The European Chemicals Agency (ECHA) has launched a public consultation on the availability of substitutes and alternatives to ethanol in certain biocidal products. This consultation is part of the European Union’s Biocidal Products Regulation (BPR), which also applies in Northern Ireland.
Criteria for Substitution and Exclusion of Active Substances
According to Article 10(1) of the BPR, an active substance may be identified as a candidate for substitution if it meets certain criteria. In such cases, the competent authority in charge of its evaluation may recommend its restriction or prohibition, unless it is demonstrated that there are no viable alternatives that:
- Present a lower risk to human health, animal health and the environment.
- Are sufficiently effective.
- Do not involve significant economic or practical disadvantages.
- The chemical diversity of available active substances is not sufficient to minimize the occurrence of resistance in the target harmful organism.
Before issuing an opinion on the approval or renewal of an active substance, ECHA launches public consultations to gather information on possible alternatives (Article 10(3) of the BPR).
In addition, an active substance may meet the exclusion criteria set out in Article 5(1) of the BPR, which would preclude its approval. These include:
- Substances that are carcinogenic, mutagenic or toxic to reproduction (category 1A or 1B under the CLP Regulation).
- Endocrine disruptors.
- Persistent, bioaccumulative and toxic substances (PBT).
- Very persistent and very bioaccumulative substances (vPvB).
Exceptions to the Exclusion Criteria
If an active substance meets the exclusion criteria, it should in principle not be approved. However, Article 5(2) of the BPR allows exceptions in cases where it is demonstrated that:
- The risk arising from its use is negligible under controlled conditions (e.g. closed systems).
- The substance is essential to prevent or control a serious hazard to human health, animal health or the environment.
- Its prohibition would have a disproportionate negative impact on society compared to the risks associated with its use.
In addition, the availability of suitable and sufficient alternative substances or technologies is a key factor in the decision on the approval of excluded substances. If at least one of these exemption conditions is met, approval of the substance may be granted for a maximum of five years and for restricted uses. Furthermore, Member States may only authorize biocidal products if they consider the conditions of use to be safe on their territory.
Public Consultation on Ethanol
Under the EU BPR, ECHA has identified ethanol (CAS 64-17-5, EC 200-578-6) as a potential candidate for substitution in Product Types 1, 2 and 4. The consultation will be open until April 28, 2025.
Comments should be sent to ECHA via the dedicated web forms, as this consultation is not applicable under the UK Biocidal Products Regulations (GB BPR).
For more information and to participate in the consultation, it is recommended to visit ECHA’s website.
