Endocrine Disruptors

The conference dives right into the ongoing debate surrounding the challenging implementation of the ECHA/EFSA guidance for the identification of Endocrine Disruptors and provides participants with all the recent regulatory and scientific developments.

Garantierte Durchführung
30.11. — 01.12.2023
Live Stream
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ÜbersichtProgrammReferent:innenVeranstaltungsortPreise & Leistungen

Übersicht

The Conference will be taking place in Cologne/Germany on 30 November and 1 December and you can follow all the exciting contributions via our live stream!

Would you instead prefer to join on-site in Cologne? Then you can find further information here.

The ECHA/EFSA guidance for the identification of Endocrine Disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 requires a highly complex and challenging assessment for all active substances. With the proposed introduction of stricter regulation for EDs under the CLP and REACH Regulations, the challenge has recently been broadened. This conference will dive into the debate surrounding Endocrine Disruptors and covers all the relevant recent regulatory and scientific developments.

Highlights

Regulatory Developments

  • Update from the EU Commission: ED-related activities
  • REACH Revision and impact on requirements for ED substances
  • The German BfR on regulatory developments relevant for PPPs and Biocides

Methods: Studies, NAMs & AOPs

  • The EU Commission’s JRC on better assessment of endocrine disruptors using non-animal approaches
  • The US Environmental Protection Agency on thyroid-relevant bioassays in ToxCast: aligning with the Adverse Outcome Pathway Network
  • Mechanistic modelling of thyroid hormone disruption as a new approach methodology (NAM) for human risk and hazard assessment: the state of the science: A mathematical model of thyroid homeostasis for multiple mammalian species, including humans
  • Update on the OECD’s ED-related activities
  • Dietary restriction: Amphibian Metamorphosis Assay

Who should attend this conference?

Professionals working in the fields of:

  • Toxicology and ecotoxicology
  • Research and development
  • Registration, regulatory affairs
  • Chemical risk assessment
  • Legal and general counselling

Sectors that should take part:

  • Chemical/biocide/agrochemical/pharmaceutical/cosmetic industries
  • Research institutes
  • Regulatory authorities
  • Environmental and health risk consultants
  • Testing laboratories and contract research organisations (CROs)
  • NGOs*Professional associations

Picture Credit: © Subbotina Anna/shutterstock.com, © chestra - Fotolia.com

 

Programm

Thursday, 30 November 2023

PLEASE NOTE: The indicated times refer to Central European Time CET.

For further time zones, please view here.



Morning Session | 09:30 – 13:05 CET
09:00
On-site registration & opening of the virtual meeting room
09:30
Welcome address by the organisers and the Chairs

Lennart Weltje, BASF, Germany
Emily McVey, National Institute for Public Health and the Environment (RIVM) The Netherlands

The presentation slots include sufficient time for questions and answers.
Regulatory Developments
09:40
Update on endocrine disruptors-related activities
  • CLP
  • Information requirements for the REACH Annexes
  • PPP-relevant activities

Jordane Wodli, European Commission, Belgium

10:15
State of play of ED under REACH
  • Way forward under CLP
  • Interplay of Candidate List and Annex VI
  • Consulting the crystal ball: Outlook and pitfalls

Christian Unkelbach, Federal Institute for Occupational Safety and Health (BAuA), Germany

10:50
REACH Revision and impact on requirements for ED substances – an indutstry view
  • Information requirement for the Reach Annexes
  • REACH Annexes update

Heli Hollnagel, Dow Europe, Switzerland

11:25
Coffee break
11:55
Linking adverse outcome to the endocrine activity in the context of the EU regulation for endocrine disrupting chemicals

Iris Mangas, European Food Safety Authority, Italy (virtual presentation)

12:30
Biocides and plant protection products: Recent regulatory developments (human health-relevant)
  • New Hazard Classes for ED in the CLP Regulation
  • Changes in the Guidance
  • Impact on Biocides and Plant Protection Products

