Regulation (EC) No 1829/2003 of the European Parliament and of the CouncilShow full title

Article 17 U.K. Application for authorisation

1. To obtain the authorisation referred to in Article 16(2), an application shall be submitted in accordance with the following provisions.

2. The application shall be sent to the national competent authority of a Member State.

(a) The national competent authority:

(i)

shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application;

(ii)

shall inform the Authority without delay; and

(iii)

shall make the application and any supplementary information supplied by the applicant available to the Authority.

(b) The Authority:

(i)

shall inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;

(ii)

shall make the summary of the dossier referred to in paragraph 3(1) available to the public.

3. The application shall be accompanied by the following:

(a) the name and the address of the applicant;

(b) the designation of the feed and its specification, including the transformation event(s) used;

(c) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol;

(d) where applicable, a detailed description of the method of production and manufacturing and intended uses of the feed;

(e) a copy of the studies including, where available, independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the feed complies with the criteria referred to in Article 16(1), and, in particular for feed falling within the scope of Directive 82/471/EEC, the information required under Council Directive 83/228/EEC of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition(1);

(f) either an analysis, supported by appropriate information and data, showing that the characteristics of the feed are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics and to the criteria specified in Article 25(2)(c), or a proposal for labelling the feed in accordance with Article 25(2)(c) and (3);

(g) either a reasoned statement that the feed does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 25(2)(d);

(h) where appropriate, the conditions for placing the feed on the market, including specific conditions for use and handling;

(i) methods for detection, sampling (including references to existing official or standardised sampling methods) and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the feed and/or in the feed produced from it;

(j) samples of the feed and their control samples and information as to the place where the reference material can be accessed;

(k) where appropriate, a proposal for post-market monitoring for the use of the feed for animal consumption;

(l) a summary of the dossier in a standardised form.

4. In the case of an application relating to a GMO for feed use, references to ‘feed’ in paragraph 3 shall be interpreted as referring to feed containing, consisting of or produced from the GMO in respect of which an application is made.

5. In the case of GMOs or feed containing or consisting of GMOs, the application shall also be accompanied by:

(a) the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMOs has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision;

(b) a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent.

In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.

6. Where the application concerns a substance, the use and placing on the market of which is subject under other provisions of Community law to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.

7. The Commission, having first consulted the Authority, shall establish, in accordance with the procedure referred to in Article 35(2), implementing rules for the application of this Article, including rules concerning the preparation and the presentation of the application.

8. Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist the applicant in the preparation and the presentation of the application.

(1)

OJ L 126, 13.5.1983, p. 23.