Commission Implementing Regulation (EU) 2024/893 of 22 March 2024 approving thermally treated garlic juice as an existing active substance for use in biocidal products of product-type 19 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journal EN of the European Union L series 2024/893 25.3.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/893 of 22 March 2024 approving thermally treated garlic juice as an existing active substance for use in biocidal products of product-type 19 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012concerning the making available on the market and use of biocidal products(1), and in particular Article 89(1), third subparagraph, thereof,

Whereas:

(1) Commission Delegated Regulation (EU) No 1062/2014(2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes garlic extract (extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Allium sativum, Liliaceae) (CAS No: 8008-99-9) for product-type 19.

(2) Garlic extract has been evaluated for use in biocidal products of product-type 19 (repellents and attractants), as described in Annex V to Regulation (EU) No 528/2012.

(3) Austria was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the European Chemicals Agency (‘the Agency’) on 23 September

2022. The Agency discussed the assessment report and the conclusions in technical meetings.

(4) During the examination of garlic extract the identity of this active substance has been redefined in accordance with Article 13 of Delegated Regulation (EU) No 1062/2014 to thermally treated garlic juice.

(5) In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency regarding the applications for approval of active substances. In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014 read in conjunction with Article 75(1) and (4) of Regulation (EU) No 528/2012, the Biocidal Products Committee adopted the opinion of the Agency on 5 June 2023(3), having regard to the conclusions of the evaluating competent authority.

(6) In that opinion, the Agency concludes that biocidal products of product-type 19 containing thermally treated garlic juice may be expected to satisfy the criteria laid down in Article 19(1), point (b), of Regulation (EU) No 528/2012,

provided that certain conditions concerning their use are complied with.

(1) OJ L 167, 27.6.2012, p. 1.

(2) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

(3) Biocidal Products Committee Opinion on the application for approval of the active substance thermally treated garlic juice, Product-type 19; ECHA/BPC/375/2023, adopted on 5 June 2023.

ELI: http://data.europa.eu/eli/reg_impl/2024/893/oj 1/3EN OJ L, 25.3.2024

(7) Taking into account the opinion of the Agency, it is appropriate to approve thermally treated garlic juice as an active substance for use in biocidal products of product-type 19 subject to compliance with certain conditions.

(8) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1 Thermally treated garlic juice is approved as an active substance for use in biocidal products of product-type 19, subject to the conditions set out in the Annex.

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, 22 March 2024.

For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg_impl/2024/893/ojELI:

http://data.europa.eu/eli/reg_impl/2024/893/oj 3/3 ANNEX IUPAC Name Minimum degree of purity of the active Expiry date of Common Name Date of approval Product type Specific conditions Identification Numbers substance(1) approval Thermally Thermally treated Thermally treated garlic juice is an 1 July 2025 30 June 2035 19 The authorisation of biocidal products is subject treated garlic garlic juice unknown or variable composition, to the following condition:

juice EC No: — complex reaction products or of biological

CAS No: — materials (UVCB) substance. The purity is the product assessment shall pay particular atten­ 100 % weight per weight (w/w). It is tion to the exposures, the risks and the efficacy derived from garlic juice that is thermally linked to any uses covered by an application for treated and has food grade quality. In authorisation, but not addressed in the Union-le­ addition, thermally treated garlic juice is vel risk assessment of the active substance.

characterised by four marker compounds: diallyl sulfide (DAS1), diallyl disulfide

(DAS2), diallyl trisulfide (DAS3) and diallyl tetrasulfide (DAS4).

(1) The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

OJ L,

25.3.2024 EN