Proposal for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food (COM(2000) 716 final — 2000/0286(COD)) (Text with EEA relevance)
Date: 2001-03-27
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food inspection, foodstuffs legislation

27.3.2001

EN

Official Journal of the European Communities

C 96 E/247

Proposal for a Regulation of the European Parliament and of the Council laying down the general
principles and requirements of food law, establishing the European Food Authority, and laying
down procedures in matters of food

(2001/C 96 E/17)

(Text with EEA relevance)

COM(2000) 716 final (cid:151) 2000/0286(COD)

(Submitted by the Commission on 29 November 2000)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

measures governing food taken in the Member States and
at Community level.

Having regard to the Treaty establishing the European
Community, and in particular Articles 37, 95, 133 and
152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

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

Whereas:

(1) 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.

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

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

(4) There are important differences in relation to concepts,
principles and definitions of food in the Member States.
When Member States adopt measures governing food,
these differences may impede the free movement of
food, create unequal conditions of competition, and may
thereby directly affect
the internal
market.

the functioning of

(5) Accordingly,

these
concepts, principles and definitions of
food in the
Member States so that they form a common basis for

to approximate

is necessary

it

(6) In this regard, water is ingested as other foods, thereby
contributing to the overall exposure of a consumer to
including chemical and microbio-
ingested substances,
logical contaminants.
It should therefore be considered
to be food, without prejudice to the requirements estab-
and
lished
98/83/EC (2) on the quality of water
intended for
human consumption.

Council Directives

80/778/EEC (1)

in

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

(8) 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.

it

(9) Experience has shown that

is necessary to adopt
measures aimed at guaranteeing that only safe food is
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.

(10)

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 provisions
with a direct or indirect effect on the safety of food and
including provisions on materials and articles in
feed,
contact with food, animal
feed and other agricultural
inputs at the level of primary production.

(11)

In order to ensure the safety of food, it is necessary to
consider all aspects of the food production chain as a
continuum because each element may have a potential
impact on food safety.

(1) OJ L 229, 30.8.1980, p. 11; Directive as last amended by the Act of

Accession of Austria, Finland and Sweden.

(2) OJ L 330, 5.12.1998, p. 32.

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(12) Experience has shown that for this reason it is necessary
to consider the production, manufacture and distribution
of feed given to food-producing animals, since the inad-
vertent or deliberate contamination of
feed, and adul-
teration or fraudulent or other bad practices in relation
to it, may give rise to a direct or indirect impact on food
safety.

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

(13) 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.

(14) Measures

and the
adopted by the Member States
Community governing food safety should not be based
on the yardstick of general conjecture but on the basis
of a risk analysis. 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.

(15) Where food law is aimed at the reduction, elimination or
avoidance of a risk to health, the three interconnected
risk
of
principles
management,
a
systematic methodology for the determination of effective,
proportionate and targeted measures or other actions to
protect health.

risk
communication,

assessment,

risk
and

analysis:

provide

risk

(16)

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.

(17)

recognised that

scientific risk assessment alone
It
is
cannot,
in some cases, provide all the information on
which a risk-management decision should be based, and
that other
under
consideration should legitimately be taken into account
including societal, economic, ethical and environmental
factors and the feasibility of controls.

to the matter

relevant

factors

(18) The precautionary principle has been invoked to ensure
health protection in the Community, thereby giving rise
to barriers to the free movement of food. By adopting a
uniform basis throughout the Community, the possibility
of an improper use of this principle is diminished.

(19)

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.

(21)

It is necessary to ensure that a food or feed business
including an importer can identify at least the business
from whom the food, feed, animal or substance that may
be incorporated into a food or feed has been supplied, to
ensure that on investigation, traceability can be assured at
all stages.

(22) A food business operator is best placed to devise a safe
system for supplying food and ensuring that the food it
thus, he should have primary legal
supplies is safe;
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 auth-
orities 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.

(23) Similar

requirements

should apply to feed and feed

business operators.

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

(25) 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.

(26) 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 in this context it has entered into international
trade agreements,
it contributes to the development of
international standards which underpin food law, and it
supports
in safe and
trade
wholesome
in a non-discriminatory manner,
following fair and ethical trading practices.

the principles of

foods

free

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(27)

It is necessary to establish the general principles upon
which food may be traded and the objectives and prin-
ciples
the Community to
developing international standards and trade agreements.

contribution of

the

for

bodies, procedures should be in place to solve the conflict
or provide the risk managers with a transparent basis of
scientific information.

(28) Food safety is of increasing concern to the general public,
non-governmental organisations, professional associations,
international trading partners and trade organisations. It is
necessary to ensure that consumer confidence and the
trading partners is secured through the
confidence of
open and transparent development of
food law and
through public authorities taking the appropriate steps
reasonable
to inform the public where
grounds to suspect that a food may present a risk to
health.

there

are

(29) The scientific and technical basis of Community legis-
lation relating to the safety of food 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 efficient scientific
and technical support.

(30) The scientific and technical

are

becoming

issues in relation to food
important
and
safety
European Food
complex. The
Authority, hereinafter
(cid:145)the Authority(cid:146),
should reinforce the present system of scientific and
technical support which is no longer able to respond to
increasing demands on it.

increasingly
a
referred to as

establishment of

(31)

It is therefore necessary to establish the Authority to serve
as a mechanism for applying the general principles of
food law,
risk
in particular by carrying out
assessments necessary for the adoption of Community
in an independent,
measures governing food safety,
objective and transparent manner.

the

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

internal market

to take

the

that

(33) The Authority’s role as an independent scientific point of
scientific opinion may be
a
reference means
requested not only by the Commission, but also by the
European Parliament and the Member States or a
competent national body. Steps should also be taken to
help avoid conflicting scientific opinions and, in the event
of conflicting scientific opinions between several scientific

(34) The Authority should be an independent

communication in order

source of
to

information and risk
improve consumer confidence.

(35) A system for rapid alert already exists in the framework of
Council Directive 92/59/EEC of 29 June 1992 (1) on
general product safety. 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 operated
by the Authority. The system should not cover the early
information in the event of a radiologi-
exchange of
cal
Council Decision
87/600/Euratom (2).

established

emergency

in

(36) The Authority should provide a comprehensive inde-
pendent scientific view of the safety and other aspects
of
the whole food supply chain, which implies wide-
ranging responsibilities for the Authority. These should
include issues having a direct or indirect impact on the
safety of the food supply chain, animal health and welfare,
plant health and nutrition.

(37) Since some products authorised under food legislation
feed may
such as pesticides or additives
involve risks to the environment or to the safety of
workers,
some environmental and worker protection
aspects should be covered by the Authority.

in animal

(38) The Authority

should

provide

scientific

opinions
concerning all genetically modified organisms within the
meaning of Council Directive 90/220/EEC of 23 April
1990 on the deliberate release into the environment of
organisms (3) whether
or
not
genetically modified
including
intended for human or animal consumption,
the scientific assessment of their environmental
impact
in order to avoid duplicated scientific assessments and
related scientific opinions on these organisms. However,
it is necessary to avoid confusion of competence with the
fields as concerns genetically modified
environmental
organisms
therefore the
Authority should be restricted in its mission in relation
to genetically modified organisms that are not food or
feed to scientific opinions.

that are not

food or

feed,

(39) The confidence of the Community institutions, the general
public and interested parties in the Authority is essential.
For this reason, it is vital to ensure its independence, high
scientific quality, transparency and efficiency; cooperation
with the Member States is also indispensable.

