Health Canada has released a new guidance document and checklist for food additive submissions, concurrent with the transition to the food additive lists (found here (http://www.hc-sc.gc.ca/fn-an/securit/addit/list/index-eng.php)) in place of the tables set out in the Food and Drug Regulations. A food additive submission may be made to:
- add a new food additive to the Lists of Permitted Food Additives;
- extend the permitted use of an existing food additive to a new food; or
- increase the maximum level of use permitted for an existing food additive.
For all submission types, the applicant must submit a cover letter, the food additive submission checklist and any other supporting documents. For submissions pertaining to an existing food additive, Health Canada has indicated that it may not be necessary to re-submit data that is already available to them (e.g. from when the food additive was originally approved). Clarification and additional information will be sought from the applicant if necessary and Health Canada may engage in stakeholder consultation regarding the submission.
A performance standard for dealing with food additive submissions has not been identified, and the approval time will of course depend in part on the length, completeness and organization of the submission. Once an additive is approved, the applicant will received a notice and a public notice will be issued. If the submission was for a new food additive there will then be a period of public consultation before it is added to the appropriate List, otherwise the public notice will coincide with the amendment of the list. The intent of these changes are to improve the speed with which applications found to be satisfactory lead to a change in the food additive lists.