Commission Implementing Regulation (EU) 2016/182 of 11 February 2016 renewing the approval of the active substance pyraflufen-ethyl 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)
Date: 2016-02-11
Institutions: European Commission
Subjects: chemical product, health risk, herbicide, market approval, plant health control








L_2016037EN.01004001.xml










12.2.2016   


EN


Official Journal of the European Union


L 37/40








            COMMISSION IMPLEMENTING REGULATION (EU) 2016/182
of 11 February 2016
         
renewing the approval of the active substance pyraflufen-ethyl 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
(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 20(1) thereof,

Whereas:







(1)


The approval of the active substance pyraflufen-ethyl, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 30 June 2016.












(2)


An application for the renewal of the inclusion of pyraflufen-ethyl in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article.












(3)


The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State.












(4)


The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 10 January 2014.












(5)


The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.












(6)


On 22 January 2015 (5) the Authority communicated to the Commission its conclusion on whether pyraflufen-ethyl can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for pyraflufen-ethyl to the Standing Committee on Plants, Animals, Food and Feed on 13 July 2015.












(7)


It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied.












(8)


The risk assessment for the renewal of the approval of pyraflufen-ethyl is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing pyraflufen-ethyl may be authorised. It is therefore appropriate not to maintain the restriction to uses as a herbicide.












(9)


It is therefore appropriate to renew the approval of pyraflufen-ethyl.












(10)


In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.












(11)


Commission Implementing Regulation (EU) 2015/1885 (6) extended the expiry date of pyraflufen-ethyl to 30 June 2016 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 April 2016.












(12)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



Article 1

Renewal of the approval of active substance

The approval of the active substance pyraflufen-ethyl is renewed as set out in Annex I.


Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.


Article 3

Entry into force and date of application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 April 2016.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 February 2016.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 309, 24.11.2009, p. 1.

(2)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(4)  Commission Regulation (EU) No 1141/2010 of 7 December 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 (OJ L 322, 8.12.2010, p. 10).

(5)  EFSA Journal 2015;13(2):4001. Available online: www.efsa.europa.eu

(6)  Commission Implementing Regulation (EU) 2015/1885 of 20 October 2015 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-D, acibenzolar-s-methyl, amitrole, bentazone, cyhalofop butyl, diquat, esfenvalerate, famoxadone, flumioxazine, DPX KE 459 (flupyrsulfuron-methyl), glyphosate, iprovalicarb, isoproturon, lambda-cyhalothrin, metalaxyl-M, metsulfuron methyl, picolinafen, prosulfuron, pymetrozine, pyraflufen-ethyl, thiabendazole, thifensulfuron-methyl and triasulfuron (OJ L 276, 21.10.2015, p. 48).




ANNEX I










Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




pyraflufen-ethyl
CAS No 129630-19-9
CIPAC No 605.202


ethyl [2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxy]acetate


≥ 956 g/kg


1 April 2016


31 March 2031


For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraflufen-ethyl, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:






—


the protection of aquatic organisms,










—


the protection of non-target terrestrial plants.




Conditions of use shall include risk mitigation measures, where appropriate.






(1)  Further details on identity and specification of active substance are provided in the review report.





ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:






(1)


in Part A, entry 24 on pyraflufen-ethyl is deleted;










(2)


in Part B, the following entry is added:











Number


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘95


pyraflufen-ethyl
CAS No 129630-19-9
CIPAC No 605.202


ethyl [2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxy]acetate


≥ 956 g/kg


1 April 2016


31 March 2031


For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraflufen-ethyl, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:






—


the protection of aquatic organisms,










—


the protection of non-target terrestrial plants.




Conditions of use shall include risk mitigation measures, where appropriate.’










(1)  Further details on identity and specification of active substance are provided in the review report.