(1) OJ L 228, 11.8.1992, p. 24.
(2) OJ L 371, 30.12.1987, p. 76.
(3) OJ L 117, 8.5.1990, p. 15; Directive as last amended by Directive

97/35/EC (OJ L 169, 27.6.1997, p. 72).

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(40) The Authority should have the means to perform all the

tasks required to enable it to carry out its role.

(41)

It is necessary to ensure that there is effective monitoring
of the Authority by the various Community institutions
involved, and for this purpose its Management Board
should include four
representatives appointed by the
European Parliament, four by the Council, and four by
the Commission. The Management Board should have
the necessary powers to establish the budget, check its
implementation, draw up internal rules, adopt financial
Scientific
regulations,
the
Committee
Executive Director.

appoint members

and Scientific

and appoint

Panels

the

of

(42) It is necessary to build up a relationship of confidence
and transparency with the general public, and therefore
the Management Board should include four represen-
tatives of consumers and industry.

(43) The Authority should cooperate closely with competent
bodies in the Member States if it is to operate effectively,
in particular with regard to the networking system, and
an Advisory Forum should be created for this purpose.

(44) The Authority should take over the role of the Scientific
Committees attached to the Commission in issuing
is
It
in its
scientific opinions
necessary 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.

field of competence.

(45) 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.

(46) 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 dupli-
cation of effort. The Authority should take into account
existing Community expertise and structures notably as
concerns networks of scientific experts established under
Community programmes for research and technological
development (RTD) and by the Joint Research Centre. In
addition, the Authority when planning its work should
take due note of relevant actions undertaken by the
Joint Research Centre
and under Community RTD
programmes.

(47) 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.
the adaptation of Community
Specific provisions for
data collection networks already existing in the fields
covered by the Authority are called for.

(48) 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.
is therefore necessary to assign to the
Authority an anticipatory task of collecting information
and exercising vigilance.

It

(49) 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. In particular, the Authority should be able to
assign certain tasks to organisations in the Member States.

(50) It is necessary to ensure that a balance is struck between
the use of national organisations carrying 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
the
the allocation of
Authority. Existing procedures
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
procedures, should be re-examined within a year to take
into account the establishment of the Authority and the
new facilities it offers.

such tasks

for

for

(51) The independence of

the Authority and its

role in
informing the public mean that
it should be able to
communicate autonomously in the fields falling within
its competence,
its purpose being to provide objective,
reliable and easily understandable information. However,
the Commission remains fully responsible for communi-
cating
appropriate
information should therefore be exchanged between the
Authority and the Commission.

risk management measures;

the

(52) Appropriate cooperation with the Member States

is
necessary in the specific field of public information
campaigns to take into account any regional parameters
and any correlation with health policy.

(53) In addition to its operating principles based on inde-
pendence and transparency, the Authority should be an
organisation open to contacts with consumers and other
interested groups and should be able to arrange their
involvement in some of its work, in accordance with its
own rules.

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(54) The Authority should be financed by the Community
budget. However, in the light of experience acquired, in
particular with regard to the processing of authorisation
dossiers presented by industry,
fees
should be examined within three years after the entry
into force of the Regulation. The Community budgetary
procedure remains applicable as far as any subsidies
chargeable to the general budget of
the Communities
are
auditing of accounts
should be undertaken by the Court of Auditors.

concerned; moreover,

the possibility of

the

28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (5),
they should be adopted by use of
the regulatory
procedure provided for in Article 5 of that Decision.

(60) Without prejudice to the obligation of the Member States
to ensure compliance with the requirements laid down in
this Regulation, a provision should be established to avoid
creating legal uncertainty as to existing Community and
national measures governing food.

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

(61)

(56) Recent food safety incidents have demonstrated the need
to establish appropriate measures in emergency situations
ensuring that all foods, whatever their type and origin,
should be subject to common measures in the event of a
serious risk to human health. Such a comprehensive
approach to emergency food safety measures
should
allow effective action to be taken and avoid artificial
food representing a
disparities
serious risk to human health.

in the treatment of

(57) Recent food crises have also shown the benefits to the
Commission of having properly adapted, more rapid
procedures for crises management. These organisational
procedures should make it possible to improve coor-
dination 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 event of a food
crisis.

(58) In order

to ensure a more effective, comprehensive
approach to the food chain, a Committee on Food
Safety and Animal Health should be established to
replace the Standing Veterinary Committee, the Standing
Committee for Foodstuffs, the Standing Committee for
Feedingstuffs and the Standing Committee on Plant
Health. Accordingly, Council Decisions 68/361/EEC (1),
69/414/EEC (2),
76/894/EEC (4),
should be repealed.

70/372/EEC (3)

and

(59) Since the measures necessary for the implementation of
this Regulation are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of

(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. 25.

this Regulation is without prejudice

It is important to avoid confusion between the missions
of the Authority and the European Medicinal Evaluation
Agency (EMEA) established by Council Regulation (EEC)
No 2309/93 (6). Consequently, it is necessary to establish
to the
that
competence conferred on the EMEA by Community legis-
lation, including powers conferred by Council Regulation
(EEC) No 2377/90 of 26 June 1990 laying down a
establishment
Community
of
for
veterinary medicinal
maximum residue
products in foodstuffs of animal origin (7).

procedure

limits

the

of

(62) In accordance with the principle of proportionality, it is
necessary and appropriate for the achievement of
the
basic objectives of this Regulation to provide for defi-
nitions, principles and measures for food legislation in
the Community and to establish a European Food
Authority. This Regulation confines itself
is
necessary in order to achieve the objectives pursued, in
accordance with the third paragraph of Article 5 of the
Treaty,

to what

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SCOPE AND DEFINITIONS

Article 1

Aim and scope

This Regulation provides the basis for the assurance of a
1.
high level of protection of human life and health and
interest in relation to food, whilst ensuring the
consumers’
effective functioning of
It establishes
the internal market.
common principles, definitions and responsibilities, a strong
and
arrangements
science
procedures to underpin decision-making in matters of
food
safety.

organisational

efficient

base,

(5) OJ L 184, 17.7.1999, p. 23.
(6) OJ L 214, 24.8.1993, p. 1; Regulation as amended by Regulation

(EC) No 649/1998 (OJ L 88, 24.3.1998, p. 7).
(7) OJ L 224, 18.8.1990, p. 1; Regulation as

last amended by
Commission Regulation (EC) No 2391/2000 (OJ L 276, 28.10.2000,
p. 5).

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For the purposes of pararaph 1,

this Regulation lays
2.
down the general definitions and principles governing food
and feed in general, and food and feed safety in particular, in
the Community.

1.

(cid:145)food law(cid:146) means the laws, regulations and administrative
provisions governing food in general, and food safety in
particular,
stages of
production and distribution of food, and also feed where
feed may have an adverse effect on food safety;

in the Community;

it covers all

It establishes the European Food Authority.

