Programme as PDF

Monday, 1st March 2021

8.30 Registration and Coffee

9.00
Opening Remarks
Dr Bjoern Nehls, Director, Chem-Academy, and
Dr Volker J. Soballa, Vice President, Head of Product Stewardship,
Corporate ESHQ, Evonik Industries AG

9.20
Regulation of Endocrine Disruptors: Challenges for the Industry
• Criteria and identification of Endocrine Disruptors
• Harmonized European approach on ED under the Green deal (CLP, data requirements)
• Industrial chemicals, biocides, plant protection products:
current issues from the industry’s point of view
• The ECHA/EFSA Guidance and how to develop from that a horizontal one
Ellen Dhein, Director Environmental Policy, Bayer AG, Germany

10.10 Coffee Break

10.40
Test Methods and ED Identification
• Progress in the FREIA project as part of the EURION cluster
• Linking biomarkers to female reproductive toxicity and test methods for measuring
• Indicators for reducing the need for test animals in the future
• Possible pathways to explain how EDs can cause female reproductive disorders
• Test methods to predict a chemical’s effect on female reproductive health
• Test methods to identify human-made chemicals that disturb hormones
Prof Dr Majorie van Duursen, Faculty of Science, E&H: Environmental Health and Toxicology, Vrije Universiteit Amsterdam, The Netherlands

11.30
Assessment of Endocrine Disruption in Ecotoxicology – an Update on EU Developments
• Regulatory context (ED guidance and regulation)
• OECD framework and guidance
• Tests for activity and adversity
• Data interpretation and difficulties
Prof Dr Lennart Weltje, Senior Regulatory Scientist, BASF SE, Germany

12.20 Lunch Break

13.40
Assessment of EDs in the Biocides Sector
• Criteria of Endocrine Disruptors and ECHA’s ED Guidance
• From scientific information and regulatory data to measures of the authorities
• Assessment on human health: conclusions so far
• How ECHA’s ED Expert Group works
• Product and product family:
assessing Endocrine Disruptors in Biocidal Products
Sander van der Linden, PhD, Scientific Officer, European Chemicals Agency (ECHA), Finland

14.30
The ECHA/EFSA Guidance for the Hazard Identification of Endocrine Disruptors in the Context of Regulation 1107/2009
• Current test methods and knowledge for the identification on ED in non-target vertebrates
• Challenges in the hazard identification of ED for non-target vertebrates
• Available test methods and knowledge gaps for invertebrates
• Available test methods and knowledge gaps for non-EATS modalities in non-target organisms
Maria Arena, Scientific Officer, European Food Safety Authority (EFSA)

15.20 Coffee Break

15.50
Weight of Evidence for Mechanistic Data including ED
• The objectives and nature of Weight of Evidence (WOE) considerations for mechanistic data
• Evolution of WOE in Mode of Action and Adverse Outcome Pathway Analysis
• Integration with systematic methods for data assimilation and assessment
• Potential path forward
Bette Meek, Ph.D., Associate Director, Chemical Risk Assessment,
McLaughlin Centre for Risk Science, University of Ottawa, Canada

16.40
Endocrine Disruptors: Hazard and Risk from a US Perspective
• Hazard vs risk: the US vs the EU’s approach
• Endocrine pathways: efficient hazard identification of EDCs
• Potency ad threshold effects
• Synthetic EDs and natural EDs
• Pesticides, biocides, industrial chemicals: impact on uses
• Where is the US regulation heading?
Dr Christopher J. Borgert, President & Principal Scientist, Applied Pharmacology and Toxicology, Inc., USA

17.30 Chairman’s Closing Remarks

17.40 End of Day One

Tuesday, 2nd March 2021

8.40
Chairman’s Opening Remarks
Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ,
Evonik Industries AG

8.50
Recent Experiences and Challenges With the ECHA/EFSA ED Guidance:
EU vs. Global Requirements
• Requirements of the ED Guidance, challenges and related workload
• Testing vs non-testing – “sufficiently investigated?” and first experiences
• Regulatory view on potential Endocrine Disruptors worldwide:
Europe vs the Americas and Asia
• Recommendations for dealing with ED assessments on a global scale
Dr Daniela Fruth, Ecotoxicology/Regulatory Affairs, Industrial Chemicals & Biocides, knoell Germany GmbH, Germany

9.40
Japanese Approach to Endocrine Disrupting Effects of Chemicals:
EXTEND2016
• Outline of the Japanese programme on endocrine disrupting effects of chemicals: EXTEND2016
• Testing and assessment under EXTEND2016
• Bilateral collaboration and contribution to OECD Test Guidelines Programme
• Path forward to regulatory environmental risk assessment
• Environmental risk assessment under Japanese Chemical Substances Control Law
Dr Kunihiko Yamazaki, Environmental Health Department,
Ministry of Environment (MOE) Japan, Japan

10.30 Coffee Break

11.00
Breaking Down the Wall Between Human Health and Environmental Testing
• The ERGO project as part of the EURION cluster
• Aiming at a new approach for identifying endocrine effects
• Key questions on thyroid hormone disruption
• Endocrine Disruption and AOPs: current research and understanding
• What does ecotox tell us about human toxicology?
• And what does it not tell?
Prof Dries Knapen, Associate Professor, Department of Veterinary Sciences, University of Antwerp

11.50
State of the Research on Metabolic Effects of ED Chemicals
• Objectives and framework of the EDCMET project
• EDCMET and the EURION cluster
• Adverse effects of metabolism disrupting chemicals
• Development of validated test methods to assess metabolic effects of EDs
• Identifying molecular initiating events linked to adverse outcomes
• Highlights of research results
Jenni Küblbeck, PhD, Project Researcher, Scientific manager | EDCMET, University of Eastern Finland, AIV Institute for Molecular Sciences, Finland

12.40 Lunch Break

14.00
Applying the ED Criteria to Pesticides and Implications for Other Chemical Sectors
• Applying ED criteria to pesticides: state of play
• EU vs rest of the world
• Challenges with implementation
• The problem with lists
• EU Chemicals Strategy for Sustainability: extending the criteria (and Guidance?) to less data rich chemical sectors?
Dr Andy Adams, Global Issue Management lead – Insecticides, Bayer S.A.S., France

14.50
Endocrine Disruptors and Health Risks – the Epidemiology’s Perspective
• Epidemiological trends: health and quality of life
• Endocrine modulation in human biology
• Endocrine Disruption: the point of view of medical science(s)
• Which kind of tox data is required?
• The role of risk perception for health
Dr Alfred Pauls, Senior Consultant, ZEG Berlin, Germany

15.20 Coffee Break

16.10
Increasing the Robustness and Transparency of Regulatory Decisions in the
Face of the Uncertainties
• The need for a plurality of scientific perspectives, taking endocrine disruptor evaluation as an example
• Distinction between the different types of uncertainties we have to deal with: technical, methodological, epistemic and societal uncertainties and how a difference in tolerance of risk and
uncertainty can feed into scientific controversies.
• Case description: scientific debate around Endocrine Disruptor evaluation
• Discussion of methods, processes and tools we could apply on the path to good regulatory answers
Annegaaike Leopold, Consultant at Calidris Environment BV, The Netherlands, and
Adjunct Professor, Institute of Resources, Environment and Sustainability (IRES),
University of British Columbia, Canada

17.00 Chairman’s Closing Remarks

17.10 End of the Conference

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