CELEX:02002R0178-20240701: 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

Legal status of the document In force

Date of effect: 01/07/2024

ELI: http://data.europa.eu/eli/reg/2002/178/2024-07-01

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This consolidated text may not include the following amendments:

Amending act Amendment type Subdivision concerned Date of effect
32025R2457 Modified by article 30 01/01/2026
32025R2457 Modified by article 23 point (m) 01/01/2026
32025R2457 Modified by article 27 paragraph 4 point (b) 01/01/2026

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►B 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 031 1.2.2002, p. 1)

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

CHAPTER I – SCOPE AND DEFINITIONS

Article 1 – Aim and scope

  1. 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. 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. 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. This Regulation shall apply to all stages of production, processing and distribution of food and feed. 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 2 – Definition 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.

‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. 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.

‘Food’ shall not include: (a) feed; (b) live animals unless they are prepared for placing on the market for human consumption; (c) plants prior to harvesting; (d) medicinal products within the meaning of Council Directives 65/65/EEC (1) and 92/73/EEC (2); (e) cosmetics within the meaning of Council Directive 76/768/EEC (3); (f) tobacco and tobacco products within the meaning of Council Directive 89/622/EEC (4); (g) narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971; (h) residues and contaminants; (i) medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (5).

Article 3 – Other definitions

For the purposes of this Regulation:

  1. ‘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. ‘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. ‘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. ‘feed’ (or ‘feeding‑stuff’) means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;
  5. ‘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. ‘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. ‘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. ‘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. ‘risk’ means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard;
  10. ‘risk analysis’ means a process consisting of three interconnected components: risk assessment, risk management and risk communication;
  11. ‘risk assessment’ means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation;
  12. ‘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. ‘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. ‘hazard’ means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect;
  15. ‘traceability’ means the ability to trace and follow a food, feed, food‑producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution;
  16. ‘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. ‘primary production’ means the production, rearing or growing of primary products harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products;
  18. ‘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 II – GENERAL FOOD LAW

Article 4 – Scope

  1. 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. 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. 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. 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.

SECTION 1 – GENERAL PRINCIPLES OF FOOD LAW

Article 5 – General objectives

  1. 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.
  2. 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.
  3. 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 6 – Risk analysis

  1. 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. Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner.
  3. 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.
  4. Risk communication shall fulfil the objectives and respect the general principles set out in Articles 8a and 8b.

Article 7 – Precautionary principle

  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. Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. 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.

Article 8 – Protection of consumers' interests

  1. Food law shall aim at the protection of the interests of consumers and shall provide a basis for consumers to make informed choices in relation to the foods they consume. It shall aim at the prevention of: (a) fraudulent or deceptive practices; (b) the adulteration of food; and (c) any other practices which may mislead the consumer.

SECTION 1A – RISK COMMUNICATION

Article 8a – Objectives of risk communication

Taking into account the respective roles of risk assessors and risk managers, risk communication shall pursue the following objectives: (a) raise awareness and understanding of the specific issues under consideration, including in cases of divergences in scientific assessment, during the entire risk analysis process; (b) ensure consistency, transparency and clarity in formulating risk‑management recommendations and decisions; (c) provide a sound basis, including, where appropriate, a scientific basis, for understanding risk‑management decisions; (d) improve the overall effectiveness and efficiency of the risk analysis; (e) foster public understanding of the risk analysis, including of the respective tasks and responsibilities of risk assessors and risk managers to enhance confidence in its outcome; (f) ensure appropriate involvement of consumers, feed and food businesses, the academic community and all other interested parties; (g) ensure appropriate and transparent exchange of information with interested parties in relation to risks associated with the food chain; (h) ensure the provision of information to consumers about risk prevention strategies; and (i) contribute to the fight against the dissemination of false information and the sources thereof.

Article 8b – General principles of risk communication

Taking into account the respective roles of risk assessors and risk managers, risk communication shall: (a) ensure that accurate and all appropriate information is exchanged in an interactive and timely manner with all interested parties, based on the principles of transparency, openness, and responsiveness; (b) provide transparent information at each stage of the risk analysis process from the framing of requests for scientific advice to the provision of risk assessment and the adoption of risk‑management decisions, including information on how risk‑management decisions were reached and which factors were considered; (c) take into account risk perceptions of all interested parties; (d) facilitate understanding and dialogue amongst all interested parties; and (e) be clear and accessible, including to those not directly involved in the process or not having a scientific background, while duly respecting the applicable legal provisions on confidentiality and protection of personal data.

Article 8c – General plan for risk communication

  1. The Commission shall adopt, by means of implementing acts, a general plan for risk communication in order to achieve the objectives set out in Article 8a, in accordance with the general principles set out in Article 8b. The Commission shall keep that general plan updated, taking into account technical and scientific progress and experience gained. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 58(2). When preparing those implementing acts, the Commission shall consult the Authority.
  2. The general plan for risk communication shall promote an integrated risk communication framework to be followed both by the risk assessors and the risk managers in a coherent and systematic manner both at Union and national level. It shall: (a) identify the key factors that need to be taken into account when considering the type and level of risk communication activities needed; (b) identify the different types and levels of risk communication activities, and the appropriate main tools and channels to be used for risk communication purposes, taking into account the needs of relevant target audience groups; (c) establish appropriate mechanisms of coordination and cooperation in order to strengthen coherence of risk communication amongst risk assessors and risk managers; and (d) establish appropriate mechanisms to ensure an open dialogue amongst consumers, food and feed businesses, the academic community and all other interested parties, and their appropriate involvement.

CHAPTER III – EUROPEAN FOOD SAFETY AUTHORITY

SECTION 1 – MISSION AND TASKS

Article 22 – Mission of the Authority

  1. A European Food Safety Authority, hereinafter referred to as the ‘Authority’, is hereby established.
  2. The Authority shall provide scientific advice and scientific and technical support for the Community's legislation and policies in all fields which have a direct or indirect impact on food and feed safety. It shall provide independent information on all matters within these fields and communicate on risks.
  3. 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.
  4. 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.
  5. The mission of the Authority shall also include the provision of: (a) scientific advice and scientific and technical support on human nutrition in relation to Community legislation and, at the request of the Commission, assistance concerning communication on nutritional issues within the framework of the Community health programme; (b) scientific opinions on other matters relating to animal health and welfare and plant health; (c) scientific opinions on products other than food and feed relating to genetically modified organisms as defined by Directive 2001/18/EC and without prejudice to the procedures established therein.
  6. The Authority shall provide scientific opinions which will serve as the scientific basis for the drafting and adoption of Community measures in the fields falling within its mission.
  7. 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.
  8. It shall act in close cooperation with the competent bodies in the Member States that carry out similar tasks to those of the Authority and, where appropriate, with the relevant Union agencies.
  9. The Authority, Commission and Member States shall cooperate to promote the effective coherence between risk assessment, risk management and risk communication functions.
  10. The Member States shall cooperate with the Authority to ensure the accomplishment of its mission.

Article 23 – Tasks of the Authority

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; (k) to ensure that the public and interested parties receive rapid, reliable, objective and comprehensible information in the fields within its mission; (l) to express independently its own conclusions and orientations on matters within its mission; (m) to undertake any other task assigned to it by the Commission within its mission.

CHAPTER IV – RAPID ALERT SYSTEM, CRISIS MANAGEMENT AND EMERGENCIES

SECTION 1 – RAPID ALERT SYSTEM

Article 50 – Rapid alert system

  1. A rapid alert system for the notification of a direct or indirect risk to human health deriving from food or feed is hereby established as a network. It shall involve the Member States, the Commission and the Authority. The Member States, the Commission and the Authority shall each designate a contact point, which shall be a member of the network. The Commission shall be responsible for managing the network.
  2. 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. The Commission shall transmit this information immediately to the members of the network.
  3. 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.
  4. 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. 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.
  5. The Commission shall immediately transmit to members of the network the notification and supplementary information received under the first and second sub‑paragraphs.
  6. 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.
  7. Where a food or feed which has been the subject of a notification under the rapid alert system has been dispatched to a third country, the Commission shall provide the latter with the appropriate information.
  8. The Member States shall immediately inform the Commission of the action implemented or measures taken following receipt of the notifications and supplementary information transmitted under the rapid alert system. The Commission shall immediately transmit this information to the members of the network.
  9. 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. The latter shall be based on reciprocity and shall include confidentiality measures equivalent to those applicable in the Community.

Article 51 – Implementing measures

The measures for implementing Article 50 shall be adopted by the Commission, after discussion with the Authority, in accordance with the procedure referred to in Article 58(2). These measures shall specify, in particular, the specific conditions and procedures applicable to the transmission of notifications and supplementary information.

Article 52 – Confidentiality rules for the rapid alert system

  1. Information, available to the members of the network, relating to a risk to human health posed by food and feed shall in general be available to the public in accordance with the information principle provided for in Article 10. In general, the public shall have access to information on product identification, the nature of the risk and the measure taken.
  2. The members of the network shall take steps to ensure that members of their staff are required not to disclose information obtained for the purposes of this Section which by its nature is covered by professional secrecy in duly justified cases, except for information which must be made public, if circumstances so require, in order to protect human health.

SECTION 2 – EMERGENCIES

Article 53 – Emergency measures for food and feed of Community origin or imported from a third country

  1. 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. However, in emergencies, the Commission may provisionally adopt the measures referred to in paragraph 1 after consulting the Member State(s concerned and informing the other Member States. 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.

Article 54 – Other emergency measures

  1. Where a Member State officially informs the Commission of the need to take emergency measures, and where the Commission has not acted in accordance with Article 53, the Member State may adopt interim protective measures. In this event, it shall immediately inform the other Member States and the Commission.
  2. Within 10 working days, the Commission shall put the matter before the Committee set up in Article 58(1) in accordance with the procedure provided for in Article 58(2) with a view to the extension, amendment or abrogation of the national interim protective measures.
  3. The Member State may maintain its national interim protective measures until the Community measures have been adopted.

SECTION 3 – CRISIS MANAGEMENT

Article 55 – General plan for crisis management

  1. 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. The general plan shall specify the types of situation involving direct or indirect risks to human health deriving from food and feed which are not likely to be prevented, eliminated or reduced to an acceptable level by provisions in place or cannot adequately be managed solely by way of the application of Articles 53 and 54. The general plan shall also specify the practical procedures necessary to manage a crisis, including the principles of transparency to be applied and a communication strategy.

Article 56 – Crisis unit

  1. 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. The Commission shall set up a crisis unit immediately, in which the Authority shall participate, and provide scientific and technical assistance if necessary.

Article 57 – Tasks of the crisis unit

  1. 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. The crisis unit may request the assistance of any public or private person whose expertise it deems necessary to manage the crisis effectively.
  3. The crisis unit shall keep the public informed of the risks involved and the measures taken.

CHAPTER V – PROCEDURES AND FINAL PROVISIONS

Article 57a – Exercise of the delegation

  1. The power to adopt delegated acts is conferred upon the Commission subject to the conditions laid down in this Article.
  2. The power to adopt delegated acts referred to in Article 28(4), Article 29(6) and Article 36(3) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five‑year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
  3. The delegation of power referred to in Article 28(4), Article 29(6) and Article 36(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
  4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Inter‑institutional Agreement of 13 April 2016 on Better Law‑Making (13).
  5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
  6. A delegated act adopted pursuant to Article 28(4), Article 29(6) and Article 36(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 58 – Committee

  1. The Commission shall be assisted by a Standing Committee on Plants, Animals, Food and Feed, hereinafter referred to as the ‘Committee’. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council (14). The Committee shall be organised in sections to deal with all relevant matters.
  2. All references in Union law to the Standing Committee on the Food Chain and Animal Health shall be construed as references to the Committee referred to in the first sub‑paragraph.

