Endocrine Disruptors

Monday, 11th September 2023

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

9.10
Key Elements of the EU’s Chemical Strategy

• Product stewardship – global challenges
• Chemicals regulation in the EU: Endocrine Disruptors within the big picture
• How do we encourage innovation?
• Enhancing sustainable solutions – the future of product stewardship

Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ, Evonik Industries AG, Germany

9.50
Regulation of Endocrine Disruptors as Part of the EU’s Chemical Strategy

• The Green Deal and sustainability – main objectives
• The EU’s chemical strategy: key elements to be implemented by the chemical industry
• REACH and CLP as key elements of European regulation
• Taxonomy and sustainability
• The timeline for upcoming changes

Julien Fabre, Policy Officer, DG ENV, European Commission

10.30     Coffee Break

11.00
Endocrine Disruptors – ECHA’s Point of View

• CLP criteria for Endocrine Disruption: the regulatory framework
• ECHA’s work on the CLP Guidance for the new ED criteria
• Recommended action for companies

Francesca Pellizzato, Scientific Officer, European Chemicals Agency (ECHA)

11.40
Legal Aspects in ED Regulation

• Relevant legal frameworks in the EU

– REACH and SVHCs from a legal point of view
– Biocides and plant protection products

• Active substance approval
• Considerations for product authorizations

– CLP
– new ED hazard classes
– One Substance one assessment (OSOA)

• Legal rights and remedies:

– During the process
– Once a regulatory decision has been adopted

Hannah Widemann, Lawyer in Chemicals & Environmental Law, Steptoe & Johnson LL, Belgium

12.20     Lunch Break

13.40
Points to Consider in Endocrine Disruptor Assessment

• Experiences so far: acceptance by the authorities
• How to figure out a realistic time schedule
• Practical examples from screening thyroid hormones
• Financial aspects for conducting studies
• NAMs and their uncertainties

Annegaaike Leopold, Director Corporate Development, ibacon GmbH, Germany

14.20
Amphibian Toxicity Testing for Identification of Thyroid Disrupting Chemicals

• Amphibian test guidelines for detecting thyroid activity and adversity
• Amphibian metamorphosis assay (AMA) vs larval amphibian growth and development assay (LAGDA)
• AMA for identification of thyroid disrupting chemicals
• LAGDA for identification of thyroid disrupting chemicals
• New developments in amphibian testing

Prof Dr ZhiChao Dang, RIVM, The Netherlands

15.00     Coffee Break

15.30
Concepts for Ecotox Testing of Plant Protection Products and Biocidal Products

• Current testing requirements
• Developing testing strategies
• Case studies: identifying endocrine vs non-endocrine effects
• Animal welfare and recommendations on future studies
• Challenges and opportunities with New Approach Methodologies

Dr James Wheeler, Global Regulatory Ecotoxicologist, Corteva Agriscience, The Netherlands

16.10
Endocrine Disruption: Ecotoxicology and its Contribution to ED Assessment

• Ecotoxicological requirements: EU vs rest of the world
• OECD framework and guidance
• How to make better use of mammalian data sets: in vitro and in vivo
• Dealing with non-specific „endocrine“ effects
• Implementing population relevance assessments
• Thoughts on hazard classes under CLP

Prof Dr Lennart Weltje, Senior Regulatory Scientist, BASF SE, Germany

16.50
Chairman’s Closing Remarks

17.00
End of Day One

18.00
Evening Reception

 

Tuesday, 12th September 2022

8.50
Chairman’s Opening Remarks
Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ,
Evonik Industries AG

9.00
Implementation of ED Criteria under CLP

• Identifying ED – UBA’s wotk within the ERGO project
• Hazard classes within the CLP regulation
• Potential elements of a new guidance
• Impact on biocides and plant protection products
• How to close existing testing gaps

Jürgen Arning, IV 2.3 Chemicals, German Federal Environment Agency (UBA), Germany

9.40
Industry´s Perspective on EURION Projects

• Processes for Endocrine Disruption Assessment
• Current Challenges of EDs
• Transparency in Research
• Requirements for research methods
• Status quo on GLP studies

Helen Tinwell, Distinguished Bayer Science Fellow and Regulatory Toxicology Group Leader, Bayer SAS, France

10.20     Coffee Break

10.50
OECD Test Guidelines Programme

Endocrine testing activities
Method validation and improvement
New innovations in ED testing • Insights in current Research Projects
How to develop new testing methods, guidelines and standards
Anne Gourmelon, Principal Administrator - Test Guidelines Programme, Environment Health and Safety Division, Environment Directorate, OECD

11.30
The US EPA’s Endocrine Disruptor Screening Program (EDSP)

Cornerstones of the US EPA’s work on assessing EDs
Rebuilding the EDSP: aims, current state and prospects
The role of NAMs (New Approach Methodologies)
Testing needs and what the EPA expects
Upcoming steps for research activities
Dr Scott Lynn, Endocrine Disruptor Screening Program, Environmental Protection Agency (EPA), USA

12.10     Lunch Break

13.30
Industry Experience of ED Evaluation for Non-Target Organisms: Case Studies, Reflections and Uncertainties

• Specificity and sensitivity
• Hepatic metabolism
• Tiers versus toolbox
• Consistency in weight of evidence evaluation

Dr Dan Pickford, Principal Technical Expert – Ecotoxicology, Syngenta Crop Protection AG, UK

14.10
Regulatory Perspective on Endocrine Disrupors: Experiences, Challenges and Outlook from a Global Point of View

• State of regulation as well as management and anticipation in major global markets, e.g.

– Europe
– Asia
– The Americas

• Experiences on ED assessments under BPR and PPPR:

– What can we learn for the assessment of chemicals - latest developments
– Status on ED risk assessment

• Global strategy on ED assessments

Dr Daniela Fruth, Regulatory Toxicologist, knoell Germany GmbH

14.50     Coffee Break

15.20
Japan’s Regulation on Endocrine Disrupting Effects

• Progress of Governmental Strategy
• Status quo: Research on endocrine disruptor issues
• Challenges with tests and animal welfare
• Japan’s regulation vs. EU regulation
• Japanese Chemical Substances Control Law: Environmental risk assessment

Prof Taisen Iguchi, National Institute for Basic Biology, Japan

16.00
Understanding the Pharmacokinetics and Toxicity of Bisphenol A

• Research at FDA/NCTR on BPA pharmacokinetics and toxicity
• Study designs and findings on BPA
• Guideline studies
• Academic studies
• Beyond the CLARITY-BPA consortium study – thoughts on further research

Luísa Camacho, Deputy Director — Division of Biochemical Toxicology, FDA/NCTR, USA

16.40     Chairman’s Closing Remarks

16.45     End of the Conference