Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
Date: 2002-01-28
Institutions: Council of the European Union, European Parliament
Subjects: European Food Safety Authority, animal feedingstuffs, consumer protection, food safety, foodstuff, foodstuffs legislation, health control, human nutrition, traceability, trading operation

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(Acts whose publication is obligatory)

REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down the general principles and requirements of food law, establishing the European Food
Safety Authority and laying down procedures in matters of food safety

of 28 January 2002

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),

(5)

Having regard to the opinion of the Economic and Social
Committee (2),

Having regard to the opinion of
Regions (3),

the Committee of

the

Acting in accordance with the procedure laid down in Article
251 of the Treaty (4),

Whereas:

(1)

(2)

(3)

The free movement of safe and wholesome food is an
essential aspect of the internal market and contributes
significantly to the health and well-being of citizens, and
to their social and economic interests.

A high level of protection of human life and health
should be assured in the pursuit of Community policies.

The free movement of
food and feed within the
Community can be achieved only if food and feed safety
requirements do not differ significantly from Member
State to Member State.

(4)

There are important differences in relation to concepts,
principles and procedures between the food laws of

(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 Offi-

cial 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 (not yet published in the Official
Journal) and
Decision of the European Parliament of 11 December 2001 (not yet
published in the Official
Journal). Council Decision of 21 January
2002.

the Member States. When Member States adopt meas-
ures governing food, these differences may impede the
free movement of food, create unequal conditions of
competition, and may thereby directly affect the func-
tioning of the internal market.

it

is necessary to approximate these
Accordingly,
concepts, principles and procedures so as to form a
common basis for measures governing food and feed
taken in the Member States and at Community level. It is
however necessary to provide for sufficient time for the
adaptation of any conflicting provisions in existing legis-
lation, both at national and Community level, and to
provide that, pending such adaptation, the relevant legis-
lation be applied in the light of the principles set out in
the present Regulation.

(6) Water is ingested directly or indirectly like other foods,
thereby contributing to the overall exposure of a
consumer to ingested substances, including chemical and
microbiological contaminants. However, as the quality
of water intended for human consumption is already
controlled by Council Directives 80/778/EEC (5) and 98/
83/EC (6), it suffices to consider water after 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
include requirements for feed, including its production
and use where that feed is intended for food-producing
animals. This is without prejudice to the similar require-
ments which have been applied so far and which will be
applied in the future in feed legislation applicable to all
animals,

including pets.

(8)

The Community has chosen a high level of health
protection as appropriate in the development of food
law, which it applies in a non-discriminatory manner
whether food or feed is traded on the internal market or
internationally.

(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.

(9)

(10)

(11)

(12)

(13)

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It is necessary to ensure that consumers, other stake-
holders and trading partners have confidence in the
decision-making processes underpinning food law,
its
scientific basis and the structures and independence of
the institutions protecting health and other interests.

Recourse to a risk analysis prior to the adoption of such
measures should facilitate the avoidance of unjustified
barriers to the free movement of foodstuffs.

Experience has shown that it is necessary to adopt meas-
ures aimed at guaranteeing that unsafe food is not
placed on the market and at ensuring that systems exist
to identify and respond to food safety problems in order
to ensure the proper functioning of the internal market
and to protect human health. Similar issues relating to
feed safety should be addressed.

(17) Where food law is aimed at the reduction, elimination or
avoidance of a risk to health, the three interconnected
components of risk analysis — risk assessment, risk
management, and risk communication — provide a
systematic methodology for the determination of effec-
tive, proportionate and targeted measures or other
actions to protect health.

In order to take a sufficiently comprehensive and inte-
grated approach to food safety, there should be a broad
definition of food law covering a wide range of provi-
sions with a direct or indirect effect on the safety of food
and feed, including provisions on materials and articles
in contact with food, animal feed and other agricultural
inputs at the level of primary production.

In order to ensure the safety of food, it is necessary to
consider all aspects of the food production chain as a
continuum from and including primary production and
the production of animal feed up to and including sale
or supply of food to the consumer because each element
may have a potential

impact on food safety.

Experience has shown that for this reason it is necessary
to consider the production, manufacture, transport and
distribution of feed given to food-producing animals,
including the production of animals which may be used
as feed on fish farms, since the inadvertent or deliberate
contamination of feed, and adulteration or fraudulent or
other bad practices in relation to it, may give rise to a
direct or indirect impact on food safety.

(14)

For the same reason, it is necessary to consider other
practices and agricultural inputs at the level of primary
production and their potential effect on the overall
safety of food.

(15) Networking of

laboratories of excellence, at regional
level, with the aim of ensuring
and/or interregional
continuous monitoring of food safety, could play an
important role in the prevention of potential health risks
for citizens.

(16) Measures adopted by the Member States and the
Community governing food and feed should generally
be based on risk analysis except where this is not appro-
priate to the circumstances or the nature of the measure.

(18)

In order for there to be confidence in the scientific basis
for food law, risk assessments should be undertaken in
an independent, objective and transparent manner, on
the basis of the available scientific information and data.

(19)

(20)

(21)

(22)

It
is recognised that scientific risk assessment alone
cannot, in some cases, provide all the information on
which a risk management decision should be based, and
that other factors relevant to the matter under considera-
tion should legitimately be taken into account including
societal, economic,
traditional, ethical and environ-
mental factors and the feasibility of controls.

The precautionary principle has been invoked to ensure
health protection in the Community, thereby giving rise
to barriers to the free movement of food or feed. There-
fore it is necessary to adopt a uniform basis throughout
the Community for the use of this principle.

scientific uncertainty persists,

In those specific circumstances where a risk to life or
health exists but
the
precautionary principle provides a mechanism for deter-
mining risk management measures or other actions in
order to ensure the high level of health protection
chosen in the Community.

Food safety and the protection of consumer's interests is
of increasing concern to the general public, non-govern-
mental organisations, professional associations,
inter-
national trading partners and trade organisations. It is
necessary to ensure that consumer confidence 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 inform the public where there are reasonable grounds
to suspect that a food may present a risk to health.

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(23)

(24)

(25)

(26)

(27)

(28)

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, in this context, it has entered into
international
it contributes to the
development of international standards which 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.

trade agreements,

It is necessary to ensure that food and feed exported or
re-exported from the Community
complies with
Community law or the requirements set up by the
food and
importing country.
feed can only be exported or
the
importing country has expressly agreed. However, it is
necessary to ensure that even where there is agreement
of the importing country, food injurious to health or
unsafe feed is not exported or re-exported.

In other circumstances,

re-exported if

ensure that on investigation, traceability can be assured
at all stages.

thus,

(30) A food business operator is best placed to devise a safe
system for supplying food and ensuring that the food it
supplies is safe;
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 not explicit or else
responsibility is assumed by the competent authorities of
the Member State through the control activities they
carry out. Such disparities are liable to create barriers to
trade and distort competition between food business
operators in different Member States.

(31)

Similar requirements should apply to feed and feed busi-
ness operators.

It is necessary to establish the general principles upon
which food and feed may be traded and the objectives
and principles for the contribution of the Community to
developing international standards and trade agreements.

Some Member States have adopted horizontal legislation
on food safety imposing, in particular, a general obliga-
tion on economic operators to market only food that is
safe. However, these Member States apply different basic
criteria for establishing whether a food is safe. Given
these different approaches, and in the absence of hori-
legislation in other Member States, barriers to
zontal
trade in foods are liable to arise. Similarly such barriers
may arise to trade in feed.

It is therefore necessary to establish general requirements
for only safe food and feed to be placed on the market,
to ensure that the internal market in such products
functions effectively.

(32)

(33)

(34)

shown that

the functioning of

Experience has
the
internal market in food or feed can be jeopardised where
it is impossible to trace food and feed. It is therefore
necessary to establish a comprehensive system of trace-
ability within food and feed businesses so that targeted
and accurate withdrawals can be undertaken or informa-
tion given to consumers or control officials, thereby
avoiding the potential for unnecessary wider disruption
in the event of food safety problems.

The scientific and technical basis of Community legisla-
tion relating to the safety of
food and feed should
contribute to the achievement of a high level of health
protection within the Community. The Community
should have access to high-quality, independent and effi-
cient scientific and technical support.

The scientific and technical issues in relation to food and
feed safety are becoming increasingly important and
complex. The establishment 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 longer able to respond to
increasing demands on it.

food law,

to the general principles of

Pursuant
the
Authority should take on the role of an independent
scientific point of reference in risk assessment and in so
doing should assist in ensuring the smooth functioning
of the internal market. It may be called upon to give
opinions on contentious
thereby
enabling the Community institutions and Member States
to take informed risk management decisions necessary
to ensure food and feed safety whilst helping avoid the
fragmentation of the internal market through the adop-
tion of unjustified or unnecessary obstacles to the free
movement of food and feed.

scientific

issues,

(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 food or feed has been supplied, to

(35)

The Authority should be an independent
scientific
source of advice, information and risk communication
in order to improve consumer confidence; nevertheless,
in order to promote coherence between the risk assess-
ment, risk management and risk communication func-
tions, the link between risk assessors and risk managers
should be strengthened.

