8.5.2018   

EN

Official Journal of the European Union

L 117/9

(1)

Commission Directive 2003/119/EC (2) included zoxamide 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 zoxamide, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2019.

(4)

An application for the renewal of the approval of zoxamide was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) 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 5 August 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 21 August 2017 the Authority communicated to the Commission its conclusion (6) on whether zoxamide 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 zoxamide to the Standing Committee on Plants, Animals, Food and Feed on 26 January 2018.

(9)

The applicant was given the opportunity to submit comments on the draft renewal report.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.

(10)

It is therefore appropriate to renew the approval of zoxamide.

(11)

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

(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 and restrictions. It is, in particular, appropriate to require further confirmatory information.

(13)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(14)

Commission Implementing Regulation (EU) 2018/84 (7) extended the expiry date of zoxamide to 31 January 2019 in order to allow the renewal process to be completed before the expiry of the approval of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 July 2018.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,