Commission Implementing Regulation (EU) 2024/235 of 15 January 2024 approving Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) as an existing active substance for use in biocidal products of product-type 2 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2024-01-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, pharmaceutical product








L_202400235EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2024/235


16.1.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/235
of 15 January 2024
         
approving Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) as an existing active substance for use in biocidal products of product-type 2 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 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,





HAS ADOPTED THIS REGULATION:



Article 1
Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) is approved as an active substance for use in biocidal products of product-type 2, 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, 15 January 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)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

(4)  Biocidal Products Committee Opinion on the application for approval of the active substance Alkyl(C12-16) dimethylbenzyl ammonium chloride; Product-type: 2; ECHA/BPC/310/2021, adopted on 2 December 2021.

(5)  Biocidal Products Committee Opinion on the application for approval of the active substance Alkyl(C12-16) dimethylbenzyl ammonium chloride; Product-type: 2; ECHA/BPC/387/2023, adopted on 7 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




Alkyl (C12-16) dimethylbenzyl ammonium chloride
(ADBAC/BKC (C12-C16))


IUPAC name: -
EC No: 270-325-2
CAS No: 68424-85-1


972 g/kg dry weight


1 July 2025


30 June 2035


2


The authorisation of biocidal products using Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) as an active substance is subject to the following conditions:






(1)


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;










(2)


the product assessment shall pay particular attention to professional users.










(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/2024/235/oj
ISSN 1977-0677 (electronic edition)