3 rd International Conference Endocrine Disruptors

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3 rd International Conference Endocrine Disruptors Hot Topics The Commission s Proposal for the Criteria Testing Strategy for the Protection of Public Health Environmental Hazard and Risk Assessment

Prof Peter Matthiessen Supported by Presenting Institutions and Companies Dr Karin M.

European Chemical Industry Council (Cefic) Graeme Taylor, European Crop Protection Association (ECPA) Prof Dr ZhiChao Dang, National Institute for Public Health and the Environment (RIVM) Dr Glenn

Dr Gerard Swaen, Maastricht University Dr Christopher J. Borgert, Applied Pharmacology and Toxicology, Inc. Dr Volker J. Soballa, Evonik Industries AG Dr Martina Duft, Dr.

1 3 rd International Conference Endocrine Disruptors Hot Topics The Commission s Proposal for the Criteria Testing Strategy for the Protection of Public Health Environmental Hazard and Risk Assessment Status Quo on Global Requirements and Challenges Workshop Gaining Experience with the Performance of Hazard Assessment of Endocrine Active Substances Annegaaike Leopold, Calidris Environment B.V. Prof Peter Matthiessen Supported by Presenting Institutions and Companies Dr Karin M. Nienstedt, European Commission, DG Health and Food Safety Dr Peter Korytar, European Commission, DG Environment Dr Elise Grignard, European Commission, Joint Research Centre (JRC) Peter Smith, European Chemical Industry Council (Cefic) Graeme Taylor, European Crop Protection Association (ECPA) Prof Dr ZhiChao Dang, National Institute for Public Health and the Environment (RIVM) Dr Glenn Lurman, Federal Institute for Risk Assessment (BfR) Dr Miriam Jacobs, Public Health England Dr Andy Adams, Bayer S.A.S. Dr Richard Green, Dow AgroSciences Ltd. Dr Gerard Swaen, Maastricht University Dr Christopher J. Borgert, Applied Pharmacology and Toxicology, Inc. Dr Volker J. Soballa, Evonik Industries AG Dr Martina Duft, Dr. Knoell Consult GmbH Dr Martina Vosteen, Ramboll Environ Germany GmbH Annegaaike Leopold, Calidris Environment B.V. Dr Daniel B. Pickford, Syngenta Ellen Dhein, Bayer AG Dr Erik K. Rushton, LyondellBasell Industries N.V. Dr Lennart Weltje, BASF SE 16 th and 17 th October 2017, Conference 18 th October 2017, Workshop Berlin, Germany Presented by

