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
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Change 1
Article 8
1. After receiving the results of the additional trials or the additional information, the rapporteur Member State must: (a) examine it in conjunction with the results of the dossier already submitted for the substance concerned; (b) immediately after such examination, ensure that the summary of the additional trials and the results of those trials or the additional information are sent by the notifier to the other Member States and to the Commission; (c) 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. 2. The procedure provided for in Article 7 (2) is applicable to the examinations referred to in paragraph 1 (a) hereof. 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. —————
Article 8
1. After receiving the results of the additional trials or the additional information, the rapporteur Member State must: (a) examine it in conjunction with the results of the dossier already submitted for the substance concerned; (b) immediately after such examination, ensure that the summary of the additional trials and the results of those trials or the additional information are sent by the notifier to the other Member States and to the Commission; (c) 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. 2. The procedure provided for in Article 7 (2) is applicable to the examinations referred to in paragraph 1 (a) hereof. 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. —————
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