Biocides are used to protect humans, animals and objects from harmful organisms. While biocidal active substances evidently have an adverse effect on target organisms (such as pests and bacteria), it is important that their use does not cause unacceptable harm to potentially-exposed humans and other non-target animals, or to the environment. In Europe, the safety, sale and use of biocidal products and their active substances are regulated under the Biocidal Products Regulation (BPR) (EU) 528/2012, and previously the Biocidal Products Directive (98/8/EC).

To sell active substances or biocidal products in the EU, companies must submit applications for approval or authorisation to the European Chemicals Agency (ECHA) in IUCLID 6 format through the Register for Biocidal Products (R4BP3) IT platform.

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

A good submission will have at its foundations a high-quality toxicity assessment, based, where possible, on existing data (to minimise laboratory testing). The bibra scientists are skilled in literature searching using data sources such as our in-house database TRACE, which has been listed as a valuable source of information by ECHA. When adequate data are available for an endpoint, the critical evaluation of relevant studies and their presentation using IUCLID are second-nature to us. For less-well-studied areas, we can consider read-across, (Q)SAR and data waivers. We can use our toxicology skillset to put together endpoint study records for your biocidal actives, and to consider relevant substances of concern (SoCs) (i.e. ingredients, other than the active, which may have an adverse effect on animals or the environment). We can also evaluate health risks for users (professional or non-professional) and bystanders by modelling appropriate exposure scenarios using software and guidance such as the Bayesian Exposure Assessment Tool (BEAT), ConsExpo, ECHA’s Biocides Human Health Exposure Methodology, EC Technical Notes for Guidance (TNsG), and Human Exposure Expert Group (HEEG) opinions.

Toxicological assessments of biocidal active substances and products (including the non-active substances they contain) should now also include a discussion on endocrine disruption. In principle, endocrine disrupters should be excluded from biocides. 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), and evaluating the resultant “Lines of evidence”. The UK Health and Safety Executive (HSE) has also proposed a pragmatic, decision-tree-based approach for the assessment of the ED properties of non-active substances (co-formulants) in biocidal products. The instructions guide the applicant through a step-wise and targeted method from which a conclusion can be drawn.

If you would like any further information on how we can help with your submissions for biocidal products or active substances, please get in touch and we would be happy to help!


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