2002R0178 — EN — 01.10.2003 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL
of28January2002
layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishingtheEuropeanFood
SafetyAuthorityandlayingdownproceduresinmattersoffoodsafety
(OJ L 31, 1.2.2002, p. 1)
Amended by:
Official Journal
No page date
►M1Regulation (EC) No 1642/2003 of the European Parliament and of the
Council of 22 July 2003L 245 4 29.9.2003
▼B
REGULATION(EC)No178/2002OFTHEEUROPEANPARLIA-
MENTANDOFTHECOUNCIL
of28January2002
laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying down
proceduresinmattersoffoodsafety
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Articles 37, 95, 133 and Article 152(4)(b) thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Having regard to the opinion of the Committee of the Regions (3),
Acting in accordance withth e procedure laid down in Article 251 of
the Treaty (4),
Whereas:
(1)The free movement of safe and wholesome food is an essential
aspect of the internal market and contributes significantly to thehealth and well-being of citizens, and to their social andeconomic interests.
(2)A high level of protection of human life and health should beassured in the pursuit of Community policies.
(3)The free movement of food and feed within the Community canbe achieved only if food and feed safety requirements do notdiffer significantly from Member State to Member State.
(4)There are important differences in relation to concepts, princi-ples and procedures between the food laws of the MemberStates. When Member States adopt measures governing food,these differences may impede the free movement of food, create
unequal conditions of competition, and may thereby directly
affect the functioning of the internal market.
(5)Accordingly, it is necessary to approximate these concepts, prin-
ciples and procedures so as to form a common basis for
measures governing food and feed taken in the Member Statesand at Community level. It is however necessary to provide forsufficient time for the adaptation of any conflicting provisions inexisting legislation, bothat national and Community level, and
to provide that, pending such adaptation, the relevant legislation
be applied in the light of the principles set out in the presentRegulation.
(6)Water is ingested directly or indirectly like other foods, therebycontributing to the overall exposure of a consumer to ingestedsubstances, including chemical and microbiological contami-nants. However, as the quality of water intended for humanconsumption is already controlled by Council Directives 80/778/EEC (
5) and 98/83/EC (6), it suffices to consider water after2002R0178 — EN — 01.10.2003 — 001.001 — 2
(1) OJ C 96 E, 27.3.2001, p. 247.
(2) OJ C 155, 29.5.2001, p. 32.
(3) Opinion delivered on 14 June 2001 (not yet published in the Official
Journal).
(4) Opinion of the European Parliament of 12 June 2001 (not yet published in
the Official Journal), Council Common Position of 17 September 2001 (notyet published in the Official Journal) and Decision of the European Parlia-
ment of 11 December 2001 (not yet published in the Official Journal).
Council Decision of 21 January 2002.
(
5) OJ L 229, 30.8.1980, p. 11. Directive repealed by Directive 98/83/EC.
(6) OJ L 330, 5.12.1998, p. 32.
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the point of compliance referred to in Article 6 of Directive 98/
83/EC.
(7)Within the context of food law it is appropriate to includerequirements for feed, including its production and use wherethat feed is intended for food-producing animals. This is without
prejudice to the similar requirements which have been applied so
far and which will be applied in the future in feed legislationapplicable to all animals, including pets.
(8)The Community has chosen a high level of health protection asappropriate in the development of food law, which it applies in anon-discriminatory manner whether food or feed is traded on theinternal market or internationally.
(9)It is necessary to ensure that consumers, other stakeholders andtrading partners have confidence in the decision-makingprocesses underpinning food law, its scientific basis and thestructures and independence of the institutions protecting healthand other interests.
(10)Experience has shown that it is necessary to adopt measuresaimed at guaranteeing that unsafe food is not placed on themarket and at ensuring that systems exist to identify and respond
to food safety problems in order to ensure the proper functioning
of the internal market and to protect human health. Similarissues relating to feed safety should be addressed.
(11)In order to take a sufficiently comprehensive and integratedapproach to food safety, there should be a broad definition offood law covering a wide range of provisions witha direct orindirect effect on the safety of food and feed, including provi-sions on materials and articles in contact withfood, animal feed
and other agricultural inputs at the level of primary production.
(12)In order to ensure the safety of food, it is necessary to consider
all aspects of the food production chain as a continuum from and
including primary production and the production of animal feed
up to and including sale or supply of food to the consumerbecause eachelement may h ave a potential impact on foodsafety.
(13)Experience has shown that for this reason it is necessary toconsider the production, manufacture, transport and distributionof feed given to food-producing animals, including the produc-tion of animals which may be used as feed on fish farms, since
the inadvertent or deliberate contamination of feed, and adultera-
tion or fraudulent or other bad practices in relation to it, maygive rise to a direct or indirect impact on food safety.
(14)For the same reason, it is necessary to consider other practicesand agricultural inputs at the level of primary production andtheir potential effect on the overall safety of food.
(15)Networking of laboratories of excellence, at regional and/orinterregional level, withth e aim of ensuring continuous moni-toring of food safety, could play an important role in theprevention of potential health risks for citizens.
(16)Measures adopted by the Member States and the Communitygoverning food and feed should generally be based on riskanalysis except where this is not appropriate to the circum-stances or the nature of the measure. Recourse to a risk analysis
prior to the adoption of such measures should facilitate the
avoidance of unjustified barriers to the free movement of food-stuffs.
(17)Where food law is aimed at the reduction, elimination or avoid-ance of a risk to health, the three interconnected components ofrisk analysis — risk assessment, risk management, and riskcommunication — provide a systematic methodology for thedetermination of effective, proportionate and targeted measuresor other actions to protect health.2002R0178 — EN — 01.10.2003 — 001.001 — 3
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(18)In order for there to be confidence in the scientific basis for food
law, risk assessments should be undertaken in an independent,
objective and transparent manner, on the basis of the availablescientific information and data.
(19)It is recognised that scientific risk assessment alone cannot, insome cases, provide all the information on which a risk manage-
ment decision should be based, and that other factors relevant to
the matter under consideration should legitimately be taken intoaccount including societal, economic, traditional, ethical andenvironmental factors and the feasibility of controls.
(20)The precautionary principle has been invoked to ensure healthprotection in the Community, thereby giving rise to barriers tothe free movement of food or feed. Therefore it is necessary toadopt a uniform basis throughout the Community for the use ofthis principle.
(21)In those specific circumstances where a risk to life or healthexists but scientific uncertainty persists, the precautionary prin-ciple provides a mechanism for determining risk managementmeasures or other actions in order to ensure the high level ofhealth protection chosen in the Community.
(22)Food safety and the protection of consumer's interests is ofincreasing concern to the general public, non-governmental orga-nisations, professional associations, international trading partnersand trade organisations. It is necessary to ensure that consumerconfidence and the confidence of trading partners is secured
through the open and transparent development of food law and
through public authorities taking the appropriate steps to informthe public where there are reasonable grounds to suspect that afood may present a risk to health.
(23)The safety and confidence of consumers within the Community,
and in third countries, are of paramount importance. The
Community is a major global trader in food and feed and, inthis context, it has entered into international trade agreements,it contributes to the development of international standardswhich underpin food law, and it supports the principles of free
trade in safe feed and safe, wholesome food in a non-discrimina-
tory manner, following fair and ethical trading practices.
(24)It is necessary to ensure that food and feed exported or re-exported from the Community complies with Community lawor the requirements set up by the importing country. In other
circumstances, food and feed can only be exported or re-
exported if the importing country has expressly agreed.However, it is necessary to ensure that even where there isagreement of the importing country, food injurious to health orunsafe feed is not exported or re-exported.
(25)It is necessary to establish the general principles upon whichfood and feed may be traded and the objectives and principlesfor the contribution of the Community to developing interna-tional standards and trade agreements.
(26)Some Member States have adopted horizontal legislation on foodsafety imposing, in particular, a general obligation on economicoperators to market only food that is safe. However, theseMember States apply different basic criteria for establishingwhether a food is safe. Given these different approaches, and inthe absence of horizontal legislation in other Member States,
barriers to trade in foods are liable to arise. Similarly such
barriers may arise to trade in feed.
(27)It is therefore necessary to establish general requirements foronly safe food and feed to be placed on the market, to ensure
that the internal market in such products functions effectively.
(28)Experience has shown that the functioning of the internal market
in food or feed can be jeopardised where it is impossible to tracefood and feed. It is therefore necessary to establish a comprehen-sive system of traceability within food and feed businesses so2002R0178 — EN — 01.10.2003 — 001.001 — 4
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that targeted and accurate withdrawals can be undertaken or
information given to consumers or control officials, therebyavoiding the potential for unnecessary wider disruption in the
event of food safety problems.
(29)It is necessary to ensure that a food or feed business including an
importer can identify at least the business from which the food,feed, animal or substance that may be incorporated into a foodor feed has been supplied, to ensure that on investigation, trace-ability can be assured at all stages.
(30)A food business operator is best placed to devise a safe systemfor supplying food and ensuring that the food it supplies is safe;thus, it should have primary legal responsibility for ensuring
food safety. Although this principle exists in some Member
States and areas of food law, in other areas this is either notexplicit or else responsibility is assumed by the competentauthorities of the Member State through the control activitiesthey carry out. Such disparities are liable to create barriers totrade and distort competition between food business operators
in different Member States.
(31)Similar requirements should apply to feed and feed businessoperators.
