Health Canada’s Proposal to Modernize the Structure and Titles of the Lists of Permitted Food Additives

Notice of Proposal – Lists of Permitted Food Additives

Reference Number: NOP/ADP-0038

December 14, 2021

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Summary

Food additives are regulated in Canada under Marketing Authorizations (MAs) issued by the Minister of Health and the Food and Drug Regulations (Regulations). Approved food additives and their permitted conditions of use are set out in the Lists of Permitted Food Additives(Lists) that are incorporated by reference in the MAs and published on the Canada.ca website.

In June 2019, Health Canada, Agriculture and Agri-Food Canada, the Canadian Food Inspection Agency, Fisheries and Oceans Canada, and the Public Health Agency of Canada committed to numerous regulatory initiatives under the Agri-food and Aquaculture Sector Regulatory Review Roadmap (Roadmap) including modernizing the regulatory framework for food additives. While these amendments are under development and will be the subject of a formal public consultation following their pre-publication in the Canada Gazette,Part I, as part of this work, Health Canada’s Food Directorate is proposing to 1) modify the structure of the Lists of Permitted Food Additives and 2) modernize the titles of certain Lists. None of the proposed changes would modify currently permitted uses of food additives.

Although these proposed changes will form part of the formal public consultation, the Food Directorate is seeking preliminary comments from the food industry and other stakeholders, including the public, on the proposed changes to the structure and titles of the Lists.

Proposed Modifications to the Structure of the Lists of Permitted Food Additives

Current Structure of the Lists

At this time, 12 of the 15 Lists have the same three-column structure while the other 3 Lists each have their own structure that includes an additional column.

Current structure for 12Footnote 1 of the 15 Lists of Permitted Food Additives:
Item No.

Column 1

Additive

Column 2

Permitted in or Upon

Column 3

Maximum Level of Use and Other Conditions

Current structure for the List of Permitted Food Enzymes:
Item No.

Column 1

Additive

Column 2

Permitted Source

Column 3

Permitted in or Upon

Column 4

Maximum Level of Use and Other Conditions

Current structure for the List of Permitted Food Additives with Other Accepted Uses:
Item No.

Column 1

Additive

Column 2

Permitted in or Upon

Column 3

Purpose of Use

Column 4

Maximum Level of Use and Other Conditions

Current structure for the List of Permitted Carrier or Extraction Solvents:
Item No.

Column 1

Additive

Column 2

Permitted in or Upon

Column 3

Maximum Residue

Column 4

Maximum Level of Use and Other Conditions

Proposed New Structure of the Lists

The Food Directorate is proposing the following new structure for all 15 Lists of Permitted Food Additives:
Item No.

Column 1

Food Additive

Column 2

Source

Column 3

Food

Column 4

Purpose of Use

Column 5

Maximum Level of Use or Maximum Level of Residue and Other Conditions

Notes / Additional remarks

The proposed changes to the structure of the 15 Lists of Permitted Food Additives would bring consistency as all the Lists would have the same five columns, as shown in the table above. Column 1 would be renamed “Food Additive”. Column 2 would be new in 14 of the 15 Lists and would be named “Source”. This would allow the Food Directorate to identify the source of certain food additives, mostly food enzymes but also the sources of other food additives.Footnote 2 Column 3 would be renamed “Food”. Column 4 would be new for 14 of the 15 Lists and would be named “Purpose of Use”. Finally, Column 5 would be named “Maximum Level of Use or Maximum Residue and Other Conditions”.

By adopting the new structure in the List of Permitted Preservatives, the four Parts of this List would be merged together, and the preservative classes would be identified in the new Column 4 – Purpose of Use. In the List of Permitted Carrier or Extraction Solvents, the type of solvent (i.e., carrier or extraction) would also be specifically identified in the new Column 4 – Purpose of Use. This is intended to facilitate the interpretation of the entries in this List.

In addition, a new, non-regulatory column would be added to each List. This new column would be used to provide additional administrative information about the food additive entries such as the number of the Notice of Modification (NOM) that resulted in this entry, the date the entry was created or modified, and any other relevant information for this entry. Since this is a non-regulatory column it would not contain any conditions for the use of food additives.

Proposed Revisions to Certain Titles of the Lists of Permitted Food Additives

The Food Directorate is also proposing to modernize the titles of certain Lists of Permitted Food Additives. The proposed changes would ensure titles reflect modern terminology and are consistent with the use of similar terms by Australia and New ZealandFootnote 3, the European Union (EU)Footnote 4, the United States of America (USA)Footnote 5, and the CodexFootnote 6. The proposed revisions are not intended to alter the scope of the Lists.

Overview of Proposed Revisions

The Food Directorate is proposing to revise the titles of six of the fifteen Lists as described in the table below. Further details on the proposed revisions to each title are provided in the sections following the table.
Current English Titles Proposed Revised English Titles Current French Titles Proposed Revised French Titles
List of Permitted Bleaching, Maturing or Dough Conditioning Agents List of Permitted Flour Treatment Agents Liste des agents autorisés de blanchiment, de maturation, ou pour conditionner les pâtes Liste des agents autorisés de traitement des farines
List of Permitted Glazing or Polishing Agents List of Permitted Glazing Agents Liste des agents de satinage ou de glaçage autorisés Liste des agents d’enrobage autorisés
List of Permitted Food Additives with Other Accepted Uses List of Permitted Food Additives with Other Purposes of Use Liste des additifs alimentaires autorisés ayant d'autres utilisations acceptées Liste des additifs alimentaires autorisés ayant d'autres buts de l’emploi
List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents List of Permitted Acidity Regulators Liste des agents rajusteurs du pH, des substances à réaction acide et des agents correcteurs de l'eau autorisés Liste des régulateurs de l’acidité autorisés
N/A N/A Liste des agents chélateurs ou séquestrants autorisés Liste des agents séquestrants autorisés
List of Permitted Carrier or Extraction Solvents List of Permitted Solvents Liste des solvants de support ou d'extraction autorisés Liste des solvants autorisés

Proposed Revisions to the Title of the List of Permitted Bleaching, Maturing or Dough Conditioning Agents

The food additives captured in the List of Permitted Bleaching, Maturing or Dough Conditioning Agents are defined in the Marketing Authorization for Food Additives That May Be Used as Bleaching, Maturing or Dough Conditioning Agents as those that act on flour or dough to improve dough handling properties or baking quality or colour of bakery products. These food additives are categorized as “flour treatment agents” by Codex and the EU or as “flour treating agents” in the USA. Hence, the Food Directorate proposes to simplify the title of this List by replacing the words “Bleaching, Maturing or Dough Conditioning” with “Flour Treatment”. The proposed new title would therefore be “List of Permitted Flour Treatment Agents” in English and “Liste des agents autorisés de traitement des farines” in French. There would be no revisions to the current definition of the food additives captured in this List.

Proposed Revisions to the Title of the List of Permitted Glazing and Polishing Agents

The food additives captured in the List of Permitted Glazing or Polishing Agents are defined in the Marketing Authorization for Food Additives That May Be Used as Glazing or Polishing Agents as those that, when applied to the external surface of a food, impart a shiny appearance or provide a protective coating. These food additives are categorized as “glazing agents” by Australia and New Zealand, Codex and the EU or as “surface-finishing agents” by the USA. Hence, the Food Directorate proposes to simplify the English title of this List by removing the words “or Polishing”. The proposed new title would therefore be “List of Permitted Glazing Agents”. There would be no revisions to the current definition of the food additives captured in this List.

With respect to the French title of this list, the words “glaçage” or “satinage” seem to only be used in Canada to refer to “glazing” or “polishing” agents used as food additives. These food additives are categorized as “agents d’enrobage” in French by Codex and the EU, and their CodexFootnote 7 and EUFootnote 8 definitions align with the Canadian definition. The word “enrobage” can be translated to “coating” in English. However, the word “coating” in English is not used by Canada or other regulatory bodies or jurisdictionsFootnote 9 to refer to food additives captured in the List of Permitted Glazing or Polishing Agents. Hence, for consistency and simplicity, the Food Directorate proposes to remove the words “de satinage ou de glaçage” from the title of the List and replace them with “d’enrobage”. The proposed new title would be “Liste des agents d’enrobage autorisés”. There would be no revisions to the current definition of the food additives captured in this List.

Proposed Revisions to the Title of the List of Food Additives with Other Accepted Uses

The List of Permitted Food Additives with Other Accepted Uses captures food additives with purposes of use that are not captured in any of the other 14 other Lists of Permitted Food Additives. For coherence with the header of the revised Column 4, the Food Directorate proposes to replace the words “Accepted Uses” with the words “Purposes of Use”. The proposed new title would therefore be “List of Permitted Food Additives with Other Purposes of Use” in English and “Liste des additifs alimentaires autorisés ayant d'autres buts de l’emploi” in French.

Proposed Revisions to the Title of the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents

The food additives captured in the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agentsare defined in the Marketing Authorization for Food Additives That May Be Used as pH Adjusting Agents, Acid-Reacting Materials or Water Correcting Agents as those that are used to alter or control the acidity or alkalinity of a food or to prevent a food from drying out. “Acid-reacting material” is a functional class specific to certain food additives that are required in baking powder, which is a standardized foodFootnote 10. As per section B.03.001 of the Regulations, an acid-reacting material is defined as one or any combination of (a) lactic acid or its salts; (b) tartaric acid or its salts; (c) acid salts of phosphoric acid; and (d) acid compounds of aluminum. These substances when used in foods other than baking powder are generally considered as acidity regulators. Finally, apart from its use in the title of the List or the title of the corresponding MA, the functional class “water correcting agents” was only mentioned in the former standard for beer.Footnote 11 These substances were used in the manufacture of beer to adjust the pH of the water.

Australia and New Zealand, Codex, and the EU categorize substances that are used to alter or control the acidity or alkalinity of a food as “acidity regulators” while in the USA, they are categorized as “pH control agents”. Australia and New Zealand, Codex, the EU, and the USA all categorize substances that are used to prevent a food from drying out as “humectants”. Hence, the Food Directorate proposes to replace the words “pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents” by “Acidity Regulators”. The proposed new title would therefore be “List of Permitted Acidity Regulators” in English and “Liste des régulateurs de l’acidité autorisés” in French. There would be an update to the definition of the food additives captured in the preamble to this List to “food additives that are used to alter or control the acidity or alkalinity of a food”. Many food additives that are used as humectants are presently captured in the List of Permitted Food Additives with Other Accepted Uses, and their uses would remain in that List.

Proposed Revisions to the French Title of the Liste des agents chélateurs ou séquestrants autorisés

The English title of this List only uses the words “sequestering agents” whereas the French title uses the words “agents chélateurs ou séquestrants” (i.e., “chelating or sequestering agents” in English). As the words “chelating” and “sequestering” are similar, and the word “chelating” is not used in the English title of this List, the Food Directorate proposes to simplify the French title by removing the words “chélateurs ou”. The proposed new French title would be “Liste des agents séquestrants autorisés”.

Proposed Revisions to the Title of the List of Permitted Carrier or Extraction Solvents

The food additives captured in the List of Permitted Carrier or Extraction Solvents are defined in the Marketing Authorization for Food Additives That May Be Used as Carrier or Extraction Solvents as those that are used to dissolve, dilute, extract, disperse, deliver or otherwise physically modify a component, ingredient, food additive or other food, without exerting any other effect on its own. These food additives are categorized as “carriers” by Codex and the EU or as “solvents and vehicles” by the USA. The Food Directorate proposes to simplify the title of this List by removing the words “Carrier or Extraction”. The proposed new title would therefore be “List of Permitted Solvents” in English and “Liste des solvants autorisés” in French. There would be no revisions to the current definition of the food additives captured in this List.

Rationale

As part of the Roadmap, Health Canada committed to pursuing amendments to the Regulations to address a number of longstanding irritants and barriers to innovation for the food industry and bring much needed flexibility and agility to Canada’s food regulations. Under the theme of “Clear, Agile, Responsive Regulations”, Health Canada committed to incrementally redesigning the food regulations, including streamlining food additive provisions.Footnote 12 The proposed changes to the structure of the Lists of Permitted Food Additives and the titles of certain Lists align with the objectives of this initiative.

Implementation and Enforcement

There is no intent to change the scope of the Lists of Permitted Food Additives, nor to alter the currently permitted food additives with this proposal. Therefore, there are no implementation or enforcement impacts.

Contact Information

For additional information or to submit comments related to this proposal, please contact:

Bureau of Chemical Safety, Food Directorate
251 Sir Frederick Banting Driveway
Tunney’s Pasture, PL: 2202C
Ottawa, Ontario K1A 0K9
E-mail: bcs-bipc@hc-sc.gc.ca

If communicating by e-mail, please use the words “Modernization of food additives lists (NOP-0038)” in the subject line of your e-mail. Health Canada is able to consider information received by February 02, 2022, 50 days from the date of this posting.

Footnotes

Footnote 1

The 12 Lists are the List of Permitted Anticaking Agents, the List of Permitted Bleaching, Maturing or Dough Conditioning Agents, the List of Permitted Colouring Agents, the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, the List of Permitted Firming Agents, the List of Permitted Glazing or Polishing Agents, the List of Permitted Sweeteners, the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents, the List of Permitted Preservatives, the List of Permitted Sequestering Agents, the List of Permitted Starch Modifying Agents, and the List of Permitted Yeast Foods.

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Footnote 2

For example, the new Column 2 would capture the various sources of steviol glycosides (captured in the List of Permitted Sweeteners) or the source of the new proposed preservative, long-chain glycolipids from Dacryopinax spathularia MUCL 53181, that is the subject of Health Canada’s Proposal to Enable the Use of Long-Chain Glycolipids from Dacryopinax spathularia MUCL 53181 as a Preservative in Various Non-Alcoholic Beverages [NOP/ADP-0037].

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Footnote 3

Australia New Zealand Food Standards Code (FSANZ) – Schedule 14 – Technological purposes performed by substances used as food additives

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Footnote 4

EC No 1333/2008, Annex I – Functional classes of food additives in foods and of food additives in food additives and food enzymes

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Footnote 5

Code of Federal Regulations (CFR), Title 21, Chapter I, Subchapter B, Part 170: 21 CFR 170.3 Definitions

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Footnote 6

Codex Class Names and the International Numbering System for Food Additives (CXG 36-1989)

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Footnote 7

“Agent d’enrobage”: Additif alimentaire qui, lorsqu’il est appliqué à la surface externe d’un aliment, lui confère un aspect brillant ou le recouvre d’un revêtement protecteur.”

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Footnote 8

“Les “agents d'enrobage” (y compris les agents de glisse) sont des substances qui, appliquées à la surface d’une denrée alimentaire, lui confèrent un aspect brillant ou constituent une couche protectrice.”

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Footnote 9

Australia and New Zealand, Codex, the EU, and the USA.

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Footnote 10

The standard for baking powder is set out in section B.03.002 of the Regulations.

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Footnote 11

Before it was modernized in May 2019, the standard for beer set out in B.02.130 of the Regulations specifically mentioned that beer may contain pH adjusting and water correcting agents. The current beer standard now refers generally to “food additives to which a marketing authorization applies and that are set out in the Lists of Permitted Food Additives published on the Health Canada website.”

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Footnote 12

This commitment can be found in the Department’s Forward Regulatory Plan, as part of its initiative to “Modernize food regulations to enable innovative and safe foods for Canadians”.

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