Common position (EC) No 2/2002 of 17 September 2001 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting 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 safety
Date: 2001-09-17
Institutions: Council of the European Union
Subjects: EU office or agency, food inspection, foodstuff, foodstuffs legislation, human nutrition, product safety

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COMMON POSITION (EC) No 2/2002

adopted by the Council on 17 September 2001

with a view to adopting Regulation (EC) No .../2002 of the European Parliament and of the
Council of ... laying down the general principles and requirements of food law, establishing the
European Food Authority and laying down procedures in matters of food safety

(2002/C 4/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

Having regard to the proposal from the Commission (1),

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

Having regard to the opinion of
Regions (3),

the Committee of

the

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

Whereas:

(1)

(2)

(3)

(4)

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

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

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

There are important differences in relation to concepts,
principles and procedures between the food laws of the
Member States. When Member States adopt measures
governing food, these differences may impede the free

(1) OJ C 96 E, 27.3.2001, p. 247.
(2) OJ C 155, 29.5.2001, p. 32.
(3) Opinion delivered on 14 June 2001 (not yet published in the

Official Journal).

(4) Opinion of the European Parliament of 12 June 2001, Council
Common Position of 17 September 2001 and Decision of the
European Parliament of ...
(not yet published in the Official
Journal).

movement of food, create unequal conditions of compe-
tition, and may thereby directly affect the functioning of
the internal market.

(5)

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

to ingested substances,

(6) Water is ingested directly or indirectly like other foods,
thereby contributing to the overall exposure of a con-
sumer
chemi-
cal and microbiological contaminants. However, as the
quality of water intended for human consumption is
already controlled by Council Directives 80/778/EEC (5)
and 98/83/EC (6), it suffices to consider water after the
point of compliance referred to in Article 6 of Directive
98/83/EC.

including

(7) Within the context of food law it is appropriate to
include requirements for feed, including its production
and use where that feed is intended for food-producing
animals. This is without prejudice to the similar require-
ments which have been applied so far and which will be
applied in the future in feed legislation applicable to all
animals, including pets.

(8)

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

(5) OJ L 229, 30.8.1980, p. 11. Directive repealed by Directive

98/83/EC.

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

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(9)

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.

(15) Measures adopted by the Member States and the Com-
munity governing food and feed should generally be
based on risk analysis except where this is not appropri-
ate to the circumstances or the nature of the measure.
Recourse to a risk analysis prior to the adoption of such
measures should facilitate the avoidance of unjustified
barriers to the free movement of foodstuffs.

(10)

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

(16) Where food law is aimed at the reduction, elimination
or avoidance of a risk to health, the three interconnected
components of risk analysis, risk assessment, risk man-
agement, and risk communication, provide a systematic
methodology for the determination of effective, pro-
portionate and targeted measures or other actions to
protect health.

(11)

In order to take a sufficiently comprehensive and
integrated 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 feed, including provisions on materials and
articles in contact with food, animal feed and other
agricultural inputs at the level of primary production.

(17)

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.

(12)

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

(18)

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

(13)

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

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

(14)

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

(20)

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

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(21)

Food safety and the protection of consumer’s interests
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
confidence of trading partners is secured through the
open and transparent development of food law and
through public authorities taking the appropriate steps
to inform the public where there are reasonable grounds
to suspect that a food may present a risk to health.

(22) The safety and confidence of consumers within the
Community, and in non-member countries, are of
paramount importance. The Community is a major
global trader in food and feed and, in this context, it has
entered into international
it con-
tributes to the development of international standards
which underpin food law, and it supports the principles
of free trade in safe feed and safe, wholesome food in a
non-discriminatory manner, following fair and ethical
trading practices.

trade agreements,

(23)

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

(24)

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

(26)

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.

(27)

the functioning of

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

(28)

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

(29) A food business operator is best placed to devise a safe
system for supplying food and ensuring that the food it
supplies is safe; thus,
it should have primary legal
responsibility for ensuring food safety. Although this
principle exists in some Member States and areas of food
law, in other areas this is either not explicit or else
responsibility is assumed by the competent authorities
of the Member State through the control activities they
carry out. Such disparities are liable to create barriers to
trade and distort competition between food business
operators in different Member States.

(30)

Similar requirements should apply to feed and feed
business operators.

(25)

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

(31) The scientific and technical basis of Community legis-
lation relating to the safety of food and feed should
contribute to the achievement of a high level of health
protection within the Community. The Community
should have access to high-quality,
independent and
efficient scientific and technical support.

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(32) The scientific and technical issues in relation to food and
feed safety are becoming increasingly important and
complex. The establishment of a European Food Auth-
ority, hereinafter referred to as ‘the Authority’, should
reinforce the present system of scientific and technical
support which is no longer able to respond to increasing
demands on it.

(33)

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

scientific issues,

(36)

(37)

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

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

(38) The Authority should contribute through the provision
of support on scientific matters, to the Community’s
and Member States’ role in the development and estab-
lishment of international food safety standards and trade
agreements.

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

(35) The Authority should provide a comprehensive indepen-
dent scientific view of the safety and other aspects of the
whole food and feed supply chains, which implies wide-
ranging responsibilities for the Authority. These should
include issues having a direct or indirect impact on the
safety of the food and feed supply chains, animal health
and welfare, and plant health. However it is necessary to
ensure that the Authority focuses on food safety, so its
mission in relation to animal health, animal welfare and
plant health issues that are not linked to the safety of
the food supply chain should be limited to the provision
of scientific opinions. The Authority’s mission should
also cover scientific advice and scientific and technical
support on human nutrition in relation to Community
legislation and assistance to the Commission at its
request on communication linked to Community health
programmes.

(39) The confidence of

the Community institutions,

the
general public and interested parties in the Authority is
essential. For
to ensure its
independence, high scientific quality, transparency and
efficiency. Cooperation with Member States is also
indispensable.

this reason,

is vital

it

(40) To that effect the Management Board should be appoint-
ed in such a way as to secure the highest standard of
competence, a broad range of relevant expertise and the
broadest possible geographic distribution within the
Union. In order to ensure that a broad range of relevant
expertise is available, it is necessary for the Council to
have a wide choice of candidates on the basis of a list
drawn up by the Commission in an open and transparent
manner. In order to build a relationship of confidence
and transparency with the general public it is appropriate
for a quarter of the members to have their background
in organisations representing consumers and other inter-
ests in the food chain.

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

tasks required to enable it to carry out its role.

(1) Directive 2001/18/EC of the European Parliament and of the
Council of 12 March 2001 on the deliberate release into the
environment of genetically modified organisms and repealing
Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

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(42) The Management Board should have the necessary
powers to establish the budget, check its implemen-
tation, draw up internal rules, adopt financial regu-
lations, appoint members of the Scientific Committee
and Scientific Panels and appoint the Executive Director.

(47) The Authority should also be able to commission
scientific studies necessary for the accomplishment of its
duties, while ensuring that the links established by it
with the Commission and the Member States prevent
duplication of effort. It should be done in an open and
transparent fashion and the Authority should take into
account existing Community expertise and structures.

(43) The Authority should cooperate closely with competent
bodies in the Member States if it is to operate effectively.
An advisory forum should be created in order to advise
the Executive Director, to constitute a mechanism of
exchange of information, and to ensure close cooper-
ation in particular with regard to the networking system.
Cooperation and appropriate exchange of information
should also minimise the potential for diverging scien-
tific opinions.

(48) The lack of an effective system of collection and analysis
at Community level of data on the food supply chain is
recognised as a major shortcoming. A system for the
collection and analysis of relevant data in the fields
covered by the Authority should therefore be set up, in
the form of a network coordinated by the Authority. A
review of Community data-collection networks already
existing in the fields covered by the Authority is called
for.

(44) The Authority should take over the role of the Scientific
Committees attached to the Commission in issuing
scientific opinions in its field of competence.
is
necessary to reorganise these Committees to ensure
greater scientific consistency in relation to the food
supply chain and to enable them to work more effec-
tively. A scientific committee and permanent scientific
panels should therefore be set up within the Authority
to provide these opinions.

It

(49)

Improved identification of emerging risks may in the
long term be a major preventive instrument at the
disposal of the Member States and the Community in
the exercise of its policies. It is therefore necessary to
assign to the Authority an anticipatory task of collecting
information and exercising vigilance and providing
evaluation of and information on emerging risks with a
view to their prevention.

(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.

(50) The establishment of the Authority should enable Mem-
ber 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.

(46) The Authority’s role as an independent scientific point
of reference means that a scientific opinion may be
requested not only by the Commission, but also by the
European Parliament and the Member States. In order to
ensure the manageability and consistency of the process
of scientific advice, the Authority should be able to
refuse or amend a request providing justification for this
and on the basis of predetermined criteria. Steps should
also be taken to help avoid diverging scientific opinions
and, in the event of diverging scientific opinions between
scientific bodies, procedures should be in place to resolve
the divergence or provide the risk managers with a
transparent basis of scientific information.

(51)

It is necessary to ensure that a balance is struck between
the need to use national organisations to carry out tasks
for the Authority and the need to ensure for the purposes
of overall consistency that such tasks are carried out in
line with the criteria established for such tasks. Existing
procedures for the allocation of scientific tasks to the
Member States, in particular with regard to the evalu-
ation of dossiers presented by industry for the authoris-
ation of certain substances, products or procedures,
should be re-examined within a year with the objective
of taking into account the establishment of the Authority
and the new facilities it offers, the evaluation procedures
remaining at least as stringent as before.

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(52) The Commission remains fully responsible for com-
municating risk management measures. The appropriate
information should therefore be exchanged between
the Authority and the Commission. Close cooperation
between the Authority, the Commission and the Member
States is also necessary to ensure the coherence of the
global communication process.

covering food and feed. This revised system should be
managed by the Commission and include as members
of the network the Member States, the Commission
and the Authority. The system should not cover the
Community arrangements for the early exchange of
information in the event of a radiological emergency as
defined in Council Decision 87/600/Euratom (2).

(53) 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.

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

(55)

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

(56) The Authority should be financed from the general
budget of the European Union. However, in the light of
in particular with regard to the
experience acquired,
processing of authorisation dossiers presented by indus-
try, the possibility of fees should be examined within
three years of the entry into force of this Regulation. The
Community budgetary procedure remains applicable as
far as any subsidies chargeable to the general budget of
the European Union are concerned. Moreover,
the
auditing of accounts should be undertaken by the Court
of Auditors.

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

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

(57)

It is necessary to allow for the participation of 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)

(58) A system for rapid alert already exists in the framework
of Council Directive 92/59/EEC of 29 June 1992 on
general product safety (1). The scope of the existing
system includes food and industrial products but not
feed. Recent food crises have demonstrated the need to
set up an improved and broadened rapid alert system

In order to ensure a more effective, comprehensive
approach to the food chain, a committee on the food
chain and animal health should be established to replace
the Standing Veterinary Committee, the Standing Com-
mittee for Foodstuffs and the Standing Committee for
Feedingstuffs.
Decisions
68/361/EEC (3), 69/414/EEC (4), and 70/372/EEC (5),
should be repealed. For the same reason the Committee
on the Food Chain and Animal Health should also
replace the Standing Committee on Plant Health in

Accordingly,

Council

(1) OJ L 228, 11.8.1992, p. 24.

(2) OJ L 371, 30.12.1987, p. 76.
(3) OJ L 255, 18.10.1968, p. 23.
(4) OJ L 291, 19.11.1969, p. 9.
(5) OJ L 170, 3.8.1970, p. 1.

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relation to its competence (for Directives 76/895/EEC (1),
86/362/EEC (2), 86/363/EEC (3), 90/642/EEC (4) and
91/414/EEC (5)) on plant-protection products and the
setting of maximum residue levels.

HAVE ADOPTED THIS REGULATION:

(62) The measures necessary for the implementation of
this Regulation should be adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (6).

(63)

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

(64)

(65)

It is important to avoid confusion between the missions
of the Authority and the European Agency for the
Evaluation of Medicinal Products (EMEA) established by
Council Regulation (EEC) No 2309/93 (7). Consequently,
it is necessary to establish that this Regulation is without
prejudice to the competence conferred on the EMEA by
Community legislation, including powers conferred by
Council Regulation (EEC) No 2377/90 of 26 June
1990 laying down a Community procedure for the
establishment of maximum residue limits of veterinary
medicinal products in foodstuffs of animal origin (8).

It is necessary and appropriate for the achievement of
the basic objectives of this Regulation to provide for
the concepts, principles and
the approximation of
procedures forming a common basis for food law in the
Community and to establish a European Food Authority.
In accordance with the principle of proportionality as
set out in Article 5 of the Treaty, this Regulation does
not go beyond what is necessary in order to achieve the
objectives pursued,

(1) OJ L 340, 9.12.1976, p. 26. Directive as last amended by
Commission Directive 2000/57/EC (OJ L 244, 29.9.2000, p. 76).
(2) OJ L 221, 7.8.1986, p. 37. Directive as last amended by
Commission Directive 2001/57/EC (OJ L 208, 1.8.2001, p. 36).
(3) OJ L 221, 7.8.1986, p. 43. Directive as last amended by

Commission Directive 2001/57/EC.

(4) OJ L 350, 14.12.1990, p. 71. Directive as last amended by

Commission Directive 2001/57/EC.

(5) OJ L 230, 19.8.1991, p. 1. Directive as last amended by
Commission Directive 2001/49/EC (OJ L 176, 29.6.2001, p. 61).

(6) OJ L 184, 17.7.1999, p. 23.
(7) OJ L 214, 24.8.1993, p. 1. Regulation amended by Commission

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

(8) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by
Commission Regulation (EC) No 1553/2001 (OJ L 205,
31.7.2001, p. 16).

CHAPTER I

SCOPE AND DEFINITIONS

Article 1

Aim and scope

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

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

It establishes the European Food Authority.

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

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

Article 2

Definition of ‘food’

‘food’

For the purposes of this Regulation,
(or ‘foodstuff’)
means any substance or product, whether processed, partially
processed or unprocessed,
intended to be, or reasonably
‘Food’ includes drink,
expected to be ingested by humans.
chewing gum and any substance, including water, intentionally
incorporated into the food during its manufacture, preparation
or treatment. It includes water after the point of compliance as
defined in Article 6 of Directive 98/83/EC and without
prejudice to the requirements of Directives 80/778/EEC and
98/83/EC.

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‘Food’ shall not include:

(a)

feed;

(b)

live animals unless they are prepared for placing on the
market for human consumption;

(c)

plants prior to harvesting;

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

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

(e)

(f)

cosmetics within the meaning of Council Direc-
tive 76/768/EEC (3);

tobacco and tobacco products within the meaning of
Council Directive 89/622/EEC (4);

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

(h)

residues and contaminants.

Article 3

Other definitions

For the purposes of this Regulation:

1.

2.

3.

‘food law’ means the laws, regulations and administrative
provisions governing food in general, and food safety in
particular, whether at Community or national level; it
covers any stage of production, processing and distri-
bution of food, and also of feed produced for, or fed to,
food-producing animals;

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

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

(1) OJ 22, 9.2.1965, p. 369/65. Directive as last amended by

Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).

(2) OJ L 297, 13.10.1992, p. 8.
(3) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2000/41/EC (OJ L 145, 20.6.2000, p. 25).
(4) OJ L 359, 8.12.1989, p. 1. Directive as last amended by

Directive 92/41/EEC (OJ L 158, 11.6.1992, p. 30).

4.

5.

6.

7.

8.

9.

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

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

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

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

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

‘risk’ means a function of the probability of an adverse
health effect and the severity of that effect, consequential
to a hazard;

10.

‘risk analysis’ means a process consisting of three inter-
connected components: risk assessment, risk manage-
ment and risk communication;

11.

12.

13.

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

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

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

feed and food businesses,

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14.

15.

16.

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

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

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

17.

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

18.

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

CHAPTER II

GENERAL FOOD LAW

Article 4

Scope

S e c t i o n 1

General principles of food law

Article 5

General objectives

1.
Food law shall pursue one or more of the general
objectives of a high level of protection of human life and
health and the protection of consumers’ interests, including
fair practices in food trade, taking account of, where appropri-
ate, the protection of animal health and welfare, plant health
and the environment.

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
development or adaptation of food law, except where such
standards or relevant parts would be an ineffective or inappro-
priate means for the fulfilment of the legitimate objectives of
food law or where there is a scientific justification, or where
they would result in a different level of protection from the
one determined as appropriate in the Community.

Article 6

Risk analysis

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

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

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

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

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

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

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Article 7

Article 10

Precautionary principle

Public information

1.
In circumstances where, following an assessment of
available information, the possibility of harmful effects on
health has been 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 comprehensive risk assessment.

2. Measures adopted on the basis of paragraph 1 shall be
proportionate and no more restrictive of trade than is required
to achieve the high level of health protection chosen in the
Community, regard being had to technical and economic
feasibility 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

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;

Without prejudice to the applicable provisions of Community
and national law on access to documents, where there are
reasonable grounds to suspect that a food or feed may present
a risk for human or animal health, then, depending on the
nature, seriousness and extent of that risk, public authorities
shall take appropriate steps to inform the general public of the
nature of the risk to health, identifying to the fullest extent
possible the food or feed, or type of food or feed, the risk that
it may present, and the measures which are taken or about to
be taken to prevent, reduce or eliminate that risk.

S e c t i o n 3

General obligations of food trade

Article 11

Food and feed imported into the Community

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

(b)

the adulteration of food;

Article 12

(c)

any other practices which may mislead the consumer.

Food and feed exported from the Community

S e c t i o n 2

Principles of transparency

Article 9

Public consultation

There shall be public consultation, directly or through rep-
resentative bodies, at an appropriate stage, during the prep-
aration of food law, except where the urgency of the matter
does not allow it.

Food and feed exported or re-exported from the Com-
1.
munity for placing on the market of a non-member country
shall comply with the relevant requirements of food law,
unless otherwise requested by the authorities of the importing
country or established by the laws, regulations, standards,
codes of practice and other legal and administrative procedures
as may be in force in the importing country.

In other circumstances, except in the case where foods are
injurious to health or feeds are unsafe, food and feed can only
be exported or re-exported if the competent authorities of the
country of destination have expressly agreed, after having been
fully informed of the reasons for which and the circumstances
in which the food or feed concerned could not be placed on
the market in the Community.

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2. Where the provisions of a bilateral agreement concluded
between the Community or one of its Member States and a
non-member country are applicable, food and feed exported
from the Community or that Member State to that non-
member country shall comply with the said provisions.

(b)

to the information provided to the consumer, including
information on the label, or other information generally
available to the consumer concerning the avoidance of
specific adverse health effects from a particular food or
category of foods.

Article 13

International standards

Without prejudice to their rights and obligations, the Com-
munity and the Member States shall:

(a)

contribute to the development of international technical
standards for food and feed and sanitary and phytosanita-
ry standards;

In determining whether any food is injurious to health,

4.
regard shall be had:

(a) not only to the probable immediate and/or short-term
and/or long-term effects of that food on the health of a
person consuming it, but also on subsequent generations;

(b)

to the probable cumulative toxic effects;

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

(c)

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

(c)

(d)

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

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

S e c t i o n 4

General requirements of food law

Article 14

Food safety requirements

1.

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

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

2.
be:

(a)

injurious to health;

(b) unfit for human consumption.

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

6. Where any food which is unsafe is part of a batch, lot or
consignment of food of the same class or description, it shall
be presumed that all the food in that batch, lot or consignment
is also unsafe, unless following a detailed assessment there is
no evidence that the rest of the batch, lot or consignment is
unsafe.

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

8.
Conformity of a food with specific provisions applicable
to that food shall not bar the competent authorities from
taking appropriate measures to impose restrictions on it being
placed on the market or to require its withdrawal from the
market where there are reasons to suspect that, despite such
conformity, the food is unsafe.

In determining whether any food is unsafe, regard shall

3.
be had:

(a)

to the normal conditions of use of the food by the
consumer and at each stage of production, processing
and distribution, and

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

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Article 15

Feed safety requirements

ing their shape, appearance or packaging, the packaging
materials used, the manner in which they are arranged and the
setting in which they are displayed, and the information which
is made available about them through whatever medium, shall
not mislead consumers.

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

1.
food-producing animal if it is unsafe.

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

2.
it is considered:

— to have an adverse effect on human or animal health,

— to make the food derived from food-producing animals

unsafe for human consumption.

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

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.

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

Article 17

Responsibilities

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

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

For that purpose, they shall maintain a system of official
controls and other activities as appropriate to the circum-
stances, including public communication on food and feed
safety and risk, food and feed safety surveillance and other
monitoring activities covering all stages of production, pro-
cessing and distribution.

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

Article 18

Traceability

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

1.
The traceability of food, feed, food-producing animals,
and any other substance intended to be, or expected to be,
incorporated into a food or feed shall be established at all
stages of production, processing and distribution.

Article 16

Presentation

2.
Food and feed business operators shall be able to identify
any person from whom they have been supplied with a food,
a feed, a food-producing animal, or any substance intended to
be, or expected to be, incorporated into a food or feed.

Without prejudice to more specific provisions of food law, the
labelling, advertising and presentation of food or feed, includ-

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.

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

which it has placed on the market may be injurious to human
health. Operators shall inform the competent authorities of
the action taken to prevent risks to the final consumer.

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,
through relevant documentation or information in accordance
with the relevant requirements of more specific provisions.

Food business operators shall collaborate with the com-
4.
petent authorities on action taken to avoid or reduce risks
posed by a food which they supply or have supplied.

Article 20

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

Responsibilities for feed: feed business operators

Article 19

Responsibilities for food: food business operators

If a food business operator considers or suspects that a
1.
food which it has imported, produced, processed, manufac-
tured or distributed is not
in compliance with the food
safety requirements, it shall immediately initiate procedures to
withdraw the food in question from the market and inform
the competent authorities thereof. Where the product may
have reached the consumer, the operator shall effectively
and accurately inform the consumers of the reason for its
withdrawal, and if necessary, recall from consumers products
already supplied to them when other measures are not
sufficient to achieve a high level of health protection.

