Quats: have you started working on your BPR dossier?
Companies placing DDAC-based disinfectants (covering human hygiene (PT1) and/or surface disinfection (PT2) use) on the EU market have less than a year to submit their dossiers for product authorisation under the EU Biocidal Products Regulation (BPR). In addition, for ADBAC/BKC-based products for PT1 use, the deadline to submit the application is 1 July 2024. With testing taking several months to complete, the time is now to start working on the BPR dossier for these quaternary ammonium (QAC or quats) based products.
Building the biocidal product family
Quats have a variety of uses in biocidal products, ranging from hard surface disinfection, to algaecides for water treatment, to remedial treatment of construction materials. While quat-based products can be grouped into product families, it may not be possible to build a unique product family comprising all products in a company’s portfolio. Defining the best family approach, with efficacy testing covering all the products’ label claims in the family (targets and use conditions), is a challenge.
Disinfectants used in food areas are controlled by a range of legislation defining the level of disinfectant that can be taken up by foodstuffs after use. Verification of maximum residue limits (MRLs) and the inclusion of appropriate risk mitigation measures to ensure quat residue levels are not exceeded is a requirement of the BPR authorisation dossier for any biocidal product that may lead to residues in food or feed.
For PT1 (human hygiene) use, a dietary risk assessment may be required if a company cannot rule out that the product may lead to food contamination as a result of its proposed biocidal use.
Different approval deadlines for DDAC and ADBAC/BKC in some PTs
How TSG can help
Whether you'd like to make a biocidal claim, single-step cleaning and disinfection, or need support in verifying MRLs and identifying appropriate risk mitigation measures to ensure limits aren't exceeded, TSG Consulting 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.
In addition, our specialists are familiar with MRLs from their experience with agricultural pesticides where information about the residue level remaining on the crop after treatment is required. Our sister company Leatherhead Food Research can assist with any specific food issues.
We can help you with:
- Building your Biocidal Product Family to group the products from your portfolio
- Defining the efficacy studies needed to support the products’ claims
- Reviewing the classification of your products
- Complying with other regulations/requirements: Classification, Labelling, Packaging No 1272/2008, Detergent Regulation (EC) No 648/2004, Poison Control Notification
- Preparing and submitting your product authorisation dossier
To learn more about our services, please contact us at [email protected]