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Document 02002R0178-20220701
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
Consolidated text: 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
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
02002R0178 — EN — 01.07.2022 — 010.001
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REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 January 2002 (OJ L 031 1.2.2002, p. 1) |
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REGULATION (EC) No 1642/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 July 2003 |
L 245 |
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29.9.2003 |
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L 100 |
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8.4.2006 |
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L 60 |
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5.3.2008 |
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REGULATION (EC) No 596/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 |
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18.7.2009 |
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REGULATION (EU) No 652/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 |
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27.6.2014 |
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L 35 |
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10.2.2017 |
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REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 |
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5.5.2017 |
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REGULATION (EU) 2019/1243 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 198 |
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25.7.2019 |
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REGULATION (EU) 2019/1381 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 231 |
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6.9.2019 |
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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
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
Aim and scope
It establishes the European Food Safety Authority.
It lays down procedures for matters with a direct or indirect impact on food and feed safety.
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:
feed;
live animals unless they are prepared for placing on the market for human consumption;
plants prior to harvesting;
cosmetics within the meaning of Council Directive 76/768/EEC ( 3 );
tobacco and tobacco products within the meaning of Council Directive 89/622/EEC ( 4 );
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;
residues and contaminants;
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:
‘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;
‘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;
‘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;
‘feed’ (or ‘feedingstuff’) means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;
‘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;
‘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;
‘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;
‘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;
‘risk’ means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard;
‘risk analysis’ means a process consisting of three interconnected components: risk assessment, risk management and risk communication;
‘risk assessment’ means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation;
‘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;
‘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;
‘hazard’ means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect;
‘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;
‘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;
‘primary production’ means the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products;
‘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
SECTION 1
GENERAL PRINCIPLES OF FOOD LAW
Article 5
General objectives
Article 6
Risk analysis
Article 7
Precautionary principle
Article 8
Protection of consumers' interests
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:
fraudulent or deceptive practices;
the adulteration of food; and
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:
raise awareness and understanding of the specific issues under consideration, including in cases of divergences in scientific assessment, during the entire risk analysis process;
ensure consistency, transparency and clarity in formulating risk management recommendations and decisions;
provide a sound basis, including, where appropriate, a scientific basis, for understanding risk management decisions;
improve the overall effectiveness and efficiency of the risk analysis;
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;
ensure appropriate involvement of consumers, feed and food businesses, the academic community and all other interested parties;
ensure appropriate and transparent exchange of information with interested parties in relation to risks associated with the food chain;
ensure the provision of information to consumers about risk prevention strategies; and
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:
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;
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;
take into account risk perceptions of all interested parties;
facilitate understanding and dialogue amongst all interested parties; and
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
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:
identify the key factors that need to be taken into account when considering the type and level of risk communication activities needed;
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;
establish appropriate mechanisms of coordination and cooperation in order to strengthen coherence of risk communication amongst risk assessors and risk managers; and
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.
SECTION 2
PRINCIPLES OF TRANSPARENCY
Article 9
Public consultation
There shall be open and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it.
Article 10
Public information
Without prejudice to the applicable provisions of Community and national law on access to documents, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, then, depending on the nature, seriousness and extent of that risk, public authorities shall take appropriate steps to inform the general public of the nature of the risk to health, identifying to the fullest extent possible the food or feed, or type of food or feed, the risk that it may present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk.
SECTION 3
GENERAL OBLIGATIONS OF FOOD TRADE
Article 11
Food and feed imported into the Community
Food and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognised by the Community to be at least equivalent thereto or, where a specific agreement exists between the Community and the exporting country, with requirements contained therein.
Article 12
Food and feed exported from the Community
In other circumstances, except in the case where foods are injurious to health or feeds are unsafe, food and feed can only be exported or re-exported if the competent authorities of the country of destination have expressly agreed, after having been fully informed of the reasons for which and the circumstances in which the food or feed concerned could not be placed on the market in the Community.
Article 13
International standards
Without prejudice to their rights and obligations, the Community and the Member States shall:
contribute to the development of international technical standards for food and feed and sanitary and phytosanitary standards;
promote the coordination of work on food and feed standards undertaken by international governmental and non-governmental organisations;
contribute, where relevant and appropriate, to the development of agreements on recognition of the equivalence of specific food and feed-related measures;
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;
promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Community is not reduced.
SECTION 4
GENERAL REQUIREMENTS OF FOOD LAW
Article 14
Food safety requirements
Food shall be deemed to be unsafe if it is considered to be:
injurious to health;
unfit for human consumption.
In determining whether any food is unsafe, regard shall be had:
to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and
to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.
In determining whether any food is injurious to health, regard shall be had:
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;
to the probable cumulative toxic effects;
to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.
Article 15
Feed safety requirements
Feed shall be deemed to be unsafe for its intended use if it is considered to:
Article 16
Presentation
Without prejudice to more specific provisions of food law, the labelling, advertising and presentation of food or feed, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, shall not mislead consumers.
Article 17
Responsibilities
For that purpose, they shall maintain a system of official controls and other activities as appropriate to the circumstances, including public communication on food and feed safety and risk, food and feed safety surveillance and other monitoring activities covering all stages of production, processing and distribution.
Member States shall also lay down the rules on measures and penalties applicable to infringements of food and feed law. The measures and penalties provided for shall be effective, proportionate and dissuasive.
Article 18
Traceability
To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand.
Article 19
Responsibilities for food: food business operators
Article 20
Responsibilities for feed: feed business operators
Article 21
Liability
The provisions of this Chapter shall be without prejudice to Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products ( 6 ).
CHAPTER III
EUROPEAN FOOD SAFETY AUTHORITY
SECTION 1
MISSION AND TASKS
Article 22
Mission of the Authority
The mission of the Authority shall also include the provision of:
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;
scientific opinions on other matters relating to animal health and welfare and plant health;
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.
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.
Article 23
Tasks of the Authority
The tasks of the Authority shall be the following:
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;
to promote and coordinate the development of uniform risk assessment methodologies in the fields falling within its mission;
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;
to commission scientific studies necessary for the accomplishment of its mission;
to search for, collect, collate, analyse and summarise scientific and technical data in the fields within its mission;
to undertake action to identify and characterise emerging risks, in the fields within its mission;
to establish a system of networks of organisations operating in the fields within its mission and be responsible for their operation;
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;
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;
to ensure that the public and interested parties receive rapid, reliable, objective and comprehensible information in the fields within its mission;
to express independently its own conclusions and orientations on matters within its mission;
to undertake any other task assigned to it by the Commission within its mission.
SECTION 2
ORGANISATION
Article 24
Bodies of the Authority
The Authority shall comprise:
a Management Board;
an Executive Director and his staff;
an Advisory Forum;
a Scientific Committee and Scientific Panels.
Article 25
Management Board
In addition to members and alternate members referred to in paragraph 1, the Management Board shall include:
two members and two alternate members appointed by the Commission as its representatives, with the right to vote;
two members appointed by the European Parliament, with the right to vote;
four members and four alternate members with the right to vote as representatives of civil society and food chain interests, namely one member and one alternate member from consumer organisations, one member and one alternate member from environmental non-governmental organisations, one member and one alternate member from farmers organisations, and one member and one alternate member from industry organisations.
The members and alternate members referred to in point (c) of the first subparagraph shall be appointed by the Council in consultation with the European Parliament on the basis of a list which shall be drawn up by the Commission and sent to the Council. The list shall include more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament by the Council, together with the relevant background documents. As quickly as possible and at the latest within three months of the receipt of that list, the European Parliament may submit its views for consideration to the Council which shall then appoint those members.
Unless otherwise provided, the Management Board shall act by a majority of its members. Alternate members shall represent the members in their absence and vote on their behalf.
Before 30 March each year, the Management Board shall adopt the general report on the Authority's activities for the previous year.
