
Biocidal Products Regulation
Intro
The
reclassification of ethanol could have far-reaching consequences.
SK – 05/2025
The ECHA (European Chemicals Agency) is
currently reviewing ethanol, which is an approved active substance that is also
used in disinfectants, preservatives and solvents. When used correctly,
activities involving ethanol are currently considered safe under the workplace
health and safety regulations. However, a possible reclassification could
result in usage restrictions with far-reaching consequences for many sectors.
Reasons for the reclassification
The EU’s Biocidal Products Regulation also
covers how products that are used to combat bacteria, fungi, insects or pests
are placed on the market and used. Due to a legal amendment implemented in
2012, all of the active substances that were launched in the European market
before 2013 must be reassessed. Ethanol is also subject to this reassessment.
This involves testing whether the substance is classified as potentially
carcinogenic, mutagenic or reprotoxic.
Three types of biocidal products containing
ethanol are being studied:
- hygiene products used by
humans, such as hand sanitisers;
- disinfectants and algaecides
not intended for direct application to humans or animals;
- products used in food and
animal feed.
Reclassification effects
The ECHA's pending decision is considered
ground-breaking as it could affect the future use of ethanol in disinfectants
and other biocidal products. Few alternatives exist, so numerous professional
associations, such as the German Society for General and Hospital Hygiene, warn
of the potential consequences of giving up on ethanol.
Ethanol is essential, especially in hand
sanitisers. It is considerably more effective against specific viruses, such as
adenoviruses, human enteroviruses or the polio virus than other alcohols (e.g.
propanol). This is why the World Health Organization counts ethanol as an
essential medicine. Restricting its use or even banning it could have
far-reaching consequences when it comes to controlling infections in hospitals
and other facilities.
ECHA’s assessment
ECHA collected feedback about alternatives
to ethanol until April. DSV also participated.
However, the collected input will not be incorporated in the Agency's decision, but it might play an important role in subsequent
decisions that the EU Member States will have to make. Together with the
European Commission, they will have to decide - based on the ECHA assessments -
whether biocidal products containing ethanol may still be approved. However,
the ECHA must first complete its assessment of reclassification before this can
happen.