1.In giving its opinion, the Authority shall endeavour to respect a time limit of six months as from the receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2.
2.The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.
3.In order to prepare its opinion the Authority:
(a)shall verify that the particulars and documents submitted by the applicant are in accordance with Article 5 and examine whether the food complies with the criteria referred to in Article 4(1);
(b)may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food in accordance with Article 36 of Regulation (EC) No 178/2002;
(c)may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Authority shall ask a national competent authority to carry out the environmental risk assessment;
(d)shall forward to the Community reference laboratory referred to in Article 32 the particulars referred to in Article 5(3)(i) and (j). The Community reference laboratory shall test and validate the method of detection and identification proposed by the applicant;
(e)shall, in verifying the application of Article 13(2)(a), examine the information and data submitted by the applicant to show that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.
4.In the case of GMOs or food containing or consisting of GMOs, the environmental safety requirements referred to in Directive 2001/18/EC shall apply to the evaluation to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of GMOs. During evaluation of requests for the placing on the market of products consisting of or containing GMOs, the national competent authority within the meaning of Directive 2001/18/EC designated by each Member State for this purpose shall be consulted by the Authority. The competent authorities shall have three months after the date of receiving the request within which to make their opinion known.
5.In the event of an opinion in favour of authorising the food, the opinion shall also include the following particulars:
(a)the name and address of the applicant;
(b)the designation of the food, and its specification;
(c)where applicable, the information required under Annex II to the Cartagena Protocol;
(d)the proposal for the labelling of the food and/or foods produced from it;
(e)where applicable, any conditions or restrictions which should be imposed on the placing on the market and/or specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and, in the case of GMOs or food containing or consisting of GMOs, conditions for the protection of particular ecosystems/environment and/or geographical areas;
(f)the method, validated by the Community reference laboratory, for detection, including sampling, identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it; an indication of where appropriate reference material can be accessed;
(g)where appropriate, the monitoring plan referred to in Article 5(5)(b).
6.The Authority shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion and the information on which this opinion is based, including the opinions of the competent authorities when consulted in accordance with paragraph 4.
7.The Authority, in conformity with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Commission within 30 days from such publication.