DIE AKADEMIE FRESENIUS Where Experts Meet!

26 and 27 March 2020 in Mainz/Germany

Biopesticides – Biofertilisers – Biostimulants

2nd International Akademie Fresenius BIOCONTROL Conference

The Experts

Gertie H. P. Arts Wageningen University and Research | Will Askew Applied Insect Sciences (APIS) | Adi Cornelese Applied Insect Sciences (APIS) | Matthias von Erffa International Biocontrol Manufacturers Association (IBMA) | Roma Gwynn Rationale Biopesticide Strategists | Ton van Huygevoort Charles River Laboratories Den Bosch | Philip Kessler Andermatt Biocontrol | Ina Kleeberg Trifilio-M | Eric Liégeois European Commission | Jeroen Meeussen EU Minor Uses Coordination Facility | Caroline Pastor Lallemand Plant Care | Outi Priha European Chemicals Agency (ECHA) | Michael Przyklenk Biocare | Anne Steenbergh Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) | Jürgen Sturma European Food Safety Authority (EFSA) | Maryam Sultan Bayer Crop Science Division | Gábor Tökés Hungarian National Food Chain Safety Office (NÉBIH) | Mark Whittaker Applied Insect Sciences (APIS)

Highlights

Regulatory Developments

• Update from the EU Commission: Activities regarding biological pesticides

• Scientific questions to be answered for the purpose of simplification of the risk assessment and registration of microbial pesticides

• A member state perspective on updating the regulatory framework for microbial PPPs

• ECHA: Update on Biological Biocides• An update of the work of the OECD Expert

Group on Biopesticides• IBMA’s work on a the decision tree focusing

on potential risk areas• Registration of a botanical within the EU

PPP Regulation

Risk Assessment

• Implications of in situ metabolite produc-tion for the human and environmental risk assessment of microbial pesticides

• Challenges in evaluating the pathogenicity of microbial pesticides in adult and immature honey bees

Updated programme

Thursday, 26 March 2020

8.30 Registration and coffee

9.00 Welcome address by the organisers and introduction by the Chair

Mark Whittaker, Applied Insect Sciences (APIS), United Kingdom

Regulatory Developments9.10 Update from the Commission: Activities regarding biological pesticides

Eric Liégeois, European Commission, Belgium

9.35 EFSA’s current activities and goals regarding biological pesticides

Jürgen Sturma, European Food Safety Authority (EFSA), Italy (to be confirmed)

10.00 ECHA update on microbial biocidal products

Outi Priha, European Chemicals Agency, Finland

10.25 Industry perspective on the current state of regulation of microbial biopesticides

• Registration of biopesticides• Experiences from different geographies• Outlooks

Philip Kessler, Andermatt Biocontrol, Switzerland

10.50 Panel discussion 11.20 Coffee break

11.50 A member state perspective on updating the regulatory framework for microbial PPPs

• Regulations• Guidances

Anne Steenbergh, Dutch Board for the Authorisation of Plant Protection Produts (Ctgb), The Netherlands

The Programme12.15 Scientific questions to be answered for the purpose of simplification of the risk assessment and registration of microbial pesticides

• Which biological characteristics should be considered in the risk assessment?

• What are the real risks?• What can be learned from approaches in other risk

assessment frameworks for microbial pesticides?

Gertie H. P. Arts, Wageningen University and Research, The Netherlands

12.40 Moving towards a more risk-based and proportionate regulation for Bioprotectants

• IBMA work on a decision tree focusing on potential risk areas

Matthias von Erffa, International Biocontrol Manu- facturers Association (IBMA), Belgium

13.05 Panel discussion13.35 Lunch

The Biologics Landscape: Regulation and Beyond14.40 An update of the work of the OECD Expert Group on Biopesticides

• What is the OECD?• Current activities and future plans• The benefits of biologicals in solving minor uses needs

Jeroen Meeusen, EU Minor Uses Coordination Facility, France

15.05 Experiences and Challenges in registration of a botanical within the EU PPP Regulation

• Data requirements - difficulties & possibilities• Interpretation of the guideline - from an industrial

point of view

Ina Kleeberg, Trifolio-M, Germany

15.30 Coffee break

16.00 A competent authority view on the recent changes regarding biostimulants and biofertilisers

Gábor Tökés, National Food Chain Safety Office, (NÉBIH), Hungary

16.25 An industry perspective on registration and compliance for biostimulants and fertilisers: Examples from Europe and abroad

Caroline Pastor, Lallemand Plant Care, France

Get-together on Wednesday,25 March 2020Will you arrive on Wednesday? Come into the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere.

16.50 Panel discussion

17:20 End of first conference day

18.20 Departure time for the evening event

Friday, 27 March 2020

9.00 Welcome address by the Chair

Mark Whittaker

Risk Assessment9.10 Implications of in situ metabolite production for the human and environmental risk assessment of microbial pesticides

• The role of microbial metabolites in ecology• Toxicity and stability of metabolites in the environment• Implications for the risk assessment

Adi Cornelese, Applied Insect Sciences (APIS), Germany

9.35 Improving ecological risk assessment for microbial pesticides.

• The current guidance framework • Relevance of methodology used and data generated

for risk assessment• Experience-based improvement

Will Askew, Applied Insect Sciences (APIS), United Kingdom

10.00 Unique challenges in evaluating the patho- genicity of microbial pesticides in adult and immature honey bees

• Assessment of suitability of OECD Guidance Document No. 239 to assess honey bee larval toxicity with micro-bial pesticides

• Possible modifications to US EPA Microbial Pesticide Test Guideline (885.4380) to improve performance

• Next steps

Maryam Sultan, Bayer Crop Science Division, Germany

10.25 Research perspective: An update on the challenges and solutions for in-vivo testing of biopesticides

• Prerequisites for animal testing• Clearance and infectivity• Biological versus pathogenic response

Ton van Huygevoort, Charles River Laboratories Den Bosch, The Netherlands

10.50 Panel discussion11.20 Coffee break

Research and Development11.50 How can bacteriophage, a new technology for plant protection, be regulated

• Bacteriophage are used widely in human health and as biocide but are new for plant protection

• The way they are regulated therefore needs to be considered

• Discussion: how, based on their biology and ecology, can they be regulated to allow them to be assessed for use in plant protection

Roma Gwynn, Rationale Biopesticide Strategists, United Kingdom

12.15 Development of an attract and kill formulation containing Metarhizium brunneum and Saccharomyces cerevisiae

• Encapsulation• Drying• Field results

Michael Przyklenk, Biocare, Germany

12.40 Questions and Answers13.00 Final discussion

13.30 Lunch and end of the conference

After the first conference day Akademie Fresenius would like to invite you to a leisurely evening in the Sparkling Wine Cel-lar Kupferberg and the Kupferberg terrace high above the city of Mainz. You have the opportunity of better getting to know other participants you met during the day over a relaxed sparkling wine tasting and meal.

Information available online at: www.akademie-fresenius.com/2703

The ExpertsGertie H. P. Arts holds a PhD in natural

sciences and works at Wageningen University and Research as a Senior Ecologist and Ecotoxi-cologist in the environmental risk

assessment team. She is involved in ecological, ecotoxicological studies and risk assessment for organic and other contaminants, especially risk assessment for aquatic macrophytes and plants as well as plant ecology and ecotoxicology.

Will Askew is a Study Director at Applied Insect Science. He develops, directs and reports ecotox and bioanalytic studies, mostly centred around microbial biopesticides.

He has a background in entomology and molecular biology and is currently completing a part-time PhD on the topic of ‘Development and Biosafety of Novel Biopesticides’ with Newcastle University.

Adi Cornelese is a senior regulatory expert at APIS. She has large experience in preparing dossiers for registration of active substances and products and was involved in developing guidance documents for EFSA and the Commission. She was  involved in drafting of EU data requirements for microorganisms under the BPR and participated in the Biopesti-cides WG for PPPs and the OECD working group on biopesticides. 

Matthias von Erffa has been working in biocontrol since 2000. Since 2013, he has been working in regulatory affairs for biocontrol agents for Bayer. Matthias is an active

member of the IBMA Germany/Austria and a member of the IBMA global’s Microbials Professional Group; he has also been a member of their steering committee since 2013.

Roma Gwynn is the Vice-President of the International Biocontrol Manufacturers Association (IBMA) and has worked within sustainable agriculture for over 30 years. She

has been an expert for EU-funded projects for regulation of biocontrol agents, the OECD Biopesticide Steering Group and EU Commission. She has been involved in the development of biopesticide regulatory guidance (FAO/WHO, EU, Kenya).

Ton van Huygevoort has been a Study Director for General Toxicity at Charles River Laboratories Den Bosch since 1997. Between 1985 and 1997 he worked as a Research

Technician at the Department of Pharmacology at TNO Rijswijk.

