Commission Implementing Regulation (EU) 2018/660
of 26 April 2018
renewing the approval of the active substance bentazone 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,
Whereas:
The approval of the active substance bentazone, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011, expires on 30 June 2018.
The applicants 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 (‘the Authority’) and the Commission on 8 January 2014.
The Authority communicated the renewal assessment report to the applicants 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.
The applicants were given the opportunity to submit comments on the draft review report.
It has been established with respect to one or more representative uses of at least one plant protection product containing bentazone that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of bentazone.
Nevertheless, several Member States have identified bentazone in the groundwater in their national groundwater monitoring programmes and EFSA indicated that for certain uses and under vulnerable soil conditions groundwater contamination cannot be excluded.
Therefore, in light of the results of national groundwater monitoring programmes, and bearing in mind the need to ensure a level of safety and protection consistent with the high level of protection that is sought within the Union, it is appropriate to provide for a renewal of the approval of bentazone for a period of seven years which ensures a priority re-assessment of bentazone over other active substances thereby also allowing to take into consideration updated results of national groundwater monitoring programmes.
The risk assessment for the renewal of the approval of bentazone is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing bentazone may be authorised. It is therefore appropriate to remove the restriction for use only as a herbicide.
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. It is, in particular, appropriate to require further confirmatory information.
The Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.
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: