Commission Implementing Regulation (EU) 2018/679

Contents

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^note, and in particular Article 20(1) thereof,Whereas:

(1)Commission Directive 2006/10/EC^note included forchlorfenuron as an active substance in Annex I to Council Directive 91/414/EEC^note.

(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^note.

(3)The approval of the active substance forchlorfenuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2018.

(4)An application for the renewal of the approval of forchlorfenuron was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012^note within the time period provided for in that Article.

(5)The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. 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 27 May 2016.

(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 31 May 2017 the Authority communicated to the Commission its conclusion^note on whether forchlorfenuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for forchlorfenuron to the Standing Committee on Plants, Animals, Food and Feed on 5 October 2017.

(9)The Commission invited the applicant to submit its comments on the review report for forchlorfenuron. The applicant submitted its comments which have been carefully examined.

(10)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.

(11)The risk assessment for the renewal of the approval of forchlorfenuron is based on a limited number of representative uses, which however does not restrict the uses for which plant protection products containing forchlorfenuron may be authorised. It is therefore appropriate not to maintain the restriction to use as a plant growth regulator.

(12)It is therefore appropriate to renew the approval of forchlorfenuron.

(13)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 and restrictions.

(14)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.

(15)Commission Implementing Regulation (EU) 2017/1511^note extended the expiry date of forchlorfenuron to 31 October 2018 in order to allow the renewal process to be completed before the expiry of the approval of that active substance. Given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 June 2018.

(16)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 1Renewal of the approval of active substance#

The approval of the active substance forchlorfenuron is renewed as set out in Annex I.

Article 2Amendments 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 3Entry 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 June 2018.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Expiration of approval	Specific provisions
ForchlorfenuronCAS No 68157-60-8CIPAC No 633	1-(2-chloro-4-pyridyl)-3-phenylurea	≥ 978 g/kg	1.6.2018	31.5.2033	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on forchlorfenuron, 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 risk to consumers as regards the potential risk from metabolites in fruit crops with edible peels.Conditions of use shall include risk mitigation measures, where appropriate.

Annex II

(1)in Part A, entry 118 on forchlorfenuron is deleted;

(2)in Part B, the following entry is added:^noteNumberCommon Name, Identification NumbersIUPAC NamePurity^noteDate of approvalExpiration of approvalSpecific provisions‘122ForchlorfenuronCAS No 68157-60-8CIPAC No 6331-(2-chloro-4-pyridyl)-3-phenylurea≥ 978 g/kg1.6.201831.5.2033For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on forchlorfenuron, 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 risk to consumers as regards the potential risk from metabolites in fruit crops with edible peels.

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

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

Commission Implementing Regulation (EU) 2018/679

Article 1Renewal of the approval of active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II

History · 2 versions

Connections

Article 1Renewal of the approval of active substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II

Key facts