COMMISSION IMPLEMENTING REGULATION (EU) 2022/1444

of 31 August 2022

concerning the non-approval of black soap E470a as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

(Text with EEA relevance)

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/EEC (1), and in particular Article 13(2) in conjunction with Article 23(5) thereof,

Whereas:

(1) On 7 February 2020, the Commission received an application from the Institut Technique de l’Agriculture Biologique (‘the applicant’) for the approval of black soap E470a as a basic substance to be used in plant protection as an insecticide on arable crops, ornamental flower beds, house plants, plant trees, ornamental woody plants, ornamental crops, vegetables crops, berry fruit crops, pome fruit crops, stone fruit and olive tree crops; and as a fungicide on vegetables and ornamental plant crops. In September 2020 and February 2021, the Commission received revised applications, which were accompanied by the information required under Article 23(3), second subparagraph, of Regulation (EC) No 1107/2009.

(2) Two 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, namely, an evaluation from the ANS Panel of the European Food Safety Authority (‘the Authority’) (2) and a conclusion on the peer review from the Authority (3). The outcome of these evaluations have been taken into account by the Authority as well as by the Commission.

(3) The Commission asked the Authority for scientific assistance. The Authority provided the Commission with a technical report on black soap E470a on 12 August 2021 (4). The Authority concluded that, even though no Union harmonised classification is available in the classification & labelling inventory (5) on the European Chemicals Agency (ECHA) website, the main hazard associated with black soap E470a is its irritation/corrosive properties.

(4) The Authority also noted that the applicant had provided no evidence that the substance for which the approval is sought, is placed on the market in products that fulfil the food additive E470a specifications.

(5) Additionally, due to the absence of data, the Authority could not conclude its assessment of non-dietary risks for operators, workers, bystanders and residents. Moreover, a quantitative consumer risk assessment through dietary intake and drinking water could not be finalised.

(6) The Commission presented the review report, concluding that the approval criteria for basic substances are not fulfilled in the case of black soap E470a and that it is therefore appropriate not to approve it as a basic substance, as well as a draft of this Implementing Regulation to the Standing Committee on Plants, Animals, Food and Feed on 30 March 2022 and 18 May 2022, respectively.

(7) 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.

(8) However, despite the arguments put forward by the applicant, the concerns related to the safety of using this substance with regard to the protection of human health could not be eliminated.

(9) Consequently, it has not been established that the conditions laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve black soap E470a as a basic substance.

(10) This Regulation does not prevent the submission of a further application for the approval of black soap E470a as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

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

HAS ADOPTED THIS REGULATION:

Article 1 The substance black soap E470a is not approved as a basic substance.

Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 31August 2022. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 309, 24.11.2009, p. 1.

(2) EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), Younes M, Aggett P, Aguilar F, Crebelli R, Dusemund B, Filipic M, Frutos MJ, Galtier P, Gott D,Gundert-Remy U, Kuhnle GG, Leblanc J-C, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A,Stankovic I, Waalkens-Berendsen I, Woutersen RA, Wright M, Boon P, Chrysafidis D, Gürtler R,Mosesso P, Parent-Massin D, Tobback P, Cascio C, Rincon AM and Lambré C, 2018. Scientific Opinion on the re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives. EFSA Journal 2018;16(3):5180, 34 pp. DOI: https://doi.org/10.2903/j.efsa.2018.5180.

(3) EFSA (European Food Safety Authority), 2013. Conclusion on the peer review of the pesticide risk assessment of the active substance Fatty acids C7 to C18 (approved under Regulation (EC) No 1107/2009 as Fatty acids C7 to C20). EFSA Journal 2013;11(1):3023. [62 pp.] doi:10.2903/j.efsa.2013.3023.

(4) EFSA (European Food Safety Authority), 2021. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for approval of black soap E470a to be used in plant protection as an insecticide on arable crops, ornamental flower beds, house plants, plant trees, ornamental woody plants, ornamental crops, vegetables crops, berry fruit crops, pome fruit crops, stone fruit and olive tree crops; and as a fungicide on vegetables and ornamental plant crops. EFSA supporting publication 2021:EN-6834. 87pp. doi:10.2903/sp.efsa.2021.EN-6834.

(5) C&L Inventory (europa.eu).