Antimicrobials & Biocides

EPA Regulatory Affairs

• Regulatory strategies for EPA regulated antimicrobial products
• Agency liaison and registration package preparation and submission

State Registration Management

• First-time registration, renewal, and fee payment support in all 50 states, California, District of Columbia, and US territories
• State and California submission package preparation (applications, labels, SDSs, reports, and authorization letters)

Efficacy Data Development & Study Monitoring

• Identification of required studies to support product efficacy
• Placement and monitoring of tests at Contract Research Organizations (CRO), review, and interpretation of study results

Toxicology & Product Chemistry

• Expert guidance on toxicology, ecotoxicology, and product chemistry
• Study placement and monitoring under required Good Laboratory Practices (GLP)

Risk Assessment

• Hazard identification, effects analysis, exposure assessment, and ecological risk characterization

Regulatory & Scientific Insights

• Advice on emerging regulatory and scientific developments that may impact current and future registrations
• Tailored approaches to bring client products into compliance with new regulations

Task Force Representation & Administration

• Client representation on industry trade association consortia
• Administrative and lead technical roles on chemical task forces

Litigation Support

• Data compensation evaluations
• Scientific case preparation
• Expert witness testimony

Established Reputation within the Biocides Sector
CSI has worked in the European biocides sector for many years and successfully obtained positive listing for several active substances on Annex I of the original Biocidal Products Directive (98/8/EC, BPD). Under both the BPD and subsequent Biocidal Products Regulation (EU) 528/2012 (BPR), numerous biocidal product dossiers, including biocidal product families (BPFs) and Union Authorisations, prepared and submitted by CSI, have received authorisation throughout Europe.

The BPR applies in the 27 member state of the European Union (EU), the additional European Economic Area members (EEA, Iceland, Liechtenstein, and Norway) and also Switzerland – and it imposes significant obligations on companies placing biocidal products on this market.

Regulatory Strategy

• Advice on regulatory options to meet registration requirements for disinfectants (Product Types 1-5), preservatives (PT 6-13), pest control including rodenticides and insecticides (PT 14-20), and other BPR-regulated products such as antifouling products (PT 21) and embalming and taxidermist fluids (PT 22).
• Support in pre-submission meetings with the evaluating Member State Competent Authority (eCA) or European Chemicals Agency (ECHA).

Data Review & Evaluation

• Identification of required studies to support registration intent (data gap analysis):
  • Expert review of existing dataset, including toxicology, product chemistry, analytical chemistry, efficacy, ecotoxicology, and environmental fate.
  • Where necessary, placement, and monitoring of additional studies at Contract Research Organizations (CRO); review and interpretation of results.
  • Preparation of data waivers based on Quantitative Structure-Activity Relationship (QSAR), reach across arguments and/or BPR-guidance.

Hazard, Exposure & Risk Assessments for Human Health & Environment

• Extensive experience in all aspects of human health (including dietary risk and livestock exposure) and environmental assessment in line with the BPR guidance document and Emission Scenario Documents (ESDs).
  • Application of various models, including: ConsExpo, BEAT, ART, EUSES or bespoke approaches, as required.
  • Endocrine Disruption assessments in accordance with European Food Safety Authority (EFSA) / European Chemicals Agency (ECHA) guidance.

Registration Dossier Preparation & Submission

• Extensive experience in preparing dossiers in IUCLID format and submission via R4BP3 under the EU BPR, whether for:
  • Active substance dossiers.
  • Biocidal product dossiers (single products of BPFs) whether for a single member state (National Authorisation (NA)), groups of member states (NA + Mutual Recognition), or all Member States (via Union Authorisation).
• During the evaluation process we can liaise with the eCA, and where necessary (ECHA) and the European Commission, until the approval is granted. 
• Support for post-approval changes, or generation of renewal dossiers. 

Although the UK left the EU on 31^st January 2020, the Biocidal Products Regulation (BPR) was transposed into UK law almost unchanged, so the provisions of the Regulation apply in full in the UK. However, under the terms of the Withdrawal Agreement and Northern Ireland Protocol, EU-BPR legislation continues to apply in Northern Ireland (NI). Therefore, the GB BPR applies to Great Britain (GB) only (i.e. England, Scotland and Wales). The Health and Safety Executive (HSE) remains the national regulator for the whole of the UK (i.e. GB + NI). Some divergence has occurred through changes to both the EU – and GB-BPR legislation and guidance, though many aspects remain identical.

Regulatory Strategy

• Advice on regulatory options to meet registration requirements for disinfectants (Product Types 1-5), preservatives (PT 6-13), pest control including rodenticides and insecticides (PT 14-20), and other BPR-regulated products such as antifouling products (PT 21) and embalming and taxidermist fluids (PT 22) in GB.
• Support in pre-submission meetings with the HSE.
• Some clients wish to submit dossiers under both EU- and GB-BPRs at the same time, we can advise on the best approaches.

Data Review & Evaluation

• Identification of required studies to support registration intent (data gap analysis);
  • Expert review of existing dataset, including toxicology, product chemistry, analytical chemistry, efficacy, ecotoxicology, and environmental fate.
  • Where necessary, placement, and monitoring of additional studies at Contract Research Organizations (CRO); review and interpretation of results.
  • Preparation of data waivers based on Quantitative Structure-Activity Relationship (QSAR), read across arguments and/or BPR-guidance.

Hazard, Exposure & Risk Assessments for Human Health & Environment

• Extensive experience in all aspects of human health (including dietary risk and livestock exposure) and environmental assessment in line with the BPR guidance document and Emission Scenario Documents (ESDs).
  • Application of various models, including: ConsExpo, BEAT, ART, EUSES or bespoke approaches, as required.
  • Endocrine Disruption assessments in accordance with European Food Safety Authority (EFSA)/European Chemicals Agency (ECHA) guidance.

Registration Dossier Preparation & Submission

• Extensive experience in preparing dossiers in IUCLID format and submission via HSE portal under the GB-BPR, whether for:
  • Active substance dossiers.
  • Biocidal product dossiers (single product or BPFs). Note that, at present an evaluation performed by HSE for Northern Ireland, cannot be mutually recognized in other EU-member states.
• During the evaluation process we can liaise with the HSE, until the approval is granted.
• Support for post-approval changes, or generation of renewal dossiers.