Active substance approval
The assessment of active substances prior to their approval for use in biocidal products is carried out by an EU country, followed by a peer review involving all EU countries, coordinated by the European Chemicals Agency (ECHA). This peer review takes place within the Biocidal Products Committee (BPC). ECHA delivers an opinion to the Commission as to whether or not an active substance can be approved.
On the basis of its conclusions, the Commission decides whether or not to approve the use of the active substance in biocidal products. Where necessary to protect human health, animal health or the environment, an approval may include certain conditions to ensure that the risks identified are properly addressed during product authorisation.
Substances of very high concern
The Regulation contains criteria to phase out the use of substances of very high concern and to ensure that, over time, better alternatives are used.
These include substances:
- Classified as carcinogens category 1A or 1B
- Classified as mutagens category 1A or 1B
- Classified as toxic for reproduction category 1A or 1B
- That are persistent, bio accumulative and toxic
- That are very persistent and very bio accumulative
- Endocrine disruptors.
A review programme has been set up to examine active substances that were already on the market when the first EU legislation on biocidal products was adopted in 1998.
When a substance is not approved under the review programme, biocidal products containing this active substance are usually removed from the market within 12 months, unless otherwise stipulated by national authorities.