DIE AKADEMIE FRESENIUS Where Experts Meet!

28 and 29 March 2019 in Dusseldorf/Germany

Food Safety and Dietary Risk Assessment

17th International Fresenius Conference

The Experts

Davide Arcella European Food Safety Authority (EFSA) | Alan R. Boobis Imperial College London | Monika Bross BASF | Coen Graven Dutch National Institute for Public Health and the Environment (RIVM) | Caroline Harris Exponent | Christer Hogstrand King’s College London | Karsten Hohgardt German Federal Office of Consumer Protection and Food Safety (BVL) | David Hrdy U.S. Environmental Protection Agency (EPA) | Carsten Kneuer German Federal Institute for Risk Assessment (BfR) | Eeva Leinala Organisation for Economic Co-operation and Development (OECD) | Pauline Mombert French Agency for Food, Environmental and Occupa-tional Health and Safety (ANSES) | Suzanne Pierlot French Agency for Food, Environmental and Occupational Health and Safety (ANSES) | Christian Prohaska Austrian Agency for Health and Food Safety (AGES) | Dieter Schrenk University of Kaiserslautern | Jens Schubert German Federal Institute for Risk Assessment (BfR) | Claire Stephenson Exponent | Trijntje van der Velde-Koerts Dutch National Institute for Public Health and the Environment (RIVM) | Jacob van Klaveren Dutch National Institute for Public Health and the Environment (RIVM) | Petra Veit BASF | Anneli Widenfalk Swedish National Food Agency

Highlights

Cumulative Risk Assessment and Evaluation of Mixtures

• EFSA and OECD guidance documents on risk assessment of combined exposure to multiple chemicals

• Swedish National Food Agency: a member state perspective on chemical mixture risk assessment

• Deliverables of the EuroMix project

Exposure Assessment and Guidelines – Recent Developments

• U.S. EPA and Dutch RIVM on the use of processing factors in dietary risk assessment

• German BVL: residues in fish – state of the play

• ANSES on EU technical guidance for setting maximum residue levels in honey

Assessment of Metabolites

• German BfR on grouping and assessment of pesticide metabolites

• Application of the residue definition guidance

Establishment of MRLs

• ANSES on MRL settings for pesticides, biocides and veterinary drugs

• Biocide residues in food • Dietary risk and hazard assessment of plant

protection products

Thursday, 28 March 2019

8.30 Registration and coffee

9.00 Welcome address by Akademie Fresenius and introduction by the Chair

Dieter Schrenk, University of Kaiserslautern, Germany

Cumulative Risk Assessment and Evaluation of Mixtures9.10 OECD document: considerations for assessing the risks of combined exposures to multiple chemicals

• General framework• Defining the scope and the risk management question• Using a tiered approach

Eeva Leinala, Organisation for Economic Co-operation and Development (OECD), France

9.35 EFSA guidance document on chemical mixtures

Christer Hogstrand, King‘s College London, United Kingdom

10.00 International harmonisation of the risk assessment of combined exposure to chemicals

• Differences between chemical sectors and geographical regions

• Importance of problem formulation• Need for common criteria and guidance• Basis for grouping chemicals• Inclusion/exclusion criteria• Consequences of different approaches and

acceptability of resulting standards

Alan R. Boobis, Imperial College London, United Kingdom

10.25 Panel discussion 10.55 Coffee break

11.25 Risk assessment of combined exposure to multi-ple chemicals – legislative and scientific approaches for implementation of a mechanism-based test strategy

• Overview on the current regulatory frameworks in the EU and non-EU countries

• Overview on recent guidelines/guidance documents published for cumulative risk assessment

The Programme• Recommendations for a harmonised implementation

of recent developments

Jens Schubert, German Federal Institute for Risk Assessment (BfR)

11.50 A member state perspective on chemical mixture risk assessment

• Mixture risk assessment of dioxines and dioxin-like PCBs in food

• Cumulative risk assessment of pesticide residues• Use of biomonitoring data for exposure assessments

of pesticide residues and mycotoxins

Anneli Widenfalk, National Food Agency, Sweden

12.15 Deliverables of the EuroMix project

• The EuroMix concept testing mixtures of concern• Improvements in combined exposure assessment to

multiple chemicals• Improvements in hazard assessment• How the EuroMix model and data platform can be

used

Jacob van Klaveren, National Institute for Public Health and the Environment (RIVM), The Netherlands

