EU notifies WTO of proposal to approve ADBAC/BKC C12-C16 for use in biocidal products

On 6 September 2023, the European Union notified to the World Trade Organization (WTO) a draft Commission Implementing Regulation 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.

Alkyl (C12-16) dimethylbenzyl ammonium chloride

Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16); CAS No: 68424-85-1) is a cationic surfactant-type active substance. The physico-chemical properties of the active substance and biocidal products have been evaluated and are considered acceptable for the appropriate use, storage and transport of the active substance and biocidal products.

Similar to other quaternary ammonium compounds, ADBAC/BKC (C12-C16) acts as a membrane-active agent that primarily interacts with the cytoplasmic (inner) membrane of bacteria and the plasma membrane of yeasts and fungi. This interaction results in membrane rupture, subsequent leakage of intracellular components such as K⁺ ions and other cytoplasmic constituents, and ultimately, the precipitation of cell contents, leading to cell death.

Product-type 2 biocidal products

Product-type 2 refers to biocidal products that are used as disinfectants and algaecides and that are not intended for direct application to humans or animals. They are used as follows:

• For the disinfection of surfaces, materials, equipment, and furniture which are not used for direct contact with food or feeding stuffs.

• For disinfection of air, water not used for human or animal consumption, chemical toilets, wastewater, hospital waste and soil.

• As algaecides for treatment of swimming pools, aquariums, and other waters and for remedial treatment of construction materials.

• For incorporation into textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.

Specific conditions

The authorisation of biocidal products using ADBAC/BKC (C12-C16) as an active substance is subject to the following conditions laid out in the Annex to the Regulation:

• 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.

• The product assessment shall pay particular attention to professional users.