Those wanting to make a biocidal product available on the market in Belgium must follow either a national registration or European authorisation procedure.
Which procedure must I follow?
There are two procedures: the national registration procedure and the European authorisation procedure. To know which procedure to follow, first check whether all the active substances in your product are approved.
- If all the active substances in your product are approved for all relevant product types, you must follow the European procedure
- If at least one active substance has not yet been approved for all relevant product types, and is therefore still under evaluation within the European Review Programme, you must follow the national procedure
At the end of the procedure, all registered/authorised biocidal products are provided with an official certificate.The certificate indicates the conditions for making the product available on the market and the conditions of use. All biocidal products also have a unique registration/authorisation number that must appear on the label.
Which suppliers of active substances are authorised?
All active substances in biocidal products intended for the Belgian market must meet the conditions set out in Article 95 of the Biocidal Products Regulation (Regulation (EU) No 528/2012).
Since 1 September 2015, a biocidal product may only be made available on the European market if the manufacturer or supplier of the active substance(s) or the manufacturer or supplier of the biocidal product is included in the Article 95 list of Regulation (EU) No 528/2012 for the relevant product type.
The European Chemicals Agency (ECHA) prepares and maintains this list. Only suppliers with a complete EU substance dossier or equivalent are included in the list. This rule is intended to prevent ‘free riding’ and unfair competition. You can find the complete Article 95 list and application instructions on the ECHA website.
Substances which, according to the European Union, pose a low risk do not need to be included in the Article 95 list. Specifically, these are the substances included in Annex I under Categories 1 to 7 of Regulation (EU) No 528/2012.