12.40 Panel discussion13.10 Lunch

Exposure Assessment and Guidelines – Recent DevelopmentsChair

Monika Bross, BASF, Germany

14.30 U.S. EPA on the derivation and use of processing factors

• Background on use of processing factors• Calculation of processing factors• Historical context – what EPA had been using for

processing factors and what they are using now

David Hrdy, U.S. Environmental Protection Agency (EPA), United States of America

14.55 Database of processing techniques and processing factors compatible with FoodEx2• Compendium of representative processing techniques• FoodEx2 system• European database of pesticide processing factors

Coen Graven, National Institute for Public Health and the Environment (RIVM), The Netherlands

Get-together on Wednesday,27 March 2019Will you arrive on Wednesday? Come into the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere.

15.20 Panel discussion15.45 Coffee break

16.15 Residues in fish – state of the play

• Nature of residues• Dietary burden calculator• Magnitude of residues

Karsten Hohgardt, Federal Office of Consumer Protection and Food Safety (BVL), Germany

16.40 Setting maximum residue levels in honey – an overview of EU technical guidance

• Residue definitions in honey and bee products• Are residues expected in honey?• Estimating residue levels in honey

Pauline Mombert, French Agency for Food, Environmental and Occupational Health and Safety (ANSES)

17.05 Residues in honey – an industry perspective

Petra Veit, BASF, Germany

17.30 Panel discussion18.00 End of first conference day

19.00 Departure time for the evening event

Friday, 29 March 2019

9.00 Welcome address by the Chair

Monika Bross, BASF, Germany

9.10 New model (GECDE) to assess less-than-lifetime dietary exposure to pesticides

Davide Arcella, European Food Safety Authority (EFSA), Italy

Assessment of MetabolitesChair

Caroline Harris, Exponent, United Kingdom

9.35 Defining residues for dietary risk assessment – application and implications of the guidance

• A review of the current state-of-the art with respect to the available guidance for proposing residue definitions for dietary risk assessment

• Experiences with the practical application of the guidance

• Implications of the guidance in terms of data generation and harmonisation

Claire Stephenson, Exponent, United Kingdom

10.00 Update on grouping and assessment of pesticide metabolites – a regulators perspective

• Current practice and developments with regard to human health

• Case studies and relevant guidance documents

Carsten Kneuer, German Federal Institute for Risk Assessment (BfR)

10.25 Panel discussion10.55 Coffee break

Establishment of MRLs11.25 Quo vadis plant protection? Dietary risk and hazard assessment

• Cut-off criteria and import tolerances• Non-approval of actives and transitional measures for

MRLs• MRL setting decisions and hazard criteria

Christian Prohaska, Austrian Agency for Health and Food Safety (AGES)

11.50 MRL settings for pesticides, biocides and veterinary drugs

• Regulatory point of view• Scientific point of view

Suzanne Pierlot, French Agency for Food, Environmental and Occupational Health and Safety (ANSES)

12.15 Biocide residue transfer into food

• Biocide residue transfer guidance developed by ARTFood

• Interim approach for the establishment of maximum residue limits

Trijntje van der Velde-Koerts, National Institute for Public Health and the Environment (RIVM), The Netherlands

12.40 Panel discussion 13.30 Lunch and end of the conference

As always you are most welcome to attend our evening event and to join us for an unhurried evening of good food and leisure time at the restaurant Biblioteca Culinaria. Continue the day’s interesting discussions in a relaxed and comfortable atmosphere.Don’t miss out on this opportunity!

Information available online at: www.akademie-fresenius.com/2600

The ExpertsDavide Arcella is Officer in the Evidence

Management Unit of the Risk Assessment and Scientific Assistance Directorate at the European Food Safety Authority (EFSA). He is leading the Exposure

Team which is responsible for the collection and analysis of food consumption data and for the development and application of new methodologies for dietary exposure assessment.

