Proposal to revise certain permitted uses of aluminum-containing food additives

Notice of Proposal - Lists of Permitted Food Additives
Reference Number: NOP/ADP-0040
March 9, 2023

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.

Aluminum is a naturally-occurring element and as a result may be found at low levels in many of the foods we eat. It can also be present in food from permitted uses of aluminum-containing food additives, a number of which have a long history of food use.

Health Canada's Food Directorate previously committed to a review of aluminum-containing food additives to ensure that dietary exposure to aluminum among Canadians continues to be within acceptable limits. The Department also communicated its intention to: identify an appropriate numerical maximum level of use for those aluminum-containing food additives that are currently permitted to be used in Canada at levels consistent with Good Manufacturing Practice (GMP); and verify whether the current maximum levels of use are still appropriate. Furthermore, this re-evaluation aims to ensure that the approved aluminum-containing food additive uses are reflective of actual uses by the food industry in Canada, and to maintain up to date the entries in the Lists of Permitted Food Additives. To inform its review, the Department also consulted with the food industry to confirm which of these additives are still in use in foods sold in Canada.

Health Canada conducted a dietary exposure assessment for aluminum in foods in Canada, based on monitoring and surveillance data collected by the Department and the Canadian Food Inspection Agency. These data reflect total aluminum content in foods from all sources, including from food additive uses. While aluminum-containing food additives are expected to be main source of Canadians' exposure to aluminum from the diet, Health Canada's assessment did not identify any concerns for human health.

Consequently, it is the Department's intent to update the permitted uses by modifying entries in certain Lists of Permitted Food Additives as described below and in the lists in the appendix.

Proposed Modification to the List of Permitted Anticaking Agents

1. Remove all permitted uses of calcium aluminum silicate (Item C.1) from the list. This would remove from the list the use of calcium aluminum silicate in or upon (1) Salt; (2) Garlic salt; Onion salt; and (3) Unstandardized dry mixes.
2. Remove certain permitted uses of sodium aluminum silicate shown by Column 3 of subitems (2), (3) and (5) of Item S.2. This would remove from the list the permitted use of sodium aluminum silicate in or upon (2) Icing sugar; (3) Dried egg-white (dried albumen); Dried whole egg; Dried whole egg mix; Dried yolk; Dried yolk mix; and (5) Unstandardized dry mixes.
3. Revise the maximum level of use (MLU) of sodium aluminum silicate shown by Column 3 of subitems S.2(1) and S.2(4):
   1. The MLU of sodium aluminum silicate in salt will be changed from "1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)" to "If used singly, the amount not to exceed 5,000 p.p.m.^[1] If used in any combination with other anticaking agents, the total combined amount not to exceed 5,000 p.p.m.".
   2. The MLU of sodium aluminum silicate in garlic salt and onion salt will be changed from "2.0% in accordance with the requirements of paragraphs B.07.020(b) and B.07.027(b) respectively" to "If used singly, the amount not to exceed 5,000 p.p.m. If used in any combination with other anticaking agents, the total combined amount not to exceed 5,000 p.p.m."
4. As a consequence of removing certain permitted uses of sodium aluminum silicate from the list, remove reference to sodium aluminum silicate in Column 3 of subitems C.2(6), C.3(6), M.1(4), M.3(4), M.4(4), and S.1(4).

Proposed Modification to the List of Permitted Colouring Agents

1. Remove the permitted uses of aluminum metal shown by Column 2 of Item No. 1 from the list. This would remove from the list the permitted use of aluminum metal in or upon (1) Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated (naming the fruit) juice except frozen concentrated orange juice; Fig marmalade with pectin; Fish roe (caviar); Ice cream mix; Ice milk mix; Icing sugar; Liqueur; Lobster paste; (naming the flavour) Milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids; (naming the fruit) Jam with pectin; (naming the fruit) Jelly with pectin; Pickles; Pineapple marmalade with pectin; Relishes; Sherbet; Smoked fish; Tomato catsup; (2) Unstandardized foods; and (3) A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n).
2. Despite the proposal above to remove from the list the permitted use of aluminum metal in "Unstandardized foods", retain a permitted use of aluminum metal in unstandardized confectionery, except chewing gum, by adding a new entry for unstandardized confectionery, except chewing gum. and by changing the MLU from "Good Manufacturing Practice" to 670 parts per million (ppm).
3. Revise the MLU of potassium aluminum silicate-based iron oxide, potassium aluminum silicate-based titanium dioxide and potassium aluminum silicate-based titanium dioxide and iron oxide shown by Column 3 of Items No. 10, 11 and 12, respectively:
   1. The MLU of these additives in unstandardized confectionery will be changed from "1.25%" to "2,500 ppm, calculated as aluminum".
   2. The MLU of these additives in unstandardized alcoholic beverages will be changed from "0.5%" to "1,000 ppm, calculated as aluminum".
   3. The MLU of these additives in gelatin desserts and unstandardized bakery products will be changed from "0.15%" to "260 ppm, calculated as aluminum".
   4. The MLU of these additives in colour formulations applied to the surface of bite sized chocolate, bite sized milk chocolate, bite sized sweet chocolate or bite sized white chocolate will be changed from "0.15%" to "300 ppm in the food as consumed, calculated as aluminum".
4. Revise also the permitted use of subitems (1) shown by Column 2 of Items No. 10, 11 and 12, respectively, by removing "chewing gum". This is because "unstandardized confectionery" is a broad category that, for the purpose of the Lists of Permitted Food Additives, includes chewing gum.
   1. Unstandardized confectionery at a MLU of "2,500 ppm, calculated as aluminum".
   2. Unstandardized alcoholic beverages at a MLU of "1,000 ppm, calculated as aluminum".
   3. Gelatin desserts; Unstandardized bakery products at a MLU of "260 ppm, calculated as aluminum".
   4. Colour formulations applied to the surface of bite sized chocolate, bite sized milk chocolate, bite sized sweet chocolate or bite sized white chocolate at a MLU of "300 ppm in the food as consumed, calculated as aluminum".

