Biocidal products contain active substances that act on the harmful organism. Only biocidal products with active substances which have been approved at the European level or which are currently still under evaluation within the Review Programme may be made available on the European (and Belgian) market.
Which active substances are authorised?
The active substances authorised in the European Union and Belgium are those that are:
- Approved OR
- Still under evaluation within the Review Programme
These active substances can be found using the ECHA (European Chemicals Agency) search engine.
Active substances not included in the list
If the active substance does not appear in the list, the biocidal product may not be registered or authorised for the Belgian or European market. In that case, you may submit an application for approval of the active substance.
Who is allowed to supply or produce an active substance?
A biocidal product may only be made available on the European market if the manufacturer or supplier of the relevant active substance in the biocidal product or of the biocidal product itself is included in the Article 95 list of Regulation (EU) No 528/2012.
The ECHA (European Chemicals Agency) maintains the Article 95 list. This list contains the active substances for which a European dossier has been submitted (‘relevant substances’). These substances may be marketed solely:
- Under the listed product types AND
- By suppliers that are established in the European Union and included in the list
The same rules apply to products containing active substances generated from one or more precursors at the place of use (in-situ generation). The manufacturer or supplier of the precursor must be included in the Article 95 list.
Some active substances are not subject to this condition: suppliers or manufacturers of active substances belonging to Categories 1 to 5 or 7 of Annex I to Regulation (EU) No 528/2012 do not need to be included in the Article 95 list. These substances are not considered to be substances of concern in the European Union.
Biocidal products are referred to as ‘in-situ generated active substances’ if they are generated from one or more precursors at the place of use. A few examples:
- Active chlorine generated from sodium chloride by electrolysis
- Active chlorine generated from potassium chloride by electrolysis
- Active bromine generated from sodium bromide and sodium hypochlorite
- Hydrogen peroxide generated from sodium percarbonate by dissolution in water
These active substances must also be approved or under evaluation in the Review Programme in order to be made available on the European market.
Biocidal products containing these substances are subject to the same requirements as other biocidal products. This means that they must be either authorised or registered. The manufacturer or supplier of the precursor must be included in the Article 95 list.