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List of Dietary Fibres Reviewed and Accepted by Health Canada’s Food Directorate

Updated June 2021

Bureau of Nutritional Sciences

Food Directorate

Health Products and Food Branch

Purpose

The purpose of this document is to provide a positive list of dietary fibres which will help food manufacturers, health professionals, consumers and other interested parties in identifying and using brand name products and generic products assessed as fibre sources and found acceptable by Health Canada’s Food Directorate.

Regulatory requirements

There is no regulatory requirement for a Health Canada premarket assessment of novel fibre sources, contrary to the premarket notification required for Novel Foods governed by Division 28 of the

Food and Drug Regulations

. However, a novel fibre source must be safe for human consumption (Section 4 of the

Food and Drugs Act

) and must have one recognized fibre physiological effect (Section 5 of the

Food and Drugs Act

; Section 6 of the

Safe Food for Canadians Act

). Fibre declaration and claims are subject to regulatory oversight and manufacturers and importers must be able to disclose the evidence substantiating the safety and the physiological effect of their novel fibre sources in accordance with Health Canada's

Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products

.

When a manufacturer or seller voluntarily submits for review a novel fibre information package, an assessment is conducted by the Food Directorate's Bureau of Nutritional Sciences and may result in the issuance of a letter of opinion about the acceptability of the food ingredient as a source of dietary fibre.

It must be noted that the list of accepted fibres in this document is not exclusive, that is, other acceptable fibre sources may be available in the Canadian marketplace. The onus is on the legal agent to comply with Sections 4 and 5 of the

Food and Drugs Act

and Section 6 of the

Safe Food for Canadians Act

.

Dietary fibre definition

The

Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products

defines dietary fibre as follows:

"Dietary fibre consists of:

carbohydrates with a degree of polymerization of 3 or more that naturally occur in foods of plant origin and that are not digested and absorbed by the small intestine; and

accepted novel fibres.

Novel fibres are ingredients manufactured to be sources of dietary fibre and consist of carbohydrates with a degree of polymerization of 3 or more that are not digested and absorbed by the small intestine. They are synthetically produced or are obtained from natural sources which have no history of safe use as dietary fibre or which have been processed so as to modify the properties of the fibre contained therein. Accepted novel fibres have at least one physiological effect demonstrated by generally accepted scientific evidence."

The four recognized physiological effects of dietary fibres are:

improving laxation or regularity by increasing stool bulk;

reducing blood total and/or low-density lipoprotein cholesterol levels;

reducing post-prandial blood glucose and/or insulin levels, or increasing sensitivity to insulin;

providing energy-yielding metabolites through colonic fermentation.

Accepted dietary fibres

Tables 1

and

2

below provide the list of dietary fibres assessed and accepted by Health Canada's Food Directorate. Fibres sharing similar characteristics are regrouped by category in Table 1. Products identified as "traditional fibres" in the third column of both tables were not considered as novel fibres and their acceptance as sources of fibre was not based on their physiological functionality as dietary fibres. These products derived from plants have a history of use as components of foods, have been minimally processed and their fibre properties have not been modified. Products identified as "novel fibres" have at least one fibre physiological effect demonstrated as recommended by Health Canada's Fibre Policy.

Accepted dietary fibre sources are permitted to be used in all unstandardized foods with the exception of infant formula unless otherwise specified. Unstandardized foods are foods for which the

Food and Drug Regulations

or other federal regulations do not provide specific compositional standards. The addition of dietary fibres is not permitted in standardized foods unless a provision for their addition is made in the

Food and Drug Regulations

or other applicable regulations.

Table 1. List of dietary fibres reviewed and accepted by Health Canada's Food Directorate - Per category

Dietary fibre name

Description

Reason for acceptance

Beta-glucans

Barley beta-glucan concentrate

Chemically extracted from barley grain using aqueous-enzymatic process and recovered by alcohol precipitation. Beta-glucan may be partially hydrolysed.

Molecular weight ≥ 175 kDa.

Novel fibre:

Reducing blood cholesterol levels.

Oat beta-glucan

concentrate

Chemically extracted from oat grain using aqueous-alcohol-alkaline process or aqueous-alcohol-enzymatic process, then recovered by alcohol precipitation. Beta-glucan may be partially hydrolysed.

Molecular weight > 250 kDa.

Novel fibre:

Reducing postprandial blood glucose levels.

Sieved barley meal

Beta-glucan concentrated via air classification of dry-milled barley grain.

Traditional fibre

Brans

Barley bran

Obtained from dehulled or hull-less barley grain using standard dry milling techniques, which may include steaming or tempering.

Novel fibre:

Reducing blood cholesterol levels.

Corn bran

Corn grain pericarp separated by conventional dry- or wet- corn milling process.

Novel fibre:

Improving laxation or regularity.

Oat bran

Derived from dehulled oat kernels (oat groat) and providing at least 13% total dietary fibre, of which at least 30 percent must be soluble fibre.

