ToxMinds develops the documentation required to register biocidal products according to the Biocidal Products Regulation (EC) No. 528/2012 (BPR). We are experienced in determining the most suitable registration strategy for your biocidal product or family and developing the required documentation under the EU BPR Regulation.
Given the complexity of the BPR and our strong background in toxicological and environmental sciences, we focus specifically on developing scientifically sound hazard, exposure and risk assessments, higher tiered, if necessary. Our experts on endocrine disruption will help identifying and assessing the endocrine disrupting properties of your actives in line with Regulation (EU) 2018/605 and associated ECHA guidance(s).
Our services related to biocidal actives, products and product families under the BPR include:
- Thorough desktop research, scientific review of available data and data gap analysis relative to BPR requirements
- Determination and advice on most cost-efficient testing and registration strategies
- ECHA-guidance compliant assessment of endocrine disrupting properties of biocidal product ingredients
- Management of testing programmes
- Development of product authorisation dossiers and R4BP
- Preparation of full human health and environmental risk assessments, including all relevant exposure modelling
- Scientific advice to deal with complex toxicological profiles threatening the success of authorisations or leading to unfavourable RCR values or PEC/PNEC ratios
- Post-submission support (e.g., client representation with – and response to – authorities)
- Consortium management and 3rd party representation
- LoA cost determinations and negotiations