Article 26
Executive Director
The Executive Director shall be the legal representative of the Authority and shall be responsible for:
the day-to-day administration of the Authority;
drawing up a proposal for the Authority's work programmes in consultation with the Commission;
implementing the work programmes and the decisions adopted by the Management Board;
ensuring the provision of appropriate scientific, technical and administrative support for the Scientific Committee and the Scientific Panels;
ensuring that the Authority carries out its tasks in accordance with the requirements of its users, in particular with regard to the adequacy of the services provided and the time taken;
the preparation of the Authority's draft statement of estimates of revenue and expenditure, and the execution of its budget;
all staff matters;
developing and maintaining contact with the European Parliament, and for ensuring a regular dialogue with its relevant committees.
Each year, the Executive Director shall submit to the Management Board for approval:
a draft general report covering all the activities of the Authority in the previous year;
draft programmes of work.
The Executive Director shall, following adoption by the Management Board, forward the programmes of work to the European Parliament, the Council, the Commission and the Member States, and shall have them published.
The Executive Director shall, following adoption by the Management Board and by 15 June, forward the Authority's general report to the European Parliament, the Council, the Commission, the Court of Auditors, the European Economic and Social Committee and the Committee of the Regions, and shall have it published.
The Executive Director shall forward annually to the budgetary authority all information relevant to the outcome of the evaluation procedures.
▼M1 —————
Article 27
Advisory Forum
The Advisory Forum shall constitute a mechanism for an exchange of information on potential risks and the pooling of knowledge. It shall ensure close cooperation between the Authority and the competent bodies in the Member States in particular on the following items:
avoidance of duplication of the Authority's scientific studies with Member States, in accordance with Article 32;
in those circumstances identified in Article 30(4), where the Authority and a national body are obliged to cooperate;
in the promoting of the European networking of organisations operating within the fields of the Authority's mission, in accordance with Article 36(1);
where the Authority or a Member State identifies an emerging risk.
Where the Advisory Forum discusses the matters referred to in Article 22(5)(b), representatives from competent bodies in the Member States which undertake tasks similar to those referred to in Article 22(5)(b) may participate in the work of the Advisory Forum, on the basis of one representative designated by each Member State.
Article 28
Scientific Committee and 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. In such cases, it shall draw on the expertise of those working groups when establishing scientific opinions.
The Scientific Panels shall be composed of independent scientific experts. When the Authority is established, the following Scientific Panels shall be set up:
the Panel on food additives and flavourings;
the Panel on additives and products or substances used in animal feed;
the Panel on plant protection products and their residues;
the Panel on genetically modified organisms;
the Panel on nutrition, novel foods and food allergens;
the Panel on biological hazards;
the Panel on contaminants in the food chain;
the Panel on animal health and welfare;
the Panel on plant health;
the Panel on food contact materials and enzymes and processing aids.
The Commission is empowered to adopt delegated acts in accordance with Article 57a amending the first subparagraph as regards the number and names of the Scientific Panels, in the light of technical and scientific development, at the Authority’s request.
The Member States shall:
publish the call for expression of interest on the websites of their competent authorities and of their competent bodies which undertake tasks similar to those of the Authority;
inform relevant scientific organisations located on their territory;
encourage potential candidates to apply; and
take any other appropriate measures to support the call for expression of interest.
The members of the Scientific Committee who are not members of Scientific Panels and the members of the Scientific Panels shall be selected and appointed in accordance with the following procedure:
on the basis of the applications received to a call for expression of interest, the Executive Director shall draw up a draft list of suitable candidates including at least twice the number of candidates necessary to fill the posts in the Scientific Committee and the Scientific Panels and send the draft list to the Management Board, indicating the specific multidisciplinary expertise needed in each Scientific Panel;
on the basis of that draft list, the Management Board shall appoint the members of the Scientific Committee who are not members of the Scientific Panels and the members of the Scientific Panels and draw up the reserve list of candidates for the scientific Committee and the Scientific Panels;
the selection procedure and the appointments of the members of the Scientific Committee who are not members of the Scientific Panels and the members of the Scientific Panels shall be made on the basis of the following criteria:
a high level of scientific expertise;
independence and absence of conflict of interests in accordance with Article 37(2) and the Authority's independence policy and implementation of that policy in respect of the members of the Scientific Panels;
meeting the needs for the specific multi-disciplinary expertise of the Scientific Panel to which they will be appointed and the applicable language regime;
where candidates have equivalent scientific expertise, the Management Board shall ensure that the broadest possible geographical distribution is achieved in the appointments.
