(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 Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) for product-type 2 (CAS No: 68424-85-1).

(2)

Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) has been evaluated for use in biocidal products of product-type 2, private area and public health area disinfectants and other biocidal products, as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which corresponds to product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, as described in Annex V to Regulation (EU) No 528/2012.

(3)

Italy was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the Commission on 10 September 2012. After the submission of the assessment report, discussions took place in technical meetings organised by the European Chemicals Agency (‘the Agency’).

(4)

It follows from Article 90(2), first subparagraph, of Regulation (EU) No 528/2012 that substances for which the Member States’ evaluation has been completed by 1 September 2013 are to be assessed in accordance with Directive 98/8/EC.

(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 2 December 2021 (4), having regard to the conclusions of the evaluating competent authority. In its opinion, the Agency concluded that Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) may be approved as an active substance, but three members of the Biocidal Products Committee provided minority opinions expressing concern for a possible risk for the soil compartment.

(6)

The Commission initiated a further consultation of Member States on the matter in the Standing Committee on Biocidal Products, where it was decided that further discussion was needed at technical level regarding the risk for the soil compartment. Subsequently, a request for an opinion was submitted to the Agency in accordance with Article 75(1), point (g), of Regulation (EU) No 528/2012. The Biocidal Products Committee adopted a revised opinion of the Agency on 7 June 2023 (5), concluding that the risk for the soil compartment is acceptable. According to that opinion of the Agency, the biocidal products of product-type 2 containing Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) may be expected to satisfy the requirements laid down in Article 5(1), points (b), (c) and (d), of Directive 98/8/EC, provided that certain requirements concerning their use are complied with.

(7)

Taking into account the opinion of the Agency, it is appropriate to approve Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) as an active substance for use in biocidal products of product-type 2 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,