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.
Demonstrating efficacy
In addition to their biocidal properties, quats are cationic surfactants allowing products to clean and disinfect in a single step. To support such a use claim, efficacy must be demonstrated under dirty (rather than clean) test conditions.
Further, while some residual activity claims are allowed in the US, existing standard tests in the EU can only demonstrate efficacy after a short period of time. Proving efficacy beyond the initial application time – ranging from several days, weeks to months or even years – means considering abrasions from contact or repeated touching, environmental conditions and cycles of exposure to other cleaning products/chemicals. All of these criteria will be difficult to demonstrate in the absence of an agreed validated test method.
Quats in disinfectants
Quats are used by industry, professionals and the general public in biocidal products including disinfectants for surfaces and human hygiene. Quats disrupt the bacterial or yeast cell walls, or the viral envelope – the outermost layer of many types of viruses – leading to their destruction; this allows biocidal claims against bacteria, yeast, fungi and enveloped viruses. In the COVID-19 pandemic context, quats, along with alcohol-based disinfectants, have been important in fighting the SARS-CoV-2 virus.
Residues
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
The product type determines the deadline for submitting product authorisation applications.
Veterinary hygiene use (PT3) / food and feed area use (PT4)
DDAC and ADBAC/BKC were approved on 1 November 2022 under the Biocidal Products Regulation (EU) No 528/2012 for use in Product Type (PT) 3 and 4 (Implementing Regulations (EU) No 2021/1063 and 2021/1045).
Human hygiene use (PT1) / surface disinfection use (PT2)
For DDAC, the EU approval date for use in PTs 1 and 2 has been set for 1 February 2024 (Implementing Regulation (EU) No 2022/1991). A draft proposed date for ADBAC/BKC is 1 July 2024 for PT1, while the date for PT2 is still pending and could be delayed by several months. While the different dates may impact your product family dossier, if your product contains both actives it’s important not to wait for the EU Commission Implementing Decisions to start working on your BPR dossier.
If a biocidal product is used in different PTs with different approval dates, for example PTs 2 and 4, the application needs to be submitted before the deadline of the last PT approved, for example before 1 February 2024 for DDAC based products.
For Great Britain (England, Scotland and Wales), a date has not yet been set for approval of either DDAC or ADBAC/BKC for disinfection use under the GB BPR. Northern Ireland falls under the EU BPR.
Quats in disinfectants
- DDAC (Didecyldimethylammonium chloride) CAS No 7173-51-5
- ADBAC/BKC (Alkyl (C12- 16) dimethylbenzyl ammonium chloride) CAS No 68424-85-1
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]
