Regulation (EEC) No 3600/92 is amended as follows:
1. In Article 6(2)(b), the following is added at the end:
"it has to be demonstrated by the notifier that, on the basis of the information submitted for one or more preparations for a limited range of representative uses, the requirements of the Directive in relation to the criteria referred to in Article 5 thereof can be met;"
2. In Article 7(4), the following is added at the end in the first indent:
"this time limit will be 25 May 2002 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."
3. In Article 7(4), the following is added at the end:"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."
4. Article 8(1)(c) shall be replaced by the following:
"communicate to the Commission as quickly as possible, and within six months at the latest following receipt of all the required information, its evaluation of the dossier as an addendum to the evaluation report already submitted to the Commission. The report shall be presented in the format recommended by the Commission in the framework of the Standing Committee on Plant Health and shall include a recommendation:
- either to include the active substance in Annex I to the Directive stating the conditions for inclusion,
- or not to include the active substance in Annex I to the Directive, mentioning the reasons for the non-inclusion."
5. Article 8(3) shall be replaced by the following:"After receiving the summary and the report referred to in paragraph 1, the Commission shall refer it 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 and may organise a consultation of experts from one or several Member States. The Commission may consult some or all of the notifiers of active substances on the report or parts of the report on the relevant active substance. The rapporteur Member State shall provide the necessary technical and scientific assistance during these consultations.
Without prejudice to Article 7 of the Directive, submission of new studies will not be accepted. The rapporteur Member State, after consultation with the Commission, may request the notifiers to submit further data necessary to clarify the dossier.
After the examination referred to in Article 7(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; or
(b) a draft decision addressed to the Member States to withdraw the authorisations 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, mentioning the reasons for the non-inclusion."
6. Article 8(4) is deleted.