Ethanol in biocidal products – ECHA postpones its decision to 2026

Ethanol in biocidal products: a never-ending saga

ECHA postpones its decision to 2026

While Grey’s Anatomy enters its 22nd season, European ethanol regulation is only getting another year of screen time.

The European Chemicals Agency (ECHA) has moved the deadline for its final opinion on ethanol as an active substance in biocidal products from December 2025 to 2026.

15+ years of evaluation. But unlike Netflix series, there is no binge-watching here: every episode lasts at least a year. And hardly anyone is still enjoying this story.

🔬 What is the context – why is ethanol a problem at all?

In October 2024, the working groups of the Biocidal Products Committee (BPC) reached a conclusion that stirred up the industry: ethanol shows the properties of a category 1 carcinogen and reproductive toxicant.

The proposed classification would automatically put ethanol on the list of candidates for substitution and subject it to the strictest restrictions under the Biocidal Products Regulation (BPR).

And this is where the problem begins

The basis for such a classification? Data on systemic toxicity after oral intake – in other words, what happens when someone drinks alcohol, not when they use a hand or surface disinfectant.

The methodological controversy is identical to the one that accompanied titanium dioxide for years: can a classification be based on effects that are not relevant to the real routes of exposure when biocides are used?

The difference is critical. Exposure to ethanol through the skin or by inhalation in the context of using biocidal products is not comparable with systemic exposure through oral intake. Biochemically, pharmacokinetically, toxicologically – these are two completely different scenarios.

⏳ Why the postponement – and is it good news?

ECHA is waiting for additional data on dermal absorption before it issues its final opinion.

That is, let’s admit it, a logical move, because if you are evaluating a substance that is mostly used through dermal application, it might be good to have reliable data on how much is actually absorbed through the skin.

Trivial? Perhaps.

But the TiO₂ lesson taught us that methodological precision is not optional. More than three years of legal uncertainty showed what happens when things are rushed without solid scientific foundations.

What did the TiO₂ saga teach us?

Titanium dioxide was classified as a carcinogen in 2020. The industry challenged the decision, and in 2022 the Court annulled the classification because of a methodological error. It found that the classification was not based on the intrinsic properties of TiO₂, but on general dust effects that are not specific to that substance.

Only in August 2025, after the appeal proceedings, did the Court of Justice finally confirm the annulment.

Three years of legal uncertainty. Companies did not know whether to change labels, SDSs, formulations. Thousands of safety data sheets were revised and then changed back again.

The Court set a precedent: classification must be based on the intrinsic chemical properties of a substance, not on secondary effects that are not specific to that substance.

The ethanol story has a similar methodological dilemma: is toxicity that stems from systemic metabolic transformation after oral intake (which does not happen with dermal/inhalation exposure in a biocidal context) relevant for classification?

🏭 What this means for the industry – and can anything be done?

Manufacturers and distributors of disinfectants get another year with the current status of ethanol.

But the status quo is not a strategy.

The industry has raised its voice – but is it right?

A.I.S.E., the European detergents industry association, came out with a clear position: such a classification does not take real exposure routes into account, ignores risk mitigation measures (such as the denaturation of ethanol), and is based on a scenario that is not relevant to biocidal use.

Their arguments:

Ethanol is the most effective available substance against a broad spectrum of microorganisms
There are no equivalent alternatives – isopropanol and n-propanol are less effective and harsher on the skin
90,000 deaths a year in the EU are linked to hospital-acquired infections – ethanol is key to preventing them
Exposure through the skin/by inhalation is negligible and comparable with the ethanol naturally present in orange juice

On the other hand…

If there is scientific evidence pointing to reproductive toxicity and carcinogenicity, shouldn’t the regulator be cautious? Especially when we are talking about products to which vulnerable populations are also exposed – patients, pregnant women, children, healthcare workers who use disinfectants every day.

What can the industry do while it waits?

If you are in the biocidal sector, now is the time for:

1. Monitoring regulatory developments

Follow ECHA consultations and BPC sessions during 2026
Sign up for notifications about all documents related to ethanol
Take part in discussions within the industry sector if you have relevant data

2. Portfolio analysis

Mapping products that contain ethanol as an active substance
Assessing dependence on ethanol (are alternative formulations possible?)
Analysing the share of ethanol-based products in total revenue

3. Exploring alternatives

Assessing the performance of isopropanol and n-propanol as substitutes
Examining new antimicrobial agents
Testing the efficacy of alternative formulations

4. Planning for both scenarios

Scenario A – Approval with conditions:

Preparing for additional safety measures
Updating SDSs and labels
Documentation for safe use

Scenario B – Restrictive measures:

A product reformulation strategy
A timeline for switching to alternatives
A communication plan for customers

Reality: Most likely, ethanol will be approved with strict conditions of use – a complete ban would have catastrophic consequences for public health, especially in the context of controlling hospital-acquired infections.

But preparation doesn’t hurt.

⚖️ The key question remains the same

Will the regulator learn from the TiO₂ case that classification must be based on the intrinsic properties of the substance and relevant exposure routes?

Or will we again see a legal battle that lasts for years, with industrial and public health consequences?

90,000 deaths a year in the EU are linked to hospital-acquired infections. Ethanol is the gold standard for preventing them.

But if there are scientifically proven risks, they must be taken into account.

Balancing public health and toxicological science is not easy. But it must be based on methodologically sound data.

📅 Timeline - where we are and what lies ahead

2000: The BPR review programme for existing active substances begins – ethanol is assigned to Greece as the responsible member state

March 2024: Greece submits a revised assessment report to ECHA

October 2024: BPC working groups conclude that ethanol shows category 1 CMR properties

February – April 2025: Public consultation on ethanol and potential alternatives

September 2025: BPC working groups finalise the scientific discussions

December 2025: Planned deadline for the BPC opinion – POSTPONED

2026: New deadline for the ECHA opinion – data on dermal absorption is awaited

2027/2028 (estimate): Final decision by the European Commission

💭 What does this mean in the long term?

This is not just a regulatory procedure.

It is about how we assess risk in the real world, how we integrate science into policy, and how we balance different aspects of public health, because infectious diseases are as much a threat as toxic substances.

It is also about whether we will learn the lesson from the TiO₂ case:

That speed should not come before precision
That the methodology must be robust
That classification must be based on data relevant to the use scenario

The consequences could be far-reaching. Manufacturers, exporters and distributors of biocidal products containing ethanol will have to be ready for all scenarios – from reformulation and requalification of products to a complete restructuring of their portfolio.

For consultants and EHS professionals, this is the moment to stay informed. No panic, but with a clear understanding of the possible scenarios.

⏳ The uncertainty continues.

We will get the answer in 2026. But preparation starts now.

Links to my articles and posts:

LinkedIn article: Ethanol in biocidal products: When scientific data becomes a battlefield
LinkedIn post: The TiO2 saga is over: the industry paid the price, and was an inadequate interpretation of scientific data the trigger?
LinkedIn post: ⚡ The TiO2 ruling: the reality on the market and how to prepare

Relevant links:

This blog post is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed chemical adviser or a lawyer specialising in chemical regulation.