The European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC) has concluded that ethanol may be approved for use in hand and general disinfectants. The Committee did not take a position on whether ethanol should be considered a carcinogenic or reprotoxic substance.
Under the Biocidal Products Regulation, all active substances used in biocidal products must be approved before those products can be authorised.
The BPC provides science-based opinions on these substances to evaluate their safety and effectiveness.
BPC approves ethanol as an active substance
In its February meeting, the BPC adopted its opinions supporting the approval of ethanol as an 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 BPC considered that safe use has been demonstrated for all uses in these product types.
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.
According to the BPC, the following factors prevented a clear hazard conclusion.
The applicant’s dossier, although considered complete, lacked data on dermal exposure, a key route of exposure for biocidal products.
The available inhalation data have not been obtained 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 BPC did not consider an appropriate basis for decisions in the context of these biocidal uses.
Furthermore, 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.
Next steps
Following the BPC adoption, ECHA will send the opinion to the European Commission for decision-making. The Commission prepares a draft Implementing Regulation proposing either approval or non-approval of the substance.
This draft is submitted to EU Member States for a vote in the Standing Committee on Biocidal Products. If supported, the Commission formally adopts the decision, and it becomes legally binding.
If approved, biocidal products containing ethanol may be authorised under the Biocidal Product Regulation. Companies will have to apply for product authorisation at the national level or through Union authorisation.
If not approved, products containing the substance must be withdrawn from the EU market within the applicable transition periods.