Traditional fibre

Wheat bran

Outer layer of wheat grain obtained during wheat flour milling process.

Traditional fibre

Cotyledons

Pea cotyledon

Derived from de-hulled peas processed for starch or protein production and obtained through conventional physical procedures (without chemical modification)

Traditional fibre

Soy cotyledon

Derived from processing dehulled and defatted soybean flakes in mild alkaline conditions.

Novel fibre:

Reducing blood cholesterol levels.

Gums

Acacia gum or

gum arabic

Dried exudate from stems and branches of Acacia senegal and Acacia seyal species, processed by water dissolution, purification, concentration and drying.

Traditional fibre

Partially hydrolyzed

guar gum

Sunfiber® (Taiyo International, Inc.).

Novel fibre:

Reducing postprandial blood glucose levels.

Hulls or seed coats

Oat hull fibre

Outer layer of oat grain processed by hydro-thermal high pressure treatment, by alkaline hydrogen peroxide treatment, or by other conventional treatments.

Novel fibre:

Improving laxation or regularity.

Pea hull fibre

Outer seed coat of field peas obtained by mechanical separation, by extraction of pea soluble material, or by other conventional processes.

Novel fibre:

Improving laxation or regularity.

Psyllium seed husk

Dried seed coat of Plantago ovata or Plantago arenaria separated from the seed through a mechanical process.

Purity ≥ 95%; Fibre ≥ 80%; Protein ≤ 3%.

Recommended warning statements on the label of psyllium-containing products: “This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium”. For products containing dry or incompletely hydrated psyllium husk, in Directions for Use section, indicate necessity to consume the product with enough fluid in order to avoid throat obstruction.

Novel fibre:

Improving laxation or regularity.

Oligosaccharides

Fructooligosaccharides or oligofructose

Mixture of fructose oligomers obtained by partial hydrolysis or by physical separation of traditional inulin sources, or enzymatically produced from sucrose.

Novel fibre:

Providing energy-yielding metabolites.

Galactooligosaccharides

Mixture of galactose oligomers produced by transgalactosylation of lactose derived from whey.

Novel fibre:

Providing energy-yielding metabolites.

Isomaltooligosaccharides

Mixture of glucose oligomers enzymatically produced from edible starch and modified through a transglycosylation reaction. The majority of oligomers consists of 3 to 6 glucose units.

Novel fibre:

Providing energy-yielding metabolites.

Peel and pulp

Apple peel

Derived from apple processing and produced through conventional physical procedures (without chemical modification).

Traditional fibre

Blueberry peel

Derived from blueberry processing and produced through conventional physical procedures (without chemical modification).

Traditional fibre

Cranberry peel

Derived from cranberry processing and produced through conventional physical procedures (without chemical modification).

Traditional fibre

Orange peel

Orange pulp

Derived from sweet orange processing and produced through conventional physical procedures (without chemical modification).

Traditional fibre

Tomato pulp

Derived from tomato processing and produced through conventional physical procedures (without chemical modification).

Traditional fibre

Resistant maltodextrin

Resistant corn maltodextrin

Corn maltodextrin (fibre)

Corn maltodextrin fibre

Corn maltodextrin (soluble fibre)

Corn maltodextrin soluble fibre

Maltodextrin (corn fibre)

Maltodextrin corn fibre

Maltodextrin (soluble corn fibre)

Maltodextrin soluble corn fibre

Note 1

: The term maltodextrin can be replaced by dextrin.

Note 2:

All names listed above are acceptable.

Note 3

: Depending on the starch source, the term corn can be replaced by potato, tapioca, rice, wheat, etc.

Obtained from edible starch by:

heat treatments, with or without addition of acids, and followed by sugar removal or

treatments with heat, acids and enzymes, and followed by sugar removal. The product consists of polymers of glucose containing α(1-4) and α(1-6) glucosidic bonds, as well as varying amounts of α/ß(1-2), α/ß(1-3), ß(1-4) and ß(1-6) bonds.

Dextrose equivalent < 20%.

Novel fibre:

Providing energy-yielding metabolites.

Resistant starches

Resistant corn starch or

high amylose corn starch

Obtained from milling process of high amylose corn grain, followed or not by hydrothermal treatment.

Amylose content in high amylose corn varies from 50 to 90%.

Novel fibre:

Increasing sensitivity to insulin.

Resistant green banana starch or green banana flour

Obtained from the pulp of raw unripe bananas using conventional physical procedures (without chemical modification).

Recommended label statement: “To maintain its fibre properties, this naturally occurring resistant starch should not be exposed to high temperatures or added to foods to be cooked”.

Traditional fibre

Resistant potato starch or

modified potato starch

Obtained from potato starch through a chemical modification using phosphorylating agents leading to the formation of a cross-linked phosphorylated starch.

Novel fibre:

Providing energy-yielding metabolites.

