1. UK approach to minor uses and Crop Grouping (extrapolation) Vivian Powell Technical Manager Horticultural Development Council Vivian Powell Technical Manager Horticultural Development Council

2. PresentationPresentation Minor Use Approvals in UK EU Extrapolation Project EU/ IR4 Collaboration Minor Use Approvals in UK EU Extrapolation Project EU/ IR4 Collaboration

3. Types of approval UK Label Recommendation Long Term Arrangements for Extension of Use Specific Off-Label Approval

4. Label Approvals Problem for Minor Crops High Cost of Product Development Ag Chem companies target high volume market High cost of generating data and registration fees Minor crops are high risk because of diversity and value

5. LTAEU Allows extrapolation of approval to similar crops without a formal approval document or liability of manufacturer Eg Lettuce to Spinach and herbs EU Changes to MRL provisions LTAEU for Edible crops expire 2006 To be replaced by SOLAs

6. SOLAs Formal document – product and crop based Requests made by grower or grower group Residue data required to support No efficacy or crop safety data Growers risk – no liability to manufacturer

7. Extrapolation/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

8. Extrapolation/ Crop Grouping Efficacy Currently no EU guidelines Member States have individual approaches Project has focussed on identifying current practice and suggesting general principles for discussion

9. Extrapolation/ Crop Grouping Residues Currently based on Lundehn guidelines across EU Some Member States also have individual approaches

10. Extrapolation/Crop Grouping Residues Project Classification of crops Current guidelines – validity, and potential to expand Specific extrapolations – new & very minor crops

11. Extrapolation/Crop Grouping IR4/UK PSD PSD aware of Crop Grouping Project Video Conference UK PSD Personnel HC, JB & DK [IR4]

12. Where next? Reports to be circulated in EU for discussion – end of October or Bury our head’s Find a solution

13. Why are we doing this? Without Crop Grouping there will be no future growth And Remember! Minor (Speciality) crops are essential for a healthy diet!