Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market

Article 7

1. For each active substance for which it has been designated rapporteur, the Member State shall: (a) examine the dossiers referred to in Article 6 (2) and (3), in the order in which they are received from the notifier or notifiers concerned, as well as any information as referred to in the third indent of Article 5 (4) and any other available information; if several dossiers are presented for one active substance, the dossier presented last will determine the order of its examination; the order of examination is, however, not affected by dossiers presented by notifiers referred to in Article 4 (1) (a); (b) immediately after examining a dossier, ensure that notifiers submit the updated summary dossier to the other Member States and to the Commission; (c) send the Commission, as quickly as possible and at the latest 12 months after receipt of a dossier as referred to in Article 6 (2) and (3), a report of its assessment of the dossier, including a recommendation: — to include the active substance in Annex I to the Directive, stating the conditions for its inclusion, or — to remove the active substance from the market, or — to suspend the active substance from the market, with the option of reconsidering the inclusion of the active substance in Annex I after submission of the results of additional trials or of additional information specified in the report, or — to postpone any decision on possible inclusion pending the submission of the results of additional trials or information specified in the report ; (d) in particular, include in the report a reference to each test and study report, for each point of Annex II to the Directive, relied on for the assessment in the form of a list of test and study reports including the title, the author(s), the date of the study or test and the date of publication, the standard to which the test or study was conducted, the holder's name and, if any, the claim made by the holder or notifier for data protection. 2. From the start of the examination referred to in paragraph 1, the rapporteur Member State may request the notifiers to improve their dossiers, or add to them. Moreover, the rapporteur Member State may, from the start of this examination, consult with experts from other Member States, and may request additional technical or scientific information from other Member States in order to assist the evaluation. 3. After receiving the summary dossier and the report referred to in paragraph 1, the Commission shall refer the dossier and the report to the Committee for examination. Before referring the dossier and report to the Committee, the Commission shall circulate the rapporteur's report to the Member States for information. The Rapporteur Member State shall make available at specific request or keep available for consultation by interested parties the following: — the information referred to in point (d) of paragraph 1, except the elements thereof which have been accepted as confidential in accordance with Article 14 of the Directive; — the name of the active substance; — the content of the pure active substance in the manufactured material; — the list of any data required for consideration of the possible inclusion of the active substance into Annex I to the Directive, first as contained in the rapporteur's report and secondly as finalised after the consultation by the Commission of the experts referred to in the next subparagraph. Before the dossier and report are referred to the Committee, a consultation of experts from the Member States may be organized and the Commission may consult some or all of the notifiers of active substances specified in the regulation referred to in Article 5 (2) on the report or parts of the report on the relevant active substance. 3A. After the examination referred to in paragraph 3, the Commission shall, without prejudice to any proposal it may submit with a view to amending the Annex to Directive 79/117/EEC, present to the Committee: (a) a draft directive to include the active substance in Annex I to the Directive, setting out where appropriate the conditions, including the time-limit, for such inclusion; (b) a draft decision addressed to the Member States to withdraw the authorizations of plant protection products containing the active substance, pursuant to the fourth subparagraph of Article 8 (2) of the Directive, whereby that active substance is not included in Annex I to the Directive; (c) a draft decision addressed to the Member States to suspend plant protection products containing the active substance from the market, with the option of reconsidering the inclusion of the active substance in Annex I to the Directive after submission of the results of additional trials or of additional information; or (d) a draft decision to postpone inclusion of the active substance in Annex I to the Directive pending the submission of the results of additional trials or information. 4. However, where, following the examination referred to in paragraph 3, the submission of the results of certain additional trials or of additional information is required, the Commission shall determine: — the time limit within which the results or information concerned must be submitted to the rapporteur Member State and the experts designated according to paragraph 2 above, this time limit will be 25 May 2002, however, as regards metalaxyl the time limit will be at the latest 31 October 2008, unless an earlier time limit is established by the Commission for a particular active substance except for the results of long-term studies, identified as being necessary by the rapporteur Member State and the Commission during the examination of the dossier and which are not expected to be fully completed by the deadline established, provided that the information submitted contains evidence that such studies have been commissioned and that their results will be submitted at the latest on 25 May 2003. In exceptional cases, where it has not been possible for the rapporteur Member State and the Commission to identify such studies by 25 May 2001, an alternative date may be established for the completion of such studies, provided the notifier supplies the rapporteur Member State with evidence that such studies have been commissioned within three months of the request to undertake the studies, and with a protocol and progress report of the study by 25 May 2002. — the time limit within which the notifiers concerned must communicate to the rapporteur Member State and to the Commission their undertaking to submit the required results or information within the time limit laid down in the first indent. However, as regards metalaxyl that time limit shall be one month after the entering into force of this Regulation. Without prejudice to Article 7 of the Directive, submission of new studies will not be accepted. The rapporteur Member State, with the agreement of the Commission, may request the notifiers to submit further data necessary to clarify the dossier. For active substances for which the results or information referred to in the first indent have not been submitted within the established time limit the rapporteur Member State shall immediately inform the Commission. The Commission shall decide, as provided for in Article 8(2), last subparagraph, of the Directive, not to include in Annex I to the Directive such active substances mentioning the reasons for the non-inclusion. Member States shall withdraw by 25 July 2003 authorisations of plant protection products containing these active substances. 5. The Commission shall submit to the Committee a draft decision for non-inclusion in Annex I to the Directive in accordance with the final subparagraph of Article 8 (2) thereof, where: — the notifiers concerned have not communicated their undertaking to submit the required results within the time-limit referred to in the second indent of paragraph 4, — the rapporteur Member State has informed the Commission that the results referred to in the first indent of paragraph 4 have not been submitted within the time-limit laid down. 6. Where the Commission presents a draft directive or a draft decision in accordance with paragraph 3A or a draft in accordance with paragraph 5, it shall at the same time present the conclusions of the Committee's examination in the format of an up-dated review report to be noted in the summary record of the meeting. The review report, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of the Directive, shall be made available by each Member State on specific request, or shall be kept available for consultation by interested parties.