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(36)

(37)

(38)

(39)

(40)

The Authority should provide a comprehensive indepen-
dent scientific view of the safety and other aspects of the
whole food and feed supply chains, which implies wide-
ranging responsibilities 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 on food safety, so its
mission in relation to animal health, animal welfare 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
cover
scientific advice and scientific and technical
support on human nutrition in relation to Community
its
legislation and assistance to the Commission at
request on communication linked to Community health
programmes.

Since some products authorised under food law such as
pesticides or additives in animal feed may involve risks
to the environment or to the safety of workers, some
environmental and worker protection aspects should
also be assessed by the Authority in accordance with the
relevant legislation.

(GMOs),

In order to avoid duplicated scientific assessments and
related scientific opinions on genetically modified organ-
isms
the Authority should also provide
scientific opinions on products other than food and feed
relating to GMOs as defined by Directive 2001/18/EC (1)
and without prejudice to the procedures established
therein.

The Authority should contribute through the provision
of support on scientific matters, to the Community's and
Member States' role in the development and establish-
ment of international food safety standards and trade
agreements.

the Community institutions,

The confidence of
the
general public and interested parties in the Authority is
essential. For this reason, it is vital to ensure its indepen-
transparency and effi-
dence, high scientific quality,
ciency. Cooperation with Member States is also indis-
pensable.

(41)

To that effect
the Management Board should be
appointed in such a way as to secure the highest
standard of competence, a broad range of relevant
for instance in management and in public
expertise,
administration, and the broadest possible geographic

(1) Directive 2001/18/EC of

the
Council of 12 March 2001 on the deliberate release into the envi-
ronment of genetically modified organisms and repealing Council
Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

the European Parliament and of

distribution within the Union. This should be facilitated
by a rotation of the different countries of origin of the
members 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)

(44)

(45)

The Management Board should have the necessary
powers to establish the budget, check its implementa-
tion, draw up internal rules, adopt financial regulations,
appoint members of
the Scientific Committee and
Scientific Panels and appoint the Executive Director.

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 Executive Director, to constitute a mechanism of
exchange of information, and to ensure close coopera-
tion in particular with regard to the networking system.
Cooperation and appropriate exchange of information
should also minimise
for diverging
scientific opinions.

the potential

The Authority should take over the role of the Scientific
Committees attached to the Commission in issuing
scientific opinions in its field of competence. It is neces-
sary to reorganise these Committees to ensure greater
scientific consistency in relation 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
provide these opinions.

(46)

In order to guarantee independence, members of the
Scientific Committee and Panels should be independent
scientists recruited on the basis of an open application
procedure.

(47)

The Authority's role as an independent scientific point
of reference means that a scientific opinion may be
requested not only by the Commission, but also by the
European Parliament and the Member States. In order to
ensure the manageability and consistency of the process
of scientific advice, the Authority should be able to
refuse or amend a request providing justification for this
and 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 or provide the risk managers
with a transparent basis of scientific information.

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(48)

(49)

(50)

(51)

(52)

The Authority should also be able to commission
scientific studies 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 should be done in an open and
transparent fashion and the Authority should take into
account existing Community expertise and structures.

The lack of an effective system of collection and analysis
at Community level of data on the food supply chain is
recognised as 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 the Authority. A
review of Community data collection networks already
existing in the fields covered by the Authority is called
for.

Improved identification of emerging risks may in the
long term be 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 anticipatory task of collecting
information and exercising vigilance and providing
evaluation of and information on emerging risks with a
view to their prevention.

The establishment of
the Authority should enable
Member States to become more closely involved in
scientific procedures. There should therefore be close
cooperation between the Authority and the Member
States for this purpose.
the Authority
should be able to assign certain tasks to organisations in
the Member States.

In particular,

It is necessary to ensure that a balance is struck between
the need to use national organisations to carry out tasks
for the Authority and the need to ensure for the
purposes of overall consistency 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 particular with regard to
the evaluation of dossiers presented by industry for the
authorisation of certain substances, products or proced-
ures, should be re-examined within a year with the
objective of 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 commu-
nicating risk management measures. The appropriate
information should therefore be exchanged between the
Authority and the Commission. Close cooperation
between the Authority,
the Commission and the
Member States is also necessary to ensure the coherence
of the global communication process.

communicate autonomously in the fields falling within
its competence, its purpose being to provide objective,
reliable and easily understandable information.

(55) Appropriate cooperation with the Member States and
other interested parties is necessary in the specific field
of public information campaigns to take into account
any regional parameters and any correlation with health
policy.

(56)

(57)

In addition to its operating principles based on indepen-
dence and transparency, the Authority should be an
organisation open to contacts with consumers and other
interested groups.

The Authority should be financed by the general budget
of the European Union. However, in the light of experi-
ence acquired, in particular with regard to the processing
of authorisation dossiers presented by industry, the poss-
ibility of fees should be examined within three years
following the entry into force of this Regulation. The
Community budgetary procedure remains applicable as
far as any subsidies chargeable to the general budget of
the European Union are concerned. Moreover,
the
auditing of accounts should be undertaken by the Court
of Auditors.

(58)

It is necessary to allow for the participation of European
the European
countries which are not members of
Union and which have concluded agreements obliging
them to transpose
the body of
Community law in the field covered by this Regulation.

and implement

(59) A system for rapid alert already exists in the framework
of Council Directive 92/59/EEC of 29 June 1992 on
general product safety (1). The scope of
the existing
system includes food and industrial products but not
feed. Recent food crises have demonstrated the need to
set up an improved and broadened rapid alert system
covering food and feed. This revised system 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
Community arrangements for the early exchange of
information in the event of a radiological emergency as
defined in Council Decision 87/600/Euratom (2).

(60)

Recent food safety incidents have demonstrated the need
to establish appropriate measures in emergency situa-
tions ensuring that all foods, whatever their type and
origin, and all feed should be subject to common meas-
ures in the event of a serious risk to human 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 disparities in the treatment of a serious risk in
relation to food or feed.

(54)

The independence of
the Authority and its role in
informing the public mean that it should be able to

(1) OJ L 228, 11.8.1992, p. 24.
(2) OJ L 371, 30.12.1987, p. 76.

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(61)

(62)

Recent food crises have also shown the benefits to the
Commission of having properly adapted, more rapid
procedures for crisis management. These organisational
procedures should make it possible to improve coordi-
nation of effort and to determine the most effective
measures on the basis of the best scientific information.
Therefore, revised procedures should take into account
the Authority's responsibilities and should provide for its
scientific and technical assistance in the form of advice
in the event of a food crisis.

In order to ensure a more effective, comprehensive
approach to the 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 the Standing Committee
for Feedingstuffs. Accordingly, Council Decisions 68/
361/EEC (1), 69/414/EEC (2), and 70/372/EEC (3), should
be repealed. For the same reason the Committee on the
Food Chain and Animal Health should also replace the
Standing Committee on Plant Health in relation to its
competence
86/
362/EEC (5), 86/363/EEC (6), 90/642/EEC (7) and 91/
414/EEC (8)) on plant protection products and the
setting of maximum residue levels.

(for Directives

76/895/EEC (4),

(64)

(65)

(66)

It is necessary that operators should have sufficient time
to adapt to some of the requirements established by the
present Regulation and that the European Food Safety
Authority should commence its operations on 1 January
2002.

It is important to avoid confusion between the missions
of the Authority and the European Agency for the Evalu-
ation of Medicinal Products
(EMEA) established by
Council Regulation (EEC) No 2309/93 (10). Conse-
quently, it is necessary to establish that this Regulation is
without prejudice to the competence conferred on the
EMEA by Community legislation,
including powers
conferred by Council Regulation (EEC) No 2377/90 of
26 June 1990 laying down a Community procedure for
the establishment of maximum residue limits of veter-
inary medicinal products
animal
origin (11).

in foodstuffs of

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 proced-
ures forming a common basis for food law in the
Community and to establish a European Food Safety
Authority. In accordance with the principle of propor-
tionality as set out in Article 5 of the Treaty, this Regula-
tion does not go beyond what is necessary in order to
achieve the objectives pursued,

(63)

The measures necessary for the implementation of this
Regulation should be adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (9).

