Public Consultation – Ethanol for Product Types 1, 2 & 4

This is to inform you that the European Chemical Agency (ECHA) have launched a public consultation on potential candidates for substitution for:

Ethanol for Product Types 1, 2 & 4.

If an active substance meets any of the criteria for substitution listed in Article 10(1) of the Biocidal Products Regulation (BPR), then the evaluating competent authority may identify the substance as a potential candidate for substitution (CfS).

If this is the case, normally before submitting its opinion on the approval or renewal of the renewal of the active substance to the Commission, ECHA will launch a consultation to collect information on potential alternatives to this substance (Article 10(3) if the BPR).

In addition to be a candidate for substitution, an active substance might meet the exclusion criteria listed in Article 5(1) of the BPR:

• carcinogens, mutagens and reprotoxic substances categories 1A or 1B according to the CLP Regulation
• endocrine disruptors
• persistent, bioaccumulative and toxic (PBT) substances
• very persistent and very bioaccumulative (vPvB) substances

Active substances meeting these exclusion criteria should normally not be approved. However, derogations may be possible as laid down in Article 5(2) of the BPR, when it is shown that:

1. the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst-case conditions of use, is negligible, in particular

where the product is used in closed systems or under other conditions which aim to exclude contact with humans and release into the environment;

2. there is evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or
3. not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.

Moreover, Article 5(2) of the BPR specifies that the availability of suitable and sufficient alternative substances or technologies shall be a key consideration when deciding on the approval of substances meeting the exclusion criteria.

If at least one of the derogation conditions is met, approval of an active substance may be granted for a maximum period of five years, and for restricted uses. In addition, Member States may only authorise biocidal products where they consider that conditions are met on their territory.

The consultation is available at the ECHA website: Consultations on potential candidates for substitution and on derogations conditions - ECHA (europa.eu)

Interested third parties wishing to contribute to the consultation need to submit their contributions by 28 April 2025, 23:59 Helsinki time (EET/EEST).