Article 6
Submission of dossiers by notifiers 1. Within the time limit referred to in Article 5(4)(c), for each active substance the notifiers specified in the Regulation referred to in that Article shall, individually or collectively, submit to the designated authority of the rapporteur Member State for any given active substance the complete dossier referred to in paragraph 3, including the summary dossier referred to in paragraph 2. Where for any substance the Regulation referred to in Article 5 indicates several notifications, the notifiers concerned shall take all reasonable steps to present collectively the dossiers as referred to in the first subparagraph. Where a dossier was not presented by all notifiers concerned, it shall mention the efforts made and the reasons why certain producers have not participated. 2. The summary dossier shall include the following: (a) a copy of the notification; in the case of a joint application made by several producers, a copy of the notifications made in accordance with Article 4 and the name of the person designated by the producers concerned as being responsible for the joint dossier and the processing of the dossier in accordance with this Regulation; (b) a limited range of representative uses of the active substance for which it has to be demonstrated by the notifier, on the basis of the data submitted, that for one or more preparations the requirements of the Directive in relation to the criteria referred to in Article 5 thereof can be met; (c) - for each point of Annex II to the Directive, the summaries and results of studies and trials, and the name of the person or institute that has carried out the trials, - the same information for each point of Annex III to the Directive relevant to the assessment of the criteria referred to in Article 5 of the Directive for one or more preparations which are representative for the uses referred to in subparagraph (b) taking into account the fact that data gaps in the information of the Annex II dossier resulting from the proposed limited range of representative uses of the active substance may lead to restrictions in the inclusion in Annex I to the Directive, - for studies not yet fully completed, the evidence that these studies have been commissioned at the latest three months after the entry into force of this Regulation with an undertaking that they will be submitted at the latest within 12 months after the time limit referred to in Article 5(4)(c); (d) a check by the notifier of the completeness of the dossier. 3. The complete dossier shall contain physically the individual test and study reports concerning all the information referred to in paragraph 2(c), or the protocols and the undertakings referred to in paragraph 2(c) where work is in progress. 4. Member States shall determine the number of copies and the format of the dossiers referred to to in paragraphs 2 and 3 to be submitted by the notifiers. In determining the format of the dossier, Member States shall take the utmost account of the recommendations made by the Commission in the framework of the Standing Committee on Plant Health. 5. Where, for any given active substance, the dossiers referred to in paragraph 1 are not sent within the time limit referred to in Article 5 (4)(c), the rapporteur Member State shall inform the Commission at the latest within three months, giving the reasons pleaded by the notifiers. 6. On the basis of the report of the rapporteur Member State referred to in paragraph 5, a new time limit shall only be established in accordance with the procedure laid down in Article 19 of the Directive in the Regulation referred to in Article 5 for the submission of a dossier fulfilling the requirements of paragraphs 2 and 3 where the delay is demonstrated to have been caused by force majeure. 7. After that examination, the Commission shall decide, as provided for in Article 8(2), fourth subparagraph, of the Directive, not to include in Annex I to the Directive an active substance for which no notification or no dossier has been submitted within the prescribed time limit mentioning the reasons for the non-inclusion. Member States shall withdraw by 25 July 2003 authorisations of plant protection products containing those active substances.