Regulation 2013/283 - Data requirements for active substances, in accordance with Regulation 1107/2009 concerning the placing of plant protection products on the market - Main contents
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official title
Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2013/283 |
| CELEX number i | 32013R0283 |
| Document | 01-03-2013 |
|---|---|
| Publication in Official Journal | 03-04-2013; Special edition in Croatian: Chapter 03 Volume 071,OJ L 93, 3.4.2013 |
| Effect | 23-04-2013; Entry into force Date pub. +20 See Art 5.1 23-04-2013; Application Partial application See Art 5.2 01-01-2014; Application Partial application See Art 5.2 |
| End of validity | 31-12-9999 |
3.4.2013 |
EN |
Official Journal of the European Union |
L 93/1 |
COMMISSION REGULATION (EU) No 283/2013
of 1 March 2013
setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
(Text with EEA relevance)
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 (1), 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 (2) 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 (3). |
(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:
Article 1
Data requirements for active substances
The data requirements for the active substance provided for in Article 8(1)(b) of Regulation (EC) No 1107/2009 shall be as set out in the Annex to this Regulation.
Article 2
Repeal
Regulation (EU) No 544/2011 is repealed.
References to the repealed Regulation shall be construed as references to this Regulation
Article 3
Transitional measures as regards procedures concerning active substances
With respect to active substances, Regulation (EU) No 544/2011 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 1141/2010 (4) have been... |
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