A food business operator

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

1.
If a feed business operator considers or suspects that a
feed which it has imported, produced, processed, manufac-
tured or distributed does not satisfy the feed safety require-
ments, it shall immediately initiate procedures to withdraw the
feed in question from the market and inform the competent
authorities thereof. The operator shall effectively and accu-
rately inform users of the feed of the reason for its withdrawal,
and if necessary, recall from them products already supplied
when other measures are not sufficient to achieve a high level
of health protection.

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

A feed business operator shall immediately inform the
3.
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.

3.
A food business operator shall immediately inform the
competent authorities if it considers or suspects that a food

Feed business operators shall collaborate with the com-
4.
petent authorities on action taken in order to avoid risks posed
by a feed which they supply or have supplied.

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Article 21

Liability

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

CHAPTER III

EUROPEAN FOOD AUTHORITY

S e c t i o n 1

Mission and tasks

Article 22

Mission of the Authority

A European Food Authority, hereinafter referred to as

1.
the ‘Authority’, is hereby established.

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

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

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

The mission of the Authority shall also include the

5.
provision of:

(a)

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

(1) OJ L 210, 7.8.1985, p. 29. Directive as last amended by
Directive 1999/34/EC of the European Parliament and of the
Council (OJ L 141, 4.6.1999, p. 20).

(b)

(c)

scientific opinions on other matters relating to animal
health and welfare and plant health;

scientific opinions on products other than food and feed
relating to genetically modified organisms as defined by
Directive 2001/18/EC and without prejudice to the
procedures established therein.

6.
The Authority shall provide scientific opinions which
will serve as the scientific basis for the drafting and adoption
of Community measures in the fields falling within its mission.

7.
The Authority shall carry out its tasks in conditions
which enable it to serve as a point of reference by virtue of its
the
independence,
opinions it issues and the information it disseminates, the
transparency of its procedures and methods of operation, and
its diligence in performing the tasks assigned to it.

the scientific and technical quality of

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

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

The Member States shall cooperate with the Authority to

9.
ensure the accomplishment of its mission.

Article 23

Tasks of the Authority

The tasks of the Authority shall be the following:

(a)

(b)

(c)

(d)

(e)

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

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

to provide scientific and technical support to the Com-
mission in the areas within its mission;

to commission scientific studies necessary for
accomplishment of its mission;

the

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

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to undertake action to identify and characterise emerging
risks, in the fields within its mission;

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

European Parliament from a list drawn up by the Commission
which includes a number of candidates substantially higher
than the number of members to be appointed, plus a
representative of the Commission. A quarter of the members
shall have their background in organisations representing
consumers and other interests in the food chain.

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

The members of the Board shall be appointed in such a way as
to secure the highest standards of competence, a broad range
of relevant expertise and the broadest possible geographic
distribution within the Union.

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

2. Members’ term of office shall be four years. However, for
the first mandate, this period shall be six years for half of the
members.

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

Members may be represented by alternates, appointed at the
same time.

to express independently its own conclusions and orien-
tations on matters within its mission;

to undertake any other task assigned to it by the
Commission within its mission.

(f)

(g)

(h)

(i)

(j)

(k)

(l)

The Management Board shall adopt

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

The Management Board shall elect one of its members as

4.
its Chair for a two-year period, which shall be renewable.

5.

The Management Board shall adopt its rules of procedure.

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

The Management Board shall meet at the invitation of

6.
the Chair or at the request of at least a third of its members.

The Management Board shall ensure that the Authority
7.
carries out its mission and performs the tasks assigned to it
under the conditions laid down in this Regulation.

8.
Before 31 January each year, the Management Board
shall adopt the Authority’s programme of work for the coming
year. It shall also adopt a revisable multiannual programme.
The Management Board shall ensure that these programmes
are consistent with the Community’s legislative and policy
priorities in the area of food safety.

S e c t i o n 2

Organisation

Article 24

Bodies of the Authority

The Authority shall comprise:

(a)

a management board;

(b)

an executive director and his staff;

(c)

an advisory forum;

(d)

a scientific committee and scientific panels.

Article 25

Management Board

1.
bers appointed by the Council

The Management Board shall be composed of 16 mem-
in consultation with the

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

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9.
The Management Board, having received the Com-
mission’s approval and the opinion of the Court of Auditors,
shall adopt the Authority’s financial regulation which specifies
in particular the procedure for drawing up and implementing
the Authority’s budget, in accordance with Article 142 of the
Financial Regulation of 21 December 1977 applicable to the
general budget of the European Communities (1) and with the
legislative requirements concerning investigations conducted
by the European Anti-fraud Office.

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

Article 26

Executive Director

1.
The Executive Director shall be appointed by the Manage-
ment Board, on the basis of a list of candidates proposed
by the Commission after an open competition, following
publication in the Official Journal of the European Communities
and elsewhere of a call for expressions of interest, for a period
of five years which shall be renewable. The Executive Director
may be removed from office by the Management Board.

The Executive Director shall be the legal representative

2.
of the Authority and shall be responsible for:

(a)

the day-to-day administration of the Authority;

drawing up a proposal for the Authority’s work pro-
grammes in consultation with the Commission;

Each year, the Executive Director shall submit to the

3.
Management Board for approval:

(a)

a draft general report covering all the activities of the
Authority in the previous year;

(b) draft programmes of work;

(c)

the draft annual accounts for the previous year;

(d)

the draft budget for the coming year.

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

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

Article 27

Advisory Forum

1.
The Advisory Forum shall be composed of representa-
tives 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.
Representatives may be replaced by alternates, appointed at
the same time.

implementing the work programmes and the decisions
adopted by the Management Board;

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

ensuring the provision of appropriate scientific, technical
and administrative support for the Scientific Committee
and the Scientific Panels;

ensuring that
its tasks in
the Authority carries out
accordance with the requirements of its users, in particu-
lar with regard to the adequacy of the services provided
and the time taken;

The Advisory Forum shall advise the Executive Director
3.
in the performance of his duties under this Regulation, in
particular in drawing up a proposal for the Authority’s work
programme. The Executive Director may also ask the Advisory
Forum for advice on the prioritisation of requests for scientific
opinions.

(f)

the preparation of the statement of revenue and expendi-
ture and the execution of the budget of the Authority;

(g)

all staff matters;

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

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

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

(a)

(b)

avoidance of duplication of the Authority’s scientific
studies with Member States,
in accordance with
Article 32;

in those circumstances identified in Article 30(4), where
the Authority and a national body are obliged to coop-
erate;

(b)

(c)

(d)

(e)

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(c)

in the promoting of the European networking of organis-
ations operating within the fields of the Authority’s
mission, in accordance with Article 36(1);

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

(d) where the Authority or a Member State identifies an

emerging risk.

The Advisory Forum shall be chaired by the Executive
5.
Director, who shall convene its meetings.
Its operational
procedures shall be specified in the Authority’s internal rules
and shall be made public.

6.
The Authority shall provide the technical and logistic
support necessary for the Advisory Forum and provide the
Secretariat for its meetings.

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

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

Article 28

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,
and shall have the possibility, where necessary, of organising
public hearings.