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SCOPE AND DEFINITIONS

Article 1

Aim and scope

1.
This Regulation provides the basis for the assurance of a
high level of protection of human health and consumers'
interest in relation to food, taking into account in particular the
diversity in the supply of food including traditional products,
whilst ensuring the effective functioning of the internal market.

(1) OJ L 255, 18.10.1968, p. 23.
(2) OJ L 291, 19.11.1969, p. 9.
(3) OJ L 170, 3.8.1970, p. 1.
(4) OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commis-

sion Directive 2000/57/EC (OJ L 244, 29.9.2000, p. 76).

(5) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commis-

sion Directive 2001/57/EC (OJ L 208, 1.8.2001, p. 36).

(6) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commis-

sion Directive 2001/57/EC.

the
It establishes common principles and responsibilities,
means to provide a strong science base, efficient organisational
arrangements and procedures to underpin decision-making in
matters of food and feed safety.

2.
For the purposes of paragraph 1, this Regulation lays
down the general principles governing food and feed in
general, and food and feed safety in particular, at Community
and national

level.

It establishes the European Food Safety Authority.

It lays down procedures for matters with a direct or indirect
impact on food and feed safety.

(7) OJ L 350, 14.12.1990, p. 71. Directive as

last amended by

(10) OJ L 214, 24.8.1993, p. 1. Regulation amended by Commission

Commission Directive 2001/57/EC.

(8) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commis-

sion Directive 2001/49/EC (OJ L 176, 29.6.2001, p. 61).

(9) OJ L 184, 17.7.1999, p. 23.

Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).

(11) 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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This Regulation shall apply to all stages of production,
3.
processing and distribution of food and feed. It shall not apply
to primary production for private domestic use or to the
domestic preparation, handling or storage of food for private
domestic consumption.

Article 2

Definition of ‘food’

For the purposes of this Regulation, ‘food’ (or ‘foodstuff’) means
any substance or product, whether processed, partially
reasonably
processed or unprocessed,
expected to be ingested by humans.

intended to be, or

includes drink, chewing gum and any substance,
‘Food’
including water,
intentionally incorporated into the food
during its manufacture, preparation or treatment. It includes
water after the point of compliance as defined in Article 6 of
Directive 98/83/EC and without prejudice to the requirements
of Directives 80/778/EEC and 98/83/EC.

‘Food’ shall not include:

(a) feed;

of food, and also of feed produced for, or fed to, food-
producing animals;

2.

‘food business’ means any undertaking, whether for profit
or not and whether public or private, carrying out any of
the activities related to any stage of production, processing
and distribution of food;

3.

‘food business operator’ means the natural or legal persons
responsible for ensuring that the requirements of food law
are met within the food business under their control;

4.

5.

‘feed’ (or ‘feedingstuff’) means any substance or product,
including additives, whether processed, partially processed
or unprocessed, intended to be used for oral feeding to
animals;

‘feed business’ means any undertaking whether for profit
or not and whether public or private, carrying out any
operation of production, manufacture, processing, storage,
transport or distribution of feed including any producer
producing, processing or storing feed for
feeding to
animals on his own holding;

(b) live animals unless they are prepared for placing on the

market for human consumption;

6.

‘feed business operator’ means the natural or legal persons
responsible for ensuring that the requirements of food law
are met within the feed business under their control;

(c) plants prior to harvesting;

(d) medicinal products within the meaning of Council Direct-

7.

ives 65/65/EEC (1) and 92/73/EEC (2);

(e) cosmetics within the meaning of Council Directive 76/

768/EEC (3);

(f) tobacco and tobacco products within the meaning of

Council Directive 89/622/EEC (4);

(g) narcotic or psychotropic substances within the meaning of
the United Nations Single Convention on Narcotic Drugs,
1961, and the United Nations Convention on Psychotropic
Substances, 1971;

(h) residues and contaminants.

Article 3

Other definitions

For the purposes of this Regulation:

‘retail’ means the handling and/or processing of food and
its storage at the point of sale or delivery to the final
consumer, and includes distribution terminals, catering
operations, factory canteens, institutional catering, restau-
rants and other similar food service operations, shops,
supermarket distribution centres and wholesale outlets;

8.

‘placing on the market’ means the holding of food or feed
for the purpose of sale, including offering for sale or any
other form of transfer, whether free of charge or not, and
the sale, distribution, and other forms of transfer them-
selves;

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 intercon-
nected components: risk assessment, risk management and
risk communication;

1.

‘food law’ means the laws, regulations and administrative
provisions governing food in general, and food safety in
particular, whether at Community or national
it
covers any stage of production, processing and distribution

level;

11.

‘risk assessment’ means a scientifically based process
consisting of four steps: hazard identification, hazard char-
acterisation, exposure assessment and risk characterisation;

(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).

12.

‘risk management’ means the process, distinct from risk
assessment, of weighing policy alternatives in consultation
with interested parties, considering risk assessment and
other legitimate factors, and, if need be, selecting appro-
priate prevention and control options;

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13.

14.

15.

‘risk communication’ means the interactive exchange of
information and opinions throughout
the risk analysis
process as regards hazards and risks, risk-related factors
and risk perceptions, among risk assessors, risk managers,
consumers,
the academic
feed and food businesses,
including the
community and other interested parties,
explanation of risk assessment findings and the basis of
risk management decisions;

‘hazard’ means a biological, chemical or physical agent in,
or condition of, food or feed with the potential to cause an
adverse health effect;

‘traceability’ means the ability to trace and follow a food,
feed, food-producing animal or substance intended to be,
or expected to be incorporated into a food or feed,
through all stages of production, processing and distribu-
tion;

16.

including import,

‘stages of production, processing and distribution’ means
any stage,
from and including the
primary production of a food, up to and including its
storage, transport, sale or supply to the final consumer
and, where relevant, the importation, production, manu-
facture, storage, transport, distribution, sale and supply of
feed;

17.

‘primary production’ means the production, rearing or
growing of primary products including harvesting, milking
and farmed animal production prior to slaughter. It also
includes hunting and fishing and the harvesting of wild
products;

18.

‘final consumer’ means the ultimate consumer of a food-
stuff who will not use the food as part of any food
business operation or activity.

CHAPTER II

GENERAL FOOD LAW

Article 4

Scope

Food law shall aim to achieve the free movement in the
2.
Community of
food and feed manufactured or marketed
according to the general principles and requirements in this
Chapter.

This Chapter relates to all stages of

1.
the production,
processing and distribution of food, and also of feed produced
for, or fed to, food-producing animals.

The principles laid down in Articles 5 to 10 shall form a
2.
general framework of a horizontal nature to be followed when
measures are taken.

Existing food law principles and procedures shall be
3.
adapted as soon as possible and by 1 January 2007 at the latest
in order to comply with Articles 5 to 10.

Until then, and by way of derogation from paragraph 2,
4.
existing legislation shall be implemented taking account of the
principles laid down in Articles 5 to 10.

3. Where international standards exist or their completion is
imminent, they shall be taken into consideration in the devel-
opment or adaptation of food law, except where such stan-
dards or relevant parts would be an ineffective or inappropriate
means for the fulfilment of the legitimate objectives of food
law or where there is a scientific justification, or where they
would result in a different level of protection from the one
determined as appropriate in the Community.

Article 6

Risk analysis

SECTION 1

GENERAL PRINCIPLES OF FOOD LAW

1.
In order to achieve the general objective of a high level of
protection of human health and life, food law shall be based on
risk analysis except where this is not appropriate to the circum-
stances or the nature of the measure.

Article 5

General objectives

2.
Risk assessment shall be based on the available scientific
evidence and undertaken in an independent, objective and
transparent manner.

Food law shall pursue one or more of the general objec-
1.
tives of a high level of protection of human life and health and
the protection of consumers' interests, including fair practices
in food trade, taking account of, where appropriate, the protec-
tion of animal health and welfare, plant health and the environ-
ment.

3.
Risk management shall take into account the results of
the
risk assessment, and in particular,
Authority referred to in Article 22, other factors legitimate to
the matter under consideration and the precautionary principle
where the conditions laid down in Article 7(1) are relevant, in
order to achieve the general objectives of food law established
in Article 5.

the opinions of

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Article 7

Precautionary principle

In specific circumstances where, following an assessment
1.
of available information, the possibility of harmful effects on
health is identified but scientific uncertainty persists, provi-
sional risk management measures necessary to ensure the high
level of health protection chosen in the Community may be
adopted, pending further scientific information for a more
comprehensive risk assessment.

2. Measures adopted on the basis of paragraph 1 shall be
proportionate and no more restrictive of trade than is required
to achieve the high level of health protection chosen in the
Community, regard being had to technical and economic feasi-
bility and other factors regarded as legitimate in the matter
under consideration. The measures shall be reviewed within a
reasonable period of time, depending on the nature of the risk
to life or health identified and the type of scientific information
needed to clarify the scientific uncertainty and to conduct a
more comprehensive risk assessment.

