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Pharma Deutschland warns against reclassification of ethanol

In the course of the evaluation of ethanol as a biocidal active substance, Greece is currently examining the classification of ethanol as a CMR substance. The associations of the German healthcare industry are looking with great concern at ECHA’s classification procedure.

Ethanol is used in particular in disinfectants and in the manufacture of medical products and medicines. It is indispensable in the healthcare sector as its antimicrobial properties are effective against bacteria and viruses. During the pandemic, ethanol-based disinfectants ensured that chains of infection were broken.

We, ACA-pharma concept GmbH, support the associations of the German healthcare industry and are participating in the ECHA’s call for consultation.

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Consultation: Ethanol as a biocidal active substance

In March 2024, Greece submitted a draft assessment report for ethanol in product groups 1, 2 and 4. This is currently being reviewed by other competent authorities in the EU and Switzerland. A decision on whether ethanol will be approved as a biocidal active substance is expected in the second half of 2025.

Part of the evaluation is also the classification of ethanol according to the CLP Regulation (EC No. 1272/2008). Ethanol is currently harmonized classified as Flammable liquid 2 (Flam. Liq. 2, H 225) according to the CLP regulation. Greece has announced to review the harmonized classification of ethanol and proposes a classification as a carcinogen (category 1A or 1B) and/or toxic for reproduction (category 1A or 1B). This is based on entries from the ECHA classification and labelling inventory. If these properties are confirmed, ethanol may not be used as an active biocidal substance.

On February 25, 2025, the consultation with the ECHA started in order to find possible alternatives for ethanol in biocidal products of PT 1, 2 and 4.

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