Commission Implementing Regulation (EU) 2016/147 of 4 February 2016 renewing the approval of the active substance iprovalicarb 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 Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)
Commission Implementing Regulation (EU) 2016/147 of 4 February 2016 renewing the approval of the active substance iprovalicarb 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 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:
The approval of the active substance iprovalicarb, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011(2), expires on 30 June 2016.
An application for the renewal of the inclusion of iprovalicarb 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.
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.
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 2 September 2013.
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.
On 14 April 2015(5) the Authority communicated to the Commission its conclusion on whether iprovalicarb 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 iprovalicarb to the Standing Committee on Plants, Animals, Food and Feed on 8 October 2015.
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.
It is therefore appropriate to renew the approval of iprovalicarb.
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. It is, in particular, appropriate to require further confirmatory information.
The risk assessment for the renewal of the approval of iprovalicarb is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing iprovalicarb may be authorised. It is therefore appropriate not to maintain the restriction to uses as a fungicide. 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.
Commission Implementing Regulation (EU) 2015/1885(6) extended the expiry date of iprovalicarb to allow the renewal process to be completed before the expiry of its approval. However, given that a decision on renewal has been taken ahead of the extended expiry date, this Regulation should apply from 1 April 2016.
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 the active substance
The approval of the active substance iprovalicarb, 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 April 2016.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 February 2016.
For the Commission
The President
Jean-Claude Juncker