ADBAC/BKC and DDAC: preparing MA dossiers before their approval
To get the answers to all your questions on the approval of ADBAC/BKC (Alkyl dimethylbenzyl ammonium chloride) and DDAC (Didecyldimethylammonium chloride) do not hesitate to register for our webinar on the issue which will take place on 10th November!
In October 2020, the Biocidal Products Committee (Biocidal Product Committee, or BPC) ruled in favour of approving these two active substances used in disinfectants.
The approval date for ADBAC/BKC and DDAC has been set for 1 November 2022 for product types (PT) 3 and 4. For PT 1 and 2, it is expected for the year 2023.
ADBAC/BKC (alkyldimethylbenzylammonium chloride) and DDAC (didecyldimethylammonium chloride) have been recommended for the following product types:
- PT 1: Disinfectant for human hygiene, e.g. wipes
- PT 2: Disinfectants and algaecidal products not intended for direct application to humans or animals, e.g. products used to disinfect the air
- PT 3: Veterinary hygiene, e.g. disinfectants and personal hygiene products
- PT 4: Food and feed area, e.g. products used to disinfect equipment, containers, consumption utensils, surfaces or pipes used for production, etc.
Before the approval date set by the Commission, you will need to complete a Marketing Authorisation (MA) dossier to be able to continue marketing your products containing these substances. To do so, different strategies are possible and allow you to optimise your costs by joining forces with other companies in the sector. We explain below the options available to you for this optimisation.
The Biocides Alliance and pre-consortium: pooling the costs of your biocides dossiers
EcoMundo brings together, through the Biocides Alliance, the stakeholders concerned by the active substances ADBAC/BKC and DDAC. The Alliance is a space designed to exchange on Marketing Authorisation (MA) strategies on a substance-by-substance basis.
In addition, EcoMundo is also in the pre-consortia phase for these substances, as many companies may be interested in setting up consortia for their marketing authorisation dossiers.
Joining a biocide consortium allows several people to submit a marketing authorisation application. By doing so, you will be able to:
- reduce the costs of fees to the competent authorities
- optimising test costs
- share the technical and regulatory work on the dossier
It is therefore a solution that can be particularly interesting. In order to succeed in implementing it, it is important to start early enough! Please feel free to express your interest in our ADBAC/ BKC and DDAC consortium and/or ask any questions you may have on the subject, via this form.
- if your product is TP 3 and/or TP 4, you have until the end of November 2021 to submit your application
- if your product is TP 1 and/or TP 2, you have until April 2022 to submit your application