Amended Proposal for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2001-08-07
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food inspection, foodstuffs legislation

30.10.2001

EN

Official Journal of the European Communities

C 304 E/273

Amended proposal for a Regulation of the European Parliament and of the Council laying down
the general principles and requirements of food law, establishing the European Food Authority,
and laying down procedures in matters of food safety (1)

(2001/C 304 E/21)

(Text with EEA relevance)

COM(2001) 475 final (cid:151) 2000/0286(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 8 August 2001)

(1) OJ C 96 E, 27.3.2001, p. 247.

INITIAL PROPOSAL

AMENDED PROPOSAL

THE EUROPEAN PARLIAMENT AND THE COUNCIL
OF THE EUROPEAN UNION,

Unchanged

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

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

Having regard to the opinion of
Committee (2),

the Economic and Social

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,

Whereas:

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

(2) A high level of protection of human life and health should

be assured in the pursuit of Community policies.

(3) The

free movement of

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

___________
(1) COM(2000) 716 final of 8.11.2000.
(2) OJ C 155, 29.5.2001, p. 32.
(3) 13.6.2001 not yet published in OJ.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(4) 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
movement of
conditions of
competition, and may thereby directly affect the func-
tioning of the internal market.

create unequal

food,

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

the principles set out

the relevant

(6) Water is ingested other foods, thereby contributing to the
overall exposure of a consumer to ingested substances,
including chemical and microbiological contaminants.
However, as water intended for human consumption is
already controlled by Council Directives 80/778/EEC (1)
and 98/83/EC (2),
it suffices to consider water after the
point of compliance as defined in Article 6 of Council
Directive 98/83/EC.

(6) Water is ingested directly or indirectly like other foods,
thereby contributing to the overall
a
consumer to ingested substances, including chemical and
microbiological contaminants. However, as water intended
for human consumption is already controlled by Council
Directives 80/778/EEC (1) and 98/83/EC (2), it suffices to
consider water after the point of compliance as defined in
Article 6 of Council Directive 98/83/EC.

exposure of

(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 requirements
which have been applied so far and which will be
applied in the future in feed legislation applicable to all
animals, including pets.

Unchanged

(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.

(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.

___________
(1) OJ L 229, 30.8.1980, p. 11.
(2) OJ L 330, 5.12.1998, p. 32.

___________
(1) OJ L 229, 30.8.1980, p. 11.
(2) OJ L 330, 5.12.1998, p. 32.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(10) Experience has

it

shown that

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.

(11) In order to take a sufficiently comprehensive and inte-
grated approach to food safety, there should be a broad
definition of food law covering a wide range of provisions
with a direct or indirect effect on the safety of food and
including provisions on materials and articles in
feed,
contact with food, animal feed.

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

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

(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, 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.

(13) Experience has shown that for this reason it is necessary
to consider the production, manufacture, and distribution
of feed given to food-producing animals,
including the
production of since the inadvertent or deliberate contami-
nation 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.

(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.

(14) For the same reason,

it is necessary to consider other
practices and and their potential effect on the overall
safety of food.

(14) For the same reason,

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

(15) Measures

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

Unchanged

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INITIAL PROPOSAL

AMENDED PROPOSAL

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

risk
communication,

assessment,

risk
and

analysis:

provide

risk

(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.

(18) It

recognised that

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

to the matter

relevant

factors

(18) It

recognised that

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

to the matter

traditional,

relevant

factors

(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
the
is necessary to adopt a uniform basis throughout
Community.

(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
the
is necessary to adopt a uniform basis throughout
Community. A measure based on the precautionary
principle should not discriminate or provide disguised
restriction on the ground of the origin of the food or feed.

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

scientific uncertainty persists,

Unchanged

trading partners and trade organisations.

(21) Food safety and the protection of consumer’s interests is
of increasing concern to the general public, non-govern-
inter-
mental organisations, professional
national
It is
necessary to ensure that consumer confidence and the
trading partners is secured through the
confidence of
open and transparent development of
food law and
through public authorities taking the appropriate steps
to inform the public where there are reasonable grounds
to suspect that a food may present a risk to health.

associations,

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INITIAL PROPOSAL

AMENDED PROPOSAL

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

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

(23) It is necessary to ensure that food and feed exported or
complies with
from the Community
re-exported
set up by the
the requirements
Community law or
food and
in other circumstances,
importing country;
feed can only be exported or re-exported provided that
the importing country has expressly agreed; however it is
necessary to ensure that even where there is an agreement
of
food injurious to health or
unsafe feeds are not exported or re-exported.

the importing country,

Unchanged

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

international

developing

standards

and

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

(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.

to trace

food and feed.

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

accurate withdrawals

undertaken

can

be

is

It

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INITIAL PROPOSAL

AMENDED PROPOSAL

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

(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, he should have primary legal
responsibility for ensuring food safety. Although this
principle exists in some Member States and areas of
in other areas, this is either not explicit or
food law,
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.

(31) Experience has shown that employees in food or feed
businesses who by virtue of their professional activities
become aware that an unsafe feed or a food with the
potential to be injurious to health has been placed on
the market, can contribute significantly to the reduction
or prevention of that risk.

(32) 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
independent and
efficient scientific and technical support.

to high-quality,

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

a
referred to as

establishment of

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INITIAL PROPOSAL

AMENDED PROPOSAL

(34) 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
It may be called upon to give
the internal market.
opinions
thereby
enabling the Community institutions and Member States
to take informed risk-management decisions necessary to
ensure food and safety whilst helping avoid the fragmen-
tation of the internal market through the adoption of
unjustified
free
movement of food and.

unnecessary

contentious

obstacles

scientific

issues,

the

on

or

to

(34) 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
It may be called upon to give
the internal market.
opinions
thereby
enabling the Community institutions and Member States
to take informed risk-management decisions necessary to
ensure food and feed safety whilst helping avoid the frag-
mentation of the internal market through the adoption of
unjustified or unnecessary obstacles to the free movement
of food and feed.

contentious

scientific

issues,

on

(35) The Authority should be an independent scientific source
of advice, information and risk communication in order
to improve consumer confidence; nevertheless in order to
promote coherence between the risk assessment, risk
management and risk communication functions.

(35) The Authority should be an independent scientific source
of advice, information and risk communication in order
to improve consumer confidence; nevertheless in order to
promote coherence between the risk assessment, risk
management and risk communication functions, the link
between risk assessors and risk managers
should be
strengthened.

Unchanged

for

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

and scientific

scientific

advice

(37) Since some products authorised under food law such as
pesticides or additives in animal feed may involve risks to
some
the environment or
environmental and worker protection aspects
should
also be assessed in accordance with the relevant legis-
lation.

to the safety of workers,

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INITIAL PROPOSAL

AMENDED PROPOSAL

opinions

scientific

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

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

roles

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

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

tasks required to enable it to carry out its role.

(42) It is necessary to ensure that there is effective monitoring
of the Authority by the various Community institutions
involved, and for this purpose its Management Board
representatives appointed by the
should include four
European Parliament, four by the Council, and four by
the Commission.

(43) The Management Board should have the necessary powers
to establish the budget, check its implementation, draw up
internal
appoint
financial
the Scientific Committee and Scientific
members of
Panels and appoint the Executive Director.

regulations,

adopt

rules,

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

___________
(1) OJ L 106, 17.4.2001, p. 1.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(45) The Authority should co-operate 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 co-operation
in particular with regard to the networking system

(45) The Authority should co-operate 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 co-operation
in particular with regard to the networking system;
co-operation and appropriate exchange of
information
should also minimise the potential for diverging scientific
opinions.

(46) The Authority should take over the role of the Scientific
Committees attached to the Commission in issuing
is
It
in its
scientific opinions
necessary to reorganise these Committees
to ensure
greater
scientific consistency in relation to the food
supply chain and to enable them to work more effectively.
A Scientific Committee and Permanent Scientific Panels
should therefore be set up within the Authority to
provide these opinions.

field of competence.

Unchanged

(47) 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.

(48) 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 several scientific
bodies, procedures
should be in place to solve the
divergence or provide the risk managers with a trans-
parent basis of scientific information.

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

States prevent duplication of

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INITIAL PROPOSAL

AMENDED PROPOSAL

(50) 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 co-ordinated by the Authority. A
review of the Community data collection networks in the
fields covered by the Authority is called for.

(50) 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 co-ordinated by the Authority with
all relevant organisations including where appropriate,
consumers and other stakeholders’ scientific organisations.
A review of the Community data collection networks in
the fields covered by the Authority is called for.

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

It

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

It

(52) The establishment of the Authority should enable Member
States
to become more closely involved in scientific
procedures; there should therefore be close co-operation
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.

Unchanged

(53) It is necessary to ensure that a balance is struck between
the use of national organisations carrying out tasks for the
Authority and the need to ensure for the purposes of
overall consistency that such tasks are carried out
in
line with the criteria established for such tasks for the
Authority. Existing procedures
the allocation of
scientific tasks to the Member States, in particular with
regard to the evaluation of dossiers presented by industry
for the authorisation of certain substances, products or
procedures, should be re-examined within a year the
establishment of the Authority and the new facilities it
offers.

for

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

it offers,

for

risk management measures;

(54) The Commission remains fully responsible for communi-
appropriate
cating
information should be therefore exchanged between the
co-operation
Authority
and
between the Authority,
the
Member States is also necessary to ensure the coherence
of the global communication process.

the Commission close

the Commission and

the

Unchanged

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INITIAL PROPOSAL

AMENDED PROPOSAL

(55) 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.

(56) Appropriate cooperation with the Member States

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

(56) Appropriate cooperation with the Member States

is
necessary in the specific field of public information
campaigns to take into account any regional parameters
and any correlation with health policy; communication on
the health implications of nutrition should take into
account
the diversity of dietary habits within the
European Union.

(57) In addition to its operating principles based on inde-
pendence and transparency, the Authority should be an
organisation open to contacts with consumers and other
interested groups.

Unchanged

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

concerned; moreover,

the possibility of

auditing of

the

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

safety (1). The scope of
food and industrial products but not

(60) A system for rapid alert already exists in the framework of
Council Directive 92/59/EEC of 29 June 1992 on general
the existing system
product
includes
feed.
Recent food crises have demonstrated the need to set up
an improved and broadened rapid alert system covering
food and feed. This revised system should be managed by
the Commission and include as members of the network
the Member States, the Commission and the Authority.
The system should not cover
the early exchange of
information in the event of a radiological emergency
established in Council Decision 87/600/Euratom (2).

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

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AMENDED PROPOSAL

(61) 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.

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

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

Unchanged

(63) In order

Feedingstuffs. Accordingly,

to ensure a more effective, comprehensive
approach to the food chain, a Committee on the Food
Chain and Animal Health should be established to
replace the Standing Veterinary Committee, the Standing
Committee for Foodstuffs, and the Standing Committee
Council Decisions
for
68/361/EEC (1),
70/372/EEC (3)
and
should be repealed. For the same reason the Committee
on the Food Chain and Animal Health should also replace
the Standing Committee on Plant health in relation
76/895/EEC (4),
to
86/362/EEC (5),
and
91/414/EEC (8)) on plant protection products and the
setting of maximum residue levels.

(for Directives

86/363/EEC (6),

69/414/EEC (2),

90/642/EEC (7)

competence

its

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

down the procedures

the

for

___________
(1) OJ L 255, 18.10.1968, p. 23.
(2) OJ L 291, 19.11.1969, p. 9.
(3) OJ L 170, 3.8.1970, p. 1.
(4) OJ L 341, 9.12.1976, p. 26. Directive as last amended 96/32/EC

(OJ L 144, 18.6.1996, p. 12).

(5) OJ L 221, 7.8.1986, p. 37.
(6) OJ L 221, 7.8.1986, p. 43.
(7) OJ L 350, 14.12.1990, p. 71.
(8) OJ L 230, 19.8.1991, p. 1.
(9) OJ L 184, 17.7.1999, p. 23.

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(65) It is necessary to give operators sufficient time to adapt to
some of the requirements established by the present Regu-
lation and to foresee that the European Food Authority
commences its operations on 1 January 2002.

this Regulation is without prejudice

(66) It is important to avoid confusion between the missions of
the Authority and the European Medicinal Evaluation
Agency (EMEA) established by Council Regulation (EEC)
No 2309/93 (1). Consequently, it is necessary to establish
that
to the
competence conferred on the EMEA by Community legis-
lation, including powers conferred by Council Regulation
(EEC) No 2377/90 of 26 June 1990 laying down a
Community
of
for
establishment
maximum residue
veterinary medicinal
products in foodstuffs of animal origin (2).

procedure

limits

the

of

(67) In accordance with the principle of proportionality it is
the
necessary and appropriate for the achievement of
basic objectives of
this Regulation to provide for the
approximation of the concepts, principles and procedures
forming a common basis for food law in the Community
and to establish a European Food Authority. This Regu-
to what is necessary in order to
lation confines itself
achieve the objectives pursued,
in accordance with the
third paragraph of Article 5 of the Treaty,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SCOPE AND DEFINITIONS

Article 1

Aim and scope

This Regulation provides the basis for the assurance of a
1.
high level of protection of human life and health and
interest in relation to food, whilst ensuring the
consumers’
effective functioning of
It establishes
the internal market.
common principles 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
or national level.

___________
(1) OJ L 214, 24.8.1993, p. 1, Regulation as amended by Regulation

(EC) No 649/1998 (OJ L 88, 24.3.1998, p. 7).

(2) OJ L 224, 18.8.1990, p. 1, Regulation as amended by Commission
Regulation (EC) No 2391/2000 (OJ L 276, 28.10.2000, p. 5).

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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,
and distribution of food and feed. It shall not apply to primary
production for private domestic use or to the domestic prep-
food for private domestic
aration, handling or storage of
consumption.

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 (cid:145)food(cid:146)

Unchanged

intended to be, or

For the purposes of this Regulation, (cid:145)food(cid:146) (or (cid:145)foodstuff(cid:146)) means
any substance or product, whether processed, partially
reasonably
processed or unprocessed,
expected to be ingested by humans.
includes drink,
chewing gum and any substance, including water, intentionally
incorporated into the food during its manufacture, preparation
or treatment. It includes water after the point of compliance as
defined in Article 6 of Directive 98/83/EC and without
prejudice to the requirements of Directive 80/778/EEC and
98/83/EC.

It

It 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 Directive

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

(e) cosmetics within the meaning of Council Directive

76/768/EEC (3);

(f) tobacco and tobacco products within the meaning of

Council Directive 89/622/EEC (4);

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

(h) residues and contaminants.

___________
(1) OJ 22, 9.2.1965, p. 369/65.
(2) OJ L 297, 13.10.1992, p. 8.
(3) OJ L 262, 27.9.1976, p. 169.
(4) OJ L 359, 8.12.1989, p. 1.

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Article 3

Other definitions

For the purposes of this Regulation:

1.

(cid:145)food law(cid:146) means the laws, regulations and administrative
provisions governing food in general, and food safety in
covers
particular;
and
any stage of production,
distribution of
food, and also feed for food-producing
animals.

it

1.

(cid:145)food law(cid:146) means the laws, regulations and administrative
provisions governing food in general, and food safety in
particular, whether at Community or national
it
covers any stage of production, processing and distribution
of food, and also feed for food-producing animals.

level;

2.

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

Unchanged

3.

(cid:145)food business operator(cid:146) means the natural or legal persons
responsible for ensuring that the requirements of food law
are met within the food business under their control.

4.

5.

(cid:145)feed(cid:146) (or (cid:145)feedingstuff(cid:146)) means any substance or product,
including
partially
whether
intended to be used for oral
processed or unprocessed,
feeding to animals.

processed,

additives,

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

production, manufacture,

of

5.

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

production, manufacture,

of

6.

(cid:145)feed business operator(cid:146) means the natural or legal persons
responsible for ensuring that the requirements of food law
are met within the feed business under their control.

Unchanged

7.

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

canteens,
similar

institutional

factory

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8.

(cid:145)placing on the market(cid:146) means the holding of food or feed
for the purpose of sale, including offering for sale or any
other form of transfer, whether free of charge or not, and
the sale, and other forms of transfer themselves.

8.

(cid:145)placing on the market(cid:146) means the holding of food or feed
for the purpose of sale, including offering for sale or any
other form of transfer, whether free of charge or not, and
the sale, distribution and other forms of transfer them-
selves.

9.

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

Unchanged

10.

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

11.

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

12.

(cid:145)risk management(cid:146) means the process, distinct from risk
assessment, of weighing policy alternatives in consultation
with interested parties, considering risk assessment and
other legitimate factors, and, if need be, selecting appro-
priate prevention and control options.

13.

risk

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

risk
feed and food businesses,
and

perceptions,

interested

assessors,

among

other

14.

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

15.

(cid:145)traceability(cid:146) 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, and distribution.

16.

(cid:145)stages of production, and distribution(cid:146) means any stage,
including, from and including the primary production of
a food, up to and sale or supply to the final consumer and,
where relevant, the production, manufacture, distribution,
sale and supply of feed.

