BAKGRUNN (fra kommisjonsforordningen)

(1) On 4 August 2020, the Commission received an application from Cérience (formerly Jouffray-Drillaud) for the approval of Vitis vinifera L. seed extract (grape seed extract) as a basic substance to be used in plant protection as a fungicide on grapevines, apples, potatoes and lettuce. 

(2) After the admissibility check, the application, as received in February 2022, 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 Vitis vinifera L. seed extract (grape seed extract) on 30 October 2023. 

(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 10 July 2024, respectively. 

(5) The information provided by the applicant shows that Vitis vinifera L. seed extract (grape seed extract) is used as food supplement and as feed additive. Moreover, it is not predominantly used for plant protection purposes, but the substance is useful in plant protection. Based on the information provided in the application and the Techncial Report from the Authority, it can also be concluded that it is not a substance of concern; it does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; and it is not placed on the market as a plant protection product. Consequently, Vitis vinifera L. seed extract (grape seed extract) fulfils the conditions set out in Article 23(1) of Regulation (EC) No 1107/2009. 

(6) Several relevant evaluations, carried out in accordance with other Union legislation, as referred to in Article 23(2) of Regulation (EC) No 1107/2009, were available. Three Scientific Opinions from the Authority were relevant: two from the FEEDAP Panel and one from the NDA Panel. The outcome of those evaluations has been taken into account by the Authority as well as by the Commission. 

(7) After examination of the application and all related documents, it may be expected that Vitis vinifera L. seed extract (grape seed extract) 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 Vitis vinifera L. seed extract (grape seed extract) 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 and taken into due consideration. 

(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 540/20115 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,