Resistant potato starch or

raw unmodified potato starch

Obtained from raw potato tubers using conventional physical procedures (without chemical modification)..

Recommended label statement: “To maintain its fibre properties, this naturally occurring resistant starch should not be exposed to high temperatures or added to foods to be cooked”.

Traditional fibre

Resistant wheat starch or

modified wheat starch

Obtained from wheat starch through a chemical modification using phosphorylating agents leading to the formation of a cross-linked phosphorylated starch.

Novel fibre:

Providing energy-yielding metabolites.

Syrup (fibre)

Corn syrup (fibre)

Corn syrup fibre

Corn syrup (soluble fibre)

Corn syrup soluble fibre

Corn syrup (soluble corn fibre)

Corn syrup soluble corn fibre

Glucose syrup (soluble corn fibre)

Glucose syrup soluble corn fibre

Dried glucose (corn fibre)

Dried glucose corn fibre

Dried glucose (soluble corn fibre)

Dried glucose soluble corn fibre

Corn glucose solids (fibre)

Corn glucose solids fibre

Glucose solids (corn fibre)

Glucose solids corn fibre

Glucose solids (soluble corn fibre)

Glucose solids soluble corn fibre

Note 1:

All names listed above are acceptable.

Note 2:

Depending on the starch source, the term corn can be replaced by potato, tapioca, rice, etc.

Obtained from edible starch by treatments with heat, acids and enzymes, and without sugar removal. The product consists of polymers of glucose containing α(1-4) and α(1-6) glucosidic bonds, as well as varying amounts of α/ß(1-2) and α/ß(1-3) bonds.

Dextrose equivalent ≥ 20%.

Novel fibre:

Providing energy-yielding metabolites.

Table 2. List of dietary fibres reviewed and accepted by Health Canada's Food Directorate - Other fibres

Dietary fibre name

Description

Reason for acceptance

Inulin from chicory root, Jerusalem artichoke tuber or Blue agave head

Standard inulin and long chain inulin obtained by hot water extraction and/or by conventional separation processes.

Traditional fibre

Polydextrose

Obtained by condensation of a melt consisting of approximately 90% glucose and 10% sorbitol in the presence of catalytic amounts of citric acid or phosphoric acid.

Novel fibre:

Providing energy-yielding metabolites.

Polysaccharide complex (glucomannan, xanthan gum, sodium alginate)

PGX®/PolyGlycopleX® (InovoBiologic).

Recommended warning statement on the label of PGX-containing products- In Directions for Use section, indicate necessity to consume the product in the hydrated form in order to avoid throat obstruction.

Novel fibre:

Reducing postprandial blood glucose levels.

Potato fibre

Derived from potato tubers processed for starch production and obtained through conventional physical procedures (without chemical modification).

Traditional fibre

Sugar beet fibre

Obtained from sugar beet pulp by pressing, steam drying and milling.

Novel fibre:

Reducing postprandial blood glucose levels.

Wheat flakes, starch-reduced

Obtained from the amylolytic digestion of milled wheat kernel used for ethanol production.

Novel fibre:

Improving laxation or regularity.

Whole or edible parts (pulp, peel) of traditional fruits, vegetables, cereals, legumes, nuts, seeds, etc.

Processed through conventional procedures.

Traditional foods

Health claims for dietary fibres

All health claims for food must be truthful and not misleading according to Section 5 of the

Food and Drugs Act

. Traditional fibres and accepted novel fibres, as any other foods, can carry health claims that are truthful and not misleading. This means that a health claim made about a beneficial effect of a specific dietary fibre source requires substantiation specific to this fibre source. Detailed information on the substantiation of health claims can be found in the

Guidance Documents for Preparing Health Claims Submissions

.

A novel fibre product with a demonstrated recognized fibre effect is primarily a source of nutrient (dietary fibre) and does not automatically qualify to carry a health claim. Thus, the demonstrated physiological effect should not be considered as a reviewed and accepted health claim.

Information about dietary fibres with health claims that have been reviewed and accepted by Health Canada’s Food Directorate (oat products, barley products, psyllium, coarse wheat bran, etc.) can be found in Health Canada’s

Health Claim Assessments

webpage and in the Canadian Food Inspection Agency’s

Table of Acceptable Food or Food Constituent Function Claims

.

Manufacturers and distributors are legally responsible for ensuring that their product complies with all relevant food legislation and regulations and for the accuracy of all information on food product labels and in advertisements.

Contact us

Manufacturers who are considering the use of novel fibre sources and require further guidance on the fibre policy or on the content of this document may contact the Bureau of Nutritional Sciences by mail or electronically.

Bureau of Nutritional Sciences

Food Directorate, Health Products and Food Branch

Health Canada

251, Sir Frederick Banting Driveway, Tunney’s Pasture, A.L. 2203E,

Ottawa, Ontario, Canada K1A 0K9

hc.bns-bsn.sc@canada.ca

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2021-06-25