Novel Food. Updated Programme. The Experts

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1 DIE AKADEMIE FRESENIUS Where Experts Meet! 4 th International Fresenius Conference Novel Food 5 and 6 July 2018 in Mainz/Germany Highlights Update: New legal framework for Novel Foods Role of National Authorities: Networking between Member States, EU Commission and EFSA Innovation in the food industry new and novel foods Differences in the categories of Novel Food Evaluation of food ingredients and transitional steps Industry experience: Novel Food implementing regulations and their impact on regulatory strategies Union List of authorised Novel Foods revision needed? Authorisation procedure: Risk assessment strategies, guidances across the EFSA and relation to other authorisation procedures Regulatory status of insects in food applications and IPIFF s position on the new Novel Food Regulation Risk assessment of novel proteins in food: Development of food allergies Novel dairy foods and the legal framework for Novel Foods in the US Share industry experience and get the latest news on regulatory issues! Updated Programme The Experts Christian Ballke Meisterernst Rechtsanwälte (law firm) Heidi de Bruin Chair of the IPIFF Novel Food Task Force Patrick Coppens Food Supplements Europe Marion Gebhart RDA Scientific Consultants Joris Geelen Food Compliance International Ingolf Grün University of Missouri Bernd Haber BASF Peter Loosen German Federation for Food Law and Food Science (BLL) Bernd van der Meulen European Institute for Food Law Patrick O Mahony Food Safety Authority of Ireland Monika Neuhäuser-Berthold Justus Liebig University Francesco Planchenstainer Ferrero Group Klaus Riediger Austrian Agency for Health and Food Safety (AGES) Nino Terjung German Institute of Food Technologies (DIL) Kitty Verhoeckx TNO Scientific director: Andreas Meisterernst Meisterernst Rechtsanwälte (law firm)

2 The Programme Get-Together on Wednesday, 4 July 2018 Will you arrive on Wednesday? Come to the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere. Thursday, 5 July Registration and coffee 9.00 Welcoming speech by Akademie Fresenius and the Chair Andreas Meisterernst, Meisterernst Rechtsanwälte (law firm), Germany 9.10 The new legal framework for Novel Foods past and future issues Experience of implementing Regulation (EC) No 258/97 Improvements introduced by Regulation (EU) 2015/2283 Potential problems with future novel food authorisations Patrick O Mahony, Food Safety Authority of Ireland, Ireland 9.40 Novel Food role of National Authorities Networking: Member States, EU Commission, EFSA HOC : History of consumption, Novel Food catalogue Unionlist: PAFF, Official food control Authorisation of traditional foods Klaus Riediger, Austrian Agency for Health and Food Safety (AGES), Austria Traditional Food from Third Countries Monika Neuhäuser-Berthold, Justus Liebig University, Germany Panel discussion Coffee break Differences in the categories of Novel Food Legislative background Comparison between old and new categories Impact and new issues Christian Ballke, Meisterernst Rechtsanwälte (law firm), Germany Botanicals in Food Supplements History and background on botanicals Relevance of the Novel Foods Regulation for botanicals How to assess Novel Food status: Guidelines Patrick Coppens, Food Supplements Europe, Belgium Union List of authorised Novel Foods from A(cetyl-neuraminic acid) to Z(inc pidolate) Establishment of the Union List Revision needed? How to update the list? Bernd Haber, BASF, Germany Panel discussion Lunch Exciting innovations within Germany s food and ingredients sector Cultured meat Natural colourant Nino Terjung, German Institute of Food Technologies (DIL), Germany Innovations in the food industry New and novel foods Procedures and timing Data protection Peter Loosen, German Federation for Food Law and Food Science (BLL), Germany/Belgium Panel discussion Coffee break Novel Food and international agreements (SPS etc.) Bernd van der Meulen, European Institute for Food Law, The Netherlands Evaluation of food ingredients and transitional steps Evaluation of Novel Food status in practice Consultation of Member States Procedure regarding new Novel Food Andreas Meisterernst, Meisterernst Rechtsanwälte (law firm), Germany

3 17.20 Panel discussion End of the first conference day Departure time for the evening event Scientific data for the authorisation procedures Risk assessment strategies Exposure assessment Quality standards for the analytical data Guidances across the EFSA Marion Gebhart, RDA Scientific Consultants, Germany Panel discussion Coffee break After the first conference day Akademie Fresenius would like to invite you to a leisurely evening at the vineyard Allendorf in the wine-growing region Rheingau. You have the opportunity of better getting to know other participants you met during the day over a relaxed wine tasting and dinner. Don t miss out on this opportunity! Friday, 6 July Novel Food Regulation regulatory status of insects in food applications Introduction IPIFF (International Platform of Insects for Feed and Food) Novel Food Regulation 2015/2283 IPIFF position on Novel Food Regulation IPIFF activities way forward Heidi de Bruin, Chair of the IPIFF Novel Food Task Force, Belgium 9.30 Risk assessment of novel proteins in food: Are insect proteins allergenic? Food safety assessment of novel protein products Risk of the development of food allergy TNO s risk assessment strategy Importance of a thorough allergenicity risk assessment Kitty Verhoeckx, TNO, The Netherlands Novel Foods and the relation to other authorisation procedures General remarks Dividing pathways (e.g. flavourings, colours) Procedures in parallel (e.g. enzymes) Conclusions Joris Geelen, Food Compliance International, Belgium The Novel Food Implementing Regulations and their impact on regulatory strategies: An insight from industry experience The consultation process with Member States How to safeguard confidentiality The importance of data protection EU rules and international dossier submissions Francesco Planchenstainer, Ferrero Group, Luxembourg Novel dairy foods and the legal framework for novel foods in the US Novel fermented and unfermented dairy products in the US US legal framework for novel foods in general and novel dairy foods in particular Novel foods and the US Food and Drug Administration s (FDA) Food Safety and Modernization Act (FSMA) and its Foreign Supplier Verification requirements Ingolf Grün, University of Missouri, United States Panel discussion and closing remarks Lunch buffet and end of the conference Information available online at:

