Ethanol as a biocidal active substance: key points for manufacturers and importers

A regulatory milestone you cannot afford to ignore

Does your company manufacture or market hydroalcoholic disinfectants or antiseptic products? If so, ECHA’s latest decision marks the beginning of a new regulatory phase for biocidal products containing ethanol.

On 23 February 2026, ECHA’s Biocidal Products Committee (BPC) adopted a positive opinion supporting the approval of ethanol as an active substance for Product Type 1 (Human hygiene), Product Type 2 (Disinfectants and algaecides not intended for direct application to humans or animals) and Product Type 4 (Food and feed area).

This is one of the most significant regulatory developments for the European disinfectants sector in recent years. On 23 June 2026, the Competent Authority Report (CAR) was published, providing the reference values and scientific conclusions that Competent Authorities will use when assessing product authorisation dossiers. Autoridades Competentes usarán para evaluar los dosieres.

What does this mean for your business? There is no longer any need to speculate about the evaluation criteria. They are now clearly defined. Companies that prepare their dossiers based on the CAR from the outset will be better positioned to submit robust applications, reduce the likelihood of questions from Competent Authorities and minimise delays during the evaluation process. Those who wait are likely to face increasing competition for regulatory resources as more applications enter the system.

What does the Competent Authority Report reveal and why does it matter?

Good news: the CMR discussion will not block the market

One of the key issues discussed during the evaluation was whether ethanol should be classified as carcinogenic or toxic for reproduction based on its effects following oral consumption. The BPC concluded that there is insufficient evidence to extrapolate those hazards to biocidal exposure routes, namely inhalation and dermal exposure.
As a result, ethanol is neither excluded under the Biocidal Products Regulation (BPR) nor identified as a candidate for substitution. This means that the regulatory pathway remains open for ethanol-based biocidal products.

Key aspects that will determine the success of your dossier

• Expanded CLP classification and labelling: in addition to the existing classification as a highly flammable liquid (H225), formulators will need to assess whether their labels should also include the following hazard classes: Eye Irritation (H319), Specific Target Organ Toxicity – Single Exposure (H336), Repeated exposure may cause skin dryness or cracking (EUH066), Specific Target Organ Toxicity – Repeated Exposure (H373), and may cause harm to breast-fed children (H362).

• Occupational exposure limit and reference dose:
  The BPC has adopted the German occupational exposure limit (MAK) of 200 ppm (380 mg/m³) as the basis for its assessment. From this value, a reference dose of 19 mg/kg body weight/day has been derived, assuming 60% absorption by inhalation and dermal penetration of 0.7 mg/cm²/hour for 25% ethanol solutions in water.
  This reference value applies to all user categories and exposure durations and will become one of the central criteria used by Competent Authorities when evaluating product safety. In addition, no Acceptable Exposure Concentrations (AECs) have been established for local effects. Consequently, local risks will need to be addressed through a qualitative assessment within the dossier, an area that requires considerable regulatory expertise to avoid questions during the evaluation.

• Minimum purity requirements: The approved active substance specification establishes a minimum ethanol purity of 92.6% (w/w) together with strict limits for impurities such as methanol, acetaldehyde and benzene. This makes quality control and supplier documentation critical components of every authorisation dossier.

Important: if not properly managed, each of these aspects may result in comments from the Competent Authority, months of delays, unexpected additional costs, and ultimately a product that cannot be placed on the market on time.

Why act now instead of waiting?

BPR product authorisation procedures are lengthy, technically demanding and increasingly competitive. Companies that incorporate the CAR conclusions into their regulatory strategy today will reach the market with stronger dossiers and a smoother evaluation process.

Starting early allows you to:

• Prioritise which products and Product Types to authorise first.

• Anticipate labelling requirements and child risk mitigation measures.

• Reduce the likelihood of objections or requests for additional information that could delay market access by several months.

How ServiREACH can help

At ServiREACH, we specialise in regulatory affairs for biocidal products and support companies throughout every stage of the BPR authorisation process, including:

• Regulatory strategy tailored to ethanol-based product portfolios.
• Preparation of complete BPR product authorisation dossiers.
• Communication and coordination with Competent Authorities.
• Human health and environmental risk assessments.

Let’s discuss your dossier: Contact our team to discuss how we can help position your products for a successful, efficient and compliant authorisation process under ECHA’s new evaluation framework. Don’t let regulatory complexity delay your market entry. We help transform new regulatory requirements into a competitive advantage.