Modification to the Lists of Permitted Food Additives as part of the modernization of Part B of the Food and Drug Regulations

Notice of modification – Lists of Permitted Food Additives
Reference number: M-FAA-RM-1
December 18, 2024

Background

In October 2012, the Minister of Health created 15 ministerial regulations ("marketing authorizations" or "MAs") that initiated the modernization of the food additive regulatory framework. These MAs incorporated by reference the Lists of Permitted Food Additives on an ambulatory basis and enabled Health Canada to authorize (or remove) most food additive uses by modifying the lists through an open and transparent administrative process. However, in many cases, certain conditions in the lists have been referencing food additive provisions that were set out in the Food and Drug Regulations (FDR), including provisions prescribed in food compositional standards.

On December 18, 2024, Health Canada published the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food in the Canada Gazette Part II. These amendments consolidate most food additive rules into Division 16 of Part B of the FDR, create a new adulteration provision and corresponding exemption provisions, repeal the obsolete food additive tables contained in Division 16, and directly incorporate by reference the 15 Lists of Permitted Food Additives into this Division.

Issue

Previously, the Lists of Permitted Food Additives set out certain rules for food additives by referring to provisions that were in the FDR. As part of the modernization of the food additive regulatory framework, Health Canada has consolidated these rules into the lists only.

Consultation

On December 14, 2021, Health Canada's Food and Nutrition Directorate signified its intent to modify the Lists of Permitted Food Additives to align with the modernized food additive regulatory framework by publishing Health Canada's Proposal to Modernize the Structure and Titles of the Lists of Permitted Food Additives (reference number: NOP/ADP-0038). The proposal was open for comment for 50 days. Health Canada took into consideration comments that were submitted and published a revised proposal on November 4, 2023, as a Notice of Health Canada's proposal to modify the Lists of permitted food additives as part of the modernization of Part B of the Food and Drug Regulations (reference number: NOP/ADP-0041). The revised proposal was open for comments for 90 days.

The comments received for both proposals were overall supportive of the proposed changes to modernize the Lists of Permitted Food Additives. The November 4, 2023 proposal contained hyperlinks to the 15 pre-published modernized Lists of Permitted Food Additives, which themselves contained the revised text and new entries proposed to consolidate and reset the specific food additive rules into the lists new format. The feedback received on the lists pre-publication proposal and Health Canada's responses are detailed below.

Summary of comments and Health Canada's responses

Health Canada received 13 comment submissions, all from the industry (11 from industry associations, 1 from a company and 1 from an industry consultant), in response to the Notice of Health Canada's proposal to modify the Lists of permitted food additives as part of the modernization of Part B of the Food and Drug Regulations. These comments and Health Canada's responses are summarized below.

Comments on the terminology used in the Lists of Permitted Food Additives:

• There was a suggestion to use standardized terminology and definitions across documents to ensure clarity and consistency, aiding in regulatory compliance and international trade.
• The need for the wording used in the food product standards incorporated by reference in the FDR to be revised to refer to the Lists of Permitted Food Additives was raised.

Health Canada's response:

Creating a food category system in Canada such as the one used by the Codex Alimentarius Commission is outside the scope of the current work to modernize the food additive regulatory framework. In developing the modernized Lists of Permitted Food Additives, the goal was to use consistent terminology across the lists where possible. For standardized foods, the same common name is used in the Lists of Permitted Food Additives and in the Canadian Food Compositional Standards. When the standards were repealed from the FDR and moved to the Canadian Food Compositional Standards incorporated by reference into the FDR, the Canadian Food Inspection Agency (CFIA) removed almost all references to food additives from the food standards, making the Lists of Permitted Food Additives the primary place where permitted uses of food additives in standardized foods are shown.

Comments related to the List of Permitted Food Enzymes:

• It was asked, in light of the removal of synonyms in the Lists of Permitted Food Additives, that "Maltogenic amylase" be considered as a synonym for "Maltogenic α-amylase". There was also a request to consider "β-Glucanase" as a synonym for "Glucanase".
• A concern was expressed about inconsistencies and possible errors related to the way source organisms are named in the List of Permitted Food Enzymes and it was suggested to create clear procedure or guidance for enzyme manufacturers to request corrections to the name of source organisms already listed without the need for a lengthy review process.

Health Canada's response:

Maltogenic amylase is considered to be maltogenic α-amylase but was set out separately in the former (now archived) List of Permitted Food Enzymes under items A.2 " Amylase (maltogenic)" and A.2(i) "α-Amylase (maltogenic)". In the modernized List of Permitted Food Enzymes, both are included under item M.2 "Maltogenic α-Amylase". For the purpose of item G.2 "Glucanase" in the modernized List of Permitted Food Enzymes, "Glucanase" is considered to also be a "β-Glucanase". Health Canada intends to modify the list at a later date to provide this clarification.

The names of food additives set out in the Lists of Permitted Food Additives are acceptable for use as common names for the purpose of declaring food additives in the list of ingredients on prepackaged foods labels. The CFIA also maintains a separate Permitted synonyms for food additives table. Requests to add synonyms to the table should be directed to the CFIA at Ask CFIA. Stakeholders concerned with potential inconsistencies or errors in the way source organisms are named in the List of Permitted Food Enzymes can send at any time a request to make technical modifications to the list to Health Canada's Bureau of Chemical Safety at bcs-bipc@hc-sc.gc.ca.

Comments related to the List of Permitted Food Colours:

• A question was raised as to why the use of caramel in meat and poultry meat products as per the previous sections B.14.004 and B.22.005 of the FDR was not reflected in the proposed List of Permitted Food Colours.
• Clarification was asked about the labelling of some spices like paprika and turmeric that are permitted to be declared as "spices" in meat products, but also have permitted use as food colours as set out in the List of Permitted Food Colours.

Health Canada's response:

Under paragraph 4(1)(d) of the Food and Drug Act (FDA), it is prohibited for a person to sell an article of food that is adulterated. Moreover, former paragraphs B.14.004(c) and B.22.005(c) of the FDR did not authorize or prohibit the use of any food colours in meat, meat by-products or preparations thereof or in poultry meat, poultry meat by-product or preparations thereof, respectively. They provided that these foods were adulterated if they contained colour or had colour added to them, with certain exceptions, including an exception if the colour is caramel.

Even though former paragraphs B.14.004(c) or B.22.005(c) of the FDR excepted these foods from being adulterated if the colour is caramel, former section B.16.007 still prohibited a person from selling them if they contained a food additive other than a food additive provided for in former sections B.01.042 and B.01.043. Essentially, when these rules are read together, they mean that a meat, meat by-product or preparation thereof or poultry meat, poultry meat by-product or preparations thereof are not adulterated under paragraphs B.14.004(c) or B.22.005(c) if they have had caramel added to them, but they still are not permitted for sale if the caramel is not permitted to be added to them.

The List of Permitted Colouring Agents (now archived) did not set out any permitted use of caramel in or on standardized meat, meat by-products or preparations thereof or poultry meat, poultry meat by-products or preparations thereof. It is the same in the modernized List of Permitted Food Colours.

For comparison, former paragraph B.14.004(c) of the FDR excepted meat, meat by-products and preparations thereof from being adulterated if the colour was annatto, allura red or sunset yellow FCF where provided for in Division 14. The List of Permitted Colouring Agents (now archived) set out that annatto was permitted in longaniza and tocino (two types of sausage) and allura red and sunset yellow FCF were permitted in longaniza. There were no other permitted uses of these colours in standardized meat, meat by-products or preparations thereof.

When spices such as paprika and turmeric are added to a food primarily to impart colour to the food, these substances are regulated as a food additive and must be used according to their permitted use as a food colour as set out in Health Canada's List of Permitted Food Colours. As a food colour it also must be declared by its common name in a list of ingredients. However, if they are added to a food primarily as a spice to impart flavour, then they may be declared as permitted for spices as set out in Item 6 of Table 2 of CFIA's Common Names for Ingredients and Components document. The CFIA can be contacted at Ask CFIA for additional guidance on ingredient declaration.

Out of scope comments – Future updates to the Lists of Permitted Food Additives:

• It was asked that Health Canada take steps to ensure comprehensive consultations before making any new changes to the Lists of Permitted Food Additives.
• The need to modify and update the Lists of Permitted Food Additives based on science while aligning them with international standards was raised. It was suggested to implement a structured process for periodic reviews of food additives, focusing on those of concern to ensure alignment with international standards and trade requirements.

Health Canada's response:

The rigorous and consistent procedures that were put in place in 2012 to manage Canada's food additive regulatory framework do not change as a result of the current modernization exercise. Before the Lists of Permitted Food Additives can be modified to include a "new" food additive (that is, one not already permitted in Canada), or to repeal or otherwise further limit the use of an already permitted food additive, a notice of proposal (NOP) is published on Health Canada's website.

This NOP informs Canadians of the Department's intent to modify one or more lists, provides details on the nature of (and rationale for) the proposed change, and establishes the duration of the consultation period during which they may provide any feedback they deem relevant to the proposal. These comments are taken into consideration and responded to in a notice of modification (NOM), which announces the final changes to the list or lists, and is published at the same time as the modified list(s). However, in instances where there is a submission requesting the extension of use of an already permitted food additive, a NOM may be published without a prior NOP. All notices provide contact information for anyone to submit feedback or request information about a change or proposed change to the Lists of Permitted Food Additives.

Health Canada reviews the safety of permitted food additives when someone files a food additive submission to request an extension of use for the additive (for example, for use in another food or at a higher level of use) or when there is an emerging scientific development about the food additive's safety. Health Canada will further restrict the permitted use of a food additive, or no longer permit a food additive to be used at all, if there is a safety reason to take such action.

