Do you market biocidal products?
Find out what a new active substance is, how it is approved in the EU, and which steps to follow to ensure compliance with the Biocidal Products Regulation (BPR).
The approval of new biocidal active substances is a crucial step for innovation in the biocides sector. It enables the development of more effective, sustainable products adapted to emerging needs — but it also represents a complex regulatory challenge that requires investment, technical expertise, and a well-defined strategy.
Under the Biocidal Products Regulation (EU) No 528/2012, any new active substance must undergo a complete evaluation and approval process before it can be used in biocidal products placed on the EU market.
A new active substance is defined as one that was not placed on the market as part of a biocidal product before 14 May 2000.
Unlike existing active substances (which are included in the EU Review Programme), new ones cannot be used in biocidal products until they have been approved through the formal regulatory procedure.
The applicant prepares a technical dossier and submits it to an evaluating Member State. The authority assesses whether the substance can be considered safe and effective for use as a biocide.
ECHA’s Biocidal Products Committee (BPC) reviews the report from the evaluating Member State and issues a scientific opinion on the suitability of the substance.
Based on the BPC opinion, the European Commission adopts the final approval decision, including the conditions of use and the date of entry into force.
Once the substance has been approved, any biocidal product containing it must obtain product authorisation before being placed on the EU market
At ServiREACH, we support you through every stage of the process — from concept to market launch:
