Notice of Intent to Issue Food Marketing Authorization
Marketing Authorization Amending Three Marketing Authorizations for Food Additives
April 8, 2019
The purpose of this notice is to inform Canadians and other interested stakeholders of the Minister of Health’s intent to amend three marketing authorizations for food additives in order to allow Health Canada to enable five new food additive uses that have been scientifically evaluated and found to be safe.
Health Canada’s Food Directorate is responsible for conducting pre-market safety evaluations of proposed new food additive uses in Canada. If the requested use of the additive is determined to be safe, then it can be approved through modification of the Lists of Permitted Food Additives which are published on the Government of Canada’s website. There are fifteen individual lists, each of which is incorporated by reference into a corresponding ministerial regulation called a marketing authorization (MA). The MAs for food additives set out specific exemptions from certain legislative prohibitions and the lists identify the food additive uses to which the exemptions apply. The exemptions are written in a way that ensures that any food additive uses not specifically listed in foods under the corresponding incorporated list continue to be prohibited.
Food additive uses found to be safe by Health Canada can generally be enabled through modification of the Lists of Permitted Food Additives and do not require amendment of corresponding MAs. However, there are instances where amending an MA is required, prior to administrative modifications of the list, in order to outline new exemptions (for example, to permit a new food additive for a new purpose of use not yet approved on the Canadian market).
Proposed Amendments to the Marketing Authorizations for Food Additives
Pursuant to section 30.3 of the Food and Drugs Act, it is the intention of the Minister of Health to make amendments to three food additive MAs as described below.
The Minister of Health intends to amend the two MAs listed below by creating an exemption from the general prohibition set out in subsection B.25.062(1) of the Food and Drug Regulations (Regulations) against the sale of an infant food containing a food additive. The exemption would apply with respect to the use or presence of a food additive in an infant food in accordance with a provision that is on the corresponding incorporated list:
- Marketing Authorization for Food Additives with Other Accepted Uses;
- Marketing Authorization for Food Additives That May Be Used as Sequestering Agents.
Any food additives not specifically allowed to be present in infant food under the corresponding incorporated list would continue to be prohibited. This would allow Health Canada to enable three food additive uses that have been found to be safe when used within specified conditions in infant food or in an ingredient used in infant food, by adding provisions for these additives on the List of Food Additives with Other Accepted Uses and the List of Permitted Sequestering Agents following an established administrative procedure.
The Minister of Health intends to amend the MA listed below by creating an exemption from the general prohibition set out in paragraph B.21.005(b) of the Regulations against the sale of a product or preparation of fish or “meat” (where “meat” refers to the flesh of marine invertebrates and marine mammals) containing preservatives. The exemption would apply with respect to the use or presence of a preservative in these particular foods in accordance with a provision that is on the corresponding incorporated list:
- Marketing Authorization for Food Additives That May Be Used as Preservatives.
Any preservatives not specifically allowed in these foods under the corresponding incorporated list would continue to be prohibited. This would allow Health Canada to enable one food additive use that has been found to be safe, following an established administrative procedure, by adding a provision in Part 4 of the List of Permitted Preservatives.
Finally, the Minister of Health intends to amend the Schedule of the following MA:
- Marketing Authorization for Food Additives with Other Accepted Uses
The Schedule will be amended to include a new food additive (L-lysine monohydrochloride) with a new purpose of use (inhibiting acrylamide formation) in Column 1 and Column 2, respectively. This inclusion in the schedule of a ‘new food additive / new purpose of use’ combination is a requirement that must be met prior to allowing Health Canada to enable to use of food additive via administrative modification of the List of Permitted Food Additives with Other Accepted Uses.
None of the proposed amendments described above are restrictive measures. Therefore, they would come into force on the day on which they are published in the Canada Gazette, Part II.
Health Canada conducts pre-market safety evaluations of requested food additive uses. If the scientific evidence supports the safety of the proposed use, then Health Canada initiates the process to legally enable the use of that food additive. Generally, the process does not require that an MA be amended because the appropriate exemptions from legislative prohibitions are already set out in the MA; the food additive use therefore becomes legal once the appropriate food additive provision is added to the Lists of Permitted Food Additives. However, five food additive uses that have been found to be safe cannot be enabled without amendment of certain MAs, as described above. Once amended, Health Canada would be able to enable them by adding provisions for each of the uses to the Lists of Permitted Food Additives following the established administrative procedure.
The proposed amendments to the three identified MAs would not affect the legislative prohibitions themselves. These prohibitions would continue to function as intended as part of the regulatory framework that ensures that any new food additive uses undergo an evaluation by Health Canada in order to demonstrate safety before being approved for use in Canada.
The consultation period for these proposed modifications to the Marketing Authorizations is 30 calendar days, ending May 8, 2019. Once modified, these food additive uses can be enabled by administratively modifying certain lists of permitted food additives to include the aforementioned food additive uses. This will be announced via a Notice of Modification (NOM) published on the Government of Canada’s website. For one food additive, which is a new food additive in Canada, a Notice of Proposal (NOP) will be published prior to modifying the list and publishing the NOM. The comment period following the publication of a NOP is 75 calendar days.
All comments must cite the title, reference number and the date of publication of this notice, and be addressed to the contact identified below.
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