The European Chemicals Agency has backed the use of ethanol in hand and surface disinfectants but has not concluded whether the substance poses cancer or reproductive risks, Indian Chemial News reported.
During its February meeting, the agency’s Biocidal Products Committee adopted opinions supporting the approval of ethanol as an active substance in several product categories. These include human hygiene products such as hand disinfectants, disinfectants and algaecides not meant for direct contact with people or animals, and products used in food and feed areas.
The committee said it found that safe use had been demonstrated for these applications. However, it did not reach a conclusion on whether ethanol should be classified as carcinogenic or harmful to reproduction. As a result, no new hazard classification has been proposed.
According to the report, the decision was influenced by gaps in available data. While the application file was considered complete, it did not include sufficient information on skin exposure, which is a key route for biocidal products. The committee also noted that available inhalation studies were not carried out in line with standard guidelines.
On concerns about cancer and reproductive effects, the committee said much of the evidence comes from studies related to the voluntary consumption of alcoholic beverages. It said this was not considered an appropriate basis for decisions regarding ethanol’s use in disinfectants.
New studies focusing on more relevant exposure routes are currently under way. The committee said these findings must be reviewed before any final decision is taken on potential cancer or reproductive risks, but warned that waiting for the results could significantly delay the approval process.
The committee’s opinion will now be sent to the European Commission, which will prepare a draft regulation proposing either approval or non-approval. Member states will then vote on the proposal in the Standing Committee on Biocidal Products.
If approved, companies will be able to seek authorisation for ethanol-based products at national or European Union level. If rejected, products containing ethanol would have to be removed from the market within a set transition period.
Under European Union rules, all active substances used in biocidal products must receive approval before the products themselves can be authorised. The Biocidal Products Committee is responsible for providing scientific opinions to assess the safety and effectiveness of such substances.
