THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 78(1)(b) thereof,
Whereas:
(1)
In accordance with Article 8(4) of Regulation (EC) No 1107/2009, Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances was adopted. It contains the requirements for the dossiers to be submitted for the approval of active substances, as set out in Annex II to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market.
(2)
It is necessary to modify the data requirements concerning chemical substances in order to take into account current scientific and technical knowledge.
(3)
More detailed information for the implementation of the data requirements is laid down in relevant guidance documents.
(4)
Regulation (EU) No 544/2011 should therefore be repealed.
(5)
A reasonable period should be allowed to elapse before the modified data requirements become applicable in order to permit applicants to prepare themselves to meet those requirements.
(6)
In order to permit Member States and the interested parties to prepare themselves to meet the new requirements, it is appropriate to lay down transitional measures concerning data submitted for applications for the approval, renewal of approval or amendment to the conditions of approval of active substances and data submitted for applications for authorisation, renewal of authorisation and amendment to the authorisation of plant protection products.
(7)
These transitional measures are without prejudice to Article 80 of Regulation (EC) No 1107/2009.
(8)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
HAS ADOPTED THIS REGULATION: