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 project management with strategic advice across product ranges, including biocidal product family construction with meta SPCs
  • Communication and advocacy meetings with Member State Competent Authorities
  • Data gap analysis
  • Literature searches and reviews
  • Letter 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

Please contact us to discuss your biocide needs.

Risk assessment

Risk assessment

Higher tier exposure scenario development and environmental and human health risk assessment

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Ecotoxicology and risk assessment

Ecotoxicology

Including novel laboratory/outdoor aquatic ecotox studies

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Toxicology

Toxicology

Expert toxicology and risk assessment advice

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Software

Software

Bespoke desktop and web-based software

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Training

Training

Generic and bespoke training courses on various aspects of the environmental risk assessment

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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

To inform product development and defense strategies as well as regulatory submissions

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