ADBAC (C12-16) extension approved by the EU – prepare your dossiers

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As of June 2021, the European Commission approved Alkyl (C12-16) Dimethylbenzyl Ammonium Chloride (ADBAC)  as an active substance for use in biocidal products of product types 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) 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.

What falls under the scope of Product-types 3 and 4?

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 in PT 3 and 4 will have to apply for Product authorization by November 1st of next year to stay on the market.

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 here. Stay up-to-date about upcoming regulatory changes by visiting our website: www.yordasgroup.com.

Reference: https://www.hse.gov.uk/reach/duin.htm