(32)The scientific and technical basis of Community legislationrelating to the safety of food and feed should contribute to the
achievement of a high level of health protection within theCommunity. The Community should have access to high-quality,independent and efficient scientific and technical support.
(33)The scientific and technical issues in relation to food and feedsafety are becoming increasingly important and complex. Theestablishment of a European Food Safety Authority, hereinafter
referred to as ‘the Authority’, should reinforce the present
system of scientific and technical support which is no longerable to respond to increasing demands on it.
(34)Pursuant to the general principles of food law, the Authorityshould take on the role of an independent scientific point ofreference in risk assessment and in so doing should assist inensuring the smooth functioning of the internal market. It maybe called upon to give opinions on contentious scientific issues,
thereby enabling the Community institutions and Member States
to take informed risk management decisions necessary to ensurefood and feed safety whilst helping avoid the fragmentation ofthe internal market through the adoption of unjustified or unne-cessary obstacles to the free movement of food and feed.
(35)The Authority should be an independent scientific source ofadvice, information and risk communication in order to improve
consumer confidence; nevertheless, in order to promote coher-
ence between the risk assessment, risk management and riskcommunication functions, the link between risk assessors andrisk managers should be strengthened.
(36)The Authority should provide a comprehensive independentscientific view of the safety and other aspects of the wholefood and feed supply chains, which implies wide-ranging respon-sibilities for the Authority. These should include issues having a
direct or indirect impact on the safety of the food and feed
supply chains, animal health and welfare, and plant health.However, it is necessary to ensure that the Authority focuses onfood safety, so its mission in relation to animal health, animalwelfare and plant health issues that are not linked to the safety
of the food supply chain should be limited to the provision of
scientific opinions. The Authority's mission should also coverscientific advice and scientific and technical support on humannutrition in relation to Community legislation and assistance tothe Commission at its request on communication linked toCommunity health programmes.2002R0178 — EN — 01.10.2003 — 001.001 — 5
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(37)Since some products authorised under food law such as pesti-
cides or additives in animal feed may involve risks to the
environment or to the safety of workers, some environmentaland worker protection aspects should also be assessed by theAuthority in accordance with the relevant legislation.
(38)In order to avoid duplicated scientific assessments and relatedscientific opinions on genetically modified organisms (GMOs),the Authority should also provide scientific opinions on products
other than food and feed relating to GMOs as defined by Direc-
tive 2001/18/EC (
1) and without prejudice to the procedures
established therein.
(39)The Authority should contribute through the provision of supporton scientific matters, to the Community's and Member States'role in the development and establishment of international food
safety standards and trade agreements.
(40)The confidence of the Community institutions, the general public
and interested parties in the Authority is essential. For thisreason, it is vital to ensure its independence, high scientificquality, transparency and efficiency. Cooperation withMemberStates is also indispensable.
(41)To that effect the Management Board should be appointed insuch a way as to secure the highest standard of competence, a
broad range of relevant expertise, for instance in management
and in public administration, and the broadest possiblegeographic distribution within the Union. This should be facili-tated by a rotation of the different countries of origin of themembers of the Management Board without any post being
reserved for nationals of any specific Member State.
(42)The Authority should have the means to perform all the tasks
required to enable it to carry out its role.
(43)The Management Board should have the necessary powers toestablish the budget, check its implementation, draw up internalrules, adopt financial regulations, appoint members of the Scien-tific Committee and Scientific Panels and appoint the ExecutiveDirector.
(44)The Authority should cooperate closely with competent bodies in
the Member States if it is to operate effectively. An Advisory
Forum should be created in order to advise the ExecutiveDirector, to constitute a mechanism of exchange of information,and to ensure close cooperation in particular withregard to th enetworking system. Cooperation and appropriate exchange of
information should also minimise the potential for diverging
scientific opinions.
(45)The Authority should take over the role of the ScientificCommittees attached to the Commission in issuing scientificopinions in its field of competence. It is necessary to reorganisethese Committees to ensure greater scientific consistency in rela-tion to the food supply chain and to enable them to work more
effectively. A Scientific Committee and Permanent Scientific
Panels should therefore be set up within the Authority to providethese opinions.
(46)In order to guarantee independence, members of the ScientificCommittee and Panels should be independent scientists recruitedon the basis of an open application procedure.
(47)The Authority's role as an independent scientific point of refer-
ence means that a scientific opinion may be requested not only
by the Commission, but also by the European Parliament and theMember States. In order to ensure the manageability and consis-2002R0178 — EN — 01.10.2003 — 001.001 — 6
(1) Directive 2001/18/EC of the European Parliament and of the Council of 12
March 2001 on the deliberate release into the environment of genetically
modified organisms and repealing Council Directive 90/220/EEC (OJ L
106, 17.4.2001, p. 1).
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tency of the process of scientific advice, the Authority should be
able to refuse or amend a request providing justification for thisand on the basis of predetermined criteria. Steps should also be
taken to help avoid diverging scientific opinions and, in the
event of diverging scientific opinions between scientific bodies,procedures should be in place to resolve the divergence orprovide the risk managers with a transparent basis of scientificinformation.
(48)The Authority should also be able to commission scientificstudies necessary for the accomplishment of its duties, while
ensuring that the links established by it with the Commission
and the Member States prevent duplication of effort. It shouldbe done in an open and transparent fashion and the Authorityshould take into account existing Community expertise andstructures.
(49)The lack of an effective system of collection and analysis atCommunity level of data on the food supply chain is recognisedas a major shortcoming. A system for the collection and analysis
of relevant data in the fields covered by the Authority should
therefore be set up, in the form of a network coordinated by theAuthority. A review of Community data collection networksalready existing in the fields covered by the Authority is calledfor.
(50)Improved identification of emerging risks may in the long termbe a major preventive instrument at the disposal of the Member
States and the Community in the exercise of its policies. It is
therefore necessary to assign to the Authority an anticipatorytask of collecting information and exercising vigilance andproviding evaluation of and information on emerging risks witha view to their prevention.
(51)The establishment of the Authority should enable Member Statesto become more closely involved in scientific procedures. Thereshould therefore be close cooperation between the Authority and
the Member States for this purpose. In particular, the Authority
should be able to assign certain tasks to organisations in theMember States.
(52)It is necessary to ensure that a balance is struck between theneed to use national organisations to carry out tasks for theAuthority and the need to ensure for the purposes of overallconsistency that such tasks are carried out in line with the
criteria established for such tasks. Existing procedures for the
allocation of scientific tasks to the Member States, in particularwithregard to th e evaluation of dossiers presented by industryfor the authorisation of certain substances, products or proce-dures, should be re-examined within a year with the objectiveof taking into account the establishment of the Authority and
the new facilities it offers, the evaluation procedures remaining
at least as stringent as before.
(53)The Commission remains fully responsible for communicatingrisk management measures. The appropriate information shouldtherefore be exchanged between the Authority and the Commis-sion. Close cooperation between the Authority, the Commissionand the Member States is also necessary to ensure the coherence
of the global communication process.
(54)The independence of the Authority and its role in informing thepublic mean that it should be able to communicate autonomously
in the fields falling within its competence, its purpose being toprovide objective, reliable and easily understandable informa-tion.
(55)Appropriate cooperation with the Member States and other inter-ested parties is necessary in the specific field of publicinformation campaigns to take into account any regional para-meters and any correlation withh ealthpolicy.2002R0178 — EN — 01.10.2003 — 001.001 — 7
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(56)In addition to its operating principles based on independence and
transparency, the Authority should be an organisation open to
contacts withconsumers and oth er interested groups.
(57)The Authority should be financed by the general budget of theEuropean Union. However, in the light of experience acquired,in particular with regard to the processing of authorisation
dossiers presented by industry, the possibility of fees should be
examined within three years following the entry into force ofthis Regulation. The Community budgetary procedure remainsapplicable as far as any subsidies chargeable to the generalbudget of the European Union are concerned. Moreover, the
auditing of accounts should be undertaken by the Court of Audi-
tors.
(58)It is necessary to allow for the participation of European coun-tries which are not members of the European Union and which
have concluded agreements obliging them to transpose and
implement the body of Community law in the field covered bythis Regulation.
(59)A system for rapid alert already exists in the framework ofCouncil Directive 92/59/EEC of 29 June 1992 on general
product safety (
1). The scope of the existing system includes
food and industrial products but not feed. Recent food criseshave demonstrated the need to set up an improved and broa-dened rapid alert system covering food and feed. This revisedsystem should be managed by the Commission and include as
members of the network the Member States, the Commission
and the Authority. The system should not cover the Communityarrangements for the early exchange of information in the eventof a radiological emergency as defined in Council Decision 87/600/Euratom (
2).
(60)Recent food safety incidents have demonstrated the need toestablishappropriate measures in emergency situations ensuringthat all foods, whatever their type and origin, and all feed shouldbe subject to common measures in the event of a serious risk tohuman health, animal health or the environment. Such a compre-
hensive approach to emergency food safety measures should
allow effective action to be taken and avoid artificial disparitiesin the treatment of a serious risk in relation to food or feed.
(61)Recent food crises have also shown the benefits to the Commis-
sion of having properly adapted, more rapid procedures for crisis
management. These organisational procedures should make itpossible to improve coordination of effort and to determine themost effective measures on the basis of the best scientific infor-mation. Therefore, revised procedures should take into accountthe Authority's responsibilities and should provide for its scien-
tific and technical assistance in the form of advice in the event
of a food crisis.
(62)In order to ensure a more effective, comprehensive approach tothe food chain, a Committee on the Food Chain and Animal
Health should be established to replace the Standing Veterinary
Committee, the Standing Committee for Foodstuffs and theStanding Committee for Feedingstuffs. Accordingly, CouncilDecisions 68/361/EEC (
3), 69/414/EEC (4), and 70/372/EEC (5),
should be repealed. For the same reason the Committee on theFood Chain and Animal Health should also replace the Standing2002R0178 — EN — 01.10.2003 — 001.001 — 8
(1) OJ L 228, 11.8.1992, p. 24.
(2) OJ L 371, 30.12.1987, p. 76.
(3) OJ L 255, 18.10.1968, p. 23.
(4) OJ L 291, 19.11.1969, p. 9.
(5) OJ L 170, 3.8.1970, p. 1.
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Committee on Plant Healthin relation to its competence (for
Directives 76/895/EEC (1), 86/362/EEC (2), 86/363/EEC (3), 90/
642/EEC (4) and 91/414/EEC (5)) on plant protection products
and the setting of maximum residue levels.
(63)The measures necessary for the implementation of this Regula-
tion should be adopted in accordance with Council Decision1999/468/EC of 28 June 1999 laying down the procedures forthe exercise of implementing powers conferred on the Commis-sion(
6).
(64)It is necessary that operators should have sufficient time to adapt
to some of the requirements established by the present Regula-
tion and that the European Food Safety Authority shouldcommence its operations on 1 January 2002.
(65)It is important to avoid confusion between the missions of theAuthority and the European Agency for the Evaluation ofMedicinal Products (EMEA) established by Council Regulation(EEC) No 2309/93(
7). Consequently, it is necessary to establish
that this Regulation is without prejudice to the competence
conferred on the EMEA by Community legislation, includingpowers conferred by Council Regulation (EEC) No 2377/90 of26 June 1990 laying down a Community procedure for the estab-lishment of maximum residue limits of veterinary medicinalproducts in foodstuffs of animal origin (
8).
(66)It is necessary and appropriate for the achievement of the basic
objectives of this Regulation to provide for the approximation of
the concepts, principles and procedures forming a common basisfor food law in the Community and to establish a European FoodSafety Authority. In accordance with the principle of proportion-ality as set out in Article 5 of the Treaty, this Regulation does
not go beyond what is necessary in order to achieve the objec-
tives pursued,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SCOPEANDDEFINITIONS
Article 1
Aimandscope
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 func-tioning of the internal market. It establishes common principles andresponsibilities, the means to provide a strong science base, efficientorganisational arrangements and procedures to underpin decision-making in matters of food and feed safety.2002R0178 — EN — 01.10.2003 — 001.001 — 9
(1) OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission
Directive 2000/57/EC (OJ L 244, 29.9.2000, p. 76).
(2) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Direc-
tive 2001/57/EC (OJ L 208, 1.8.2001, p. 36).
(3) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Direc-
tive 2001/57/EC.
(4) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission
Directive 2001/57/EC.
(5) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Direc-
tive 2001/49/EC (OJ L 176, 29.6.2001, p. 61).
(6) OJ L 184, 17.7.1999, p. 23.
(7) OJ L 214, 24.8.1993, p. 1. Regulation amended by Commission Regulation
(EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).
(8) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission
Regulation (EC) No 1553/2001 (OJ L 205, 31.7.2001, p. 16).
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2. For the purposes of paragraph 1, this Regulation lays down the
general principles governing food and feed in general, and food andfeed safety in particular, at Community and national level.
It establishes the European Food Safety Authority.
It lays down procedures for matters witha 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 produc-tion for private domestic use or to the domestic preparation, handling
or storage of food for private domestic consumption.
Article 2
Definitionof‘food’
For the purposes of this Regulation, ‘food’ (or ‘foodstuff’) means any
substance or product, whether processed, partially processed or unpro-cessed, intended to be, or reasonably expected to be ingested byhumans.
‘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 complianceas 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 Direc-
tive 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.
Article 3
Otherdefinitions
For the purposes of this Regulation:
1. ‘food law’ means the laws, regulations and administrative provi-
sions 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 feedproduced 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 activitiesrelated to any stage of production, processing and distribution offood;2002R0178 — EN — 01.10.2003 — 001.001 — 10
(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).
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3. ‘food business operator’ means the natural or legal persons respon-
sible for ensuring that the requirements of food law are met withinthe food business under their control;
4. ‘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;
5. ‘feed business’ means any undertaking whether for profit or not
and whether public or private, carrying out any operation ofproduction, manufacture, processing, storage, transport or distribu-tion of feed including any producer producing, processing orstoring feed for feeding to animals on his own holding;
6. ‘feed business operator’ means the natural or legal persons respon-
sible 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, factorycanteens, institutional catering, restaurants and other similar foodservice operations, shops, supermarket distribution centres andwholesale 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 oftransfer, 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 communi-cation;
11. ‘risk assessment’ means a scientifically based process consisting of
four steps: hazard identification, hazard characterisation, exposureassessment and risk characterisation;
12. ‘risk management’ means the process, distinct from risk assess-
ment, of weighing policy alternatives in consultation withinterested 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 informa-
tion and opinions throughout the risk analysis process as regardshazards and risks, risk-related factors and risk perceptions, amongrisk assessors, risk managers, consumers, feed and food businesses,the academic community and other interested parties, including theexplanation 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 withth e potential to cause an adversehealth effect;
15. ‘traceability’ means the ability to trace and follow a food, feed,
food-producing animal or substance intended to be, or expected tobe incorporated into a food or feed, through all stages of produc-tion, 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, produc-tion, manufacture, storage, transport, distribution, sale and supplyof feed;
17. ‘primary production’ means the production, rearing or growing of
primary products including harvesting, milking and farmed animalproduction prior to slaughter. It also includes hunting and fishingand the harvesting of wild products;2002R0178 — EN — 01.10.2003 — 001.001 — 11
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18. ‘final consumer’ means the ultimate consumer of a foodstuff who
will not use the food as part of any food business operation oractivity.
CHAPTER II
GENERALFOODLAW
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 aretaken.
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 complywithArticles 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
GENERALPRINCIPLESOFFOODLAW
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 ofconsumers' interests, including fair practices in food trade, takingaccount 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 Commu-
nity of food and feed manufactured or marketed according to thegeneral principles and requirements in this Chapter.
3. Where international standards exist or their completion is immi-
nent, they shall be taken into consideration in the development oradaptation of food law, except where such standards or relevant partswould be an ineffective or inappropriate means for the fulfilment ofthe legitimate objectives of food law or where there is a scientific justi-
fication, or where they would result in a different level of protection
from the one determined as appropriate in the Community.
Article 6
Riskanalysis
1. In order to achieve the general objective of a high level of protec-
tion of human health and life, food law shall be based on risk analysisexcept where this is not appropriate to the circumstances or the natureof the measure.
2. Risk assessment shall be based on the available scientific
evidence and undertaken in an independent, objective and transparentmanner.
3. Risk management shall take into account the results of risk
assessment, and in particular, the opinions of the Authority referred toin Article 22, other factors legitimate to the matter under considerationand the precautionary principle where the conditions laid down inArticle 7(1) are relevant, in order to achieve the general objectives offood law established in Article 5.2002R0178 — EN — 01.10.2003 — 001.001 — 12
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Article 7
Precautionary principle
1. In specific circumstances where, following an assessment of
available information, the possibility of harmful effects on health isidentified but scientific uncertainty persists, provisional risk manage-
ment measures necessary to ensure the high level of health protection
chosen in the Community may be adopted, pending further scientificinformation for a more comprehensive risk assessment.
2. Measures adopted on the basis of paragraph 1 shall be propor-
tionate and no more restrictive of trade than is required to achieve the
high level of health protection chosen in the Community, regard beinghad to technical and economic feasibility and other factors regarded aslegitimate in the matter under consideration. The measures shall bereviewed within a reasonable period of time, depending on the natureof the risk to life or health identified and the type of scientific informa-
tion needed to clarify the scientific uncertainty and to conduct a more
comprehensive risk assessment.
Article 8
Protection ofconsumers'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 inrelation 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 2
PRINCIPLESOFTRANSPARENCY
Article 9
Public consultation
There shall be open and transparent public consultation, directly or
through representative bodies, during the preparation, evaluation andrevision of food law, except where the urgency of the matter does not
allow it.
Article 10
Publicinformation
Without prejudice to the applicable provisions of Community and
national law on access to documents, where there are reasonablegrounds to suspect that a food or feed may present a risk for humanor 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 thefullest extent possible the food or feed, or type of food or feed, therisk that it may present, and the measures which are taken or about tobe taken to prevent, reduce or eliminate that risk.
SECTION 3
GENERALOBLIGATIONSOFFOODTRADE
Article 11
FoodandfeedimportedintotheCommunity
Food and feed imported into the Community for placing on the market
within the Community shall comply with the relevant requirements offood law or conditions recognised by the Community to be at leastequivalent thereto or, where a specific agreement exists between the2002R0178 — EN — 01.10.2003 — 001.001 — 13
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Community and the exporting country, with requirements contained
therein.
Article 12
FoodandfeedexportedfromtheCommunity
1. Food and feed exported or re-exported from the Community for
placing on the market of a third country shall comply with the relevantrequirements of food law, unless otherwise requested by the authorities
of the importing country or established by the laws, regulations, stan-
dards, codes of practice and other legal and administrative proceduresas may be in force in the importing country.
