3.

The application shall be accompanied by the following: the name and the address of the applicant; the designation of the feed and its specification, including the transformation event(s) used; where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol; where applicable, a detailed description of the method of production and manufacturing and intended uses of the feed; 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(28); 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); 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); where appropriate, the conditions for placing the feed on the market, including specific conditions for use and handling; 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; samples of the feed and their control samples and information as to the place where the reference material can be accessed; where appropriate, a proposal for post-market monitoring for the use of the feed for animal consumption; a summary of the dossier in a standardised form.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.