2.
The Scientific Committee shall be responsible for the
general coordination necessary to ensure the consistency of
the scientific opinion procedure, in particular with regard to
the adoption of working procedures and harmonisation of
working methods. It shall provide opinions on multisectoral
issues falling within the competence of more than one
Scientific Panel, and on issues which do not fall within the
competence of any of the Scientific Panels.

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

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

(a)

the Panel on food additives, flavourings, processing aids
and materials in contact with food;

(b)

the Panel on additives and products or substances used in
animal feed;

(c)

the Panel on plant health, plant protection products and
their residues;

(d)

the Panel on genetically modified organisms;

(e)

the Panel on dietetic products, nutrition and allergies;

(f)

the Panel on biological hazards;

(g)

the Panel on contaminants in the food chain;

(h)

the Panel on animal health and welfare.

The number and names of the Scientific Panels may be adapted
in the light of technical and scientific development by the
Commission, at the Authority’s request, in accordance with
the procedure referred to in Article 58(2).

5.
The members of the Scientific Committee who are not
members of Scientific Panels and the members of the Scientific
Panels shall be appointed by the Management Board, acting on
a proposal from the Executive Director, for a three-year term
of office, which shall be renewable, following publication in
the Official Journal of the European Communities,
in relevant
leading scientific publications and on the Authority’s website
of a call for expressions of interest.

6.
The Scientific Committee and the Scientific Panels shall
each choose a chair and two vice-chairs from among their
members.

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

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8.
The representatives of the Commission’s departments
shall be entitled to be present in the meetings of the Scientific
Committee, the Scientific Panels and their working groups. If
invited to do so, they may assist for the purposes of clarification
or information but shall not seek to influence discussions.

The European Parliament or a Member State may request the
Authority to issue a scientific opinion on matters falling within
its mission.

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:

(a)

to the number of
times that a member can serve
consecutively on a scientific committee or scientific panel;

(b)

to the number of members in each Scientific Panel;

(c)

(d)

(e)

to the procedure for reimbursing the expenses of mem-
bers of the Scientific Committee and the Scientific Panels;

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

to 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)

to the possibility of observers being invited to meetings
of the Scientific Committee and the Scientific Panels;

(g)

to the possibility of organising public hearings.

S e c t i o n 3

Operation

Article 29

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

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

4. Where different requests are made on the same issues or
where the request is not in accordance with paragraph 2, or is
unclear, the Authority may either refuse, or propose amend-
ments to a request
for an opinion in consultation with
the institution or Member State(s) that made the request.
Justifications for the refusal shall be given to the institution or
Member State(s) that made the request.

5. Where the Authority has already delivered a scientific
opinion on the specific topic in a request, it may refuse the
request if it concludes there are no new scientific elements
justifying the re-examination. Justifications for the refusal shall
be given to the institution or Member State(s) that made the
request.

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

(a)

the procedure to be applied by the Authority to the
requests referred to it;

Scientific opinions

(b)

1.

The Authority shall issue a scientific opinion:

(a)

at the request of the Commission, in respect of any matter
within its mission, and in all cases where Community
legislation makes provision for the Authority to be
consulted;

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

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

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

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Article 30

Diverging scientific opinions

Article 32

Scientific studies

1.
The Authority shall exercise vigilance in order to identify
at an early stage any potential source of divergence between
its scientific opinions and the scientific opinions issued by
other bodies carrying out similar tasks.

2. Where the Authority identifies a potential source of
divergence, it shall contact the body in question to ensure that
all relevant scientific information is shared and in order to
identify potentially contentious scientific issues.

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

4. Where a substantive divergence over scientific issues has
been identified and the body in question is a Member State
body, the Authority and the national body shall be obliged to
cooperate with a view to either resolving the divergence or
preparing a joint document clarifying the contentious scientific
issues and identifying the relevant uncertainties in the data.
This document shall be made public.

Article 31

Scientific and technical assistance

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 shall consist of scientific or technical work involving
the application of well-established scientific or technical prin-
ciples which does not require scientific evaluation by the
Scientific Committee or a scientific panel. Such tasks may
include in particular assistance to the Commission for the
establishment or evaluation of
technical criteria and also
assistance to the Commission in the development of technical
guidelines.

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

2.
The Authority shall inform the European Parliament, the
Commission and the Member States of the results of its
scientific studies.

Article 33

Collection of data

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

(a)

food consumption and the exposure of individuals to
risks related to the consumption of food;

(b)

incidence and prevalence of biological risk;

(c)

contaminants in food and feed;

(d)

residues.

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

The Member States shall take the measures necessary to
in the fields referred to in

3.
enable the data they collect
paragraphs 1 and 2 to be transmitted to the Authority.

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

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

it shall specify,

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

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

Article 36

(a)

(b)

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

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

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

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

Article 34

Identification of emerging risks

1.
The Authority shall establish monitoring procedures for
systematically searching for, collecting, collating and analysing
information and data with a view to the identification of
emerging risks in the fields within its mission.

2. Where the Authority has information leading it to
suspect an emerging serious risk, it shall request additional
information from the Member States, other Community
agencies and the Commission. The Member States, the Com-
munity agencies concerned and the Commission shall reply as
a matter of urgency and forward any relevant information in
their possession.

The Authority shall use all the information it receives in

3.
the performance of its mission to identify an emerging risk.

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

Article 35

Rapid alert system

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

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

1.
The Authority shall promote the European networking
of organisations operating in the fields within the Authority’s
mission. The aim of such networking is,
in particular, to
facilitate a scientific cooperation framework by the coordi-
nation of activities, the exchange of information, the develop-
ment and implementation of joint projects, the exchange of
expertise and best practices in the fields within the Authority’s
mission.

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

3.
The implementing rules for the application of para-
graphs 1 and 2 shall be laid down by the Commission, after
consulting the Authority, in accordance with the procedure
in
referred to in Article 58(2). Those rules shall specify,
particular, the criteria for inclusion of an institute on the list
of competent organisations designated by the Member States,
arrangements for setting out harmonised quality requirements
and the financial rules governing any financial support.

4. Within one year of the entry into force of this Regulation,
the Commission shall publish an inventory of Community
systems existing in the fields within the mission of
the
Authority which make provision for Member States to carry
in
out certain tasks in the field of scientific evaluation,
particular the examination of authorisation dossiers. The
report, which shall be accompanied, where appropriate, by
proposals, shall indicate in particular, for each system, any
modifications or improvements which might be required to
enable the Authority to carry out its mission, in cooperation
with the Member States.

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S e c t i o n 4

(c) without prejudice to Articles 39 and 41, the information

on which its opinions are based;

Independence, transparency, confidentiality
and communication

Article 37

Independence

The members of the Management Board, the members
the Advisory Forum and the Executive Director shall

1.
of
undertake to act independently in the public interest.

For this purpose, they shall make a declaration of commitment
and a declaration of interests indicating either the absence of
any interests which might be considered prejudicial to their
independence or any direct or indirect interests which might
be considered prejudicial to their independence. Those declar-
ations shall be made annually in writing.

The members of

the Scientific Committee and the
2.
Scientific Panels shall undertake to act independently of any
external influence.

For this purpose, they shall make a declaration of commitment
and a declaration of interests indicating either the absence of
any interests which might be considered prejudicial to their
independence or any direct or indirect interests which might
be considered prejudicial to their independence. Those declar-
ations shall be made annually in writing.

