The European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC) has thrown its weight behind ethanol for use in hand and general disinfectants—but stopped short of declaring the alcohol safe from cancer or reproductive risks.
At its February meeting, the BPC “adopted its opinions supporting the approval of ethanol as active substance in the following product-types”:
Product-type 1: Human hygiene products, such as hand disinfectants
Product-type 2: Disinfectants and algaecides not intended for direct contact with humans or animals
Product-type 4: Products used in food and feed areas
“In its opinions, the Committee considered that safe use has been demonstrated for all uses in these product-types,” the report stated. However, “BPC did not reach a conclusion on the carcinogenic or reproductive properties of ethanol. As a result, no new hazard classification has been proposed.”
The committee cited gaps in data and limitations in existing studies. “The applicant’s dossier, although considered complete, lacks data on dermal exposure, a key route of exposure for biocidal products. The available inhalation data has not been performed in accordance with the standard guidelines.”
On cancer and reproductive concerns, the BPC noted, “Most of the evidence relating to the carcinogenic and reproductive properties of ethanol is from voluntary oral consumption of alcoholic beverages, which the Committee did not consider an appropriate basis for decisions in the context of these biocidal uses.”
New studies on more relevant exposure routes are underway. “These must be considered before determining carcinogenic or reprotoxic properties,” the committee said, warning that waiting could “significantly delay the approval process.”
The committee’s opinion now goes to the European Commission, which will draft an Implementing Regulation proposing either approval or non-approval. EU Member States will vote on it in the Standing Committee on Biocidal Products. If approved, companies can apply for product authorisation nationally or at the Union level; if rejected, ethanol-containing products must be withdrawn within transition periods.
Under EU rules, “all active substances used in biocidal products must be approved before those products can be authorised,” ECHA notes. The BPC’s role is to provide “science-based opinions on these substances to evaluate their safety and effectiveness.”
