Assessment, Regulation, Testing, Modelling and Prediction

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1 DIE AKADEMIE FRESENIUS Where Experts Meet! International Fresenius Gene-Tox Conference Genotoxicity Assessment, Regulation, Testing, Modelling and Prediction 21 and 22 June 2018 in Mainz/Germany Highlights Regulatory Developments EFSA overview of genotoxicity testing requirements Genotoxicity assessment under REACH Update on genotoxicity and biocides Testing Genotoxicity Development of new test guidelines Changes in OECD Test Guidelines - practical experiences Follow Up in Case of Positive Results Weight of Evidence Issues with in vivo genotoxicity studies Thresholds for carcinogens and the derivation of occupational exposure limits Different choices for in vivo genotoxicity testing Impurities: Risk assessment through BMD derivation Modelling and Prediction of Genotoxicity Genotoxicity TTC safe thresholds for humans EFSA initiatives facilitating implementation of QSAR models and read across in the process of risk assessment of pesticides The Experts Carol Beevers Exponent International Marc Cronin Liverpool John Moores University Gisela H. Degen Leibniz Research Centre for Working Environment and Human Factors (IfADo) Nathalie Delrue Organisation for Economic Co-operation and Development (OECD) Claudia Flohr-Beckhaus Dr. Knoell Consult George Johnson Swansea University David Kirkland Kirkland Consulting Andreas Luch German Federal Institute for Risk Assessment (BfR) Hans-Jörg Martus Novartis Pharma AG Daniela Maurici European Food Safety Authority (EFSA) Stephanie Melching-Kollmuss BASF Krista Meurer BASF Angelo Moretto University of Milan / International Centre for Pesticides and Health Risk Prevention (ICPS) Lutz Müller La Roche Paschalina Papadaki European Chemicals Agency (ECHA) Rositsa Serafimova European Food Safety Authority (EFSA)

2 The Programme Get-Together on Wednesday, 20 June 2018 Will you arrive on Wednesday? Come into the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere. Thursday, 21 June Registration and coffee 9.00 Welcome address by the organisers and introduction by the Chair Stephanie Melching-Kollmuss, BASF, Germany Regulatory Developments 9.10 Overview of genotoxicity testing requirements in the different legal frameworks and guidance on genotoxicity assessment Daniela Maurici, European Food Safety Authority (EFSA), Italy 9.35 Genotoxicity assessment within agricultural regulation practical hurdles Krista Meurer, BASF, Germany Update on genotoxicity and biocides (BPR) Paschalina Papadaki, European Chemicals Agency (ECHA), Finland Panel discussion Coffee break Genotoxicity assessment under REACH Testing requirements depending on the tonnage Testing strategies a step-wise approach Considerations of test results for Classification and Labelling under CLP Andreas Luch, German Federal Institute for Risk Assessment (BfR), Germany Testing Genotoxicity Development of new test guidelines Current activities Update on the status of assays under development Nathalie Delrue, Organisation for Economic Co-operation and Development (OECD), France Changes in OECD Test Guidelines - practical experiences Key changes to the study designs and their impact What to look for in your testing facility Carol Beevers, Exponent International, United Kingdom Panel discussion Lunch Summary of the 7 th International Workshop on Genotoxicity Tests, Tokyo, Japan Purpose, structure and history of IWGT Topics discussed in Tokyo Key messages and consensus statements from the working groups Hans-Jörg Martus, Novartis, Switzerland Genotoxicity assessment in different regulations Claudia Flohr-Beckhaus, Dr. Knoell Consult, Germany Panel discussion Coffee break Follow Up in Case of Positive Results Weight of Evidence Issues with in vivo genotoxicity studies criteria and when to perform them Data that trigger the studies What design and which parameters? Evaluation of data within the toxicological profile of the compound Angelo Moretto, University of Milan/International Centre for Pesticides and Health Risk Prevention (ICPS), Italy Thresholds for carcinogens and the derivation of occupational exposure limits Gisela H. Degen, Leibniz Research Centre for Working Environment and Human Factors (IfADo) Panel discussion End of the first conference day Departure time for the evening event

3 As always, you are most welcome to attend our evening event, which will take us to the former monastery named Wasem Kloster Engelthal. We will have a short tour of the wine cellar and afterwards we will enjoy a dinner and have time to continue the days interesting conversations in a relaxed atmosphere. Don t miss out on this opportunity! Friday, 22 June Welcome address by the Chair 9.10 Different choices for in vivo genotoxicity testing: Comparing transgenics and comet Follow up of in vitro gene mutagens with a transgenic mutation assay (TGR) in vivo Is the recommendation for a TGR supported by data? Could comet assay be an alternative choice? Data on analysis of TGR versus comet (key tissues, ability to detect bacterial mutagens and mutagenic carcinogens) David Kirkland, Kirkland Consulting, United Kingdom 9.35 Impurities: Risk assessment through BMD derivation, despite initial positive genetic toxicity results Using in vivo genetic toxicity data for BMD derivation Calculating human exposure limits from BMD derived reference doses Case study impurity examples to demonstrate these approaches George Johnson, Swansea University Medical School, European Environmental Mutagenesis and Genomics Society (EEMGS), United Kingdom The ICH M7 Guideline and how to handle mutagenic impurities in drugs History of ICH M7 Risk evaluation basics, less than lifetime risk model ICH M7 - how to handle mutagenic impurities in drugs in practice Lutz Müller, La Roche, Germany Panel discussion Coffee break Modelling and Prediction of Genotoxicity EFSA initiatives facilitating implementation of QSAR models and read across in the process of risk assessment of pesticides. Rositsa Serafimova, European Food Safety Authority (EFSA), Italy (Video Presentation) Genotoxicity TTC Safe thresholds for humans The historical Cancer Potency Database has been updated including a more comprehensive assessment of genotoxicity Identification of potential genotoxic chemicals from experimental data or in silico assessment Recalculation of Thresholds of Toxicological Concern (TTC values) on the basis of mode of action Marc Cronin, Liverpool John Moores University/Cefic Long Range Research Initiative (LRI) Project, United Kingdom Final discussion Lunch and end of the conference Information available online at:

The Experts Carol Beevers is a Consultant Toxicologist at Exponent International Ltd, specialising in genetic toxicology.

She is a member of the UK Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM).

He has expertise in the application of in silico methods and TTC for the risk assessment of chemicals. Gisela H.

Ministry of Labour and Social Affairs and in the Scientific Committee on Consumer Products/Safety (SCCP/SCCS 2004 2016) of the European Commission.

She is in charge of the development and revision of Test Guidelines and related documents in the field of human health and has been coordinating the recent update of the set of OECD Test Guidelines

Claudia Flohr-Beckhaus is currently the Head of Industrial Chemicals & Biocides for Environmental and Human Safety at Dr Knoell Consult.

He is also Chair of the Health and Environmental Sciences Institute (HESI) Genetic Toxicology Technical Committee (GTTC) Quantitative Group, and Vice-President of the European Environmental

His main interests are in utilising genetic toxicity data for human health risk assessment purposes through dose response modelling, as well as developing in vitro test systems for use in supporting

He has received recognition awards from the US, Japanese and UK environmental mutagen societies, was chair of IWGT for 20 years and is a member of the UK Government Advisory Committee on Mutagenicity.

He is currently the Head of the Department of Safety of Consumer Products at the German Federal Institute for Risk Assessment (BfR) in Berlin.

Hans-Jörg Martus is currently the Global Head of Genetic Toxicology and Photosafety at the Novartis Institutes for Bio Medical Research in Basel, Switzerland.

Daniela Maurici is a Senior Scientific Officer at the European Food Safety Authority, (EFSA) in Parma, Italy.