4 The Experts Christian Ballke is a Partner of the law firm Meisterernst Rechtsanwälte in Munich, Germany. He advises and represents his clients on food law matters and on issues of intellectual property law, especially trademark and unfair competition law. Heidi de Bruin is the Chair of the Novel Food Task Force at IPIFF (International Platform Insects Feed & Food) in Brussels and the 2nd Vice President of IPIFF. She is actively involved in interactions with the European Commission, EFSA and other relevant stakeholders to jointly continue working on the IPIFF roadmap. Monika Neuhäuser-Berthold is full professor of human nutrition at the Justus Liebig University and member of the EFSA NDA Panel. Her major research interests are the interrelations between nutrition and health status of the elderly. Patrick Coppens has extensive knowledge and experience with the application of the novel foods legislation and the issues that have been covered since Food Supplements Europe has been deeply involved in the development of the principles of the new Novel Foods Regulation. It has developed an extensive guidance document to help companies to apply the new rules. Marion Gebhart is Managing Director of RDA Scientific Consultants. She is an officially qualified food chemist and expert for food chemistry publicly sworn and duly admitted by the Munich Chamber of Commerce (IHK). She has more than 10 years of experience in regulatory affairs and application procedures for health claims and authorisations of new substances. Joris Geelen is a Partner at the consulting firm Food Compliance International based in Brussels with an in-depth knowledge of the scientific and regulatory aspects of botanicals used in food, supplements and other products. For 7 years he worked in the Belgian Ministry of Health where he collaborated with experts of the Advisory Commission on Botanicals and extended his knowledge of these diverse ingredients. Ingolf Grün has been a Professor of Food Chemistry at the University of Missouri since His research is focused on the effects of adding novel food constituents on functional properties of foods, including the volatile profile and sensory characteristics. Bernd Haber is a Food Chemist and with BASF since He held various regulatory positions in the food additives and ingredients industry. In his current role he is responsible for regulatory work on BASF s novel food portfolio including plant sterols, lycopene or DHA-rich Schizochytrium sp. oil. Peter Loosen has been Managing Director of the BLL since He became Head of the Brussels Office in Besides counselling members he focuses on the representation of members interests to the European institutions. Moreover, he is a Visiting Lecturer for food law at the University of Bonn. Andreas Meisterernst is a Lawyer at Meisterernst Rechtsanwälte (law firm) in Munich, Germany. He is a Visiting Lecturer at the Technical University of Munich as well as author and editor of a large number of publications. Bernd van der Meulen is a Private Consultant in food legal affairs at the European Institute for Food Law and Professor of Food Law at Wageningen University. He has a background in public law which comprises administrative law, human rights, European law, international law and competition law. Patrick O Mahony is the Chief Specialist, Food Science & Technology at the Food Safety Authority of Ireland. His responsibilities include the implementation of Novel Food legislation including carrying out safety assessments and generating substantial equivalence opinions. He is the Irish delegate on the EU Commission working groups on Novel Food and GM Food and on the OECD Working Group on the Safety of Novel Foods and Feeds. Furthermore he is the Irish representative on the EFSA Novel Food, GMO and Nanotechnology Networks. Francesco Planchenstainer is a Senior Regulatory Counsel at Ferrero Group, a global leader in confectionery and chocolate manufacturing. After collecting experience in the US special nutrition industry, he currently supports Ferrero s regulatory strategy for innovation at the global level. Klaus Riediger is an Expert for Official Food Control in the field of Novel Foods, food supplements and foods of plant origin at the Austrian Agency for Health and Food Safety. Among others, he is member of the EU CAFAB Novel Food Working Group (CAFAB = Competent Authorities and Food Assessment Bodies ) and EFSA Network on Novel Foods. Nino Terjung works as a Meat Scientist and is leading the business unit at the German Institute of Food Technologies (DIL). His field of interest in research and development is the whole meat sector. Kitty Verhoeckx has been a Visiting Researcher at the University Medical Centre in Utrecht (UMCU) and has been involved in food allergy projects (predicting allergenicity of novel proteins for instance insects) since Among others, she is also a member of the EFSA focus group on food allergy.

5 About Who do you meet? Sectors that can benefit from this platform include: Food and drink industry Regulatory authorities Research organisations and institutes Scientific consultancies Groups that should take part: Legal and regulatory affairs Registration Research and development Risk assessment Quality assurance and control Marketing 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. Semsigül Yalcin phone: syalcin@akademie-fresenius.de 20 and 21 June 2018 in Cologne/Germany 7 th International Fresenius Conference "Residues of Food Contact Materials in Food" info@akademie-fresenius.com 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 Sophie Witzleben phone: switzleben@akademie-fresenius.de Organisation and participant management Analisa Mills phone: amills@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 4 th International Fresenius Conference Novel Food, 5 and 6 July 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 5 July 2018 (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 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 ( 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 setory, mything, Fukurou, koft - Fotolia.com, SusaZoom - Fotolia.com Venue Atrium Hotel Mainz Flugplatzstraße 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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