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
extend the permitted use of an existing food additive to a new
increase the maximum level of use permitted for an existing
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.
Prepared with assistance from Katrina
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