Biocides
Already in September 2013 the European Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) became law. The BPR regulates placing on the market and use of biocidal products.
Like REACH, BPR aims to harmonize the European domestic market and to ensure a high level of protection for humans, animals, and the environment.
BPR however is more complex than REACH, as biocidal products must undergo a complex two-stage process. In the first step, the active biocidal substance is approved at EU level and then the biocidal product must be authorized.
Our team knows the requirements and challenges of biocides regulation from both sides (industry and authorities) and we can bring a unique perspective to the processes resulting from the BPR and to use this unique insight to your advantage.
Manufacturers/importers (suppliers) of biocidal active substances that are not already involved in the approval process, must either submit an application for review of a novel active substance or participate in the existing active substance procedure by applying for inclusion on the Art. 95 list. In the first case, the biocidal product can only be placed on the market after the Commission decision on the active substance; in the second case, the BPR provides for a transitional arrangement that grants biocidal products marketability at least until the decision on the inclusion of the existing active substance has been taken.
After the approval of an active substance on an EU-level, all biocidal products containing this substance are subject to authorization. Furthermore, BPR explicitly defines treated articles and in situ generated actives and sets specific provisions for these.
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