Article 59 – Functions assigned to the Committee

The 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. 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 60 – Mediation procedure

  1. Without prejudice to the application of other Community provisions, where a Member State is of the opinion that a measure taken by another Member State in the field of food safety is either incompatible with this Regulation or is likely to affect the functioning of the internal market, it shall refer the matter to the Commission, which will immediately inform the other Member State concerned.
  2. The two Member States concerned and the Commission shall make every effort to solve the problem. If agreement cannot be reached, the Commission may request an opinion on any relevant contentious scientific issue from the Authority. 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.

Article 61 – Review clause

  1. The Commission shall ensure the regular review of the application of this Regulation.
  2. By 28 March 2026, and every five years thereafter, the Commission shall evaluate the Authority's performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines. That evaluation shall also cover the impact of Article 32a on the functioning of the Authority with particular attention to the relevant workload and mobilisation of staff, and to any shifts in the allocation of the Authority's resources that may have taken place, at the expense of activities of public interest. The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification.
  3. In the evaluation referred to in paragraph 2, the Commission shall also evaluate whether the organisational framework of the Authority needs to be further updated with regard to decisions on requests for confidentiality and confirmatory applications, namely by setting up a specific Board of Appeal or by other appropriate means.
  4. Where the Commission considers that the continued operation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.
  5. The Commission shall report to the European Parliament, to the Council and to the Management Board on the findings of its reviews and evaluations under this Article. Those findings shall be made public.

Article 61a – Fact‑finding missions

Commission experts shall perform fact‑finding missions in Member States to assess the application, by laboratories and by other testing facilities, of the relevant standards for carrying out tests and studies submitted to the Authority as part of an application, as well as compliance with the notification obligation set out in Article 32b(3), by 28 March 2025. By that date, Commission experts shall also perform fact‑finding missions to assess the application of those standards by laboratories and other testing facilities located in third countries insofar as set out in relevant agreements and arrangements with those third countries, including as referred to in Article 49. Non‑compliance identified during those fact‑finding missions shall be brought to the attention of the Commission, Member States, the Authority as well as the assessed laboratories and other testing facilities. The Commission, the Authority and Member States shall ensure the appropriate follow‑up to such identified non‑compliance. The outcome of these fact‑finding missions shall be presented in an overview report. On the basis of that report, the Commission shall submit a legislative proposal, if appropriate, as regards, in particular, any necessary control procedures, including audits.

Article 62 – References to the European Food Safety Authority and to the Standing Committee on the Food Chain and Animal Health

  1. Every reference in Community legislation to the Scientific Committee on Food, the Scientific Committee on Animal Nutrition, the Scientific Veterinary Committee, the Scientific Committee on Pesticides, the Scientific Committee on Plants and the Scientific Steering Committee shall be replaced by a reference to the European Food Safety Authority.
  2. Every reference in Community legislation to the Standing Committee on Foodstuffs, the Standing Committee for Feedingstuffs and the Standing Veterinary Committee shall be replaced by a reference to the Standing Committee on the Food Chain and Animal Health.
  3. For the purpose of paragraphs 1 and 2, ‘Community legislation’ shall mean all Community Regulations, Directives and Decisions.
  4. Decisions 68/361/EEC, 69/414/EEC and 70/372/EEC are hereby repealed.

Article 63 – Competence of the European Agency for the Evaluation of Medicinal Products

This Regulation shall be without prejudice to the competence conferred on Agency for the Evaluation of Medicinal Products by Regulation (EEC) No 2309/93, Regulation (EEC) No 2377/90, Council Directive 75/319/EEC (15) and Council Directive 81/851/EEC (16).

Article 64 – Commencement of the Authority's operation

The Authority shall commence its operations on 1 January 2002.

Article 65 – Entry into force

This 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.