Food Additive Submission Checklist

December 2012

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A Food Additive Submission Checklist has been developed to assist petitioners as they assemble the components of a typical food additive submission. The checklist includes space for entering administrative information, that is, name, title, full address and other means of communication (telephone and fax numbers, e-mail address, etc.)

This electronically-available checklist does not replace the cover letter or any other required documents pertaining to the submission. It is an additional document summarizing both administrative and scientific/technical information that is meant to assist both the petitioner in the preparation of a submission as well as the Submission Management and Information Unit in verifying that the required information has been submitted. Although not a statutory requirement, it is requested that completed checklists be submitted with the submission and cover letter.

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Food Additive Submission Checklist

Please provide all information in black ink. Where appropriate, place checkmarks () in the boxes to indicate the desired response. For submissions involving more than one food additive, please complete a separate submission checklist for each food additive.

We request that the completed and signed checklist accompany the submission package. The package, if less than 20 pages, may be sent electronically, using the words "Food Additive Submission" in the subject line of the E-mail: smiu-ugdi@hc-sc.gc.ca. Otherwise, a hardcopy and, if possible, a softcopy (e.g. CD-ROM, DVD) of the submission package must be mailed to the Submission Management and Information Unit, Food Directorate, Health Products and Food Branch, Health Canada, 251 Sir Frederick Banting Driveway, Postal Locator: 2202E, Ottawa, Ontario, Canada, K1A 0K9. For additional information on submission preparation, please refer to A Guide for the Preparation of Submissions on Food Additives.

Type of Food Additive Submission

Please place a checkmark in the appropriate box to indicate the nature of the submission:

This is a submission for a new food additive, not approved for any use by Health Canada
This is a submission requesting an extension of use to foods of an additive already approved by Health Canada for uses in other foods
This is a submission requesting a change to the level of use in a food of an additive already approved for use by Health Canada

Petitioner Information

Name of Petitioner (manufacturer, company, consultant, importer, etc.):

Full postal address (street, city, country, postal code):

E-mail:____________________________________________________

Telephone No.: (     )____________ Fax No.: (     )_________________

Alternative name and address for correspondence:

Description of the Submission

Title

Date of Submission
(DD/MM/YYYY)

Name of the Food Additive as commonly used (indicate also chemical, synonymous and trade names):

Chemical Identification of the substance (CAS No, Enzyme Commission No., other):

Is the food additive already listed in one of the lists of permitted food additives (published on Health Canada's website) or has a Temporary Market Authorization (TMA) been issued for its use in any foods?

 Yes
No
Do not know

If you answered positively to the previous question and were the petitioner of the previously approved submission, please list any current new studies or other elements not previously submitted with the earlier submission.

Are you requesting a Temporary Market Authorization (TMA) pursuant to section B.01.054, Division 1 of the Food and Drug Regulations?

Yes
No

Is the food additive subject to the New Substances Notification Regulations (NSNR), and if yes, do you intend to notify under the NSNR? If you do not intend to notify, please provide a rationale:

Checklist of enclosed information and data pursuant to Section B.16.002 

Cover letter
 Yes  N/A

Specifications, Chemistry (B.16.002  a)
 Yes  N/A

Intended Use, Proposed Levels of use (B.16.002  b)
 Yes  N/A

Analytical method of the food additive detection (B.16.002  c)
 Yes  N/A

Technological justification (B.16.002  d)
 Yes  N/A

Safety-related data (B.16.002  e)

Amounts of the additive remaining in/on food if level of use consistent with GMP (B.16.002  f)
 Yes  N/A

Proposed maximum limit for residue of the food additive in /upon the finished (if different from B.16.002  b), B.16.002  g
 Yes  N/A

Proposed labelling (B.16.002  h)
 Yes  N/A

A sample of the food additive (B.16.002  i)
This is not required at the time of providing your submission package but you should be prepared to provide a sample upon request.

If you checkmarked "N/A" for any items listed above, please provide a rationale for not providing that information.

Summary of the Submission

Please succinctly summarize the components of this submission, including, for example; the food additive's technical function and its intended use; if the additive is part of a preparation that includes other ingredients, full identification of the components and their proportions must be provided; the proposed use levels in the food or food categories; the estimated exposure to (intake of) the food additive; if known, the status of the food additive in other countries or according to the international Codex Alimentarius, including any internationally-established Acceptable Daily Intake (ADI) and/or other toxicological reference values; the advantages the additive provides over approved additives that have the same technological function; and any other important information.