Biocides

Biocides

Cambridge Environmental Assessments (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 are 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, CEA can provide a full dossier preparation and support service under the BPR, throughout the entire regulatory process, including:

  • Regulatory strategic advice across product ranges, including biocidal product family construction
  • Communication and advocacy meetings with Member State Competent Authorities
  • Data gap analysis and expert review including data sharing negotiations
  • Literature searches and reviews
  • Placement and monitoring of studies, including higher tier options
  • 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
  • Consortium services
  • National level support
  • Training
  • Software development

Please contact us to discuss your biocide needs or contact Philippa O'Donovan by phone on +44(0)7741 384 448 or email at philippa.odonovan@cea-res.co.uk

 Strategy, Data Gap Analysis and Preliminary Risk Assessment                      

  • Overview of regulatory requirements and processes
  • Review of existing data and identifying data gaps
  • Preliminary risk assessments for human health and the environment for each relevant substance

 Data Sharing and Data Generation                                                                                  

  • Literature search and review
  • Letter of access and data sharing negotiation
  • Study placement, design and monitoring
  • Data review and evaluation

 Dossier Preparation (IUCLID 6, SPC EDITOR)                                                         

  • Human health and environmental risk assessments
  • Representation at meetings with regulators
  • Robust study summaries 

 Dossier Submission (R4BP 3) and Follow-up                                                            

 

Risk assessment

Risk assessment


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Ecotoxicology and risk assessment

Ecotoxicology


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Toxicology

Toxicology


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Software

Software


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Training

Training


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Full dossier support

Full dossier support


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Data gap analysis and expert review

Data gap analysis and expert review


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