UK approach to minor usesUK approach to minor usesand and

Crop Grouping (extrapolation) Crop Grouping (extrapolation)

UK approach to minor usesUK approach to minor usesand and

Crop Grouping (extrapolation) Crop Grouping (extrapolation)

Vivian Powell

Technical Manager

Horticultural Development Council

Vivian Powell

Technical Manager

Horticultural Development Council

PresentationPresentationPresentationPresentation

• Minor Use Approvals in UK• EU Extrapolation Project• EU/ IR4 Collaboration

• Minor Use Approvals in UK• EU Extrapolation Project• EU/ IR4 Collaboration

Types of approvalTypes of approvalUKUK

Label RecommendationLong Term Arrangements for

Extension of UseSpecific Off-Label Approval

Label ApprovalsLabel Approvals

Problem for Minor CropsHigh Cost of Product DevelopmentAg Chem companies target high volume

marketHigh cost of generating data and

registration feesMinor crops are high risk because of

diversity and value

LTAEULTAEU

Allows extrapolation of approval to similar crops without a formal approval document or liability of manufacturer

Eg Lettuce to Spinach and herbsEU Changes to MRL provisions LTAEU for Edible crops expire 2006To be replaced by SOLAs

SOLAsSOLAs

Formal document – product and crop basedRequests made by grower or grower groupResidue data required to supportNo efficacy or crop safety dataGrowers risk – no liability to manufacturer

Extrapolation/Crop GroupingExtrapolation/Crop Grouping

EU recognise need for extrapolation EC Review 91/414 – loss of actives and uses Cost to generate data on wide crop range

Two EU projects conducted by PSD in UK

in consultation with other Member States

Extrapolation/ Crop GroupingExtrapolation/ Crop GroupingEfficacyEfficacy

Currently no EU guidelines Member States have individual approachesProject has focussed on identifying current

practice and suggesting general principles for discussion

Extrapolation/ Crop GroupingExtrapolation/ Crop GroupingResiduesResidues

Currently based on Lundehn guidelines across EU

Some Member States also have individual approaches

Extrapolation/Crop GroupingExtrapolation/Crop GroupingResidues Project Residues Project

Classification of crops Current guidelines – validity, and

potential to expandSpecific extrapolations – new & very

minor crops

Extrapolation/Crop GroupingExtrapolation/Crop GroupingIR4/UK PSDIR4/UK PSD

PSD aware of Crop Grouping Project Video Conference

UK PSD Personnel

HC, JB & DK [IR4]

Where next?Where next?Reports to be circulated in EU for discussion – end

of October

or

Bury our head’s Find a solution

Why are we doing Why are we doing this? this?

Without Crop Grouping there will be Without Crop Grouping there will be no future growthno future growth

And Remember!

Minor (Speciality) crops are essential for a healthy diet!