Those wanting to make a biocidal product available on the market in Belgium must follow either a national registration or European authorisation procedure. A European or Union authorisation is only possible if the active substances are approved at the European level.
How do I submit an application for European authorisation?
Applying for authorisation of a biocidal product is only possible if all the active substances have been approved for the relevant product type.
For biocidal products already authorised on the Belgian market, a European authorisation must be applied for at the latest by the date on which the last active substance is approved. The registration of the biocidal product concerned will then be extended for 3 years.
If the application for authorisation is not submitted in time, the product in question must be withdrawn from the market. This must be done within 180 days of the approval of the last active substance. Existing stocks of the biocidal product remaining after that date must be used up within 365 days.
You can submit two types of applications at the European level:
- An application for a single biocidal product
- An application for a biocidal product family, with products having a similar classification and labelling
Application for single biocidal product - Belgium as the evaluating Member State
To make a biocidal product available on the market in the European Union, you must have either a national or Union authorisation. An application for such an authorisation is evaluated by a single Member State. If you wish, Belgium can act as the evaluating Member State.
Application for single biocidal product - Belgium as the Member State concerned
The ‘Member States concerned’ are not the Member States that evaluate the application, but the Member States in which you want to obtain an authorisation for a biocidal product. How do you apply for a single biocidal product if Belgium is not the evaluating Member State?
Application for a biocidal product family
A biocidal product family is a group of biocidal products with similar product characteristics. A European authorisation for a biocidal product family applies to all the biocidal products in that family. The possible authorisation procedures are identical to those for a single biocidal product. The processing times are also identical.
Application for post-Annex I extension
A European authorisation application of a registered biocidal product in Belgium must be submitted at the latest by the date of approval of the last active substance. If the application is submitted within that deadline and the fee is paid on time, the registration of the biocidal product in question will be extended by 3 years. This extension is known as a ‘post-Annex I extension’ and is only possible if the evaluation of a product is delayed at the European level. To apply for a post-Annex I extension, you must send an email to email@example.com with the following information:
- Subject matter of the application (a post-Annex I extension for an existing product)
- Case number of the application in the European Register for Biocidal Products (R4BP)
- .csv list of products already existing on the market
For more information, you may contact the Helpdesk of the Biocidal Products Service.