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 reasonsfor which and the circumstances in which the food or feed concernedcould not be placed on the market in the Community.
2. Where the provisions of a bilateral agreement concluded between
the Community or one of its Member States and a third country are
applicable, food and feed exported from the Community or thatMember State to that third country shall comply with the said provi-sions.
Article 13
Internationalstandards
Without prejudice to their rights and obligations, the Community and
the Member States shall:
(a) contribute to the development of international technical standards
for food and feed and sanitary and phytosanitary standards;
(b) promote the coordination of work on food and feed standards
undertaken by international governmental and non-governmental
organisations;
(c) contribute, where relevant and appropriate, to the development of
agreements on recognition of the equivalence of specific food and
feed-related measures;
(d) give particular attention to the special development, financial and
trade needs of developing countries, witha view to ensuring th at
international standards do not create unnecessary obstacles to
exports from developing countries;
(e) promote consistency between international technical standards and
food law while ensuring that the high level of protection adopted
in the Community is not reduced.
SECTION 4
GENERALREQUIREMENTSOFFOODLAW
Article 14
Foodsafetyrequirements
1. Food shall not be placed on the market if it is unsafe.
2. Food shall be deemed to be unsafe if it is considered to be:
(a) injurious to health;
(b) unfit for human consumption.
3. In determining whether any food is unsafe, regard shall be had:
(a) to the normal conditions of use of the food by the consumer and at
eachstage of production, processing and distribution, and
(b) to the information provided to the consumer, including information
on the label, or other information generally available to the2002R0178 — EN — 01.10.2003 — 001.001 — 14
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consumer concerning the avoidance of specific adverse health
effects from a particular food or category of foods.
4. In determining whether any food is injurious to health, regard
shall be had:
(a) not only to the probable immediate and/or short-term and/or long-
term effects of that food on the health of a person consuming it,but also on subsequent generations;
(b) to the probable cumulative toxic effects;
(c) to the particular health sensitivities of a specific category of consu-
mers where the food is intended for that category of consumers.
5. In determining whether any food is unfit for human consumption,
regard shall be had to whether the food is unacceptable for humanconsumption according to its intended use, for reasons of contamina-tion, whether by extraneous matter or otherwise, or throughputrefaction, deterioration or decay.
6. Where any food which is unsafe is part of a batch, lot or consign-
ment of food of the same class or description, it shall be presumed thatall the food in that batch, lot or consignment is also unsafe, unlessfollowing a detailed assessment there is no evidence that the rest of
the batch, lot or consignment is unsafe.
7. Food that complies with specific Community provisions
governing food safety shall be deemed to be safe insofar as the aspects
covered by the specific Community provisions are concerned.
8. Conformity of a food withspecific provisions applicable to th at
food shall not bar the competent authorities from taking appropriatemeasures to impose restrictions on it being placed on the market or to
require its withdrawal from the market where there are reasons to
suspect that, despite such conformity, the food is unsafe.
9. Where there are no specific Community provisions, food shall be
deemed to be safe when it conforms to the specific provisions of
national food law of the Member State in whose territory the food ismarketed, suchprovisions being drawn up and applied with out preju-dice to the Treaty, in particular Articles 28 and 30 thereof.
Article 15
Feed safetyrequirements
1. Feed shall not be placed on the market or fed to any food-produ-
cing animal if it is unsafe.
2. Feed shall be deemed to be unsafe for its intended use if it is
considered to:
— have an adverse effect on human or animal health;
— make the food derived from food-producing animals unsafe for
human consumption.
3. Where a feed which has been identified as not satisfying the feed
safety requirement is part of a batch, lot or consignment of feed of thesame class or description, it shall be presumed that all of the feed inthat batch, lot or consignment is so affected, unless following adetailed assessment there is no evidence that the rest of the batch, lotor consignment fails to satisfy the feed safety requirement.
4. Feed that complies with specific Community provisions
governing feed safety shall be deemed to be safe insofar as the aspectscovered by the specific Community provisions are concerned.
5. Conformity of a feed withspecific provisions applicable to th at
feed shall not bar the competent authorities from taking appropriatemeasures to impose restrictions on it being placed on the market or torequire its withdrawal from the market where there are reasons to
suspect that, despite such conformity, the feed is unsafe.
6. Where there are no specific Community provisions, feed shall be
deemed to be safe when it conforms to the specific provisions of2002R0178 — EN — 01.10.2003 — 001.001 — 15
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national law governing feed safety of the Member State in whose terri-
tory the feed is in circulation, such provisions being drawn up andapplied without prejudice to the Treaty, in particular Articles 28 and
30 thereof.
Article 16
Presentation
Without prejudice to more specific provisions of food law, the label-
ling, advertising and presentation of food or feed, including theirshape, 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 themthrough whatever medium, shall not mislead consumers.
Article 17
Responsibilities
1. Food and feed business operators at all stages of production,
processing and distribution within the businesses under their control
shall ensure that foods or feeds satisfy the requirements of food law
which are relevant to their activities and shall verify that such require-ments are met.
2. Member States shall enforce food law, and monitor and verify
that the relevant requirements of food law are fulfilled by food andfeed business operators at all stages of production, processing anddistribution.
For that purpose, they shall maintain a system of official controls and
other activities as appropriate to the circumstances, including publiccommunication 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 andpenalties provided for shall be effective, proportionate and dissuasive.
Article 18
Traceability
1. The traceability of food, feed, food-producing animals, and any
other substance intended to be, or expected to be, incorporated into a
food or feed shall be established at all stages of production, processing
and distribution.
2. Food and feed business operators shall be able to identify any
person from whom they have been supplied with a food, a feed, afood-producing animal, or any substance intended to be, or expectedto be, incorporated into a food or feed.
To this end, such operators shall have in place systems and procedures
which allow for this information to be made available to the competentauthorities on demand.
3. Food and feed business operators shall have in place systems and
procedures to identify the other businesses to which their products have
been supplied. This information shall be made available to the compe-
tent authorities on demand.
4. Food or feed which is placed on the market or is likely to be
placed on the market in the Community shall be adequately labelledor identified to facilitate its traceability, through relevant documenta-tion or information in accordance withth e relevant requirements ofmore specific provisions.
5. Provisions for the purpose of applying the requirements of this
Article in respect of specific sectors may be adopted in accordancewithth e procedure laid down in Article 58(2).2002R0178 — EN — 01.10.2003 — 001.001 — 16
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Article 19
Responsibilitiesforfood:foodbusinessoperators
1. If a food business operator considers or has reason to believe that
a food which it has imported, produced, processed, manufactured or
distributed is not in compliance withth e food safety requirements, it
shall immediately initiate procedures to withdraw the food in questionfrom the market where the food has left the immediate control of thatinitial food business operator and inform the competent authoritiesthereof. Where the product may have reached the consumer, theoperator shall effectively and accurately inform the consumers of the
reason for its withdrawal, and if necessary, recall from consumers
products already supplied to them when other measures are not suffi-cient to achieve a high level of health protection.
2. A food business operator responsible for retail or distribution
activities which do not affect the packaging, labelling, safety or integ-rity of the food shall, within the limits of its respective activities,
initiate procedures to withdraw from the market products not in
compliance with the food-safety requirements and shall participate incontributing to the safety of the food by passing on relevant informa-tion necessary to trace a food, cooperating in the action taken byproducers, processors, manufacturers and/or the competent authorities.
3. A food business operator shall immediately inform the competent
authorities if it considers or has reason to believe that a food which it
has placed on the market may be injurious to human health. Operators
shall inform the competent authorities of the action taken to preventrisks to the final consumer and shall not prevent or discourage anyperson from cooperating, in accordance withnational law and legalpractice, with the competent authorities, where this may prevent,
reduce or eliminate a risk arising from a food.
4. Food business operators shall collaborate with the competent
authorities on action taken to avoid or reduce risks posed by a foodwhich they supply or have supplied.
Article 20
Responsibilitiesforfeed:feedbusinessoperators
1. If a feed business operator considers or has reason to believe that
a feed which it has imported, produced, processed, manufactured ordistributed does not satisfy the feed safety requirements, it shall imme-diately initiate procedures to withdraw the feed in question from the
market and inform the competent authorities thereof. In these circum-
stances or, in the case of Article 15(3), where the batch, lot orconsignment does not satisfy the feed safety requirement, that feedshall be destroyed, unless the competent authority is satisfied other-wise. The operator shall effectively and accurately inform users of the
feed of the reason for its withdrawal, and if necessary, recall from them
products already supplied when other measures are not sufficient toachieve a high level of health protection.
2. A feed business operator responsible for retail or distribution
activities which do not affect the packaging, labelling, safety or integ-rity of the feed shall, within the limits of its respective activities,initiate procedures to withdraw from the market products not in
compliance with the feed-safety requirements and shall participate in
contributing to the safety of food by passing on relevant informationnecessary to trace a feed, cooperating in the action taken by producers,processors, manufacturers and/or the competent authorities.
3. A feed business operator shall immediately inform the competent
authorities if it considers or has reason to believe that a feed which it
placed on the market may not satisfy the feed safety requirements. It
shall inform the competent authorities of the action taken to preventrisk arising from the use of that feed and shall not prevent or discou-rage any person from cooperating, in accordance withnational law andlegal practice, with the competent authorities, where this may prevent,reduce or eliminate a risk arising from a feed.2002R0178 — EN — 01.10.2003 — 001.001 — 17
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4. Feed business operators shall collaborate with the competent
authorities on action taken in order to avoid risks posed by a feedwhich they supply or have supplied.
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 thelaws, regulations and administrative provisions of the Member Statesconcerning liability for defective products (
1).
CHAPTER III
EUROPEANFOODSAFETYAUTHORITY
SECTION 1
MISSIONANDTASKS
Article 22
MissionoftheAuthority
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 thesefields 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 theoperation of the internal market.
4. The Authority shall collect and analyse data to allow the charac-
terisation 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 requestof the Commission, assistance concerning communication on nutri-tional 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, thescientific and technical quality of the opinions it issues and the infor-
mation it disseminates, the transparency of its procedures and methods
of operation, and its diligence in performing the tasks assigned to it.
It shall act in close cooperation with the competent bodies in the
Member States carrying out similar tasks to these of the Authority.2002R0178 — EN — 01.10.2003 — 001.001 — 18
(1) 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).
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8. The Authority, Commission and Member States shall cooperate to
promote the effective coherence between risk assessment, risk manage-ment and risk communication functions.
9. The Member States shall cooperate with the Authority to ensure
the accomplishment of its mission.
Article 23
TasksoftheAuthority
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 byCommunity legislation and on any question within its mission;
(b) to promote and coordinate the development of uniform risk assess-
ment 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 interpreta-tion and consideration of risk assessment opinions;
(d) to commission scientific studies necessary for the accomplishment
of its mission;
(e) to searchfor, 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 establisha system of networks of organisations operating in th e
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 imple-
mented by the Commission with regard to the safety of food andfeed;
(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 organi-
sations and third countries, in the fields within its mission;
(j) to ensure that the public and interested parties receive rapid, reli-
able, objective and comprehensible information in the fieldswithin its mission;
(k) to express independently its own conclusions and orientations on
matters within its mission;
(l) to undertake any other task assigned to it by the Commission
within its mission.
SECTION 2
ORGANISATION
Article 24
BodiesoftheAuthority
The Authority shall comprise:
(a) a Management Board;
(b) an Executive Director and his staff;
(c) an Advisory Forum;
(d) a Scientific Committee and Scientific Panels.
Article 25
ManagementBoard
1. The Management Board shall be composed of 14 members
appointed by the Council in consultation with the European Parliamentfrom a list drawn up by the Commission which includes a number of2002R0178 — EN — 01.10.2003 — 001.001 — 19
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candidates substantially higher than the number of members to be
appointed, plus a representative of the Commission. Four of themembers shall have their background in organisations representing
consumers and other interests in the food chain.
The list drawn up by the Commission, accompanied by the relevant
documentation, shall be forwarded to the European Parliament. Assoon as possible and within three months of such communication, theEuropean Parliament may make its views available for consideration bythe Council, which will then appoint the Management Board.
The members of the Board shall be appointed in such a way as to
secure the highest standards of competence, a broad range of relevant
expertise and, consistent with these, the broadest possible geographicdistribution within the Union.
2. Members' term of office shall be four years, and may be renewed
once. However, for the first mandate, this period shall be six years forhalf of the members.
3. The Management Board shall adopt the Authority's internal rules
on the basis of a proposal by the Executive Director. These rules shall
be made public.
4. The Management Board shall elect one of its members as its
Chair for a two-year period, which shall be renewable.
5. The Management Board shall adopt its rules of procedure.Unless otherwise provided, the Management Board shall act by a
majority of its members.
6. The Management Board shall meet at the invitation of the Chair
or at the request of at least a third of its members.
7. The Management Board shall ensure that the Authority carries out
its mission and performs the tasks assigned to it under the conditionslaid down in this Regulation.
8. Before 31 January each year, the Management Board shall adopt
the Authority's programme of work for the coming year. It shall alsoadopt a revisable multi-annual programme. The Management Boardshall ensure that these programmes are consistent with the Commu-
nity's legislative and policy priorities in the area of food safety.
Before 30 March each year, the Management Board shall adopt the
general report on the Authority's activities for the previous year.
9. The financial rules applicable to the Authority shall be adopted
by the Management Board after the Commission has been consulted.They may not depart from Commission Regulation (EC, Euratom) No
2343/2002 of 19 November 2002 on the framework Financial Regula-
tion for the bodies referred to in Article 185 of Council Regulation(EC, Euratom) No 1605/2002 on the Financial Regulation applicableto the general budget of the European Communities (
1) unless such
departure is specifically required for the Authority's operation and the
Commission has given its prior consent.
10. The Executive Director shall take part in the meetings of the
Management Board, without voting rights, and shall provide the Secre-tariat. The Management Board shall invite the Chair of the ScientificCommittee to attend its meetings without voting rights.
Article 26
ExecutiveDirector
1. The Executive Director shall be appointed by the Management
Board, on the basis of a list of candidates proposed by the Commission2002R0178 — EN — 01.10.2003 — 001.001 — 20
(1) OJ L 357, 31.12.2002, p. 72; corrigendum in OJ L 2, 7.1.2003, p. 39.▼M1
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after an open competition, following publication in the Official Journal
of the European Communities and elsewhere of a call for expressions
of interest, for a period of five years which shall be renewable. Before
appointment the candidate nominated by the Management Board shall
be invited without delay to make a statement before the EuropeanParliament and answer questions put by members of this institution.The Executive Director may be removed from office by a majority ofthe Management Board.
2. The Executive Director shall be the legal representative of the
Authority and shall be responsible for:
(a) the day-to-day administration of the Authority;
(b) drawing up a proposal for the Authority's work programmes in
consultation withth e Commission;
(c) implementing the work programmes and the decisions adopted by
the Management Board;
(d) ensuring the provision of appropriate scientific, technical and
administrative support for the Scientific Committee and the Scien-
tific Panels;
(e) ensuring that the Authority carries out its tasks in accordance with
the requirements of its users, in particular with regard to the
adequacy of the services provided and the time taken;
(f) the preparation of the Authority's draft statement of estimates of
revenue and expenditure, and the execution of its budget;
(g) all staff matters;
(h) developing and maintaining contact with the European Parliament,
and for ensuring a regular dialogue withits relevant committees.
3. Each year, the Executive Director shall submit to the Manage-
ment Board for approval:
(a) a draft general report covering all the activities of the Authority in
the previous year;
(b) 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 theEuropean Parliament, the Council, the Commission, the Court of Audi-tors, the European Economic and Social Committee and the Committeeof 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 evaluationprocedures.
Article 27
AdvisoryForum
1. The Advisory Forum shall be composed of representatives from
competent bodies in the Member States which undertake tasks similar
to those of the Authority, on the basis of one representative designatedby eachMember State. Representatives may be replaced by alternates,appointed at the same time.
2. Members of the Advisory Forum may not be members of the
Management Board.2002R0178 — EN — 01.10.2003 — 001.001 — 21
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3. The Advisory Forum shall advise the Executive Director in the
performance of his duties under this Regulation, in particular indrawing up a proposal for the Authority's work programme. The
Executive Director may also ask the Advisory Forum for advice on
the prioritisation of requests for scientific opinions.
4. The Advisory Forum shall constitute a mechanism for an
exchange of information on potential risks and the pooling of knowl-
edge. It shall ensure close cooperation between the Authority and the
competent bodies in the Member States in particular on the followingitems:
(a) avoidance of duplication of the Authority's scientific studies with
Member States, in accordance withArticle 32;
(b) in those circumstances identified in Article 30(4), where the
Authority and a national body are obliged to cooperate;
(c) in the promoting of the European networking of organisations oper-
ating within the fields of the Authority's mission, in accordance
withArticle 36(1);
(d) where the Authority or a Member State identifies an emerging risk.
5. The Advisory Forum shall be chaired by the Executive Director.
It shall meet regularly at the invitation of the Chair or at the request ofat least a third of its members, and not less than four times per year. Itsoperational procedures shall be specified in the Authority's internal
rules and shall be made public.
6. The Authority shall provide the technical and logistic support
necessary for the Advisory Forum and provide the Secretariat for itsmeetings.
7. Representatives of the Commission's departments may participate
in the work of the Advisory Forum. The Executive Director may inviterepresentatives of the European Parliament and from other relevantbodies to take part.
Where the Advisory Forum discusses the matters referred to in Article
22(5)(b), representatives from competent bodies in the Member Stateswhich undertake tasks similar to those referred to in Article 22(5)(b)may participate in the work of the Advisory Forum, on the basis ofone representative designated by eachMember State.
Article 28
Scientific Committee andScientific Panels
1. The Scientific Committee and permanent Scientific Panels shall
be responsible for providing the scientific opinions of the Authority,each within their own spheres of competence, and shall have the possi-bility, where necessary, of organising public hearings.
2. The Scientific Committee shall be responsible for the general
coordination necessary to ensure the consistency of the scientific
opinion procedure, in particular withregard to th e adoption of workingprocedures and harmonisation of working methods. It shall provideopinions on multisectoral issues falling within the competence ofmore than one Scientific Panel, and on issues which do not fall within
the competence of any of the Scientific Panels.
Where necessary, and particularly in the case of subjects which do not
fall within the competence of any of the Scientific Panels, the Scien-tific Committee shall set up working groups. In such cases, it shalldraw on the expertise of those working groups when establishing scien-
tific opinions.