Article 8

Protection of consumers' interests

1.
Food law shall aim at the protection of the interests of
consumers and shall provide a basis for consumers to make
informed choices in relation to the foods they consume. It shall
aim at the prevention of:

(a) fraudulent or deceptive practices;

(b) the adulteration of food; and

a risk for human or animal health, then, depending on the
nature, seriousness and extent of that risk, public authorities
shall take appropriate steps to inform the general public of the
nature of the risk to health, identifying to the fullest extent
possible the food or feed, or type of food or feed, the risk that
it may present, and the measures which are taken or about to
be taken to prevent, reduce or eliminate that risk.

SECTION 3

GENERAL OBLIGATIONS OF FOOD TRADE

Article 11

Food and feed imported into the Community

Food and feed imported into the Community for placing on
the market within the Community shall comply with the rele-
vant requirements of food law or conditions recognised by the
Community to be at
thereto or, where a
least equivalent
specific agreement exists between the Community and the
exporting country, with requirements contained therein.

(c) any other practices which may mislead the consumer.

Article 12

SECTION 2

PRINCIPLES OF TRANSPARENCY

Article 9

Public consultation

There shall be open and transparent public consultation,
directly or through representative bodies, during the prepara-
tion, evaluation and revision of food law, except where the
urgency of the matter does not allow it.

Article 10

Public information

Without prejudice to the applicable provisions of Community
and national
law on access to documents, where there are
reasonable grounds to suspect that a food or feed may present

Food and feed exported from the Community

Food and feed exported or

1.
re-exported from the
Community for placing on the market of a third country shall
comply with the relevant requirements of food law, unless
otherwise requested by the authorities of the importing country
or established by the laws, regulations, standards, codes of
practice and other legal and administrative procedures as 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 reasons for which and the circumstances
in which the food or feed concerned could 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 that Member State to that third country shall
comply with the said provisions.

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Article 13

International standards

Without prejudice
Community and the Member States shall:

to their

rights

and obligations,

In determining whether any food is injurious to health,

4.
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;

the

(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 stan-
dards undertaken by international governmental and non-
governmental organisations;

(c) contribute, where relevant and appropriate, to the develop-
ment of agreements on recognition of the equivalence of
specific food and feed-related measures;

(d) give particular attention to the special development, finan-
cial and trade needs of developing countries, with a view to
ensuring that
create
unnecessary obstacles to exports from developing coun-
tries;

standards do not

international

(e) promote consistency between international technical stan-
dards and food law while ensuring that the high level of
protection adopted in the Community is not reduced.

SECTION 4

GENERAL REQUIREMENTS OF FOOD LAW

Article 14

Food safety requirements

1.

Food shall not be placed on the market if it is unsafe.

Food shall be deemed to be unsafe if it is considered to

2.
be:

(a) injurious to health;

(b) unfit for human consumption.

In determining whether any food is unsafe, regard shall

3.
be had:

(a) to the normal conditions of use of

the food by the
consumer and at each stage 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 the consumer concerning the avoidance of
specific adverse health effects from a particular food or
category of foods.

(b) to the probable cumulative toxic effects;

(c) to the particular health sensitivities of a specific category of
consumers where the food is intended for that category of
consumers.

In determining whether any food is unfit for human
5.
consumption, regard shall be had to whether the food is unac-
ceptable for human consumption according to its intended use,
for reasons of contamination, whether by extraneous matter or
otherwise, or through putrefaction, deterioration or decay.

6. Where any food which is unsafe is part of a batch, lot or
consignment of food of the same class or description, it shall
be presumed that all the food in that batch, lot or consignment
is also unsafe, unless following 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 with specific provisions applicable
to that food shall not bar the competent authorities from
taking appropriate measures to impose restrictions on it being
placed on the market or to require its withdrawal from the
market where there are reasons to suspect that, despite such
conformity, the 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 is marketed, such provisions being drawn up
and applied without prejudice to the Treaty,
in particular
Articles 28 and 30 thereof.

Article 15

Feed safety requirements

Feed shall not be placed on the market or fed to any

1.
food-producing animal

if it is unsafe.

Feed shall be deemed to be unsafe for its intended use if it

2.
is considered to:

— have an adverse effect on human or animal health;

— make the food derived from food-producing animals unsafe

for human consumption.

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3. Where a feed which has been identified as not satisfying
the feed safety requirement is part of a batch, lot or consign-
ment of feed of the same class or description,
it shall be
presumed that all of the feed in that batch, lot or consignment
is so affected, unless following a detailed assessment there is no
evidence that the rest of the batch, lot or consignment fails to
satisfy the feed safety requirement.

monitoring activities
processing and distribution.

covering all

stages of production,

Member States shall also lay down the rules on measures and
penalties applicable to infringements of food and feed law. The
measures and penalties provided for shall be effective, propor-
tionate and dissuasive.

4.
Feed that complies with specific Community provisions
governing feed safety shall be deemed to be safe insofar as the
aspects covered by the specific Community provisions are
concerned.

Conformity of a feed with specific provisions applicable
5.
to that feed shall not bar the competent authorities from taking
appropriate measures to impose restrictions on it being placed
on the market or to require its withdrawal from the market
where
such
conformity, the feed is unsafe.

that, despite

to suspect

there are

reasons

6. Where there are no specific Community provisions, feed
shall be deemed to be safe when it conforms to the specific
provisions of national law governing feed safety of the Member
State in whose territory the feed is in circulation, such provi-
sions being drawn up and applied 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
labelling, advertising and presentation of
feed,
including their shape, appearance or packaging, the packaging
materials used, the manner in which they are arranged and the
setting in which they are displayed, and the information which
is made available about them through whatever medium, shall
not mislead consumers.

food or

Article 17

Responsibilities

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, a food-producing animal, or any substance intended to
be, or expected to 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 avail-
able to the competent authorities 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 competent authorities on
demand.

Food or feed which is placed on the market or is likely to
4.
be placed on the market in the Community shall be adequately
labelled or identified to facilitate its traceability, through rele-
vant documentation or information in accordance with the
relevant requirements of more specific provisions.

5.
Provisions for the purpose of applying the requirements
of this Article in respect of specific sectors may be adopted in
accordance with the procedure laid down in Article 58(2).

1.
Food and feed business operators at all stages of produc-
tion, processing and distribution within the businesses under
their control shall ensure that foods or feeds satisfy the require-
ments of food law which are relevant to their activities and
shall verify that such requirements are met.

2. Member States shall enforce food law, and monitor and
verify that the relevant requirements of food law are fulfilled by
food and feed business operators at all stages of production,
processing and distribution.

For that purpose,
they shall maintain a system of official
controls and other activities as appropriate to the circum-
stances,
including public communication on food and feed
safety and risk, food and feed safety surveillance and other

Article 19

Responsibilities for food: food business operators

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 with the food
safety requirements, it shall immediately initiate procedures to
withdraw the food in question from the market where the food
has left the immediate control of that initial food business
operator and inform the competent authorities thereof. Where
the product may have reached the consumer, the operator 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 sufficient to achieve a high level of health protection.

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responsible for

A food business operator

retail or
2.
distribution activities which do not affect the packaging, label-
ling, safety or integrity 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 in contributing to the safety
of the food by passing on relevant information necessary to
trace a food, cooperating in the action taken by producers,
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
inform the competent
authorities of the action taken to prevent risks to the final
consumer and shall not prevent or discourage any person from
cooperating, in accordance with national law and legal practice,
with the competent authorities, where this may prevent, reduce
or eliminate a risk arising from a food.

shall

Food business operators

4.
shall collaborate with the
competent authorities on action taken to avoid or reduce risks
posed by a food which they supply or have supplied.

Article 20

Responsibilities for feed: feed business operators

If a feed business operator considers or has reason to
1.
believe that a feed which it has imported, produced, processed,
manufactured or distributed does not satisfy the feed safety
requirements, it shall immediately initiate procedures to with-
draw the feed in question from the market and inform the
competent authorities thereof. In these circumstances or, in the
case of Article 15(3), where the batch, lot or consignment does
not satisfy the feed safety requirement,
feed shall be
destroyed, unless the competent authority is satisfied otherwise.
The operator shall effectively and accurately inform users of the

that

feed of the reason for its withdrawal, and if necessary, recall
from them products already supplied when other measures are
not sufficient to achieve a high level of health protection.

A feed business operator responsible for retail or distribu-
2.
tion activities which do not affect the packaging,
labelling,
safety or integrity of the feed shall, within the limits of its
respective activities, initiate procedures to withdraw from the
market products not
in compliance with the feed-safety
requirements and shall participate in contributing to the safety
of food by passing on relevant information necessary to trace a
feed, cooperating in the action taken by producers, processors,
manufacturers and/or the competent authorities.

