Update on ethanol classification and biocides processes

Biocide Process
 
The Greek competent authority report (CAR) regarding the approval of Ethanol as active substance according to BPR has now been published on the ECHA website. Link: Information on biocides
 
Regarding the carcinogenic and reproductive toxicity of ethanol as an active substance, it is noted that no conclusion can be made.
 
However, reference is made to the upcoming CLH process and the assessment by the RAC.
 
Unfortunately, the CAR mentions a classification as a CMR (based on human data from oral consumption of alcoholic beverages) for the relevant biocidal product authorisations, which leaves considerable scope for national interpretation.
 
It remains unclear what the wording of the Commission implementing regulation will be.
 
We are continuing to work to ensure that the Commission and the Member States adopt a clear and workable implementing regulation. We expect a final decision in the first quarter of 2027.

 
CLH process
 
Furthermore, there is a risk that the CLH dossier will be submitted to ECHA by Greece at the end of this year. Link: Registry of CLH intentions until outcome | ECHA
 
Once this happens, the RAC will discuss a new harmonised classification for ethanol. Given the current legal and data situation, a classification as a Category 1A CMR is likely.
 
Further data is currently being generated and evaluated in Greece regarding inhalation and dermal exposure.
 
We are therefore working with the Greek ethanol associations to seek a postponement of the process.
 
In parallel, we are currently engaged with the European associations that are downstream users of ethanol about ways out of the C&L process.
 
The Ethanol REACH Association as Consortium will continue to support the classification process financially, technically, and scientifically.
 
A scientific expert discussion to find potential data gaps and to find arguments to avoid a C&L of CMR is being organised.