The BPC (Biocidal Products Committee) 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; and
- 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. BPC did not reach a conclusion on the carcinogenic or reproductive properties of ethanol. As a result, no new hazard classification has been proposed.
According to the BPC, the following factors prevented a clear hazard conclusion:
- 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.
- 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, and the BPC believes these must be considered before determining carcinogenic or reprotoxic properties. However, waiting for these studies to become available could significantly delay the approval process.
