Prováděcí nařízení Komise (EU) 2024/2878 ze dne 8. listopadu 2024, kterým se v souladu s nařízením Evropského parlamentu a Rady (ES) č. 1107/2009 schvaluje základní látka Allium fistulosum, zpracovaný, 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: https://eur-lex.europa.eu/eli/reg/2009/1107/oj. , and in particular Article 23(5) in conjunction with Article 13(2) thereof,

The substance Allium fistulosum , processed, 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: https://eur-lex.europa.eu/eli/reg/2009/1107/oj.

(1) On 5 March 2021 , the Commission received an application from Institut Technique de l’Agriculture Biologique (the applicant) for the approval of Allium fistulosum extract as a basic substance to be used in plant protection as a bactericide for soil treatment before tomato sowing in the field and in permanent greenhouses. A revised application was submitted by the applicant in June 2021, and it was accompanied by the information required under Article 23(3), second subparagraph, of Regulation (EC) No 1107/2009.

(2) 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 Allium fistulosum on 31 October 2023 EFSA (European Food Safety Authority), 2023. Overall conclusions on the application for approval of Allium fistulosum as a basic substance to be used in plant protection as a bactericide. EFSA supporting publication 2023: EN-8433. 119pp.; doi:10.2903/sp.efsa.2023.EN-8433. .

(3) The application has been made for Allium fistulosum extract. However, the documentation provided by the applicant shows that the Allium fistulosum plant can be used in two different formulations: as a water extract or in the form of chopped fresh pieces of the plant. It was therefore considered appropriate to include both processing methods in the name of the basic substance and to define the scope of the application as covering Allium fistulosum , processed.

(4) The information provided by the applicant shows that Allium fistulosum fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and the CouncilRegulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1 , ELI: http://data.europa.eu/eli/reg/2002/178/oj). . Moreover, it is not predominantly used for plant protection purposes but nevertheless Allium fistulosum , processed, is useful for plant protection purposes when contained in a product consisting of either the substance itself or the substance and a simple diluent. Consequently, it is to be considered as a basic substance.

(5) Based on the information provided in the application and the technical report from the Authority, it can also be concluded that Allium fistulosum , processed, is not a substance of concern, and it does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects. Furthermore, it is not placed on the market as a plant protection product. Consequently, Allium fistulosum , processed, meets the conditions set out in Article 23(1) second subparagraph, of Regulation (EC) No 1107/2009.

(6) The examination of the application and all related documents has led to the conclusion that Allium fistulosum , processed, 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 Allium fistulosum , processed, as a basic substance.

(7) In accordance with Article 23(5) of Regulation (EC) No 1107/2009, read 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, as laid down in Annex I to this Regulation.

(8) The Commission presented the review reportFinal Review report for the basic substance Allium fistulosum , processed, finalised by the Standing Committee on Plants, Animals, Food and Feed on 3 October 2024 in view of the approval of Allium fistulosum , processed, 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 23 May 2024 and 11 July 2024 , respectively.

(9) In accordance with Article 23(5) of Regulation (EC) No 1107/2009, read in conjunction with Article 13(4) thereof, 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.

(10) 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. Overall conclusions on the application for approval of Allium fistulosum as a basic substance to be used in plant protection as a bactericide. EFSA supporting publication 2023: EN-8433. 119pp.; doi:10.2903/sp.efsa.2023.EN-8433.

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 .

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1 , ELI: http://data.europa.eu/eli/reg/2002/178/oj).

Final Review report for the basic substance Allium fistulosum , processed, finalised by the Standing Committee on Plants, Animals, Food and Feed on 3 October 2024 in view of the approval of Allium fistulosum , processed, 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: