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08:50 09:00 (10 mins)

The Biocidal Products Regulation

Opening remarks from the chairperson- Ian Pepper

  • Ian Pepper - Director, Biotactix

08:50 09:00 (10 mins)

REACH

Opening remarks from the chairperson

  • Roger Van der Linden - Consultant, Product Stewardship, Belgium

08:50 09:00 (10 mins)

Main agenda

Opening remarks from the chairperson

  • Robert Birkett - News Reporter, Agrow, Agribusiness Intelligence, informa

09:00 10:00 (60 mins)

Main agenda

OPENING KEYNOTE PANEL: The politicisation of the decision-making process for agrochemical registration: what does it mean for the future of the Plant Protection Industry?

  • Understanding ECJ access to data and assessing the dossier’s vulnerability to political attack
  • Understanding the technicalities of co-decision and the role of European Parliament
  • Bentazone and European Parliament decisions on European Commission proposals
  • Examining the role of social media and populism
  • What lessons can be learned from the glyphosate issue?
  • Moving forward
  • Julie Girling - MEP for the South West of England and Gibraltar, European Parliament
  • Paul Leonard - Head of Innovation Technology Policy, BASF
  • Alastair Leake, Ph.D. - Director of Policy & Parliamentary Affairs, Game & Wildlife Conservation Trust
  • Moderator Robert Birkett - News Reporter, Agrow, Agribusiness Intelligence, informa

09:00 09:30 (30 mins)

REACH

KEYNOTE: Beyond the 2018 deadline: the journey continues

  • Towards reaching the WSSD 2020 goals: mapping the “chemical universe”
  • Progress with ECHA’s regulatory strategy – evaluation processes and link with further regulatory risk management
  • Follow-up and enforcement of ECHA decisions
  • Ofelia Bercaru, ECHA

09:00 09:30 (30 mins)

The Biocidal Products Regulation

How you prove your products do what they say they do?

  • Understanding efficacy claims
  • Issue for concern is efficacy. How you prove your products do as they say they do?
  • Benchmarks for performance
  • Criteria, what if it doesn’t pass? Disinfectant dossiers to rethink about!
  • What is the data you have got and will it meet the requirements of the regulators
  • David Ashworth - Managing Director, Klarus Consulting

09:30 10:30 (60 mins)

REACH

REACH 2018: How are Competent Authorities helping SMEs?

  • Developing collective partnerships across all stakeholders to ensure a joint effort
  • Getting ready to support stakeholders for the next deadline
  • Helpdesk and stakeholder engagement programmes
  • What are the specific challenges, guidance and exemptions for SMEs?
  • Mike Potts - HM Inspector of Health and Safety , Health & Safety Executive, Chemicals Regulation Directorate, UK
  • Maria Letizia Polci - DG Health Prevention REACH&CLP CA, Ministry of Health, Italy
  • Hermann Goetsch - Division Legal Services 2, Division External Legislation and Legal Coordination , FEDERAL MINISTRY OF AGRICULTURE, FORESTRY, ENVIRONMENT AND WATER MANAGEMENT, Austria
  • Suzanne Wiandt - Head of Unit – REACH Helpdesk, Chemical Assessment, BAuA – Federal Office for Chemicals, Germany

09:30 10:00 (30 mins)

The Biocidal Products Regulation

The Impact of the ECHA Board of Appeal on the BPR

  • The appeals process in brief
  • Findings from appeals made under the BPR so far (data sharing)
  • Experience to date and lessons learned
  • Andrew Fasey, ECHA Board of Appeal

10:00 10:30 (30 mins)

Main agenda

Intensive agriculture: good for business & the environment

  • Pressure on land and the environment from population growth will intensify
  • Farmers are a key part of the solution for increasing wildlife not just part of the problem
  • Research has shown that by pro-actively managing wildlife, farmland bird numbers can double
  • Crop protection and fertiliser inputs can be used to positively benefit wildlife
  • High yield farming and high levels of biodiversity can co-exist
  • Alastair Leake, Ph.D. - Director of Policy & Parliamentary Affairs, Game & Wildlife Conservation Trust

10:00 10:30 (30 mins)

The Biocidal Products Regulation

Updates by Fieldfisher

  • Koen Van Maldegem - Partner, EU Regulatory & Competition, Fieldfisher, Belgium

10:30 11:10 (40 mins)

Main agenda

Networking Break

11:05 11:15 (10 mins)

AgChem Forum: Regulatory Frameworks

Opening remarks from the chairperson

  • Mike Carroll - Head of Research and Development, EMEA, Arysta LifeSciences, UK

11:05 11:15 (10 mins)

