Ethanol: which biocidal uses are covered by the proposed approval?
On 24 September 2026, the Commission notified the World Trade Organization (WTO) of a draft implementing regulation seeking to approve ethanol for the following product types (PTs):
- PT1: Human hygiene disinfectants;
- PT2: Disinfectants and algaecides not intended for direct application to humans or animals;
- PT4: Disinfectants for food and feed areas.
The WTO notification does not yet constitute final approval
The proposed approval would cover the period from 1 May 2028 to 30 April 2038.
This WTO notification is an important step in the procedure, but does not yet constitute final approval. The draft must still be reviewed and approved by the Member States within the Standing Committee on Biocidal Products (SCBP). The Commission currently plans to adopt the implementing regulation in February 2027. It would enter into force 20 days after its publication in the Official Journal of the European Union.
Ethanol and CMR classification: why the dossier sparked debate
The evaluation of ethanol had prompted significant discussion due to the possibility of classifying the substance as carcinogenic and/or toxic to reproduction.
The BPC ultimately does not support a carcinogenic or reprotoxic classification
The BPC ultimately did not conclude that ethanol should be classified as carcinogenic or toxic to reproduction as part of the evaluation of its biocidal uses. In particular, the Committee considered that the available data, mainly derived from exposure associated with alcoholic beverage consumption, did not provide an appropriate basis for assessing the risks associated with biocidal uses of ethanol, which involve in particular dermal and inhalation exposure.
A position that differs from the conclusions considered in 2024
This position differs from the conclusions reached by the BPC working groups in September 2024, which had considered classifying ethanol as carcinogenic and toxic to reproduction, in Category 1A or 1B.
What would have been the consequences of a CMR classification for ethanol?
The exclusion criteria under Article 5 of the BPR
Such a classification would have had significant regulatory consequences. As a CMR substance meeting the relevant criteria, ethanol could have fallen within the exclusion criteria laid down in Article 5 of the BPR. Its approval would then have been subject to specific conditions and would in particular have required the use of a derogation.
The Commission’s current proposal therefore represents an important development for manufacturers and formulators using ethanol in disinfectant products.
Approval currently envisaged without specific restrictions
The draft currently provides for standard approval, without specific restrictions. Competent authorities evaluating biocidal products containing ethanol will nevertheless need to pay particular attention to exposure, risks and efficacy where the uses concerned are not covered by the active substance assessment.
Anticipate the impact of ethanol approval on your biocidal products
Changes to the regulatory status of ethanol may have direct consequences for your authorisation dossiers, claimed uses and market access strategy.
EcoMundo can support you in:
- analysing the impact of the proposed approval on your PT1, PT2 and PT4 products;
- checking whether your uses are consistent with the active substance approval conditions;
- assessing the consequences for your marketing authorisation dossiers;
- identifying any additional exposure, risk or efficacy data that may be required;
- anticipating upcoming regulatory deadlines and adapting your compliance strategy.
👉 Do you use ethanol in your biocidal products? Our experts can help you assess the impact of this development on your portfolio and authorisations. Contact us!
Ethanol: which biocidal uses are covered by the proposed approval?
On 24 September 2026, the Commission notified the World Trade Organization (WTO) of a draft implementing regulation seeking to approve ethanol for the following product types (PTs):
- PT1: Human hygiene disinfectants;
- PT2: Disinfectants and algaecides not intended for direct application to humans or animals;
- PT4: Disinfectants for food and feed areas.
The WTO notification does not yet constitute final approval
The proposed approval would cover the period from 1 May 2028 to 30 April 2038.
This WTO notification is an important step in the procedure, but does not yet constitute final approval. The draft must still be reviewed and approved by the Member States within the Standing Committee on Biocidal Products (SCBP). The Commission currently plans to adopt the implementing regulation in February 2027. It would enter into force 20 days after its publication in the Official Journal of the European Union.
Ethanol and CMR classification: why the dossier sparked debate
The evaluation of ethanol had prompted significant discussion due to the possibility of classifying the substance as carcinogenic and/or toxic to reproduction.
The BPC ultimately does not support a carcinogenic or reprotoxic classification
The BPC ultimately did not conclude that ethanol should be classified as carcinogenic or toxic to reproduction as part of the evaluation of its biocidal uses. In particular, the Committee considered that the available data, mainly derived from exposure associated with alcoholic beverage consumption, did not provide an appropriate basis for assessing the risks associated with biocidal uses of ethanol, which involve in particular dermal and inhalation exposure.
A position that differs from the conclusions considered in 2024
This position differs from the conclusions reached by the BPC working groups in September 2024, which had considered classifying ethanol as carcinogenic and toxic to reproduction, in Category 1A or 1B.
What would have been the consequences of a CMR classification for ethanol?
The exclusion criteria under Article 5 of the BPR
Such a classification would have had significant regulatory consequences. As a CMR substance meeting the relevant criteria, ethanol could have fallen within the exclusion criteria laid down in Article 5 of the BPR. Its approval would then have been subject to specific conditions and would in particular have required the use of a derogation.
The Commission’s current proposal therefore represents an important development for manufacturers and formulators using ethanol in disinfectant products.
Approval currently envisaged without specific restrictions
The draft currently provides for standard approval, without specific restrictions. Competent authorities evaluating biocidal products containing ethanol will nevertheless need to pay particular attention to exposure, risks and efficacy where the uses concerned are not covered by the active substance assessment.
Anticipate the impact of ethanol approval on your biocidal products
Changes to the regulatory status of ethanol may have direct consequences for your authorisation dossiers, claimed uses and market access strategy.
EcoMundo can support you in:
- analysing the impact of the proposed approval on your PT1, PT2 and PT4 products;
- checking whether your uses are consistent with the active substance approval conditions;
- assessing the consequences for your marketing authorisation dossiers;
- identifying any additional exposure, risk or efficacy data that may be required;
- anticipating upcoming regulatory deadlines and adapting your compliance strategy.
👉 Do you use ethanol in your biocidal products? Our experts can help you assess the impact of this development on your portfolio and authorisations. Contact us!
