Will the EU Ban Hand Sanitizer Ingredient? Ethanol Faces Cancer Risk Review

EU considers reclassifying ethanol, a hand sanitizer ingredient, as potentially carcinogenic; decision pending.
A person dispenses blue hand sanitizer from a pump bottle into their cupped hand to practice good hygiene. A person dispenses blue hand sanitizer from a pump bottle into their cupped hand to practice good hygiene.
A person uses a pump bottle to apply blue hand sanitizer to their hands for cleanliness. By MDL.

Executive Summary

  • The European Union is evaluating a potential reclassification of ethanol, a key hand sanitiser ingredient, as a dangerous substance with links to increased cancer risk and pregnancy complications, based on an ECHA internal recommendation.
  • The ECHA’s Biocidal Products Committee will discuss this recommendation in late November, with the European Commission making the final decision, potentially recommending substitution if ethanol is deemed carcinogenic.
  • While the EU reviews its classification, the World Health Organization currently considers ethanol safe for hand hygiene, highlighting a divergence that could lead to significant implications for manufacturers and consumers if reclassified by the EU.
  • The Story So Far

  • The European Union is currently evaluating a potential reclassification of ethanol, a key ingredient in many hand sanitisers, as a dangerous substance following an internal October 10 recommendation from a European Chemicals Agency (ECHA) working group. This recommendation flagged ethanol as potentially toxic and linked to increased cancer risk and pregnancy complications, prompting the ECHA’s Biocidal Products Committee to further discuss its implications and potentially recommend its substitution in products, despite the World Health Organization currently classifying it as safe.
  • Why This Matters

  • Should the EU reclassify ethanol as a dangerous substance, particularly if linked to cancer, it would significantly impact manufacturers by potentially requiring its substitution in products like hand sanitisers, leading to changes in product formulation and availability for consumers across the European market, while also highlighting the EU’s stringent approach to chemical safety that diverges from some global standards like the WHO.
  • Who Thinks What?

  • A working group within the European Chemicals Agency (ECHA) has issued an internal recommendation flagging ethanol as potentially toxic and associated with increased cancer risk and pregnancy complications.
  • The ECHA, as an institution, indicates that ethanol might still be approved for its intended biocidal uses if exposure levels are deemed safe or viable alternatives are not found, stressing that no definitive decision has yet been reached.
  • The World Health Organization (WHO) currently classifies both ethanol and isopropanol as safe for use in hand hygiene products.
  • The European Union is evaluating a potential reclassification of ethanol, a key ingredient in many hand sanitisers, as a dangerous substance with links to increased cancer risk. This consideration follows an internal recommendation issued on October 10 by a working group within the European Chemicals Agency (ECHA), which flagged the substance as potentially toxic and associated with pregnancy complications.

    EU Regulatory Review

    The ECHA’s Biocidal Products Committee is scheduled to convene between November 25 and November 28 to further discuss the implications of this recommendation. Should the expert committee conclude that ethanol is carcinogenic, it would recommend its substitution in cleaning and other products.

    The final decision regarding ethanol’s classification would ultimately rest with the European Commission. This process highlights the EU’s stringent approach to chemical safety and public health.

    ECHA’s Stance and Global Context

    Despite the internal recommendation, the ECHA indicated that ethanol might still be approved for its intended biocidal uses. This approval would hinge on whether exposure levels are deemed safe or if viable alternatives are not found, emphasizing that no definitive decision has yet been reached.

    In contrast to the ECHA’s ongoing review, the World Health Organization (WHO) currently classifies both ethanol and isopropanol as safe for use in hand hygiene products. This divergence in assessment underscores the complex scientific and regulatory considerations involved in chemical classifications.

    Outlook

    The upcoming ECHA committee meeting will be a critical step in determining the future regulatory status of ethanol within the EU. Any reclassification could have significant implications for manufacturers and consumers of products, particularly hand sanitisers, across the European market, balancing public health concerns with practical applications.

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