Commission Regulation (EU) No 78/2010 of 27 January 2010 amending Regulation (EC) No 33/2008 as regards the scope and the period granted under the regular procedure to the Authority for the adoption of its conclusions concerning the inclusion of certain active substances in Annex I to Directive 91/414/EEC (Text with EEA relevance)

1 The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 5 of Directive 91/414/EEC within six months from the end of the period provided for in the third paragraph of Article 9 of this Regulation and communicate it to the applicant, the Member States and the Commission. Where appropriate, the Authority shall address in its conclusion the risk mitigation options in relation to the intended uses identified in the draft assessment report.

2 Where the Authority needs additional information, it shall, in consultation with the rapporteur Member State, set a time period of maximum ninety days for the applicant to supply it to the Authority and the rapporteur Member State. It shall inform the Commission and the Member States. Only information submitted within the time period granted shall be taken into account. The rapporteur Member State shall assess the additional information and submit it to the Authority without delay and at the latest within sixty days after the receipt of the additional information. In that case, the six months period for the adoption of the conclusion by the Authority, as provided for in paragraph 1, shall be extended by a period which shall cease at the moment when the assessment of the additional information is received by the Authority.

3 The Commission and the Authority shall agree on a schedule for the delivery of the conclusions in order to facilitate the planning of the work. The Commission and the Authority shall agree on the format in which the conclusions of the Authority are submitted.’

Article 10 of Regulation (EC) No 33/2008 shall continue to apply, as unamended, to active substances for which the draft assessment report by the rapporteur Member State was submitted to the Commission, as provided for in Article 8(1) of Regulation (EC) No 33/2008, before the entry into force of this Regulation.

This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.