The Biocidal Products Regulation (BPR) (EU) 528/2012, which repeals the Biocidal Products Directive (98/8/EC), 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 active substances. Use of biocidal products should be acceptable to potentially-exposed humans and other non-target animals, and to the environment.

Product types cover those used as disinfectants; preservatives; pest control agents; antifouling products, and Embalming and taxidermist fluids.

Companies can apply for the approval of an active substance by submitting a dossier to the European Chemicals Agency (ECHA). As of 1 September 2015, you also need to be included in ECHA’s Article 95 List of approved suppliers if you want to sell active substances in the EU market. Companies wishing to place a biocidal product on the market must apply for product authorisation at a national or Union level. Data requirements include those relating to toxicity in humans, potential exposures, and toxicity and fate in the environment. Submissions are made in IUCLID 6 format via the Register for Biocidal Products (R4BP3) IT platform.

Bibra has 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 literature searching and the evaluation of data on substances of concern (SoCs), 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 6
  • Biocidal Product authorisation – expert support with data on product formulations, including substances of concern (SoCs)
  • 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))
  • Endocrine Disruption – an amendment to the biocidal products regulation (Regulation (EU) 2017/2100, applying as of 7 June 2018) sets out the scientific criteria for the assessment of the endocrine-disrupting properties of biocidal products. A guidance document produced jointly by ECHA and the European Food Safety Authority (EFSA), provides a detailed methodology for gathering, evaluating and considering all relevant information and fulfilling these regulatory obligations. Bibra has experience of filling the recommended Excel template (Appendix E1) with the relevant data, following the accompanying instructions (Appendix E2) (both available by clicking on “Supplements” in the top left-hand corner of the guidance webpage), and evaluating the resultant “Lines of evidence”. For the biocidal products, the UK Health and Safety Executive (HSE) has proposed a pragmatic, decision-tree-based approach for the assessment of the ED properties of non-active substances (co-formulants). The instructions guide the applicant through a step-wise and targeted method from which a conclusion can be drawn on any indications regarding the ED properties of the co formulant.


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