Dossiers
Article 4
1. The summary dossier shall include the following: (a) data with respect to a limited range of representative uses of at least one plant protection product containing the active substance, demonstrating that the requirements of Article 5 of Directive 91/414/EEC are met; (b) for each point of the data requirements for the active substance referred to in Annex II to Directive 91/414/EEC, the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies; (c) for each point of the data requirements for the plant protection product referred to in Annex III to Directive 91/414/EEC, the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies relevant to the assessment of the requirements referred to in Article 5 of that Directive taking into account that data gaps in the Annex II or Annex III dossier, resulting from the proposed limited range of representative uses, may lead to restrictions in the Annex I inclusion; (d) a checklist demonstrating that the dossier provided for in paragraph 2 is complete; (e) the reasons why the test and study reports submitted are necessary for first inclusion of the active substance; (f) an assessment of all information submitted. 2. The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1.