What is transitional law?
Not all biocidal products are yet covered by the Biocidal Products Regulation (BPR). For example, biocidal products containing an active substance included in the Review Programme of the European Commission are subject to national rules pending the final decision on the approval of the active substance (and up to 3 years after). Biocidal products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted.
Biocidal products and transitional law
Under transitional law, you must apply for authorisation in each individual Member State in which you wish to place the biocidal product on the market. The biocidal product dossier must be submitted directly to the Member State competent authority. As each application must meet the requirements stipulated by the respective national law, the application processes and associated costs may vary from country to country.
We are experienced with the preparation of biocidal product authorisation applications under transitional law in multiple countries, and can support you throughout the application process.
Please note: after the date of active substance approval, your biocidal product will fall under the BPR. In order to (continue to) place the product on the market, you must submit your BPR authorisation application latest by the date of approval of the active substance. The Commission decision to approve an active substance for a specific substance/Product Type combination is typically published 18 months prior to the date of approval.
CtgB and Dutch transitional law
In the Netherlands, biocidal product authorisation applications under transitional law (as well as under the BPR) are assessed by the Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) in accordance to the “Wet Gewasbeschermingsmiddelen en Biociden (Wgb)”. Visit the central website for government information on biocides for more information on biocide legislation in the Netherlands
The CtgB places high demands on the submitted application dossiers. For example, the information in the dossier must be obtained from studies conducted by independent laboratories that meet the criteria for “Good Laboratory Practice” and “Good Experimental Practice”. The Ctgb conducts a critical assessment about whether all the studies provided by the applicant meet these criteria. The actual assessment begins only after the application dossier is complete. The assessment procedure is strict, and highly science-based.
Like many other SMEs, you may discover during the application process that your organisation lacks the regulatory and/or scientific expertise to fulfil the requirements. Don’t hesitate to contact us. Our native Dutch speaking consultants can assist you in identifying which steps you must take to comply and help you to communicate effectively with the CtgB.