Contents of supplementary dossiers
Article 10
1. The supplementary summary dossier shall include the following: (a) a copy of the application, where the applicant is joined by another applicant the name and address of that applicant and of the joint representative, provided for in Article 4(4), where the applicant is replaced by another applicant the name and address of that applicant; (b) information with respect to one or more representative uses on a widely grown crop of at least one plant protection product containing the active substance, demonstrating that the inclusion requirements provided for in Article 5(1) and (2) of Directive 91/414/EEC are fulfilled; where the information submitted does not concern a widely grown crop, a justification shall be submitted; (c) data and risk assessments which were not part of the original dossiers and which are necessary to reflect changes: (i) in requirements under Annexes II and III to Directive 91/414/EEC; (ii) in scientific and technical knowledge since the first inclusion of the active substance concerned; or (iii) to representative uses; (d) for each point of the requirements for the active substance, as set out in Annex II to Directive 91/414/EEC, for which new data are necessary within the meaning of point (c), the summaries and results of tests and studies, the name of their owner and of the person or institute having carried these out and the reason why each test or study is necessary either in the light of current scientific and technical knowledge or with a view to an amended renewal; (e) for each point of the requirements for the plant protection product, as set out in Annex III to Directive 91/414/EEC, for which new data are necessary within the meaning of point (c), the summaries and results of tests and studies, the name of their owner and of the person or institute having carried out the tests and studies, for one or more plant protection products which are representative of the supported uses, and the reason why each test or study is necessary either in the light of current scientific and technical knowledge or with a view to an amended renewal of the active substance; (f) for each test or study involving vertebrate animals, a description of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals; (g) where relevant, a copy of an application for maximum residue levels as referred to in Article 7 of Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 3 ) ; (h) an assessment of all information submitted; (i) a checklist demonstrating that the supplementary dossiers referred to in paragraph 3 are complete, indicating which data are new. 2. The uses referred to in point (b) of paragraph 1 shall, where appropriate, include the uses evaluated for the first inclusion. At least one plant protection product referred to in that point (b) shall contain no other active substance, where such a product exists for a representative use. 3. The complete supplementary dossiers shall contain the full text of each test and study report referred to in points (d) and (e) of paragraph 1.