15.

16.

(cid:145)traceability(cid:146) means the ability to trace and follow a food,
feed, food-producing animal or substance intended to be,
feed,
or expected to be incorporated into a food or
through
and
processing
all
distribution.

production,

stages

of

including import,

(cid:145)stages of production, processing and distribution(cid:146) means
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.

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17.

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

17.

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

18.

(cid:145)final consumer(cid:146) 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

Unchanged

Article 4

Scope

This Chapter shall relate to all stages of the production,
food and feed produced for, or fed to,

1.
and distribution of
food-producing animals.

1.
This Chapter shall relate to all stages of the production,
processing and distribution of food and 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.

Unchanged

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.

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

S e c t i o n 1

General principles of food law

Article 5

General objectives

Food law shall pursue one or more of

1.
the general
objectives of a high level of protection of human life and
in food trade, taking account of, where appropriate,
health,
the protection of animal health and welfare, plant health and
the environment.

Food law shall pursue one or more of

1.
the general
objectives of a high level of protection of human life and
including fair
health, the protection of consumers’
practices in food trade, taking account of, where appropriate,
the protection of animal health and welfare, plant health and
the environment.

interests,

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.

Unchanged

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3. Where international standards exist or their completion is
imminent, they shall be taken into consideration in the devel-
opment or adaptation of food law.

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

Article 6

Risk analysis

Unchanged

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.

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

to the matter under

consideration,

Article 7

Precautionary principle

In circumstances where,

following an assessment of
1.
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 feasi-
bility and other factors regarded as legitimate in the matter
under consideration. The measures shall be reviewed within a
reasonable period of time, depending on the nature of the risk
to life or health identified and the type of scientific information
needed to clarify the scientific uncertainty and to conduct a
more comprehensive risk assessment.

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Article 8

Protection of consumers’ interests

Food law shall aim at
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:

the protection of

(a) fraudulent or deceptive practices;

(b) the adulteration of food; and

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

S e c t i o n 2

Principles of Transparency

Article 9

Public consultation

shall be public

There
through
representative bodies, at an appropriate stage, during the prep-
aration of food law.

consultation, directly or

shall be public

There
through
representative bodies, at an appropriate stage, during the prep-
aration of food law, except where the urgency of the matter
does not allow it.

consultation, directly or

Article 10

Public information

Unchanged

to suspect

that a food or

Without prejudice to the applicable provisions of Community
law on access to documents, where there are
and national
reasonable grounds
feed may
present a risk for human or animal health, then, depending
on the nature, seriousness and extent of that risk public auth-
orities 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 being placed
therein shall
on the market
relevant
food law or conditions recognised by the
requirements of
Community to be at
least equivalent or, where a specific
agreement exists between the Community and the exporting
country, with requirements contained therein.

comply with the

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Article 12

AMENDED PROPOSAL

Food and exported from the Community

Food and feed exported from the Community

1.
Food and exported or re-exported from the Community
for being placed on the market of a third country shall comply
with the relevant requirements of food law, unless otherwise
requested by the authorities of the importing country or estab-
lished by the laws, regulations, standards, codes of practice and
other legal and administrative procedures as may be in force in
the importing country.

Food and feed exported or

1.
re-exported from the
Community for being placed on the market of a third
country shall comply with the relevant requirements of food
the
law, unless otherwise requested by the authorities of
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.

circumstances

food can only be
the competent authorities of

exported or
In other
the
re-exported provided that
country of destination have expressly agreed, after having
been fully informed of the reasons for which and the circum-
stances under which the concerned food or feed could not be
placed on the market in the Community.

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

applicable,

are

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

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

Article 13

Unchanged

International standards

Without prejudice
Community and the Member States shall:

to their

rights

and obligations,

the

(a) contribute to the development of

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

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

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

(d) give particular attention to the

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

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S e c t i o n 4

General Requirements of food Law

Article 14

Food safety requirements

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

1.
be:

2.
be:

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

1.

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

(a) injurious to health;

Unchanged

(b) unfit for human consumption.

In determining whether any food is unsafe, regard shall

2.
be had:

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, and distribution,
and

(a) to the normal conditions of use of

the food by the
consumer and at each stage of production, processing
and distribution, and

(b) to the information provided to the consumer,

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

Unchanged

In determining whether any food is injurious to health,

3.
regard shall be had:

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.

Unchanged

(b) to the probable cumulative toxic effects.

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

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

In determining whether any food is unfit

4.
for human
consumption, regard shall be had to whether the food is unac-
ceptable for human consumption according to its intended use,
for reasons of contamination, whether by extraneous matter or
otherwise, or through putrefaction, deterioration or decay.

In determining whether any food is unfit

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

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

the food in that batch,

is also unsafe, unless

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

the food in that batch,

is also unsafe, unless

6.
Food that complies with specific Community provisions
of food law shall be deemed to be safe insofar as the aspects
covered by the specific Community provisions are concerned.

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

Conformity of a food with specific provisions applicable
8.
food shall not bar the competent authorities from
to that
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.

7. 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, and in particular
Articles 28 and 30 thereof.

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, and in particular
Articles 28 and 30 thereof.

Article 15

Unchanged

Feed safety requirements

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

1.
food-producing animal if it is unsafe.

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

2.
is considered to:

(cid:151) have an adverse effect on human or animal health;

(cid:151) 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
lot or
consignment of feed of the same class or description, it shall
lot or
be presumed that all of

the feed in that batch,

is part of a batch,

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is

consignment
following a detailed
assessment there is no evidence that the rest of the batch, lot
or consignment fails to satisfy the feed safety requirement.

so affected, unless

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

5.
Conformity of a feed with specific provisions applicable
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
such
where
conformity, the feed is unsafe.

that despite

to suspect

reasons

there

are

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 of the Member State governing feed
safety in whose territory the feed is in circulation, such
provisions being drawn up and applied without prejudice to
the Treaty, and in particular Articles 28 and 30 thereof.

