Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents to extend the use of polysorbate 80

Notice of Modification – Lists of Permitted Food Additives
Reference number: M-FAA-25-02
September 15, 2025

Summary

The purpose of this notice is to publicly announce Health Canada's decision to permit polysorbate 80 to be used as an emulsifying agent in unstandardized dips at a maximum level of use of 0.05%. This modification will come into force on October 20, 2025, the date on which the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents is modified, which is 5 weeks from the date of publication of this notice.

Background

The food additives authorized in Canada are set out in the Lists of Permitted Food Additives. These lists are incorporated by reference into Division 16 of the Food and Drug Regulations (FDR).

There is a premarket authorization process to ask Health Canada to permit a new food additive or modify the use of an already permitted food additive. The process is started by filing a food additive submission that contains scientific information that Health Canada will review to determine if the safety of the food additive is supported for its requested use.

Issue

Health Canada received a food additive submission asking that polysorbate 80 be authorized for use as an emulsifying agent in unstandardized dips at a maximum level of 0.05%.

At the time of the petitioner’s submission, polysorbate 80 was already permitted for this purpose of use in certain other foods, but not unstandardized dips.

Rationale

Health Canada completed a premarket safety assessment of polysorbate 80 for its requested use. The assessment considered allergenicity, chemistry, nutrition, and toxicology aspects.

The results of the assessment support the safety of polysorbate 80 for use as an emulsifying agent in unstandardized dips at a level up to 0.05%.

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

Health Canada will permit the use of polysorbate 80 as requested by the petitioner by adding a new entry to item P.6 of the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, as shown in the table below (in bold font in this notice to illustrate the change).

List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents

Item	Column 1	Column 2	Column 3	Column 4	Column 5	Notes
	Food additive	Source	Food	Purpose of use	Maximum level of use, maximum level of residue and other conditions
P.6	Polysorbate 80	n/a	(r.1) Unstandardized dips	(r.1) Emulsifying agent	(r.1) 0.05%	M-FAA-25-02

Corrective modification

To restore the alphabetical order in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, Health Canada will modify the item numbers of sodium stearate and sodium stearoyl-2-lactylate as shown in the table below:

List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents

Item	Column 1	Column 2	Column 3	Column 4	Column 5	Notes
	Food additive	Source	Food	Purpose of use	Maximum level of use, maximum level of residue and other conditions
S.18	Sodium Stearate	n/a	Fillings; Icings; Unstandardized bakery products; Unstandardized confectionery	Emulsifying, stabilizing or thickening agent	Good Manufacturing Practice	n/a
S.19	Sodium Stearoyl-2-Lactylate	n/a	(a) Batter mix	(a) Emulsifying, stabilizing or thickening agent	(a) 7,500 ppm of the dry ingredients	n/a
			(b) Filling mixes; Fillings	(b) Emulsifying, stabilizing or thickening agent	(b) 5,000 ppm of the dry ingredients	n/a
			(c) French dressing; Salad dressing	(c) Emulsifying agent	(c) 4,000 ppm	n/a
			(d) Icing mixes; Icings	(d) Emulsifying, stabilizing or thickening agent	(d) 4,000 ppm of the dry ingredients	n/a
			(e) Pudding mixes; Puddings	(e) Emulsifying agent	(e) 2,000 ppm in the food as consumed	n/a
			(f) Soups	(f) Emulsifying, stabilizing or thickening agent	(f) 2,000 ppm	n/a
			(g) Sour cream substitutes	(g) Emulsifying, stabilizing or thickening agent	(g) 1.0% of the dry ingredients	n/a
			(h) Unstandardized cream-based liquors	(h) Emulsifying agent	(h) 3,500 ppm	n/a
			(i) Vegetable oil creaming agents	(i) Emulsifying, stabilizing or thickening agent	(i) 2.0% of the dry ingredients	n/a

Other relevant information

Food additive specifications

Food additives must meet the specifications set out in the Table of Food Additive Specifications , if they exist.

Food additives which do not have specifications in this table must meet the specifications, if any, set out in the latest edition of one of the following documents:

• Food Chemicals Codex ^{Footnote 1}
• Combined Compendium of Food Additive Specifications ^{Footnote 2}

Implementation and enforcement

The modification described in this notice will come into force October 20, 2025, the day it is published in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, which is 5 weeks from the date of publication of this notice.

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

If you wish to submit an inquiry or new scientific information about a food additive permitted for use in Canada, please contact Health Canada’s Bureau of Chemical Safety (BCS). If your communication is specific to this notice, please use the words "polysorbate 80 (M-FAA-25-02)" in the subject line of your message.

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

Useful links

• Health Canada: Regulation of food additives
• Canadian Food Inspection Agency: Permitted synonyms for food additives

Endnotes