If any combination of potassium aluminum silicate-based iron oxide, potassium aluminum silicate-based titanium dioxide or potassium aluminum silicate-based titanium dioxide and iron oxide is used, the total amount not to exceed the MLU set out above (4.a, 4.b, 4.c and 4.d) in the food category.

Proposed Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents

1. Remove all permitted uses of sodium aluminum phosphate (Item S.2A) from the list. This would remove from the list the permitted use of sodium aluminum phosphate in or upon (1) Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients); Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredients).
2. As a consequence of removing sodium aluminum phosphate from the list, remove reference to sodium aluminum phosphate in Column 3 of subitems C.4(1), C.9(1), P.9(1), P11(1), P.11A(1), S.1(1), S.6(1), S.8(1), S.9(6), S.11(6), S.12(1), S.13(1), S.13A(6), S.14(1), S.15(1), and S.16(1).

Proposed Modification to the List of Permitted Firming Agents

1. Remove all permitted uses of aluminum sulphate (Item A.1) from the list. This would remove from the list the permitted use of aluminum sulphate in or upon (1) Canned crabmeat, lobster, salmon, shrimp and tuna; Pickles and relishes; and (2) Unstandardized foods.
2. Remove all permitted uses of ammonium aluminum sulphate (Item A.2) from the list. This would remove from the list the permitted use of ammonium aluminum sulphate in or upon (1) Pickles and relishes; and (2) Unstandardized foods.
3. Remove the permitted uses of potassium aluminum sulphate in or upon Pickles and relishes, and Unstandardized foods (subitems (1) and (2) of Item P.1) from the list.
4. Remove all permitted uses of sodium aluminum sulphate (Item S.1) from the list. This would remove from the list the permitted use of sodium aluminum sulphate in or upon (1) Pickles and relishes; and (2) Unstandardized foods.

Proposed Modification to the List of Permitted Food Additives with Other Accepted Uses

1. Remove all permitted uses of aluminum sulphate (Item A.1.1) from the list. This would remove from the list the permitted use of aluminum sulphate in or upon Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk.
2. Remove the permitted use of magnesium aluminum silicate (Item M.1) in or upon Chewing gum.

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

1. Revise the permitted use of ammonium aluminum sulphate in or upon baking powder shown by Column 3 of subitem (1) of Item A.3 by changing the MLU from "Good Manufacturing Practice" to "3.5%, calculated as aluminum".
2. Remove the permitted use of ammonium aluminum sulphate in or upon Unstandardized foods (subitem (2) of Item A.3) from the list.
3. Remove the permitted uses of potassium aluminum sulphate (Item P.3) from the list. This would remove from the list the permitted use of potassium aluminum sulphate in or upon (1) Ale; Baking powder; Beer; Light beer; Malt liquor; Oil-soluble annatto; Porter; Stout; and (2) Unstandardized foods.

Despite the change described above for subitem (1), retain the permitted use of potassium aluminum sulphate in Baking powder by adding to Item P.3 new subitem (3) Baking powder and by changing the MLU from Good Manufacturing Practice to 3.5%, calculated as aluminum.

4. Remove the permitted use of sodium aluminum phosphate in or upon Unstandardized foods (Item S.4) from the list.
5. Revise the permitted use of sodium aluminum sulphate in or upon baking powder shown by Column 3 of Item S.5 by changing the MLU from "Good Manufacturing Practice" to "3.5%, calculated as aluminum".
6. Remove the permitted use of sodium aluminum sulphate in or upon Unstandardized foods (subitem (2) of Item S.5) from the list.