Out of scope comments – Requests for an extension of use of food additives:

• A request to modify the List of Permitted Acidity Regulators and Acid-Reacting Materials to permit the use of citric acid in pumping pickle, cover pickle, and dry cure employed in the curing of preserved meat products was made.
• It was proposed to extend the use of certain food additives to standardized foods and to include provision for certain non-additive ingredients in some food standards.
• It was suggested to replace specific food entries with the broader food category of "unstandardized foods" in the List of Permitted Food Enzymes.
• It was proposed to align the maximum level of use of alkalizing agents in cocoa products with Codex rules.
• It was requested to add propylene glycol to the List of Permitted Food Additives with Other Purposes of Use as a humectant in dry cures.
• It was requested to increase the permitted maximum level of use of allura red in longaniza.
• It was proposed that the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents be amended to include poultry meat binder used in prepared poultry meat products for agar, gelatin and carrageenan.

Health Canada's response:

As set out in the List of Permitted Sequestering Agents, citric acid is already permitted for use in "Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product" at a maximum level of use of "Good Manufacturing Practice".^{Footnote 1} It's permitted purpose of use is as a sequestering agent.

All of the other suggestions above are for extensions of use of one or more permitted food additives, which is outside the scope of the current work to modernize the food additive regulatory framework. Extensions of use of permitted food additives can be requested by filing a food additive submission with Health Canada (see Food Additives – Submission Preparation).

Out of scope comment – Searchability of the Lists of Permitted Food Additives:

• It was recommended to create a function or tool that would allow to search across the 15 Lists of Permitted Food Additives simultaneously.

Health Canada's response:

Health Canada agrees the Lists of Permitted Food Additives would benefit from an extended searchability function. However, this would be a technical project outside the scope of the current work to modernize the food additive regulatory framework and will be explored at a future date.

Comment for the Canadian Food Inspection Agency:

• There was a comment that Division 22 in the FDR does not have a standard for pumping pickle, cover pickle, and dry cure used in the curing of preserved poultry products and that industry has been using section B.14.009 as a guide for poultry products along with the Canadian Standards of Identity: Volume 7 – Meat Products.

Health Canada's response:

Questions about standardized foods should be directed to the CFIA at Ask CFIA.

Rationale

The Food and Nutrition Directorate has modified the Lists of Permitted Food Additives to align with amendments made to Part B of the FDR under the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food.

Changes to modernize the lists included standardizing their structure, revising some of their titles, revising the existing text for consistency or clarity and adding new text to move food additive rules that were previously set out in compositional standards or elsewhere in Part B into the lists. The Directorate considered scientific, policy and legal input, as well as comments received from 2 public consultations on the proposed changes. Comments submitted to Health Canada as part of the public consultations did not result in modifications to the November 4, 2023 proposal.

The Directorate further advanced the modernization of the lists by making minor modifications (such as, correcting grammatical errors, restoring the alphabetical order, addressing inconsistencies). Certain expressions were further aligned in French and English to ensure the same translation is used in the same context, for clarity and consistency.

The Directorate also removed from the List of Permitted Food Colours the references to proposed subsection B.16.007(2) of the FDR (set to replace former section B.06.002) as this subsection was not included in the amended FDR. This modification does not change the permitted uses for the affected food colours. For each of their modernized list entries, the text in column 5 sets out their maximum level of use and any other conditions that apply for a corresponding food, and has the same intent as did the rules set out in former subsection B.06.002 and the proposed B.16.007(2).

New entries were added to the List of Permitted Emulsifying, Gelling, Stabilizing and Thickening Agents, the List of Permitted Food Colours and the List of Permitted Preservatives to extend the use of certain emulsifiers, food colours and preservatives to one or two types of standardized flavouring preparations (see NOM M-FAA-24-14).

Finally, the Directorate added to the modernized Lists of Permitted Food Additives the uses of food additives that have been authorized since November 4, 2023.^{Footnote 2}

Therefore, since there was no indication from stakeholders that the modernization of the lists introduced changes to the already authorized uses of additives in foods sold in Canada, Health Canada went ahead with the publication of the 15 modernized Lists of Permitted Food Additives identified below:

1. List of Permitted Anticaking Agents
2. List of Permitted Flour Treatment Agents
3. List of Permitted Food Colours
4. List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
5. List of Permitted Food Enzymes
6. List of Permitted Firming Agents
7. List of Permitted Glazing Agents
8. List of Permitted Food Additives with Other Purposes of Use
9. List of Permitted Sweeteners
10. List of Permitted Acidity Regulators and Acid-Reacting Materials
11. List of Permitted Preservatives
12. List of Permitted Sequestering Agents
13. List of Permitted Starch-Modifying Agents
14. List of Permitted Yeast Foods
15. List of Permitted Solvents

Other relevant information

Food additives set out in the Lists of Permitted Food Additives are required under section B.16.011 of the FDR to meet food-grade specifications set out in the Table of Food Additive Specifications, where such specifications exist, or those set out, if any, in the most recent edition of the Food Chemicals Codex, published by the United States Pharmacopeial Convention or the Combined Compendium of Food Additive Specifications, prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and published by the Food and Agriculture Organization of the United Nations.

Implementation and enforcement

The modifications to the Lists of Permitted Food Additives described in this notice came into force December 18, 2024, the day they were published on the Canada.ca website, concurrently with the publication of the the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food in the Canada Gazette Part II.

The Canadian Food Inspection Agency is responsible for the enforcement of 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 the modifications to the lists described in this notice, please use the words "Modernization of the food additive lists (M-FAA-RM-1)" 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