1. Training Session Product File Notes and Registration Reports, 23 October 2006 1 Registration Report Part Residues Frédéric Joris and Bruno Dujardin Federal Public Service of Public Health, Food Chain Safety and Environment Belgium

2. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 2 Training Session Product File Notes and Registration Reports Overview General structure Summary of residue data (point 5.1) Maximum Residue Levels (point 5.2) Typical cases

3. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 3 Training Session Product File Notes and Registration Reports General structure (part B, point 5)

4. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 4 Training Session Product File Notes and Registration Reports Summary of residue data (point 5.1) (1) Every issue listed in Annex III must be dealt with  Proposed use patterns  Plant metabolism residue definition in plant products (monitoring and risk assessment)  Livestock metabolism residue definition in animal products (monitoring and risk assessment)  Stability of residues in stored analytical samples

5. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 5 Training Session Product File Notes and Registration Reports Summary of residue data (point 5.1) (2) Every issue listed in Annex III must be dealt with  Results of supervised residue trials + validation of analytical methods  Livestock dietary burden + livestock feeding studies  Fate of residues during processing  Residues in rotational crops  Dietary risk assessment + source of toxicological endpoints  Conclusion (proposed MRLs + proposed PHIs)

6. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 6 Training Session Product File Notes and Registration Reports First principle (1) First principle: refer to existing evaluations as much as possible  Data assessed for the Annex I inclusion  Data assessed for the setting of Community MRLs If the intended uses were already discussed residue data package considered to be complete and acceptable N.B.: 2 processes are linked: within one year after a 91/414/EEC Annex I inclusion decision, Community MRLs are set or revised by the RMS.

7. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 7 Training Session Product File Notes and Registration Reports First principle (2) How to refer to EU assessments? Complete list of endpoints EFSA scientific reports Community MRL proposals N.B.: In comparison with the data submitted for the Annex I inclusion, Community MRL proposals generally contain supplementary studies (metabolism, residue trials…) Conclusions can be cut and paste + a brief comment to explain that they are relevant for the intended uses

8. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 8 Training Session Product File Notes and Registration Reports First principle (3) Particular case: application for a provisional authorisation of a new a.s.  No evaluation document agreed at European level  Refer to the Draft Assessment Report using the list of endpoints…  … and it will be up to the national authorities to check the methodologies used and to give their own opinion.

9. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 9 Training Session Product File Notes and Registration Reports Second Principle Second principle: A clear distinction is necessary between the data already evaluated and the new provided data  Any new data must be fully assessed according to the residue guidance documents. How to summarize new data?  According to templates for DAR  Documents M. This summary level is in general considered to be sufficiently detailed.  Summary sheets for residue trials

10. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 10 Training Session Product File Notes and Registration Reports Maximum Residue Levels (point 5.2) Summary of MRLs and application conditions  State existing MRLs (European or national)  State whether intended uses will comply with existing MRLs…  … or whether new MRLs have to be proposed.  State the application conditions that have to be endorsed in order to comply with existing or proposed MRLs:  Number of applications  Application rate  PHI or stage of application  …

11. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 11 Training Session Product File Notes and Registration Reports Maximum Residue Levels: example

12. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 12 Training Session Product File Notes and Registration Reports Typical Cases  Use already covered by Annex I inclusion  Use already covered by MRL harmonisation  Use not covered by previous assessment

13. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 13 Training Session Product File Notes and Registration Reports Use covered by Annex I inclusion 5.1 Summary of residue data Refer to DAR and Compare GAPs Check for conditions in the Review Report Check for outdated information 5.2 Maximum Residue levels Summary table Check whether proposed EU MRL is already applicable in Belgium

14. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 14 Training Session Product File Notes and Registration Reports Use covered by MRL harmonisation 5.1 Summary of residue data Every section of the assessment must be adressed:  Refer to annex I inclusion as much as possible (copy/paste from endpoint list)  Refer to EU MRL proposal if not assessed for annex I inclusion  Explain the relevance for the intended uses Check for conditions in the Review Report or EU MRL proposal Check for outdated information 5.2 Maximum Residue levels Summary table

15. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 15 Training Session Product File Notes and Registration Reports Use not covered by previous assessment 5.1 Summary of residue data Every section of the assessment must be adressed  Refer to annex I inclusion as much as possible (copy/paste from endpoint list)  Refer to EU MRL proposal if not assessed for annex I inclusion  Summarize new data according to templates of DAR  Explain the relevance for the intended uses Check for conditions in the Review Report or EU MRL proposal Check for outdated information 5.2 Maximum Residue levels Summary table

16. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 16 Training Session Product File Notes and Registration Reports Conclusion Each section of the residue assessment must be adressed according to EU guidance Refer to previous EU assessments as much as possible Summary of the new data according to DAR templates State relavance for the intended use in Belgium

17. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 17 Training Session Product File Notes and Registration Reports Thank you for listening!