An exclusive Series Webinar

Biocide Series

Hosted by
Kerona Scientific Ltd
November 28th | 10:00 GMT | Show in my timezone
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Series Schedule

Nov 28

10:00 GMT

Human Health data requirements and risk assessment under the BPR

SESSION 3

Here is What You'll Learn

Introduction

This series of webinars provides a thorough overview of the regulation of biocides in the EU under the BPR, from the regulatory environment in which biocides are marketed, to the data requirements for biocidal products, and the necessary risk assessments required for human health and the environment.

Session 1 – An Overview of the BPR (Regulation (EU) No. 528/2012)

This session provides an understanding of the EU regulation of biocidal active substances, biocidal products and biocidal product families. It goes through the background and fundamentals of Regulation (EU) No 528/2012, including:

–    terminology and definitions

–    biocidal product types and main groups

–    exclusion and substitution criteria

–    the review programme of existing active substances

–    approval of a new active substance in the EU

–    procedures for biocidal product authorisation (union, national, MR, simplified)

–    the biocidal product family concept

–    same biocidal products

–    obligations under Article 95

–    technical equivalence

–    available guidance

–    data protection

–    dossier submission and compilation

–    treated articles

–    in-situ generated active substances


Session 2 - Data requirements for Biocidal Products and Biocidal Product Families under the BPR 

This session provides a good understanding of the data requirements for biocidal products and biocidal product families under the BPR. The training will provide an overview of the data requirements, including:

–    structure of the data requirements (core data set, additional data set)

–    access to protected data

–    avoidance of vertebrate testing

–    possibilities for data waiving

–    available guidance on conducting testing

–    summary of the data requirements, section by section

–    GLP requirements

–    considerations for biocidal product families

–    extrapolation between formulations, minor changes

Session 3 – Human Health data requirements and risk assessment under the BPR


The webinar provides a more detailed understanding of the toxicological data required for the regulation of biocidal products, and goes through the background and fundamentals of human health risk assessment under the BPR, including:

–    introduction to risk assessment, hazard versus risk

–    toxicological data requirements for biocidal products (skin irritation/corrosion, eye irritation, skin sensitisation, respiratory sensitisation, acute toxicity)

–    use of CLP classification based on individual components

–    dermal absorption

–    hazard identification

–    hazard characterisation, dose response relationship

–    exposure calculation

–    case study – worked example of a human health risk assessment for PT18

–    sources of guidance

–    models available

–    primary (direct) versus secondary (indirect) exposure

–    exposure paths

–    exposure scenarios, combined scenarios

–    risk characterisation

–    tiered approach to risk assessment

–    considerations for biocidal product families


Module 4 – Environmental risk assessment under the BPR


The webinar goes through the background and fundamentals of environmental risk assessment under the BPR, including:

–    key parameters and inputs

–    end-points (environmental fate, ecotoxicological)

–    interpretation and refinements of the exposure assessment

–    sources of guidance

–    environmental compartments considered (emission pathways)

–    application scenarios, emission scenario documents

–    calculation of emissions and PECs

–    models available, EUSES 2.2.0

–    risk characterisation

–    risk management measures, refinement options

–    considerations for biocidal product families


Other information

To ensure the most effective training with optimal involvement from the attendees, and encourage attendees to ask questions during the training, places are strictly limited to 30 delegates per webinar.

All registrants to the training webinar will receive a copy of all slides and access to a recording of the webinars for your personal review.

In addition, all registrants to this webinar series will be registered to receive a complimentary copy of the revised and updated 2020 edition of the BPR Vademecum due to be publihed in Jan. 2020.


about

Dr. Irene McGrath

Irene studied Analytical Science at Dublin City University before completing a Ph.D. in Chemistry.


She has spent over 26 years managing Regulatory Departments and working as a consultant for the regulation of plant protection products, biocides, plant biostimulants and fertilisers in the EU.


Irene manages the regulatory team of consultants at Kerona Scientific in Ireland, working with clients worldwide.

about

Catherine Alhaddad


Catherine studied Analytical Chemistry and completed a Masters in Toxicology at Jordan University and has worked for over 12 years as a toxicology and chemistry consultant for the regulation of biocides, plant protection products and REACH in the EU and Middle East.


Catherine is an expert in human health risk assessment, toxicology, classification and labelling and chemistry requirements for active substances and biocidal products, working with many different product types over the years. 

November
28
Thursday
November 28th
10:00 GMT