F1Commission 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
(Text with EEA relevance) (repealed)
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 the first sentence of Article 8(4) thereof,
After consulting the Standing Committee on the Food Chain and Animal Health,
Whereas:
In accordance with Regulation (EC) No 1107/2009, the dossier to be submitted for the approval of an active substance or for the authorisation of a plant protection product is to fulfil the same requirements in respect of the data requirements for the plant protection product as under the previously applicable rules which are set out in Annexes II and III to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market.
It is therefore necessary for the implementation of Regulation (EC) No 1107/2009 to adopt a regulation containing those data requirements for active substances. Such a regulation is not to include any substantial modification,
HAS ADOPTED THIS REGULATION:
F2Article A1Scope and interpretation
(1.
This Regulation applies in relation to—
(a)
an application under Article 7 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market as it had effect immediately before IP completion day where—
(i)
paragraph 6 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and
(ii)
on or before 31st December 2013 dossiers were submitted in accordance with Article 8(1) and (2) of Regulation (EC) No 1107/2009 as it had effect immediately before IP completion day;
(b)
an application under Article 15 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market as it had effect immediately before IP completion day where—
(i)
paragraph 7 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and
(ii)
on or before 31st December 2013 dossiers were submitted in accordance with Article 9 of Commission Regulation (EU) No 1141/2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances as it had effect immediately before IP completion day;
(c)
an application for authorisation of a plant protection product, as referred to in Article 28 of Regulation (EC) No 1107/2009, which was submitted before 31st December 2015, as regards the submission of data concerning an active substance—
(i)
to which point (a) or (b) applies, or
(ii)
for which approval has not been renewed in accordance with Article 14 of Regulation (EC) No 1107/2009 or Commission Implementing Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, whether before or after IP completion day.
(2.
Paragraph 1(b) does not apply where the applicant for the authorisation notifies the competent authority in writing when submitting the application that the data requirements of Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances apply instead.
(3.
Paragraph 4 applies where Commission Regulation (EU) No 284/2013 setting out the data requirements for active substances applies in relation to an application by virtue of—
(a)
Article 1 of that Regulation, or
(b)
Article A1(2) of Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products.
(4.
Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 545/2011, or a specified part of Commission Regulation (EU) No 545/2011, is to be read in relation to the application as a reference to Commission Regulation (EU) No 284/2013, or the equivalent part of Commission Regulation (EU) No 284/2013 (as the case may be).
Article 1
F1The data requirements for the approval of an 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.
F3Article 2
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