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

This Regulation shall apply to all stages of production
It shall not apply to
to the
food for

3.
and distribution of
primary production for private domestic use or
domestic preparation, handling or
domestic consumption.

food and feed.

storage of

Article 2

Definition of (cid:145)food(cid:146)

2. (cid:145)food business(cid:146) means any undertaking, whether for profit
or not and whether public or private, carrying out any of
the activities related to the stages of production and
distribution of food;

3. (cid:145)food business operator(cid:146) means the person or persons
responsible for ensuring that
food
law are met within the food business under their control;

the requirements of

(cid:145)Food(cid:146) (or (cid:145)foodstuff(cid:146)) means any substance or product, whether
processed, partially processed or unprocessed, intended to be,
or expected to be ingested by humans.

4. (cid:145)feed(cid:146) or (cid:145)feedingstuff(cid:146) means products of vegetable or
animal origin in their natural state, fresh or preserved,
and products derived from industrial preparation thereof,
intended for oral feeding to food-producing animals;

It includes drink, chewing gum and any substance intentionally
incorporated into the food during its manufacture, preparation
includes water, without prejudice to the
or
requirements of Directives 80/778/EEC and 98/83/EC.

treatment.

It

It shall not include:

(a) feed;

5. (cid:145)feed business(cid:146) means any undertaking whether for profit or
not and whether public or private, carrying out any
operation of production, manufacture, processing, storage
or distribution of feed including any agricultural producer
producing, processing or storing feed for feeding to food
animals on his own holding;

(b) live animals unless they are prepared, packaged and/or

served for human consumption;

(c) plants prior to harvesting;

6. (cid:145)feed business operator(cid:146) means the person or persons
food
responsible for ensuring that
law are met within the feed business under their control;

the requirements of

(d) medicinal products within the meaning of Council Directive

65/65/EEC (1);

7.

(e) cosmetics within the meaning of Council Directive

76/768/EEC (2);

(f)

tobacco and tobacco products within the meaning of
Council Directive 89/622/EEC (3);

(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.

Article 3

Other definitions

For the purposes of this Regulation:

(1) OJ 22, 9.2.1965, p. 369/65.
(2) OJ L 262, 27.9.1976, p. 169.
(3) OJ L 359, 8.12.1989, p. 1.

(cid:145)retail trade(cid:146) means the handling and/or processing of food
and its storage at the point of sale or delivery to the final
consumer, and includes mass catering operations, factory
restaurants and other
canteens,
catering,
supermarket
food service operations,
similar
distribution centres and wholesale outlets;

institutional

shops,

8. (cid:145)placing on the market(cid:146) 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, to
third parties, and the sale and other forms of
transfer
themselves;

of

performing

9. (cid:145)official control(cid:146) means any inspection, verification audit,
laboratory examination or analysis or other
sampling,
means
competent
authority of the Member States or their agents or by the
services of
the Commission with a view to ensuring
compliance with food law and to protecting human
health and consumer interests;

controls

the

by

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10.

(cid:145)risk(cid:146) means a function of the probability of an adverse
health effect and the severity of that effect, consequential
to a hazard;

11.

(cid:145)risk analysis(cid:146) means a process consisting of three intercon-
nected components: risk assessment, risk management and
risk communication;

CHAPTER II

GENERAL FOOD LAW

Article 4

Scope

This Chapter shall relate to all stages of the production and
distribution of food and to feed produced for, or fed to, food-
producing animals.

12. (cid:145)risk assessment(cid:146) means a scientifically based process
consisting of four steps: hazard identification, hazard char-
acterisation, exposure assessment and risk characterisation;

The general principles laid down in Articles 5 to 8 shall form a
general framework of a horizontal nature to be followed when
new measures are established.

13.

(cid:145)risk management(cid:146) 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;

S e c t i o n 1

Principles of and requirements of food law

Article 5

General objectives

14.

(cid:145)risk communication(cid:146) means the interactive exchange of
information and opinions throughout
the risk analysis
process as regards hazards and risks, risk-related factors
risk
risk
and
the
managers,
academic
parties,
including the explanation of risk-assessment findings and
the basis of risk-management decisions;

risk
feed and food businesses,
and

perceptions,
consumers,
community

interested

assessors,

among

other

Food law shall pursue one or more of

1.
the general
objectives of the protection of human life, health or safety,
interests, and other objectives,
the protection of consumers’
the
protection
including, where
environment, the protection of animal health, life and welfare
and the protection of plant health and life.

appropriate,

the

of

15.

(cid:145)hazard(cid:146) means a biological, chemical or physical agent in,
or condition of, food or feed with the potential to cause an
adverse health effect;

16.

(cid:145)traceability(cid:146) means the ability to trace a food, feed, food-
through all stages of
ingredient,
producing animal or
production and distribution;

17.

(cid:145)all stages of production and distribution(cid:146) means all stages
from and including the primary production of a food, up
to and including its sale or supply to the final consumer
and, where relevant to food safety, the production, manu-
facture and distribution of feed;

18.

food

is unacceptable

(cid:145)unfit for human consumption or contaminated(cid:146) means that
for human consumption
the
according to its intended use, for reasons of contamination,
whether by extraneous matter or otherwise, or through
putrefaction, deterioration or decay;

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.

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 standards
or relevant parts would be an ineffective or inappropriate
means for the fulfilment of the legitimate objectives of food
law or there is a scientific justification, or where they would
result in a different level of protection than the one determined
as appropriate in the Community.

Article 6

Protection of health

1.
Food law shall aim to achieve a high level of health
protection, and shall be based on risk analysis except where
this is not appropriate to the circumstances or the nature of
the measure.

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

19.

(cid:145)primary production(cid:146) means the production, rearing or
growing of primary products up to and including
harvesting, milking and farmed animal production prior
to slaughter. It also includes hunting and fishing.

3.
Risk management shall take into account the results of
risk assessment, and in particular, the opinions of the European
Food Authority established in Article 21, and other factors as
legitimate to the matter under consideration.

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Article 7

Precautionary principle

feed, a food-producing animal, or any substance intended to be,
or expected to be, incorporated into a food or feed.

In those specific circumstances where,

1.
following an
assessment of available pertinent information, a risk to health
is identified but scientific uncertainty persists, provisional risk
management measures necessary to ensure the high level of
health protection chosen in the Community may be adopted,
pending further scientific information for a more compre-
hensive 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

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

2. Without prejudice to more specific provisions of food
foods,
law,
the labelling, advertising and presentation of
the
their
including
packaging,
or
packaging materials used,
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.

appearance
the manner

shape,

Article 9

Traceability

feed,

food,

The traceability of

1.
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 and distribution, where necessary under
the conditions laid down pursuant to paragraph 5.

To this end, such operators shall have in place systems and
procedures which allow for
this information to be made
available to the competent authorities on demand.

Food and feed business operators shall have in place
3.
systems and procedures to identify other businesses to whom
their products have been supplied. This information shall be
made available to the competent authorities on demand.

4.
Food or feed which is placed on the market or is likely to
be placed on the market in the Community shall be adequately
labelled or identified to facilitate its traceability, 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 shall be adopted in
accordance with the procedures laid down in Article 57(2).

Article 10

Responsibilities

Food and feed business operators at all

1.
stages of
production and distribution within the businesses under their
control shall ensure that foods or feeds satisfy the relevant
requirements of food law and shall put in place systems and
procedures to verify and monitor 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 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
monitoring activities covering all stages of production and
distribution.

Member States shall also lay down the rules on measures and
penalties applicable to infringements of food and feed law. The
measures
effective,
proportionate and dissuasive.

and penalties provided for

shall be

Article 11

Liability

The provisions of this Chapter shall be without prejudice to
Council Directive 85/374/EEC (1)
for
defective products.

concerning liability

2.
Food and feed business operators shall be able to identify
any person from whom they have been supplied with a food, a

(1) OJ L 210, 7.8.1985, p. 29.

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S e c t i o n 2

Requirements of food safety

Article 12

Food safety requirements

Only food that is safe under normal and reasonably fore-

1.
seeable conditions of use shall be placed on the market.

2.

Food shall be considered as unsafe if it is:

(a) potentially injurious to health;

(b) unfit for human consumption or contaminated.

3.
The safety of food shall be considered at all stages of
taking into account, at each
production and distribution,
stage, its normal and reasonably foreseeable conditions of use.

is also unsafe, unless

following a detailed
consignment
assessment there is no evidence that the rest of the batch, lot
or consignment is unsafe.

7.
Food that complies with specific Community provisions
of food law shall be deemed to be safe in so far as the aspects
covered by the specific Community provisions are concerned.

8. 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 in circulation, such provisions being drawn
up and applied without prejudice to the Treaty, and in
particular Articles 28 and 30 thereof.

Article 13

Feed safety requirements

No feed shall be place on the market or fed to any food-
safety

satisfies

animal

unless

feed

the

it

1.
producing
requirements.

In determining whether any food is potentially injurious

4.
to health, regard shall be had:

2.

A feed does not satisfy the feed safety requirement if it:

(a) to the normal and reasonably foreseeable conditions of use
of the food so that the food does not present a risk which
is unacceptable or which is inconsistent with the high level
of protection for the health of a person consuming the
food;

(b) not only to the possible immediate or short term effect of
that food on the health of a person consuming it, but also
to the potential cumulative toxic effects of a food on the
health of a person, or on subsequent generations of a
person consuming that food in ordinary quantities;

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

5.
In determining whether the food is safe, consideration
shall also be given to the information provided to the
consumer,
including information on the label, or other
information generally available to the consumer concerning
from a
the avoidance of
particular food or category of
foods, and whether, despite
such information, the consumer has chosen to ignore such
instructions or other information concerning that
food or
categories of foods.

specific adverse health effects

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
lot or
be presumed that all of

the food in that batch,

(cid:151) has a detrimental effect on human or animal health;

(cid:151) makes the food derived from the food-producing animal to
which it is fed or to which it may be expected to be fed,
unsafe for human consumption;

(cid:151) harms the consumer by impairing the distinctive features of

the animal products.

is part of a batch,

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

the feed in that batch,

so affected, unless

is

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

5. Where there are no specific Community provisions, feed
shall be deemed to be safe when it conforms to the specific
provisions of national law of the Member State governing feed
safety in whose territory the feed is in circulation, such
provisions being drawn up and applied without prejudice to
the Treaty, and in particular Articles 28 and 30 thereof.

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Article 14

Responsibilities for food safety: food businesses

1.
Food business operators shall ensure that all stages of
production and distribution under their control are carried
out in such a manner that food complies with the relevant
provisions of food law, and in particular, food safety.

A food business operator shall

2.
immediately inform the
competent authorities if he considers or suspects that a food
which it has placed on the market may be potentially injurious
to human health. The operators shall
inform the competent
authorities of the action taken to prevent risks to the final
consumer.

In cases where the food business operator considers or suspects
that a food may present a serious risk to human health he shall
notify the competent authority thereof.

Food business operators

3.
collaborate with the
competent authorities according to the requests of the latter,
on action taken to avoid risks posed by a food which they
supply or have supplied.

shall

4.
If a food business operator considers or suspects that a
food which it has imported, produced, processed, manufactured
in compliance with the food safety
or distributed is not
to withdraw the
requirements,
initiate procedures
it shall
shall
food in question from the market. The operator
the
adequately and effectively inform the consumers of
reason for
from
its withdrawal, and if necessary,
consumers products already supplied to them when other
measures are not sufficient to achieve a high level of health
protection.

recall

A food business operator responsible for import, retail or
5.
distribution activities which do not affect
the packaging,
labelling, safety or integrity of the food shall act with due
care
food safety
requirements.

compliance with the

to help ensure

their

Within the limits of
respective activities, such food
business operators shall 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
information
the food by passing on relevant
necessary to trace a food, cooperating in the action taken by
producers, processors, manufacturers and/or the competent
authorities.

out in such a manner that the feed they produce or handle
complies with the relevant provisions of
food law, and in
particular that the feed satisfies the feed safety requirements.

A feed business operator shall

2.
immediately inform the
competent authorities if it considers or suspects that a feed
which it placed on the market may not satisfy the feed safety
requirements. It shall inform the competent authorities of the
action taken to prevent risk arising from the use of that feed.

In cases where the feed business operator considers or suspects
that the use of the feed would present a serious risk to human
health he shall notify the competent authority thereof.

Feed business operators

collaborate with the
3.
competent authorities according to the requests of the latter,
on action taken to avoid risks posed by a feed which they
supply or have supplied.

shall

4.
If a feed business operator considers or suspects that a
feed which it has imported, produced, processed, manufactured
or distributed does not satisfy the feed safety requirements, it
shall initiate procedures to withdraw the feed in question from
shall adequately and effectively
the market. The operator
inform users 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.

the feed of

A feed business operator responsible for import, retail or
5.
distribution activities which do not affect
the packaging,
labelling, safety or integrity of the feed, shall act with due
care
feed safety
requirements.

compliance with the

to help ensure

Within the limits of their respective activities, such operators
shall 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.

S e c t i o n 3

Principles of food trade

Article 16

Article 15

Food imported into the Community

Responsibilities for food safety: feed businesses

1.
Feed business operators shall ensure that all stages of
production and distribution under their control are carried

Food imported into the Community shall comply with
food law or, where specific
least

requirements of
exist, with requirements which are at

1.
the relevant
agreements
equivalent.

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By way of derogation from paragraph 1, food which is
2.
not intended to be placed on the market in the Community by
reason of its being in transit from one third country to another,
or intended to be processed for immediate exportation, may be
allowed on to the territory of the Community provided that
such food or its derivatives do not enter the Community
market.

Feed imported into the Community shall comply with the
specific
least

3.
relevant
agreements
equivalent. Paragraph 2 shall apply to feed similarly.

exist, with requirements which are at

food law, or, where

requirements of

Article 17

Food exported from the Community

requirements of

Food exported from the Community shall comply with
1.
food law, unless otherwise
the relevant
requested by the authorities of
the importing country or
stated by the laws, regulations, standards, codes of practice
and other legal and administrative procedures as may be in
force in the importing country.

2. Where the provisions of a bilateral agreement concluded
between the Community or one of its Member States and a
food exported from the
third country
Community to that third country shall comply with the said
provisions.

applicable,

are

Food exported from the Community shall not be unsafe,
3.
or labelled or presented in a manner that is false, misleading or
deceptive.