2 Regulatory Challenges wi Monday, 16 th October Registration and Coffee 8.50 Chairman s Opening Remarks Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ, Evonik Industries AG, Germany 9.00 Regulatory Status Quo Challenges for the Industry Definition of science-based criteria for ED: impact on the industry Risk characterisation as a means to deal with ED What do the ED criteria mean for related regulation? Industry s view on political and public debates on ED Ellen Dhein, Manager Regulatory and Environmental Affairs, Bayer AG, Germany 9.40 Criteria for ED Identification Under EU Regulations on Plant Protection Products and on Biocidal Products: an Update Content Process for adoption Where do we stand? Dr Karin M. Nienstedt, Policy Officer, Unit E4 Pesticides and Biocides, DG Health and Food Safety, European Commission, Belgium Activities under the EU Strategy for EDs: Towards Better Identification of Endocrine Disruptors - Focus for the Future Gaps in test methods Approach to address gaps Factors for prioritising further TG development Dr Peter Korytar, DG Environment, Unit B2 Sustainable Chemicals, European Commission Belgium Networking and Coffee Break Activities under the EU Strategy for EDs: Towards Better Identification of Endocrine Disruptors Addressing the Gaps Recommendations from recent EC funded workshops regarding: - Thyroid disruption - Retinoid signalling pathway - Temporal aspects - Other aspects Dr Elise Grignard, Scientific Officer, European Commission, Joint Research Centre (JRC), Italy An Industry View of the Criteria for Identifying Endocrine Disruptors Regulatory criteria: where science meets politics and emotions run high What about REACH: how could progress look like even without criteria? Biocides Substances or Active Substances: what s all the fuss about? Guidance next up: what to expect What is the rest of the world going to do? Peter Smith, Executive Director of the Product Stewardship Programme, European Chemical Industry Council (Cefic), Belgium Endocrine Disruptors: On the Way to a Harmonised Approach Current regulatory framework and its implications Scientific discussion concerning EDs The European Commission s Proposals, 2016 Dr Glenn Lurman, Scientist, Federal Institute for Risk Assessment (BfR), Germany Lunch Break Endocrine Disruptors Global Requirements and Challenges Current regulatory developments worldwide: Europe vs the Americas and Asia Keys to understand hazard and risk assessment in varying regulatory frameworks Testing requirements and related efforts Recommendations for managing potential EDs on a global scale Dr Martina Duft, Ecotoxicology/Regulatory Affairs, Industrial Chemicals & Biocides, Dr. Knoell Consult GmbH, Germany Industry View on Endocrine Disruptor Assessments ED Regulation challenges during ECHA s substance evaluation - Proposing a pro-active industry approach Balancing research and regulatory science - Pros and cons for requesting limits Getting back to the basics of regulatory assessment - How does the LOAEL/NOAEL fit into natural variation? - Data assessment in light of biological and statistical significance Dr Erik K. Rushton, DABT, Senior Toxicologist, Corporate HSE/Product Safety, LyondellBasell Industries N.V., the Netherlands Networking and Coffee Break Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Chemicals What s so difficult about environmental safety assessment of endocrine disrupting substances? Background and set-up of the SETAC Pellston Workshop Risk or hazard assessment when to do what? Remaining areas of scientific concern and future research 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 Endocrine Disruptors within the REACH Authorisation Framework Regulatory requirements for EDs under the REACH authorisation regime Consequence of the threshold discussion for the affected companies (e.g. pharmaceutical industry) Outcome of the ECHA/CEFIC workshop Effects of analytical constraints Dr Martina Vosteen, Principal, Ramboll Environ Germany GmbH, Germany Chairman s Closing Remarks End of Day 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.

