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Commission Regulation (EEC) No 3600/92 Article 6

Commission Regulation (EEC) No 3600/92 Article 6

Article 6

1. Within the time-limit referred to in the third indent of Article 5 (4), the notifiers specified in the regulation referred to in that Article must, individually or collectively, send to the designated authority of the rapporteur Member State, for any given active substance: (a) the summary dossier referred to in paragraph 2 hereof; and (b) the complete dossier referred to in paragraph 3 hereof. They shall also send this information to the experts as referred to in Article 7 (2), and, if so requested, to the competent authority referred to in Article 3 of each Member State. Where for any substance the regulation as envisaged in Article 5 (4) indicates several notifications, the notifiers concerned shall take all reasonable steps to present collectively the dossiers 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 presented 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) the recommended conditions for the use of an active substance, to be considered in relation to its inclusion in Annex I to the Directive; (c) for each point of Annex II to the Directive, the available summaries and results of trials, 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 and for one or more preparations which are representative for the conditions of use referred to in subparagraph (b); (d) when the information referred to in certain points of subparagraph (c) is not available: - either, in accordance with the introductory provisions of Annexes II and III of the Directive, the scientific or technical reasons demonstrating that the information is not necessary for the assessment of the active substance according to the criteria referred to in Article 5 of the Directive, - or an undertaking by the producer or producers submitting the dossier that the missing information will be sent at a later date; a detailed timetable and documents showing that the undertaking can be fulfilled must be submitted. 3. The complete dossier shall contain the protocols and the complete study reports concerning all the information referred to in paragraph 2 (c). 4. Where, for any given active substance, the dossiers referred to in paragraph 1 are not sent within the time-limit laid down in Article 5 (4) or where the dossiers sent clearly do not satisfy the requirements laid down in paragraphs 2 and 3 hereof, the rapporteur Member State shall inform the Commission, giving the reasons pleaded by the notifiers. 5. On the basis of the report of the rapporteur Member State referred to in paragraph 4, the Commission shall present to the Committee a draft decision not to include the active substance in Annex I, in accordance with the final subparagraph of Article 8 (2) of the Directive, unless: - a new time-limit has been granted for the submission of a dossier fulfilling the requirements of paragraphs 2 and 3; a new time-limit willl only be granted where the delay is proved to have been caused by efforts to present collective dossiers or by force majeure, - a Member State informs the Commission of its wish to secure the inclusion of the active substance concerned in Annex I to the Directive and its readiness to ensure the composition of the dossiers as referred to in paragraph 1 hereof and to carry out the duties of notifier as set out in Articles 7 and 8 hereof.

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Other provisions in Commission Regulation (EEC) No 3600/92

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 6 of Commission Regulation (EEC) No 3600/92 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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