(d)

the annual declarations of interest made by members of
the Management Board, the Executive Director, members
of the Advisory Forum and members of the Scientific
Committee and Scientific Panels, as well as the declar-
ations of interest made in relation to items on the agendas
of meetings;

(e)

the results of its scientific studies;

(f)

the annual report of its activities;

(g)

requests from the European Parliament, the Commission
or a Member State for scientific opinions which have
been refused or modified and the justifications for the
refusal or modification.

2.
The Management Board, 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.

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

Article 39

Confidentiality

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

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

Article 38

Transparency

1.
The Authority shall ensure that it carries out its activities
with a high level of transparency. It shall in particular make
public without delay:

agendas and minutes of the Scientific Committee and the
Scientific Panels;

(a)

(b)

the Management Board,

2. Members of
the Executive
Director, members of the Scientific Committee and Scientific
Panels as well as external experts participating in their working
groups, members of the Advisory Forum and members of the
staff of the Authority, even after their duties have ceased, shall
be subject to the requirements of confidentiality pursuant to
Article 287 of the Treaty.

3.
The conclusions of the scientific opinions delivered by
the Authority relating to foreseeable health effects shall on no
account be kept confidential.

the opinions of the Scientific Committee and the Scientific
Panels immediately after adoption, minority opinions
always being included;

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

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Article 40

Communications from the Authority

1.
The Authority shall communicate on its own initiative
in the fields within its mission without prejudice to the
Commission’s competence to communicate its risk manage-
ment decisions.

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

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

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

Article 41

Access to documents

The Authority shall ensure wide access to the documents

1.
which it possesses.

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

Article 42

Consumers, producers and other interested parties

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

S e c t i o n 5

Financial provisions

Article 43

Adoption of the Authority’s budget

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

In good time, before the date referred to in paragraph 5,
3.
the Executive Director shall draw up an estimate of the
Authority’s revenue and expenditure for the coming financial
year, and shall
to the Management Board,
accompanied by a provisional list of posts.

forward it

4.

Revenue and expenditure shall be in balance.

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

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

Article 44

Implementation of the Authority’s budget

The Executive Director shall implement the Authority’s

1.
budget.

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

3.
By 31 March each year at the latest, the Executive
Director shall forward to the Commission, the Management
Board and the Court of Auditors the detailed accounts for all
the revenue and expenditure in respect of the previous financial
year.

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

The revenues of the Authority shall consist of a contri-
1.
bution from the Community and, in addition, any fees received
by the Authority in payment for the services it provides.

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

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Article 45

Fees received by the Authority

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

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

S e c t i o n 6

General provisions

Article 46

Legal personality and privileges

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

Article 49

Participation of non-member countries

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

Arrangements shall be made under the relevant pro-
2.
visions of those agreements, specifying in particular the nature,
extent and manner in which these countries will participate
in the Authority’s work,
including provisions relating to
participation in the networks operated by the Authority,
inclusion in the list of competent organisations to which
certain tasks may be entrusted by the Authority, financial
contributions and staff.

CHAPTER IV

The Protocol on the privileges and immunities of the

2.
European Communities shall apply to the Authority.

RAPID ALERT SYSTEM, CRISIS MANAGEMENT AND EMERG-
ENCIES

Article 47

Liability

1.
The contractual liability of the Authority shall be gover-
ned by the law applicable to the contract in question. The
Court of Justice of the European Communities shall have
jurisdiction to give judgment pursuant to any arbitration
clause contained in a contract concluded by the Authority.

In the case of non-contractual

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

3.
The personal liability of its servants towards the Auth-
ority shall be governed by the relevant provisions applying to
the staff of the Authority.

Article 48

Staff

S e c t i o n 1

Rapid alert system

Article 50

Rapid alert system

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

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

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

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

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

(a)

(b)

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

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

(c)

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

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

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

Where a batch, container or cargo is rejected by a competent
authority at a border post within the European Union, the
immediately notify all the border posts
Commission shall
within the European Union, as well as the non-member
country of origin.

6.
Participation in the rapid alert system may be opened up
to applicant countries, non-member countries or international
organisations, on the basis of agreements between the Com-
munity and those countries or international organisations, in
accordance with the procedures defined in those agreements.
The latter shall be based on reciprocity and shall
include
confidentiality measures equivalent to those applicable in the
Community.

Article 51

Implementing measures

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

Article 52

Confidentiality rules for the rapid alert system

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

4. Where a food or feed which has been the subject of a
notification under the rapid alert system has been dispatched
to a non-member country, the Commission shall provide the
latter with the appropriate information.

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

5.
The Member States shall immediately inform the Com-
mission of the action implemented or measures taken follow-
ing receipt of the notifications and supplementary information
transmitted under the rapid alert system. The Commission
shall immediately transmit this information to the members of
the network.

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

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S e c t i o n 2

Emergencies

Article 53

As soon as possible, and at most within 10 working days, the
measures taken shall be confirmed, amended, revoked or
extended in accordance with the procedure referred to in
Article 58(2).

Article 54

Emergency measures for food and feed of Community
origin or imported from a non-member country

Other emergency measures

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

(a)

in the case of food or feed of Community origin:

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

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

(i)

suspension of the placing on the market of the food
in question;

3.
The Member State may maintain its national interim
protective measures until the Community measures have been
adopted.

(ii)

suspension of the placing on the market or use of
the feed in question;

(iii)

laying down special conditions for the food or feed
in question;

(iv) any other appropriate interim measure;

S e c t i o n 3

Crisis management

Article 55

(b)

in the case of food or feed imported from a non-member
country:

General plan for crisis management

(i)

imports of

suspension of
the food or feed in
question from all or part of the non-member country
concerned and, where applicable, from the non-
member country of transit;

(ii)

laying down special conditions for the food or feed
in question from all or part of the non-member
country concerned;

(iii) any other appropriate interim measure.

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

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

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

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

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Article 56

Crisis unit

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

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

Article 57

Tasks of the crisis unit

referred to as the ‘Committee’, composed of representatives of
the Member States and chaired by the representative of the
Commission. The Committee shall be organised in sections to
deal with all relevant matters.

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

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

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

Article 59

Functions assigned to the Committee

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

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

Article 60

Mediation procedure

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

The crisis unit shall keep the public informed of the risks

3.
involved and the measures taken.

CHAPTER V

PROCEDURES AND FINAL PROVISIONS

S e c t i o n 1

Committee and mediation procedures

Article 58

Committee

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

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

S e c t i o n 2

Final provisions

Article 61

Review clause

1.
The Commission shall be assisted by a Standing Com-
mittee on the Food Chain and Animal Health, hereinafter

1.
Authority,

Before 1 January 2005 and every six years thereafter, the
shall
in collaboration with the Commission,

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

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

2.
Before 1 January 2005, the Commission shall publish a
report on the experience acquired from implementing Sec-
tions 1 and 2 of Chapter IV.

3.
The reports and recommendations referred to in para-
graphs 1 and 2 shall be forwarded to the Council and the
European Parliament.

91/414/EEC relating to plant-protection products and the
setting of maximum residue levels shall be replaced by a
reference to the Standing Committee on the Food Chain and
Animal Health.

For the purpose of paragraphs 1 and 2,

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

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

4.
repealed.

