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Registration Report Part Residues. Frédéric Joris and Bruno Dujardin Federal Public Service of Public Health, Food Chain Safety and Environment Belgium. Overview. General structure Summary of residue data (point 5.1) Maximum Residue Levels (point 5.2) Typical cases. - PowerPoint PPT Presentation
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Training Session Product File Notes and Registration Reports, 23 October 2006
Registration ReportPart Residues
Frédéric Joris and Bruno DujardinFederal Public Service of Public Health,
Food Chain Safety and EnvironmentBelgium
23 October 2006
2
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Overview
General structure
Summary of residue data (point 5.1)
Maximum Residue Levels (point 5.2)
Typical cases
23 October 2006
3
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
General structure (part B, point 5)5. Residues
Considered acceptable for Annex I inclusion of the <active>, see DAR’, or: 5.1 Summary of residues data and consumer exposure
Details of the evaluation Conclusions
5.2 Maximum Residue Levels
Details of any EU MRLs that have been set for the uses considered for the product
Does the product comply with the MRL Directives/Regulation Proposals for national/temporary MRLs
23 October 2006
4
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
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
23 October 2006
5
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
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)
23 October 2006
6
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
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.
23 October 2006
7
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
First principle (2)
How to refer to EU assessments?
Complete list of endpointsEFSA scientific reportsCommunity 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
23 October 2006
8
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
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.
23 October 2006
9
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
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
23 October 2006
10
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
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 …
23 October 2006
11
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Maximum Residue Levels: example
5.2 Maximum Residue Levels
Crop Existing EU MRL
for sum of tolylfluanid and DMST expressed
as tolylfluanid
Existing National MRL for sum of
tolylfluanid and DMST expressed
as tolylfluanid
New MRL Proposal
for sum of tolylfluanid and DMST expressed
as tolylfluanid
Application conditions
Remarks
Tomatoes 0.05* 0.05* 5 3 x 40 g a.i./ha leaf wall area, PHI = 3d
Intended use requires a new MRL of 5 mg/kg
Lettuce 10 10 - 2 x 120 g a.i./ha, PHI = 7d
Intended use complies with EU MRL regulation
23 October 2006
12
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Typical Cases
Use already covered by Annex I inclusion
Use already covered by MRL harmonisation
Use not covered by previous assessment
23 October 2006
13
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
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
23 October 2006
14
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
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
23 October 2006
15
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Use not covered by previous assessment5.1 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
23 October 2006
16
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
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
23 October 2006
17
Training Session Product File Notes and Registration Reports
Federal Public Service ‘Public Health, Food Chain Safety and Environment’
Thank you for listening!