Article 16

Presentation

Without prejudice to more specific provisions of food law, the
feed,
advertising and presentation of
labelling,
food or
or
including
the
their
packaging,
packaging materials used,
in which they are
arranged and the setting in which they are displayed, and the
information which is made available about
them through
whatever medium, shall not mislead consumers.

appearance
the manner

shape,

Article 17

Responsibilities

Food and feed business operators at all

1.
stages of
production, and distribution within the businesses under their
control shall ensure that foods or feeds satisfy the relevant
requirements of
such
food law and shall
requirements are met.

verify

that

Food and feed business operators at all

1.
stages of
production, processing and distribution within the businesses
under their control shall ensure that foods or feeds satisfy the
relevant 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,
and distribution.

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.

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And other activities as appropriate to the circumstances,
including public communication on food and feed safety and
risk, food and feed safety surveillance and other monitoring
activities.

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

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

and penalties provided for

shall be

Unchanged

Article 18

Traceability

The traceability of

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

food,

feed,

The traceability of

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

food,

feed,

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.

Unchanged

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

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

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

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
traceability,
labelled or
through
identified to facilitate its
relevant documentation or information,
in accordance with
the relevant requirements of more specific provisions.

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

Unchanged

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Article 19

Responsibilities for food: food business operators

AMENDED PROPOSAL

it

1.
If a food business operator considers or suspects that a
food which it has imported, produced, processed, manufactured
in compliance with the food safety
or distributed is not
requirements,
to
immediately initiate procedures
shall
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 with-
drawal, and if necessary,
from consumers products
recall
already supplied to them when other measures are not
sufficient to achieve a high level of health protection.

safety or

responsible for

A food business operator

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

food-safety requirements

food shall,

the

its

respective

responsible for

A food business operator

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

requirements

food-safety

participate

shall

and

A food business operator shall

3.
immediately inform the
competent authorities if it considers or suspects that a food
which it has placed on the market may be injurious to human
health. The operators shall inform the competent authorities of
the action taken to prevent risks to the final consumer.

A food business operator shall

3.
immediately inform the
competent authorities if it considers or suspects that a food
which it has placed on the market may be injurious to human
health. The operators shall inform the competent authorities of
the action taken to prevent risks to the final consumer and
shall not prevent or discourage any person from co-operating
with the competent authorities, where this may prevent, reduce
or avoid a risk arising from a food.

Food business operators

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

shall

Food business operators

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

shall

Article 20

Unchanged

Responsibilities for feed: feed business operators

1.
If a feed business operator considers or suspects that a
feed which it has imported, produced, processed, manufactured
or distributed does not satisfy the feed safety requirements, it
shall immediately initiate procedures to withdraw the feed in
question from the market and inform the competent auth-

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orities thereof. The operator shall effectively and accurately
inform users of
the reason for its withdrawal,
and if necessary, recall from them products already supplied
when other measures are not sufficient to achieve a high level
of health protection.

the feed of

responsible for,

A feed business operator

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

participate

feed-safety

shall

and

its

respective

integrity of

responsible for,

A feed business operator

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

participate

feed-safety

shall

and

A feed business operator shall

3.
immediately inform the
competent authorities if it considers or suspects that a feed
which it placed on the market may not satisfy the feed safety
requirements. It shall inform the competent authorities of the
action taken to prevent risk arising from the use of that feed.

Feed business operators

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

shall

A feed business operator shall

3.
immediately inform the
competent authorities if it considers or suspects that a feed
which it placed on the market may not satisfy the feed safety
requirements. It shall inform the competent authorities of the
action taken to prevent risk arising from the use of that feed
and shall not prevent or discourage
any person from
co-operating with the competent authorities, where this may
prevent, reduce or avoid a risk arising from a feed.

Unchanged

Article 21

Liability

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

concerning liability

The provisions of this Chapter shall be without prejudice to
Council Directive 85/374/EEC (1)
for
defective products, as amended by Directive 1999/34/EC (2).

concerning liability

CHAPTER III

Unchanged

EUROPEAN FOOD AUTHORITY

S e c t i o n 1

Mission and tasks

Article 22

Mission of the Authority

A European Food Authority is hereby established, here-

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

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

___________
(1) OJ L 210, 7.8.1985, p. 29.
(2) OJ L 141, 4.6.1999, p. 20.

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

shall provide

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

The Authority shall collect and analyse to allow the char-
2.
acterisation and monitoring of risks which have a direct or
indirect.

The Authority shall collect and analyse data to allow the char-
acterisation 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 provision
of:

Unchanged

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

the Commission,

request of

the

at

(b) scientific opinions on other matters relating to animal

health and welfare and plant health;

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

3.
The Authority shall provide scientific opinions which will
serve as the scientific basis for the drafting and adoption of
Community measures in the fields falling within its mission.

The Authority shall carry out

4.
its tasks in conditions
which enable it to serve as a point of reference by virtue of
its independence, the scientific and technical quality of the
opinions it
the
transparency of its procedures and methods of operation, and
its diligence in performing the tasks assigned to it.

issues and the information it disseminates,

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

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5.
The Authority, Commission and Member States shall
co-operate to promote the necessary coherence between risk
communication
assessment,
functions.

risk management

risk

and

The Member States shall co-operate with the Authority to

6.
ensure the accomplishment of its mission.

Article 23

Tasks of the Authority

The tasks of the Authority shall be the following:

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

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

(c) to provide

scientific

and technical

support

to the

Commission in the areas within its mission

(c) to provide

scientific

to the
Commission in the areas within its mission and when so
requested,
in the interpretation and consideration of risk
assessment opinions;

and technical

support

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

Unchanged

plishment of its mission;

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

(f)

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

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

(h) to provide

scientific

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

and technical

(i)

scientific

and technical

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

co-operation

between

the

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(j)

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

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

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

within its mission;

tations on matters within its mission;

(l)

to undertake any other
Commission within its mission.

task assigned to it by the

Unchanged

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

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

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

The Management Board shall adopt

3.
the Authority’s
internal rules on the basis of a proposal by the Executive
Director.

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.

4.
The Management Board shall elect its Chairman from
among its members for a two-year period, which shall be
renewable.

Unchanged

5.
The Management Board shall adopt its rules of procedure.
Unless otherwise provided, the Management Board shall act by
a majority of its members.

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6.
The Management Board shall meet at the Chairperson’s
invitation or at the request of at least a third of its members.

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

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

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

legislative

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

Unchanged

Board,

having

shall adopt

The Management

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

the Authority’s

the financial

financial

Board,

having

shall adopt

The Management

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

the Authority’s

the financial

financial

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

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

Article 26

Executive Director

Unchanged

The Executive Director

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

for a period of

The Executive Director

shall be appointed by the
1.
Management Board, on the basis of a list of candidates
proposed by the Commission after an open competition,
following publication in the Official
the European
Communities and elsewhere of a call
for expressions of
interest, and after a hearing of the candidate selected by the
Management Board in the European Parliament, for a period of
five years which shall be renewable. He may be removed from
office by the Management Board.

Journal of

The Executive Director shall be the legal representative of

2.
the Authority. He shall be responsible:

Unchanged

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

(b) for drawing up a proposal

for

the Authority’s work

programmes in consultation with the Commission;

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(c) for implementing the work programmes and the decisions

adopted by the Management Board;

(d) for

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

appropriate
for

scientific,
the Scientific

(e) for ensuring that

the Authority carries out

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

(f)

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

(g) for all staff matters;

Each year,

3.
Management Board for approval:

the Executive Director shall submit

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

to the

Unchanged

(a) a draft report covering all the activities of the Authority in

the previous year;

(a) a draft general report covering all
Authority in the previous year;

the activities of

the

(b) draft programmes of work;

Unchanged

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

(d) the draft budget for the coming year;

The Executive Director shall,

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

shall,

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

Unchanged

Article 27

Advisory Forum

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

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

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3.
The Advisory Forum shall advise the Executive Director
in the performance of his duties under this Regulation. The
Executive Director may also request the Advisory Forum for
advice on the prioritisation of requests for scientific opinions.

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 request
the
Advisory Forum for advice on the prioritisation of requests
for scientific opinions.

4.
It shall ensure close co-operation between the Authority
and the competent bodies in the Member States in particular
on the following items:

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 co-operation between the
Authority and the competent bodies in the Member States in
particular on the following items:

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

Unchanged

with Member States in accordance with Article 32;

(b) in those circumstances identified in Article 30, paragraph 4,
where the Authority and a national body shall be obliged to
co-operate;

(c) in the promoting of the European networking of organi-
the Authority’s

sations operating within the fields of
mission, in accordance with Article 36, paragraph 1;

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

emerging risk.

5.
The Advisory Forum shall be chaired by the Executive
Director. Its operational procedures shall be specified in the
Authority’s internal rules

5.
The Advisory Forum shall be chaired by the Executive
Director. It shall meet regularly at the Chairperson’s invitation
or at the request of at least a third of its members. Its oper-
ational 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 of its meetings.

Unchanged

Representatives of

the Commission’s departments may
7.
participate
the Advisory Forum. The
Executive Director may invite and from other relevant bodies
to take part.

in the work of

Representatives of

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

in the work of

Where the Advisory Forum discusses the matters referred to in
Article 22(2)(b), representatives from competent bodies in the
Member States which undertake tasks similar to those referred
to in Article 22(2)(b) may participate in the work of
the
Advisory Forum, on the basis of one representative designated
by each Member State.

Unchanged

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Article 28

Scientific Committee and Scientific Panels

AMENDED PROPOSAL

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

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

falling within the competence of

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

3.
The Scientific Committee shall be composed of the Chair-
persons of the Scientific Panels and 6 independent scientific
experts who do not belong to any of the Scientific Panels.

The Scientific Panels shall be composed of independent
the

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

(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.

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

The members of the Scientific Committee that are not
5.
members of Scientific Panel and the members of the Scientific
Panels shall be appointed by the Management Board, acting
upon a proposal from the Executive Director, for a three-year
term of office, which shall be renewable, following publication
in the Official Journal of the European Communities, of a call for
expressions of interest.

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

Journal of

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

Unchanged

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

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

in the meetings of

information but

shall not

The procedures for the operation and co-operation of the
9.
Scientific Committee and the Scientific Panels shall be laid
down in the Authority’s internal rules.

These procedures shall relate in particular to:

(a) the number of times that a Member can serve consecutively

on a Scientific Committee or Scientific Panel;

(b) the number of members in each Scientific Panel;

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

the Scientific Committee and the Scientific Panels;

(d) the manner

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

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

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(f)

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

(g) the possibility to organise public hearings.

Unchanged

S e c t i o n 3

Operation

Article 29

Scientific opinions

1.

The Authority shall issue a scientific opinion:

(a) at the request of the Commission, in respect of any matter
within its mission, and in all cases where Community legis-
lation makes provision for the Authority to be consulted;

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

or a Member State may request
scientific opinion on matters falling within its mission.

the Authority to issue a

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

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

Unchanged

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.

the Authority may

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

either

5. Where the Authority has already delivered a scientific
opinion on the specific topic in a request, the Authority 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.

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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

(b) the guidelines governing the

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

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

Article 30

scientific opinions

Diverging scientific opinions

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

Unchanged

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
co-operate with a view to either resolving the divergence or
presenting a joint document to the Commission clarifying the
contentious scientific issues. 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
co-operate 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.

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Article 31

Scientific and technical assistance

AMENDED PROPOSAL

shall

consist of

scientific or

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

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

specify,

it

Article 32

Scientific studies

shall

The Authority

commission scientific

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

The Authority shall inform the European Parliament, the
its

2.
Commission and the Member States of
scientific studies.

the results of

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

Unchanged

Article 33

Collection of data

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

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

related to the consumption of food;

(b) incidence and prevalence of biological risk;

(c) contaminants in food and feed;

(d) residues.

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

Unchanged

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

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

in the fields

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

analyses,

facilitate

order

to

in

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

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

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

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

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

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

Article 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

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.

a

serious

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

request

shall

risk,

it

a

risk,

serious

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

request

shall

it

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AMENDED PROPOSAL

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

Unchanged

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

The Authority

4.
evaluation and
information collected on emerging risks to the European
Parliament, the Commission and the Member States.

forward

shall

the

Article 35

Unchanged

Rapid alert system

Unchanged

risks of

foods as effectively as possible,

To enable it to perform its task of monitoring the health and
nutritional
the
Authority shall be the recipient of any messages forwarded
via the rapid alert network.
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 assessment.

Article 36

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

1.
The Authority shall promote the European networking of
organisations operating in the fields within the Authority’s
mission. The aim of such networking is,
to
facilitate a scientific co-operation framework by the co-ordi-
nation of activities, the exchange of information, the devel-
opment and implementation of
joint projects, the exchange
of expertise and best practices in the fields within the Auth-
ority’s mission.

in particular,

The Management Board, acting on a proposal from the
2.
Executive Director, shall draw up a list of competent organi-
sations 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.

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

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

financial

Unchanged

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

indicate in particular,

S e c t i o n 4

Independence, transparency and communication

Article 37

Independence

1.
The members of the Management Board, the members of
the Advisory Forum shall undertake to act independently in the
public interest.

1.
The members of the Management Board, the members of
the Advisory Forum and the Executive Director shall undertake
to act independently in the public interest.

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

considered prejudicial

to their

Unchanged

The members of

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

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

independence.

prejudicial

their

to

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

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

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Article 38

Transparency

AMENDED PROPOSAL

Unchanged

The Authority shall ensure that it carries out its activities

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

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

(a) agendas and minutes of the Scientific Committee and the

Scientific Panels;

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

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

immediately after

Panels
always being included;

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

which its opinions are based;

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

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

(c) the results of its scientific studies;

(e) the results of its scientific studies;

(d) the annual report of its activities;

(f)

the annual report of its activities;

(e) 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.

(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.

Unchanged

The Authority shall

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

lay down in its internal rules the
implementing the transparency

for

Article 39

Confidentiality

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

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the

the Management Board,

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

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

The Authority shall

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

Article 40

Communications from the Authority

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

communicate

1.
the
Commission’s
management decisions.

competence

its

to

The Authority shall ensure that

the public and any
2.
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.

The Authority shall ensure appropriate co-operation with
4.
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.

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

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Article 42

AMENDED PROPOSAL

Consumers, and other interested parties

Consumers, producers, and other interested parties

The Authority shall develop contacts with consumer represen-
tatives and any 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

Unchanged

Financial provisions

Article 43

Adoption of the Authority’s budget

The revenues of

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

the Authority shall

for

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

By 31 March each year at

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

the latest,

4.

Revenue and expenditure shall be in balance.

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

The Management Board shall, by 31 March at the latest,
5.
adopt
the draft estimates including the provisional estab-
lishment plan accompanied by the preliminary work program
and forward it to the Commission which on that basis shall
enter the relevant estimates in the preliminary draft general
the European Communities, which it shall put
budget of
before the Council pursuant to Article 272 of the Treaty.

The Management Board shall adopt

adjusting where necessary

the Authority’s
to the Community’s

6.
budget,
contribution.

After

the adoption of

the general Budget by the
6.
budgetary authority, the Management Board shall adopt the
Authority’s final budget and work program, adjusting them
where
It
forwards them without delay to the Commission and the
budgetary authority.

the Community’s

contribution.

necessary

to

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AMENDED PROPOSAL

Article 44

Unchanged

Implementation of the Authority’s budget

The Executive Director shall

1.
budget.

implement the Authority’s

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

By 31 March each year at

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

the latest,

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

examine

shall

the

accounts
in
It shall publish

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

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.

Article 45

Unchanged

Fees received by the Authority

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

S e c t i o n 6

General provisions

Article 46

Legal personality and privileges

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

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AMENDED PROPOSAL

The Protocol on the privileges and immunities of the

2.
European Communities shall apply to the Authority.

Article 47

Liability

liability of

The contractual

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

liability,

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

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

The personal

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

liability of

servants

towards

its

Article 48

Staff

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

1.
regulations applicable to officials and other
European Communities.

staff of

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

Article 49

Participation of third countries

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

agreements with the

concluded

Arrangements shall be made under the relevant provisions of
those agreements, specifying in particular the nature, extent
and manner in which these countries will participate in the
Authority’s work,
financial
contributions and staff.

including provisions relating to,

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

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AMENDED PROPOSAL

CHAPTER IV

Unchanged

RAPID ALERT SYSTEM, CRISIS MANAGEMENT AND
EMERGENCIES

S e c t i o n 1

Rapid alert system

Article 50

Rapid alert system

A rapid alert system for the notification of a direct or
1.
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.

1. 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
this
transmit
system. The Commission shall
information immediately to the members 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
this
transmit
system. The Commission shall
information immediately to the members of the network.

