Endocrine Disruptors

March 1st and 2nd, 2021 – Conference
Berlin, Germany

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Programme as PDF

Monday, 1st March 2021

8.30 Registration and Coffee

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

The EU’s New Green Deal:
The Future of Chemicals Regulation from the Industry’s Perspective

• Relevant trends in global product stewardship
• Chemicals regulation: the EU and country specific requirements
• Key elements of the New Green Deal
• How to encourage sustainability
Dr Volker J. Soballa, Vice President, Head of Product Stewardship,
Corporate ESHQ, Evonik Industries AG, Germany

Regulation of Endocrine Disruptors: Challenges for the Industry
• Criteria and identification of Endocrine Disruptors
• Hazard vs risk and how it affects safety
• Industrial chemicals, biocides, plant protection products:
current issues from the industry’s point of view
• The ECHA/EFSA Guidance and how to work with it
• Impact on related regulation: REACH and CLP
Ellen Dhein, Product Stewardship, Bayer AG, Germany

10.20 Coffee Break

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

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

12.30 Lunch Break

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

Risk Assessment With Plant Protection Products: Objectives and Methods
• Concerns with regard to PPP and residues
• Focal points of research within EFSA’s Pesticide Unit
• The regulatory framework on terrestrial ecotox
• Soil organisms, the soil ecosystem and how they are affected by Endocrine Disruptors
• A hazard based approach for the identification of endocrine disrupters in non target organisms
• SPG: the concept of Specific Protection Goal Options
Maria Arena, Scientific Officer, European Food Safety Authority (EFSA)

15.30 Coffee Break

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

16.50 Chairman’s Closing Remarks

17.00 End of Day One

Tuesday, 2nd March 2021

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

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

Japanese Approach to Endocrine Disrupting Effects of Chemicals:

• 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

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

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

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

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

How to Develop Methods, Processes and Tools to Increase the Robustness
and Transparency of Regulatory Decisions in the Face of the Uncertainties

• The evaluation of endocrine disrupting substances: the need for a plurality of scientific perspectives
• The role of risk perception
• Uncertainties we have to live with: technical, methodological, epistemic and societal
• The scientific debate around Endocrine Disruptors
• Methods, processes and tools: the path to good regulatory answers
Annegaaike Leopold, Adjunct Professor, Institute of Resources, Environment and Sustainability, University of British Columbia, Canada

17.00 Chairman’s Closing Remarks

17.10 End of the Conference


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