Minor Use Authorisations –

A Structured Approach

An Industry Perspective

Peter A Watson – Dow AgroSciences

EPPO Workshop on Mutual Recognition of Minor Uses - Berlin - October 2006

We are where we are !
„ What is needed ?
„ Piecemeal adaptations of national
procedures or a transparent, responsive and
functional EU-wide system ?
„ Top-down or Bottom-up design ?
„ Consequences of inactivity

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Where are we today ?
„ Multitude of national approaches
„ Operationally distinct
„ Stakeholder involvement diverse
„ Liability obligations unclear
„ Mutual recognitions improving
„ Lack of consistency across Member States

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What is needed ?
„ Growers/farmers
„ Consumers
„ Food Value Chain
„ Crop Protection Industry
„ PPP manufacturers
„ Advisers
„ Public and their political representatives
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Growers/farmers
„ Range of safe and effective products
„ Authorised and appropriate GAP
„ Responsive, understandable procedure
„ Competitive opportunities in niche markets

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Consumers
„ Safe and wholesome food
„ Sustainable production systems
„ Reliability of supply
„ High quality produce
„ Viable ‘local’ Agricultural/Horticultural
industry

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Food value chain
„ Predictability
„ Acceptability
„ Consistency
„ Reliability

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Crop Protection Industry
- PPP Manufacturers
„ Input as key stakeholder
„ Reliable cogent system
„ Liabilities clearly defined between producer
and user
„ Appropriate data requirements
„ Responsiveness

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Crop Protection Industry
- Advisers
„ Input as major stakeholder
„ Understandable practical system
„ Clearly defined liabilities
„ Appropriate data requirements
„ Responsiveness

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Public and their political
representatives
„ Wholesome and nutritional food supplies
„ Acceptable Regulatory system
„ Equal opportunity for ‘local’ producers
„ Sustainable crop production systems
„ No ‘food scares’

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Areas of concern
„ MRL issues
„ Risk cups
„ Liability
„ Data Protection
„ Data requirements
„ Responsivity
„ Funding
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What is needed ?
„ Creative solutions
„ Visionary leadership
„ Expert judgement
„ Pragmatic approach to extrapolation of data,
especially biology !!
„ A responsive procedure
„ Willingness to ‘share’
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New EU-wide system ?
„ Revision of EU Authorisation process (Directive
91/414/EEC) presents unique opportunity for
wholistic approach
„ Establishment of small key Stakeholder group to
design and propose an EU-wide system taking into
account the full range of issues
„ Co-ordination through Member States Expert
Group on Minor Uses
„ A streamlined authorisation procedure

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Likely features of new
EU-wide system
„ Data requirements – appropriate to
situation, not ‘standard’ set for major
crops/uses
„ Reduced liabilities for PPP manufacturers
„ Acceptance of ‘Expert’ judgement for
indicative efficacy considerations
„ Independent Steering Group to decide
priorities

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Likely features of new
EU-wide system
„ Consumer risk assessment procedure to
reflect minor dietary component nature of
most minor crops
„ Responsive system to meet grower needs
„ Fast-track procedure for MRL
establishment

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Minor Use Authorisations –
Timetable
„ Against the background of reduced
availability of many older active substances

„ The time for action is NOW !!

„ The train is about to leave the station, will

we be on it ?

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Minor Use Authorisations –
Conclusion
„ Streamlined Authorisations procedure for
Minor Uses
„ Transparent, responsive and functional
across Member States
„ Top-down system designed jointly by
Stakeholders

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Minor Use Authorisations –
A Structured Approach
Thank you for your attention

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