ADBAC/BKC approved as an active substance for use in PT2 according to BPR
The approval date for Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) for use in biocidal products of product-type 2 is 1st July 2025.
ADBAC/BKC will be approved for PT2 (Disinfectants and algaecides not intended for direct application to humans or animals). 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. |
Italy was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions.
What is ADBAC/BKC?
ADBAC/BKC, is a ubiquitous biocide widely used in various applications ranging from household disinfectants to industrial cooling towers. Its broad-spectrum activity against bacteria, fungi, and even enveloped viruses has made it a popular choice for decades. However, with increasing scrutiny on biocidal agents and growing environmental concerns, ADBAC/BKC finds itself under the microscope.
Chemical Identity and Mechanism of Action:
ADBAC/BKC belongs to the family of quaternary ammonium compounds (QACs). It’s a mixture of several organic salts with varying chain lengths (C12-C16), hence the «(C12-C16)» designation. These positively charged molecules interact with the negatively charged membranes of microorganisms, disrupting their structure and function, ultimately leading to cell death. This mechanism makes ADBAC/BKC effective against a diverse range of microbes, including Gram-positive and Gram-negative bacteria, fungi like yeasts and molds, and even some enveloped viruses.
What should companies that market biocidal products with ADBAC/BKC do now?
- Obtain a letter of access to the active substance. The letter of access must be provided by an authorized supplier of the active substance.
- Be aware of the BPR requirements for the specific uses of your biocidal products.
- Define a current and future (5 or 6 year) commercial strategy in the EU. This will be essential for marketing in other markets and carrying out notification/registration procedures in those countries according to their transitional laws (pre-BPR). The procedures must be carried out before the approval of the active substance in BPR, as it is not possible to notify or register the product afterwards and it cannot be marketed until the authorities have resolved the BPR application.
- Prepare a BPR application of authorisation (which Nordiik can prepare) for the formulated biocidal products.
- Determine the applicable fees according to the countries of marketing.
- Have the BPR application ready and submit it to the competent authorities before the approval date.
Do you need support to prepare the BPR Application of your biocidal products? Nordiik can help, contact us!
Download the Implementing regulation approving ADBAC/BKC here: OJ_L_202400235_EN_TXT
Source: CELEX
Image: Freepik
