Quats: have you decided on your label claim strategy for disinfectants?
Two very commonly used quaternary ammonium compounds (QAC or quats) are currently progressing through the Biocidal Products Regulation (BPR) review programme – DDAC (Didecyldimethylammonium chloride) CAS No 7173-51-5 and ADBAC/BKC (Alkyl (C12- 16) dimethylbenzyl ammonium chloride) CAS No 68424-85-1. If you have any quat-based disinfectants in your portfolio, now is the time to start planning your Data Gap Analysis and label claim strategy to ensure sufficient time for efficacy testing.
Cleaning and disinfection claims
Because of their widespread use in fabric softeners, antistatic agents, disinfectants, detergents and cosmetics, companies have been making a variety of claims for products containing quats.
For biocidal products, claims range from destroying or preventing the development of microbials on surfaces or corpses, to algaecides for water treatment or preservation of construction materials.
In addition to their biocidal properties, quats are cationic surfactants allowing products to claim single step cleaning and disinfection, provided biocidal efficacy is demonstrated under dirty test conditions. It should be noted that making ‘cleaning’ claims means the product will also need to comply with the Detergent Regulation (EC) No 648/2004.
In the USA, some residual activity claims are allowed, however 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 and will be difficult to demonstrate in the absence of an agreed validated test method.
Why use 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.
In the past, increasing amounts of quaternary ammonium residues, mainly benzalkonium chloride and DDAC, have been detected in and on food, leading to a proposed default threshold value which is valid until a specific maximum residue limit (MRL) has been reached. This is why the verification of MRLs and the inclusion of appropriate risk mitigation measures to ensure that these levels are not exceeded is a requirement of the 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 disinfectant use
The product type determines the deadline for submitting product authorisation applications.
Veterinary hygiene use (PT3) / food and feed area use (PT4)
According to Implementing Regulations (EU) No 2021/1063 and 2021/1045 of June 2021, DDAC and ADBAC/BKC will be approved on 1 November 2022 under the Biocidal Products Regulation (EU) No 528/2012 for use in Product Type (PT) 3 and 4. This will also be the deadline for submitting EU product authorisation applications to keep existing disinfectants on the market.
Human hygiene use (PT1) / surface disinfection use (PT2)
In December last year, the Biocidal Products Committee gave a positive opinion for the approval of DDAC and ADBAC/BKC for use in PTs 1 and 2. December 2023 is therefore the expected approval date for these active substances. However, it is important to note that Finland, Germany and Sweden submitted minority opinions against the approval of ADBAC/BKC in PT2 because of identified unacceptable risk for soil in the environmental risk assessment.
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 December 2023.
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:
- Reviewing the classification of your products
- Building your Biocidal Product Family to group the products from your portfolio
- Undertaking a Data Gap Analysis (DGA) to identify the studies required to complete your registration dossier
- Changing your products’ composition to meet efficacy requirements depending on claims and latest guidance
- 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]
