Nařízení Komise (EU) č. 284/2013 ze dne 1. března 2013, kterým se v souladu s nařízením Evropského parlamentu a Rady (ES) č. 1107/2009 o uvádění přípravků na ochranu rostlin na trh stanoví požadavky na údaje o přípravcích na ochranu rostlin (Text s významem pro EHP)

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/EECOJ L 309, 24.11.2009, p. 1 . , and in particular Article 78(1)(b) thereof,

The data requirements for plant protection products provided for in Article 8(1)(c) of Regulation (EC) No 1107/2009 shall be as set out in the Annex to this Regulation.

OJ L 309, 24.11.2009, p. 1 .

(1) In accordance with Article 8(4) of Regulation (EC) No 1107/2009, Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection productsOJ L 155, 11.6.2011, p. 67 . was adopted. It contains the data requirements for the authorisation of plant protection products, as set out in Annex III to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant products on the marketOJ L 230, 19.8.1991, p. 1 . .

(2) It is necessary to modify the data requirements concerning chemical preparations 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(4) Regulation (EU) No 545/2011 should therefore be repealed.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 and amendment to the conditions of approval of active substances and for applications for authorisation, renewal of authorisation and amendment to 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,

Regulation (EU) No 545/2011 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation.

OJ L 155, 11.6.2011, p. 67 .

Article 1 Article 1 Data requirements for plant protection products

Article 2 Article 2 Repeal

Article 3 Article 3 Transitional measures as regards procedures concerning active substances

Article 4 Article 4 Transitional measures as regards procedures concerning plant protection products 1.Regulation (EU) No 545/2011 shall continue to apply as regards procedures concerning the authorisation of a plant protection product, as referred to in Article 28 of Regulation (EC) No 1107/2009, provided that the respective application has been submitted by 31 December 2015 and that the plant protection product contains at least one active substance for which the dossiers or supplementary dossiers have been submitted in compliance with Article 3. 2.By way of derogation from paragraph 1, from 1 January 2014 applicants may choose to apply the data requirements, as set out in the Annex to this Regulation. This choice shall be made in writing when submitting the application and shall be irrevocable.

Article 5 Article 5 Entry into force and date of application 1.This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . 2.For procedures concerning the renewal of approval of active substances whose approval expires on 1 January 2016 or later, this Regulation shall apply as of entry into force. As regards all other procedures, it shall apply from 1 January 2014 .

With respect to active substances, Regulation (EU) No 545/2011 shall continue to apply as regards the following:

(a) procedures concerning the approval of an active substance or an amendment to the approval of such a substance pursuant to Article 13 of Regulation (EC) No 1107/2009 for which the dossiers provided for in Article 8(1) and (2) thereof have been submitted by 31 December 2013 ;

(b) procedures concerning the renewal of approval of an active substance pursuant to Article 20 of Regulation (EC) No 1107/2009 for which the supplementary dossiers referred to in Article 9 of Commission Regulation (EU) No 1141/2010OJ L 322, 8.12.2010, p. 10 . have been submitted by 31 December 2013 .

OJ L 230, 19.8.1991, p. 1 .

Regulation (EU) No 545/2011 shall continue to apply as regards procedures concerning the authorisation of a plant protection product, as referred to in Article 28 of Regulation (EC) No 1107/2009, provided that the respective application has been submitted by 31 December 2015 and that the plant protection product contains at least one active substance for which the dossiers or supplementary dossiers have been submitted in compliance with Article 3.

By way of derogation from paragraph 1, from 1 January 2014 applicants may choose to apply the data requirements, as set out in the Annex to this Regulation. This choice shall be made in writing when submitting the application and shall be irrevocable.

OJ L 322, 8.12.2010, p. 10 .

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

For procedures concerning the renewal of approval of active substances whose approval expires on 1 January 2016 or later, this Regulation shall apply as of entry into force.

As regards all other procedures, it shall apply from 1 January 2014 .

HAS ADOPTED THIS REGULATION: