Modifications to the Lists of Permitted Food Additives to set out the use of certain food colours, emulsifying agents and preservatives in two types of standardized flavouring preparations

Notice of Modification – Lists of Permitted Food Additives

Reference number: M-FAA-24-14
November 8, 2024

Background

As part of the modernization of food regulations in Canada, Health Canada and the Canadian Food Inspection Agency (CFIA) are removing almost all food additive provisions from the food compositional standards prescribed by the Food and Drug Regulations (FDR) and maintaining or setting out the permitted uses of food additives in these standardized foods in the Lists of Permitted Food Additives.

These changes relate to the proposed Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food, which were pre-published in Canada Gazette, Part I, in November 2023 for public and stakeholder consultation.Footnote a As indicated by the Regulatory Impact Analysis Statement (RIAS) for the proposed regulations, the standard for "(naming the flavour) Extract or (naming the flavour) Essence", and the standard for "(naming the flavour) Flavour", set out in sections B.10.003 and B.10.005, respectively, of the FDR, provide that flavouring preparations subject to these standards may contain a food colour, a Class II preservative, a Class IV preservative and, in the case of "(naming the flavour) Flavour," an emulsifying agent.

However, the standards do not prescribe maximum levels of use for these functional classes in the flavouring preparations nor indicate which food additives from these functional classes may be used. And, there are no entries in the applicable Lists of Permitted Food Additives specifically setting out the corresponding permitted use of food additives from these functional classes in "(naming the flavour) Extract or (naming the flavour) Essence".

The RIAS explained that these general provisions for food additives would remain in these two standards as an interim measure until Health Canada permits individual food additives in these flavouring preparations by modifying the Lists of Permitted Food Additives, and that Health Canada intended to take into consideration information industry had submitted on the use of food additives in flavouring preparations, and to propose new list entries for public and stakeholder comments prior to finalizing them.

Health Canada received information from industry in response to the Department's Call for data on food additives in certain food flavouring preparations issued in April 2020, as well as in subsequent meetings and correspondence.

Issue

Health Canada intends to set out specific permitted uses of food colours and preservatives in "(naming the flavour) Extract or (naming the flavour) Essence" and of food colours, preservatives and emulsifying agents in "(naming the flavour) Flavour" in the Lists of Permitted Food Additives. The specific uses are based on the functional class food additive provisions currently set out in the food compositional standards for these two types of flavouring preparations and information Health Canada received from industry on the use of food additives from these functional classes in flavouring preparations.

The new list entries will accommodate uses of food additives where the food additive is intended to function as such in the standardized flavouring preparation. Premixes of the standardized flavouring preparation and one or more food additives where the food additive(s) is/are intended to function in the food manufactured with the premix are not covered by these new list entries. However, such premixes will be addressed by separate regulatory provisions in the final Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food, which will be published in Canada Gazette, Part II.

Rationale for action

To be consistent with what is being done for most other food additive provisions in food compositional standards as part of the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food, the functional class food additive provisions also need to be removed from the standard for "(naming the flavour) Extract or (naming the flavour) Essence" and the standard for "(naming the flavour) Flavour".

Industry provided information to Health Canada on current use of food colours, emulsifying agents and preservatives in these standardized flavourings, as applicable. For industry to be permitted to continue using food additives from these functional classes in these two types of standardized flavourings, as applicable, Health Canada needs to modify the Lists of Permitted Food Additives that will be incorporated by reference directly into the FDR to set out corresponding permitted uses of these additives in the flavourings.

More specifically, Health Canada intends to modify:

  1. The List of Permitted Food Colours that will be incorporated by reference directly into the FDR to set out the permitted use of 17 food colours in "(Naming the flavour) extract", "(Naming the flavour) essence" and "(Naming the flavour) flavour" at a maximum level consistent with Good Manufacturing Practice (GMP);Footnote b
  2. The List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents that will be incorporated by reference directly into the FDR to set out the permitted use of 28 emulsifying agents in "(Naming the flavour) flavour" at a maximum level consistent with GMP and the permitted use of acacia gum modified with octenyl succinic anhydride (OSA) in "(Naming the flavour) flavour" at a maximum level of 500 ppm;Footnote c and
  3. The List of Permitted Preservatives that will be incorporated by reference directly into the FDR to set out the permitted use of 15 preservatives in "(Naming the flavour) extract", "(Naming the flavour) essence" and "(Naming the flavour) flavour" at a maximum level consistent with GMP.Footnote dFootnote e

All these food additives are already permitted for use for their respective technological purpose in Canada. Where the maximum level of use is set out as "Good Manufacturing Practice", the amount of the food additive must not exceed the amount that is required to accomplish the purpose for which it is added to the flavouring.

Implementation and enforcement

These modifications will come into force the day on which they are published in the Lists of Permitted Food Additives that will be incorporated by reference directly into the FDR. Health Canada will publish these lists on the Canada.ca website concurrently with the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food, which will be published in the Canada Gazette, Part II.

The CFIA is responsible for enforcing the Food and Drugs Act and its associated regulations with respect to foods.

Contact information

Health Canada's Food and Nutrition Directorate is committed to reviewing new scientific information on the safety in use of any permitted food additive. Anyone wishing to submit an inquiry or new scientific information on the use of a permitted food additive may do so by regular mail or email. If you wish to contact the Food and Nutrition Directorate by email about food colours, emulsifying agents and preservatives used in standardized flavouring preparations, please use the words "flavouring preparations (M-FAA-24-14)" in the subject line of your email.

Bureau of Chemical Safety
Food and Nutrition Directorate
251 Sir Frederick Banting Driveway
Postal locator 2202C
Tunney's Pasture
Ottawa ON K1A 0K9

Email: bcs-bipc@hc-sc.gc.ca

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