These procedures shall relate in particular to:
the number of times that a member can serve consecutively on a Scientific Committee or Scientific Panel;
the number of members in each Scientific Panel but no more than the maximum number provided for in paragraph 5f;
the procedure for reimbursing the expenses of members of the Scientific Committee and the Scientific Panels;
the manner in which tasks and requests for scientific opinions are assigned to the Scientific Committee and the Scientific Panels;
the creation and organisation of the working groups of the Scientific Committee and the Scientific Panels, and the possibility of external experts being included in those working groups;
the possibility of observers being invited to meetings of the Scientific Committee and the Scientific Panels;
the possibility of organising public hearings.
SECTION 3
OPERATION
Article 29
Scientific opinions
The Authority shall issue a scientific opinion:
at the request of the Commission, in respect of any matter within its mission, and in all cases where Community legislation makes provision for the Authority to be consulted;
on its own initiative, on matters falling within its mission.
The European Parliament or a Member State may request the Authority to issue a scientific opinion on matters falling within its mission.
In order to apply this Article, the Commission after consulting the Authority shall adopt:
delegated acts in accordance with Article 57a in order to supplement this Regulation by establishing the procedure to be applied by the Authority to the requests for a scientific opinion;
implementing acts laying down the guidelines governing the scientific evaluation of substances, products or processes which are subject, under Union legislation, to a system of prior authorisation or entry on a positive list, in particular where Union legislation makes provision for, or authorises, a dossier to be presented for this purpose by the applicant. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 58(2).
Article 30
Diverging scientific opinions
Article 31
Scientific and technical assistance
Article 32
Scientific studies
Article 32a
Pre-submission advice
Article 32b
Notification of studies
This paragraph shall also apply, mutatis mutandis, to 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.
Where studies have not been previously notified in accordance with paragraph 2 or 3, and where a valid justification has not been provided, an application or notification may be re-submitted, provided that the applicant or notifier notifies to the Authority those studies, in particular their title and their scope, the laboratory or testing facility carrying them out as well as their starting and planned completion dates.
The assessment of the validity or the admissibility of such re-submitted application or notification shall commence six months after the notification of the studies pursuant to the second subparagraph.
Where the studies which have previously been notified in accordance with paragraph 2 or 3 were not included in the application or notification, and where a valid justification has not been provided, an application or notification may be resubmitted, provided that the applicant or notifier submits all the studies that were notified in accordance with paragraph 2 or 3.
The assessment of the validity or admissibility of such re-submitted application or notification shall commence six months after the submission of the studies pursuant to the second subparagraph.
Article 32c
Consultation of third parties
Article 32d
Verification studies
Without prejudice to the obligation on applicants to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances of serious controversies or conflicting results, may request the Authority to commission scientific studies with the objective of verifying evidence used in its risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.
Article 33
Collection of data
The Authority shall search for, collect, collate, analyse and summarise relevant scientific and technical data in the fields within its mission. This shall involve in particular the collection of data relating to:
food consumption and the exposure of individuals to risks related to the consumption of food;
incidence and prevalence of biological risk;
contaminants in food and feed;
residues.
The report, which shall be accompanied, where appropriate, by proposals, shall indicate in particular:
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;
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.
Article 34
Identification of emerging risks
Article 35
Rapid alert system
To enable it to perform its task of monitoring the health and nutritional risks of foods as effectively as possible, the Authority shall be the recipient of any messages forwarded via the rapid alert system. It shall analyse the content of such messages with a view to providing the Commission and the Member States with any information required for the purposes of risk analysis.
