BAKGRUNN (fra kommisjonsforordningen)

(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 (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 Allium fistulosum on 31 October 2023. 

(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 Council3 . 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 itselfor 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 techncial Report from the Authority, it can also be concluded that Allium fistulosum, processed, is not a substance of concern, as 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 report4 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 540/20115 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,