REGULATION 41
Ethanol in the EU: how to respond to regulation
Samantha Walker, Helena Eixarch - Sagentia Regulatory
Ethanol is widely used in personal care formulations, but its future in the EU is unclear with discussions on regulatory hazard classification ongoing. Decisions expected under the Biocidal Products Regulation (BPR) and the Classification, Labelling, and Packaging (CLP) Regulation this year could influence everything from the placement of products on market to long-term formulation strategy. For the many cosmetic and personal care
products that use ethanol as a co-formulant, this primarily means monitoring developments so timely action can be taken if needed. However, for biocidal personal care products, a change in regulatory status may have more immediate and direct impacts. Hand sanitisers that use ethanol as a biocidal active substance are a prime example, and topical insect repellents that use it as a solvent or evaporation aid also warrant close attention. If ethanol plays a critical functional role in
your products, now may be a good time to review portfolios, identify any potential data gaps, and consider strategic responses to different regulatory outcomes. Across all categories that use ethanol, manufacturers can take sensible, proportionate steps to enhance regulatory readiness while the situation evolves.
The ongoing review of ethanol From a biocidal perspective, ethanol has been under review in the EU for many years. Systematic evaluation of existing biocidal active substances already on market was initiated in the early 2000s, and the review programme has been extended multiple times. The programme now comes under the BPR, with Article 19 outlining transitional measures that allow substances to remain on market while evaluation continues. Ethanol’s use in biocidal products is currently
allowed under these transitional measures. So, ethanol-based products intended for human sanitation purposes – such as hand sprays, gels, foams, or wipes – can be placed on market. EU-wide product authorisation under BPR is not required while ethanol remains under review as an active substance. Instead, manufacturers must comply with the relevant rules of individual Member States where a product is sold. The lengthiness of ethanol’s review is partly
due to a proposal from the EU’s BPR Working Group on toxicology suggesting it should be classified for carcinogenic, mutagenic, or toxic for reproduction (CMR) properties.
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This is significant, because if the Biocidal
Products Committee (BPC) ultimately issues an Opinion that ethanol should be approved as a biocidal active substance with CMR classification, this will inform its approval as an active substance under BPR.
CMR classification results in a de facto ban on the use of a substance in consumer-use biocidal products. That could bring immediate repercussions for ethanol-based hand sanitisers, preventing them from being placed on the EU market. While the reference data underpinning the
BPR Working Group proposal relates to the hazards of oral consumption of ethanol rather than dermal application, it has complicated the review process. It has also resulted in a high level of industry uncertainty, which looks set to continue in the short to medium term at least. On 28 September 2025, the European
Chemicals Agency (ECHA) Human Health Toxicology Working Group recommended that ethanol should be classified as a Category 1A reproductive toxicant and carcinogen. However, in December 2025, the BPC postponed its Opinion on the matter, saying discussions would continue into 2026. In addition to the ongoing evaluation under BPR, ethanol is scheduled for review under the EU’s CLP Regulation in December 2026.
At present, ethanol has a harmonised CLP classification as a highly flammable liquid and vapour, but it is possible that it will be classified as a CMR substance under this regulation. Ultimately, any CLP decision will take
precedence over classification assigned under BPR. So, regardless of any progress – or lack of it – with the biocidal active substance review, the ethanol situation could become much clearer by the end of the year. It is worth noting that if ethanol is classified as a CMR substance under the BPR, it will likely trigger a domino effect across categories that use ethanol in non-biocidal applications (such as cosmetics), most likely driven by consumer opinion and preference. If ethanol is classified as a CMR substance under CLP, cosmetic products will be directly affected by regulatory measures.
What can ethanol-based hand sanitiser manufacturers do? The appropriate level of action in the near term varies across product categories. For ethanol- based hand sanitiser manufacturers, it may be prudent to take early action. We recommend the following steps.
1. Evaluate your product portfolio Start by mapping all hand sanitiser products that contain ethanol. Record key details such as
March 2026 PERSONAL CARE MAGAZINE
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