Vera Ritz, Federal Institute for Risk Assessment, Germany

13:05
Lunch break


Afternoon Session 14:15 – 17:40 CET
14:15
Industry perspective on the ECHA ED Draft Guidance CLP
  • Presentation of cases for ED category 1 or 2 / no classification
  • Challenges in using NAMs for classification purposes
  • Expanding scope of ED

Helen Tinwell, Bayer CropScience, France

14:50
Global perspectives on the regulatory framework for endocrine disrupting chemicals
  • Regulatory situation in the EU ‘one substance, one assessment’
  • Considerations and/or approaches to regulate EDCs in a global context
  • Challenges

Bieke Scharlaken, knoell Germany, Germany

15:25
Coffee break
Methods: Studies, NAMs & AOPs
15:55
Thyroid-relevant bioassays in ToxCast: Aligning with the Adverse Outcome Pathway Network
  • Thyroid-relevant bioassay data in the publicly available ToxCast database and their review
  • Example case studies of a few chemicals and interpretation of bioactivity assay data
  • Work-in-progress on understanding thyroid-relevant bioactivity in the maternal-fetal dose context

Katie Paul Friedman, United States Environmental Protection Agency (US EPA), United States (virtual presentation)

16:30
Better assessment of endocrine disruptors using non-animal approaches
  • JRC’s scientific and strategic input to the activities relevant to the Community Strategy on Endocrine Disruptors
  • Thyroid validation study
  • APCRA classifier for chemicals with ER- and AR-mediated activity
  • Better use of academic data for ED identification
  • Readiness criteria for validation of in vitro methods relevant to characterisation of endocrine disruptors

Effrosyni Katsanou, European Commission’s Joint Research Centre, Italy

17:05
Population relevance of endocrine disruptors
  • Presenting different modelling solutions
  • Consideration of field studies and monitoring approaches
  • Case studies

Alice Tagliati, Enviresearch, United Kingdom

17:40
End of the first day


Friday, 1 December 2023

PLEASE NOTE: The indicated times refer to Central European Time CET.

For further time zones, please view here.



Morning Session | 09:30 – 13:30 CET
09:30
Brief address by the Chairs

Lennart Weltje, BASF, Germany
Emily McVey, National Institute for Public Health and the Environment (RIVM) The Netherlands

Continuation: Methods, Studies, NAMs & AOPs
09:40
ED-related activities
  • General updates on recent TGs approved and draft TGs on the work plan
  • In-vitro thyroid assays and work of the OECD Expert Group
  • OECD GHS group on ED

Anne Gourmelon, Organisation for Economic Co-operation and Development (OECD), France (virtual presentation)

10:15
Human epidemiology: Trends in hormone-related diseases and conditions – an epidemiological analysis?

Eva Vanna Lorenza Negri, University of Bologna, Italy

Thyroid
10:50
Mechanistic modelling of thyroid hormone disruption as a new approach methodology (NAM) for human risk and hazard assessment: the state of the science
  • Current approaches
  • Quantitative and qualitative differences between humans and laboratory species
  • A mathematical model of thyroid homeostasis for multiple mammalian species, including humans
  • The different approach taken in current mathematical models
  • Future steps identified

Alex Charlton, Syngenta, United Kingdom

11:25
Coffee break
11:55
An Amphibian Metamorphosis Assay (AMA) dietary restriction study: Lessons for data interpretation
  • The results of an AMA study conducted with five different feeding rations equivalent to 50% to 5% of the recommended feeding rate
  • Implications for the Test Guideline and testing strategies
  • Maximum Tolerable Concentration setting
  • Test Guideline decision logic
  • General lessons for the assessment of endocrine disrupting properties

James Wheeler, Corteva Agriscience, The Netherlands

12:30
The ENDpoiNTs project: identifying endocrine disruption-induced developmental neurotoxicity – thyroid disruption and beyond
  • Establishment of novel in vitro ED-DNT assays ready for, or in the process of, pre-validation
  • Sex-specific DNT effects of EDCs found using in vitro and in vivo models
  • First tier ED-DNT screening in silico tools (QSARs) developed for endocrine-induced neurodevelopmental effects

Pim Leonards, Vrije Universiteit Amsterdam, The Netherlands

13:05
Summary and final discussion

Referent:innen

 

Name

Unternehmen

Alex Charlton

Syngenta, United Kingdom

Alex Charlton is a Senior Ecotoxicologist and Technical Expert with Syngenta. His focus is Regulatory toxicology, with a special attention to Mechanistic Toxicology.

mehrweniger
Gourmelon

Anne Gourmelon

Organisation for Economic Co-operation and Development (OECD), France

Anne Gourmelon has been working for the Organisation for Economic Co-operation and Development (OECD) for twenty years. She started as a Project Manager for chemical safety, including the validation of methods for endocrine disruptors screening and testing, and is now Principal Administrator of the OECD’s Test Guidelines Programme. The programme aims at the development and harmonisation of test methods for chemical safety to meet regulatory needs in OECD member countries, and to enable the mutual acceptance of data across countries.

mehrweniger
Hollnagel

Heli M. Hollnagel

Dow Europe, Switzerland

countries, and to enable the mutual acceptance of data across countries. Heli M Hollnagel is a EUROTOX registered Toxicologist, working as Regulatory Toxicologist and EMEA Science Leader at Dow Europe. She is also the Chair of Cefic's Polymers Issue Team and Cefic's LRI Issue Team, as well as a member of the ECETOC Scientific Committee.

mehrweniger
Katsanou

Effrosyni Katsanou

European Commission - Joint Research Centre, Italy

Effrosyni Katsanou is a project officer in the European’s Commission Joint Research Centre (JRC) in Ispra, Italy. Her role includes scientific input to the activities relevant to the Community Strategy on Endocrine Disruptors such as the REACH information requirements update relevant to EDs, the new ECHA guidance document in relation to the new hazard classes for EDs under the CLP regulation, OECD’s activities on endocrine disruptors as well as involvement in PARC-related ED activities. She is a member of the OECD’s Expert Group on better use of academic data and she is leading a case study on how to better use academic data for ED identification.

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Leonards

Pim Leonards

Vrije Universiteit Amsterdam, The Netherlands

Pim Leonards is a Professor for Environmental Bioanalytical Chemistry at Vrije Universiteit Amsterdam. He has more than 20 years of experience in field and experimental studies related to environmental chemistry, analytical method development, bioaccumulation, indoor exposure assessment, and metabolomics. Nowadays, his focus is on emerging chemicals, indoor exposure assessment and metabolomics.

mehrweniger

Iris Mangas

European Food Safety Authority (EFSA), Italy

Iris Mangas is a Regulatory Toxicologist. She holds a Ph D in molecular toxicology. Since 2018, she has been a Scientific Officer at EFSA. She is currently in charge of the Peer Review of Pesticides Risk Assessment and supports the developmental activities for improving EFSA Risk assessment methods in the area of developmental neurotoxicity and Endocrine Disruptor properties, including development of IATA case studies and AOPs.

mehrweniger
McVey

Emily McVey

National Institute for Public Health and the Environment (RIVM), The Netherlands

Emily McVey is an experienced Regulatory Toxicologist and works at the dutch National Institute for Public Health and the Environment – RIVM. Her specialties include environmental toxicology, wild vertebrates (birds, mammals, amphibians, fish), molecular mechanisms of toxicity, neurodevelopmental toxicity and endocrine disruption testing and assessment.

mehrweniger

Eva Vanna Lorenza Negri

University of Bologna, Italy

Eva Vanna Lorenza Negri is an Associate Professor at the Department of Medical and Surgical Sciences at the University of Bologna. Her main interests are epidemiology and biostatistics, in particular cancer epidemiology, occupational epidemiology, environmental epidemiology and statistical methods for descriptive and observational epidemiology.

mehrweniger
Paul Friedman

Katie Paul Friedman

United States Environmental Protection Agency (US EPA), United States

Katie Paul Friedman joined the National Center for Computational Toxicology in the Office of Research and Development at the US EPA in August 2016, where she is currently focused on integration of multiple information streams to address the needs of preliminary risk assessment, with additional interests in uncertainty in alternative and traditional toxicity information, endocrine bioactivity prediction and in vitro kinetics. Previously, she worked as a Regulatory Toxicologist at Bayer CropScience with specialties in neurodevelopmental and endocrine toxicity, high-throughput science, and predictive toxicology. She has been actively involved in multi-stakeholder projects to develop adverse outcome pathways, alternative testing approaches, and the regulatory acceptance of these tools.

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Ritz

Vera Ritz

Federal Institute for Risk Assessment (BfR), Germany

Vera Ritz is Head of the Unit „Steering and Overall Assessment Biocides“ in the Department „Pesticides Safety“ at the Federal Institute for Risk Assessment (BfR) in Berlin. She has been working at the BfR since 2006 and is involved in assessments, conceptual and research activities regarding EDs.

mehrweniger
Scharlaken

Bieke Scharlaken

knoell, Belgium

Bieke Scharlaken is a Regulatory Ecotoxicologist at knoell Germany. She studied Biotechnology at Ghent University in Belgium and is holding a PhD in Biochemistry. Before joining knoell in 2020, she worked in the crop protection and biocide industry in various regulatory roles, for 10 years. At knoell she works in the crop protection sector with a focus on ecotoxicology as well as regulatory affairs. She is also part of the knoell ED expert team and is involved in the assessment of active substances (biocides and crop protection) and co-formulants with respect to endocrine disrupting properties.

mehrweniger
Tagliati

Alice Tagliati

Enviresearch, United Kingdom

Alice Tagliati is a Senior Ecotoxicologist at Enviresearch. She provides environmental risk assessments for plant protection products active substances and related formulations to aid products registration in the EU. Alice has a keen interest in ecotoxicological modelling, and at Enviresearch she specialised in in novel ecotoxicological approaches such as population modelling to answer regulatory questions.

mehrweniger
Tinwell

Helen Tinwell

Bayer CropScience, France

Helen Tinwell has a PhD in genotoxicity and joined Bayer Crop Science in 2005 after having spent 17 years at Syngenta. Until recently, she has worked in research toxicology focusing on method development and mode of action investigations to address endocrine disruption. In 2017 she became team leader of the Regulatory Toxicology group. She leads the development and application of testing strategies for evaluating potential endocrine-disrupting properties of plant protection molecules in mammals and is a member of the ECPA ED Expert Group.

mehrweniger
Unkelbach

Christian Unkelbach

Federal Institute for Occupational Safety and Health (BAuA), Germany

Christian Unkelbach holds a PhD in chemistry and a certificate in toxicology. He is currently a scientific officer at the Federal Institute for Occupational Safefy and Health (BAuA), the German Competent Authority for REACH, Biocides, CLP and PIC regulations. Christian serves as the Alternate German member in ECHA's Member State Committee and participates in the Endocrine Disruptors Expert Group.

mehrweniger
Weltje

Lennart Weltje

BASF, Germany

Lennart Weltje holds a PhD in ecotoxicology and environmental chemistry and currently works as a Senior Ecotoxicologist at BASF conducting risk assessments for PPPs and biocides. He is also an honorary Professor at the Faculty of Agricultural Sciences of the Georg-August University in Goettingen. His former stations include the Dutch National Institute for Public Health and the Environment (RIVM).

mehrweniger
Wheeler

James Wheeler

Corteva Agriscience, United Kingdom

James Wheeler works as Global Regulatory Ecotoxicologist at Corteva Agriscience. His work focuses on environmental risk assessment and ecotoxicology testing. He has a particular interest in fish and amphibian endocrine test methods and is a member of several industry and OECD work groups active in this area.

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Jordane Wodli

European Commission, Belgium

Jordane Wodli currently serves as a policy advisor national expert on chemicals in the European Commission’s DG Environment.

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