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)

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:

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.

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.

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

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

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.

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 Regulation shall apply.

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.

The Authority may ask the applicant for additional information where this is necessary in order to deal with the request.

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.

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

If several requests for opinions which partly or completely 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.

If several requests for opinions which partly or completely overlap are received during a specific period of time, which shall be set by the Authority taking account of the circumstances but shall not exceed 45 days, the Authority shall 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.

Where consultation leads to agreement among the applicants 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 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.

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.

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.

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 applicant of the final deadline.

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.

An urgent need shall be deemed to exist in the following cases:

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 scientific elements which might be introduced by this new request are considered when dealing with the urgent request already received.