Before all other considerations, it should be borne in mind that European authorisation is applicable when active substances are approved - list of approved substances (EU) - at European level in accordance with Regulation (EU) No 528/2012.
To see the European requirements for biocides, please consult the website of the European Commission, which outlines the procedures to be followed to authorise a biocidal product in accordance with Regulation (EU) No 528/2012.
If a company wants to submit a European authorisation request in which Belgium is chosen as the competent receiving authority, it should contact the "Biocides" service on email@example.com.
You can submit four types of European request:
- a national authorisation request, in which the company chooses Belgium as the competent receiving authority; or
- a mutual recognition request, at the same time as or sequentially with an authorisation, if the product is being assessed or is already authorised in another Member State; or
- a European Union authorisation request; or
- a simplified authorisation request, if the active substance is included in Annex I of Regulation (EU) No 528/2012.
If a product contains several active substances, the deadline for submitting a European authorisation request is set out in the approval decision for the last active substance.
Is your product already authorised or notified in Belgium in accordance with the national procedure?
In that case, the current holder of the authorisation or notification (and this person only!) must submit a European request within the deadline set out at European level (this person will then become the future authorisation holder at European level).
If this European request is submitted within the deadlines, the existing authorisation or notification at national level is extended until the deadline set out in the approval decision for the last active substance (= post-Annex I extension).
In that case, the European request can be submitted at any time after the approval decision for the last active substance contained in the product. However, please note that the product covered by this request cannot be placed on the Belgian market until it has been fully assessed.
Creating your European request file
Submitting the European request
You must use the European Register (ECHA website) for Biocidal Products:
You must pay a fee to the ECHA and to the "Biocides" department for this request. To see the exact amount, consult the table of fees.