Prováděcí nařízení Komise (EU) 2024/1768 ze dne 26. června 2024, kterým se v souladu s nařízením Evropského parlamentu a Rady (ES) č. 1107/2009 schvaluje základní látka sušené pelety z Onobrychis viciifolia (vičenec ligrus) a mění prováděcí nařízení Komise (EU) č. 540/2011

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EECOJ L 309, 24.11.2009, p. 1 , ELI: http://data.europa.eu/eli/reg/2009/1107/oj. , and in particular Article 23(5) in conjunction with Article 13(2) thereof,

The substance Onobrychis viciifolia (sainfoin) dried pellets as specified in Annex I is approved as a basic substance subject to the conditions laid down in that Annex.

OJ L 309, 24.11.2009, p. 1 , ELI: http://data.europa.eu/eli/reg/2009/1107/oj.

(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 (the Authority) 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 EFSA (European Food Safety Authority), 2023. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for approval of sainfoin (Onobrychis viciifolia var. Perly) dried pellets to be used in plant protection as a nematicide in grapevines (EFSA supporting publication 2023:EN-7763, 94 pp., doi:10.2903/sp.efsa.2023.EN-7763). .

(4) The Commission presented the review reportFinal Review report for the basic substance Onobrychis viciifolia (sainfoin) dried pellets finalised by the Standing Committee on Plants, Animals, Food and Feed on 23 May 2024 in view of the approval of Onobrychis viciifolia (sainfoin) dried pellets as basic substance in accordance with Regulation (EC) No 1107/2009. 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 540/2011Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1 , ELI: http://data.europa.eu/eli/reg_impl/2011/540/oj). 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,

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

EFSA (European Food Safety Authority), 2023. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for approval of sainfoin (Onobrychis viciifolia var. Perly) dried pellets to be used in plant protection as a nematicide in grapevines (EFSA supporting publication 2023:EN-7763, 94 pp., doi:10.2903/sp.efsa.2023.EN-7763).

Article 1 Article 1 Approval of a basic substance

Article 2 Article 2 Amendments to Implementing Regulation (EU) No 540/2011

Article 3 Article 3 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Final Review report for the basic substance Onobrychis viciifolia (sainfoin) dried pellets finalised by the Standing Committee on Plants, Animals, Food and Feed on 23 May 2024 in view of the approval of Onobrychis viciifolia (sainfoin) dried pellets as basic substance in accordance with Regulation (EC) No 1107/2009.

Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1 , ELI: http://data.europa.eu/eli/reg_impl/2011/540/oj).

HAS ADOPTED THIS REGULATION: