3.

The application shall be accompanied by the following: the name and the address of the applicant; the designation of the food, 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 on Biosafety to the Convention on Biological Diversity (hereinafter referred to as the Cartagena Protocol); where applicable, a detailed description of the method of production and manufacturing; 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 food complies with the criteria referred to in Article 4(1); either an analysis, supported by appropriate information and data, showing 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 and to the criteria specified in Article 13(2)(a), or a proposal for labelling the food in accordance with Article 13(2)(a) and (3); either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 13(2)(b); where appropriate, the conditions for placing on the market the food or foods produced from it, 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 food and/or in foods produced from it; samples of the food 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 regarding use of the food for human 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.