Food which has been found to be injurious to health, or
4.
labelled or presented in a manner that is false, misleading or
deceptive in the Community, or has been otherwise denied
access to the Community market shall not be exported or
re-exported from the Community, unless the competent auth-
orities of the country of destination have expressly agreed, after
having been fully informed of the reasons for which and the
circumstances under which, the concerned food could not be
placed on the market in the Community.

5.

Paragraphs 1 to 4 shall apply similarly to feed.

Article 18

International food standards

Without prejudice to its rights and obligations, the Community
shall:

(a) contribute to the development of

international technical
standards for food and feed and sanitary and phytosanitary
standards;

(b) promote the coordination of work on food and feed
standards undertaken by international governmental and
non-governmental organisations;

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

(d) give particular attention to the

special development,
financial and trade needs of developing countries, with a
view to ensuring that international standards do not create
unnecessary obstacles to exports from developing countries.

S e c t i o n 4

Principles of transparency

Article 19

Public consultation

Wherever circumstances allow there shall be effective public
consultation, directly or through representative bodies, at an
appropriate stage, during the preparation of food law.

Article 20

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 may present a risk
for human, animal or plant 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 type of food, the risk that it may present,
and the measures which are taken or about to be taken to
prevent, reduce or eliminate that risk.

CHAPTER III

EUROPEAN FOOD AUTHORITY

S e c t i o n 1

Mission and tasks

Article 21

Mission of the Authority

A European Food Authority is hereby established, here-

1.
inafter referred to as the (cid:145)Authority(cid:146).

2.
The mission of the Authority shall be to contribute to a
high level of protection of human life and health, protection of
animal health and welfare, protection of plant life, protection
of the environment and protection of the health of workers,
while facilitating the functioning of the internal market, by
setting up an integrated, coherent system of scientific and
technical
legislation and
policies and by the provision of independent information and
risk communication.

the Community’s

support

for

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That mission shall cover:

(a) all fields having a direct or indirect impact on the safety of

the food;

(b) animal health and welfare, plant health;

(c) nutrition;

(d) any matter

relating to genetically modified organisms

within the meaning of Directive 90/220/EC.

As regards genetically modified organisms that are not food or
the Authority shall be limited to the
feed,
provision of scientific opinions.

the mission of

The mission of the Authority shall include the operation of the
rapid alert system for food and feed.

3.
The Authority shall provide 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

4.
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
the
opinions it
transparency of its procedures and methods of operation and
its diligence in performing the tasks assigned to it.

issues and the information it disseminates,

(g)

to establish a system of networks of organisations
operating in the fields within its mission and shall be
responsible for their operation;

(h)

the rapid alert
to be responsible for the operation of
system for food and feed established by this Regulation;

(i)

(j)

(k)

(l)

scientific

and technical

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

scientific

and technical

assistance, when
to provide
requested to do so by the Commission, with a view to
improving
Community,
European Union applicant countries, international organi-
sations and third countries, in the fields within its mission;

cooperation

between

the

to provide, when requested to do so by the Commission,
assistance concerning communication on health-policy-
related nutritional issues;

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

(m) to express its own conclusions and orientations on matters

within its mission;

It shall act in close cooperation with the competent bodies in
the Member States carrying out similar tasks.

(n)

The Member States shall cooperate with the Authority to

5.
ensure the accomplishment of its mission.

Article 22

Tasks of the Authority

The tasks of the Authority shall be the following:

to undertake any other
Commission within its mission.

task assigned to it by the

S e c t i o n 2

Organisation

Article 23

Bodies of the Authority

(a)

(b)

(c)

(d)

(e)

(f)

to provide the Community institutions and the Member
States with the best possible scientific opinions in all cases
provided for by Community legislation and on any
question within its mission;

The Authority shall comprise:

(a) a Management Board;

to promote and coordinate the harmonisation of risk
assessment methodologies in the fields falling within its
mission;

(b) an Executive Director and his staff;

to provide
Commission in the areas within its mission;

and technical

scientific

support

(c) an Advisory Forum;

to the

(d) a Scientific Committee and Scientific Panels.

to commission scientific studies necessary for the accom-
plishment of its mission;

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

to undertake action to identify and characterise emerging
risks with a view to reducing or preventing them, in the
fields within its mission;

Article 24

Management Board

four
1.
The Management Board shall be composed of
representatives appointed by the European Parliament,
four
representatives appointed by the Council, four representatives
appointed by the Commission and four representatives of
consumers and industry designated by the Commission.

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Representatives may be replaced by alternates, appointed
2.
at the same time. Their term of office shall be four years, and
may be renewed once.

The Management Board shall elect its Chairperson from
3.
among its members for a two-year period, which shall be
renewable.

4.

The Management Board shall adopt its rules of procedure.

Unless otherwise provided, the Management Board shall act by
a majority of its members.

5.
The Management Board shall meet at the Chairperson’s
invitation or at the request of at least a third of its members.

6.
The Management Board shall ensure that the Authority
carries out its mission and performs the tasks assigned to it
under the conditions laid down in this Regulation.

7.
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 Commission’s
and policy
priorities in the area of food safety.

legislative

Before 30 March each year, the Management Board shall adopt
the general report on the Authority’s activities for the previous
year.

forward the programmes and
The Executive Director shall
the
report
Commission and the Member States, and shall have them
published.

European Parliament,

the Council,

to the

The Management Board shall adopt

8.
the Authority’s
internal rules on the basis of a proposal by the Executive
Director.

Board,

having

shall adopt

The Management

received
the
9.
the Court of
Commission’s approval and the opinion of
Auditors,
regulation
which specifies in particular the procedure for drawing up
and implementing the Authority’s budget, in accordance with
Article 142 of
regulation applicable to the
European Union’s general budget.

the Authority’s

the financial

financial

10.
The Executive Director shall take part in the meetings of
the Management Board, without voting rights, and shall
provide the Secretariat.

Article 25

Executive Director

The Executive Director

shall be appointed by the
1.
Management Board, on the basis of a proposal by the
Commission,
five years which shall be
renewable. He may be removed from office by the Management
Board.

for a period of

The Executive Director shall be the legal representative of

2.
the Authority. He shall be responsible:

(a) for the day-to-day administration of the Authority;

(b) for drawing up the Authority’s work programmes

in

agreement with the Commission;

(c) for implementing the work programmes and the decisions

adopted by the Management Board;

(d) for

ensuring the provision of
technical and administrative support
Committee and the Scientific Panels;

appropriate
for

scientific,
the Scientific

(e) for ensuring that

the Authority carries out

its tasks in
accordance with the requirements of its users, in particular
with regard to the adequacy of the services provided and
the time taken;

(f)

for the preparation of the statement of revenue and expen-
diture and the execution of the budget of the Authority;

(g) for all staff matters.

Each year,

3.
Management Board for approval:

the Executive Director shall submit

to the

(a) a draft 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.

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

Article 26

Advisory Forum

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.

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

3.
The Advisory Forum shall advise the Executive Director
in the performance of his duties under this Regulation and
shall ensure close cooperation between the Authority and the
competent bodies in the Member States which undertake tasks
similar to those of the Authority.

