These days, anyone who deals with disinfectants cannot help but look with fear at the outcome of the public consultation on Ethanol.
The consultation, which began on 25th February 2025, will end the 28th April 2025.
Historical Background
In October 2024, the BPC Working Groups concluded that ethanol meets the exclusion criteria for carcinogenicity and reproductive toxicity but has not yet reached a decision on mutagenicity. Additionally, the classification of ethanol under category 1A or 1B for carcinogenicity and reprotoxicity remains unresolved, with further discussions planned. Because of these regulatory developments, the evaluating Competent Authority (Greece) and ECHA requested the Applicant to conduct an Analysis of Alternatives (AoA) as ethanol is now regarded as a candidate for substitution (CfS) according to Article 10(1) to determine if viable substitutes exist for ethanol in PT1, 2 and 4 applications:
- 5(1)(a): criteria to be classified as carcinogen category 1A or 1B
- 5(1)(c): criteria to be classified as toxic for reproduction category 1A or 1B
- Under discussion and not yet concluded: 5(1)(b): criteria to be classified as, mutagen category 1A or 1B
Ethanol in Biocides
As all formulators know, ethanol is essential not only for its strong disinfectant action, but also for being the most used solvent in the formulation of all product categories.
The property of ethanol is in fact unique: non-soluble in water active ingredients dissolve easily and are extremely stable during the shelf life and as soon as the product is applied to a surface the solvent evaporates, and only the benefits of the active ingredient remain. This characteristic leads the substance to be used widely, and at concentrations higher than those that usually lead to the classification of mixtures as carcinogenic (0.1% for categories 1A and 1B) or toxic for reproduction (6% for category 1A and 0.3% for category 1B).
Ethanol is commonly present in the formulation of all those products that are usually sold to non-consumer user and that require rapid evaporation of the solvent after application, such as skin repellents (PT19), ready-to-use insecticides (PT18) or perfumes (contained in most of consumer products).
What Regulation states:
Regulation 528/2012 is clear: a biocidal product cannot be authorised for use by the general public if meets the criteria set out in regulation 1272/2008 to be classified as:
— carcinogen category 1A or 1B
— mutagen category 1A or 1B, or
— toxic for reproduction category 1A or 1B
without taking in account the risk assessment.
What will happen in the future
Once approved (or not…) as a biocide in PT 1, 2 and 4 following re-classifications, the active substance will be fully included in the evaluation of all PTs as a SoC (Substance of Concern). Furthermore, even if we all hope that trigger values will be set for the carcinogenic and reprotoxic categories higher than those currently provided by default in the CLP regulation, it will necessarily lead to a re-evaluation of a big quantity of products sold today on the consumer market.
