Endocrine Disruptors

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Intro
Agenda
Speakers
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Venue
Presentations

Monday, 16th September 2024

8.30
Registration and Coffee

8.55
Opening Remarks
Dr Bjoern Nehls, Director, Chem-Academy, and
Dr Volker J. Soballa, Vice President, Head of Product Stewardship,
Corporate ESHQ, Evonik Industries AG

9.00
Chemicals Regulation – Global and European Challenges

  • Product Stewardship and its growing impact

– The EU’s Green Deal
– Evolving requirements in Asia
– The Americas

  • The path to sustainable solutions and how they can be achieved
  • Safe today, but safe tomorrow…?

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

9.40
ED Within the EU's Regulatory Framework

  • The current roadmap to phasing out animal testing for chemicals legislation
  • The industry’s point of view on required policy objectives and milestones
  • The need for NAMs (and a common understanding of their goals)
  • Industrial Chemicals and Endocrine Disruptors: REACH and CLP
  • Risk assessment – methods and state of research

Dr Heli Hollnagel, Regulatory Toxicologist, EMEA Science Leader, Regulatory
Toxicologist, EMEA Science Leader, Dow Europe / The Dow Chemical Company,
Switzerland

10.20 Coffee Break

10.50
Evaluation of Endocrine Disruptors

  • ED regulation within the BPR and PPP legislation
  • The EFSA/ECHA Guidance and identifying ED properties
  • Information and study requirements
  • Risk assessment as a key element
  • Upcoming regulatory requirements

Dr Maristella Rubbiani, Policy Officier, European Commission, Directorate-
General for Health and Food Safety, Unit E4 – Pesticides and Biocides

11.30
Endocrine Disruptors in the Context of the EU’s Chemicals Regulation

  • ED regulation from a member state perspective
  • Authorization, identification and evaluation of EDs
  • Impact of the postponed REACH revision
  • CLP hazard classes for EDs
  • Elements of the upcoming Guidance
  • The role of the ED Expert Group

Dr Christian Unkelbach, Federal Office for Chemicals (BfC), Federal Institute for
Occupational Safety and Health (BAuA), Germany

12.10 Lunch Break

13.40
Conducting Studies on Chemical Risks

  • The need for studies and data

– The EU’s Chemicals Strategy for Sustainability
– Endocrine Disruption
– Further global requirements

  • The OECD Conceptual framework for Testing and Assessment of Endocrine Disrupting Chemicals
  • A variety of ecotoxicological studies and their pros and cons
  • Conducting studies: costs factors and potential bottlenecks
  • NAMs – experiences so far

Dr Melanie Lichtenberger, Managing Director, ibacon GmbH, Germany

14.20
The US EPA’s Endocrine Disruptor Screening Program (EDSP)

  • Cornerstones of the US EPA’s work on assessing EDs
  • Rebuilding the EDSP: aims, recent announcements, and progress
  • Testing status and what the EPA expects
  • The role of NAMs (New Approach Methodologies)
  • Update on research activities

Dr Scott Lynn, Endocrine Disruptor Screening Program, Environmental Protection Agency (EPA), USA

15.00 Coffee Break

15.30
Endocrine Disruptors and What Science Can Contribute to Assessing Their Risks

  • The role of dose for assessing ED related risks
  • What does it need to achieve scientific evidence (example thyroid effects)?
  • Using NAMs for risk assessment (news from PARC)

Dr Philip Marx-Stölting, Scientific Director, Head of Unit Testing and Assessment Strategies, BfR German Federal Institute for Risk Assessment

16.10
ED, Science, Regulation, and Public Perception

  • Dimensions of current debates on ED active substances
  • The prospects of ED classification
  • Ongoing ED assessment activities within the regulatory framework…
  • … vs the Commission‘s objective of One Substance One Assessment
  • Recent court decisions and their potential impact on future data requirements

Andy Adams, PhD, Senior Advisor, FleishmanHillard, France

16.50 Chairman’s Closing Remarks

17.00 End of Day One

18.00 Evening Reception

Tuesday, 17th September 2024

8.45
Chairman’s Opening Remarks
Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ,
Evonik Industries AG

8.50
ED Regulation from a Lawyer’s Point of View

  • The EU’s legal framework and the Green Deal
  • Challenges with One Substance One Assessment
  • Impact of REACH (with or wothout revision) and CLP
  • Planning certainty: how to deal with political and regulatory changes

Zanda Romata, Partner, Avocat, Barrister, Steptoe LLP, Belgium


9.30
The EU’s Green Deal and ED Regulation

  • OSOA as a concept
  • CLP and REACH after and before its revision: educated guesses?
  • ED criteria in the internaational system
  • The state of science – discussions between the EU Commission and the industry

Jordane Wodli, European Commission, DG Environment, Unit B.2 – Safe and Sustainable Chemicals

10.10 Coffee Break

10.40
Approach to ED Effects by the Ministry of the Environment, Japan

  • Outline and update of EXTEND 2022
  • The risk-based approach to substances with ED effects
  • Activities and achievements on test methods development
  • Risk assessment and regulation under the Chemical Substances Control Law
  • Challenges to develop a framework on ED assessment for regulatory evaluation

Kunihiko Yamazaki, Deputy Director, Chemical Safety Division,
Environmental Health Department, Ministry of the Environment,
Government of Japan

11.20
Pesticides and Chemicals: Regulation, Requirements, and the Contribution
from Ecotox

  • Testing strategies and requirements and a reasonable time schedule
  • Update on studies for Fish short reproduction tests
  • Endocrine vs non-endocrine effects: impact on risks
  • Enhancing non-animal testing
  • Perception by the authorities

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

12.00 Lunch Break

13.20
Ecotoxicology and ED Assessment

  • Ecotoxicology and its contribution to the risk assessment of chemicals
  • OECD framework and guidance
  • Study requirements: the EU vs the rest of the world
  • Adversity vs activity and how to deal with it in a scientific way

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

14.00
NAMs and Applying the 3Rs

  • The 3Rs: replacement, refinement and reduction of animals in research
  • The implementation of NAMs for safety assessment – where do we stand?
  • The challenges
  • Current NAMs on endocrine-disrupting properties of chemicals in fish and amphibians
  • Looking to the future of better integration of NAMs into regulatory paradigms

Dr Natalie Burden, ERT, Head of NAMs Strategy, NC3Rs, United Kingdom

14.40 Coffee Break

15.10
Endocrine Activity vs Endocrine Disruptors – Issues with Articles

  • ED active vs disrupting – substances in articles
  • Methods for identifying potential endocrine disruptors in plastics
  • Examples from scientific work and what conclusions have to be drawn
  • Uncertainties in studies and existing information gaps
  • ED and the circular economy: recycling as a challenge

Dr Christian Kirchnawy, Leitung Mikrobiologie und Zellkultur,
OFI Technologie & Innovation GmbH, Austria

15.50
Liability Risks From the Manufacturing and Use of Chemicals

  • Identifying and understanding risks: manufacturing, supply chain and use
  • Consumer and investor expectations
  • Risks related to Endocrine Disruptors
  • Risk management: explore risk and liability implications for a transformed economy
  • How the EU’s Green Deal and the Circular Economy will shape industrial risk profiles
  • The future of monitoring and mitigating risks

Jelena Buha, PhD, Life Science Industry Practice Leader | Commercial Insurance,
Zurich Insurance Group Ltd, Switzerland

16.30 Chairman’s Closing Remarks

16.40 End of the Conference