A feed business operator shall

3.
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 authori-
ties of the action taken to prevent risk arising from the use of
that feed and shall not prevent or discourage any person from
cooperating, in accordance with national law and legal practice,
with the competent authorities, where this may prevent, reduce
or eliminate a risk arising from a feed.

Feed business operators

4.
collaborate with the
competent authorities on action taken in order to avoid risks
posed by a feed which they supply or have supplied.

shall

Article 21

Liability

The provisions of this Chapter shall be without prejudice to
Council Directive 85/374/EEC of 25 July 1985 on the approx-
imation of the laws, regulations and administrative provisions
of the Member States concerning liability for defective prod-
ucts (1).

CHAPTER III

EUROPEAN FOOD SAFETY AUTHORITY

SECTION 1

MISSION AND TASKS

The Authority shall provide scientific advice and scientific
2.
and technical support
for the Community's legislation and
policies in all fields which have a direct or indirect impact on
food and feed safety. It shall provide independent information
on all matters within these fields and communicate on risks.

Article 22

Mission of the Authority

A European Food Safety Authority, hereinafter referred to

1.
as the ‘Authority’,

is hereby established.

3.
The Authority shall contribute to a high level of protec-
tion of human life and health, and in this respect take account
of animal health and welfare, plant health and the environ-
ment, in the context of the operation of the internal market.

(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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The Authority shall collect and analyse data to allow the
4.
characterisation and monitoring of risks which have a direct or
indirect impact on food and feed safety.

The mission of the Authority shall also include the provi-

5.
sion of:

(a) scientific advice and scientific and technical support on
human nutrition in relation to Community legislation and,
at the request of the Commission, assistance concerning
communication on nutritional issues within the framework
of the Community health programme;

(b) scientific opinions on other matters relating to animal

health and welfare and plant health;

(c) scientific opinions on products other than food and feed
relating to genetically modified organisms as defined by
Directive 2001/18/EC and without prejudice to the proced-
ures 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.

The Authority shall carry out

7.
its tasks in conditions
which enable it to serve as a point of reference by virtue of its
independence, the scientific and technical quality of the opin-
ions it issues and the information it disseminates, the transpar-
ency 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.

The Authority, Commission and Member States shall
8.
cooperate to promote the effective coherence between risk
assessment, risk management and risk communication func-
tions.

The Member States shall cooperate with the Authority to

9.
ensure the accomplishment of its mission.

(d) to commission scientific studies necessary for the accom-

plishment of its mission;

(e) to search for, collect, collate, analyse and summarise
scientific and technical data in the fields within its mission;

(f) to undertake action to identify and characterise emerging

risks,

in the fields within its mission;

(g) to establish a system of networks of organisations oper-
ating in the fields within its mission and be responsible for
their operation;

(h) to provide

scientific

and technical

assistance, when
requested to do so by the Commission,
in the crisis
management procedures implemented by the Commission
with regard to the safety of food and feed;

(i) to provide

scientific

and technical

assistance, when
requested to do so by the Commission, with a view to
improving cooperation between the Community, applicant
countries, international organisations and third countries,
in the fields within its mission;

(j) to ensure that the public and interested parties receive
rapid, reliable, objective and comprehensible information in
the fields within its mission;

(k) to express independently its own conclusions and orienta-

tions on matters within its mission;

(l) to undertake any other task assigned to it by the Commis-

sion within its mission.

SECTION 2

ORGANISATION

Article 24

Bodies of the Authority

The Authority shall comprise:

(a) a Management Board;

Article 23

(b) an Executive Director and his staff;

Tasks of the Authority

(c) an Advisory Forum;

The tasks of the Authority shall be the following:

(a) to provide the Community institutions and the Member
States with the best possible scientific opinions in all cases
provided for by Community legislation and on any ques-
tion within its mission;

(b) to promote and coordinate the development of uniform
risk assessment methodologies in the fields falling within
its mission;

(c) to provide scientific and technical support to the Commis-
sion in the areas within its mission and, when so requested,
in the interpretation and consideration of risk assessment
opinions;

(d) a Scientific Committee and Scientific Panels.

Article 25

Management Board

1.
The Management Board shall be composed of 14
members appointed by the Council in consultation with the
European Parliament from a list drawn up by the Commission
which includes a number of candidates substantially higher
than the number of members to be appointed, plus a repres-
entative of the Commission. Four of the members shall have
their background in organisations representing consumers and
other interests in the food chain.

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The list drawn up by the Commission, accompanied by the
relevant documentation, shall be forwarded to the European
Parliament. As soon as possible and within three months of
such communication, the European Parliament may make its
views available for consideration by the 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 geographic distribution 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 for half of the members.

The Management Board shall adopt

3.
the Authority's
internal rules on the basis of a proposal by the Executive
Director. These rules shall be made public.

The Management Board shall elect one of its members as

4.
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.

The Management Board shall ensure that the Authority
7.
carries out its mission and performs the tasks assigned to it
under the conditions laid 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 also adopt a revisable multi-annual programme. The
Management Board shall ensure that these programmes are
consistent with the Community's legislative and policy priori-
ties 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 Management Board, having received the Commis-
sion's approval and the opinion of the Court of Auditors, shall
adopt the Authority's financial regulation which specifies in
particular the procedure for drawing up and implementing the
Authority's budget,
the
Financial Regulation of 21 December 1977 applicable to the
general budget of the European Communities (1) and with the
legislative requirements concerning investigations conducted by
the European Anti-Fraud Office.

in accordance with Article 142 of

10.
The Executive Director shall take part in the meetings of
the Management Board, without voting rights, and shall
provide the Secretariat. The Management Board shall invite the
the Scientific Committee to attend its meetings
Chair of
without voting rights.

Article 26

Executive Director

Journal of

The Executive Director shall be appointed by the Manage-
1.
ment Board, on the basis of a list of candidates proposed by
the Commission after an open competition, following publica-
tion in the Official
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 European Parlia-
ment and answer questions put by members of this institution.
The Executive Director may be removed from office by a
majority of the Management Board.

The Executive Director shall be the legal representative of

2.
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 with the 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 Scientific Panels;

(e) ensuring that the Authority carries out its tasks in accord-
ance 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 statement of revenue and expendi-
ture and the execution of the budget of the Authority;

(g) all staff matters;

(h) developing and maintaining contact with the European
Parliament, and for ensuring a regular dialogue with its
relevant committees.

Each year, the Executive Director shall submit to the

3.
Management Board for approval:

(a) a draft general report covering all the activities of the

Authority in the previous year;

(b) draft programmes of work;

(c) the draft annual accounts for the previous year;

(d) the draft budget for the coming year.

shall,

following adoption by the
The Executive Director
report and the
Management Board,
forward the general
programmes to the European Parliament,
the
the Council,
Commission and the Member States, and shall have them
published.

(1) OJ L 356, 31.12.1977, p. 1. Regulation as last amended by Regula-
tion (EC, ECSC, Euratom) No 762/2001 (OJ L 111, 20.4.2001, p.
1).

4.
The Executive Director shall approve all financial expen-
diture of the Authority and report on the Authority's activities
to the Management Board.

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Article 27

Advisory Forum

Article 28

Scientific Committee and Scientific Panels

The Advisory Forum shall be composed of representatives
1.
from competent bodies in the Member States which undertake
tasks similar to those of the Authority, on the basis of one
representative designated by each Member State. Representa-
tives may be replaced by alternates, appointed at the same
time.

2. Members of the Advisory Forum may not be members of
the Management Board.

The Advisory Forum shall advise the Executive Director
3.
in the performance of his duties under this Regulation,
in
particular in drawing 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.

The Advisory Forum shall constitute a mechanism for an
4.
exchange of information on potential risks and the pooling of
knowledge.
It shall ensure close cooperation between the
Authority and the competent bodies in the Member States in
particular on the following items:

(a) avoidance of duplication of the Authority's scientific studies

with Member States,

in accordance with Article 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 organ-
the Authority's

isations operating within the fields of
mission,

in accordance with Article 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 of at least a third of its members, and not less
than four times per year. Its operational 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 its meetings.

7.
Representatives of the Commission's departments may
participate in the work of the Advisory Forum. The Executive
Director may invite representatives of the European Parliament
and from other relevant bodies to take part.

Where the Advisory Forum discusses the matters referred to in
Article 22(5)(b), representatives from competent bodies in the
Member States which undertake tasks similar to those referred
to in Article 22(5)(b) may participate in the work of
the
Advisory Forum, on the basis of one representative designated
by each Member State.