3. The Scientific Committee shall be composed of the Chairs of the
Scientific Panels and six independent scientific experts who do notbelong to any of the Scientific Panels.2002R0178 — EN — 01.10.2003 — 001.001 — 22
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4. The Scientific Panels shall be composed of independent scientific
experts. When the Authority is established, the following ScientificPanels shall be set up:
(a) the Panel on food additives, flavourings, processing aids and mate-
rials in contact withfood;
(b) the Panel on additives and products or substances used in animal
feed;
(c) the Panel on plant health, plant protection products and their resi-
dues;
(d) the Panel on genetically modified organisms;
(e) the Panel on dietetic products, nutrition and allergies;
(f) the Panel on biological hazards;
(g) the Panel on contaminants in the food chain;
(h) the Panel on animal health and welfare.
The number and names of the Scientific Panels may be adapted in the
light of technical and scientific development by the Commission, at the
Authority's request, in accordance with the procedure referred to inArticle 58(2).
5. The members of the Scientific Committee who are not members
of Scientific Panels and the members of the Scientific Panels shall beappointed by the Management Board, acting upon a proposal from theExecutive Director, for a three-year term of office, which shall berenewable, following publication in the Official Journal of the
European Communities , in relevant leading scientific publications and
on the Authority's website of a call for expressions of interest.
6. The Scientific Committee and the Scientific Panels shall each
choose a Chair and two Vice-Chairs from among their members.
7. The Scientific Committee and the Scientific Panels shall act by a
majority of their members. Minority opinions shall be recorded.
8. The representatives of the Commission's departments shall be
entitled to be present in the meetings of the Scientific Committee, the
Scientific Panels and their working groups. If invited to do so, they
may assist for the purposes of clarification or information but shallnot seek to influence discussions.
9. The procedures for the operation and cooperation of the Scientific
Committee and the Scientific Panels shall be laid down in the Author-ity's internal rules.
These procedures shall relate in particular to:
(a) the number of times that a member can serve consecutively on a
Scientific Committee or Scientific Panel;
(b) the number of members in each Scientific Panel;
(c) the procedure for reimbursing the expenses of members of the
Scientific Committee and the Scientific Panels;
(d) the manner in which tasks and requests for scientific opinions are
assigned to the Scientific Committee and the Scientific Panels;
(e) the creation and organisation of the working groups of the Scien-
tific Committee and the Scientific Panels, and the possibility ofexternal experts being included in those working groups;
(f) the possibility of observers being invited to meetings of the Scien-
tific Committee and the Scientific Panels;
(g) the possibility of organising public hearings.2002R0178 — EN — 01.10.2003 — 001.001 — 23
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SECTION 3
OPERATION
Article 29
Scientific opinions
1. The Authority shall issue a scientific opinion:
(a) 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;
(b) 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.
2. Requests referred to in paragraph1 sh all be accompanied by
background information explaining the scientific issue to be addressed
and the Community interest.
3. Where Community legislation does not already specify a time
limit for the delivery of a scientific opinion, the Authority shall issuescientific opinions within the time limit specified in the requests foropinions, except in duly justified circumstances.
4. Where different requests are made on the same issues or where
the request is not in accordance with paragraph 2, or is unclear, the
Authority may either refuse, or propose amendments to a request for
an opinion in consultation with the institution or Member State(s) thatmade the request. Justifications for the refusal shall be given to theinstitution or Member State(s) that made the request.
5. Where the Authority has already delivered a scientific opinion on
the specific topic in a request, it may refuse the request if it concludes
there are no new scientific elements justifying the re-examination.
Justifications for the refusal shall be given to the institution or MemberState(s) that made the request.
6. The implementing rules for the application of this Article shall be
established by the Commission after consulting the Authority, in accor-dance with the procedure provided for in Article 58(2). These rulesshall specify in particular:
(a) the procedure to be applied by the Authority to the requests
referred to it;
(b) the guidelines governing the scientific evaluation of substances,
products or processes which are subject under Community legisla-tion to a system of prior authorisation or entry on a positive list, in
particular where Community legislation makes provision for, or
authorises, a dossier to be presented for this purpose by the appli-cant.
7. The Authority's internal rules shall specify requirements in regard
to format, explanatory background and publication of a scientificopinion.
Article 30
Diverging scientific opinions
1. The Authority shall exercise vigilance in order to identify at an
early stage any potential source of divergence between its scientific
opinions and the scientific opinions issued by other bodies carrying
out similar tasks.
2. Where the Authority identifies a potential source of divergence, it
shall contact the body in question to ensure that all relevant scientificinformation is shared and in order to identify potentially contentiousscientific issues.
3. Where a substantive divergence over scientific issues has been
identified and the body in question is a Community agency or one of2002R0178 — EN — 01.10.2003 — 001.001 — 24
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the Commission's Scientific Committees, the Authority and the body
concerned shall be obliged to cooperate with a view to either resolvingthe divergence or presenting a joint document to the Commission clar-
ifying the contentious scientific issues and identifying the relevant
uncertainties in the data. This document shall be made public.
4. Where a substantive divergence over scientific issues has been
identified and the body in question is a Member State body, the
Authority and the national body shall be obliged to cooperate with a
view to either resolving the divergence or preparing a joint documentclarifying the contentious scientific issues and identifying the relevantuncertainties in the data. This document shall be made public.
Article 31
Scientific andtechnical assistance
1. The Authority may be requested by the Commission to provide
scientific or technical assistance in any field within its mission. Thetasks of providing scientific and technical assistance shall consist ofscientific or technical work involving the application of well-estab-
lished scientific or technical principles which does not require
scientific evaluation by the Scientific Committee or a Scientific Panel.Suchtasks may include in particular assistance to th e Commission forthe establishment or evaluation of technical criteria and also assistanceto the Commission in the development of technical guidelines.
2. Where the Commission refers a request for scientific or technical
assistance to the Authority, it shall specify, in agreement with theAuthority, the time limit within which the task must be completed.
Article 32
Scientific studies
1. Using the best independent scientific resources available, the
Authority shall commission scientific studies necessary for the perfor-mance of its mission. Suchstudies sh all be commissioned in an openand transparent fashion. The Authority shall seek to avoid duplication
withMember State or Community researchprogrammes and sh all
foster cooperation through appropriate coordination.
2. The Authority shall inform the European Parliament, the
Commission and the Member States of the results of its scientificstudies.
Article 33
Collectionofdata
1. 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:
(a) food consumption and the exposure of individuals to risks related
to the consumption of food;
(b) incidence and prevalence of biological risk;
(c) contaminants in food and feed;
(d) residues.
2. For the purposes of paragraph 1, the Authority shall work in close
cooperation withall organisations operating in th e field of data collec-tion, including those from applicant countries, third countries orinternational bodies.
3. The Member States shall take the necessary measures to enable
the data they collect in the fields referred to in paragraphs 1 and 2 tobe transmitted to the Authority.
4. The Authority shall forward to the Member States and the
Commission appropriate recommendations which might improve the2002R0178 — EN — 01.10.2003 — 001.001 — 25
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technical comparability of the data it receives and analyses, in order to
facilitate consolidation at Community level.
5. Within one year following the date of entry into force of this
Regulation, the Commission shall publish an inventory of data collec-tion systems existing at Community level in the fields within the
mission of the Authority.
The report, which shall be accompanied, where appropriate, by propo-
sals, shall indicate in particular:
(a) for each system, the role which should be assigned to the
Authority, and any modifications or improvements which might be
required to enable the Authority to carry out its mission, in coop-eration withth e Member States;
(b) the shortcomings which should be remedied to enable the Authority
to collect and summarise at Community level relevant scientific
and technical data in the fields within its mission.
6. The Authority shall forward the results of its work in the field of
data collection to the European Parliament, the Commission and the
Member States.
Article 34
Identificationofemerging risks
1. The Authority shall establish monitoring procedures for systema-
tically searching for, collecting, collating and analysing informationand data with a view to the identification of emerging risks in the fields
within its mission.
2. Where the Authority has information leading it to suspect an
emerging serious risk, it shall request additional information from the
Member States, other Community agencies and the Commission. TheMember States, the Community agencies concerned and the Commis-sion shall reply as a matter of urgency and forward any relevantinformation in their possession.
3. The Authority shall use all the information it receives in the
performance of its mission to identify an emerging risk.
4. The Authority shall forward the evaluation and information
collected on emerging risks to the European Parliament, the Commis-
sion and the Member States.
Article 35
Rapidalertsystem
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 reci-pient of any messages forwarded via the rapid alert system. It shallanalyse 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'smission
1. The Authority shall promote the European networking of organi-
sations operating in the fields within the Authority's mission. The aim
of suchnetworking is, in particular, to facilitate a scientific cooperation
framework by the coordination of activities, the exchange of informa-tion, the development and implementation of joint projects, theexchange of expertise and best practices in the fields within theAuthority's mission.
2. The Management Board, acting on a proposal from the Executive
Director, shall draw up a list to be made public of competent organisa-tions designated by the Member States which may assist the Authority,2002R0178 — EN — 01.10.2003 — 001.001 — 26
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either individually or in networks, with its mission. The Authority may
entrust to these organisations certain tasks, in particular preparatorywork for scientific opinions, scientific and technical assistance, collec-
tion of data and identification of emerging risks. Some of these tasks
may be eligible for financial support.
3. The 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 procedure referred to in Article 58(2). Thoserules shall specify, in particular, the criteria for inclusion of an instituteon the list of competent organisations designated by the MemberStates, arrangements for setting out harmonised quality requirements
and the financial rules governing any financial support.