AgChem Forum: Environmental Safety

Opening remarks from the chairperson

  • Véronique Poulsen - Head of the Ecotoxicology and Environmental Fate Unit Regulated Products Directorate, Anses

11:10 11:40 (30 mins)

Biopesticides

BIOPESTICIDES AND BIOLOGICAL PRODUCTS – CONDUCTING PRACTICAL PROJECTS

Topic to be confirmed 

  • David Esdaile - Director of Science and Regulatory Affairs, Citoxlab

11:10 11:45 (35 mins)

AgChem Forum: Regulatory Frameworks

EFSA feedback: current developments and future plans

  • Highlighting the latest guidance and clarifying how to implement it the submission
  • EFSA feedback on endocrine disruptors
  • EFSA and proposals for grouping substances in risk operations
  • AIR 4 renewal of active substances
  • Future plans from EFSA
  • Dimitra Kardassi, EFSA

11:10 11:40 (30 mins)

AgChem Forum: Environmental Safety

Guidance documents: Assessing challenges and opportunities

  • The wave: What has recently been published
  • What can we expect in 2018 and beyond?
  • To what extent are MS using guidance’s and opinions?
  • Could guidance’s be simplified and made more user friendly?
  • Long term planning -how can industry and MS plan to prepare what will be in the final guidance document? How much resource should be spent on this?
  • Patrick Kabouw - Global Ecotoxicology / Global Registration Manager, BASF

11:10 11:40 (30 mins)

The Biocidal Products Regulation

BPR: a shared road to market

  • Cécile Rousseau - Product Stewardship Lead for Southern Europe., ERM

11:10 11:40 (30 mins)

REACH

Industry experience in substance and dossier evaluation

  • Evaluation under REACH: Areas of focus, Requirements, Timelines
  • Approaches to address Evaluation letters - Dos and Don'ts
  • Strategies to avoid Evaluation


  • Gesine Fickel - Manager Scientific Advocacy, Celanese, Germany

11:40 12:20 (40 mins)

Biopesticides

Feedback from the OECD Expert Group on Biopesticides (EGBP)

  • What is OECD?
  • How is OECD involved in the registration of biopesticides
  • What do we consider 'biopestcides'?
  • What has the Expert Group on Biopesticides achieved until now?
  • The role of OECD EGBP in harmonizing the registration of biopestcides.
  • How to deal with new innovations?
  • Jeroen Meeussen - EU Minor Uses Coordinator , EU Minor Uses Coordination Facility

11:40 12:15 (35 mins)

AgChem Forum: Regulatory Frameworks

Development of Criteria for the Identification of EDCs

  • Outcome of the Berlin Workshop
  • Draft regulations proposed by the EU Commission
  • Glenn Lurmann - Scientist, Federal Institute for Risk Assessment (BfR)

11:40 12:20 (40 mins)

AgChem Forum: Environmental Safety

Aquatic guidance document – EFSA amendments – Member State feedback

  • Clarifying the scope
  • Key updates
  • Implications for industry and Member States
  • Experience with the EFSA guidance on tiered risk assessment for aquatic organisms in edge-of -field surface waters


  • Véronique Poulsen - Head of the Ecotoxicology and Environmental Fate Unit Regulated Products Directorate, Anses

11:40 12:10 (30 mins)

REACH

Experience of the ECHA Board of Appeal after 100 Appeals

  • The role of the ECHA Board of Appeal (BoA)
  • The appeals process
  • The impact of the BoA on REACH and its implementation
  • What have we learnt after 100 appeals.
  • Andrew Fasey, ECHA Board of Appeal

11:45 12:15 (30 mins)

The Biocidal Products Regulation

Ensuring compliance and enforcement -feedback from the HSE

  • Remaining compliant with the BPR
  • Actions for non compliance
  • How HSE enforce the BPR
  • Consequences on breaching the BPR
  • Mike Potts - HM Inspector of Health and Safety , Health & Safety Executive, Chemicals Regulation Directorate, UK

12:20 13:50 (90 mins)

Main agenda

Networking lunch

13:50 14:25 (35 mins)

AgChem Forum: Environmental Safety

E-FLOWS: The Edge-of-Field Waterbody Safety Assessment Facility – The First Fully Flow-through Field Scale Mesocosm

  • Higher Tier Study Guidance in the 2013 EFSA ‘Guidance on Tiered Risk Assessment for Plant Protection Products for Aquatic Organisms in Edge- of- Field Surface Waters’
  • Common problems arising and issues encountered to date in higher tier (mesocosm) aquatic studies
  • Delivering the Future; the design of a new field scale fully flow through aquatic mesocosm at the Centre for Applied Crop Science
  • Rachel Benstead - Senior Aquatic Ecotoxicologist, Fera Science Ltd.

