Endocrine Disruptors

September 23rd and 24th, 2019 – Conference
September 25th, 2019 – Workshop
Berlin, Germany

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Monday, 23rd September 2019

8.30 Registration and Coffee

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

Regulatory Status Quo – Challenges for the Industry
• State of the political and societal discussion on Endocrine Disruptors
• Criteria and Guidance and their impact on the industry
• Key questions on risk vs hazard and the role of potency
• Chemicals, plant protection products and biocides: the struggle with regulatory inconsistencies
• Upcoming initiatives within ED related sectors
Ellen Dhein, Manager Regulatory and Environmental Affairs, Bayer AG, Germany

Endocrine Disruptors and Key Aspects of a Science Based Risk Assessment
• Challenges for European risk assessors
• The impact of the ED criteria and the Guidance from an authority’s point of view
• Why will there always be room for different interpretations?
• Maximising the use of available data
• Regulation of chemical safety in various sectors: what will the future bring?
Dr Roland Solecki, Head of Department Pesticide Safety, Federal Institute for
Risk Assessment (BfR), Germany

10.20 Networking and Coffee Break

Challenges with Endocrine Disruptors from a Competent Authority’s Point of View
• Implementation of ED-criteria
• The path from research to regulation
• Improving our understanding of chemical cocktails
• Differences between national lists of chemicals and the ECHA ED-list
• European harmonisation vs domestic initiatives
• The OECD guidelines as a point of reference
• The challenge with the communication of ED related activities
Dr Gregory Moore, Swedish Chemicals Agency (KEMI), Sweden

Polymers: Analysis of Decomposition Products
• Developing analytical methods for the decomposition of polymers
• Endocrine disrupting effects of decomposition products
• Simulating and modelling
• Lessons learned from a project on PNECs (Predicted No Effect Concentration)
• State of discussions by the RAC (Risk Assessment Committee)
• How to deal with critical molecules
Dr Thomas Sendor, Senior Managing Consultant, Ramboll Environment &
Health GmbH, Germany

12.10 Lunch Break

Applying the ED Guidance to Crop Protection Products
• Views of the crop protection industry on the criteria and the guidance
• First experiences with application of the Guidance
• Assessing the weight of evidence
• Potential impact on additional vertebrate testing
• The burden of decision-making
• Broader implications for policy and future regulation of ED in EU?
Dr Andy Adams, Global Agricultural Policy and Stakeholder Affairs, Bayer S.A.S., France

Endocrine Disruptors in the Biocide Sector: Regulatory Developments from the
Commission’s Point of View

• Regulatory state of affairs: the Biocidal Products Regulation
• Key elements for identifying endocrine disrupting properties in biocidal products
• How the criteria and the guidelines are related to each other
• Implementation challenges for biocides and plant products
• Outlook: upcoming regulatory challenges
Martinus Nagtzaam, Policy Officer, Unit E4 – Pesticides and Biocides, DG Health and Food Safety, European Commission

The Causes of the Increases of Endocrine Related Diseases
• Changing trends in endocrine related diseases
• Impact of changes in human reproduction on the incidence of testicular cancer, hypospadias, and childhood obesity
• Impact of smaller family size on children born from subfertile couples
• Identifying factors at play in the etiology of ED diseases
Dr Gerard Swaen, Senior Epidemiologist, Department of Complex Genetics,
Maastricht University, Netherlands

15.30 Networking and Coffee Break

Endocrine Disruption Regulation of Biocidal Products Industry – Learnings
from Assessments so far

• The importance of ED assessment
• Regulating science and the challenges at the different stages
• Harmonisation between the member states on BP regulation
• Overview of the different implementation strategies that have been enforced so far for both active substances and biocidal products
• Harmonisation and cooperation across legislations (PPP and REACH) at this point
Stine Jensen, Academic Officer, Doctor of Veterinary Medicine, Pesticides &
Biocides, Ministry of Environment and Food of Denmark, Environmental
Protection Agency, Denmark

ED Criteria and their Impact on Biocidal Products
• Challenges for the Biocides Product sector
• Criteria and how they apply to Biocidal Products
• Interaction with European and domestic competent authorities
• What does the burden of proof mean in terms of time to market?
• Regulation of endocrine Disruptors: how to deal with overlaps and differences between Biocidal Products and REACH
Dr Sylvia Jacobi, Corporate Toxicology Director, Albemarle, Belgium

17.20 Chairman’s Closing Remarks

17.30 End of Day 1

18.00 Evening Reception
Following the official part of the conference, Chem-Academy invites you to a social evening reception at an atmospheric local restaurant. Benefit from the informal surrounding to intensify business contacts and extend your network.

Tuesday, 24th September 2019

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

Horizon 2020: Research on Chemicals Safety
• H2020: vision and aims of the EU’s funding program
• Research and activities related to chemical safety assessment
• Research on endocrine disrupting substances
• Human biomonitoring and exposome research activities
• The role of industry stakeholders and regulators in EU-supported research on chemical safety Horizon Europe
• Environment & Health research: challenges and opportunities
Christian Desaintes, Scientific Officer, DG Research & Innovation, European

A Global View on the New EU ED Guidance: Requirements, Experiences and Challenges
• The new EU ED Guidance - requirements and first experiences
• Testing vs non-testing - “sufficient data”?
• Recent regulatory developments worldwide: Europe vs the Americas and Asia
• Practical implications, regulatory consequences
• Recommendations for managing potential EDs on a global scale
Dr Martina Duft, Ecotoxicology/Regulatory Affairs, Industrial Chemicals &
Biocides, knoell Germany GmbH, Germany

10.10 Networking and Coffee Break

The US Regulatory Framework on Endocrine Disruptors
• The US EPA’s ED Screening Program: lessons learned and developments
• Hazard vs risk – methodological principles in approaching ED issues
• Screening, testing and assessing: what has to be done by the industry and how?
• New assessment methodologies and their challenges
Ellen Mihaich,PhD., DABT, President, Environmental and Regulatory
Resources, LLC, Adjunct Professor, Duke University, USA

Endocrine Disruptor: Regulatory Requirements and Challenges in Japan
• Conclusions from Japan’s program on endocrine disrupting chemicals EXTEND 2016
• The program’s contribution to international cooperation and information sharing
• Concepts of assessment framework
• Criteria for selecting candidate chemicals
• A multi-tier framework for testing and assessing of ED effects
• Environmental risk assessment
Prof Taisen Iguchi, National Institute for Basic Biology, Yokohama City
University, Japan

12.00 Lunch Break

Regulation of Endocrine Disruptors in India
• Regulatory requirements
• The authorities’ roles in regulating EDs in India
• Interaction NGOs, industry and authorities
• Current activities and methods in detecting EDs
• Cooperation of Indian authorities with EU institutions
Dr Padmaja Jonnalagadda, Ph.D., Scientist F-Sr.Gr Dy.Director, National
Institute of Nutrition, Indian Council of Medical Research, India

Challenges with Environmental Hazard and Risk Assessment for Chemicals
• Hazard vs risk in environment
• Endocrine active vs endocrine disruptive: how to detect the fine line
• Results from this year’s SETAC meeting
• Issues of concern in the need for improved methods of assessment
• How can we find a broader consensus on key scientific questions?
Annegaaike Leopold, Consultant, Calidris Environment B.V., the Netherlands

14.40 Networking and Coffee Break

Latest Developments on Endocrine Testing and Assessment in Ecotoxicology with a Focus on Europe
• The ED assessment according to EFSA
• Insights from fish and amphibian studies
• Distinguishing endocrine activity from endocrine disruption
• Consequences for the industry and for animal welfare
Prof Dr Lennart Weltje, Senior Regulatory Scientist, BASF SE, Germany

Endocrine Disrupting Substances in Articles
• Consumer concerns and ED in the media vs the scientific point of view
• Methods for identifying potential endocrine disruptors in plastics
• How do in vitro bioassays work?
• Examples and results
  - Food packaging materials
  - Plastic in toys
• How to detect weaknesses in studies
Dr Christian Kirchnawy, Team Leader, OFI Technologie & Innovation GmbH,

16.30 Chairman’s Closing Remarks

16:45  End of the Conference


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