© 2023 by sciBASICS sprl

Belgium

How to put a biocidal product on the Belgian market - in a nutshell

January 03, 2023

Before you can put a biocidal product on the Belgian market, it needs to be either authorised or notified. An authorisation requires the submission of a full dossier and a form called "formulaire A". After the opinion of the committee for biocides (CAB) the authorisation is granted (or not). At best, the authorisation procedure takes 180 (working) days. A notification may be sufficient in some cases and requires only an administrative paper dossier. A response is then to be expected within 90 working days. A simple administrative demand can be expected to be handled within 40 days.

For a biocidal product to be accepted by the Belgian authorities the active substances contained therein must be either on the European list of existing substances or on the list of substances under revision. Fees are to be paid when applying for an authorisation or notification and in addition, an annual fee is to be paid (depending on volume sold and other parameters). It is possible to apply for an authorisation for experimental purposes, to do so the "Formulaire A" is to be used.

Depending on the product's toxicology profile (for instance), the competent authority might assign the product to the "restricted circuit - circuit restreint" or the "free circuit- circuit libre". In case of a product being assigned to the "restricted circuit, sellers and users must be registered. 

The Belgian national law in place concerning biocides is the Royal Decree of May 2014 (Arrêté Royal du 8 Mai 2014) . 

Please reload

Biocidal Products

The authorisation procedure in Europe for biocides requests a 2-step approach:

First, the biocidal active substance has to be approved at European level for a given Product Type (PT);

 

Second, the product containing these active substances has to be authorised. This authorisation is only possible with an approved active substance. 

 

Since September 2015 biocidal products must contain substances from suppliers that are listed on a list maintained by ECHA.

 

Approval applications for new active substances are no longer handled by an evaluating Member State but are processed by the European Chemicals Agency ECHA.  Active substances that are PBT or CMR (both exclusion criteria) will no longer be approved as active substances, unless they are needed for an urgency use.

 

There are various authorisation procedures. Besides national authorisations union authorisations are now possible. This means that these products can be placed on the market in every EU Member State.

 

The BPR introduced the concept of “product families”. These are groups of products that vary, for instance, only in fragrance or color. If you got a product family authorisation, all products belonging to that group may then be placed on the market through a simple notification.

Last but not least there is a simplified authorisation procedure for those products that contain active substances listed in annex I of the BPR and that contain no substances of concern.

Treated articles, that were not within the scope of the old BPD are now regulated by the biocides regulation. For instance, wood from outside the EU treated with insecticides may only be imported if the applied insecticide is approved in the EU.

 

As for the REACH regulation 1907/2006 there is also a provision within the BPR that data must be shared to avoid testing on vertebrates. That means that before conducting such study a request in that sense must be submitted to ECHA. In case the data are available from a different organisation the applicant and the concerned organisation must find an agreement on data sharing.

(Source)