Ethanol: Get prepared for BPR product authorisations
June 20, 2025
The use of ethanol (CAS No 64-17-5) as a biocidal active substance in disinfectant products is commonplace in the EU. A recent public consultation by ECHA was held on a proposal to classify ethanol as a Category 1 carcinogen and reproductive toxicant. This CLP classification is worse than previously anticipated and, if adopted, will have wide-reaching impact for biocidal products, especially in the FMCG sector.
If your biocidal products contain ethanol as an active substance, or as a co-formulant, planning ahead for your product authorisation applications is more important than ever.
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 proposed a more stringent hazard classification for ethanol, including Category 2 reproductive toxicity (H361d), effects on or via lactation (H362), and STOT SE 3 (H336) and STOT RE 2 (H373).
However, the recent ECHA public consultation identified a proposal from the BPR Working Group on toxicology to classify the substance as a Category 1 carcinogen and Category 1 reproductive toxicant, with a decision pending on classification as a Category 1 mutagen.
If these proposed hazard classifications are adopted, approval of the substance for Product Types 1, 2 and 4 is jeopardised as the substance will meet the BPR exclusion criteria. Meeting the exclusion criteria means that the substance can only be approved if it can be shown that non-approval is essential to control serious danger to human health, or the environment, or that non-approval would have a disproportionate negative impact on society. Industry representatives continue to lobby for reconsideration of these classifications, the lack of technically feasible alternatives, and on the socio-economic impacts of non-approval of ethanol.
If ethanol is approved for use as an active substance under BPR with the aforementioned CLP classifications, there will be wide-reaching impacts on biocidal products that contain ethanol, and biocidal products that use ethanol as a co-formulant due to its unique volatility and solvency properties. Article 19(4) of BPR legislates that products classified as a Category 1 carcinogen, mutagen, or reproductive toxicant shall not be made available for use by the general public. As such, the FMCG sector will be significantly impacted, not just for PTs 1, 2 and 4, but also for insecticides and repellents in PTs 18 and 19.
By implementing Article 19(5) of BPR EU Member States can consider product authorisation for use by the general public, if it deems that not authorising would have a disproportionate negative impact to society. However, Member States may not agree on approaches, with the consequence that the product is authorised in some Member States but not others, or that conditions of authorisation for a product are significantly different across the EU. National policies may also come into play. For example, the German Maternity Protection Act (Mutterschutzgesetz, MuSchG) places restrictions on the use of products classified as toxic to reproduction.
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. The recent ECHA public consultation indicates progress is being made towards an Opinion and could potentially arrive later 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 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.
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:
- Strategic advice for FMCGs containing ethanol, either as an active substance or as a co-formulant
- Impact assessment of proposed ethanol classification to your product portfolio
- 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: National registrations, 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]
