DIE AKADEMIE FRESENIUS

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1 DIE AKADEMIE FRESENIUS Where Experts Meet! 8 th International Fresenius Conference Endocrine Disruptors 29 and 30 November 2017 in Cologne/Germany Highlights Regulatory Developments and socio-political context Update from the European Commission s DG SANTE: Criteria for ED identification under EU Regulations on plant protection products and on biocidal products Update on the ongoing activities in the ECETOC task force on endocrine disruption ANSES: Past, present and future EDs under REACH Influence of the criteria on the French strategy A critical view of the common perception of EDs in a societal context Developments outside of Europe The US Environmental Protection Agency on extrapolation of mammalian-based ToxCast assay results to non-mammalian species to evaluate endocrine disruption Test Methods EU Commission DG ENV: Activities under the EU strategy for ED towards better identification of endocrine disruptors OECD guidance document 150 revision Methods and Epidemiology Update from the EU Joint Research Centre: The EU strategy for ED towards better identification of endocrine disruptors addressing the gaps Review of non-monotonic dose responses of substances for human risk Assessment The Experts Bernhard Allner Gobio-Institute for Ecology of Waters & Applied Biology Jürgen Arning German Federal Environment Agency (UBA) Patience Browne Organisation for Economic Co-operation and Development (OECD) Laura Fabrizi European Commission Richard Green DowAgroSciences/ ECETOC ED Task Force Henrik Holbech Syddansk Universitet Odense/ECHA ED Expert Group Peter Korytar European Commission Carlie A. LaLone Environmental Protection Agency Gregory Lemkine Laboratoire Watchfrog Cécile Michel French Agency for Food, Environmental and Occupational Health and Safety (ANSES) Sharon Munn European Commission Joint Research Centre Jenny Odum Regulatory Science Associates Ltd. (RSC) Camila Queiroz Moreira National Health Surveillance Agency (ANVISA) Christophe Rousselle French Agency for Food, Environmental and Occupational Health and Safety (ANSES) Michael Warhurst Chem Trust Lennart Weltje BASF James Wheeler Dow AgroSciences David Zaruk Odisee University College

2 The Programme Get-Together on Tuesday, 28 November 2017 Will you arrive on Tuesday? Come to the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere. Wednesday, 29 November Registration and coffee 9.00 Welcome address by Akademie Fresenius and introduction by the Chair Lennart Weltje, BASF, Germany Regulatory Developments in the EU 9.10 Criteria for ED identification under EU Regulations on plant protection products and on biocidal products: an update Laura Fabrizi, European Commission, DG SANTE, Belgium 9.40 Past, present and future EDs under REACH: Influence of the criteria on the French strategy Cécile Michel, French Agency for Food, Environmental and Occupational Health and Safety (ANSES), France Panel discussion Coffee break Industry perspective: Update on the ongoing activities in the ECETOC task force on endocrine disruption ECETOC view on draft EFSA/ECHA guidance on identification of endocrine disruptors Overview of proposed ECETOC approach for identification of endocrine disruptors ECETOC view on recent thyroid-related activities in the EU Alex Charlton, Syngenta/ ECETOC ED Task Force, United Kingdom EU action on endocrine disruptors: some progress, many concerns Why EU action on EDCs is needed The EU s progress so far EDC regulation through REACH, and the process of setting criteria to identify EDCs Future prospects for effective identification and control of EDCs in Europe Michael Warhurst, Chem Trust, United Kingdom Ongoing activities within the ECHA ED Expert Group Mandate of the ECHA ED EG Working procedures Special issues Jürgen Arning, Federal Environment Agency (UBA), Germany Panel discussion Lunch Developments Outside Europe Extrapolation of mammalian-based ToxCast assay results to non-mammalian species to evaluate endocrine disruption Use of US EPA ToxCast data for screening potential endocrine disrupting chemicals Challenge of extrapolating mammalian-based data to non-mammalian species Evaluation of the ToxCast Assay molecular targets Identification of species similarities and differences based on such data Identification