Health Canada’s Proposal to Enable the Use of Tamarind Gum as an Emulsifying, Gelling, Stabilizing and Thickening Agent in Unstandardized Foods and Certain Standardized Foods – Reference Number: NOP/ADP-0026

Notice of Proposal – Lists of Permitted Food Additives

Reference Number: [NOP/ADP-0026]

August 15, 2017

(PDF Version - 1 MB)

Summary

Food additives are regulated in Canada under Marketing Authorizations (MAs) issued by the Minister of Health and the Food and Drug Regulations. Approved food additives and their permitted conditions of use are set out in the Lists of Permitted Food Additives that are incorporated by reference in the MAs and published on Health Canada’s website. A petitioner can request that Health Canada approve a new additive or a new condition of use for an already approved food additive by filing a food additive submission with the Department's Food Directorate. Health Canada uses this premarket approval process to determine whether the scientific data support the safety of food additives when used under specified conditions in foods sold in Canada.

Health Canada received a food additive submission seeking approval for the use of tamarind gum as an emulsifying, gelling, stabilizing and thickening agent. The foods it is intended to be used in are the same foods, or foods that fall within the same food categories, as those to which carob bean gum (locust bean gum) may be added, as well as mincemeat and (naming the fruit) jelly.

The results of Health Canada’s evaluation of available scientific data support the safety and efficacy of tamarind gum for its requested uses. Therefore, Health Canada intends to modify the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents by adding the entries to the list as set out in the table below.

Proposed Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
Item No. Column 1
Additive
Column 2
Permitted In or Upon
Column 3
Maximum Level of Use and Other Conditions
T.2A Tamarind gum (1)
Cream; French dressing; Mincemeat; Mustard pickles; (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) Jelly with pectin; Relishes; Salad dressing
(1)
Good Manufacturing Practice
(2)
Cottage cheese; Creamed cottage cheese
(2)
0.5% in accordance with the requirements of sections B.08.051 and B.08.052
(3)
Ice cream mix
(3)
0.5%. If used in combination with microcrystalline cellulose, other stabilizing agents, or both, the total amount not to exceed 0.5%
(4)
Ice milk mix
(4)
0.5%. If used in combination with other stabilizing agents, the total amount not to exceed 0.5%
(5)
Calorie-reduced margarine
(5)
0.5%. If used in combination with other food additives from this list except gelatin and lecithin, the total amount not to exceed 0.5%
(6)
Sherbet
(6)
0.75%. If used in combination with other stabilizing agents, the total amount not to exceed 0.75%
(7)
Sour cream
(7)
0.5%. If used in combination with other food additives from this list except monoglycerides, mono- and diglycerides, and sodium phosphate dibasic, the total amount not to exceed 0.5%
(8)
Unstandardized foods
(8)
Good Manufacturing Practice
(9)
Cold-pack cheese food; Cold-pack cheese food with (naming the added ingredients); Cold-pack (naming the variety) cheese with (naming the added ingredients); Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)
(9)
0.5% singly or in combination in accordance with the same conditions of use as prescribed for those food additives referred to in sub-paragraphs or clauses B.08.035.(1)(b)(iv), B.08.037.(1)(b)(v), B.08.038.(1)(b)(v)(A), B.08.039.(1)(b)(v)(A), B.08.041.3.(1)(b)(v)(A), B.08.041.4.(1)(b)(v)(A), B.08.041.6.(1)(b)(v), B.08.041.7.(1)(b)(v) and B.08.041.8.(1)(b)(v)

Rationale

Health Canada’s Food Directorate has completed a pre-market safety and efficacy assessment of tamarind gum when used as described in the table above. The assessment considered information related to chemistry, microbiology, nutrition, toxicology, and the efficacy of tamarind gum for its requested uses.

Tamarind gum, also referred to as “tamarind seed polysaccharide” and “tamarind seed gum”, is obtained from the seed of the tamarind tree (Tamarindus indica L), which grows in subtropical and tropical climates. Tamarind gum is comprised mainly of a water soluble galactoxyloglucan polysaccharide that is obtained by extraction from tamarind seed. Galactoxyloglucan is composed of a linear chain of (1→4)-β-d-glucan that is partially substituted with side chains of (1→6)-α-d-xylopyranose and β-d-galactopyranosyl linked with (1→2)-a-d-xylopyranose linked (1→6) to glucose residues. The ratio by weight of the three sugar constituents (glucose, xylose, and galactose) in tamarind gum is approximately 3:2:1 respectively.

