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 second alternative of Article 21(3) and Article 78(2) thereof,
Whereas:
(1)
Commission Directive 2011/6/EU included buprofezin as active substance in Annex I to Council Directive 91/414/EEC, under the condition that the Member States concerned ensure that the notifier, at whose request buprofezin was included in that Annex, provides further confirmatory information as regards the processing and conversion factors for consumer risk assessment.
(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.
(3)
On 30 January 2013, the applicant submitted additional information concerning the processing and conversion factors to the rapporteur Member State United Kingdom within the time period provided for its submission.
(4)
The United Kingdom assessed the additional information submitted by the applicant. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 9 September 2014.
(5)
The Commission consulted the Authority which presented its conclusion on the risk assessment of buprofezin on 28 July 2015. The draft assessment report, the addendum and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 24 January 2017 in the format of the Commission review report for buprofezin.
(6)
The Commission invited the applicant to submit its comments on the review report for buprofezin.
(7)
The Commission has considered that the additional information provided showed that under high-temperature processing conditions buprofezin is degraded into several metabolites, including aniline. Aniline is a carcinogen for which a genotoxic mechanism cannot be excluded and therefore no threshold for acceptable exposure can be assumed.
(8)
The Commission has concluded that the further confirmatory information required has not been fully provided and that exposure of consumers to aniline via consumption of processed crops cannot be excluded except by imposing further restrictions. In particular, the use of buprofezin should be limited to non-edible crops only.
(9)
It is confirmed that the active substance buprofezin is to be deemed to have been approved under Regulation (EC) No 1107/2009. In order to minimise the exposure of consumers to aniline, it is, however, appropriate to amend the conditions of use of this active substance.
(10)
The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(11)
Member States should be provided with time to amend or withdraw authorisations for plant protection products containing buprofezin.
(12)
For plant protection products containing buprofezin, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 21 June 2018.
(13)
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: