Commission Regulation (EC) No 1304/2003 of 11 July 2003 on the procedure applied by the European Food Safety Authority to requests for scientific opinions referred to it (Text with EEA relevance)
Date: 2003-07-23
Institutions: European Commission
Subjects: European Food Safety Authority, food safety, opinion, scientific report

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Official Journal of the European Union

24.7.2003

COMMISSION REGULATION (EC) No 1304/2003

of 11 July 2003

on the procedure applied by the European Food Safety Authority to requests for scientific
opinions referred to it

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

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 the European Food Safety Authority and
laying down procedures in matters of food safety (1), and in
particular Article 29(6)(a) thereof,

Having consulted the European Food Safety Authority,

Whereas:

(1)

(2)

(3)

(4)

(5)

It is necessary to lay down the conditions for the imple-
mentation of Article 29 of Regulation (EC) No 178/
2002 with regard to requests for scientific opinions
submitted to the European Food Safety Authority (here-
inafter referred to as the Authority) and with regard to
own-initiative opinions.

The Community legislation governing the scientific
evaluation of substances, products or procedures subject
to a system of prior authorisation or entry in a positive
list stipulates specific procedures for referring authorisa-
tion dossiers to the Authority for its opinion. It is impor-
tant to make it clear that the provisions of the present
Regulation do not prejudice these specific procedures.

To ensure sound management, a register of requested
and own-initiative opinions should be established, which
is accessible to the public and allows the progress of
requests for opinions and own-initiative opinions to be
followed.

It is essential for the Authority to bear in mind the fact
that, where Community legislation provides for
the
Authority to be consulted by the Commission, the effi-
ciency of the Community legislative process depends on
the Commission receiving a scientific opinion from the
Authority in all cases, unless the Authority has already
delivered a
scientific opinion on the matter and
considers that there are no new scientific elements.

The procedures
scientific
opinions must generally ensure that the process is objec-
tive, transparent and functional. The Authority must be

relating to requests

for

(1) OJ L 31, 1.2.2002, p. 1.

able to propose amendments to requests in the cases
referred to in Article 29(4) of Regulation (EC) No 178/
2002, explaining the reasons.

(6) With regard to all requests for scientific opinions, it is
essential for the applicant to remain responsible for the
substance of the question posed and to agree to any
amended request before it is forwarded to the scientific
the
committee or a permanent
Authority.

scientific panel of

(7)

(8)

(9)

In the event of different requests on the same subject, in
order to avoid the procedure for the amending of
requests leading to repeated changes to the mandate
given to the scientific committee or permanent scientific
panel,
to ensure that only requests
received during the same period are taken into account
when preparing an amended joint request.

is important

it

is also important

It
to ensure that new scientific
elements which might be introduced by subsequent
requests on the same subject as a request already
forwarded to the scientific committee or a permanent
scientific panel can be taken into account by the scien-
tific committee or permanent scientific panel.

In the event of complete or partial overlapping of
requests, if the applicants cannot agree on the content of
a joint request, it is important both to maintain the prin-
ciple of the applicants' responsibility for the substance of
their questions and to avoid blocking up the system.

(10)

The Authority's right to issue own-initiative opinions is
an essential aspect of its independence; in the context of
its internal organisation, the Authority must ensure that
this right
is exercised in line with the provisions of
Article 29 of Regulation (EC) No 178/2002 and of the
present Regulation.

(11) Opinions requested from the Authority must be deliv-
ered within a time limit, so as to ensure that the proce-
dure is reliable and that there is an effective order of
priority consistent with the Community interest. It is
therefore necessary to lay down provisions relating to
time limits and the procedures to be followed in an
emergency.

(12)

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

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HAS ADOPTED THIS REGULATION:

Article 1

Aim

1.
This Regulation establishes the procedure applied by the
European Food Safety Authority (hereinafter referred to as the
Authority)
to the types of requests for scientific opinions
referred to in Article 29 of Regulation (EC) No 178/2002,
which are as follows:

(a) requests referred to the Authority under Community legis-
lation making provision for the Authority to be consulted
by the Commission;

(b) other requests from the Commission on any matter within

the Authority's mission;

(c) requests where the Authority is asked by the European
to issue a scientific opinion on any matter

Parliament
falling within its mission;

(d) requests where the Authority is asked by a Member State to
issue a scientific opinion on any matter falling within its
mission.

2.
The provisions of this Regulation shall also apply where
the Authority acts on its own initiative to issue a scientific
opinion on any matter falling within its mission.

3.
The provisions of this Regulation shall apply without
prejudice to specific procedures applicable to requests for
opinions referred to the Authority which are laid down in
Community legislation governing the scientific evaluation of
substances, products or procedures subject to a system of prior
authorisation or entry in a positive list.

Article 2

Register

of

requested opinions

and own-initiative

opinions

The Authority shall establish a register of requested opinions
and own-initiative opinions which is accessible to the public.
This register shall allow the progress of requests for opinions
to be followed with effect from the date on which they are
received.