Article 63

Competence of the European Agency for the Evaluation
of Medicinal Products

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

Article 62

Article 64

References to the European Food Authority and to the
Standing Committee on the Food Chain and Animal
Health

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

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

Every reference to the Standing Committee on Plant Health in
Community legislation based on and including Directives
76/895/EEC, 86/362/EEC, 86/363/EEC, 90/642/EEC and

Commencement of the Authority’s operation

The Authority shall commence its operations on 1 Jan-
uary 2002.

Article 65

Entry into force

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

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

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

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

Done at ...

For the European Parliament

The President

For the Council

The President

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STATEMENT OF THE COUNCIL’S REASONS

I.

INTRODUCTION

On 30 November 2000 the Commission presented a proposal for a Regulation of the European
Parliament and of the Council, based on Articles 37, 95, 133 and 152(4)(b) of the Treaty, laying
down the general principles and requirements of food law, establishing the European Food Authority,
and laying down procedures in matters of food safety.

The European Parliament delivered its opinion at first reading at its part-session from 11 to 14 June
2001. The Economic and Social Committee and the Committee of the Regions delivered their
opinions on 28 March and 14 June 2001 respectively.

The Council adopted its Common Position on 17 September 2001, in accordance with the procedure
laid down in Article 251 of the Treaty.

II. OBJECTIVES

The proposal is intended to:

— create a European Food Authority, defining its mission, tasks and responsibilities, as well as its

structure and operating methods,

— define the general principles and requirements of food law,

— establish appropriate procedures to guarantee food safety.

The role of the European Food Authority will essentially consist of providing scientific and technical
opinions on which food safety policy and legislation can then be based. The new body will ensure
that a high level of protection for human health is achieved in the Community. It will carry out its
task on the basis of the principles of independence, transparency and scientific excellence.

The proposal is generally intended to apply the key objectives identified in the White Paper on Food
Safety, which was presented by the Commission in January 2000.

III. ANALYSIS OF THE COMMON POSITION

A.

GENERAL OBSERVATIONS

The Council’s Common Position broadly accords with the positions taken by the Commission
and the Parliament, inasmuch as it:

— confirms the objectives and most of the arrangements proposed by the Commission and

supported by the European Parliament,

— includes a large number of the amendments passed at first reading by the European

Parliament.

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In particular, the Council has retained the legal form of a Regulation, despite the real difficulties
which this choice posed as regards implementation of the provisions on food law by the
Member States. For this reason, it was felt necessary to amend the provisions on the timetable
for application of the Regulation, so as to reduce these difficulties as much as possible and to
ensure effective and non-discriminatory introduction of the provisions on food law.

The Council also felt that it was appropriate to introduce a number of amendments, some of
them at the suggestion of the Parliament, either to define the scope of some provisions, or to
make the wording of the Regulation more explicit and guarantee legal certainty, or to increase
its consistency with other Community instruments and the transparency of some of the
arrangements for its operation.

Finally it should be noted that in organising its work on this subject, the Council has always
taken care to respect the instructions given by the Nice European Council and confirmed in
Stockholm, namely to enable the future European Food Authority to be operational at the
beginning of 2002.

B.

SPECIFIC COMMENTS

1. Main amendments to the Commission proposal

(a) Concerning the provisions on the timetable for applying the Regulation

(Articles 4 and 65)

The Council amended the provisions on the timetable for the Regulation’s application
for reasons of legal certainty, by defining more closely the relationship between this
new instrument and existing food legislation, and providing a sufficient period of
time for the adaptation of any provision which may prove incompatible in existing
legislation at both national and Community level. Thus the Council was able to
delete Article 66 of the original proposal, which would have allowed national and
Community legislation not complying with the principles and procedures set out in
the Regulation to be retained indefinitely.

The Common Position specifies that Articles 11, 12, and 14 to 20 (1), which form a
general framework of obligations imposed on operators, and require some time for
adaptations to be made, will apply from 1 January 2005.

It also states that principles and procedures already in force should be adapted by
1 January 2007 at the latest to render any incompatible provisions in existing
legislation compatible with the principles and procedures set out in Articles 5
to 10 (2).

Also, so there is no dislocation between the work currently being carried out by the
Commission’s scientific committees and the work of the future Authority’s scientific
bodies, while enabling the latter to start operating as soon as possible, the Common
Position provides that Articles 29, 56, 57 and 60 and Article 61(1) shall apply as
from the date of appointment of the members of the Scientific Committee and of the
Scientific Panels.

(1) Imports and exports, food and feed safety requirements, presentation, responsibilities, traceability, responsibilities

of operators in the food and feed sectors.

(2) General objectives of food law, risk analysis, precautionary principle, protection of consumers’ interests, public

consultation and information.

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(b) Concerning food law

Definitions (Articles 2 and 3)

Firstly, the Council amended the definition of ‘food (or foodstuff)’ in order to define
more closely the circumstances in which water is covered by the Regulation.

Thus, the Regulation only covers water once it has left the tap, as well as bottled
water and water used in the manufacture, preparation or treatment of food; it
excludes water contained in municipal distribution systems, which is already
regulated by existing Directives.

For the sake of clarity the Council has added residues and contaminants to the list of
substances and products which are not covered by the definition of ‘food’.

The Council has also incorporated the definition of ‘final consumer’ as proposed by
Parliament and has deleted two other definitions (‘official control’ and ‘unfit for
human consumption or contaminated’) which appear to be superfluous in the
context of this Regulation.

Food safety requirements (Articles 14 and 15)

The Council has strengthened safety requirements with the addition of a provision
enabling the competent authorities to impose restrictions on a food or feed being
placed on the market or to require its withdrawal from the market where there are
reasons to suspect that it is unsafe, even if it complies with the legislation.

(c) Concerning the European Food Authority

Mission and tasks of the authority (Articles 22 and 23)

The Common Position is intended to give the future European Food Authority a
wide-ranging mission, explicitly covering animal feedingstuffs, to provide it with an
overall view of the food chain, which is essential if it is to identify emerging risks.

At the same time, some tasks which do not have a direct connection with food safety
are being entrusted to the Authority for practical reasons, to avoid wasting resources
by the duplication of effort. However, this will only be a question of providing
scientific advice, and this task should not in any way lead to a dilution of the
resources made available to the Authority.

Food safety will be the focus of the Authority’s activities. Indeed, it can be envisaged
that work which does not have any connection with this principal mission, and
which is currently carried out by scientific committees under the aegis of the
Commission, will remain on the same scale as at present, and represent a very minor
part of the total work carried out by the Authority.

The Common Position confirms the operational separation between the tasks of risk
assessment and risk management. However, it seemed appropriate to add an extra
provision concerning the Authority’s mission, to ensure an interface between its
various functions: assessment, management and communication.

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The mission entrusted to the Authority by the common position is as follows:

— the principal mission of the Authority will consist of the provision of scientific
advice and scientific and technical support in all fields which have a direct or
indirect impact on food and feed safety. It will contribute to a high level of
protection of human health, taking account of animal health and welfare, plant
health and the environment. It will also communicate on risks, in cooperation
with the Commission and the Member States, and collect and analyse data to
allow the characterisation and monitoring of risks:

— its other missions will consist of providing scientific advice on

(i)

questions of human nutrition in relation to Community legislation;

(ii) matters relating to animal health and welfare and plant health not related

to food safety;

(iii) products related to genetically modified organisms, other than food and

feed, but without prejudice to existing Community legislation.

Composition of the Management Board (Article 25)

On this point, the Council differed with the Commission and was influenced by
Parliament’s position; it chose a system for appointing members of the Management
Board which should be better at ensuring excellence and independence, and in which
the Commission, Parliament and Council are involved in the choice of all the
members.

