Renewal of approval of the active substance Clonostachys rosea strain J1446 as a low-risk active substance

(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 Clonostachys rosea strain J1446, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2019.

(4)

An application for the renewal of the approval of Clonostachys rosea strain J1446 was submitted by Verdera Oy (‘the applicant’) 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 6 July 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 June 2017 the Authority communicated to the Commission its conclusion (6) on whether Clonostachys rosea strain J1446 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 Clonostachys rosea strain J1446 to the Standing Committee on Plants, Animals, Food and Feed on 11 December 2017.

(9)

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

(10)

It has been established with respect to one or more representative uses of at least one plant protection product containing Clonostachys rosea strain J1446 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 Clonostachys rosea strain J1446.

(11)

The risk assessment for the renewal of the approval of Clonostachys rosea strain J1446 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Clonostachys roseastrain J1446 may be authorised. It is therefore appropriate not to maintain the restriction to use only as a fungicide.

(12)

The Commission further considers that Clonostachys rosea strain J1446 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Clonostachys rosea strain J1446 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.

(13)

It is therefore appropriate to renew the approval of Clonostachys rosea strain J1446 as a low-risk substance.

(14)

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.

(15)

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.

(16)

Commission Implementing Regulation (EU) 2018/917 (7) extended the approval period of Clonostachys rosea strain J1446 to 31 July 2019 in order to allow the renewal process to be completed before the expiry date of the approval of that substance. However, given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 April 2019.