3 th Endocrine Disruptors Tuesday, 17 th October Chairman s Opening Remarks Dr Volker J. Soballa, Head of Product Stewardship, Corporate ESHQ, Evonik Industries AG, Germany 8.30 Testing Strategy for Endocrine Disruptors: Environmental Perspective Overview of the EU regulations addressing Endocrine Disruptors from an environmental perspective Hazard vs risk-based approaches to chemical regulation Considerations for endocrine disruption testing in different legal frameworks Case study on fish toxicity testing Prof Dr ZhiChao Dang, Senior Risk Assessor, Centre for Safety of Substances and Products, RIVM - National Institute for Public Health and the Environment, the Netherlands 9.10 Endocrine Disruptors: the Point of View of Ecotoxicology Definition: ecotoxicology and toxicology and how they work together Challenges for regulatory ecotoxicology Key elements of ecotox testing The ED criteria in regard to ecotoxicology Hazard characterisation - how to assess effects? Dr Lennart Weltje, Senior Regulatory Scientist, BASF SE, Germany 9.50 Networking and Coffee Break The Application of Adverse Outcome Pathways (AOPs) for the Identification of Endocrine Disruptors Application of AOPs in the identification of Endocrine Disruptors in the context of emerging EU criteria (EFSA/ECHA) The importance of considering both endocrine and non-endocrine AOPs How much data is needed to be able to make decisions? How can Aggregated Exposure Pathways (AEPs) be used in combination with AOPs? Dr Richard Green, Toxicologist and Risk Assessor, Human Health Assessment, Dow AgroSciences Ltd., presenting on behalf of an ECETOC Task Force, United Kingdom Human-Relevant Potency-Threshold (HRPT) for Estrogen Receptor Alpha Agonists - Prototype for Hazard Identification of EDCs Methodology for development of HRPTs Basis of the HRPT for ER-alpha agonists Case study chemical showing consistency with other regulatory approaches Implications for other endocrine pathways: efficient hazard identification of EDCs Dr Christopher J. Borgert, President & Principal Scientist, Applied Pharmacology and Toxicology, Inc., USA Considerations in Identifying Thyroid Active Chemicals as Endocrine Disruptors - Potential Impacts under 1107/2009 Thyroid-active chemicals and endocrine disruption Adversity of effects on the thyroid hormone system Human and wildlife population relevance of thyroid axis disruption Specific vs non-specific effects on thyroid hormone system Adequacy of test methods Dr Daniel B. Pickford, Senior Technical Expert and Lead Ecotoxicologist, Syngenta, United Kingdom Lunch Break The Challenges Facing the Crop Protection Industry EU s approach in dealing with EDs medium and long term actions Challenges of providing sufficient, safe and affordable food for an evergrowing world population: with or without pesticides? Ban on glyphosate: why does this question divide Europe? Ensuring consumers safety: how to turn into action Implications of the current ED approach on crop protection and society Which scientific principles could be acceptable for all parties? Graeme Taylor, Director of Public Affairs, European Crop Protection Association (ECPA), Belgium ED Criteria: Application, Burden of Proof and Potential Impact on Health and Agriculture Criteria for regulatory purposes or political compromise? Guilty until proven innocent? Which improvements in human and environmental safety will the proposed criteria deliver? What do we need for our food supply to be safe, plentiful and affordable? Dr Andy Adams, Global Agricultural Policy and Stakeholder Affairs, Bayer S.A.S., France Networking and Coffee Break Endocrine Disruptor Testing Needs for the Protection of Public Health: Progress and Challenges Developing and using test guidelines: strengths and limitations - Short term goals with developing in vitro tests - Additions of ED endpoints to current in vivo TGs - Difficulties with potency comparisons Potential implications of IATA, ITS and Defined Approaches developments - Role for epigenetics in reproductive toxicity and carcinogenicity testing Dr Miriam Jacobs, Principal Toxicologist, Public Health England, United Kingdom An Epidemiological Perspective on Endocrine Disruption Current state of affairs on the human health field Increasing level of available information vs real increase in ED related health outcomes? How reliable are the epidemiologic studies on exposure to chemicals and ED related health outcomes? Which other factors can explain the changing incidences? How can epidemiology be brought even more thoroughly into the debates on ED? Dr Gerard Swaen, Senior Epidemiologist, Department of Complex Genetics, Maastricht University, the Netherlands Chairman s Closing Remarks End of the conference

Workshop Wednesday, 18 th October 2017 8.30 Reception and Coffee 9.00 to 16.

