THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, and in particular Article 6(5) thereof,
Whereas:
(1)
It is necessary to adopt rules on a procedure for the submission and appraisal of applications for inclusion in Annex I to Directive 91/414/EEC of active substances which were not yet on the market 2 years after the date of notification of that Directive. In particular periods should be set for the different steps of that procedure to ensure that they are carried out rapidly.
(2)
Additional information submitted after the application and the dossiers should only be taken into account if it was requested by the European Food Safety Authority, hereinafter ‘the Authority’, or the rapporteur Member State and submitted within the time period set.
(3)
As regards applications submitted before the entry into force of this Regulation transitional measures should be provided for. In particular, it is appropriate to extend the period which may be granted to the applicant to submit additional information requested by the Authority or the rapporteur Member State. As regards such applications, it is further necessary to set periods for the circulation of the draft assessment report by the Authority and the submission of comments by the Member States, other than the rapporteur Member State, and the applicant.
(4)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION: