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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Training Session Product File Notes and Registration Reports

Federal Public Service ‘Public Health, Food Chain Safety and Environment’

Thank you for listening!