The Advisory Forum shall be chaired by the Executive
4.
Director, who shall convene its meetings.
Its operational
procedures shall be specified in the Authority’s internal rules.

The Authority shall provide the technical and logistic
5.
support necessary for the Advisory Forum and provide the
secretariat of its meetings.

Representatives of the Commission’s departments shall be

6.
entitled to take part in the work of the Advisory Forum.

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Article 27

Scientific Committee and Scientific Panels

1.
The Scientific Committee and permanent Scientific Panels
shall be responsible for providing the scientific opinions of the
Authority, each within their own spheres of competence.

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. It shall provide opinions on multisectoral
issues
several Scientific
Panels, and on issues which do not fall within the competence
of any of the Scientific Panels.

falling within the competence of

3.
The Scientific Committee shall be composed of the chair-
persons of the Scientific Panels and 6 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:

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

The representatives of the Commission’s services shall be
8.
entitled to be present
the Scientific
Committee, the Scientific Panels and their working groups. If
invited to do so, they may assist for the purposes of clarifi-
seek to influence
cation or
discussions.

in the meetings of

information but

shall not

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;

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

and materials in contact with food;

(c) the procedure for reimbursing the expenses of members of

the Scientific Committee and the Scientific Panels;

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

animal feed;

(c) the Panel on plant protection products and their residues;

(d) the manner

in which tasks and requests for scientific
opinions are assigned to the Scientific Committee and the
Scientific Panels;

(d) the Panel on genetically modified organisms;

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

(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 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
in accordance with
Commission, at the Authority’s request,
the procedure referred to in Article 57(2).

5.
The members of the Scientific Committee that are not
members of Scientific Panel 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 of a call for
expressions of interest.

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

S e c t i o n 3

Operation

Article 28

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 legis-
lation makes provision for the Authority to be consulted;

(b) at the request of the European Parliament or a Member
State or a national competent body as mentioned in
Article 21(4), in respect of any matter within its mission,
where Community legislation makes no specific provision
for the Authority to be consulted on such a matter;

(c) on its own initiative, on matters falling within its mission.

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2. 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.

3.
The implementing rules for the application of this Article
shall be established by the Commission after consulting the
in accordance with the procedure referred to in
Authority,
Article 57(2). These rules shall specify:

(a) the procedure to be applied by the Authority to the
requests
the
circumstances in which it may refuse or modify a request
for an opinion;

laying down in particular

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
in particular where Community
entry on a positive list,
legislation makes provision for, or authorises, a dossier to
be presented for this purpose by the applicant.

4.
The Authority’s internal rules shall specify requirements
in regard to format, explanatory background and publication of
a scientific opinion.

Article 29

Conflicting scientific opinions

1.
The Authority shall exercise vigilance in order to identify
at an early stage any potential source of conflict 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
conflict, 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.

3. Where a substantive conflict 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
cooperate with a view to either resolving the conflict or
presenting a joint document to the Commission clarifying the
contentious scientific issues.

4. Where a substantive conflict 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,
in consultation with the Advisory Forum, with a
view to either resolving the conflict or presenting a joint
document clarifying the contentious scientific issues.

Article 30

Scientific and technical assistance

shall

consist of

1.
The Authority may be requested by the Commission to
provide scientific or technical assistance in any field within its
mission. The tasks of providing scientific and technical
assistance
technical work
involving the application of well-established scientific or
technical principles which do not require scientific evaluation
by the Scientific Committee or a Scientific Panel. Such tasks
may include in particular the establishment or evaluation of
technical criteria, the development of technical guidelines or
guides as to good practice.

scientific or

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

specify,

it

Article 31

Scientific studies

shall

The Authority

commission scientific

1.
studies
necessary for the performance of its mission. The Authority
shall
seek to avoid duplication with Member State or
Community research programmes and shall foster cooperation
through appropriate coordination.

The Authority shall inform the European Parliament, the
its

2.
Commission and the Member States of
scientific studies.

the results of

Article 32

Collection of data

1.
The Authority shall search for, collect, collate, analyse and
summarise relevant scientific and technical data in the fields
within its mission. This shall involve in particular the collection
of data relating to:

(a) food consumption and the exposure of individuals to risks

related to the consumption of food;

(b) incidence and prevalence of biological risk;

(c) contaminants in food intended for human and animal

consumption, including residues.

2.
For the purposes of paragraph 1, the Authority shall
work in close cooperation with all organisations operating in
including those from European
the field of data collection,
Union applicant countries,
third countries or international
bodies.

3.
The Member States shall take the necessary measures to
enable the data collected in the fields referred to in paragraphs
1 and 2 to be transmitted to the Authority.

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

comparability of

the data it

5. Within one year from 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 scope of the Authority.

The report, which shall be accompanied, where appropriate, by
proposals, shall indicate in particular:

(a) for each system, the role which should be assigned to the
Authority, and any modifications or improvements which
might be required to enable the Authority to carry out its
mission, in cooperation with the Member States;

(b) the shortcomings which should be remedied to enable the
Authority to collect and summarise at Community level
relevant scientific and technical data in the fields within
its scope.

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 33

Identification of emerging risks

The Authority shall search for, collect, collate, analyse and
to identify
information and data enabling it

1.
summarise all
emerging risks in the fields within its mission.

a

risk,

serious

2. Where the Authority has information leading to the
suspicion of
additional
information from the Member States, other Community
agencies and the Commission. The Member States,
the
Community agencies concerned and the Commission shall
reply as quickly as possible and forward any relevant
information in their possession.

request

shall

it

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

The Authority shall forward the information collected on
4.
emerging risks to the European Parliament, the Commission
and the Member States.

rapid transmission of information required for the operation of
the rapid alert system.

Article 35

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

The Authority shall promote the European networking of
1.
organisations operating in the fields within the Authority’s
in particular,
mission. The aim of such networking is,
to
the exchange of
facilitate the coordination of activities,
joint
information,
projects, the exchange of expertise and best practices in the
fields within the Authority’s mission.

the development and implementation of

2.
The Management Board, acting on a proposal from the
Executive Director, shall draw up a list of competent and inde-
pendent 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 organi-
sations certain tasks,
in particular, preparatory work for
scientific opinions, scientific and technical assistance, scientific
studies, 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 57(2). Those rules shall specify, in particular, the criteria
for inclusion of an institute on the list of competent and inde-
pendent organisations designated by the Member States,
modalities setting out harmonised quality requirements and
the financial rules governing any financial support.

4. Within one year from the entry into force of this Regu-
the Commission shall publish an inventory of
lation,
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
the examination of authorisation dossiers. The
particular
report, which shall be accompanied, where appropriate, by
proposals, shall
for each system, any
modifications or improvements which might be required to
enable the Authority to carry out its mission, in cooperation
with the Member States.

indicate in particular,

Article 34

Rapid alert system

S e c t i o n 4

Independence, transparency and communication

1.
The Authority shall be responsible for the operation of
the rapid alert system for food and feed established in Article
49.

Article 36

Independence

2.
The Authority, in consultation with the Member States
and the Commission, shall set up the facilities necessary for the

The members of

1.
the Management Board and the
members of the Advisory Forum shall undertake to act inde-
pendently in the public interest.