of remaining requirements Carlie A. LaLone, Environmental Protection Agency, USA Brazilian perspective: Current activities concerning Human Health and Endocrine Disruptors Camila Queiroz Moreira, National Health Surveillance Agency (ANVISA), Brazil Test Methods 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 Peter Korytar, European Commission DG ENV, Belgium OECD guidance document 150 revision Expansion of standardised assays for EDs Use of cross-species data Experiences after 5 years of using GD 150 Jenny Odum, Regulatory Science Associates Ltd. (RSC), United Kingdom Evaluating chemicals for endocrine disruption at OECD A discussion of new methods for endocrine screening and testing Validation and harmonisation of alternative methods for evaluating endocrine active chemicals at OECD Patience Browne, Organisation for Economic Co-operation and Development (OECD), France

3 17.10 Panel discussion End of first day Departure time for the evening event At the end of the first conference day, Akademie Fresenius invites you to a leisurely evening in Cologne. After a short visit to the local Christmas market, we will have dinner at a traditional brewpub with local beer. Don t miss out on this opportunity! Thursday, 30 November Welcome address by the Chair Henrik Holbech, Syddansk Universitet Odense/ ECHA ED Expert Group, Denmark Methods and Endpoints for Measuring Endocrine Activity 9.10 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 Sharon Munn, European Commission Joint Research Centre, Italy Kinetic determination of vitellogenin induction in the epidermis of cyprinid and perciform fishes: Evaluation of sensitive enzyme-linked immunosorbent assays (ELISA) Proof of concept for VTG identification and quantification Advantages of kinetic VTG measurements in terms of animal protection in field monitoring studies, comprehensive data sets for chemical registration procedures and laboratory handling of VTG samples Bernhard Allner, Gobio-Institute for Ecology of Waters & Applied Biology, Germany Panel discussion Coffee break Differentiating endocrine and non-endocrine toxicities Hazard based regulation means it is important to distinguish endocrine mechanisms from other toxicities Overview of how endpoints may be affected by endocrine and non-endocrine toxicities Recommendations on how to better incorporate these considerations in testing and assessment James Wheeler, Dow AgroSciences, United Kingdom Review of non-monotonic dose responses of substances for human risk assessment Christophe Rousselle, French Agency for Food, Environmental and Occupational Health and Safety (ANSES), France A critical view of the common perception and ongoing debate about EDs David Zaruk, Odisee University College, Belgium Final Remarks and discussion Lunch and end of the conference 9.40 Alternative methods as internationally agreed protocols for detecting endocrine disruptors in Europe Alternatives for replacing laboratory animals Biological equivalence concentrations and physiological thresholds Endocrine potential differs from adverse effect Gregory Lemkine, Laboratoire WatchFrog, France Information available online at:

4 The Experts Bernhard Allner has been the Technical Director of the Gobio Institute for the Ecology of Waters & Applied Biology since He is responsible for biological test method based monitoring in the field of municipal and industrial water management. He is a member of the ISO standardisation panels for ED and genotoxicity testing methods. Jürgen Arning holds a PhD in Biochemistry and works as a Regulatory Scientist at the German Federal Environment Agency. His main tasks comprise the identification and evaluation of endocrine disruptors in the environment under the REACH framework. Additionally, he is involved in initiating risk management measures for environmental ED and in accompanying scientific research projects. Since 2015 he has been a member of the ECHA Endocrine Disruptors Expert Group. Patience Browne is currently an Administrator in the OECD s Test Guidelines Programme. Previously she was a Senior Scientist in the US EPA s Endocrine Disruptor Screening Programme. Patience began her career as a field biologist studying marine mammals in Alaska and has worked in both human health and wildlife science. Laura Fabrizi works as a Policy Officer at the European Commission, DG for Health and Food Safety (DG SANTE), Unit Pesticides and Biocides. She has been working for 15 years as a Researcher in toxicology and food chemistry. Laura has been involved in the work for developing criteria to identify endocrine disruptors in DG SANCO/DG SANTE since Richard Green currently works as a Toxicologist for Dow AgroSciences and is an active member of a number of ED expert groups, including those of the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) and the European Crop Protection Association (ECPA). He is also involved in redrafting OECD Guidance Document 150. Henrik Holbech holds a PhD in Ecotoxicology and currently works as Associate Professor at Department of Biology, University of Southern Denmark. He has been involved in the development of OECD Test Guidelines for endocrine disrupters in aquatic vertebrates and invertebrates for more than 15 years. Henrik was selected by the Danish EPA to represent Denmark in the OECD VMG-Eco and ECHA ED expert group. Peter Korytar holds a PhD in Analytical Chemistry from the Free University of Amsterdam. Before joining the European Commission in 2008, he worked at Wageningen IMARES as a Researcher. At DG Environment, Unit Sustainable Chemicals, he is a Leader of the team in charge of policy development areas such as EDs, chemical mixtures, non-toxic environment strategy and pharmaceuticals in the environment. Carlie A. LaLone is a Bioinformaticist at the Mid-Continental Ecology Division, in the Office of Research and Development with the U.S. Environmental Protection Agency. From she was a postdoctoral Biologist for the US EPA and the University of Minnesota. She serves as a task lead for research aimed at defining the taxonomic relevance of adverse outcome pathway (AOP) knowledge to support regulatory toxicology. Gregory Lemkine is the Founder and Chief Executive Officer of Laboratoire WatchFrog. He has a thorough understanding of the technical, scientific side and the marketing of biotechnologies and completed a training/action cycle of HEC school of management. He also holds a PhD in Physiology with a specific interest on the role of hormones to determine neural stem cells. Cécile Michel is a Regulatory Toxicologist at ANSES. After working for the pharmaceutical industry, Cécile has been working at ANSES for 9 years. She is a member of the ED expert group of ECHA. Sharon Munn is a Project Manager at the European Commission, in the DG Joint Research Centre. Her background is in human toxicology and risk assessment. She is working in support of the Community Strategy for Endocrine Disruptors focusing on improved approaches for the detection of endocrine disrupting substances. Jenny Odum is an Independent Consultant Toxicologist with a broad range of experience. She is an expert in the ED field and a member of OECD groups on testing for endocrine disruption and the development of test guidelines. Christophe Rousselle is a Toxicologist and currently the Manager of the Chemical Risk Assessment Unit at the French Agency for Food, Occupational and Environmental Health. Michael Warhurst has been the Executive Director of CHEM Trust since At CHEM Trust, a UK registered charity, he works at EU, UK and international levels to prevent man-chemicals from causing long term damage to wildlife or humans, by ensuring that chemicals which cause such harm are substituted with safer alternatives. Lennart Weltje holds a PhD in Ecotoxicology and Environmental Chemistry and currently works as a Senior Ecotoxicologist at BASF conducting risk assessments for PPPs and biocides. His former stations include the Dutch National Institute for Public Health and the Environment (RIVM). James Wheeler works as an Ecotoxicologist for Dow AgroSciences based in the UK. His work focuses on environmental risk assessment and ecotoxicology testing with a particular interest in fish endocrine test methods. David Zaruk is an Environmental-health Risk Governance Analyst and a Professor at Odisee University College and Université Saint-Louis in Brussels. He sits on various research ethics panels and frequently serves as a chair, expert, rapporteur, ethics adviser or evaluator for Europeanfunded research projects. David worked 12 years in chemicals issue management for Solvay, Cefic and Burson-Marstelle.