13:50 14:20 (30 mins)

AgChem Forum: Regulatory Frameworks

Data protection and access to documents

  • Experiences and strategies for addressing data protection under 1107/2009
  • Examining the procedure at authorities to follow up data protection requests from third parties
  • Understanding the differences in Member State requirements
  • Claudio Mereu - Partner, EU Regulatory & Competition, Fieldfisher, Belgium

13:50 14:20 (30 mins)

The Biocidal Products Regulation

KEMI perspective on treated articles

  • Useful information for industry on recent developments for treated articles
  • Exploring the extent to which Member States differ in their enforcement of treated article requirements
  •  Outlining labelling requirements for treated articles
  • Mary Iakovidou, KEMI

13:50 14:20 (30 mins)

Biopesticides

The 4th “P” in Sustainable Agriculture

  • Guy Elitzur - CEO, Stockton Group

13:50 14:20 (30 mins)

REACH

Data sharing in practice and assessing how improvements can be made to the process

  • Examining the impact of ECHA’s data sharing principles
  • Assessing how the term co-registrant is defined and understanding how cost deviation and division is managed between the two parties
  • Understanding why data sharing disputes are becoming more common
  • Examining the impact data sharing disputes have on resource
  • Other legal challenges
  • Feedback from large and small companies
  • Petra Weber - Head of Global Inventory and REACH Management, Clariant

14:20 14:50 (30 mins)

Biopesticides

Regulatory experiences on Biopesticides

  • Discussing developments of the last 5 year and 10 years
  • Looking globally including the USA and South America 
  • Feedback from leading consultancy 
  • Rüdiger Hauschild - Director & Head of Biopesticides, GAB Consulting

14:20 14:50 (30 mins)

AgChem Forum: Regulatory Frameworks

Low Risk Substances

  • Regulatory and political framework
  • Handling of revised criteria
  • Guidance related to low risk
  • Industry experience and way ahead
  • Bernd Brielbeck - Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides, SCC Scientific Consulting Company GmbH

14:20 14:55 (35 mins)

AgChem Forum: Environmental Safety

Update of the EFSA guidance document on birds and mammals – Industry view

  • Industry experience with current EFSA Guidance Document
  • Update of GD: scope and timelines
  • Contribution of industry to the update of the GD
  • Industry data for the update of the GD
  • Sharing industry data with EFSA
  • Juan Pascual - Senior Ecotoxicologist, BASF

14:25 14:55 (30 mins)

The Biocidal Products Regulation

Treated articles and biocides: An industry perspective

An overview on treated articles- what we know to date.

This session is tentative and requires confirmation from the speaker and company involved.

  • Ian Watt - European Product Stewardship and Regulatory Manager, Dow Microbial Control

14:50 15:20 (30 mins)

Biopesticides

Assessing current regulatory issues with Biopesticides including Industry perspective

  • Discussing timelines for Biopesticides
  •  Improving Global harmonisation
  • Are the data requirements currently too harsh?
  • Scope for the future
  • Rebecca Reboul, Institute for Plant Protection Products, Austrian Agency for Health and Food Safety, Austria
  • Jeroen Meeussen - EU Minor Uses Coordinator , EU Minor Uses Coordination Facility
  • Christina Donat - Technical Director Substitutional COO, BIO-FERM GmbH

14:50 15:20 (30 mins)

AgChem Forum: Regulatory Frameworks

A proposal to improve the protection of the environment and streamline the authorisation process.

  • The environmental risk assessment should contain fewer, robust and high-quality factors appropriate for the general protection goals and should be continuously improved by feed-back from environmental monitoring
  • Calibrated assessment factors for the first-tier risk assessment could considerably faster deliver the same results as today in terms of risk levels for authorised products.
  • A more holistic approach should be applied in the management of environmental risks of pesticides. Key elements to achieve this are: stakeholder engagement, improved environmental monitoring and coordination of work in different regulatory areas
  • Johan Axelman - Strategic Adviser, Authorisation and Guidance, Swedish Chemicals Agency

14:50 15:20 (30 mins)

AgChem Forum: Environmental Safety

Question & Answer session

14:50 15:20 (30 mins)

The Biocidal Products Regulation

Management of in-situ generated active substances under the BPR

  • Implications of the new scope of the BPR for in-situ generated biocides
  • Outlining experiences and a case example with application for approval
  • Challenges, (practical) solutions, recommendations for the future

14:50 15:20 (30 mins)

REACH

Examining the interface between the PPP regulation and REACH: Applying REACH requirements to the co-formulants used in Plant Protection Products

