Commission Implementing Regulation (EU) 2017/753 of 28 April 2017 renewing the approval of the active substance cyhalofop-butyl 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: 2017-04-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_2017113EN.01002401.xml










29.4.2017   


EN


Official Journal of the European Union


L 113/24








            COMMISSION IMPLEMENTING REGULATION (EU) 2017/753
of 28 April 2017
         
renewing the approval of the active substance cyhalofop-butyl 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)


Commission Directive 2002/64/EC (2) included cyhalofop-butyl as an active substance in Annex I to Council Directive 91/414/EEC (3).












(2)


Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).












(3)


The approval of the active substance cyhalofop-butyl, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 June 2017.












(4)


An application for the renewal of the inclusion of cyhalofop-butyl in Annex I to Directive 91/414/EEC was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (5) within the time period provided for in that Article.












(5)


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.












(6)


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 (‘the Authority’) and the Commission on 18 October 2013.












(7)


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.












(8)


On 9 December 2014, the Authority communicated to the Commission its conclusion (6) on whether cyhalofop-butyl 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 cyhalofop-butyl to the Standing Committee on Plants, Animals, Food and Feed on 28 May 2015.












(9)


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.












(10)


It is therefore appropriate to renew the approval of cyhalofop-butyl.












(11)


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












(12)


In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions.












(13)


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.












(14)


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 cyhalofop-butyl, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.


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 July 2017.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 April 2017.


For the Commission


The President

Jean-Claude JUNCKER
            





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

(2)  Commission Directive 2002/64/EC of 15 July 2002 amending Council Directive 91/414/EEC to include cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M and picolinafen as active substances (OJ L 189, 18.7.2002, p. 27).

(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 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).

(5)  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).

(6)  
            EFSA Journal 2014;12(1):3943. Available online: www.efsa.europa.eu.




ANNEX I










Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




Cyhalofop-butyl
CAS No 122008-85-9
CIPAC No 596


butyl (R)-2-[4-(4-cyano-2-fluorophenoxy) phenoxy]propionate


950 g/kg


1 July 2017


30 June 2032


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 cyhalofop-butyl, 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 operators,










—


the technical specification,










—


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 34 on Cyhalofop butyl is deleted;










(2)


in Part B, the following entry is added:











‘113


Cyhalofop-butyl
CAS No 122008-85-9
CIPAC No 596


butyl (R)-2-[4-(4-cyano-2-fluorophenoxy) phenoxy]propionate


950 g/kg


1 July 2017


30 June 2032


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 cyhalofop-butyl, 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 operators,










—


the technical specification,










—


the protection of non-target terrestrial plants.




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