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 2012 concerning 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.

(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

(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.

ANNEX

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance(1)

Date of approval

Expiry date of approval

Product type

Specific conditions

Thermally treated garlic juice

EC No: —

CAS No: —

Thermally treated garlic juice is an unknown or variable composition, complex reaction products or of biological materials (UVCB) substance. The purity is 100 % weight per weight (w/w). It is derived from garlic juice that is thermally treated and has food grade quality. In addition, thermally treated garlic juice is characterised by four marker compounds: diallyl sulfide (DAS1), diallyl disulfide (DAS2), diallyl trisulfide (DAS3) and diallyl tetrasulfide (DAS4).

1 July 2025

30 June 2035

The authorisation of biocidal products is subject to the following condition:

the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

(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.

ELI: http://data.europa.eu/eli/reg_impl/2024/893/oj

ISSN 1977-0677 (electronic edition)