4 Workshop Wednesday, 18 th October Reception and Coffee 9.00 to Gaining Experience with the Performance of Hazard Assessment of Endocrine Active Substances Breaks will be arranged flexibly. About Your Workshop Leaders Annegaaike Leopold is an ecotoxicologist, now working as a consultant in the field of science communication as well as endocrine and regulatory ecotoxicology, building on 25 years of involvement in ecotoxicology and contract laboratory research with a specific focus on birds and the development of scientifically sound, ethically defensible, resource friendly test methods. Her previous roles have included that of Director of European and subsequently Global Business Development at Wildlife International, now part of EAG, Inc. Preceding these roles she set up and ran the avian toxicology laboratory at NOTOX (now WIL Research) and managed the aquatic toxicology laboratory before that. She has been heavily involved in developing (endocrine) test methods in birds, fish and terrestrial organisms as a member of OECD working groups. Annegaaike has organised and co-chaired a SETAC Europe Special Symposium (in 2012) and a SETAC North America Focused Topic Meeting (in 2014) on Endocrine Testing and Evaluation and a SETAC Pellston Workshop on Environmental Hazard and Risk Assessment of Endocrine Active Substances in She was corresponding guest editor of the 5 papers that emanated from this workshop and were published in IEAM in March of Peter Matthiessen is a UK-based self-employed consultant in aquatic ecotoxicology with 40 years of experience in conducting research on, and providing advice about, the effects of aquatic pollution. His major research interests are endocrine disruption and its ecosystem impacts. Peter is the author of about 140 research publications and major reports, and has experience both in the environmental risk assessment of pesticides and other chemicals and in design and operation of environmental monitoring for chemical effects, and in the development of environmental quality standards. He has owned a strong advisory role in bodies such as Defra, EA, HSE, OECD and EFSA. Content of the Workshop The purpose of the workshop is to make participants familiar with the steps that need to be taken when evaluating an endocrine disrupting substance (EDS). Participants will be guided through the process of making a scientifically sound decision on whether an EDS can be safely regulated in the basis of risk assessment or alternatively, whether a more conservative approach is required in the form of regulation on the basis of hazard alone. During the first part of the day the steps to be gone through from data collection to weight of evidence assessment to hazard characterisation will be dealt with. After exposure estimates have been incorporated differences are then discussed between hazard and risk-based decisions. One or more of the case studies worked through in preparation of the SETAC Pellston workshop on Endocrine Hazard and Risk Assessment of Endocrine Active Substances (EHRA) will be used as examples. During the second part of the workshop participants will learn to work with a series of questions that need to be answered in order to determine whether there is a sufficiently sound scientific basis to perform an ecotoxicological risk assessment whether a hazard assessment only should be undertaken. The subject of the third part of the workshop will be examples of uncertainties that may influence a hazard or risk assessment and hence the regulation of an EDC and how to deal with these uncertainties. Examples of uncertainties that will be discussed include 1) in vivo studies with apical endpoints: delayed effects; 2) in vitro and in vivo studies: non-monotonic dose relationships and the presence or absence of thresholds; extrapolation from studies in individual organisms to the population level. The final part of the workshop will deal with examples of one or more data sets in which we do not have sufficient data to make a firm judgement about the feasibility of doing a risk assessment. Advance Notice Seminar Regulatory Toxicology 4 th and 5 th September, th to 27 th February, Seminar Language German 9 th Annual Conference CLP 23 rd to 25 th October, 2017 Dusseldorf, Germany Conference Language German 11 th Annual Conference Product Safety in the Chemical Industry 22 nd to 24 th January, 2018 Bonn, Germany Conference Language German

5 About us About Chem-Academy Chem-Academy is a division of Vereon AG and is running both industry specific conferences and courses since Its main target groups are the chemical and the pharmaceutical industry. Events mainly focus on regulatory topics, e.g. chemical regulation like REACH or the GMP framework for pharmaceutical companies. Representatives of all major companies as well as of the most important public authorities give presentations or facilitate courses. Impressions Q&A Session Graphic Recording Evening Reception Case Studies Networking Partner knoell is a full service provider, supporting you in all phases of registration from planning right through to the market launch of your product. We also assist you with know-how and the necessary resources for the registration of different categories of substances. We have been an independent service provider for the chemical and pharmaceutical industries since 1996, with currently more than 550 employees at sites within the EU, Asia and the USA. The outstanding technical qualification of our experts and their international language competence serves as a guarantee for our deep understanding of your products. In addition to German and English, they speak many other European languages, as well as Arabic, Chinese, Japanese, Korean and Thai. Your contact: Dr. Michael Cleuvers, Industrial Chemicals & Biocides, Managing Director, T: , mcleuvers@knoell.com Dr. Knoell Consult GmbH, Dynamostraße 19, Mannheim, Germany Ramboll Environ is the global Environment and Health practice of leading engineering, design and consultancy company Ramboll. Our experts demonstrate product safety, ensuring regulatory compliance and preventing product liability. We offer hazard, exposure risk assessment and management services for a range of innovative new and existing products including industrial chemicals, biocides, consumer products, food and food packaging, plant protection products and pharmaceuticals. Trusted by clients to manage their most challenging environmental, health and social issues, Ramboll Environ has more than 2,700 staff worldwide. Ramboll works across the areas of Buildings, Transport, Planning and Urban Design, Water, Environment and Health, Energy, Oil and Gas, and Management Consulting, and has more than 13,000 experts across 300 offices in 35 countries. Your contact: Dr Martina Vosteen, Principal, T: +49 (0) , mvosteen@ramboll.com Ramboll Environ Germany GmbH, Werinher Str. 79, München

