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. 3. Without 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. (10) Experience has shown that it is necessary to adopt measures aimed at guaranteeing that unsafe food is not placed on the market and at ensuring that systems exist to identify and respond to food safety problems in order to ensure the proper functioning of the internal market and to protect human health. (6) Water is ingested directly or indirectly like other foods, thereby contributing to the overall exposure of a consumer to ingested substances, including chemical and microbiological contaminants. 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 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.SECTION 4INDEPENDENCE, TRANSPARENCY, CONFIDENTIALITY AND COMMUNICATIONArticle 37Independence1. 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. 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. (23) The safety and confidence of consumers within the Community, and in third countries, are of paramount importance. 2. Article 1 Aim and Scope; 1.the assurance of a high level of protection of human health and consumers interest in relation to food 2.lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and 1. A Scientific Committee and Permanent Scientific Panels should therefore be set up within the Authority to provide these opinions. These rules shall be made public.4. 0000116276 00000 n Directive as last amended by Directive 92/41/EEC) (OJ L 158, 11.6.1992, p. 30). The Commission shall set up a crisis unit immediately, in which the Authority shall participate, and provide scientific and technical assistance if necessary. In particular, the Authority should be able to assign certain tasks to organisations in the Member States. 2. Piqué i Camps(1) OJ C 96 E, 27.3.2001, p. Those declarations shall be made annually in writing.3. (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. The expenditure of the Authority shall include the staff, administrative, infrastructure and operational expenses, and expenses resulting from contracts entered into with third parties or resulting from the financial support referred to in Article 36.3. 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. The measures and penalties provided for shall be effective, proportionate and dissuasive.Article 18Traceability1. 3. 0 (61) Recent food crises have also shown the benefits to the Commission of having properly adapted, more rapid procedures for crisis management. 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.3. 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. Directive as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22). endobj CoxFor the CouncilThe PresidentJ. 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. It is necessary to reorganise these Committees to ensure greater scientific consistency in relation to the food supply chain and to enable them to work more effectively. If agreement cannot be reached, the Commission may request an opinion on any relevant contentious scientific issue from the Authority. 0000040234 00000 n The Authority shall use all the information it receives in the performance of its mission to identify an emerging risk.4. 32. Such studies shall be commissioned in an open and transparent fashion. 3. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment. The evaluation will assess the working practices and the impact of the Authority. (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. 1). 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. It establishes common principles and responsibilities, the means to provide a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food and feed safety.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.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. Where reference is made to this paragraph, the procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Articles 7 and 8 thereof. It shall aim at the prevention of: (c) any other practices which may mislead the consumer. Accordingly, Council Decisions 68/361/EEC(10), 69/414/EEC(11), and 70/372/EEC(12), should be repealed. The Authority shall search for, collect, collate, analyse and summarise relevant scientific and technical data in the fields within its mission. 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.2. The Committee shall be organised in sections to deal with all relevant matters. (65) It is important to avoid confusion between the missions of the Authority and the European Agency for the Evaluation of Medicinal Products (EMEA) established by Council Regulation (EEC) No 2309/93(19). 1. 811 0 obj (53) The Commission remains fully responsible for communicating risk management measures. Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met.2. The Authority shall carry out its tasks in conditions which enable it to serve as a point of reference by virtue of its independence, the scientific and technical quality of the opinions it issues and the information it disseminates, the transparency of its procedures and methods of operation, and its diligence in performing the tasks assigned to it. 1. 0000002247 00000 n 0000040137 00000 n 3. In this event, it shall immediately inform the other Member States and the Commission. "food business operator" means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control; 4. When the Authority is established, the following Scientific Panels shall be set up: (a) the Panel on food additives, flavourings, processing aids and materials in contact with food; (b) the Panel on additives and products or substances used in animal feed; (c) the Panel on plant health, plant protection products and their residues; (d) the Panel on genetically modified organisms; (e) the Panel on dietetic products, nutrition and allergies; (g) the Panel on contaminants in the food chain; (h) the Panel on animal health and welfare. The Scientific Committee and the Scientific Panels shall each choose a Chair and two Vice-Chairs from among their members.7. 2. 1. 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. 1. 2. (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. It establishes common principles and responsibilities, the means to provide a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food and feed safety. 7. The Executive Director may invite representatives of the European Parliament and from other relevant bodies to take part. If invited to do so, they may assist for the purposes of clarification or information but shall not seek to influence discussions.9. The Member State may maintain its national interim protective measures until the Community measures have been adopted.SECTION 3CRISIS MANAGEMENTArticle 55General plan for crisis management1. (59) A system for rapid alert already exists in the framework of Council Directive 92/59/EEC of 29 June 1992 on general product safety(8). (12) OJ L 170, 3.8.1970, p. %PDF-1.4 0000003699 00000 n This document shall be made public.Article 31Scientific and technical assistance1. endobj In determining whether any food is injurious to health, regard shall be had:(a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations;(b) to the probable cumulative toxic effects;(c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.5. 3. 2. This Regulation provides the basis for the assurance of a high level of protection of human health and consumers' interest in relation to food, taking into account in particular the diversity in the supply of food including traditional products, whilst ensuring the effective functioning of the internal market. Close cooperation between the Authority, the Commission and the Member States is also necessary to ensure the coherence of the global communication process. It came into force on 21 February 2002, although certain key 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. (2) A high level of protection of human life and health should be assured in the pursuit of Community policies. The Executive Director shall approve all financial expenditure of the Authority and report on the Authority's activities to the Management Board. It also includes hunting and fishing and the harvesting of wild products;18. It shall provide opinions on multisectoral issues falling within the competence of more than one Scientific Panel, and on issues which do not fall within the competence of any of the Scientific Panels.Where necessary, and particularly in the case of subjects which do not fall within the competence of any of the Scientific Panels, the Scientific Committee shall set up working groups. The Authority's internal rules shall specify requirements in regard to format, explanatory background and publication of a scientific opinion.Article 30Diverging scientific opinions1. 1. (60) Recent food safety incidents have demonstrated the need to establish appropriate measures in emergency situations ensuring that all foods, whatever their type and origin, and all feed should be subject to common measures in the event of a serious risk to human health, animal health or the environment. Directive repealed by Directive 98/83/EC. 0000122549 00000 n COMMISSION REGULATION (EC) No 178/2006. 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. 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. In 2000, the European Commission issued a Communication on the Precautionary Principle.The objective of the Communication is to outline the Commission's approach t… You have remained in right site to start getting this info. (31) Similar requirements should apply to feed and feed business operators. The Management Board shall adopt its rules of procedure. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC and without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC. 3. 23. This Regulation shall apply to all stages of production, processing and distribution of food and feed. "food business" means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food; 3. (18) OJ L 184, 17.7.1999, p. 3. (16) OJ L 350, 14.12.1990, p. 71. (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. 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. Accordingly, Council Decisions 68/361/EEC(10), 69/414/EEC(11), and 70/372/EEC(12), should be repealed. 0000039308 00000 n (25) It is necessary to establish the general principles upon which food and feed may be traded and the objectives and principles for the contribution of the Community to developing international standards and trade agreements. Food law shall aim to achieve the free movement in the Community of food and feed manufactured or marketed according to the general principles and requirements in this Chapter. The Scientific Committee and the Scientific Panels shall each choose a Chair and two Vice-Chairs from among their members. It may be called upon to give opinions on contentious scientific issues, thereby enabling the Community institutions and Member States to take informed risk management decisions necessary to ensure food and feed safety whilst helping avoid the fragmentation of the internal market through the adoption of unjustified or unnecessary obstacles to the free movement of food and feed. 0000122352 00000 n 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. (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. Responsibilities for food: food business operators. The Executive Director shall approve all financial expenditure of the Authority and report on the Authority's activities to the Management Board.Article 27Advisory Forum1. (20) OJ L 224, 18.8.1990, p. 1. A review of Community data collection networks already existing in the fields covered by the Authority is called for. 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. There should therefore be close cooperation between the Authority and the Member States for this purpose. (10) OJ L 255, 18.10.1968, p. Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner. "feed business operator" means the natural or legal persons responsible for ensuring that the requirements of food law are met within the feed business under their control;7. (47) The Authority's role as an independent scientific point of reference means that a scientific opinion may be requested not only by the Commission, but also by the European Parliament and the Member States. /H [ 2247 663 ] 0000003603 00000 n (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. The Commission shall be assisted by a Standing Committee on the Food Chain and Animal Health, hereinafter referred to as the "Committee", composed of representatives of the Member States and chaired by the representative of the Commission. 0000096697 00000 n Directive as last amended by Commission Directive 2001/57/EC (OJ L 208, 1.8.2001, p. The Protocol on the privileges and immunities of the European Communities shall apply to the Authority. 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.Article 60Mediation procedure1. 1. 2. (65) It is important to avoid confusion between the missions of the Authority and the European Agency for the Evaluation of Medicinal Products (EMEA) established by Council Regulation (EEC) No 2309/93(19). 811 71 (51) The establishment of the Authority should enable Member States to become more closely involved in scientific procedures. This shall involve in particular the collection of data relating to: (a) food consumption and the exposure of individuals to risks related to the consumption of food; (b) incidence and prevalence of biological risk; 2. Close cooperation between the Authority, the Commission and the Member States is also necessary to ensure the coherence of the global communication process. The Scientific Committee and the Scientific Panels shall act by a majority of their members. 0000004271 00000 n Regulation as last amended by Regulation (EC, ECSC, Euratom) No 762/2001 (OJ L 111, 20.4.2001, p. 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. 22). Current consolidated version: 26/07/2019, ELI: http://data.europa.eu/eli/reg/2002/178/oj, 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 Council Decision of 21 January 2002. (51) The establishment of the Authority should enable Member States to become more closely involved in scientific procedures. /Type /Catalog 0000095941 00000 n 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 the Authority identifies a potential source of divergence, it shall contact the body in question to ensure that all relevant scientific information is shared and in order to identify potentially contentious scientific issues.3. Conformity of a feed with specific provisions applicable to that feed shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the feed is unsafe.6. 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. (4) There are important differences in relation to concepts, principles and procedures between the food laws of the Member States. 247. 9. 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. The personal liability of its servants towards the Authority shall be governed by the relevant provisions applying to the staff of the Authority. These rules shall be made public. This Regulation shall be binding in its entirety and directly applicable in all Member States. 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. Where the Authority identifies a potential source of divergence, it shall contact the body in question to ensure that all relevant scientific information is shared and in order to identify potentially contentious scientific issues. 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. The Community should have access to high-quality, independent and efficient scientific and technical support. 1. (57) The Authority should be financed by the general budget of the European Union. The Community should have access to high-quality, independent and efficient scientific and technical support. The General Food Law Regulation is the foundation of food and feed law. 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. Food shall not be placed on the market if it is unsafe.2. "retail" means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets; 8. Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied.