Following ECHA’s review of ethanol as a biocidal active substance, is its approval at risk?
Review of Ethanol. The ubiquitous presence of ethanol in biocidal products, notably hand and surface disinfectants, has prompted a rigorous evaluation under the European Union’s Biocidal Products Regulation (BPR). This regulatory framework, designed to ensure the safety and efficacy of substances used in biocides, mandates the assessment of all active ingredients present on the EU market in 2000. The responsibility for this comprehensive review was distributed amongst member states, with Greece designated as the competent authority for ethanol.
Background: Review of Ethanol by the Greek’s eCA
In March 2024, Greece submitted its revised assessment report to the European Chemicals Agency (ECHA). This document scrutinized ethanol’s suitability across three pivotal biocidal product types:
- Human hygiene products (PT1)
- Disinfectants and algaecides intended for non-direct human or animal contact (PT2), and
- Products employed within the food and feed sectors (PT4).
This evaluation encompassed a thorough investigation of ethanol’s inherent hazard properties, a risk assessment based on typical product applications, and an examination of its efficacy.
Current status
The report is currently undergoing peer review. This is a critical phase involving experts from all European Economic Area (EEA) countries and Switzerland, within ECHA’s Biocidal Products Committee (BPC) and its associated working groups. The BPC is expected to render its opinion in the latter half of 2025, which will subsequently inform the European Commission’s final decision regarding ethanol’s approval.
The BPC is expected to render its opinion in the latter half of 2025, which will subsequently inform the European Commission’s final decision regarding ethanol’s approval.
It is crucial to distinguish between the BPR and the Classification, Labelling and Packaging (CLP) Regulation, two distinct regulatory domains. While the BPR focuses on the suitability of substances for biocidal applications, the CLP Regulation aims to establish harmonized classifications based on intrinsic hazard properties, irrespective of intended use.
During the BPR assessment, the evaluating authority and the BPC assess an active substance’s hazard properties in accordance with the CLP Regulation’s hazard criteria. They are particularly attentive to whether a substance meets the exclusion and substitution criteria outlined in the BPR. This includes potential carcinogenic, mutagenic, or reprotoxic classifications. Currently, ethanol holds a harmonized classification as a highly flammable liquid and vapor under the CLP Regulation. Greece has signaled its intention to submit a dossier for a re-examination of this classification, triggering a consultation process involving interested parties and an opinion from ECHA’s Risk Assessment Committee (RAC).
What’s next?
Should the BPC determine that ethanol possesses carcinogenic, mutagenic, or reprotoxic properties (category 1A or 1B), it would be considered a substance meeting exclusion criteria and a candidate for substitution within biocidal products. Even in such a scenario, approval remains possible if safe exposure levels can be demonstrated. ECHA will also launch a public consultation to gather information on alternative substances, which will inform the BPC’s opinion.
Pending the BPR decision, biocidal products containing ethanol can continue to be marketed under transitional national legislation in each member state. It is important to note that any authorized biocidal products will adhere to CLP Regulation requirements for labeling and packaging based on their hazard classification.
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Source: ECHA
