(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Abiopep Plant Health S.L. submitted to Spain on 27 November 2017 an application for the approval of the active substances Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2.

(2)

In accordance with Article 9(3) of that Regulation, Spain, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority‘) on 15 February 2018 of the admissibility of the application.

(3)

On 22 July 2019, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether these active substances can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(4)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009.

(5)

On 22 October 2019, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substances Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

(6)

On 25 January 2021, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed a review report and a draft Regulation regarding Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2.

(7)

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

(8)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substances, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to approve Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2.

(9)

The Commission further considers that Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 are low-risk active substances pursuant to Article 22 of Regulation (EC) No 1107/2009. Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 are not substances of concern and they fulfil the conditions set out in point 5.2 of Annex II to Regulation (EC) No 1107/2009. Taking into account the assessment by the rapporteur Member State and the Authority, as regards the intended uses in permanent greenhouses (soil-bound and hydroponics), Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 are microorganisms which are expected to have a low risk for humans, animals and the environment. Pepino mosaic virus infection and its replication are known to be very specific to some plants (Solanaceae family) and have not been reported to occur in other organisms. No critical areas of concern were identified, and the two strains are unlikely to have a potential of toxicity, infectivity and pathogenicity. For these reasons, only general mitigation measures should be taken for operators and workers.

(10)

It is therefore appropriate to approve Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 as low-risk substances.

(11)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions.

(12)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

(13)

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