1.The procedure for authorisation of an alternative method of use or disposal of animal by-products or derived products may be initiated either by the Commission or, following an application, by a Member State or by an interested party, which may represent several interested parties.
2.Interested parties shall send their applications to the competent authority of the Member State where they intend to use the alternative method.
The competent authority shall evaluate, within a period of two months following receipt of a complete application, whether the application complies with the standard format for applications referred to in paragraph 10.
3.The competent authority shall communicate the applications of the Member States and interested parties, together with a report on its evaluation to the European Food Safety Authority (EFSA) and inform the Commission thereof.
4.When the Commission initiates the procedure for authorisation, it shall send a report on its evaluation to EFSA.
5.EFSA shall assess, within six months following receipt of a complete application, whether the method submitted ensures that risks to public or animal health are:
(a)controlled in a manner which prevents their proliferation before disposal in accordance with this Regulation or the implementing measures thereof; or
(b)reduced to a degree which is at least equivalent, for the relevant category of animal by-products, to the processing methods laid down pursuant to point (b) of the first subparagraph of Article 15(1).
EFSA shall issue an opinion on the application submitted.
6.In duly justified cases where EFSA requests additional information from applicants, the period provided for in paragraph 5 may be extended.
After consulting the Commission or the applicant, EFSA shall decide on a period within which that information shall be provided to it and inform the Commission and the applicant as appropriate of the additional period needed.
7.Where applicants wish to submit additional information on their own initiative, they shall send it directly to EFSA.
In that case the period provided for in paragraph 5 shall not be extended by an additional period.
8.EFSA shall forward its opinion to the Commission, the applicant and the competent authority of the Member State concerned.
9.Within three months following receipt of the opinion of EFSA and taking account of that opinion, the Commission shall inform the applicant of the proposed measure to be adopted in accordance with paragraph 11.
10.A standard format for applications for alternative methods shall be adopted in accordance with the advisory procedure referred to in Article 52(2).
11.Following receipt of the opinion of EFSA, the following shall be adopted:
(a)either a measure authorising an alternative method of use or disposal of animal by-products or derived products; or
(b)a measure rejecting the authorisation of such an alternative method.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).