Sector
Antimicrobials & Biocides
CSI has an established reputation in supporting registration of a diverse range of biocidal products including disinfectants, sterilizers, preservatives, and unique antimicrobial applications. We support clients introducing their products in North American and European markets through cost-effective strategies.
In the US, we help clients with US Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) regulated antimicrobial products, as well as State registration management. In Europe, we assist with active substance approval and biocidal product authorizations to comply with European Economic Area (EEA) (i.e. EU27 plus Iceland, Liechtenstein and Norway) and UK requirements. We also support the global marketplace and have successfully assisted firms with registrations in Canada, Latin America, Asia (China/Taiwan), Australasia, and other geographical markets.
Experienced Support For:
- Global Regulatory Strategy
- Dossier Preparation & Submission
- Regulatory Agency Liaison
- Human Health & Environmental Risk Assessment
- Endocrine Disruptor Data Review
- Task Force Representation & Administration
- Applied Economic Analysis
Antimicrobial Support in North America
EPA Regulatory Affairs
- Regulatory strategies for EPA and FDA 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, District of Columbia, and US territories
- State submission package preparation (applications, labels, SDSs, technical data, reports, authorization letters, product summaries)
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 for required Good Laboratory Practice (GLP) data
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
- Our staff serve in management, administrative and lead technical roles on chemical task forces
Litigation Support
- Data compensation evaluations
- Intellectual property assessment
- Scientific case preparation
- Expert witness testimony
Biocides Support in Europe (EEA)
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 to the Biocidal Products Directive (BPD). Under both the BPD and Biocidal Products Regulation (EU) 528/2012 (BPR), numerous biocidal product dossiers, including frame formulations and union authorisation, prepared and submitted by CSI, have received authorisation throughout Europe, and we have extensive experience through participation in the four existing active substance review lists.
The BPR applies to the EEA - the 27 EU Member States, plus Iceland, Liechtenstein, and Norway - and imposes significant obligations on companies placing biocidal products on the EEA market.
Registration Dossier Preparation & Submission
- Preparation and submission of active substance dossiers for approval under the EU BPR
- Preparation and submission of biocidal product / Biocidal Product Family (BPF) dossiers for EEA Member States (i.e. EU-27 plus Iceland, Liechtenstein and Norway) including union authorisation and mutual recognition
- Liaison with European regulatory agencies including European Chemicals Agency (ECHA) and the European Commission, in addition to EEA Member State national regulatory authorities
- Support for Post Annex I (re-)registration and existing product registration needs
- Extensive experience with International Uniform ChemicaL Information Database (IUCLID) and R4BP3 submissions
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)
- Identification of required studies to support registration intent, data gap analysis, placement, and monitoring of tests at Contract Research Organizations (CRO), review and interpretation of study results, and assurance of compliance with Good Laboratory Practice (GLP) standards
- Preparation of data waivers based on Quantitative Structure-Activity Relationship (QSAR), read across arguments, generation of frame formulations, and acceptable justifications
- Organisation for Economic Co-operation and Development (OECD) format dossiers
- Litigation support including data compensation evaluations, intellectual property assessment, scientific case preparation, and expert witness testimony
Data Review & Evaluation
- Expert data review and evaluation for mammalian toxicology including Endocrine Disruptor (ED) assessments, product chemistry, analytical chemistry, efficacy, ecotoxicology, and environmental fate of subject products
Hazard, Exposure & Risk Assessments for Human Health & Environment
- Extensive experience in all aspects of human health and environmental assessment
- Application of various models, including: ConsExpo, BEAT, BPD TNsG, EUSES and ESD
- ED assessments in accordance with European Food Safety Authority (EFSA)/European Chemicals Agency (ECHA) guidance
Task Force Management
- Our staff serve in management, administrative and lead technical roles representing clients in industry task forces
Litigation Support
- Data compensation evaluations
- Intellectual property assessment
- Scientific case preparation
- Expert witness testimony
Biocides Support in Europe (UK)
Although the UK left the EU on 31st 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).
Registration Dossier Preparation & Submission
- Preparation and submission of active substance dossiers for approval under the GB Biocidal Products Regulation (GB BPR)
- Preparation and submission of biocidal product / Biocidal Product Family (BPF) dossiers under the GB BPR
- Liaison with European regulatory agencies including European Chemicals Agency (ECHA) and the European Commission, if necessary
- Support for Post Annex I (re-)registration and existing product registration needs
- Extensive experience with International Uniform ChemicaL Information Database (IUCLID) and R4BP3 submissions
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)
- Identification of required studies to support registration intent, data gap analysis, placement, and monitoring of tests at Contract Research Organizations (CRO), review and interpretation of study results, and assurance of compliance with Good Laboratory Practice (GLP) standards
- Preparation of data waivers based on Quantitative Structure-Activity Relationship (QSAR), read across arguments, generation of frame formulations, and acceptable justifications
- Organisation for Economic Co-operation and Development (OECD) format dossiers
- Litigation support including data compensation evaluations, intellectual property assessment, scientific case preparation, and expert witness testimony
Data Review & Evaluation
- Expert data review and evaluation for mammalian toxicology including Endocrine Disruptor (ED) assessments, product chemistry, analytical chemistry, efficacy, ecotoxicology and environmental fate of subject products
Hazard, Exposure & Risk Assessments for Human Health & Environment
- Extensive experience in all aspects of human health and environmental assessment
- Application of various models, including: ConsExpo, BEAT, BPD TNsG, EUSES and ESD
- ED assessments in accordance with EFSA/ECHA guidance
Task Force Management
- Our staff serve in management, administrative and lead technical roles representing clients in industry task forces
Litigation Support
- Data compensation evaluations
- Intellectual property assessment
- Scientific case preparation
- Expert witness testimony
Industry Note:
Emerging Viral Pathogen Update:
EPA has added Monkeypox virus to the list of Emerging Viral Pathogens. Product labels containing EPA’s Emerging Viral Pathogen (EVP) claim terminology, and which claim efficacy against an appropriate tier of viral pathogens, can now apply EPA’s EVP guidance to OFF-LABEL claims against the monkeypox virus. EPA’s Emerging Viral Pathogen listing currently contains the following viruses:
Contact CSI to learn more about how you may apply the EVP to your product claims, or if you need assistance amending your product label to take advantage of the EVP provisions.
Industry Note:
Article 95 List
A biocidal product consisting of, containing, or generating a relevant substance, cannot be made available on the EU market unless the substance supplier or product supplier is included in the list for the product type(s) to which the product belongs.
The suppliers on the Article 95 list comprise:
- Participants in the Review Programme
- Supporters of new active substances, who have submitted a dossier under Article 11 of the Biocidal Products Directive (Directive 98/8/EC) or under Article 7 of the Biocidal Products Regulation
- Submitters of product authorisation applications where the application includes an alternative active substance dossier (the so called ‘third party dossier’)
- Suppliers who submitted an application in accordance with Article 95(1) of the BPR and which has been found compliant by ECHA
Antimicrobials & Biocides Experts
Jennifer Stafford
Principal Consultant
Washington State