5 About Who do you meet? Groups that should take part: Professionals working in the fields of Toxicology and ecotoxicology Research and development Registration, regulatory affairs Chemical risk assessment Legal and general counselling Sectors taking part: Chemical/biocide/agrochemical/ pharmaceutical/cosmetic industries Research institutes Regulatory authorities Environmental and health risk consultants Testing laboratories and contract research organisations (CROs) NGOs Trade Exhibition Our conference provides you with the opportunity of presenting your company in a trade display. Present your products and services and reach out to your specific target groups. We would be happy to provide you with information on all the various options available from displaying product information to an exhibition stand with no further obligation on your part. Use the attached fax reply sheet to request our information material. Or simply call us. We would be more than pleased to assist you personally. Frank Ropers phone: fropers@akademie-fresenius.de The Organiser For over 20 years, Akademie Fresenius has been your partner for practice-orientated training on all the latest topics surrounding the safety and quality of food, consumer goods and chemical products along the whole production chain. Our portfolio not only includes international conferences but also offers national trade meetings, intensive practical seminars and training in small work groups. Our events are designed to promote an active exchange amongst our participants and offer the perfect platform for bringing the industry, the scientific sector, the authorities and the consulting field together. Excellent service, all-inclusive. Our wide-ranging advanced training opportunities contribute to giving our customers the competitive edge in all quality assurance, risk assessment, legal, production and technical questions. Akademie Fresenius is a joint venture between Cognos, one of the largest private and independent education groups in Germany, and SGS Institut Fresenius, one of the leading German providers of chemical laboratory analysis. You can find details on upcoming and new events at Do you have any questions? Programme and conceptual design Anne Möller phone: amoeller@akademie-fresenius.de Organisation and participant management Annika Koterba phone: akoterba@akademie-fresenius.de

6 Registration By web By By fax Hotline Die Akademie Fresenius GmbH Alter Hellweg 46, Dortmund Participation I would like to take part in the 8 th International Fresenius Conference Endocrine Disruptors, 29 and 30 November 2017 in Cologne/Germany. Fee: 1, plus VAT. I am a representative of an authority or a public university and therefore eligible for a reduced fee of plus VAT per person (please provide evidence). The reduced fee cannot be combined with other rebates. I would like to take part in the evening event on 29 November 2017 (included in the above price). Event Documentation Unfortunately, I am unable to attend. Please send me the complete documentation for plus VAT. Trade Exhibition Please send me information on available options for trade exhibition and presenting product information. Your Account Number (if available): Title / First name / Name Position Department Phone / Fax Company (complete company name including legal form) Street / Number or P.O. Box / Building ZIP-code / City / Country Your order number / Cost unit (if required) Your VAT ID No. (for registrations from EU countries except Germany) Date Signature Billing Address (only if different from the above address) Terms of Participation and Purchase The registration fee includes the event participation, event documentation, lunch, coffee breaks, beverages as well as the evening event. You will receive written confirmation of your registration. Upon receiving our invoice, please transfer the amount due without further deductions before the event begins. The price of the conference documentation includes a hard copy of the documentation as weii as an access code to the secure Akademie Fresenius download area. Both the documents and the secure access code will be dispatched around two weeks after the event and as soon as advance payment has been received. Group Reductions For joint bookings received from one company we grant a 15% discount from the third participant onwards. Terms of Cancellation Written cancellations or transfers will be accepted free of charge up to four weeks prior to the start of the event. After this date and up to a week prior to the start of the event we will reimburse 50% of the registration fee. We cannot, unfortunately, provide refunds for later cancellations. Please note that you can name a substitute free of charge at any time. General Terms and Conditions By registering, you agree to our General Terms and Conditions as well as to our Privacy Policy. You can find our GTC on the internet (www. akademie-fresenius.com/general-terms) or receive them on request. Personal Data The Akademie Fresenius will keep your personal data for the purpose of organising this event. We will under no circumstances use your data for commercial trade purposes. In signing this form you consent to our occasionally contacting you by mail, , fax or phone (please strike through if unwanted) in order to provide you with further information from our company. You can, of course, withdraw your consent whenever you wish. Occasionally we go around taking photos at our event. These are then published anonymously on our website. Further information can be found at: Picture Credit Subbotina Anna/shutterstock.com, chestra - Fotolia.com RalfenByte - Fotolia.com Venue Park Inn by Radisson Köln City West Innere Kanalstraße 15, Cologne/Germany phone: koeln@proventhotels.com, parkinn-hotel-koeln.de We have reserved a limited number of rooms for our participants at reduced rates at the hotel. These rooms can be booked up to 6 weeks prior to the start of the event. Please book early and directly through the hotel quoting Fresenius as reference.