The Scientific Committee and permanent Scientific Panels
1.
shall be responsible for providing the scientific opinions of the
Authority, each within their own spheres of competence, and
shall have the possibility, 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 with regard to the
adoption of working procedures and harmonisation of working
methods.
issues
falling within the competence of more than one Scientific
Panel, and on issues which do not fall within the competence
of any of the Scientific Panels.

It shall provide opinions on multisectoral

Where necessary, and particularly in the case of subjects which
do not fall within the competence of any of the Scientific
Panels, the Scientific Committee shall set up working groups.
In such cases, it shall draw on the expertise of those working
groups when establishing scientific opinions.

3.
The Scientific Committee shall be composed of the Chairs
of the Scientific Panels and six independent scientific experts
who do not belong to any of the Scientific Panels.

The Scientific Panels shall be composed of independent
the

4.
scientific experts. When the Authority is established,
following Scientific Panels shall be set up:

(a) the Panel on food additives, flavourings, processing aids

and materials in contact with food;

(b) the Panel on additives and products or substances used in

animal feed;

(c) the Panel on plant health, plant protection products and

their residues;

(d) the Panel on genetically modified organisms;

(e) the Panel on dietetic products, nutrition and allergies;

(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 in Article 58(2).

5.
The members of the Scientific Committee who are not
members of Scientific Panels and the members of the Scientific
Panels shall be appointed by the Management Board, acting
upon a proposal from the Executive Director, for a three-year
term of office, which shall be renewable, 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.

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The Scientific Committee and the Scientific Panels shall
6.
each choose a Chair and two Vice-Chairs from among their
members.

Requests referred to in paragraph 1 shall be accompanied
2.
by background information explaining the scientific issue to be
addressed and the Community interest.

7.
The Scientific Committee and the Scientific Panels shall
act by a majority of their members. Minority opinions shall be
recorded.

The representatives of

8.
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 clarifica-
tion or information but shall not 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 Authority'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 opin-
ions are assigned to the Scientific Committee and the
Scientific Panels;

(e) the creation and organisation of the working groups of the
Scientific Committee and the Scientific Panels, and the
possibility of external experts being included in those
working groups;

(f) the possibility of observers being invited to meetings of the

Scientific Committee and the Scientific Panels;

(g) the possibility of organising public hearings.

3. Where Community legislation does not already specify a
time limit for the delivery of a scientific opinion, the Authority
shall issue scientific opinions within the time limit specified in
the requests for opinions, except
in duly justified circum-
stances.

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 amend-
ments to a request for an opinion in consultation with the
institution or Member State(s) that made the request. Justifica-
tions for the refusal shall be given to the institution 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 Member State(s) that made the
request.

The implementing rules for the application of this Article
6.
shall be established by the Commission after consulting the
Authority, in accordance with the procedure provided for in
Article 58(2). These rules shall specify in particular:

(a) the procedure to be applied by the Authority to the

requests referred to it;

scientific

(b) the guidelines governing the

evaluation of
substances, products or processes which are subject under
Community legislation to a system of prior authorisation
or entry on a positive list, in particular where Community
legislation makes provision for, or authorises, a dossier to
be presented for this purpose by the applicant.

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.

7.
The Authority's internal rules shall specify requirements
in regard to format, explanatory background and publication of
a scientific opinion.

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 scientific information is shared and in order to
identify potentially contentious scientific issues.

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3. Where a substantive divergence over scientific issues has
been identified and the body in question is a Community
agency or one of the Commission's Scientific Committees, the
Authority and the body concerned shall be obliged to co-
operate with a view to either resolving the divergence or
presenting a joint document to the Commission clarifying the
contentious scientific issues and identifying the relevant uncer-
tainties 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 document clarifying the contentious scientific
issues and identifying the relevant uncertainties in the data.
This document shall be made public.

Article 31

Scientific and technical assistance

The Authority may be requested by the Commission to
1.
provide scientific or technical assistance in any field within its
mission. The tasks of providing scientific and technical assis-
tance shall consist of scientific or technical work involving the
application of well-established scientific or technical principles
which does not require scientific evaluation by the Scientific
Committee or a Scientific Panel. Such tasks may include in
particular assistance to the Commission for the establishment
or evaluation of technical criteria and also assistance to the
Commission in the development of technical guidelines.

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 with all organisations operating in
the field of data collection,
including those from applicant
countries, third countries or international bodies.

3.
The Member States shall take the necessary measures to
enable the data they collect in the fields referred to in para-
graphs 1 and 2 to be transmitted to the Authority.

4.
The Authority shall forward to the Member States and
the Commission appropriate recommendations which might
improve the technical comparability of the data it receives and
in order to facilitate consolidation at Community
analyses,
level.

5. Within one year following the date of entry into force of
this Regulation, the Commission shall publish an inventory of
data collection systems existing at Community level
in the
fields within the mission of the Authority.

The report, which shall be accompanied, where appropriate, by
proposals, shall

indicate in particular:

2. Where the Commission refers a request for scientific or
technical assistance to the Authority, it shall specify, in agree-
ment with the Authority, the time limit within which the task
must be completed.

(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
in cooperation with the Member States;
mission,

Article 32

Scientific studies

1.
Using the best independent scientific resources available,
the Authority shall commission scientific studies necessary for
the performance of its mission. Such studies shall be commis-
sioned in an open and transparent fashion. The Authority shall
seek to avoid duplication with Member State or Community
foster cooperation through
research programmes and shall
appropriate coordination.

The Authority shall inform the European Parliament, the
its

2.
Commission and the Member States of
scientific studies.

the results of

Article 33

Collection of data

1.
The Authority shall search for, collect, collate, analyse
and summarise relevant scientific and technical data in the

(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.

The Authority shall forward the results of its work in the
the

6.
field of data collection to the European Parliament,
Commission and the Member States.

Article 34

Identification of emerging risks

1.
The Authority shall establish monitoring procedures for
systematically searching for, collecting, collating and analysing
information and 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
it shall request additional
suspect an emerging serious risk,
information from the Member States, other Community agen-
cies and the Commission. The Member States, the Community
agencies concerned and the Commission shall reply as a matter
of urgency and forward any relevant
information in their
possession.

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The Authority shall use all the information it receives in
3.
the performance of its mission to identify an emerging risk.

enable the Authority to carry out its mission, in cooperation
with the Member States.

4.
The Authority shall forward the evaluation and informa-
tion collected on emerging risks to the European Parliament,
the Commission and the Member States.

Article 35

Rapid alert system

risks of

foods as effectively as possible,

To enable it to perform its task of monitoring the health and
nutritional
the
Authority shall be the recipient of any messages forwarded via
the rapid alert system. It shall analyse the content of such
messages with a view to providing the Commission and the
Member States with any information required for the purposes
of risk analysis.

Article 36

Networking of organisations operating in the fields within
the Authority's mission

1.
The Authority shall promote the European networking of
organisations operating in the fields within the Authority's
mission. The aim of such networking is, in particular, to facili-
tate a scientific cooperation framework by the coordination of
activities, the exchange of information, the development and
implementation of joint projects, the exchange of expertise and
best practices in the fields within the Authority's mission.

2.
The Management Board, acting on a proposal from the
Executive Director, shall draw up a list to be made public of
competent organisations designated by the Member States
which may assist
the Authority, either individually or in
networks, with its mission. The Authority may entrust to these
organisations certain tasks, in particular preparatory work for
scientific opinions, scientific and technical assistance, collection
of data and identification of emerging risks. Some of these
tasks may be eligible for financial support.

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). Those rules shall specify, in particular, the criteria
for inclusion of an institute on the list of competent organ-
isations designated by the Member States, 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 systems existing in the fields within the mission of
the Authority which make provision for Member States to
carry out certain tasks in the field of scientific evaluation, in
particular
the examination of authorisation dossiers. The
report, which shall be accompanied, where appropriate, by
proposals, shall
indicate in particular, for each system, any
modifications or improvements which might be required to

SECTION 4

INDEPENDENCE, TRANSPARENCY, CONFIDENTIALITY AND
COMMUNICATION

Article 37

Independence

The members of the Management Board, the members of
1.
the Advisory Forum and the Executive Director shall undertake
to act independently 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 to their independence. Those declara-
tions shall be made annually in writing.

The members of

2.
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 any direct or indirect interests which might be
considered prejudicial to their independence. Those declara-
tions shall be made annually in writing.

3.
The members of the Management Board, the Executive
Director, the members of the Advisory Forum, the members of
the Scientific Committee and the Scientific Panels, as well as
external experts participating in their working groups shall
declare at each meeting any interests which might be consid-
ered 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;

(b) the opinions of the Scientific Committee and the Scientific
immediately after adoption, minority opinions

Panels
always being included;

(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
Advisory Forum and members of the Scientific Committee
and Scientific Panels, as well as the declarations of interest
made in relation to items on the agendas of meetings;

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(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 the proceedings of some of the
Authority's activities.