Alan R. Boobis retired from his chair at Imperial College London June 2017, and now works part-time at the College as Professor of Toxicolo-gy. His research interests include mechanistic toxicology, risk

assessment and the effects of mixtures. He has been a member of the EFSA PPR Panel, the Panel on Contaminants in the Food Chain, a member/Chair of Joint FAO/WHO Meeting on Pesticide Residues and of the Joint FAO/WHO Expert Committee on Food Additives (residues of veterinary drugs) for approx. 20 years.

Monika Bross has been working at BASF Agricultural Center in Limburgerhof for more than 20 years. Within BASF she has been involved in all types of residue and metabolism studies, but also in

dietary exposure assessment and the preparation of submission documents to authorities (EU, US, JMPR). Monika is chairing the ECPA Residue Expert Group and is a member of related ad-hoc teams on dietary exposure assessment and cumulative assessment.

Coen Graven is a registered Toxicologist, residue specialist and project leader at RIVM. Since 2014 he has been working in the area of biocide and plant protection product risk assessment and

methodology development. He has previously worked at the Dutch competent authority Ctgb.

Caroline Harris is the Centre Director for Chemical Regulation and Food Safety in Exponent International’s UK office. After many years as a Regulator at CRD, she continues to be involved with MRLs, import

tolerances and pesticide residues in international trade. She also remains highly active in the field of consumer risk assessment.

Christer Hogstrand is a Professor at the Department of Nutritional Sciences at King’s College London. Besides this role, he is an Expert for the EFSA and currently a member of its Panel on Contaminants in

the Food Chain. He has been involved in 12 EFSA working groups and is presently chairing three, including the working group on Chemical Mixtures.

Karsten Hohgardt is the Head of the unit responsible for risk management in the field of toxicology and residue behaviour at BVL. Since 2006 he has also been Deputy Head of Department “Plant

Protection Products“. His main experience lies in MRL setting and residue behaviour.

David Hrdy works in the U.S. EPA as a Senior Scientist. He is EPA’s liaison with FDA and USDA, reviews residue chemistry studies, calculates dietary exposures estimates and works with human health

risk assessments primarily in pesticides.

Carsten Kneuer is a Toxicologist and the Head of the Unit “Toxicology of Active Substances and their Metabolites“ in the Pesticides Safety Department of the BfR. He started working for

the BfR in 2007 as a Senior Scientist Risk Assessment.

Eeva Leinala is a Principal Administrator in the Environment Health and Safety Division of the OECD, where she advances projects related to risk assessment and risk reduction of chemicals. She is the

Principal Administration for both the Hazard Assessment Programme and the Risk Reduction Programme. Prior to the OECD she worked in the area of chemical risk assessment at Health Canada for 12 years.

Pauline Mombert has been working at ANSES as a Scientific Risk Assessor after graduating with a major in nutritional sciences from AgroParis- Tech. She took part in the drafting of the EU technical guideline for

determining the magnitude of pesticide residues and setting maximum residue levels in honey that was adopted last September by the European Commission.

Suzanne Pierlot joined ANSES in 2007 to work on consumer safety in the field of plant protection products and biocides and has been Deputy Unit Manager of the residues and food safety unit of the

regulated products assessment depart-ment since 2015.

Christian Prohaska studied food and biotechnology in Vienna. He worked for public bodies dealing with the risk assessment of plant protection products before he gained a postgraduate degree in

toxicology and started working at AGES in 2002.

Dieter Schrenk has been a Professor for Food Chemistry and Environmental Toxicology at the University of Kaisers-lautern since 1996. In 2005 he took on the full professorship for Food

Chemistry and Toxicology. He joined the EFSA CONTAM Panel in 2003. Since this year he has been the Chair of this panel.

Jens Schubert is working as a scientist at the German Federal Institute for Risk Assessment, BfR in the Department Steering and Overall Assessment – Plant Protection since 2014. The main area of

responsibility is the management of the EU evaluation of active substances in plant protection products within the BfR as well as participation in several groups and projects (e.g. EuroMix, Co-Formulants).

Claire Stephenson is a Senior Managing Scientist in residues and dietary exposure at Exponent International. Prior to this, she worked at the UK CRD where she lead on technical aspects of MRLs. She has

represented the UK as a technical expert at a range of EC and EFSA meetings and holds a PhD in biochemistry.

