ADBAC/BKC (C12-16) extension approved: PT 1 and 2
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As of June 2021, the European Commission approved Alkyl (C12-16) Dimethylbenzyl Ammonium Chloride (ADBAC/BKC, CAS: 68424-85-1) as an active substance for use in biocidal products of product types (PT) 3 and 4 subject to the specifications and conditions set out in the Annex. The Approval Start Date - the date by which the active will be added to the Union List of Approved Active is November 1st, 2022.
Companies that have biocidal products with Alkyl (C12-16) Dimethylbenzyl Ammonium Chloride (ADBAC/BKC) in PT 3 and 4 must submit an application for Product Authorization by the Approval Start date to ensure continuity on the market.
ADBAC is a well-known cationic surfactant-type active substance added to products to function as a cleaning agent or antimicrobial agent and can be found in products that are used as general disinfectants.
Following on from PT 3 and 4 approval, during December's Biocidal Products Committee (BPC) meeting, the opinion to approve ADBAC/BKC was adopted for use in disinfectants for personal hygiene (PT1 and 2).
What falls under the scope of Product-types 1, 2 3 and 4?
Product Type 1: covers products used for human hygiene purposes, applied on or in contact with human skin for the primary purpose of disinfecting the skin or scalp.
Product Type 2: covers products used for the disinfection of surface, materials, equipment and furniture which are not used for direct application to humans or animals. Usage areas include swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas as well as in other areas of professional activities.
Product-type 3: covers products used for veterinary hygiene purposes, such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function, and the products used to disinfect the materials and surfaces associated with the housing or transportation of animals.
Product-type 4: covers the products used to disinfect equipment, containers, and surfaces needed in the production, transport, storage, or consumption of food or feed for people and animals
Why is this important?
Any business with products containing ADBAC/BKC in PT 3 and 4 will have to apply for product authorization by November 1st of this year to stay on the market.
Businesses with products containing ADBAC/BKC in PT 1 and 2 should:
1. Follow the regulatory status of this active substance very closely for the European Commission decision and
2. Look out for the publication of the legal act incorporating both the date of approval and the time when the relevant biocidal product can be submitted for authorisation
This is important so businesses can maximise the time to prepare for product authorisation.
How can Yordas help?
Rosalinda Gioia, Principal Science (UK) said: “We have supported clients with Product Authorisation applications under EU BPR for the last 10 years. Throughout our work, we have forged excellent working relationships with several EU Member States Competent Authorities, and have developed a network of service providers such as test laboratories and legal advisers to contribute at all stages of the application process.”
We can help you comply with regulatory updates by providing you with insight, strategic advice, preparing the dossier, submission, and follow-up with the authorities. Get in touch today by sending us a message: click here. Stay up-to-date about upcoming regulatory changes by visiting our website: www.yordasgroup.com.