The Authority shall

3.
lay down in its internal rules the
practical arrangements for implementing the transparency rules
referred to in paragraphs 1 and 2.

Article 39

Confidentiality

By way of derogation from Article 38, the Authority shall
1.
not divulge to third parties confidential
information that it
receives for which confidential treatment has been requested
and justified, except for information which must be made
public if circumstances so require, in order to protect public
health.

the Management Board,

2. Members of
the Executive
Director, members of the Scientific Committee and Scientific
Panels as well as external experts participating in their working
groups, members of the Advisory Forum and members of the
staff of the Authority, even after their duties have ceased, shall
be subject to the requirements of confidentiality 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.

The Authority shall

4.
lay down in its internal rules the
practical arrangements for implementing the confidentiality
rules referred to in paragraphs 1 and 2.

Article 40

Communications from the Authority

The Authority shall communicate on its own initiative in
1.
the fields within its mission without prejudice to the Commis-
sion's competence to communicate its risk management deci-
sions.

2.
The Authority shall ensure that the public and any inter-
ested parties are rapidly given objective, reliable and easily
accessible information, in particular with regard to the results
of its work. In order to achieve these objectives, the Authority
for the
shall develop and disseminate information material
general public.

3.
The Authority shall act in close collaboration with the
Commission and the Member States to promote the necessary
coherence in the risk communication process.

The Authority shall publish all opinions issued by it in accord-
ance with Article 38.

4.
The Authority shall ensure appropriate cooperation with
the competent bodies in the Member States and other inter-
ested parties with regard to public information campaigns.

Article 41

Access to documents

The Authority shall ensure wide access to the documents

1.
which it possesses.

The Management Board, acting on a proposal from the
2.
Executive Director, shall adopt the provisions applicable to
access to the documents referred to in paragraph 1, taking full
account of the general principles and conditions governing the
right of access to the Community institutions' documents.

Article 42

Consumers, producers and other interested parties

The Authority shall develop effective contacts with consumer
representatives, producer representatives, processors and any
other interested parties.

SECTION 5

FINANCIAL PROVISIONS

Article 43

Adoption of the Authority's budget

1.
The revenues of the Authority shall consist of a contribu-
tion from the Community and, from any State with which the
Community has concluded the agreements referred to in
Article 49, and charges for publications, conferences, training
and any other similar activities provided by the Authority.

The expenditure of the Authority shall include the staff,
2.
administrative,
infrastructure and operational expenses, and
expenses resulting from contracts entered into with third
parties or resulting from the financial support referred to in
Article 36.

3.
In good time, before the date referred to in paragraph 5,
the Executive Director shall draw up an estimate of the Author-
ity's revenue and expenditure for the coming financial year, and
shall forward it to the Management Board, accompanied by a
provisional

list of posts.

4.

Revenue and expenditure shall be in balance.

5.
By 31 March each year at the latest, the Management
Board shall adopt the draft estimates including the provisional
list of posts accompanied by the preliminary work programme
and forward them to the Commission, and the States with
which the Community has concluded the agreements referred
to in Article 49. On the basis of that draft, the Commission
shall enter the relevant estimates in the preliminary draft
general budget of the European Union to be put before the
Council pursuant to Article 272 of the Treaty.

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After the adoption of the general budget of the European
6.
Union by the budgetary authority, the Management Board shall
adopt
the Authority's final budget and work programme,
adjusting them where necessary to the Community's contribu-
tion. It shall forward them without delay to the Commission
and the budgetary authority.

persons. In particular, it may acquire and dispose of movable
and immovable property and institute legal proceedings.

The Protocol on the privileges and immunities of the

2.
European Communities shall apply to the Authority.

Article 44

Implementation of the Authority's budget

The Executive Director shall implement the Authority's

1.
budget.

2.
Control of commitment and payment of all expenditure
and control of the existence and recovery of all the Authority's
revenue shall be carried out by the Commission's financial
controller.

By 31 March each year at

3.
the Executive
Director shall forward to the Commission, the Management
Board and the Court of Auditors the detailed accounts for all
the revenue and expenditure in respect of the previous financial
year.

the latest,

The Court of Auditors shall examine the accounts in accord-
ance with Article 248 of the Treaty. It shall publish each year a
report on the Authority's activities.

The European Parliament, acting on a recommendation
4.
from the Council, shall give a discharge to the Authority's
Executive Director in respect of the implementation of the
budget.

Article 47

Liability

liability of

The contractual

the Authority shall be
1.
governed by the law applicable to the contract in question. The
Court of Justice of the European Communities shall have juris-
diction to give judgment pursuant to any arbitration clause
contained in a contract concluded by the Authority.

In the case of non-contractual

2.
liability, the Authority
shall, in accordance with the general principles common to the
laws of the Member States, make good any damage caused by
it or its servants in the performance of their duties. The Court
of Justice shall have jurisdiction in any dispute relating to
compensation for such damage.

The personal

the
3.
Authority shall be governed by the relevant provisions
applying to the staff of the Authority.

liability of

servants

towards

its

Article 48

Staff

Article 45

Fees received by the Authority

1.
The staff of the Authority shall be subject to the rules and
regulations applicable to officials and other staff of the Euro-
pean Communities.

Within three years following the date of entry into force of this
Regulation and after consulting the Authority, the Member
States and the interested parties, the Commission shall publish
a report on the feasibility and advisability of presenting a
legislative proposal under the co-decision procedure and in
accordance with the Treaty and for other services provided by
the Authority.

SECTION 6

GENERAL PROVISIONS

Article 46

Legal personality and privileges

1.
The Authority shall have legal personality. In all Member
States it shall enjoy the widest powers granted by law to legal

2.
In respect of its staff, the Authority shall exercise the
powers which have been devolved to the appointing authority.

Article 49

Participation of third countries

The Authority shall be open to the participation of countries
which have
concluded agreements with the European
Community by virtue of which they have adopted and apply
Community legislation in the field covered by this Regulation.

Arrangements shall be made under the relevant provisions of
those agreements, specifying in particular the nature, extent
and manner in which these countries will participate in the
Authority's work, including provisions relating to participation
in the networks operated by the Authority, inclusion in the list
of competent organisations to which certain tasks may be
entrusted by the Authority, financial contributions and staff.

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RAPID ALERT SYSTEM, CRISIS MANAGEMENT AND EMERGENCIES

CHAPTER IV

SECTION 1

RAPID ALERT SYSTEM

Article 50

Rapid alert system

1.
A rapid alert system for the notification of a direct or
indirect risk to human health deriving from food or feed is
hereby established as a network. It shall involve the Member
States, the Commission and the Authority. The Member States,
the Commission and the Authority shall each designate a
contact point, which shall be a member of the network. The
Commission shall be responsible for managing the network.

2. Where a member of the network has any information
relating to the existence of a serious direct or indirect risk to
human health deriving from food or feed, this information
shall be immediately notified to the Commission under the
rapid alert system. The Commission shall transmit this infor-
mation immediately to the members of the network.

The Authority may supplement
the notification with any
scientific or technical information, which will facilitate rapid,
appropriate risk management action by the Member States.

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

(a) any measure they adopt which is aimed at restricting the
placing on the market or forcing the withdrawal from the
market or the recall of food or feed in order to protect
human health and requiring rapid action;

(b) any recommendation or agreement with professional oper-
ators which is aimed, on a voluntary or obligatory basis, at
preventing, limiting or imposing specific conditions on the
placing on the market or the eventual use of food or feed
on account of a serious risk to human health requiring
rapid action;

(c) any rejection, related to a direct or indirect risk to human
health, of a batch, container or cargo of food or feed by a
competent authority at a border post within the European
Union.

The Commission shall immediately transmit to members of the
network the notification and supplementary information
received under the first and second subparagraphs.

Where a batch, container or cargo is rejected by a competent
authority at a border post within the European Union, the
Commission shall
the border posts
immediately notify all
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.

The Member States

5.
immediately inform the
shall
Commission of the action implemented or measures taken
following receipt of the notifications and supplementary infor-
mation transmitted under the rapid alert system. The Commis-
sion shall
information to the
members of the network.

immediately transmit

this

6.
Participation in the rapid alert system may be opened up
to applicant countries, third countries or international organ-
isations, on the basis of agreements between the Community
and those countries or international organisations, in accord-
ance with the procedures defined in those agreements. The
latter shall be based on reciprocity and shall include confiden-
tiality measures
in the
Community.

equivalent

applicable

to those

Article 51

Implementing measures

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

Article 52

Confidentiality rules for the rapid alert system

The notification shall be accompanied by a detailed explanation
of the reasons for the action taken by the competent authori-
ties of the Member State in which the notification was issued. It
shall be followed, in good time, by supplementary information,
in particular where the measures on which the notification is
based are modified or withdrawn.