4. Within one year following the entry into force of this Regulation,
the Commission shall publish an inventory of Community systemsexisting 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 authorisationdossiers. The report, which shall be accompanied, where appropriate,by proposals, shall indicate in particular, for each system, any modifi-cations or improvements which might be required to enable the
Authority to carry out its mission, in cooperation with the Member
States.
SECTION 4
INDEPENDENCE, TRANSPARENCY, CONFIDENTIALITY AND
COMMUNICATION
Article 37
Independence
1. The members of the Management Board, the members of the
Advisory Forum and the Executive Director shall undertake to act inde-
pendently in the public interest.
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 totheir independence. Those declarations shall be made annually inwriting.
2. The members of the Scientific Committee and the Scientific
Panels shall undertake to act independently of any external influence.
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 anydirect or indirect interests which might be considered prejudicial totheir independence. Those declarations shall be made annually inwriting.
3. The members of the Management Board, the Executive Director,
the members of the Advisory Forum, the members of the ScientificCommittee and the Scientific Panels, as well as external experts parti-cipating 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.
Article 38
Transparency
1. The Authority shall ensure that it carries out its activities with a
high level of transparency. It shall in particular make public without
delay:
(a) agendas and minutes of the Scientific Committee and the Scientific
Panels;2002R0178 — EN — 01.10.2003 — 001.001 — 27
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(b) the opinions of the Scientific Committee and the Scientific Panels
immediately after adoption, minority opinions always beingincluded;
(c) without prejudice to Articles 39 and 41, the information on which
its opinions are based;
(d) the annual declarations of interest made by members of the
Management Board, the Executive Director, members of the Advi-
sory Forum and members of the Scientific Committee and
Scientific Panels, as well as the declarations of interest made inrelation to items on the agendas of meetings;
(e) the results of its scientific studies;
(f) the annual report of its activities;
(g) requests from the European Parliament, the Commission or a
Member State for scientific opinions which have been refused or
modified and the justifications for the refusal or modification.
2. 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 theproceedings of some of the Authority's activities.
3. The Authority shall lay down in its internal rules the practical
arrangements for implementing the transparency rules referred to in
paragraphs 1 and 2.
Article 39
Confidentiality
1. By way of derogation from Article 38, the Authority shall not
divulge to third parties confidential information that it receives forwhich confidential treatment has been requested and justified, exceptfor information which must be made public if circumstances so require,
in order to protect public health.
2. Members of the Management Board, the Executive Director,
members of the Scientific Committee and Scientific Panels as well asexternal 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 confi-dentiality pursuant to Article 287 of the Treaty.
3. The conclusions of the scientific opinions delivered by the
Authority relating to foreseeable health effects shall on no account be
kept confidential.
4. The Authority shall lay down in its internal rules the practical
arrangements for implementing the confidentiality rules referred to inparagraphs 1 and 2.
Article 40
CommunicationsfromtheAuthority
1. The Authority shall communicate on its own initiative in the
fields within its mission without prejudice to the Commission's compe-tence to communicate its risk management decisions.
2. The Authority shall ensure that the public and any interested
parties are rapidly given objective, reliable and easily accessible infor-
mation, in particular withregard to th e results of its work. In order to
achieve these objectives, the Authority shall develop and disseminateinformation material for the general public.
3. The Authority shall act in close collaboration with the Commis-
sion and the Member States to promote the necessary coherence in the
risk communication process.
The Authority shall publish all opinions issued by it in accordance with
Article 38.2002R0178 — EN — 01.10.2003 — 001.001 — 28
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4. The Authority shall ensure appropriate cooperation with the
competent bodies in the Member States and other interested partieswithregard to public information campaigns.
Article 41
Accesstodocuments
1. Regulation (EC) No 1049/2001 of the European Parliament and
of the Council of 30 May 2001 regarding access to European Parlia-ment, Council and Commission documents(
1) shall apply to
documents held by the Authority.
2. The Management Board shall adopt the practical arrangements for
implementing Regulation (EC) No 1049/2001 within six months after
the entry into force of Regulation (EC) No 1642/2003 of the EuropeanParliament and of the Council of 22 July 2003 amending Regulation(EC) No 178/2002 laying down the general principles and requirementsof food law, establishing the European Food Safety Authority and
laying down procedures in matters of food safety (
2).
3. Decisions taken by the Authority pursuant to Article 8 of Regula-
tion (EC) No 1049/2001 may form the subject of a complaint to theOmbudsman or of an action before the Court of Justice, under theconditions laid down in Articles 195 and 230 of the EC Treaty respec-
tively.
Article 42
Consumers,producersandotherinterestedparties
The Authority shall develop effective contacts with consumer represen-
tatives, producer representatives, processors and any other interestedparties.
SECTION 5
FINANCIALPROVISIONS
Article 43
AdoptionoftheAuthority'sbudget
1. The revenues of the Authority shall consist of a contribution from
the Community and, from any State with which the Community hasconcluded the agreements referred to in Article 49, and charges forpublications, conferences, training and any other similar activitiesprovided by the Authority.
2. The expenditure of the Authority shall include the staff, adminis-
trative, infrastructure and operational expenses, and expenses resultingfrom contracts entered into with third parties or resulting from thefinancial support referred to in Article 36.
3. The Executive Director shall draw up, in good time before the
date referred to in paragraph5, a draft statement of estimates of th eAuthority's revenue and expenditure for the following financial year
and shall forward it to the Management Board, together with the estab-
lishment plan.
4. Revenue and expenditure shall be in balance.5. Each year the Management Board, on the basis of a draft state-
ment of estimates of revenue and expenditure, shall produce a
statement of estimates of revenue and expenditure of the Authority forthe following financial year. This statement of estimates, which shall2002R0178 — EN — 01.10.2003 — 001.001 — 29
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include a draft establishment plan together with the provisional work
programmes, shall be forwarded by 31 March at the latest by theManagement Board to the Commission and to the countries with which
the Community has concluded agreements in accordance with Article
49.
6. The statement of estimates shall be forwarded by the Commission
to the European Parliament and the Council (hereinafter referred to asthe budgetary authority) together with the preliminary draft generalbudget of the European Union.
7. 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 amountof the subsidy to be charged to the general budget, which it shall placebefore the budgetary authority in accordance with Article 272 of theTreaty.
8. The budgetary authority shall authorise the appropriations for the
subsidy to the Authority.
The budgetary authority shall adopt the establishment plan for the
Authority.
9. The budget shall be adopted by the Management Board. It shall
become final following final adoption of the general budget of theEuropean Union. Where appropriate, it shall be adjusted accordingly.
10. The Management Board shall, as soon as possible, notify the
budgetary authority of its intention to implement any project whichmay have significant financial implications for the funding of the
budget, in particular any projects relating to property suchas th e rental
or purchase of buildings. It shall inform the Commission thereof.
Where a branch of the budgetary authority has notified its intention to
deliver an opinion, it shall forward its opinion to the ManagementBoard within a period of six weeks from the date of notification ofthe project.
Article 44
ImplementationoftheAuthority'sbudget
1. The Executive Director shall implement the Authority's budget.2. By 1 March at the latest following each financial year, the
Authority's accounting officer shall communicate the provisionalaccounts 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 provisionalaccounts of the institutions and decentralised bodies in accordancewithArticle 128 of th e general Financial Regulation.
3. By 31 March at the latest following each financial year, the
Commission's accounting officer shall forward the Authority's provi-sional 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 shallalso be forwarded to the European Parliament and the Council.
4. On receipt of the Court of Auditors' observations on the Author-
ity's provisional accounts under Article 129 of the general FinancialRegulation, the Executive Director shall draw up the Authority's final
accounts under his own responsibility and submit them to the Manage-
ment Board for an opinion.
5. The Management Board shall deliver an opinion on the Author-
ity's final accounts.
6. The Executive Director shall, by 1 July at the latest following
each financial year, forward the final accounts to the European Parlia-ment, the Council, the Commission and the Court of Auditors, togetherwithth e Management Board's opinion.
7. The final accounts shall be published.2002R0178 — EN — 01.10.2003 — 001.001 — 30
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8. The Executive Director shall send the Court of Auditors a reply
to its observations by 30 September at the latest. He shall also sendthis reply to the Management Board.
9. The Executive Director shall submit to the European Parliament,
at the latter's request, all information necessary for the smooth applica-tion of the discharge procedure for the financial year in question, as
laid down in Article 146(3) of the general Financial Regulation.
10. 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.
Article 45
Feesreceived bytheAuthority
Within three years following the date of entry into force of this Regu-
lation and after consulting the Authority, the Member States and theinterested parties, the Commission shall publish a report on the feasi-
bility and advisability of presenting a legislative proposal under the
co-decision procedure and in accordance with the Treaty and for otherservices provided by the Authority.
SECTION 6
GENERALPROVISIONS
Article 46
Legalpersonalityandprivileges
1. The Authority shall have legal personality. In all Member States
it shall enjoy the widest powers granted by law to legal persons. Inparticular, it may acquire and dispose of movable and immovable prop-
erty and institute legal proceedings.
2. The Protocol on the privileges and immunities of the European
Communities shall apply to the Authority.
Article 47
Liability
1. The contractual liability of the Authority shall be governed by the
law applicable to the contract in question. The Court of Justice of theEuropean Communities shall have jurisdiction to give judgmentpursuant to any arbitration clause contained in a contract concluded
by the Authority.
2. 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 juris-diction in any dispute relating to compensation for suchdamage.
3. The personal liability of its servants towards the Authority shall
be governed by the relevant provisions applying to the staff of the
Authority.
Article 48
Staff
1. The staff of the Authority shall be subject to the rules and regula-
tions applicable to officials and other staff of the European
Communities.
2. In respect of its staff, the Authority shall exercise the powers
which have been devolved to the appointing authority.2002R0178 — EN — 01.10.2003 — 001.001 — 31
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Article 49
Participation ofthirdcountries
The Authority shall be open to the participation of countries which
have concluded agreements with the European Community by virtueof which they have adopted and apply Community legislation in thefield covered by this Regulation.
Arrangements shall be made under the relevant provisions of those
agreements, specifying in particular the nature, extent and manner inwhich these countries will participate in the Authority's work, includingprovisions 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 contributionsand staff.
CHAPTER IV
RAPIDALERTSYSTEM,CRISISMANAGEMENTANDEMER-
GENCIES
SECTION 1
RAPIDALERTSYSTEM
Article 50
Rapidalertsystem
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 theAuthority. The Member States, the Commission and the Authority shalleach designate a contact point, which shall be a member of thenetwork. The Commission shall be responsible for managing thenetwork.
2. Where a member of the network has any information relating to
the existence of a serious direct or indirect risk to human healthderiving from food or feed, this information shall be immediately noti-
fied to the Commission under the rapid alert system. The Commission
shall transmit this information immediately to the members of thenetwork.
The Authority may supplement the notification with any scientific or
technical information, which will facilitate rapid, appropriate riskmanagement action by the Member States.
3. Without prejudice to other Community legislation, the Member
States shall immediately notify the Commission under the rapid alertsystem 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 recallof food or feed in order to protect human health and requiring rapidaction;
(b) any recommendation or agreement withprofessional operators
which is aimed, on a voluntary or obligatory basis, at preventing,limiting or imposing specific conditions on the placing on themarket or the eventual use of food or feed on account of a seriousrisk to human health requiring rapid action;
(c) any rejection, related to a direct or indirect risk to human health, of
a batch, container or cargo of food or feed by a competent
authority at a border post within the European Union.
The notification shall be accompanied by a detailed explanation of the
reasons for the action taken by the competent authorities of the
Member State in which the notification was issued. It shall befollowed, in good time, by supplementary information, in particularwhere the measures on which the notification is based are modified orwithdrawn.2002R0178 — EN — 01.10.2003 — 001.001 — 32
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The Commission shall immediately transmit to members of the
network the notification and supplementary information received underthe 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 shallimmediately notify all the border posts within the European Union, as
well as the third country of origin.
4. 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.
5. The Member States shall immediately inform the Commission of
the action implemented or measures taken following receipt of the noti-
fications and supplementary information transmitted under the rapid
alert system. The Commission shall immediately transmit this informa-tion to the members of the network.
6. Participation in the rapid alert system may be opened up to appli-
cant countries, third countries or international organisations, on thebasis of agreements between the Community and those countries orinternational organisations, in accordance withth e procedures definedin those agreements. The latter shall be based on reciprocity and shallinclude confidentiality measures equivalent to those applicable in the
Community.
Article 51
Implementingmeasures
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 shallspecify, in particular, the specific conditions and procedures applicableto the transmission of notifications and supplementary information.
Article 52
Confidentialityrulesfortherapidalert 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 beavailable to the public in accordance with the information principleprovided for in Article 10. In general, the public shall have access toinformation on product identification, the nature of the risk and the
measure taken.
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 informationwhich must be made public, if circumstances so require, in order toprotect human health.
2. Protection of professional secrecy shall not prevent the dissemina-
tion to the competent authorities of information relevant to theeffectiveness of market surveillance and enforcement activities in thefield of food and feed. The authorities receiving information coveredby professional secrecy shall ensure its protection in conformity with
paragraph1.
SECTION 2
EMERGENCIES
Article 53
Emergency measures for food and feed of Community origin or
importedfromathirdcountry
1. Where it is evident that food or feed originating in the Commu-
nity or imported from a third country is likely to constitute a serious2002R0178 — EN — 01.10.2003 — 001.001 — 33
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risk to human health, animal health or the environment, and that such
risk cannot be contained satisfactorily by means of measures taken bythe Member State(s) concerned, the Commission, acting in accordance
withth e procedure provided for in Article 58(2) on its own initiative or
at the request of a Member State, shall immediately adopt one or moreof 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 ques-
tion;
(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 theMember 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 accordancewith the procedure referred to in Article 58(2), and the reasons for theCommission'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 notacted in accordance withArticle 53, th e Member State may adoptinterim protective measures. In this event, it shall immediately informthe 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) witha view to th e 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
CRISISMANAGEMENT
Article 55
General planforcrisismanagement
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 feedwhich are not likely to be prevented, eliminated or reduced to anacceptable level by provisions in place or cannot adequately bemanaged solely by way of the application of Articles 53 and 54.2002R0178 — EN — 01.10.2003 — 001.001 — 34
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The general plan shall also specify the practical procedures necessary
to manage a crisis, including the principles of transparency to beapplied and a communication strategy.
Article 56
Crisisunit
1. Without prejudice to its role of ensuring the application of
Community law, where the Commission identifies a situation involvinga serious direct or indirect risk to human health deriving from food andfeed, and the risk cannot be prevented, eliminated or reduced byexisting provisions or cannot adequately be managed solely by way ofthe 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 technicalassistance if necessary.
Article 57
Tasksofthecrisisunit
1. The crisis unit shall be responsible for collecting and evaluating
all relevant information and identifying the options available toprevent, eliminate or reduce to an acceptable level the risk to humanhealth 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 effec-tively.
3. The crisis unit shall keep the public informed of the risks
involved and the measures taken.
CHAPTER V
PROCEDURESANDFINALPROVISIONS
SECTION 1
COMMITTEEANDMEDIATIONPROCEDURES
Article 58
Committee
1. The Commission shall be assisted by a Standing Committee on
the Food Chain and Animal Health, hereinafter referred to as the‘Committee’, composed of representatives of the Member States andchaired by the representative of the Commission. The Committee shallbe organised in sections to deal withall relevant matters.
2. Where reference is made to this paragraph, the procedure laid
down in Article 5 of Decision 1999/468/EC shall apply, in compliancewithArticles 7 and 8 th ereof.
3. The period provided for in Article 5(6) of Decision 1999/468/EC
shall be three months.
Article 59
FunctionsassignedtotheCommittee
The Committee shall carry out the functions assigned to it by this
Regulation and by other relevant Community provisions, in the casesand conditions provided for in those provisions. It may also examineany issue falling under those provisions, either at the initiative of theChairman or at the written request of one of its members.2002R0178 — EN — 01.10.2003 — 001.001 — 35
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Article 60
Mediationprocedure
1. Without prejudice to the application of other Community provi-
sions, where a Member State is of the opinion that a measure takenby another Member State in the field of food safety is either incompa-tible 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 thatrequest and the time limit within which the Authority is requested togive its opinion shall be established by mutual agreement between theCommission and the Authority, after consulting the two Member Statesconcerned.
SECTION 2
FINALPROVISIONS
Article 61
Reviewclause
1. Before 1 January 2005 and every six years thereafter, the
Authority, in collaboration with the Commission, shall commission anindependent external evaluation of its achievements on the basis of theterms of reference issued by the Management Board in agreement withthe Commission. The evaluation will assess the working practices and
the impact of the Authority. The evaluation will take into account the
views of the stakeholders, at both Community and national level.
The Management Board of the Authority shall examine the conclusions
of the evaluation and issue to the Commission such recommendations
as may be necessary regarding changes in the Authority and its
working practices. The evaluation and the recommendations shall bemade public.
2. Before 1 January 2005, the Commission shall publish a report on
the experience acquired from implementing Sections 1 and 2 of
Chapter IV.
3. The reports and recommendations referred to in paragraphs 1 and
2 shall be forwarded to the Council and the European Parliament.
Article 62
References to the European Food Safety Authority and to the
StandingCommitteeontheFoodChainandAnimalHealth
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 Pesti-cides, the Scientific Committee on Plants and the Scientific SteeringCommittee shall be replaced by a reference to the European FoodSafety Authority.
2. Every reference in Community legislation to the Standing
Committee on Foodstuffs, the Standing Committee for Feedingstuffsand the Standing Veterinary Committee shall be replaced by a refer-ence to the Standing Committee on the Food Chain and Animal Health.
Every reference to the Standing Committee on Plant Health in Commu-
nity legislation based upon and including Directives 76/895/EEC, 86/362/EEC, 86/363/EEC, 90/642/EEC and 91/414/EEC relating to plantprotection products and the setting of maximum residue levels shallbe replaced by a reference to the Standing Committee on the FoodChain and Animal Health.2002R0178 — EN — 01.10.2003 — 001.001 — 36
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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 Medic-
inalProducts
This Regulation shall be without prejudice to the competence conferred
on the European Agency for the Evaluation of Medicinal Products byRegulation (EEC) No 2309/93, Regulation (EEC) No 2377/90, CouncilDirective 75/319/EEC (
1) and Council Directive 81/851/EEC (2).
Article 64
CommencementoftheAuthority'soperation
The Authority shall commence its operations on 1 January 2002.
Article 65
Entryintoforce
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.2002R0178 — EN — 01.10.2003 — 001.001 — 37
(1) 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).
(2) 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).