Renewal of the approval of the active substance Purpureocillium lilacinum strain 251

(1)

Commission Directive 2008/44/EC (2) included Purpureocillium lilacinum strain 251 (formerly Paecilomyces lilacinus strain 251), 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 Purpureocillium lilacinum strain 251 as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 July 2022.

(4)

An application for the renewal of the approval of the active substance Purpureocillium lilacinum strain 251 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 draft 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 30 July 2018.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

On 21 August 2020, the Authority communicated to the Commission its conclusion (6) on whether Purpureocillium lilacinum strain 251 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

The Commission presented a renewal report and a draft Regulation regarding Purpureocillium lilacinum strain 251 to the Standing Committee on Plants, Animals, Food and Feed on 26 January 2021 and on 5 July 2021 respectively.

(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined.

(11)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance Purpureocillium lilacinum strain 251 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(12)

The risk assessment for the renewal of the approval of the active substance Purpureocillium lilacinum strain 251 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Purpureocillium lilacinum strain 251 may be authorised.

(13)

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 provide for certain conditions.

(14)

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

(15)

Commission Implementing Regulation (EU) 2021/745 (7) extended the approval period of Purpureocillium lilacinum strain 251 to 31 July 2022 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation shall apply as soon as possible.

(16)

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