ADBAC and DDAC: approvals for biocidal active substances are approaching
Producers of disinfectant products containing the active substances commonly known as ADBAC/BKC and DDAC should be getting ready to meet the requirements of the EU Biocidal Products Regulation.
An approval date of 1st November 2022 has been set for both ADBAC/BKC (Alkyl (C12-16) dimethylbenzyl ammonium chloride, or benzalkonium chloride) and DDAC (Didecylmethyl-ammonium chloride) for product types 3 and 4 (biocidal products for use in veterinary hygiene and in disinfecting food and feed areas). This means that products containing these active substances can remain on the market in the EU after that date only if an application for product authorisation is submitted to ECHA by then.
Moreover, the approval of ADBAC/BKC and DDAC for product types 1 and 2 (biocidal products for use in human hygiene and disinfectants not intended for direct application to humans and animals) is expected next year. The Biocidal Products Committee of ECHA will be discussing the substances at its November 2021 meeting, which will be followed a few months later by the final Opinion and then a Commission Implementing Regulation that sets the approval date.
Therefore, anyone producing disinfectants containing ADBAC/BKC or DDAC for use as product types 1 to 4 in any EU Member State should be actively preparing their applications for biocidal product authorisation.
The application requires the preparation of a dossier that includes studies of the physical-chemical properties, storage stability and efficacy of the product, as well as assessments of the risk for human health and the environment. The active substance must be sourced from a supplier on the Article 95 list, and technical equivalence to the reference source must be shown; the applicant will also need a letter of access to data on the active substance.
The applicant can choose which Member State they want to evaluate their application, but it is important to check Member State availability beforehand, especially if the application involves a biocidal product family.
Note that products for sale in Northern Ireland must meet the requirements of the EU BPR, whereas for the rest of the UK the appropriate regulation is the GB BPR, under which approval dates for these substances have not yet been set.
Kerona Scientific can assist with all aspects of dossier preparation (including risk assessment) from the commissioning of studies to the final submission. Contact our team at +353 (0)1 8495 284 or firstname.lastname@example.org.