BAKGRUNN (fra kommisjonsforordningen)

(1) On 18 March 2021, the Commission received an application from Multifolia Sas for the approval of Onobrychis viciifolia (sainfoin) dried pellets as a basic substance to be used in plant protection as a nematicide in grapevines. 

(2) After the admissibility check, the application, as received in March 2021, was accompanied by the information required under Article 23(3), second subparagraph, of Regulation (EC) No 1107/2009. 

(3) The Commission asked the European Food Safety Authority (ʽthe Authorityʼ) for scientific assistance pursuant to Article 23(4) of Regulation (EC) No 1107/2009. The Authority provided the Commission with a technical report on Onobrychis viciifolia (sainfoin) dried pellets on 9 December 2022. 

(4) The Commission presented the review report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 21 March 2024 and 23 May 2024, respectively. 

(5) The information provided by the applicant shows that Onobrychis viciifolia (sainfoin) dried pellets is currently on the market as animal feed and as a fertiliser. Moreover, it is not predominantly used for plant protection purposes, but Onobrychis viciifolia (sainfoin) dried pellets is useful in plant protection. Based on the information provided in the application and the technical report from the Authority, it can also be concluded that Onobrychis viciifolia (sainfoin) dried pellets is not a substance of concern. It does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects and is not placed on the market as a plant protection product. Consequently, Onobrychis viciifolia (sainfoin) dried pellets meets the conditions set out in Article 23(1) of Regulation (EC) No 1107/2009. 

(6) No relevant evaluation, carried out in accordance with other Community legislation was available. 

(7) After examination of the application and all related documents, it may be expected that Onobrychis viciifolia (sainfoin) dried pellets satisfies, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Onobrychis viciifolia (sainfoin) dried pellets as a basic substance. 

(8) The Commission invited the applicant to submit its comments on the technical report of the Authority and on the Commission’s draft review report. The applicant submitted its comments, which have been carefully examined. 

(9) 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, however, necessary to include certain conditions for the approval. 

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

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