Article 36
Networking of organisations operating in the fields within the Authority's mission
Other implementing rules for the application of paragraphs 1 and 2 shall be laid down by the Commission, after consulting the Authority, in accordance with the regulatory procedure referred to in Article 58(2).
SECTION 4
INDEPENDENCE, TRANSPARENCY, CONFIDENTIALITY AND COMMUNICATION
Article 37
Independence
For this purpose, they shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be considered prejudicial to their independence. Those declarations shall be made annually in writing.
For this purpose, they shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be considered prejudicial to their independence. Those declarations shall be made annually in writing.
Article 38
Transparency
The Authority shall carry out its activities with a high level of transparency. It shall in particular make public:
agendas, participant lists and minutes of the Management Board, the Advisory Forum, the Scientific Committee and the Scientific Panels and their working groups;
all its scientific outputs, including the opinions of the Scientific Committee and the Scientific Panels after adoption, minority opinions and results of consultations performed during the risk assessment process always being included;
scientific data, studies and other information supporting applications, including supplementary information supplied by applicants, as well as other scientific data and information supporting requests from the European Parliament, the Commission and the Member States for a scientific output, including a scientific opinion, taking into account the protection of confidential information and the protection of personal data in accordance with Articles 39 to 39e;
the information on which its scientific outputs, including scientific opinions are based, taking into account the protection of confidential information and the protection of personal data in accordance with Articles 39 to 39e;
the annual declarations of interest made by the members of the Management Board, the Executive Director and the members of the Advisory Forum, the Scientific Committee and the Scientific Panels, as well as the members of the working groups, and the declarations of interest made in relation to items on the agendas of meetings;
its scientific studies in accordance with Articles 32 and 32d;
the annual report of its activities;
requests from the European Parliament, from the Commission or from a Member State for scientific opinions which have been refused or modified and the justifications for the refusal or modification;
a summary of the advice provided to potential applicants at pre-submission phase pursuant to Articles 32a and 32c.
Information referred to in the first subparagraph shall be made public without delay, with the exception of the information referred to in point (c) thereof, as far as applications are concerned, and in point (i) thereof, which shall be made public without delay once an application has been considered valid or admissible.
The information referred to in the second subparagraph shall be made public in a dedicated section of the Authority's website. That dedicated section shall be publicly available and easily accessible. That information shall be available to be downloaded, printed and searched through in an electronic format.
The disclosure of the information referred to in points (c), (d) and (i) of the first subparagraph of paragraph 1 to the public shall be without prejudice to:
any existing rules concerning intellectual property rights which set out limitations on certain uses of the disclosed documents or their content; and
any provisions set out in Union law protecting the investment made by innovators in gathering the information and data supporting relevant applications for authorisations (‘data exclusivity rules’).
The disclosure to the public of the information referred to in point (c) of the first subparagraph of paragraph 1 shall not be considered to be explicit or implicit permission or licence for the relevant data and information and their content to be used, reproduced, or otherwise exploited in breach of any intellectual property right or data exclusivity rules, and the Union shall not be responsible for its use by third parties. The Authority shall ensure that clear undertakings or signed statements are given to that effect by those who access the relevant information prior to its disclosure.
Article 39
Confidentiality
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 manufacturing or production process, including the method and innovative aspects thereof, as well as other technical and industrial specifications inherent to that process or method, except for information which is relevant to the assessment of safety;
commercial links between a producer or importer and the applicant or the authorisation holder, where applicable;
commercial information revealing sourcing, market shares or business strategy of the applicant; and
quantitative composition of the subject matter of the request, except for information which is relevant to the assessment of safety.
Notwithstanding paragraphs 2 and 3:
where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to in paragraphs 2 and 3;
information which forms part of conclusions of scientific outputs, including scientific opinions, delivered by the Authority and which relate to foreseeable effects on human health, animal health or the environment, shall nevertheless be made public.
