Impact of tightening the classification of ethanol: what might await us?

Ethanol (CAS: 64-17-5) is a widely used chemical substance that finds application in many areas – from industry to everyday consumer products. It is also significantly used in biocidal products, such as disinfectants for hands and surfaces.

At present, ethanol is harmonised classified under Annex VI of the CLP Regulation as a highly flammable liquid (H225). However, a tightening of this classification is being discussed, specifically the inclusion of additional health hazards.

What is being proposed?

The new proposal considers classifying ethanol among substances with a serious impact on human health, in one of the following categories:

• H340 – may cause genetic defects (mutagenicity)
• H350 – may cause cancer (carcinogenicity)
• H360 – may damage fertility (reproductive toxicity)

In all cases, this would be a classification in Category 1A or 1B, which would place ethanol among so-called CMR substances. This step would have far-reaching impacts across both the chemical and consumer markets.

Key impacts of the proposed change

1. Safety data sheets – In the event of a tightening of ethanol’s classification, safety data sheets (SDS) will need to be updated and the classification of products containing ethanol reassessed.

2. Labels – A change in classification will require the addition of new hazard pictograms and H statements, leading to relabelling of products – with all associated costs and a possible loss of value of existing stocks.

3. PCN notifications – Notifications in the PCN format will need to be updated. A change in the classification of ethanol may require the creation of a new UFI code.

4. Sale to consumers – A stricter classification may mean restrictions or even a ban on the sale of products containing ethanol to consumers, which would result in the need to withdraw them from the market.

5. Biocidal products – CMR substances are generally not permitted in biocides. A new classification of ethanol could therefore lead to a loss of authorisation or the need for a fundamental change in the composition of biocidal products.

6. CLP notification – Notifications in the Classification and Labelling Inventory (C&L Inventory) will need to be updated in accordance with the new classification.

Why is ethanol so highly valued?

Despite the discussed classification, ethanol has a number of advantages:

• well researched and used for a long time,
• compatible with various materials,
• highly effective against pathogens,
• good availability and low price,
• low risk to humans, animals and the environment when used correctly.

Broader impacts of the tightening

A change in classification could affect not only industry, but society as a whole. It could lead to:

• reduced availability of effective disinfection, including in developing states,
• loss of jobs and weakening of the market (e.g. Germany, Poland or France),
• costs associated with the development of alternative substances,
• complications for small businesses,
• financial losses in relation to investments (e.g. due to changes in production technology).

When can we expect a decision?

The final decision is expected at the end of 2025. If the proposal is adopted, the new classification could enter into force around the turn of 2027/2028.

How to prepare?

Companies should already analyse the impacts of the change on their documentation, products and regulatory obligations. If you work with chemical substances or manufacture biocidal products, we recommend closely monitoring developments and, if necessary, starting to look for an equally effective alternative to ethanol.

Timely preparation may determine the future of your products on the market.

Recommended sources:

• Regulation (EC) No 1272/2008 (CLP)
• ECHA