Ethanol Classification Decision Delayed to December 2026 

If your biocidal product contains ethanol as an active substance, or even as a co-formulant, this decision could affect your product.

On the EU and GB markets, there are many biocidal products that use ethanol as their active substance, or as a solvent within the product formulation. However, as ethanol is not currently approved under the BPR, manufacturers have been using transitional measures to bring their products to market. Aside from the BPR delays, CLP harmonised classification has been under review for ethanol, with the exact classification under debate for some time. With new data on dermal adsorption expected, the classification decision has been delayed until the end of 2026.

The current classification of Ethanol is:

• Flammable Liquid, Category 2 (H225).

Notably, the above describes a physical hazard only. However, the proposed classification following review by the EU BPR eCA (Greece) might be:

• Flam. Liq. 2, H225
• Eye Irrit. 2, H319 (eye irritant)
• Repr. 2, H361d (Category 2 reproductive toxicity – suspected of damaging the unborn child)
• Lact., H362 (effects on or via lactation – may cause harm to breast-fed children)
• STOT SE 3, H336 (may cause drowsiness or dizziness)
• STOT RE 2, H373 (may cause damage to organs through prolonged or repeated exposure)

However, more recently, the BPR Biocidal Products Committee (BPC) Working Groups have proposed:

• Category 1 carcinogen
• Category 1 reproductive toxicant
• Category 1 mutagen (decision pending)

This substantially more stringent classification could have significant implications for a number of biocidal product types (it is under review for PT 1,2,4 and 6 but is a common co-formulant in many others). At this level of classification, substances classified as carcinogenic, mutagenic and toxic for reproduction (CMR) 1A fall under exclusion criteria as per Article 5 of the BPR. This means that it could be excluded or substituted from biocidal product formulations.

It is possible that a derogation case may be proposed if certain criteria are met. For example, derogations may be permitted if the negative impact of not having this active substance is greater than the risks of allowing its use, and there are no suitable alternatives available.

With the BPR WG classification, a cascade of other Articles within the BPR then become applicable such as Article 19 (4) which states substances classified as Category 1 CMRs should not be made available to the general public. Conversely, Article 19 (5) indicates that individual EU Member States can allow Cat1 CMRs in product authorisation for the general public (if the alternative of not having the product is considered worse). Allowing member states to interpret and implement approvals individually effectively undoes the intended harmonisation of the BPR.

As has been the case for a number of years now, we must continue to wait for finalised outcomes but be prepared to adapt as necessary.