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)

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) It is necessary to lay down the conditions for the implementation of Article 29 of Regulation (EC) No 178/2002 with regard to requests for scientific opinions submitted to the European Food Safety Authority (hereinafter referred to as the Authority) and with regard to own-initiative opinions.
(2) 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 authorisation dossiers to the Authority for its opinion. It is important to make it clear that the provisions of the present Regulation do not prejudice these specific procedures.
(3) 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.
(4) 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 efficiency 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.
(5) The procedures relating to requests for scientific opinions must generally ensure that the process is objective, transparent and functional. The Authority must be 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 committee or a permanent scientific panel of the Authority.
(7) 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, it is important to ensure that only requests received during the same period are taken into account when preparing an amended joint request.
(8) It is also important 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 scientific committee or permanent scientific panel.
(9) 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 principle 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 delivered within a time limit, so as to ensure that the procedure 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,