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

Notice of Modification – Lists of Permitted Food Additives
Reference number: M-FAA-25-04
September 15, 2025

Summary

The purpose of this notice is to publicly announce Health Canada's decision to permit the use of pectin as a stabilizing and thickening agent in human milk fortifier and infant formula at a maximum level of use of 2000 ppm as consumed. 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 the use of a new food additive or to 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 pectin be permitted for use as a thickener and stabilizer in human milk fortifier and infant formula at a maximum level of use of 0.2%^{Footnote 1} as consumed. The petitioner explained that pectin is intended to be used to increase viscosity, thereby serving to minimize product separation and to maintain homogeneity during shelf life and feeding, thus consistently delivering the appropriate level of essential nutrients to infants. The petitioner also indicated that pectin functions during thermal processing of the requested foods by stabilizing proteins, which maintains stable emulsions and reduces protein aggregation and sedimentation.

Pectin is already permitted for use as an emulsifying, stabilizing or thickening agent in a variety of standardized foods and in unstandardized foods in general, but not in human milk fortifier and infant formula specifically.^{Footnote 2}

Rationale

Health Canada completed a premarket safety and efficacy assessment of pectin for its requested use. The assessment considered allergenicity, chemistry, microbiology, nutrition, and toxicology aspects as well as technical information supporting the efficacy of pectin for its requested use.

The results of the assessment support the safety and efficacy of pectin for use as a stabilizing agent and a thickening agent in human milk fortifier and infant formula at a maximum level of use of 2000 ppm as consumed.

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

Health Canada will permit the use of pectin as requested by the petitioner by adding the new paragraphs P.1(d.1) and P.1(f.1) to 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 addition).

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.1	Pectin	n/a	(d.1) Human milk fortifier	(d.1) Stabilizing or thickening agent	(d.1) 2,000 ppm in the human milk as consumed, containing the human milk fortifier	M-FAA-25-04
			(…)	(…)	(…)	(…)
			(f.1) Infant formula	(f.1) Stabilizing or thickening agent	(f.1) 2,000 ppm in the infant formula as consumed	M-FAA-25-04

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 3}
• Combined Compendium of Food Additive Specifications ^{Footnote 4}

Pre-market authorization for human milk fortifier and infant formula

Manufacturers must submit a premarket application to Health Canada prior to selling or advertising any new infant formula or human milk fortifier, or an infant formula or human milk fortifier that has undergone a major change, including the addition of a new ingredient (for example, a food additive, such as pectin, newly permitted for use in human milk fortifier and infant formula).

Implementation and enforcement

The modification described in this notice will come into force on 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 "pectin (M-FAA-25-04)" 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