Commission Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority’s missionText with EEA relevance
Date: 2004-12-23
Institutions: European Commission
Subjects: EU Member State, European Food Safety Authority, food safety, information network, operation of the Institutions, scientific cooperation

L 379/64

EN

Official Journal of the European Union

24.12.2004

COMMISSION REGULATION (EC) No 2230/2004

of 23 December 2004

laying down detailed rules for the implementation of European Parliament and Council Regulation
(EC) No 178/2002 with regard to the network of organisations operating in the fields within the
European Food Safety Authority’s mission

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 178/2002 of the European
Parliament and of the Council of 28 January 2002 laying down
the general principles and requirements of food law, establishing
and laying down
the European Food Safety Authority
food safety (1), and in particular
procedures in matters of
Article 36(3) thereof,

Having consulted the European Food Safety Authority,

Whereas:

referred to as

Networking between the European Food Safety Authority
‘the Authority’) and the
(hereinafter
Member States’ organisations operating in the fields
within the Authority’s mission is one of the basic prin-
ciples of
therefore
necessary to stipulate how this principle should be imple-
in accordance with Article 36(1) and (2) of
mented,
Regulation (EC) No 178/2002,
in order to ensure effi-
ciency.

the Authority’s operation.

is

It

scientific

Certain bodies in the Member States carry out tasks at
national level which are similar to those of the Authority.
Networking must make it possible to foster a framework
for
cooperation allowing information and
knowledge to be shared, common tasks to be identified,
and optimum use to be made of resources and expertise.
It is also important to facilitate the compilation of a
Community-level summary of
the data on food and
feed safety collected by these bodies.

As these bodies are to be entrusted with certain tasks
with a view to assisting the Authority with its general
mission as defined by Regulation (EC) No 178/2002, it is
essential for them to be designated by the Member States
on the basis of criteria covering scientific and technical
competence, efficiency and independence.

(1)

(2)

(3)

(4)

Member States must also stipulate the specific areas
of competence of the competent bodies designated, so
in
as to facilitate the operation of the network. Thus,
accordance with European Parliament
and Council
Regulation (EC) No 1829/2003 (2), when preparing an
opinion on a request for authorisation of a genetically
modified food or feed, the Authority may ask a Member
State’s competent body for assessing foods and feeds to
carry out a safety assessment of the relevant food or feed
in accordance with Article 36 of Regulation (EC) No
178/2002.

In accordance with the provisions of Article 27(4)(c) of
Regulation (EC) No 178/2002,
it is important for the
Advisory Forum to be able to ensure close cooperation
with the Authority and the competent bodies of
the
Member States by promoting the European networking
the
of organisations operating within the fields of
Authority’s mission.

The tasks entrusted to the competent bodies on the list
must
involve providing the Authority with assistance
with its mission to provide scientific and technical
support in relation to Community policy and legislation,
without prejudice to the Authority’s responsibility for
performing its tasks pursuant
to Regulation (EC) No
178/2002.

Financial support must be granted on the basis of criteria
which ensure that such support contributes efficiently
the Authority’s
and effectively to the performance of
regards
tasks and to the Community priorities as
scientific and technical support in the fields concerned.

It is important to ensure on a general basis that the tasks
entrusted by the Authority to the network’s member
organisations are performed to high scientific and
efficiently (also with regard to
technical
deadlines) and independently. However,
the Authority
remain responsible for allocating tasks to the
must
competent bodies and for monitoring performance.

standards,

(6)

(7)

(8)

(9)

Member States need to provide the Authority with
evidence of compliance with the necessary criteria for
the inclusion of competent bodies on the list drawn up
by the Authority’s Management Board.

(10)

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(1) OJ L 31, 1.2.2002, p. 1. Regulation amended by Regulation (EC) No

1642/2003 (OJ L 245, 29.9.2003, p. 4).

(2) OJ L 268, 18.10.2003, p. 1.

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Official Journal of the European Union

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HAS ADOPTED THIS REGULATION:

Article 1

Competent organisations designated by the Member States

1.
The competent organisations designated by the Member
States in accordance with Article 36(2) of Regulation (EC) No
178/2002 shall meet the following criteria:

(a)

they must carry out scientific and technical support tasks in
the fields within the mission of the European Food Safety
Authority (hereinafter referred to as ‘the Authority’), espe-
cially those with a direct or indirect impact on food or feed
safety; in particular, these tasks must include the collection
and analysis of data connected with risk identification,
food or feed safety
exposure to risks, risk assessment,
assessment, scientific or technical studies, or scientific or
technical assistance for risk managers;

(b) they must be

legal

entities pursuing public

interest
objectives, and their organisational arrangements must
include specific procedures and rules ensuring that any
tasks
the Authority will be
performed with independence and integrity;

entrusted to them by

(c)

they must possess a high level of scientific or technical
fields within the Authority’s
expertise in one or several
mission, especially those with a direct or indirect impact
on food or feed safety;

(d) they must have the capacity to operate in a network on
scientific actions as referred to in Article 3 of this Regu-
lation and/or the capacity to perform efficiently the types of
task referred to in Article 4 of this Regulation which may be
entrusted to them by the Authority.

in paragraph 1, and details of

2. Member States shall forward to the Authority, with a copy
to the Commission, the names and details of the designated
organisations, evidence that they comply with the criteria set
out
their specific fields of
competence. In particular, for the purposes of application of
Articles
(EC) No
1829/2003, Member States
forward the names and
details of the competent organisations in the field of safety
assessment of genetically modified foods and feeds.

of Regulation

18(3)(b)

6(3)(b)

shall

and

Where a designated organisation operates as part of a network,
this shall be mentioned, and the network operating conditions
shall be described.

In cases where it is a specific part of the designated organisation
which has the ability and the capacity to operate in a network
on scientific actions and/or perform the tasks which may be
entrusted to them by the Authority, this shall be stipulated by
the Member States.

the
3. Where designated organisations no longer meet
criteria set out in paragraph 1, Member States shall withdraw
their designation and immediately inform the authority, with a
copy to the Commission, accompanied by the relevant evidence.

Member States shall review the list of organisations they have
designated regularly, and at least every three (3) years.

Article 2

Establishing of the list of competent organisations

shall

ensure

The Authority

the organisations
1.
designated by the Member States comply with the criteria set
out in Article 1(1). Where necessary, the Member States shall be
asked, by reasoned request, to add to the evidence referred to in
Article 1(2).

that

The Authority’s Management Board, acting on a proposal
2.
from the Executive Director, shall draw up the list of competent
organisations, stating their specific fields of competence, espe-
cially in the field of safety assessment of genetically modified
foods and feeds, on the basis of
in
paragraph 1.

the procedure set out

3.
The list provided for in paragraph 2 (hereinafter referred
to as ‘the list’) shall be published in the Official Journal of the
European Union (‘C’ series).

The list shall be updated regularly, on the basis of
4.
from the Authority’s Executive Director,
proposals
taking
account of reviews or new designation proposals from the
Member States.

Article 3

Networking between the Authority and the organisations
on the list

1.
The Authority shall foster networking with the organi-
sations on the list so as to promote active scientific cooperation
in the fields within its mission, especially those with a direct or
indirect impact on food or feed safety.

To this end the Authority, on the basis of work carried out
within its Advisory Forum, shall
identify scientific actions of
common interest which could be undertaken within the
network. The work carried out within the Advisory Forum
shall take account of proposals from the organisations on the
list.

In accordance with Article 27(4)(c) of Regulation (EC) No
178/2002, the Advisory Forum shall contribute to networking.

2.
The Commission and the Authority shall cooperate in
order to avoid overlaps with existing scientific and technical
work at Community level.