Article 39a
Confidentiality request
Article 39b
Decision on confidentiality
The Authority shall:
make public the non-confidential version of the application as submitted by the applicant without delay once that application has been considered valid or admissible;
proceed, without delay, to a concrete and individual examination of the confidentiality request in accordance with this Article;
inform the applicant in writing of its intention to disclose information and the reasons for that, before the Authority formally takes a decision on the confidentiality request. If the applicant disagrees with the assessment of the Authority, the applicant may state its views or withdraw its application within two weeks of the date on which it was notified of the Authority's position;
adopt a reasoned decision on the confidentiality request, taking into account the observations of the applicant, within 10 weeks of the date of receipt of the confidentiality request with respect to applications and without delay in the case of supplementary data and information; notify the applicant of its decision and provide information on the right to submit a confirmatory application in accordance with paragraph 2; and inform the Commission and the Member States, where appropriate, of its decision; and
make public any additional data and information for which the confidentiality request has not been accepted as justified at the earliest two weeks after the notification of its decision to the applicant has taken place pursuant to point (d).
Article 39c
Review of confidentiality
Before the Authority issues its scientific outputs, including scientific opinions, it shall review whether information that has been previously accepted as confidential may nevertheless be made public in accordance with point (b) of Article 39(4). Should that be the case, the Authority shall follow the procedure laid down in Article 39b, which shall apply mutatis mutandis.
Article 39d
Obligations with regard to confidentiality
Article 39e
Protection of personal data
With respect to requests for scientific outputs, including scientific opinions under Union law, the Authority shall always make public:
the name and address of the applicant;
the names of authors of published or publicly available studies supporting such requests; and
the names of all participants and observers in meetings of the Scientific Committee and the Scientific Panels, their working groups and any other ad hoc group meeting on the subject matter.
Article 39f
Standard data formats
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:
not be based on proprietary standards;
ensure interoperability with existing data submission approaches to the extent possible;
be user-friendly and adapted for the use by small and medium-sized enterprises.
For the adoption of standard data formats referred to in paragraph 1, the following procedure shall be followed:
the Authority shall draw up draft standard data formats for the purposes of the different authorisation procedures and relevant requests for a scientific output by the European Parliament, by the Commission and by the Member States;
the Commission shall, taking into account the applicable requirements in the different authorisation procedures and other legal frameworks and following any necessary adaptations, adopt, by means of implementing acts, standard data formats. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 58(2);
the Authority shall make the standard data formats, as adopted, available on its website;
where standard data formats have been adopted pursuant to this Article, applications as well as requests for a scientific output, including a scientific opinion by the European Parliament, by the Commission and by the Member States, shall only be submitted in accordance with those standard data formats.
Article 39g
Information systems
The information systems operated by the Authority to store its data, including confidential and personal data shall be designed in a way that guarantees that any access to it is fully auditable and that the highest standards of security appropriate to the security risks at stake are attained, taking into account Articles 39 to 39f.
Article 40
Communications from the Authority
The Authority shall make public all scientific outputs including the scientific opinions issued by it and supporting scientific data and other information in accordance with Articles 38 to 39e.
Article 41
Access to documents
Where environmental information is concerned, Regulation (EC) No 1367/2006 of the European Parliament and of the Council ( 11 ) shall also apply. Directive 2003/4/EC of the European Parliament and of the Council ( 12 ) shall apply to environmental information held by Member States, notwithstanding the rules on confidentiality provided for in Articles 39 to 39d of this Regulation.
Article 42
Consumers, producers and other interested parties
The Authority shall develop effective contacts with consumer representatives, producer representatives, processors and any other interested parties.
SECTION 5
FINANCIAL PROVISIONS
Article 43
Adoption of the Authority's budget
The budgetary authority shall adopt the establishment plan for the Authority.
Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.
Article 44
Implementation of the Authority's budget
Article 45
Fees received by the Authority
Within 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 6
GENERAL PROVISIONS
Article 46
Legal personality and privileges
Article 47
Liability
Article 48
Staff
Article 49
Participation of third countries
The Authority shall be open to the participation of countries which have concluded agreements with the European Community by virtue of which they have adopted and apply Community legislation in the field covered by this Regulation.