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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
independence. Those
be
declarations shall be made annually in writing.

considered prejudicial

to their

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 lack of any
interests which might be considered prejudicial to their inde-
interests which might
pendence or any direct or
be
independence. Those
declarations shall be made annually in writing.

considered prejudicial

indirect
to their

The members of the Management Board, the members of
3.
the Advisory Forum, the members of the Scientific Committee
and the Scientific Panels, as well as external experts partici-
pating in their working groups shall declare at each meeting
any special interests which might be considered prejudicial to
their independence in relation to the items on the agenda.

Article 37

Transparency

The Authority shall ensure that it carries out its activities

1.
with a high level of transparency. It shall make public:

(a) the opinions of the Scientific Committee and the Scientific
Panels as soon as possible after adoption, minority opinions
always being included;

(b) the annual declarations of interest made by members of the
Management Board, 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;

(c) the results of its scientific studies;

(d) its annual report of its activities.

2.
The Management Board, acting on a proposal from the
Executive Director, may decide to hold some of its meetings in
public and may authorise consumer representatives or other
interested parties to observe the proceedings of some of the
Authority’s activities.

The Authority shall

3.
practical arrangements
rules referred to in paragraphs 1 and 2.

lay down in its internal rules the
implementing the transparency

for

Article 38

Confidentiality

By way of derogation from Article 37, the Authority shall
1.
not divulge to third parties confidential
information that it
receives for which confidential treatment has been requested
for information which must be made
and justified, except

public if circumstances so require, in order to protect human
health.

the

the Management Board,

2. Members of
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, are subject to the requirements of confidentiality
pursuant to Article 287 of the EC Treaty.

3.
The conclusions of the scientific opinions delivered by
the Authority in relation with foreseeable health effects shall
not on any 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 39

Communication

The Authority shall communicate on its own initiative in
to the
fields within its mission without prejudice
risk-

communicate

1.
the
Commission’s
management decisions.

competence

its

to

The Authority shall ensure that

2.
interested parties are rapidly given objective,
easily understandable information,
to the results of
standing of
information material for the general public.

the public and any
reliable and
in particular with regard
its work. To facilitate the public’s under-
shall develop and disseminate

its work,

it

The Commission and the Authority shall ensure appro-
3.
priate exchange of information on matters relating to their
respective competence in the field of risk communication.

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

Article 40

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
the general principles and conditions
into full account
governing the right of access to the Community institutions’
documents.

Article 41

Consumers and other interested parties

The Authority
consumer representatives and any other interested parties.

shall develop appropriate

contacts with

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S e c t i o n 5

Financial provisions

Article 42

Adoption of the Authority’s budget

The revenues of

1.
consist of a
contribution from the Community and, in addition, any fees
received by the Authority in payment
the services it
provides.

the Authority shall

for

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 35.

By 31 March each year at

3.
the Executive
Director shall draw up an estimate of the Authority’s revenue
and expenditure for
the coming financial year, and shall
forward it to the Management Board, accompanied by a list
of posts.

the latest,

4.

Revenue and expenditure shall be in balance.

the draft budget and forward it

The Management Board shall, by 31 March at the latest,
5.
adopt
to the Commission
which on that basis shall enter the relevant estimates in the
preliminary draft general budget of the European Communities,
which it shall put before the Council pursuant to Article 272 of
the Treaty

The Management Board shall adopt

6.
the Authority’s
budget, adjusting it where necessary to the Community’s
contribution.

Article 43

Implementation of the Authority’s budget

The Executive Director shall

1.
budget.

implement the Authority’s

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 previous
the revenue and expenditure in respect of
financial year.

the latest,

The Court of Auditors
accordance with Article 248 of the Treaty.
each year a report on the Authority’s activities.

examine

shall

the

accounts
in
It shall publish

Authority’s Executive Director in respect of the implementation
of the Budget.

Article 44

Fees received by the Authority

Within three years from the date of entry into force of this
Regulation, the Commission shall publish, after consulting the
the Member States and the interested parties, a
Authority,
report on the feasibility and advisability of introducing fees
payable by undertakings for obtaining a Community author-
isation and for other services provided by the Authority.

S e c t i o n 6

General provisions

Article 45

Legal personality and privileges

The Authority shall have legal personality. In all Member
1.
States it shall enjoy the widest powers granted by law to legal
persons. In particular, it may acquire and dispose of movable
and immovable property and institute legal proceedings.

The Protocol on the privileges and immunities of the

2.
European Communities shall apply to the Authority.

Article 46

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
jurisdiction to give judgment pursuant to any arbitration clause
contained in a contract concluded by the Authority.

liability,

In the case of non-contractual
the Authority
in accordance with the general principles common to
the Member States, make good any damage
their
its servants in the performance of
Justice shall have jurisdiction in any

2.
shall,
the laws of
caused by it or
duties. The Court of
dispute relating to compensation for such damage.

The personal

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

liability of

servants

towards

its

Article 47

Staff

The staff of the Authority shall be subject to the rules and
the

1.
regulations applicable to officials and other
European Communities.

staff of

4.
The European Parliament, acting on a recommendation
from the Management Board, shall give a discharge to the

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

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Article 48

Participation of third countries

1.
The Authority shall be open to the participation of
agreements with the
concluded
countries which have
European Community by virtue of which they have adopted
and apply Community legislation in the field covered by this
Regulation.

shall

Arrangements

be made under

2.
relevant
provisions of those agreements, specifying in particular the
in which these countries will
nature, extent and manner
participate in the Authority’s work,
including provisions
relating to financial contributions and staff.

the

CHAPTER IV

RAPID ALERT SYSTEM, CRISIS MANAGEMENT AND
EMERGENCIES

S e c t i o n 1

Rapid alert system

Article 49

Rapid alert system

It

shall

A rapid alert system for food and feed shall be established
1.
as a network.
the
Commission and the Authority, which is responsible for its
operation. The Member States,
the Commission and the
Authority shall each designate a contact point, which shall
be a member of the network.

involve the Member States,

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 Authority under
the
rapid alert system. The Authority shall establish whether, on
the basis of the notification, the product in question presents a
serious risk to human health, necessitating rapid action. If this
is the case, it shall transmit this information immediately via
the rapid alert system. It may supplement the notification with
facilitate
any scientific or technical
rapid, appropriate action by the Member States.

information, which will

3. Where a national competent authority is notified by a
food business operator pursuant to Article 14(2) or by a feed
business operator pursuant to Article 15(2), it shall, after verifi-
cation, inform the Authority via the rapid alert system. The
Authority shall thereafter act as laid down in paragraph 2.

4. Without prejudice to other Community legislation, the
Member States shall
immediately notify the Authority 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

at preventing,

agreement with professional
operators which is aimed, on a voluntary or obligatory
basis,
specific
limiting
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;

imposing

or

(c) any rejection of a batch, container or cargo of food or feed
by a competent authority at a border post within the
European Union.

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

The Authority 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
Authority shall immediately notify all the border posts within
the European Union, as well as the third country of origin.

5. 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 Authority shall provide the latter with the
appropriate information.