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Article 4

Tasks to be entrusted to organisations on the list

— preparing the Authority’s

including
preparatory work relating to the assessment of authorisation
dossiers;

scientific opinions,

1. Without prejudice to the fulfilment of its mission and
to Regulation (EC) No
performance of
178/2002, the Authority may, with their agreement, entrust
to one or more of the organisations on the list tasks which
involve them providing it with scientific and technical support.

tasks pursuant

its

2.
The Advisory Forum shall ensure that there is a good
general match between the requests for contributions which
the Authority puts to the organisations on the list and the
scope of those organisations to respond favourably. To this
end the Executive Director shall make all the necessary infor-
mation available to the Advisory Forum.

The tasks which may be entrusted to the organisations on
to several working

3.
the list, either
together, are those which consist in:

to one organisation or

— disseminating best practices and improving methods of
collecting and analysing scientific and technical data, parti-
cularly for the purposes of facilitating comparability and
producing a Community-level summary;

— collecting and analysing specific data in response to a
common priority,
in particular the Community priorities
contained in the Authority’s work programmes, and in
cases where the Authority’s scientific assistance is urgently
needed by the Commission, especially in the context of the
general plan for crisis management referred to in Article 55
of Regulation (EC) No 178/2002;

— collecting and analysing data with a view to facilitating risk
assessment by the Authority, including assessment tasks in
the field of human nutrition in relation to Community
legislation, especially the compiling and/or processing of
scientific data on any substance, treatment, food or feed,
preparation, organism or contaminant which may be
linked with a health risk, and the collection and/or
analysis of data on the exposure of Member States’ popu-
lations to a health risk associated with food or feed;

— producing scientific data or works contributing to the risk
assessment tasks, including assessment tasks in the field of
human nutrition in relation to Community legislation, for
which the Authority is responsible; this type of task must
correspond to precise problems identified in the course of
the work of the Authority, and in particular that of
its
Committee and permanent Scientific Panels, and must not
duplicate Community research projects or data or contri-
butions which it is the industry’s duty to provide, especially
in the context of authorisation procedures;

— preparing the harmonisation of risk assessment methods;

— sharing data of common interest, e.g. the establishing of

databases;

— the tasks referred to in Articles 6 and 18(3)(b) of Regulation

(EC) No 1829/2003.

Article 5

Financial support

1.
The Authority may decide to allocate financial support for
tasks entrusted to the organisations on the list where they are of
particular interest as regards contributing to the performance of
the Authority’s tasks or addressing the priorities laid down in its
work programmes, or where the Authority’s assistance is
urgently needed by the Commission, particularly in order to
deal with crisis situations.

2.
Financial support shall take the form of subsidies awarded
in accordance with the Authority’s financial regulation and
implementing rules.

Article 6

Harmonised quality criteria and implementing conditions

1.
After consulting the Commission, the Authority shall lay
down harmonised quality criteria for the performance of tasks
which it entrusts to the organisations on the list, in particular:

(a) criteria to ensure that tasks are performed to high scientific
standards, especially with regard to the
and technical
scientific and/or technical qualifications of staff assigned to
them;

(b) criteria relating to the resources which may be allocated to
the performance of tasks, especially with a view to ensuring
that they are completed by pre-established deadlines;

(c) criteria relating to the existence of rules and procedures for
ensuring that specific categories of tasks are carried out with
independence, integrity and respect for confidentiality.

The precise conditions

2.
tasks
for
entrusted to organisations on the list shall be laid down in
specific agreements between the Authority and each organi-
sation concerned.

the performance of

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Article 7

Monitoring the performance of tasks

the
In the case of
penalties provided for by the Authority’s financial regulation
and implementing rules shall apply.

tasks for which subsidies are awarded,

The Authority shall ensure that the tasks it entrusts to the
organisations on the list are properly carried out. It shall take
all the necessary steps to ensure that the criteria and conditions
laid down in Article 6 are complied with. In the event of failure
to comply with those criteria and the conditions, the Authority
shall take remedial action. Where necessary, it may replace the
organisation.

Article 8

Entry into force

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

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

Done at Brussels, 23 December 2004.

For the Commission

Markos KYPRIANOU
Member of the Commission