  • Assessing the dual regulation for the same chemical
  • How co-formulants are regulated under REACH?
  • Interface PPP, REACH and BPR
  • A systematic approach to applying REACH requirements to the co-formulants used in Plant Protection Products
  • Securing agrochemical uses are covered in the manufacturer’s registration dossiers of co-formulants
  • What ECPA tools are available to help suppliers apply REACH requirements to the co-formulants used in PPP?
  • Florie Bolliot - Chemical Legislation Group Leader & REACH Technical Leader, Dow AgroSciences

15:25 15:55 (30 mins)

Main agenda

Networking and afternoon tea

15:55 16:25 (30 mins)

Biopesticides

Regulating Biopesticides in South America with focus on Brazil

  • Maria Luiza Castro - Director at CESIS Solucoes em Regulamentacao e Registro de Productos, Cesis

15:55 16:30 (35 mins)

AgChem Forum: Environmental Safety

Data requirements, bee testing and risk assessment of PPPs under EU Regulation No 1107/2009

  • Status of bee testing and risk assessment
  • Challenges with bee testing and risk assessment approaches
  • Needs for improvement
  • Axel Dinter - Global Regulatory Ecotoxicologist, Du Pont

15:55 16:30 (35 mins)

The Biocidal Products Regulation

In situ biocidal products generated from devices

This session will provide a practical case history of how a group of companies new to the BPR have organised themselves together to meet the many challenges of active substance Approval and product authorisation.

  • Ian Pepper - Director, Biotactix
  • Mike Prince - Chairman, European Ozone Trade Association

15:55 16:25 (30 mins)

AgChem Forum: Regulatory Frameworks

Designing non-dietary human exposure studies to meet regulatory data requirements

  • Identifying when exposure data are needed
  • Which crops and GAP need to be covered
  • Regional and agronomic variations
  • Application techniques
  • Future trends in exposure risk assessment
  • Richard Glass - Team Leader, Exposure Assessment Team, Eurofins

15:55 16:30 (35 mins)

REACH

Improving Communication Channels along the Supply Chain to Ensure Compliance

  • New obligations imposed by REACH
  • Set up of new organisational models
  • Set up of new communication processes
  • Set up of communication protocols
  • How to implement these changes into the daily operations
  • Roger Van der Linden - Consultant, Product Stewardship, Belgium

16:25 16:55 (30 mins)

Biopesticides

Presentation to be delivered by Imme Gerke

Topic to be confirmed 

16:25 17:00 (35 mins)

AgChem Forum: Environmental Safety

An update on the future SETAC Soil organism and non- target arthropod workshop

  • Following on from the successful SETAC tripartite workshops on non- target plants it was decided to organise similar joint events for soil organisms and non- target arthropods 
  • A steering committee has been formed
  • This is a first opportunity to share more information and ideas with a wider audience
  • Mike Coulson - Mike Coulson Senior Managing Scientist - Ecotoxicology, Exponent International Limited

16:25 16:55 (30 mins)

The Biocidal Products Regulation

Exploring recent court cases in the field of chemical legislation (European Court of Justice, ECHA Board of Appeal)

  • Reviewing recent court cases
  • Updates on ECHA board of appeal decisions
  • Looking at consequences to be drawn on the basis of these decisions
  • Hermann Goetsch - Division Legal Services 2, Division External Legislation and Legal Coordination , FEDERAL MINISTRY OF AGRICULTURE, FORESTRY, ENVIRONMENT AND WATER MANAGEMENT, Austria

16:25 16:35 (10 mins)

REACH

End of Day One: REACH

16:25 16:55 (30 mins)

AgChem Forum: Regulatory Frameworks

DISCUSSION PANEL: 1107/2009 – an extension of the 5- year anniversary

  • Assessing the progress so far
  • Is 1107/2009 fit for purpose? What can we learn from 1107/2009 going forward?
  • Cut off criteria
  • Zonal harmonisation
  • Renewals of plant protection products under 1107/2009
  • Johan Axelman - Strategic Adviser, Authorisation and Guidance, Swedish Chemicals Agency
  • Christian Prohaska - Head of Department for Residue Behaviour , AGES - Austrian Agency for Health and Food Safety, Austria
  • Donal Griffin, CRD

17:00 18:00 (60 mins)

Biopesticides

End of Biopesticides

17:00 17:10 (10 mins)

AgChem Forum: Environmental Safety

End of Day One: AgChem Forum: Environmental Safety

17:00 18:00 (60 mins)

The Biocidal Products Regulation

End of Biocidal Products Regulations

17:10 17:20 (10 mins)

AgChem Forum: Regulatory Frameworks

End of Day One: AgChem Forum: Regulatory Frameworks