(fra kommisjonsforordningen)

(1) On 18 June 2020, Austria received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from AMOEBA SA for the approval of the active substance lysate of Willaertia magna C2c Maky. 

(2) In accordance with Article 9(3) of that Regulation, Austria, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 4 November 2020 of the admissibility of the application. 

(3) On 29 July 2022, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. 

(4) In accordance with Article 12(1) of Regulation (EC) No 1107/2009, the Authority circulated the draft assessment report to the applicant and to the other Member States and made it available to the public. 

(5) In accordance with Article 12(3) of Regulation (EC) No 1107/2009, the Authority requested the applicant to supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated draft assessment report on 4 June 2024. 

(6) On 13 December 2024 the Authority communicated to the applicant, the Member States and the Commission its conclusion2 on whether the active substance lysate of Willaertia magna C2c Maky 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. 

(7) The Authority confirmed that, based on the available evidence, the scientific conclusions on the lysate of Willaertia magna strain C2c Maky are also applicable to Willaertia magna as a species. In order to reduce the administrative burden and the risk of resistance building, it is therefore appropriate not to limit the approval to the strain Willaertia magna C2c Maky but to approve the active substance as lysate of the species Willaertia magna. 

(8) The Commission presented to the Standing Committee on Plants, Animals, Food and Feed a review report and a draft Regulation regarding the lysate of Willaertia magna on 11 March 2025 and 14 May 2025, respectively. 

(9) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 13(1) of Regulation (EC) No 1107/2009, on the review report. The applicant submitted its comments, which have been carefully examined. 

(10) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance lysate of Willaertia magna, and in particular with respect to 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. 

(11) The Commission further considers that lysate of Willaertia magna is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. The lysate of Willaertia magna is not a substance of concern and fulfils the conditions set in Annex II, point 5, to Regulation (EC) No 1107/2009. Lysate of Willaertia magna is an active substance for which a low-risk for humans, animals and the environment is expected, its components are naturally-occurring, and it is readily biodegradable. 

(12) It is therefore appropriate to approve lysate of Willaertia magna as a low-risk active substance. 

(13) 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 in order to ensure quality control during the manufacturing process and during the use of plant protection products containing lysate of Willaertia magna. 

(14) In accordance with Article 13(4) of Regulation (EC) No 1107/2009 in conjunction with Article 22(2) thereof, Implementing Regulation (EU) No 540/20113 should be amended accordingly. 

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