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 Authority shall promote the European networking of organisations operating in the fields within the Authority's mission. 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.

The Management Board, acting on a proposal from the Executive Director, shall draw up a list to be made public of competent organisations designated by the Member States which may assist the Authority, either individually or in networks, with its mission. 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. Some of these tasks may be eligible for financial support.

The Commission is empowered to adopt delegated acts in accordance with Article 57a in order to supplement this Regulation by establishing the criteria for the inclusion of an institute on the list of competent organisations designated by the Member States, the arrangements for setting out harmonised quality requirements and the financial rules governing any financial support.

Within one year following the entry into force of this Regulation, the Commission shall publish an inventory of Community systems existing in the fields within the mission of the Authority which make provision for Member States to carry out certain tasks in the field of scientific evaluation, in particular the examination of authorisation dossiers. 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.

The members of the Management Board, the members of the Advisory Forum and the Executive Director shall undertake to act independently in the public interest.

The members of the Scientific Committee and the Scientific Panels shall undertake to act independently of any external influence.

The members of the Management Board, the Executive Director, the members of the Advisory Forum, the members of the Scientific Committee and the Scientific Panels, as well as external experts participating in their working groups shall declare at each meeting any interests which might be considered prejudicial to their independence in relation to the items on the agenda.

The Authority shall carry out its activities with a high level of transparency. It shall in particular make public:

The Management Board shall hold its meetings in public unless, acting on a proposal from the Executive Director, it decides otherwise for specific administrative points of its agenda, and may authorise consumer representatives or other interested parties to observe the proceedings of some of the Authority's activities.

The Authority shall lay down the practical arrangements for implementing the transparency rules referred to in paragraphs 1, 1a and 2 of this Article, taking into account Articles 39 to 39g and 41.

By way of derogation from Article 38, the Authority shall not make public any information for which confidential treatment has been requested under the conditions laid down in this Article.

Upon the request of an applicant, the Authority may grant confidential treatment only with respect to the following items of information where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:

The list of information referred to in paragraph 2 shall be without prejudice to any sectoral Union law.

Notwithstanding paragraphs 2 and 3:

When submitting an application, supporting scientific data and other supplementary information in accordance with Union law, the applicant may request certain parts of the information submitted to be treated as confidential in accordance with Article 39(2) and (3). Such request shall be accompanied by verifiable justification that demonstrates how making public the information concerned significantly harms the interests concerned in accordance with Article 39(2) and (3).

Where an applicant submits a confidentiality request, it shall provide a non-confidential version and a confidential version of the information submitted in accordance with standard data formats, where they exist, pursuant to Article 39f. The non-confidential version shall not include the information the applicant deems confidential on the basis of Article 39(2) and (3) and shall indicate the places where such information has been deleted. The confidential version shall contain all information submitted, including information the applicant deems confidential. Information requested to be treated as confidential in the confidential version shall be clearly marked. The applicant shall clearly indicate the grounds on the basis of which confidentiality is requested for the different pieces of information.

The Authority shall:

Within two weeks of the notification of the Authority's decision on the confidentiality request to the applicant pursuant to paragraph 1, the applicant may submit a confirmatory application asking the Authority to reconsider its decision. The confirmatory application shall have suspensive effect. The Authority shall examine the grounds for the confirmatory application and shall adopt a reasoned decision on that confirmatory application. It shall notify the applicant of that decision within three weeks of submitting the confirmatory application and shall include in that notification information on the available remedies, namely an action before the Court of Justice of the European Union (the ‘Court of Justice’) against the Authority pursuant to paragraph 3. The Authority shall make public any additional data and information for which the confidentiality request has not been accepted by the Authority as justified, at the earliest two weeks after the notification of the Authority's reasoned decision on the confirmatory application to the applicant has taken place pursuant to this paragraph.

Decisions taken by the Authority pursuant to this Article may be subject to an action before the Court of Justice, under the conditions laid down in Articles 263 and 278 of the Treaty on the Functioning of the European Union (TFEU) respectively.

The Authority shall make available, upon request, to the Commission and the Member States all information in its possession relating to an application or to a request by the European Parliament, by the Commission or by the Member States for a scientific output, including a scientific opinion, unless otherwise indicated in Union law.

The Commission and the Member States shall take the necessary measures so that information received by them under Union law for which confidential treatment has been requested is not made public until a decision on the confidentiality request has been taken by the Authority and has become final. The Commission and the Member States shall also take the necessary measures so that information for which confidential treatment has been accepted by the Authority is not made public.

If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of information as granted by the Authority in accordance with Articles 39 to 39e. The application shall be considered withdrawn as of the moment the written request to that effect is received by the competent body that had received the original application. Where the withdrawal of the application takes place before a final decision on the confidentiality request has been adopted by the Authority pursuant to, where appropriate, Article 39b(1) or (2), the Commission, the Member States and the Authority, shall not make public the information for which confidentiality has been requested.

Members of the Management Board, the Executive Director, members of the Scientific Committee and Scientific Panels as well as external experts participating in their working groups, members of the Advisory Forum and members of the staff of the Authority, even after their duties have ceased, shall be subject to the requirements of the obligation of professional secrecy pursuant to Article 339 TFEU.

The Authority shall lay down in consultation with the Commission the practical arrangements for implementing the confidentiality rules laid down in Articles 39, 39a, 39b, 39e and in this Article, including arrangements concerning the submission and treatment of confidentiality requests with respect to information to be made public under Article 38, and taking into account Articles 39f and 39g. As regards Article 39b(2), the Authority shall ensure that appropriate separation of tasks is applied for the assessment of confirmatory applications.

With respect to requests for scientific outputs, including scientific opinions under Union law, the Authority shall always make public:

Notwithstanding paragraph 1, disclosure of names and addresses of natural persons involved in testing on vertebrate animals or in obtaining toxicological information shall be deemed to significantly harm the privacy and the integrity of those natural persons and shall not be made publicly available unless otherwise specified in Regulations (EU) 2016/679 ([^E0009]) and (EU) 2018/1725 ([^E0010]) of the European Parliament and of the Council.

Regulations (EU) 2016/679 and (EU) 2018/1725 shall apply to the processing of personal data carried out pursuant to this Regulation. Any personal data made public pursuant to Article 38 of this Regulation and this Article shall only be used to ensure the transparency of the risk assessment under this Regulation and shall not be further processed in a manner that is incompatible with these purposes, in accordance with point (b) of Article 5(1) of Regulation (EU) 2016/679 and point (b) of Article 4(1) of Regulation (EU) 2018/1725, as the case may be.

For the purposes of point (c) of Article 38(1) and in order to ensure the efficient processing of requests to the Authority for a scientific output, standard data formats shall be adopted in accordance with paragraph 2 of this Article to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union law. Those standard data formats shall:

For the adoption of standard data formats referred to in paragraph 1, the following procedure shall be followed:

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.

The Authority shall ensure that the public and any interested parties are rapidly given objective, reliable and easily accessible information, in particular with regard to the results of its work. In order to achieve these objectives, the Authority shall develop and disseminate information material for the general public.

The Authority shall act in close collaboration with the Commission and the Member States to promote the necessary coherence in the risk communication process.

The Authority shall ensure appropriate cooperation with the competent bodies in the Member States and other interested parties with regard to public information campaigns.

Notwithstanding the rules on confidentiality provided for in Articles 39 to 39d of this Regulation, Regulation (EC) No 1049/2001 of the European Parliament and of the Council ([^E0011]) shall apply to documents held by the Authority.

The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001 and Articles 6 and 7 of Regulation (EC) No 1367/2006 by 27 March 2020, ensuring as wide access as possible to documents in its possession.

Decisions taken by the Authority pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman or of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the EC Treaty respectively.

The revenues of the Authority shall consist of a contribution from the Community and, from any State with which the Community has concluded the agreements referred to in Article 49, and charges for publications, conferences, training and any other similar activities provided by the Authority.

The 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.

The Executive Director shall draw up, in good time before the date referred to in paragraph 5, a draft statement of estimates of the Authority's revenue and expenditure for the following financial year and shall forward it to the Management Board, together with the establishment plan.

Revenue and expenditure shall be in balance.

Each year the Management Board, on the basis of a draft statement of estimates of revenue and expenditure, shall produce a statement of estimates of revenue and expenditure of the Authority for the following financial year. This statement of estimates, which shall include a draft establishment plan together with the provisional work programmes, shall be forwarded by 31 March at the latest by the Management Board to the Commission and to the countries with which the Community has concluded agreements in accordance with Article 49.

The statement of estimates shall be forwarded by the Commission to the European Parliament and the Council (hereinafter referred to as the budgetary authority) together with the preliminary draft general budget of the European Union.

On the basis of the statement of estimates, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.

The budgetary authority shall authorise the appropriations for the subsidy to the Authority.

The budget shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly.

The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of the budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof.

The Executive Director shall implement the Authority's budget.

By 1 March at the latest following each financial year, the Authority's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the general Financial Regulation.

By 31 March at the latest following each financial year, the Commission's accounting officer shall forward the Authority's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded to the European Parliament and the Council.

On receipt of the Court of Auditors' observations on the Authority's provisional accounts under Article 129 of the general Financial Regulation, the Executive Director shall draw up the Authority's final accounts under his own responsibility and submit them to the Management Board for an opinion.

The Management Board shall deliver an opinion on the Authority's final accounts.

The Executive Director shall, by 1 July at the latest following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion.

The final accounts shall be published.

The Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board.

The Executive Director shall submit to the European Parliament, at the latter's request, all information necessary for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of the general Financial Regulation.

The European Parliament, on a recommendation from the Council acting by a qualified majority, shall, before 30 April of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.

The Authority shall have legal personality. In all Member States it shall enjoy the widest powers granted by law to legal persons. In particular, it may acquire and dispose of movable and immovable property and institute legal proceedings.

The Protocol on the privileges and immunities of the European Communities shall apply to the Authority.

The contractual liability of the Authority shall be governed by the law applicable to the contract in question. The Court of Justice of the European Communities shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by the Authority.

In the case of non-contractual liability, the Authority shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or its servants in the performance of their duties. The Court of Justice shall have jurisdiction in any dispute relating to compensation for such damage.

The personal liability of its servants towards the Authority shall be governed by the relevant provisions applying to the staff of the Authority.

The staff of the Authority shall be subject to the rules and regulations applicable to officials and other staff of the European Communities.

In respect of its staff, the Authority shall exercise the powers which have been devolved to the appointing authority.

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.

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.

Without prejudice to other Community legislation, the Member States shall immediately notify the Commission under the rapid alert system of:

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.

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.

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.

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.

Protection of professional secrecy shall not prevent the dissemination to the competent authorities of information relevant to the effectiveness of market surveillance and enforcement activities in the field of food and feed. The authorities receiving information covered by professional secrecy shall ensure its protection in conformity with paragraph 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:

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.

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.

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.

The Member State may maintain its national interim protective measures until the Community measures have been adopted.

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’).

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.

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.

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

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.

The crisis unit may request the assistance of any public or private person whose expertise it deems necessary to manage the crisis effectively.

The crisis unit shall keep the public informed of the risks involved and the measures taken.

The power to adopt delegated acts is conferred upon the Commission subject to the conditions laid down in this Article.

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.

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.

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making ([^E0014]).

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

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.

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 ([^E0015]). The Committee shall be organised in sections to deal with all relevant matters.

Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

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.

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.

The Commission shall ensure the regular review of the application of this Regulation.

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. That evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification.

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.

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.

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.

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.

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.

For the purpose of paragraphs 1 and 2, ‘Community legislation’ shall mean all Community Regulations, Directives and Decisions.

Decisions 68/361/EEC, 69/414/EEC and 70/372/EEC are hereby repealed.