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Guidance Document for Preparing a Submission for Food Health Claims: Forms

Tables shown in Sections 2.0 through 6.0 of the Guidance Document for Preparing a Submission for Food Health Claims are available below as forms to make the preparation of submissions easier. Please note that these tables do not reperesent the totality of submission information required and that the Guidance Document for Preparing a Submission for Food Health Claims should be consulted for additional requirements i.e Table 4, etc.

Please use the Microsoft Word version to fill the forms out - the HTML format should only be used for viewing the forms.

The Magnitude of Effect Calculations Excel spreadsheet below, is also available to petitioners to assist them in the filing of submission information.

Magnitude of Effect Calculations
Forms Microsoft Word HTML
Table 1.  Applicant Information
(MS Version - 109 K)
HTML
Table 2.  Details pertaining to health claims
(MS Version - 529 K)
HTML
Table 3.  Regulatory Status of the health claims in other jurisdictions
(MS Version - 523 K)
HTML
Table 5.  Identification of databases and search parameters used for literature retrieval
(MS Version - 530 K)
HTML
Table 6.  Keywords and their combinations used to retrieve literature on the food/health relationship from electronic databases
(MS Version - 487 K)
HTML
Table 7.  Number of references retrieved from electronic and non-electronic sources
(MS Version - 519 K)
HTML
Table 8a.  Inclusion and exclusion criteria used to filter the literature
(MS Version - 526 K)
HTML
Table 9.  Results of literature filtering
(MS Version - 521 K)
HTML
Table 10.  List of references that met the inclusion criteria at the full text filtering stage
(MS Version - 527 K)
HTML
Table 11.  List of references excluded at the full text filtering stage and reason(s) for exclusion
(MS Version - 529 K)
HTML
Table 12a.  Summary of intervention studies addressing the food/health relationship
(MS Version - 520 K)
HTML
Table 12b.  Summary of prospective observational studies addressing the food/health relationship.
(MS Version - 518 K)
HTML
Table 13a.  Quality appraisal tool for intervention studies
(MS Version - 541 K)
HTML
Table 13b.  Quality appraisal tool for prospective observational studies
(MS Version - 537 K)
HTML
Table 14a.  Summary of study findings from intervention studies per health outcome
(MS Version - 528 K)
HTML
Table 14b.  Summary of study findings from prospective observational studies per health outcome
(MS Version - 541 K)
HTML
Table 15a.  Rating of consistency in direction of effect for intervention studies, considering study quality.
(MS Version - 529 K)
HTML
Table 15b.  Rating of consistency in direction of effect for prospective observational studies, considering study quality
(MS Version - 530 K)
HTML
Table 16.  Checklist for submission
(MS Version - 547 K)
HTML

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2017-05-04

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