Data was provided demonstrating that tamarind gum can be manufactured, following good manufacturing practices, such that it consistently meets the manufacturer’s in-house specifications, including specifications for lead, arsenic, and microbial pathogens. These specifications are generally consistent with internationally-established specifications for many other food additives, including other plant-based gums.

No nutritional or microbiological concerns were identified for the requested uses of tamarind gum.

Toxicological data showed that tamarind gum is not absorbed into the general circulation and it is not broken down by digestive enzymes and therefore, there is no systemic exposure to it. In the absence of systemic exposure, the possibility of an allergic reaction to tamarind gum is considered to be negligible. However, tamarind gum is fermented by bacteria in the colon into individual sugars and short-chain fatty acids. These breakdown products are normal constituents of the diet and, once absorbed, they are incorporated into normal metabolic processes. These constituents are also not allergens.

The stability of tamarind gum under different conditions was demonstrated using data comparing heat resistance, acid resistance, freeze-thaw resistance and salt resistance for tamarind gum relative to two already-approved gums, guar gum and xanthan gum. The data submitted to Health Canada demonstrated that tamarind gum is at least as effective as guar gum and xanthan gum in maintaining a stable viscosity. Data from some of the tests (e.g., acid resistance, freeze-thaw resistance) showed that tamarind gum could be more effective.

Depending on the food matrix, data was provided showing degree of shape retention, prevention of syneresis (expulsion of liquid from a gel), gel formation, and effect on stabilizing ice crystals in foods made using tamarind gum. The data are considered to have demonstrated the ability of tamarind gum to function as an emulsifying, gelling, stabilizing and thickening agent.

Tamarind gum is to be used as a replacement for, or in combination with, other permitted gums such as carob bean gum, guar gum, acacia gum, karaya gum, tragacanth gum, and xanthan gum. For many of the standardized foods in which the use of tamarind gum was requested, a numerical maximum level of use is proposed in order that the requirements of the relevant compositional standards are respected. However, for some of the standardized foods and for unstandardized foods, allowing tamarind gum at a maximum use level of good manufacturing practice (GMP) as indicated in the table will provide the same flexibility in levels of use afforded to these other gums, all of which are permitted in unstandardized foods and some of the requested standardized foods at GMP.

Health Canada’s Food Directorate considers that the outcome of the safety assessment supports the safety of tamarind gum when used under the conditions of use set out in the table above. The Department is therefore proposing to enable the use of tamarind gum as described in the table above.

Other Relevant Information

In the United States of America, tamarind gum is “self-affirmed” GRAS (Generally Recognized as Safe) when used as a thickener, stabilizer, emulsifier and gelling agent in various food categories at levels ranging from 0.2% to 1.5%.Footnote 1

The Food and Drug Regulations require that food additives such as tamarind gum that do not have specifications set out in Part B of the Regulations meet the most recent specifications set out in the Food Chemicals Codex or the Combined Compendium of Food Additive Specifications. 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. Specifications for tamarind gum were not set out in either of these sources at the time of publication of this Notice of Proposal. However, JECFA has scheduled tamarind gum for evaluation this calendar year with a view to potentially establishing specifications. Until such time that a specification is established within the FCC or by JECFA, tamarind gum that meets the manufacturer’s in-house specifications as presented to Health Canada are considered acceptable.

Implementation and enforcement

The proposed change will be effective the day on which it is published in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents. This will be announced via a Notice of Modification which will be published on Health Canada’s Website.

The Canadian Food Inspection Agency is responsible for the enforcement of the food-related aspects of the Food and Drugs Act and its associated regulations.

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 0L2
E-mail: bcs-bipc@hc-sc.gc.ca

If communicating by e-mail, please use the words “Tamarind gum” in the subject line of your e-mail. The comment period for this proposal is open until December 3, 2017.

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