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

Unchanged

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

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

shall

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

Unchanged

(b) any recommendation or

at preventing,

agreement with professional
operators which is aimed, on a voluntary or obligatory
specific
limiting
basis,
conditions on the placing on the market or the eventual
use of food or feed on account of a serious risk to human
health requiring rapid action;

imposing

or

(c) any rejection, 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.

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AMENDED PROPOSAL

The notification shall be accompanied by a detailed explanation
of the reasons for the action taken by the competent auth-
the Member State in which the notification was
orities of
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.

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

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

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

Unchanged

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

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

shall

States

immediately

The Member

inform the
4.
the action implemented or measures taken
Commission of
following receipt of
the notifications and supplementary
information transmitted under the rapid alert system. The
Commission shall
this information to
immediately transmit
the Members of the network.

shall

immediately

The Member States

inform the
5.
the action implemented or measures taken
Commission of
following receipt of
the notifications and supplementary
information transmitted under the rapid alert system. The
Commission shall
this information to
immediately transmit
the Members of the network.

5.
Participation in the rapid alert system may be opened up
to European Union applicant countries, third countries or inter-
national organisations, on the basis of agreements between the
Community and those countries or international organisations,
in accordance with the procedures defined in those agreements.
The latter shall be based on reciprocity and shall include confi-
dentiality measures equivalent
to those applicable in the
Community.

6.
Participation in the rapid alert system may be opened up
to European Union applicant countries, third countries or inter-
national organisations, on the basis of agreements between the
Community and those countries or international organisations,
in accordance with the procedures defined in those agreements.
The latter shall be based on reciprocity and shall include confi-
dentiality measures equivalent
to those applicable in the
Community.

Article 51

Unchanged

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
and
procedures applicable to the transmission of notifications and
supplementary information.

in particular,

conditions

specific

specify,

the

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Article 52

Confidentiality rules for the rapid alert system

AMENDED PROPOSAL

Information available to the members of

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

in general be available to the public.

In general,

the members of

the members of

the network shall

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

information obtained for

justified cases,

in duly

secrecy

except

their

Information available to the members of

1.
the network
relating to 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 identi-
fication, the nature of the risk and the measure taken.

Unchanged

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

to the effectiveness of market

S e c t i o n 2

Emergencies

Article 53

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

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

Unchanged

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

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

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

question;

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AMENDED PROPOSAL

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

feed in question;

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

question,

(iv) any other appropriate interim measure;

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

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

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

question from all or part of
concerned;

the

(iii) any other appropriate interim measure.

in

However,

emergencies,

2.
the Commission may
provisionally adopt the measures referred to in paragraph 1
and
after
informing the other Member States.

the Member

consulting

concerned

State(s)

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

taken shall be confirmed, amended,

Article 54

Other Emergency Measures

emergency measures, and where

Where a Member State officially informs the Commission of
the need to take
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.

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.

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

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S e c t i o n 3

Crisis management

Article 55

General plan for crisis management

The Commission shall draw up,

1.
in close co-operation
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 (cid:145)the general plan(cid:146)).

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

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

Article 56

Crisis unit

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

it shall

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

Article 57

Tasks of the Crisis Unit

all

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

information and identifying

relevant

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

3.

The crisis unit shall.

The crisis unit shall keep the public informed on the risks

3.
involved and the measures taken.

CHAPTER V

Unchanged

PROCEDURES AND FINAL PROVISIONS

S e c t i o n 1

Committee and Mediation procedures

Article 58

Committee

The Commission shall be

1.
assisted by a Standing
Committee on the Food Chain and Animal Health, hereinafter
referred to as the (cid:145)Committee(cid:146), composed of representatives of
the Member States and chaired by the representative of the
Commission. The Committee shall be organised in sections to
deal with all relevant matters.

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

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 written
request of one of its members.

the Chairman or at

the initiative of

Article 60

Mediation procedure

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

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

S e c t i o n 2

Final provisions

Article 61

Review clause

1. Within three years of the date established in Article 65,
the Authority, in collaboration with the Commission, shall an
independent evaluation of its achievements on the basis of the
terms of
reference issued by the Management Board in
agreement with the Commission. The evaluation will assess
the working practices of the Authority and the impact of the
Authority, acting as such.

1. Within three years of the date established in Article 65,
and every six years thereafter, the Authority, in collaboration
with the Commission,
shall commission an independent
external evaluation of its achievements on the basis of the
reference issued by the Management Board in
terms of
agreement with the Commission. The evaluation will assess
the working practices of the Authority and the impact of the
Authority, acting as such. The evaluation will take into account
the views of the stakeholders, both at European and national
level.

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

as may be necessary,

Unchanged

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

The

reports

3.
referred to in
and recommendations
paragraphs 1 and 2 shall be forwarded to the Council and
the European Parliament.

Article 62

Unchanged

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.

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

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

For the purpose of paragraphs 1 and 2,

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

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

4.
hereby repealed.

Article 63

Competence of the European Medicines Evaluation
Agency

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 64

Seat

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

The location of
criteria:

the Authority should meet

the following

(i) It should be easily accessible in terms of communications

and have good and rapid transport connections;

(ii) It

should enable the Authority to work closely and
efficiently with those Commission services which deal
with public health and consumer protection issues;

(iii) It should be cost-effective and enable the Authority to start

its work immediately;

(iv) It should provide for the necessary infrastructure for the

personnel of the Authority.

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Article 65

Unchanged

Commencement of the Authority’s operation

The Authority shall commence its operations on 1 January
2002.

Article 66

Entry into force

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

Articles 29, 56, 57, 60 and 62(1) shall apply as from the date
of appointment of the scientific committee and scientific panels
which shall be announced by means of a notice in the (cid:145)C(cid:146) series
of the Official Journal of the European Communities.

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

Articles 11, 12 and 14 to 20 shall apply from 1 January 2004.

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

Unchanged