Philip Kessler has been working for Andermatt Biocontrol since 2005. In different roles he has been responsible for the registration of biopesticides, as well as

the market development in Africa, Asia and Australia. From 2011 to 2016 he was the Head of Regulatory Affairs and in 2016 he was assigned as Director International Market Development. He is active in the Professional Group for Microbials within IBMA and has been a member of their Steering Committee since 2012.

Ina Kleeberg holds a master in mechani-cal and process engineering  which she completed at TU Darmstadt in 2013. She has been employed with Trifilo-M since 2008,

starting in the area of process planning and development. For the last 5 years she has been the CEO of Trifilo-M.

Eric Liégeois is a Policy Officer at the European Commission in charge of Pesticides Legislation, moderating the Working Group on Biopesticides and contributing to risk

mitigation measures policy for DG SANTE. Formerly he was the Head-of-Sector for Fertilisers, Plastics and Circular Economy at DG GROW.

Jeroen Meeussen has been working as coordinator for the EU Minor Uses Coordination Facility since 2015. From 2010 until 2015 he has worked for the European Commission (DG SANTE).

Before that, he worked for the Dutch Ctgb and since 2005 Jeroen has also been chairing the OECD Expert Group on Biopesticides (EGBP).

Caroline Pastor holds a master in international business. She has been em-ployed with Lallemand since 2007 and is working as a Regulatory Affairs Specialist, responsible for analysing and opening markets for biostimulants, fertilisers & biopesticides.

Outi Priha joined the European Chemicals Agency (ECHA) in March 2016, and is chairing the Biocidal Products Committee Ad hoc Working Group on Micro-organisms. She

has a PhD in environmental microbiology. Before, she worked as a Scientist at VTT Technical Research Centre of Finland for 14 years, where her main research activity was on detection and control of biofouling in close co-operation with the industry.

Michael Przyklenk has been working for Biocare since 2016. He is responsible for the quality assurance, production and F&E of their encapsulated product ATTRA-CAP. His expertise stems from his PhD project, which dealt with encapsulation of the biological insecticide Metarhizium brunnuem.

Anne Steenbergh is a Microbial Ecologist employed at Ctgb Netherlands as an Assessor for environ-mental fate and behaviour. As part of the Ctgb ‘GreenTEAM’ she

focuses on the risk assessment of biopesticides.

Jürgen Sturma is a Scientific Officer at EFSA and the Scientific Co-ordinator for the European evaluation process for ac-tive substances used in plant protection products in the framework of Regulation (EC) No 1107/2009. He is a member of the Working Group on biopesticides at EU Commission. 

Maryam Sultan is a Pollinator Safety Expert within the Environmental Safety function at Bayer. She is responsible for generating and assessing environmental

hazard endpoints and performing risk characterisation of both chemical plant protection products as well as microbial/biochemical biopesticides. 

Gábor Tökés is the Head of the Author-ization Department in the Hungarian Food Chain Safety Office (NÉBIH). His scientific background is bioengineering and plant physiology. Since 2010 he has been responsible for the authorization of both plant protection products and yield enhancers (fertilizers).

Mark Whittaker has a PhD in entomology and is an established expert on the registra-tion of biopesticides. He is the Managing Director of APIS, a specialist contract research lab for

microbial safety testing.

The Organiser

For 25 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

• Biological control for the agricultural use

• Production/distribution of biological/microbial pesticides and biocides

• Research & development

• Risk assessment

• Toxicology

• Ecotoxicology

• Registration

Sectors that should take part:

• Agrochemical industry

• Biocontrol industry

• Research institutes

• Authorities

• Professional associations

• Contract laboratories/ consultancies

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.

Dominique Bischoff phone: +49 231 75896-64 dbischoff@akademie-fresenius.de

About

Do you have any questions?

Programme and conceptual design

Anne Möller phone: +49 231 75896-84 amoeller@akademie-fresenius.de

Organisation and participant management

Danielle Sörries phone: +49 231 75896-74 dsoerries@akademie-fresenius.de

VenueAtrium Hotel Mainz Flugplatzstr. 44, 55126 Mainz/Germany phone: +49 6131 491-0 info@atrium-mainz.de, www.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 “Akademie Fresenius” as reference.

By web www.akademie-fresenius.com/2703By 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

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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.

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ParticipationI would like to take part in the International Akademie Fresenius BIOCONTROL Conference “Biopesticides – Biofertilisers – Biostimulants“, 26 and 27 March 2020 in Mainz/Germany.Fee: € 1,695.00 plus VAT.

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