3.

The application shall be accompanied by the following: for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product; for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist; for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals; the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation; where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information; where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1); a draft label.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.