In essence, the new approach aims:

— to meet the objectives of independence, transparency and efficiency to be

pursued by the Authority,

— to secure the highest standards of competence, a broad range of relevant

expertise and the broadest possible geographic distribution,

— to provide a specific role for the Commission, enabling it to provide some

continuity at the Authority.

The Management Board will be composed of 16 members appointed by the Council
from a list drawn up by the
in consultation with the European Parliament
Commission which includes a number of candidates substantially higher than the
number of members to be appointed. It will also include a Commission representative.
A quarter of the members will have their background in organisations representing
consumers and other interests in the food chain. Members’ term of office will
generally be four years, with half of the Management Board being renewed every two
years.

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Executive Director (Article 26)

At the suggestion of Parliament, the Council has introduced a more transparent and
open procedure than initially proposed for the appointment of the Executive
Director. A list of candidates will be proposed by the Commission after an open
competition, following publication in the Official Journal of the European Communities
and elsewhere of a call for expressions of interest. The Executive Director will be
appointed by the Management Board.

The Council agrees with Parliament that it will be sufficient for the Executive
Director simply to consult the Commission before proposing the Authority’s work
programmes, which will strengthen his independence.

Advisory Forum (Article 27)

The Council has made substantial amendments to the provisions on the Advisory
Forum, in order to set out in more detail its role within the Authority.

Thus, the Advisory Forum will:

— advise the Executive Director, drawing up a proposal for the Authority’s work
programme and advising on the prioritisation of requests for scientific opinions,

— constitute a mechanism for an exchange of information on potential risks and

the pooling of knowledge,

— ensure close cooperation between the Authority and the competent bodies in
the Member States, in order to avoid duplication, encourage cooperation in the
case of differences between the Authority and a national body and promote the
networking of organisations operating within the fields of the Authority’s
mission,

— ensure close cooperation between the Authority and the competent bodies

when an emerging risk is identified.

Scientific Committee and Scientific Panels (Article 28)

The Council has added to the provisions relating to the Scientific Committee and
Scientific Panels, which will be responsible for providing the scientific opinions of
the Authority, so as to set out their operating arrangements in more detail, to allow:

— the creation of specific working groups,

— observers to be invited to meetings of the Scientific Committee and Scientific

Panels,

— the organisation of public hearings.

Requests for scientific opinions (Article 29)

The Council did not want to restrict requests to the Authority by the European
Parliament and by the Member States only to cases where consultation was not
specifically provided for by Community legislation. Therefore, contrary to the
original proposal, Parliament and the Member States will be able to request an
opinion from the Authority on any matter within its mission.

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However, this right to request an opinion is formulated in such a way as not to
conflict with the Commission’s right of initiative, and not to create a risk that the
Authority will be overburdened with an excessive number of requests.

The Common Position also sets out the circumstances in which the Authority might
refuse a request for an opinion or propose changes to such a request.

Seat of the Authority (former Article 63)

The Article in the original proposal relating to the decision on the seat of the
Authority, which merely referred to a subsequent decision and thus provided no
added value, no longer appears in the Common Position. Since such an Article does
not constitute a legally necessary condition for the creation of the Authority, the
Council has judged it preferable not to include it at all.

(d) Regarding procedures relating to food safety

Rapid alert system (Articles 35 and 50)

The Council accepted Parliament’s position, keeping the management of the rapid
alert system established by the Regulation under the Commission’s responsibility,
although some aspects of this fall rather under risk management.

However, the Common Position provides that the Authority will automatically
receive information circulating on the rapid alert network, so that it will be able to
analyse it and thus fulfil its general mission as effectively as possible.

Crisis management (Articles 53 and 54)

To ensure the safety of the food chain as a whole, the Council has extended to animal
feed the emergency measures applicable to food. The wording used in the Common
Position is aligned on Community provisions on official controls in the field of
animal feed. The same procedures will thus be applied in both sectors.

2. Council’s position on the European Parliament’s amendments

The Council has incorporated the following amendments in its Common Position:

— 3, 6, 7, 14, 22, 25, 30, 31, 64 to 66, 71, 79, 86, 104, 105, 109, 110, 116, 119,

124, 127 to 131, 135 to 142, 152, 154, 164, 166, 176 and 186,

and retained the principle, or incorporated part of, amendments

— 2, 5, 16, 20, 27, 35, 38, 42, 45, 47, 57, 58, 60, 61, 62, 67, 73, 76, 80, 82 to 84,
93, 98, 103, 107, 108, 111 to 115, 120, 134, 144, 149, 155, 156, 160, 170, 177,
183, 207 and 220.

The Council followed the Commission and did not incorporate amendments

— 1, 4, 12, 13, 15, 17 to 19, 21, 23, 24, 26, 28, 29, 32 to 34, 36, 37, 39 to 41, 43,
44, 46, 48 to 56, 59, 63, 68, 72, 74, 77, 78, 81, 87 to 89, 91, 94, 95, 97, 99, 102,
117, 118, 121 to 123, 125, 133, 143, 145 to 148, 153, 157 to 159, 161 to 163,
169, 172 to 175, 179 to 182, 185, 187, 189, 202, 205, 209, 212 and 213.

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Regarding the other amendments which it did not incorporate, the Council’s views were
as follows:

— amendment 8: for simple reasons of consistency, the provisions on the precautionary
principle are worded in accordance with the resolution adopted by the Council on
this subject on 4 December 2000. Furthermore, it was felt that it would be better
legislative drafting not to introduce a sentence which was purely declaratory and
simply repeated a principle which was already apparent from the Regulation,

— amendments 10, 70 and 75: these amendments are intended to encourage any person
having knowledge of risks to food safety to inform the public authorities, while
guaranteeing special protection for the employees of the companies concerned. The
Council felt that these proposals, the scope and implications of which are hard to
see, probably fell outside the scope of the Regulation, and also that very serious
thought was needed before legislating in this area,

— amendment 69: the amendments to Article 19 make this amendment irrelevant,

— amendment 90: this amendment appears to be superfluous, since the European

Parliament is one of the institutions of the European Union,

— amendments 92 and 150: the Council felt that to provide that the Authority could
address recommendations to those responsible for risk management and give advice
on the choice of options went against the principle of a separation between the
functions of risk assessment and risk management, which is one of the basic
principles of the Regulation,

— amendment 96: the amendments to Article 23 make this amendment irrelevant. The
Common Position also already provides that communications should take account
of the special characteristics of different regions of the Union,

— amendment 106: it was felt more appropriate that the Authority itself, by means of its
rules of procedure, should lay down the provisions governing the participation of
the Chair of the Scientific Committee in the work of the Management Board,

— amendment 126: it was felt that this amendment would have the effect of restricting
the Authority’s ability to collect data in the important area of biological risk, thus
prejudicing the execution of its mission,

— amendment 132: as does the proposal, the Common Position provides that it is for
the Authority to chose the bodies which may assist it in accomplishing its mission.
The independence of the Authority should not be encroached on by deciding in
advance with which organisations it may cooperate;

— amendment 178: Article 12 of the Common Position prohibits food being exported if
it is harmful to health. This amendment to Article 53 is therefore no longer necessary,
since Parliament’s concerns have been taken into account,

— amendment 188: the deletion of the Article relating to the decision on the seat of the

Authority makes this amendment irrelevant.