DEKRA: Active substance approval in accordance with BPR announced

New Requirements for the Distributors of Ethanol-based Disinfectants

Oct 22, 2026

In the future, the EU Commission will approve ethanol as an active substance in accordance with the Biocidal Products Regulation (Regulation (EU) No 528/2012). Publication of the implementing regulation is planned for February 2027. At present, ethanol-based disinfectants are still permitted in line with national transitional provisions. However, this option will expire when the approval requirement in accordance with the Biocidal Products Regulation comes into force on May 1, 2028. DEKRA’s chemical experts advise that the distributors of ethanol-based disinfectants should apply for authorization of their products before this deadline to ensure uninterrupted marketability.

On September 24, 2026, the EU Commission informed the World Trade Organization of the pending approval of ethanol as a biocidal active substance. In the opinion of DEKRA’s experts, this is a sure signal that the corresponding regulation will be enacted in this form. According to the regulation, this approval will come into force on May 1, 2028. This date is of great significance for all companies that currently market ethanol-based disinfectants because national transition provisions will gradually expire:

Up to 180 days after active substance approval: The product may still be made available on the market.
Up to 365 days after active substance approval: Existing stocks may still be used.
Thereafter, the product may no longer be marketed or used on a regular basis without authorization.

If an application for the authorization of an ethanol-based disinfectant is submitted before May 1, 2028, the product may continue to be marketed until a final decision on authorization is taken. However, the application for authorization must include comprehensive data about the safety, effectiveness, and stability of the product. Experience has shown that it can take several months to prepare and submit the application.

DEKRA provides support in compiling the data and preparing the application for authorization using the specified IUCLID format. On the basis of their experience and DEKRA’s partner network, the company’s experts support applicants in all phases of the process through to the granting of authorization.

Further information can be found at: https://www.dekra.de/de/biozidprodukte/