Article 3

Refusal of requests for opinions

1.
The Authority shall not issue a scientific opinion in the
event of requests from applicants not authorised to ask the
Authority for a scientific opinion under Community legislation
or requests for opinions on matters which are not part of the
Authority's mission. The Authority shall inform the applicant
accordingly, explaining the reasons, within 30 days of receipt
of the request.

The Authority may refuse a request in the cases described

2.
in Article 29(4) and (5) of Regulation (EC) No 178/2002.

3.
However, requests from the Commission for opinions
under Community legislation providing for consultation of the
in the circumstances
Authority shall not be refused except

referred to in Article 29(5) of Regulation (EC) No 178/2002. In
the cases referred to in Article 29(4) of the said Regulation, the
Authority may ask the Commission for additional information
or propose an amendment to the request in consultation with
the Commission, applying the procedure laid down in Article 5
of the present Regulation.

4.
In cases of refusal provided for in paragraph 2 of the
present article, the Authority shall inform the applicant of the
reasons for its refusal within a reasonable period of time.

5. Where an applicant other than the Commission requests
an opinion on a matter on which Community legislation makes
provision for the Authority to be consulted by the Commission,
the Authority shall consult the Commission so that the latter is
in a position to submit its own request in accordance with the
relevant Community legislation.
If the Commission submits
such a request, the provisions of Article 6 of the present Regu-
lation shall apply.

Article 4

Acceptance of requests for opinions

1. Where the Authority accepts a request, it shall forward it
to the scientific committee or a permanent scientific panel of
the Authority for preparation of an opinion.

2.
The Authority may ask the applicant for additional infor-
mation where this is necessary in order to deal with the
request.

Article 5

Amendments to requests for opinions

1.
In the cases referred to in Article 29(4) of Regulation (EC)
No 178/2002, the Authority may propose amendments to a
request for an opinion, explaining the reasons.

2.
The finalised request, as agreed to by the applicant, shall
be forwarded to the scientific committee or a permanent scien-
tific panel of the Authority for preparation of an opinion.

Article 6

Combining of requests

1.
If several requests for opinions which partly or comple-
tely overlap are submitted to the Authority, the Authority may
propose to the applicants that their requests be amended in
accordance with Article 29(4) of Regulation (EC) No 178/2002.

2.
If several requests for opinions which partly or comple-
tely overlap are received during a specific period of time, which
shall be set by the Authority taking account of the circum-
the Authority shall
stances but shall not exceed 45 days,
propose amendments with a view to reaching agreement with
the applicants on a joint amended request. The Authority's
assessment of the period of time for application of this Article
shall not prejudice the priority to be given to urgent situations
as referred to in Article 8, and in particular the absolute
priority of requests from the Commission in urgent situations.

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3. Where consultation leads to agreement among the appli-
cants on a joint amended request, the Authority shall forward
this to the scientific committee or a permanent scientific panel
of the Authority for preparation of an opinion. Otherwise, the
different requests, accompanied by any amendments agreed to
by the applicant concerned, shall be forwarded to the scientific
committee or a permanent scientific panel for preparation of
an opinion. An overall opinion taking account of the contents
of the various requests shall be delivered.

If a request which partly or completely overlaps with a
4.
request already forwarded to the scientific committee or a
permanent scientific group is submitted to the Authority, the
Authority shall ensure that new scientific elements which might
be introduced by this new request are considered in connection
with the request for an opinion already forwarded.

An urgent need shall be deemed to exist in the following

2.
cases:

— an emerging risk likely to constitute a serious risk to human
or animal health or the environment and likely to have a
Community dimension,

— an urgent need on the part of the Commission for a more
detailed scientific basis for managing a serious risk to
human or animal health or the environment.

3.
If a request which partly or completely overlaps with an
urgent request for an opinion already received is submitted to
the Authority, the Authority shall ensure that any new scien-
tific elements which might be introduced by this new request
are considered when dealing with the urgent request already
received.

Article 7

Time limits

1.
In as far as Community legislation does not specify a time
limit for the delivery of scientific opinions, the applicant may
stipulate a deadline by when the opinion is required, giving the
reasons.

2.
If the applicant does not stipulate a deadline pursuant to
paragraph 1, the Authority shall inform the applicant of the
anticipated time needed to deliver the opinion.

3. Where the Authority cannot meet the deadline stipulated
by the applicant pursuant to paragraph 1, it shall inform the
applicant, explain the reasons and propose a new deadline. The
final deadline shall be set by the Authority, taking account of
the applicant's comments. The Authority shall inform the appli-
cant of the final deadline.

Article 9

Notification by Member States

Member States shall inform the Authority of the government
authority or authorities authorised to request scientific opinions
from the Authority.

Article 10

Review

The Commission shall consult the Authority no later than 30
June 2005 on the need to amend the present Regulation on the
basis of the experience acquired.

Article 8

Emergencies

Article 11

Entry into force

1.
The Authority shall take the necessary measures to ensure
that a requested or own-initiative opinion is delivered as soon
as possible where the information accompanying the request or
self-referral testifies to an urgent need for a scientific opinion.

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, 11 July 2003.

For the Commission

Franz FISCHLER

Member of the Commission