4 The Experts Carol Beevers is a Consultant Toxicologist at Exponent International Ltd, specialising in genetic toxicology. She has 20 years of experience at a contract research organisation, study directing in vitro and in vivo genotoxicity tests. She is a member of the UK Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM). She was also a member of the OECD Expert Group for test guideline 489 on the comet assay. Mark Cronin is Professor of Predictive Toxicology at Liverpool John Moores University, England. He has expertise in the application of in silico methods and TTC for the risk assessment of chemicals. Gisela H. Degen is a Professor of toxicology and now a Senior Fellow Scientist and was formerly the Head of the Research Group Chemical Risks at IfADo, the Leibniz Research Centre for Working Environment and Human Factors. She has also served as expert member in various scientific advisory committees, for instance in the UA III of the Committee on Hazardous Chemicals (AGS), the advisory body of the German Federal Ministry of Labour and Social Affairs and in the Scientific Committee on Consumer Products/Safety (SCCP/SCCS ) of the European Commission. Nathalie Delrue joined the OECD in 2006 as an Administrator of the Programme of the OECD guidelines for the testing of chemicals. She is in charge of the development and revision of Test Guidelines and related documents in the field of human health and has been coordinating the recent update of the set of OECD Test Guidelines on genotoxicity as well as recent projects for the development of new test methods on genotoxicity. Claudia Flohr-Beckhaus is currently the Head of Industrial Chemicals & Biocides for Environmental and Human Safety at Dr Knoell Consult. She has previously focused on molecular mechanism of genotoxcity for many years. George Johnson is an Associate Professor at Swansea University Medical School, UK. He is also Chair of the Health and Environmental Sciences Institute (HESI) Genetic Toxicology Technical Committee (GTTC) Quantitative Group, and Vice-President of the European Environmental Mutagenesis and Genomics Society (EEMGS). His main interests are in utilising genetic toxicity data for human health risk assessment purposes through dose response modelling, as well as developing in vitro test systems for use in supporting the 3Rs of animals in science. David Kirkland is a Professor with over 35 years of experience in regulatory genetic toxicology and has worked as an Independent Consultant since He has received recognition awards from the US, Japanese and UK environmental mutagen societies, was chair of IWGT for 20 years and is a member of the UK Government Advisory Committee on Mutagenicity. Andreas Luch is a Professor of Pharmacology & Toxicology and Eurotox Registered Toxicologist. He is currently the Head of the Department of Safety of Consumer Products at the German Federal Institute for Risk Assessment (BfR) in Berlin. Priorly he held positions at the Department of Cell Biology at Harvard Medical School (ICCB Institute of Chemistry and Cell Biology) and the MIT Cancer Center in Cambridge, MA. Hans-Jörg Martus is currently the Global Head of Genetic Toxicology and Photosafety at the Novartis Institutes for Bio Medical Research in Basel, Switzerland. Priorly he held positions at Sandoz, the Harvard Medical School and the Institute of Toxicology in Mainz, Germany. Daniela Maurici is a Senior Scientific Officer at the European Food Safety Authority, (EFSA) in Parma, Italy. She is contributing to the activities of the Scientific Committee and Emerging Risks Unit (SCER Unit). Her work focusses on cross-cutting and methodological guidance development for risk assessment. She has priorly held positions at the European Centre for the Validation of Alternative Methods (ECVAM) at the Joint Research Centre of the European Commission in Ispra, Italy. Stephanie Melching-Kollmuss has been working as European and Global Regulatory Toxicologist for plant protection products at BASF since Her main research interest is combined toxicity assessment and she continues to be involved in ECETOC and Cefic LRI projects. She is member of ECPA working groups on cumulative risk assessment. Krista Meurer has been a Regulatory Toxicologist for Crop Protection at BASF since In support of European and global registrations, she is responsible for human health risk assessment for pesticide products and active substances. Before, Christa has been a study director at RCC/ Harlan Cytotest Cell Research in Germany. Angelo Moretto is an Associate Professor of Occupational Medicine at the Department of Biomedical and Clinical Sciences at the University of Milan as well as the Director of the International Centre for Pesticides and Health Risk Prevention, Luigi Sacco Hospital in Milan. He has been involved in risk assessment of chemicals, especially pesticides, for many years and also in many EFSA projects, including the development of the database on genotoxicity of metabolites of pesticides. Lutz Müller is a Distinguished Scientist and has been a Project Leader for the area toxicology at F. Hoffmann-La Roche since He previously served as Head of Investigational and in silico Safety & Metabolism at Novartis Pharma in Switzerland and held positions at the Department of Toxicology of the German Federal Institute for Drugs and Medical Devices (BfArM). Paschalina Papadaki is currently a Scientific Officer for ECHA s Biocides Unit, where she is involved in the peer review programme of active substances. She has also worked in the REACH Evaluation Unit in ECHA. She has previously held positions at the Department of Pesticides, Control and Phytopharmacy of Benaki Phytopathological Institute, Greece and at Battelle UK. Rositsa Serafimova is currently a Scientific Officer at EFSA s Pesticides Unit. She previously held a position at Joint Research Centre-European Commission. Her research interests are development, assessment and implementation of computational tools (e.g. (Q)SAR, read across) for prediction of toxicological properties of chemicals.

Research and development Legal and general counselling Sectors that should take part: Chemical/biocide/agrochemical/ pharmaceutical/cosmetic industries Research institutes Regulatory authorities

5 About Who do you meet? Groups that should take part: Professionals working in the fields of: Toxicology Registration, regulatory affairs Chemical risk assessment Hazard, exposure and risk assessment for human health Research and development Legal and general counselling Sectors that should take part: Chemical/biocide/agrochemical/ pharmaceutical/cosmetic industries Research institutes Regulatory authorities Health risk consultants Testing laboratories and contract research organisations (CROs) Authorities Professional associations Autumn 2018 Trade Exhibition 9 th International Fresenius Conference "Endocrine Disruptors" Please order information now! info@akademie-fresenius.com 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. Semsigül Yalcin phone: syalcin@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 Analisa Mills phone: amills@akademie-fresenius.de

6 Registration By web By By fax Participation I would like to take part in the International Fresenius Gene- Tox Conference "Genotoxicity Assessment, Regulation, Testing, Modelling and Prediction", 21 and 22 June 2018 in Mainz/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 (please provide evidence). The reduced fee cannot be combined with other rebates. I would like to take part in the evening event on 21 June 2018 (included in the above price). Hotline Die Akademie Fresenius GmbH Alter Hellweg 46, Dortmund 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 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 event 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 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 events. These are then published anonymously on our website. Further information can be found at: Picture Credit Sashkin - Fotolia.com, Stadt Ingelheim Billing Address (only if different from the above address) Venue Atrium Hotel Mainz Flugplatzstr. 44, Mainz/Germany Phone: info@atrium-mainz.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 four weeks prior to the start of the event. Please book early and directly through the hotel quoting Fresenius as reference.

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