6 Contact us Web chem-academy.com Fax Mail Vereon AG Chem-Academy Postfach Kreuzlingen 1, Switzerland Conference Venue Web Telefon Anschrift Hotel Pullman Berlin Schweizer Hof Budapester Str Berlin, Germany Individual accomodation and travel are not included in the registration fee. Please arrange your own bookings respectively. Besides an inquiry to the venue hotel we recommend to consult the common hotel reservation portals. 3 rd International Conference Endocrine Disruptors I would like to register: Conference and Workshop* 16 th to 18 th October 2017 Conference 16 th and 17 th October 2017 Workshop* 18 th October 2017 Unfortunately, I am not able to participate at the conference. Please send me more information via Person Title First Name Second Name Position Department Phone 2. Person Title First Name Second Name Position Department Phone Organisation Street or P.O. Box Postal Code City Country Billing Address - EUR EUR (plus VAT) EUR (plus VAT) EUR (plus VAT) Order Reference VAT Number Company Department Address Postcode, City Terms and Conditions 1. Registration Registration is confirmed in writing by the organisers. The registration fee covers attendance at the lectures for the number of days selected, full documentation, entrance to the exhibition area, lunch and refreshments. VAT has to be added. Important note in terms of late payment: As mentioned in the registration form all payments must be received within the due date given in the invoice. If you assume that your company is not able to manage payment in-time by bank transfer, please provide your credit card details in order to guarantee your booking. This helps to avoid any inconvenience upon your arrival at the event. At that time the full amount of the payment must be received in our accounts at latest. Thank you very much for your co-operation. 2. Cancellations Cancellations of a registration by a delegate has to be received in writing at least 30 days prior to the event and will be subject to a service charge of 200 Euro. Substitutions are acceptable at any time. Where cancellations are received later, the registration fee remains payable in its entirety. In case the event has to be cancelled by the organiser payments already received will be credited for the following year's event. 3. Copyright All material (documents, photos etc.) issued in connection with the events are copyrighted. Duplications and otherwise use must be authorised in writing by Vereon AG. You may use personal cameras and video cameras for private use only. Professional photography and recording equipment are not permitted. With your attendance you consent to being photographed, filmed and recorded. Unless otherwise agreed with Vereon AG, you consent to Vereon AG and third parties using images and recordings of you for broadcast, publication and licensing without compensation or acknowledgement. 4. Liability It may be necessary for reasons beyond the control of the organiser to alter the content or the timing of the programme or to cancel the event. The organiser of the event is not liable to pay any compensation or damages resulting from alteration, cancellation or postponement of the event. The organiser will do the upmost to inform the delegates of such modifications as early as possible, but is especially not liable if higher force or unforeseen incidences are affecting the meaningful implementation of the event. Force majeure includes: armed conflicts, civil strife, terrorist threats, natural disasters, political constraints, significant influence of transport, etc. 5. Data Protection The organiser gathers and processes data in accordance with data protection laws. Your data is stored electronically for the purpose of future updates of our services. If you wish your data to be amended, removed or not passed to an external organisation, please write to info@chem-academy.com. 6. Final Clauses The contract is subject to the Swiss law. Area of jurisdiction is Kreuzlingen (Switzerland). Date, Signature *limited number of seats Register now on

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