Ethanol: Get prepared for BPR product authorisations
September 25, 2024
The use of ethanol (CAS No 64-17-5) as a biocidal active substance in disinfectant products is commonplace in the EU. Ethanol for Product Types 1, 2 and 4 is going to be discussed during the November Biocidal Product Committee meeting and it is understood that the approval process is nearing completion. The potential for a restrictive CLP classification and predictions of a short submission deadline mean that planning ahead for your product authorisation applications is more important than ever.
Application timelines and preparation
The publication of the Biocidal Product Committee (BPC) opinion on the approval of ethanol as a biocidal active substance for Product Types (PTs) 1 (human hygiene), 2 (hard surface disinfection) and 4 (food contact hard surface disinfection) has been pending for several years. However, it is understood that finalisation of this opinion should be available by the end of this year. The subsequent deadline for submission of product authorisation applications, to be set by the EU Commission Approval Decision, could be as short as 12 months.
Confirmation of the date of approval will therefore create pressure to prepare the authorisation dossier. Availability of contract laboratories to carry out testing is at a premium and will likely only get more restricted once ethanol is formally approved. Consequently, TSG recommends an early start in your preparations for product authorisation applications, whether that is for a single product or complex product families.
BPR efficacy testing
In December 2023, the Technical Agreements for Biocides (TAB) for efficacy were updated for disinfectants PTs 1 to 5 with 3 important rules:
- For mandatory target organisms (e.g., bacteria and yeast) 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 target organisms within the same use, subject to rule 2, the product will get higher use-concentrations or longer contact times than the ones claimed for basic mandatory organisms, if data identify this is necessary to meet relevant criteria.
However, as a general rule, it is preferrable that the claimed contact time and use concentration is the same for mandatory and optional target organisms in order to avoid user confusion.
It is important to consider these new rules when optimising the efficacy testing strategy for a biocidal product family where testing should aim to cover all product label claims (targets and use conditions) across the whole family.
Proposed amendment to the harmonised classification of ethanol
Ethanol is currently included in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) with a harmonised classification as Flammable Liquid, Category 2 (H225). The Competent Authority evaluating ethanol under BPR (EU) No 528/2012 is proposing a more stringent hazard classification for ethanol, as follows:
- Flammable Liquid 2 (H225)
- Eye Irritant 2 (H319)
- Reproductive toxicity 2 (H361d)
- Effects on or via lactation (H362)
- STOT SE 3 (H336)
- STOT RE 2 (H373)
If this proposed hazard classification is adopted, it will impact the labelling of ethanol-based disinfectants in scope of PTs 1, 2, and 4 which may lead to reduced acceptance of ethanol-based products by certain end-user groups (e.g., healthcare settings and the general public) particularly for products applied directly to skin (PT 1). At a national level, the new classification may potentially result in limitations to the use of ethanol-based products. For example, the German Maternity Protection Act (Mutterschutzgesetz, MuSchG) places restrictions on the use of products classified as toxic to reproduction.
How TSG can help
With success in gaining product authorisation for our clients’ alcohol-based disinfectants, TSG is ideally positioned to work with you and support your business’s ethanol-based biocidal product needs. We can help you with:
- Checking the classification of your products
- Building Biocidal Product Families
- Defining the efficacy studies needed to support your product’s claims
- Complying with other regulations/requirements: Detergents Regulation, Harmonised Poison Centre Notifications
- Preparing and submitting your product authorisation dossiers, including production of detailed risk assessments of human health and environmental exposure
To learn more about our EU biocide regulatory consulting services, please contact us at [email protected]
