CEA provides specialist regulatory support and consultancy to industry clients seeking approval/Annex I inclusion and Article 95 support of their active substances and authorisation of their biocidal products, including biocidal product families. We have a wide range of experience with various product types and can offer expert guidance on the requirements of EU No 528/2012, the Biocidal Products Regulation (BPR).
A thorough understanding of a substance’s properties, use patterns and exposure pathways is necessary to demonstrate safety to human health and the environment. Because of our multidisciplinary expertise and building on our track record of higher-tier environmental risk assessment, we have built a full dossier-preparation and support service under the BPR throughout the entire regulatory process, including
- regulatory project management with strategic advice across product ranges, including biocidal product family construction with meta summaries of product characteristics (SPC)
- communication and advocacy meetings with Member State competent authorities
- data-gap analysis
- literature searches and reviews
- letters of access and data sharing negotiations
- placement and monitoring of studies, including higher-tier options
- expert review and evaluation of data
- environmental risk assessments
- human health risk assessments
- endocrine disruptor assessments
- preparation and presentation of position papers, read across and waivers
- support from across the CEA team, including toxicology, ecotoxicology and environmental fate and behaviour
- dossier preparation (IUCLID 6 and SPC Editor), submission (R4BP 3) and follow-up
- coverage of all product authorisation routes and active substance support, including technical equivalence and renewals
- EU BPR Representative offer
- consortium services
- national level support
- training
- software development.
