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, as Sagentia Regulatory explains.
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.
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.
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