The Member States

6.
Authority of
following receipt of
information transmitted under the rapid alert system.

inform the
taken
the notifications and supplementary

the action implemented or measures

immediately

shall

The Authority shall draw up a summary report of the
system at
the rapid
to those

7.
information transmitted under
sufficiently regular intervals to keep members of
alert system well-informed, and shall
forward it
members.

the rapid alert

8.
Participation in the rapid alert system may be opened up
to European Union applicant countries, third countries or inter-
national organisations, on the basis of agreements between the
Community and those countries or international organisations,
in accordance with the procedures defined in those agreements.
The latter shall be based on reciprocity and shall include confi-
dentiality measures equivalent
to those applicable in the
Community.

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Article 50

Implementing measures

The general plan shall also specify the practical and operational
procedures necessary to manage a crisis, including the prin-
ciples of transparency to be applied.

The measures for implementing Article 49 shall be adopted by
the Commission, after consulting the Authority, in accordance
with the procedure referred to in Article 57(2). These measures
shall
and
procedures applicable to the transmission of notifications and
supplementary information and the specific rules applicable to
information transmitted by business operators.

in particular,

conditions

specific

specify,

the

Article 51

Confidentiality rules for the rapid alert system

Information available to the members of

1.
the network
relating to risk to human health posed by food and feed
shall
the
public shall have access to information on product identifi-
cation, the nature of the risk and the measure taken.

in general be available to the public.

In general

the members of

the members of

the network shall

take steps
However,
staff are
necessary to ensure that
the
to disclose
required not
purposes of this Section which by its nature is covered by
professional
for
information which must be made public if circumstances so
require, in order to protect human health.

information obtained for

justified cases,

in duly

secrecy

except

their

Article 53

Crisis unit

1. Without prejudice to its role of ensuring the application
of Community law, where the Commission identifies a situation
involving a serious direct or indirect risk to human health
deriving from food and feed, and the risk cannot be prevented,
eliminated or
reduced by existing provisions or cannot
adequately be managed solely by way of the application of
Articles 55 and 56,
immediately notify the Member
States and the Authority.

it shall

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

Article 54

Tasks of the Crisis Unit

all

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

information and identifying

relevant

2.
Protection of professional secrecy shall not prevent the
dissemination to the competent authorities of
information
surveillance and
relevant
enforcement activities in the field of food and feed. The auth-
orities receiving information covered by professional secrecy
shall ensure its protection in conformity with paragraph 1.

to the effectiveness of market

2.
The crisis unit may call upon the assistance of any public
or private person whose expertise is necessary to manage the
crisis effectively.

The crisis unit shall

3.
inform the public.

take any measures necessary to

S e c t i o n 2

Crisis management

Article 52

General plan for crisis management

1.
The Commission shall draw up, in close cooperation with
the Authority and where appropriate with the Member States,
a general plan for crisis management in the field of the safety
of food and feed (hereinafter referred to as (cid:145)the general plan(cid:146)).

S e c t i o n 3

Emergencies

Article 55

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

it

is

evident

1. Where
food originating in the
that
Community or imported from a third country is likely to
constitute a serious risk to human health, the Commission,
acting on its own initiative or at the request of a Member
State, may immediately adopt one or more of the following
interim measures, depending on the gravity of the situation:

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 55 and 56.

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

(i) suspension of the placing on the market of the food in

question;

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(ii) laying down special

conditions

for

the

food in

CHAPTER V

question;

PROCEDURES AND FINAL PROVISIONS

(iii) any other appropriate interim measure;

S e c t i o n 1

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

(i) suspension of imports of the food 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 in question
from all or part of the third country concerned;

Committee and mediation procedures

Article 57

Committee

1.
The Commission shall be assisted by a Committee on
Food Safety and Animal Health, hereinafter referred to as the
(cid:145)Committee(cid:146), composed of representatives of the Member States
and chaired by the representative of the Commission.

(iii) any other appropriate interim measure.

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

Within 10 working days,
taken shall be
confirmed, amended, revoked or extended in accordance with
the procedure referred to in Article 57(2).

the measures

2. Where a Member State officially informs the Commission
of the need to take emergency measures with regard to food or
establishments in another Member State, or with regard to a
third country or a food from a third country or an estab-
in a third country, and the Commission has not
lishment
applied the provisions in paragraph 1, the Member State may
take interim protective measures.
shall
it
immediately inform the other Member States
and the
Commission.

In this event,

Within 10 working days, the Commission shall put the matter
before the Committee set up in Article 57(1) in accordance
with the procedure provided for in Article 57(2) with a view
to the extension, amendment or abrogation of the national
interim protective measures.

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

Article 56

Other measures

Where it is evident that food originating in the Community or
imported from a third country is likely to constitute a serious
risk to human health and the Commission does not consider it
appropriate to adopt an emergency measure pursuant
to
Article 55,
the Commission may examine the situation as
soon as possible within the Committee set up in Article 57
and adopt
the necessary measures in accordance with the
procedure referred to in Article 57(2). It shall follow the devel-
opment of the situation and, if necessary, it shall amend or
revoke, in accordance with the procedure referred to in Article
57(2), the measures taken.

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

3.
1999/468/EC shall be three months.

Article 58

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 Chairperson or at the written
request of one of its members.

Article 59

Mediation procedure

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

The two Member States concerned and the Commission
2.
shall make every effort to solve the problem.
If agreement
cannot be reached, the Commission may request an opinion
on the 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.

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S e c t i o n 2

Final provisions

Article 60

Review clause

1. Within three years of the date established in Article 65,
in collaboration with the Commission, shall
the Authority,
carry out an independent evaluation of its achievements 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 of the Authority and the impact of
the Authority, acting as such.

The Management Board of the Authority shall examine the
conclusions of the evaluation and issue to the Commission
such recommendations
regarding
changes in the Authority and its working practices. The
evaluation and the recommendations shall be made public.

as may be necessary,

2. Within three years from the date established in Article
65, the Commission shall publish a report on the experience
acquired from implementing Sections 1 and 2 of Chapter IV.

Article 61

References to the European Food Authority and to the
Committee on Food Safety 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 Authority.

2.
Every reference in Community legislation to the Standing
Committee on Foodstuffs, the Standing Committee for Feed-
ingstuffs,
the
Standing Committee on Plant Health shall be replaced by a
reference to the Committee on Food Safety and Animal Health.

Standing Veterinary Committee

and

the

For the purpose of paragraphs 1 and 2,

3.
(cid:145)Community
legislation(cid:146) shall mean all Community regulations, directives
and decisions.

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

4.
76/894/EEC are hereby repealed.

Article 62

Competence of the European Medicines Evaluation
Agency

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

Article 63

Seat

The seat of the Authority shall be decided by the competent
authorities, on the basis of a proposal of the Commission.

Article 64

Relationship between this Regulation and existing food
law

Existing food law shall continue to apply until amended to
ensure conformity with the provisions laid down in Chapters
I and II.

Article 65

Commencement of the Authority’s operation

The Authority shall take up its responsibilities on [. . .].

Article 66

Entry into force

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

Articles 49, 51, 52, 53, 54, 59 and 61(1) shall apply from the
date provided for in Article 65.

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

(1) OJ L 147, 9.6.1975, p. 13.
(2) OJ L 317, 6.11.1981, p. 1.