Proposed Modification to the List of Permitted Starch-Modifying Agents

1. Revise the permitted use of aluminum sulphate (Item A.3) in or upon starch by modifying the entry in Column 2 of Item A.3 to specify "Starch used in the manufacture of modified starch for use in confectionery" and by changing the MLU from "Good Manufacturing Practice" to "330 p.p.m., calculated as aluminum".

Rationale

Health Canada has completed its review of Canadians' dietary exposure to aluminum. While the results of this review did not present a concern from a food chemical safety perspective, the Food Directorate committed to reviewing the permitted uses of aluminum containing food additives to further reduce Canadians' exposure to aluminum to "as low as reasonably achievable".

Based on the results of this review, Health Canada is proposing to remove permitted uses that are no longer needed and revise a number of others, including updating some maximum levels of use from "Good Manufacturing Practice" (GMP) to numerical maximum levels that are a reflection of current industry practices. For this proposal, Health Canada considers a permitted use to no longer be needed if there was no information from industry about the use (null response) or if industry indicated it was not needed.

Health Canada's proposal to update the permitted uses of aluminum-containing food additives will better align the food additive provisions with actual food uses and help ensure that intake of aluminum from those uses remains within acceptable levels. This proposal fulfills the commitment the Department communicated in 2008.

Health Canada is interested to hear from stakeholders if current uses of aluminum-containing food additives in foods sold in Canada have changed since the Department last issued a call for data, such that they would not be captured in the proposed modifications to the lists described above.

Other Relevant Information

Food additives such individual aluminum-containing food additives are required to meet food-grade specifications set out in Part B of the Regulations, where such specifications exist, or those set out in the most recent edition of the Food Chemicals Codex or the Combined Compendium of Food Additive Specifications where there are no specifications in Part B. The Food Chemicals Codex is a compendium of standards for purity and identity for food ingredients, including food additives, published by the United States Pharmacopeial Convention. The Combined Compendium of Food Additive Specifications, which contains specifications prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), is published by the Food and Agriculture Organization of the United Nations.

Implementation and Enforcement

The proposed changes will be effective on the day in which they are published in the Lists of Permitted Food Additives. This will be announced via a Notice of Modification which will be published on the Government of Canada's website.

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

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 "aluminum-containing food additives (NOP-0040)" in the subject line of your e-mail. Health Canada is able to consider information received by May 22, 2023, 75 days from the date of this posting.

Appendix

In the List of Permitted Anticaking Agents:

• Replace the text in columns 2 and 3 of subitems C.1(1), C.1(2), C.1(3), of item C.1 and subitems S.2(1), S.2(2), S.2(3), S.2(4) and S.2(5) of item S.2 by the text in bold.
• Remove the strikethrough text in column 3 of subitems C.2(6), C.3(6), M.1(4), M.3(4), M.4(4), and S.1(4) and add the text in bold.

In the List of Permitted Colouring Agents:

• Remove the strikethrough text in column 1 of item 1;
• Add new item 1.01 and the text in bold to columns 1, 2, and 3 of subitem 1.01
• Remove the strikethrough text in column 2 of subitems 10.(1), 11.(1) and 12.(1) of items 10, 11 and 12 respectively; and
• Replace the text in column 3 of subitems 10.(1), 10.(2), 10.(3), 10.(4) of item 10, the text in column 3 of subitems 11.(1), 11.(2), 11.(3), 11.(4) of item 11 and the text in column 3 of subitems 12.(1), 12.(2), 12.(3), 12.(4) of item 12 by their corresponding texts in bold.

In the List of Emulsifying, Gelling, Stabilizing or Thickening Agents:

• Replace the text in columns 2 and 3 of subitem S.2A(1) of item S.2A by the following text in bold;
• Remove the strikethrough text in column 3 of subitems C.4(1), C.9(1), P.9(1), P11(1), P.11A(1), S.1(1), S.6(1), S.8(1), S.9(6), S.11(6), S.12(1), S.13(1), S.13A(6), S.14(1), S.15(1), and S.16(1).

In the List of Permitted Firming Agents:

• Replace the text in columns 2 and 3 of subitems A.1(1), A.1(2), A.2(1), A.2(2), P.1(1), P.1(2), S.1(1) and S.1(2) by the text in bold.

In the List of Permitted Food Additives with Other Accepted Uses:

• Replace the text in columns 2, 3 and 4 of items A.1.1 and M.1 by the text in bold.

In the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents :

• Replace the text in columns 2 and 3 of subitems A.3(1), A.3(2), P.3(1) and P.3(2), item S.4 and subitem S.5(1) and S.5(2) by the text in bold;
• Add the text in bold to columns 2 and 3 of new subitem P.3(3).

In the List of Permitted Starch-Modifying Agents:

• Add the text in bold to column 2 of item A.3, and
• Replace the text in column 3 of item A.3 by the following text in bold: