New quat/product type combination approved: start work on your BPR dossier
March 7, 2024
The commonly used quat ADBAC/BKC (Alkyl (C12-C16) dimethylbenzyl ammonium chloride) CAS No 68424-85-1 will be approved for surface disinfection use (Product Type 2) in the EU on 1 July 2025. Now is the time to start thinking about the strategy for your BPR dossier.
While authorities are increasingly experienced in the evaluation of PT2 products, guidance and requirements have been refined and what was done in the past no longer strictly applies. Not only will registrants need to consider new rules when developing an efficacy testing strategy, they will also need to determine whether application rates need to be adjusted in order to pass the environmental risk assessment, as well as submit SPCs via IUCLID.
Efficacy to support label claims – new rules
If you submitted a disinfectant dossier before December 2023, you may need to consider some new restrictions for use instructions for ADBAC/BKC (C12-C16).
In December 2023, the Technical Agreements for Biocides (TAB) for efficacy were updated for disinfectants PTs 1 to 5, and include three important rules.
- For mandatory target organisms (e.g., bacteria and yeast for use in healthcare) within the same use, the same use concentration and contact time should now be claimed.
- For optional target organisms within the same use, the product cannot claim shorter contact times and/or lower use concentrations than the ones claimed for basic mandatory organisms.
- For optional additional target organisms within the same use, for example fungi or bacterial spores subject to rule 2, the use directions could include a higher in-use concentration or longer contact times than the ones claimed for basic mandatory organisms.
However, as a general rule, it is preferred that the claimed contact time or use concentration is the same for mandatory and optional target organisms in order to avoid confusion.
It is important to consider these new rules when developing the efficacy testing strategy for a biocidal product family where testing should aim to cover all product label claims (target organisms, use conditions and contact times) across the whole family.
New SPC format
A very recent change has occurred in relation to the preparation of the Summary of Product Characteristics (SPC) for biocidal product dossiers. ECHA’s SPC Editor tool is no longer in use and the preparation of SPCs has instead been transitioned to IUCLID. However, this will not change the content of SPCs for which the use of harmonised terms and sentences is recommended when applicable.
Environmental risk assessment
ADBAC/BKC (C12-C16) is an active substance found in biocidal products with different uses such as hard surface disinfection in industrial, professional, and domestic settings, and algaecidal surface treatment (e.g., roofs, patios). ADBAC/BKC (C12-C16) can be used on its own, or in combination with other quats such as DDAC (CAS No 7173-51-5).
While the delay in the approval of ADBAC/BKC (C12-C16) for PT2 was due to problematic risk assessments for the soil compartment, outdoor uses may also need more scrutiny and risk mitigation measures proposed in order to pass the risk assessment.
For indoor uses, the application rate may need adjusting to pass some scenarios for concentrates applied at different dilutions. This will also have an impact on the efficacy testing strategy.
How TSG can help
Our team of consultants has many years’ experience assisting clients in navigating the BPR from active substance approval applications to gaining product authorisations across Europe for a wide range of products and use areas, with very recent experience of DDAC-based disinfectants.
We can help you with:
- Building your Biocidal Product Family
- Defining the efficacy studies needed to support products’ claims
- Complying with other regulations/requirements: Classification, Labelling, Packaging No 1272/2008, Detergent Regulation (EC) No 648/2004, EU Poison Centre Notification
- Preparing and submitting your product authorisation dossier
- Verifying MRLs with our pesticides specialists or assisting with food issues through our sister company Leatherhead Food Research
For support in any of these areas, please contact us at [email protected]
Follow the link to learn more about our EU biocidal products regulatory services
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