REGULATION 43
is more, a change in the classification of any ingredient under the BPR would trigger updates to existing product authorisations, bringing additional costs and potential loss of market access.
Non-biocidal products Fragrances, perfumes, and other personal care formulations containing ethanol typically use it as a solvent or a carrier. Where ethanol is not used for biocidal purposes, it will only be subject to classification assigned under the CLP, not the BPR. There are cases where CMR-classified
ingredients have been allowed for use in cosmetic products following toxicology assessment by the Scientific Committee on Consumer Safety (SCCS). For example, titanium dioxide is classified as
Carcinogen Category 2 by inhalation under the CLP. However, a positive SCCS assessment saw it allowed in cosmetic products under certain restrictions, with the Annexes of the EU Cosmetics Regulation amended accordingly. Similarly, tea tree oil is undergoing assessment
for cosmetic safety and hazard classification, but a recent SCCS opinion states that it is safe in cosmetic products under certain restrictions. If the substance is assigned a CMR classification, its use will still be allowed in cosmetic products once the Annexes of the EU Cosmetics Regulation are amended to include the restrictions. The CLP and Cosmetics Regulations form the primary regulatory framework for cosmetic
products and fragrances. Nevertheless, these products are not entirely shielded from regulatory changes that may follow if ethanol is assigned CMR status under the BPR. Any future decisions on ethanol’s classification
could influence downstream requirements under related obligations, such as those for transport, storage, or workplace safety. Even small changes in these areas can have significant operational and commercial implications. The potential impact on consumer attitudes to
personal care products containing ethanol should not be underestimated either. At this stage, close monitoring of the regulatory
situation represents a proportionate response for non-biocidal products. This includes following developments in hazard classification discussions, understanding how they may be reflected in guidance, and assessing whether any changes could affect existing compliance strategies. Tracking progress empowers manufacturers to
engage R&D, regulatory, and supply chain teams early if any changes are needed. For non-biocidal products, regulatory readiness around ethanol is less about immediate action and more about maintaining informed oversight as the regulatory picture continues to evolve.
Fostering a pragmatic response In the wake of the largest pandemic in a century – and given the BPC’s commitment to the protection of human health – it seems unlikely
that fundamental biocidal products like personal hand sanitisers would be taken off market. Yet, if the BPC adopts the Opinion that ethanol
should be classified for CMR properties, market access and regulatory obligations will change for some product types. So, it is advisable to understand which
personal care products sold in the EU contain ethanol and where future regulatory developments could have the greatest impact. This typically starts with mapping product lines, distinguishing between those where ethanol is used as a biocidal active substance, where it plays a critical function, and where it supports general performance or sensorial characteristics. For biocidal personal care products such as hand sanitiser gels, sprays, foams, or wipes, a more detailed portfolio review may be justified. This could include an assessment of data availability and potential business implications of future regulatory outcomes. For other product categories, structured regulatory monitoring and horizon scanning may be sufficient. Looking ahead, decisions expected in 2026 are
likely to bring greater clarity rather than sudden disruption. Manufacturers that have maintained oversight of regulatory developments and taken proportionate early steps will be well placed to respond calmly and efficiently if changes are required. Regulatory readiness will enable flexibility and confidence as the picture becomes clear.
PCM
www.personalcaremagazine.com
March 2026 PERSONAL CARE MAGAZINE
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