mission; (g) to establish a system of networks of organisations operating in the fields within its mission and be responsible for their operation; (h) to provide scientific and technical assistance, when requested to do so by the Commission, in the crisis management procedures implemented by the Commission with regard to the safety of food and feed; (i) to provide scientific and technical assistance, when requested to do so by the Commission, with a view to improving cooperation between the Community, applicant countries, international organisations and third countries, in the fields within its mission; (j) to ensure that the public and interested parties receive rapid, reliable, objective and comprehensible information in the fields within its mission; (k) to express independently its own conclusions and orientations on matters within its mission; (l) to undertake any other task assigned to it by the Commission within its mission. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC 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. 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. Articles 29, 56, 57 and 60 and Article 62(1) shall apply as from the date of appointment of the members of the Scientific Committee and of the Scientific Panels which shall be announced by means of a notice in the "C" series of the Official Journal. Revenue and expenditure shall be in balance. (51) The establishment of the Authority should enable Member States to become more closely involved in scientific procedures. 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. 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. 0000053973 00000 n The reports and recommendations referred to in paragraphs 1 and 2 shall be forwarded to the Council and the European Parliament. (21) In those specific circumstances where a risk to life or health exists but scientific uncertainty persists, the precautionary principle provides a mechanism for determining risk management measures or other actions in order to ensure the high level of health protection chosen in the Community. The two Member States concerned and the Commission shall make every effort to solve the problem. (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. 9. 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. 0000120978 00000 n In order to achieve these objectives, the Authority shall develop and disseminate information material for the general public.3. These rules shall specify in particular: (a) the procedure to be applied by the Authority to the requests referred to it; (b) the guidelines governing the scientific evaluation of substances, products or processes which are subject under Community legislation to a system of prior authorisation or entry on a positive list, in particular where Community legislation makes provision for, or authorises, a dossier to be presented for this purpose by the applicant. 1. (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. Cooperation and appropriate exchange of information should also minimise the potential for diverging scientific opinions. 0000120390 00000 n 6. 0000119801 00000 n Therefore it is necessary to adopt a uniform basis throughout the Community for the use of this principle. (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. 4. (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. By 31 March each year at the latest, the Executive Director shall forward to the Commission, the Management Board and the Court of Auditors the detailed accounts for all the revenue and expenditure in respect of the previous financial year.The Court of Auditors shall examine the accounts in accordance with Article 248 of the Treaty. 0000116668 00000 n 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. 6. 1. 1. In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.2. This Regulation shall apply to all stages of production, processing and distribution of food and feed. 24. Participation in the rapid alert system may be opened up to applicant countries, third countries or international organisations, on the basis of agreements between the Community and those countries or international organisations, in accordance with the procedures defined in those agreements. 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. 0000117454 00000 n 5. The Authority's internal rules shall specify requirements in regard to format, explanatory background and publication of a scientific opinion. For this reason, it is vital to ensure its independence, high scientific quality, transparency and efficiency. A Scientific Committee and Permanent Scientific Panels should therefore be set up within the Authority to provide these opinions. (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. 1. 3. 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.2. In determining whether any food is unsafe, regard shall be had: (a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and. 2. 0000055175 00000 n The Member States shall cooperate with the Authority to ensure the accomplishment of its mission. 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 Authority shall have legal personality. 3. 4. 3. 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. 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. 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. Those declarations shall be made annually in writing.3. It also includes hunting and fishing and the harvesting of wild products;18. The Authority shall be open to the participation of countries which have concluded agreements with the European Community by virtue of which they have adopted and apply Community legislation in the field covered by this Regulation. Decisions 68/361/EEC, 69/414/EEC and 70/372/EEC are hereby repealed.Article 63Competence of the European Agency for the Evaluation of Medicinal ProductsThis 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).Article 64Commencement of the Authority's operationThe Authority shall commence its operations on 1 January 2002.Article 65Entry into forceThis Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Articles 11 and 12 and Articles 14 to 20 shall apply from 1 January 2005.Articles 29, 56, 57 and 60 and Article 62(1) shall apply as from the date of appointment of the members of the Scientific Committee and of the Scientific Panels which shall be announced by means of a notice in the "C" series of the Official Journal.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 28 January 2002.For the European ParliamentThe PresidentP. The appropriate information should therefore be exchanged between the Authority and the Commission. Consumers, producers and other interested parties. The evaluation and the recommendations shall be made public.2. Therefore it is necessary to adopt a uniform basis throughout the Community for the use of this principle. (21) OJ 22, 9.2.1965, p. 369. (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 legal basis of the RASFF is Regulation EC/178/2002 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 (O.J. 0000040137 00000 n The crisis unit shall keep the public informed of the risks involved and the measures taken. It also includes hunting and fishing and the harvesting of wild products; 18. Without prejudice to other Community legislation, the Member States shall immediately notify the Commission under the rapid alert system of:(a) any measure they adopt which is aimed at restricting the placing on the market or forcing the withdrawal from the market or the recall of food or feed in order to protect human health and requiring rapid action;(b) any recommendation or agreement with professional operators which is aimed, on a voluntary or obligatory basis, at preventing, limiting or imposing specific conditions on the placing on the market or the eventual use of food or feed on account of a serious risk to human health requiring rapid action;(c) any rejection, related to a direct or indirect risk to human health, of a batch, container or cargo of food or feed by a competent authority at a border post within the European Union.The notification shall be accompanied by a detailed explanation of the reasons for the action taken by the competent authorities of the Member State in which the notification was issued.

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