42 REGULATION
ethanol concentration, formulation type (liquid, gel, foam), intended BPR product type, claims and target organisms, and shelf life. Note how each product is applied, i.e., by pouring, spraying, pumping, or wiping, and the expected frequency of use. Capturing additional information, such as the number of fragrance or dye variants, and segmenting the portfolio into product families is also a good idea. This gives you a complete picture of how many formulations could be affected by future regulatory change. It also provides a robust framework for analysing costs associated with compliance as well as facilitating portfolio rationalisation.
2. Review efficacy and active substance sourcing Check that all your ethanol suppliers are listed on ECHA’s Article 95 list for the human hygiene product type. This is already mandatory. It confirms that the substance originates from a recognised source compliant with BPR data- sharing requirements, and it will be essential for continued market access. Where necessary, start technical equivalence applications to ensure the specification of your ethanol source is compliant. Efficacy data should also be reviewed to
confirm that it fully supports product claims. Ensure that claimed activity against relevant target organisms, such as bacteria and viruses, can be clearly demonstrated in line with current EU standards. It is also advisable to identify and assess
any additional biocidal active substances or co-formulants that contribute to efficacy in formulations, as their presence requires additional assessment. This is especially true for co-formulants that are designated substances of concern under the BPR.
3. Audit technical documentation and data Maintaining strong technical documentation will enable a smooth transition if the EU approves ethanol under BPR. Ethanol-based hand sanitiser products would have to be authorised at the EU level, and labels and safety data sheets included with product submissions would need to be updated to reflect new requirements. Review existing records for each product
in readiness for this, noting the concentration of ethanol. Check that any studies for physical hazards, such as explosivity, flammability and corrosiveness to metals are complete and up to date. It is also important to revisit any data for
toxicological and ecotoxicological properties – you can contact your suppliers in the interim before the final assessment report is published. Robust, well organised documentation and
data will make it easier to respond to evolving regulatory obligations, or to prepare BPR dossiers if required.
4. Assess packaging and labelling Product packaging and labelling should already be aligned with existing CLP requirements. However, it is worth conducting a review of products’ claims, instructions, and safety guidance. Collating this
PERSONAL CARE MAGAZINE March 2026
information now will make it easier to adapt to any new classification, storage, or hazard communication requirements that emerge. Key information to record includes the
intended use area (indoors, outdoors, or both) and the claimed shelf life for each product. Review pack sizes and packaging materials to ensure they are appropriate for the intended use and compatible with highly flammable formulations. Also verify that product labels and safety data sheets are accurate, consistent, and up to date.
5. Consider portfolio rationalisation It is worth thinking about how hand sanitiser product portfolios might benefit from rationalisation if ethanol becomes more tightly regulated. Product variations – in active inclusion level, uses, packaging type, fragrances, colours, suppliers – all add to the regulatory burden. The workload for a biocidal product family
grows almost exponentially with each new variant, bringing more data to generate, more scenarios to assess, and more points for authorities to scrutinise. What is more, assessors focus on the worst case for efficacy and the worst case for safety, so variants that don’t perform well impact the entire family. Portfolio rationalisation helps identify
which variants add the greatest value, enabling the creation of product families that are both compliant and commercially advantageous. Having fewer variants reduces the risk of setbacks
during regulatory assessment, and ensures resources are focused on products with the strongest overall market potential.
6. Plan for potential substitution or derogation If ethanol is assigned CMR classification, consumer-use hand sanitisers containing it will face a de facto ban. In this situation, manufacturers would need to substitute ethanol with an alternative active substance or remove their products from the EU market. Now is the time to identify which products
would be most affected, and to assess their technical and commercial flexibility. Exploring alternative active ingredients or co-formulants with comparable efficacy and lower regulatory risk is highly recommended. It is also advisable to gather data which could support human health justifications if derogation becomes necessary.
What about topical insect repellents? Many topical insect repellents use ethanol as the solvent base, but not as the biocidal active substance. So, CMR classification of ethanol under the BPR would not automatically lead to these products being classified as CMR. However, harmonised classification as a CMR under the CLP Regulation is still a possibility. It is therefore important for manufacturers to
monitor developments and consider whether it would be prudent to change the solvent. What
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