First of all, you need to know that only when active substances are approved at EU level, we are talking about 'European authorisation'.
Is your product already authorised or notified in Belgium in accordance with the national procedure? Please consult then at first this page.
You can submit 4 types of European applications:
- an application for a national authorisation if you just want to place your product on the market only in Belgium and you choose this country as the reference Member State
- an application for mutual recognition when you want to place your product on the market in a number of countries and it is already under evaluation or authorised in a particular reference Member State
- an application for a union authorisation when you want to place your product on the market in one go in all EU Member States
- an application for simplified authorisation if your product meets certain criteria, such as the absence of substances of concern
Some additional options:
- Application for the renewal of a national authorisation or mutual recognition
- Notification for listing a product in a product family
On the website of ECHA, you will also find a global overview of the various types of applications in R4BP 3.
For each of these applications, you will have to pay a fee to the European Chemicals Agency (ECHA) as well as to the biocidal service. Here you can find an overview of the amounts, and supporting documents for the various application types. Unless otherwise stated, these can be charged in R4BP 3.
If you also need to add a summary of product characteristics to your application, please make use of the SPC Editor from ECHA.
For more information, please contact also the ECHA helpdesk.
Important:
- If you wish to submit a European application for authorisation for which you choose Belgium as receiving competent authority, please contact the biocidal service via info.gestautor@environment.belgium.be
- Declaration at the Poison Centre
- Please note the requirements of Article 95 of the Biocidal Products Regulation concerning suppliers of active substances (Dutch / French)
- Information regarding the payment of the fee
- Information regarding the annual contribution of sales volume
- Information regarding the approval number that has to appear on your label
- Information regarding the closed circuit (Dutch/ French)