Trijntje van der Velde-Koerts is a Chemist and a Scientific Employee at RIVM in the field of pesticides, biocides and veterinary medicines. She is a member of the BPC ad-hoc working group ARTFood (Assessment of

Residue Transfer to Food) since its establishment in 2014.

Jacob van Klaveren has been working for RIVM as a Senior Scientific Advisor since 2010. He coordinates the R&D programme on food safety for Wageningen Research, EU funded ACROPOLIS project and

the EFSA-RIVM partnership on the follow-up ACROPOLIS. Since 2015 he is coordinating the EuroMix project, which is a new strategy for mixture testing.

Petra Veit is a Biologist by training and works as a Global Team Leader for consumer safe-ty within BASF. She is responsible for the field and the analytical part of all kind of residue studies for MRL setting.

Anneli Widenfalk has a scientific background in biology and ecotoxicology and has been working with risk assessment of pesticide residues at the Risk and Benefit Assessment Department

of the National Food Agency in Sweden for 10 years. She is involved in the processes of active substance approvals, plant protection products registration and MRLs setting and review and is a member of EFSA´s PPR Panel since 2018.

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 interna-tional 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 op portunities contribute to giving our customers the competitive edge in all quality assurance, risk assess-ment, legal, production and techni-cal questions.

Akademie Fresenius is a joint ven-ture between Cognos, one of the largest private and independent education groups in Germany, and SGS Institut Fresenius, one of the leading German providers of chemi-cal laboratory analysis.

You can find details on upcoming and new events at www.akademie-fresenius.com

Who do you meet?

Groups that should take part:

Managing directors, boards of directors, managers, consultants and scientists in the fields of

• Quality assurance & control

• Product safety

• Legal & regulatory affairs

• Registration and authorisation

• Toxicology

• Risk assessment

• Research & development

Sectors that should take part:

• Food industry

• Food retailing

• Agrochemical industry

• Authorities (e.g. agricultural and food inspection offices, registration and control authorities)

• Laboratories

• Research institutes

• Professional associations

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 perso- nally.

Semsigül Yalcin phone: +49 231 75896-94 syalcin@akademie-fresenius.de

About

Do you have any questions?

Programme and conceptual design

Claudia Werner phone: +49 231 75896-84 cwerner@akademie-fresenius.de

Organisation and participant management

Analisa Mills phone: +49 231 75896-77 amills@akademie-fresenius.de

Billing Address (only if different from the above address)

Date Signature

VenueNovotel Düsseldorf City West Niederkasseler Lohweg 179, 40547 Düsseldorf/Germany phone: +49 211 52060-0 h3279@accor.com, www.novotel.com

We have reserved a limited number of rooms for our participants at reduced rates at the hotel. These rooms can be booked up to six weeks prior to the start of the event. Please book early and directly through the hotel quoting “Fresenius” as reference.

By web www.akademie-fresenius.com/2600By email registration@akademie-fresenius.comBy fax +49 231 75896-53

Hotline +49 231 75896-50 Die Akademie Fresenius GmbH Alter Hellweg 46, 44379 Dortmund

Registration

Terms of Participation and PurchaseThe registration fee includes the event participation, event documenta-tion, 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 docu-mentation 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 ReductionsFor joint bookings received from one company we grant a 15% discount from the third participant onwards.

Terms of CancellationWritten 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 ConditionsBy 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 DataThe 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, email, 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 and videos at our events. These are then published anonymously on our website. Further information can be found at: www.akademie-fresenius.com/dataprotection.

Picture Credit © Gordon Bussiek – Fotolia.com

Your Account Number (if available)

Title / First name / Name

Position

Department

Phone / Fax

Email

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)

Company (complete company name including legal form)

ParticipationI would like to take part in the 17th International Fresenius Conference “Food Safety and Dietary Risk Assessment“, 28 and 29 March 2019 in Dusseldorf/Germany.Fee: € 1,895.00 plus VAT.

Event DocumentationUnfortunately, I am unable to attend. Please send me the complete documentation for € 295.00 plus VAT.

I would like to take part in the evening event on 28 March 2019 (included in the above price).

Trade ExhibitionPlease send me information on available options for trade exhibition and presenting product information.

I am a representative of an authority or a public university and therefore eligible for a reduced fee of € 795.00 plus VAT (please provide evidence). The reduced fee cannot be combined with other rebates.