Information, available to the members of the network,
1.
relating to a risk to human health posed by food and feed shall
in general be available to the public in accordance with the
information principle provided for in Article 10. In general, the
public shall have access to information on product identifica-
tion, the nature of the risk and the measure taken.

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However, the members of the network shall take steps to
ensure that members of their staff are required not to disclose
information obtained for the purposes of this Section which by
its nature is covered by professional secrecy in duly justified
cases, except for information which must be made public, if
in order to protect human health.
circumstances so require,

2.
Protection of professional secrecy shall not prevent the
dissemination to the competent authorities of information rele-
vant to the effectiveness of market surveillance and enforce-
ment activities in the field of food and feed. The authorities
receiving information covered by professional secrecy shall
ensure its protection in conformity with paragraph 1.

SECTION 2

EMERGENCIES

Article 53

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

1. Where it is evident that food or feed originating in the
Community or imported from a third country is likely to
constitute a serious risk to human health, animal health or the
environment, and that such risk cannot be contained satisfac-
torily by means of measures taken by the Member State(s)
concerned, the Commission, acting in accordance with the
procedure provided for in Article 58(2) on its own initiative or
at the request of a Member State, shall immediately adopt one
or more of the following measures, depending on the gravity of
the situation:

(a) in the case of food or feed of Community origin:

(i) suspension of the placing on the market or use of the

food in question;

(ii) suspension of the placing on the market or use of the

feed in question;

(iii) laying down special conditions for the food or feed in

question;

(iv) any other appropriate interim measure;

(b) in the case of food or feed imported from a third country:

(i) suspension of imports of the food or feed in question
from all or part of the third country concerned and,
where applicable, from the third country of transit;

(ii) laying down special conditions for the food or feed in
the third country

question from all or part of
concerned;

(iii) any other appropriate interim measure.

However, in eMERGENCIES, the Commission may provi-
2.
sionally adopt the measures referred to in paragraph 1 after
consulting the Member State(s) concerned and informing the
other Member States.

As soon as possible, and at most within 10 working days, the
measures taken shall be confirmed, amended, revoked or
extended in accordance with the procedure referred to in
Article 58(2), and the reasons for the Commission's decision
shall be made public without delay.

Article 54

Other emergency measures

1. Where a Member State officially informs the Commission
of
the need to take emergency measures, and where the
Commission has not acted in accordance with Article 53, the
Member State may adopt interim protective measures. In this
event, it shall immediately inform the other Member States and
the Commission.

2. Within 10 working days, the Commission shall put the
matter before the Committee set up in Article 58(1) in accord-
ance with the procedure provided for in Article 58(2) with a
view to the extension, amendment or abrogation of
the
national

interim protective measures.

The Member State may maintain its national

3.
interim
protective measures until the Community measures have been
adopted.

SECTION 3

CRISIS MANAGEMENT

Article 55

General plan for crisis management

1.
The Commission shall draw up, in close cooperation with
the Authority and the Member States, a general plan for crisis
management in the field of the safety of food and feed (herein-
after referred to as ‘the general plan’).

The general plan shall specify the types of situation
2.
involving direct or indirect risks to human health deriving from
food and feed which are not likely to be prevented, eliminated
or reduced to an acceptable level by provisions in place or
cannot adequately be managed solely by way of the application
of Articles 53 and 54.

The general plan shall also specify the practical procedures
necessary to manage a crisis, including the principles of trans-
parency to be applied and a communication strategy.

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Official Journal of the European Communities

L 31/23

Article 56

Crisis unit

Article 57

Tasks of the crisis unit

1. Without prejudice to its role of ensuring the application
of Community law, where the Commission identifies a situa-
tion involving a serious direct or indirect risk to human health
deriving from food and feed, and the risk cannot be prevented,
reduced by existing provisions or cannot
eliminated or
adequately be managed solely by way of the application of
Articles 53 and 54,
immediately notify the Member
States and the Authority.

it shall

1.
The crisis unit shall be responsible for collecting and
evaluating all relevant information and identifying the options
available to prevent, eliminate or reduce to an acceptable level
the risk to human health as effectively and rapidly as possible.

2.
The crisis unit may request the assistance of any public or
private person whose expertise it deems necessary to manage
the crisis effectively.

The Commission shall set up a crisis unit immediately, in
2.
which the Authority shall participate, and provide scientific and
technical assistance if necessary.

The crisis unit shall keep the public informed of the risks

3.
involved and the measures taken.

CHAPTER V

PROCEDURES AND FINAL PROVISIONS

SECTION 1

COMMITTEE AND MEDIATION PROCEDURES

Article 60

Mediation procedure

Article 58

Committee

The Commission shall be

assisted by a Standing
1.
Committee on the Food Chain and Animal Health, hereinafter
referred to as the ‘Committee’, composed of representatives of
the Member States and chaired by the representative of the
Commission. The Committee shall be organised in sections to
deal with all 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
compliance with Articles 7 and 8 thereof.

The period provided for in Article 5(6) of Decision 1999/

3.
468/EC shall be three months.

Article 59

Functions assigned to the Committee

The Committee shall carry out the functions assigned to it by
this Regulation and by other relevant Community provisions,
in the cases and conditions provided for in those provisions. It
may also examine any issue falling under those provisions,
either at the initiative of the Chairman or at the written request
of one of its members.

1. Without prejudice to the application of other Community
provisions, where a Member State is of the opinion that a
measure taken by another Member State in the field of food
safety is either incompatible with this Regulation or is likely to
affect the functioning of the internal market, it shall refer the
matter to the Commission, which will immediately inform the
other Member State concerned.

2.
The two Member States concerned and the Commission
shall make every effort to solve the problem. If agreement
cannot be reached, the Commission may request an opinion on
any relevant contentious scientific issue from the Authority.
The terms of that request and the time limit within which the
Authority is requested to give its opinion shall be established
by mutual agreement between the Commission and the
Authority, after consulting the two Member States concerned.

SECTION 2

FINAL PROVISIONS

Article 61

Review clause

Before 1 January 2005 and every six years thereafter, the
1.
Authority,
shall
in collaboration with the Commission,
commission an independent external evaluation of its achieve-
ments on the basis of the terms of reference issued by the
Management Board in agreement with the Commission. The
evaluation will assess the working practices and the impact of
the Authority. The evaluation will take into account the views
level.
of the stakeholders, at both Community and national

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1.2.2002

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 be made 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.

The reports and recommendations referred to in para-
3.
graphs 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 Standing Committee on the Food Chain and Animal
Health

Every reference in Community legislation to the Scientific
1.
Committee on Food,
the Scientific Committee on Animal
Nutrition, the Scientific Veterinary Committee, the Scientific
Committee on Pesticides, the Scientific Committee on Plants
and the Scientific Steering Committee shall be replaced by a
reference to the European Food Safety Authority.

2.
Every reference in Community legislation to the Standing
Committee on Foodstuffs, the Standing Committee for Feeding-
stuffs and the Standing Veterinary Committee shall be replaced
by a reference to the Standing Committee on the Food Chain
and Animal Health.

Every reference to the Standing Committee on Plant Health in
Community legislation based upon and including Directives
76/895/EEC, 86/362/EEC, 86/363/EEC, 90/642/EEC and 91/
414/EEC relating to plant protection products and the setting
of maximum residue levels shall be replaced by a reference to
the Standing Committee on the Food Chain and Animal
Health.

For the purpose of paragraphs 1 and 2,

‘Community
3.
legislation’ shall mean all Community Regulations, Directives
and Decisions.

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

4.
hereby repealed.

Article 63

Competence of the European Agency for the Evaluation of
Medicinal Products

This Regulation shall be without prejudice to the competence
conferred on the European Agency for the Evaluation of Medi-
cinal Products by Regulation (EEC) No 2309/93, Regulation
(EEC) No 2377/90, Council Directive 75/319/EEC (1) and
Council Directive 81/851/EEC (2).

Article 64

Commencement of the Authority's operation

The Authority shall commence its operations on 1 January
2002.

Article 65

Entry into force

This Regulation shall enter
into force on the 20th day
following that of its publication in the Official Journal of the
European Communities.

Articles 11 and 12 and Articles 14 to 20 shall apply from 1
January 2005.

Articles 29, 56, 57 and 60 and Article 62(1) shall apply as
from the date of appointment of the members of the Scientific
Committee and of
the Scientific Panels which shall be
announced by means of a notice in the ‘C’ series of the Official
Journal.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 28 January 2002.

For the European Parliament

The President

P. COX

For the Council

The President

J. PIQUÉ I CAMPS

(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).