Antimicrobials & Biocides

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) 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 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

Antimicrobials & Biocides

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:

On June 29, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will close out notifications of minor pesticide label or product formulation changes to reduce its non-Pesticide Registration Improvement Act (non-PRIA) action backlog. On June 28, 2023, approximately 2,000 antimicrobial actions submitted to the Antimicrobials Division (AD) of EPA prior to October 1, 2022, were closed. This action was intended to save the Agency time and resources to address the remaining notification backlog while maintaining full protection of human health and the environment.

AD now plans to implement a non-PRIA amendment consolidation and prioritization initiative. EPA plans to send registrants two spreadsheets to review. One will show registrant specific overdue label and CSF amendments pending EPA review, and one will allow for the registrant to indicate the top ten priority actions for EPA to address. The second spreadsheet will also allow registrants to indicate if the pending action can be bundled with other pending actions. EPA will contact a restricted number of registrants at a time in order to better manage responses to the initiative.

Registrants should be aware that the non-PRIA backlog covers many years. Registrants are encouraged to review their own records to identify the point of contact listed in each pending non-PRIA action, and ensure that automatic replies are enabled for any employee or consultant no longer supporting the action, and new points of contact be provided.

Please contact us if you need help navigating EPA’s initiatives and understanding registrant responsibilities.

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:

Antimicrobials & Biocides

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

Stuart Green

Stuart Green

Senior Consultant

United Kingdom

Lorna Phillips

Lorna Phillips

Senior Consultant

United Kingdom

Jennifer Stafford's Picture

Jennifer Stafford

Principal Consultant

Washington State

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Stuart Green
Senior Consultant

Expertise: Biocides, REACH & Plant Protection

Stuart specialises in the preparation of dossiers for Biocides and provides technical support for REACH and Plant Protection.

Stuart has over 12 years regulatory affairs experience and previously worked as a Biocides Regulatory Manager for Lonza (now Arxada) and has held Regulatory positions with BWA (now Italmatch) Water Additives and ThermoFischer Scientific. He has experience with active substance registrations under the EU-BPR Review Program, and notification/authorisation of biocidal products, as well as classification and labelling and SDA authoring. Stuart is an industry advocate and active member of trade association expert groups and task forces.

EDUCATION
Ph.D., Organic Chemistry, Newcastle University.
MSc, Environmental Toxicology & Pollution Monitoring, Ultster University (in progress).
BSc (Hons), Chemistry, University of St. Andrews.

Lorna Phillips
Senior Consultant

Expertise: Biocides and plant protection dossier preparation

Lorna specialises in the preparation of dossiers for Biocides and Plant Protection Products, including post-submission support for clients during evaluation by regulatory authorities. Lorna has over 25 years of relevant GLP and regulatory affairs experience.

She has served as a QA auditor for Field Trials, Animal Health Product Development, Environmental Fate and Metabolism, and Chemistry and toxicology departments and as a scientist and Good Laboratory Practice (GLP) Study Director in the Environmental Fate and Metabolism department at Charles River Laboratories (CRL).

EDUCATION
BSc (Hons), Life Sciences, Napier University.

Jennifer Stafford
Principal Consultant

Expertise: Regulatory Compliance, Terrestrial Ecotoxicology, & Wildlife Science.

Jennifer leads CSI’s US Regulatory Affairs team, managing FIFRA and non-FIFRA (crop nutrition) product registrations, including those for biocides and biologicals. Jennifer participates in projects related to ecotoxicology, wildlife biology/ecology, GLP Compliance, database management, and USEPA guideline study management. Jennifer’s skills support regulatory staff, pesticide risk assessment, and endangered species assessments.

Jennifer has over 28 years of field research and laboratory ecotoxicology experience, including 20 years of Good Laboratory Practice (GLP) avian and wildlife study directorship and laboratory management. She has extensive experience interpreting the difference between animal behavior in the wild versus in captivity, and how these differences impact study design, husbandry practices and test results.  She has experience with developing and utilizing large data sets and is thoroughly familiar with EPA and OECD regulatory testing guidelines, Good Laboratory Practices guidelines, EPA and OECD guidance on pesticide risk assessment and EPA process for endangered species Biological Evaluation.

EDUCATION
M.S., Biology/Ecology, Utah State University.
B.S., Environmental Biology, Grand Canyon University.