Arrangements shall be made under the relevant provisions of those agreements, specifying in particular the nature, extent and manner in which these countries will participate in the Authority's work, including provisions relating to participation in the networks operated by the Authority, inclusion in the list of competent organisations to which certain tasks may be entrusted by the Authority, financial contributions and staff.
CHAPTER IV
RAPID ALERT SYSTEM, CRISIS MANAGEMENT AND EMERGENCIES
SECTION 1
RAPID ALERT SYSTEM
Article 50
Rapid alert system
The Authority may supplement the notification with any scientific or technical information, which will facilitate rapid, appropriate risk management action by the Member States.
Without prejudice to other Community legislation, the Member States shall immediately notify the Commission under the rapid alert system of:
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;
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;
any rejection, related to a direct or indirect risk to human health, of a batch, container or cargo of food or feed by a competent authority at a border post within the European Union.
The notification shall be accompanied by a detailed explanation of the reasons for the action taken by the competent authorities of the Member State in which the notification was issued. 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.
The Commission shall immediately transmit to members of the network the notification and supplementary information received under the first and second subparagraphs.
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.
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
However, 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
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:
in the case of food or feed of Community origin:
suspension of the placing on the market or use of the food in question;
suspension of the placing on the market or use of the feed in question;
laying down special conditions for the food or feed in question;
any other appropriate interim measure;
in the case of food or feed imported from a third country:
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;
laying down special conditions for the food or feed in question from all or part of the third country concerned;
any other appropriate interim measure.
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
SECTION 3
CRISIS MANAGEMENT
Article 55
General plan for crisis management
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
Article 57
Tasks of the crisis unit
CHAPTER V
PROCEDURES AND FINAL PROVISIONS
SECTION 1
EXERCISE OF THE DELEGATION, COMMITTEE AND MEDIATION PROCEDURES
Article 57a
Exercise of the delegation
Article 58
Committee
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 subparagraph.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
▼M8 —————
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
SECTION 2
FINAL PROVISIONS
Article 61
Review clause
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
Every reference to the Standing Committee on Plant Health in Community legislation based upon and including Directives 76/895/EEC, 86/362/EEC, 86/363/EEC, 90/642/EEC and 91/414/EEC relating to plant protection products and the setting of maximum residue levels shall be replaced by a reference to the Standing Committee on the Food Chain and Animal Health.
Article 63
Competence of the European Agency for the Evaluation of Medicinal Products
This Regulation shall be without prejudice to the competence conferred on the European Agency for the Evaluation of Medicinal Products by Regulation (EEC) No 2309/93, Regulation (EEC) No 2377/90, Council Directive 75/319/EEC ( 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.
( 1 ) OJ 22, 9.2.1965, p. 369. Directive as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
( 2 ) OJ L 297, 13.10.1992, p. 8.
( 3 ) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2000/41/EC (OJ L 145, 20.6.2000, p. 25).
( 4 ) OJ L 359, 8.12.1989, p. 1. Directive as last amended by Directive 92/41/EEC) (OJ L 158, 11.6.1992, p. 30).
( 5 ) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
( 6 ) OJ L 210, 7.8.1985, p. 29. Directive as last amended by Directive 1999/34/EC of the European Parliament and of the Council (OJ L 141, 4.6.1999, p. 20).
( 7 ) OJ L 357, 31.12.2002, p. 72; corrigendum in OJ L 2, 7.1.2003, p. 39.
( 8 ) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
( 9 ) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
( 10 ) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
( 11 ) Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13).
( 12 ) Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26).
( 13 ) OJ L 123, 12.5.2016, p. 1.
( 14 ) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
( 15 ) OJ L 147, 9.6.1975, p. 13. Directive amended by Directive 2001/83/EC of the European Parliament and of the Council (OJ L 311, 28.11.2001, p. 67).
( 16 ) OJ L 317, 6.11.1981, p. 1. Directive amended by Directive 2001/82/EC of the European Parliament and of the Council (OJ L 311, 28.11.2001, p. 1).