Biocidal Products Regulation
The Biocidal Products Regulation (BPR) (EU) 528/2012 (which applied from 1 September 2013) replaced the Biocidal Products Directive (98/8/EC). Like its predecessor, the BPR is designed to harmonise the European market for a wide range of biocidal product types that are used to protect humans, animals, materials or articles against harmful organisms such as pests or bacteria, by the action of the active substances contained within the formulation. Alongside the efficacy, use of the product should be acceptable to potentially exposed humans, animals, and also to the environment.
Product types cover those used as Disinfectants; Preservatives; Pest control agents; Antifouling products, and Embalming and taxidermist fluids.
All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. Companies can apply for approval of an active substance by submitting a dossier to the European Chemicals Agency (ECHA). Once an active substance has been approved, companies wishing to place a biocidal product on the market must then apply for product authorisation at national or Union level. Data requirements include that relating to the toxicity to humans, potential human exposure, and the toxicity and fate in the environment. Submissions are made in IUCLID 5 format via the Register for Biocidal Products (R4BP) IT platform.
As of 1st September 2015, you need to be included in the Article 95 list of active substance suppliers if you want to continue selling your product in the EU market. We have many years of experience in supporting companies with their biocide regulatory submissions, and working within IUCLID. Not only can we help with the data requirements for active substance approval, but we can assist with all aspects of product authorisation, including the search for and evaluation of data on substances of concern and the modelling of appropriate exposure scenarios.
Registration of Biocidal Products in the EU
- Active substance approval – help with compilation of submission dossiers in IUCLID 5
- Biocidal Product authorisation – expert support with data on product formulations, including substances of concern
- Exposure modelling for users (professional or non-professional), workers and bystanders (e.g. BEAT, ConsExpo, ECHA’s Biocides Human Health Exposure Methodology, EC Technical Notes for Guidance (TNsG), Human Exposure Expert Group (HEEG opinions))
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