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.
| 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.
|
Novel fibre: |
Oat beta-glucan |
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.
|
Novel fibre: |
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: |
Corn bran |
Corn grain pericarp separated by conventional dry- or wet- corn milling process. |
Novel fibre: |
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: |
| Gums | ||
Acacia gum or |
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 |
Sunfiber® (Taiyo International, Inc.). |
Novel fibre: |
| 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: |
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: |
Psyllium seed husk |
Dried seed coat of Plantago ovata or Plantago arenaria separated from the seed through a mechanical process.
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: |
| 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: |
Galactooligosaccharides |
Mixture of galactose oligomers produced by transgalactosylation of lactose derived from whey. |
Novel fibre: |
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: |
| 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 |
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 |
Obtained from edible starch by:
|
Novel fibre: |
| Resistant starches | ||
Resistant corn starch or |
Obtained from milling process of high amylose corn grain, followed or not by hydrothermal treatment.
|
Novel fibre: |
Resistant green banana starch or green banana flour |
Obtained from the pulp of raw unripe bananas using conventional physical procedures (without chemical modification). |
Traditional fibre |
Resistant potato starch or |
Obtained from potato starch through a chemical modification using phosphorylating agents leading to the formation of a cross-linked phosphorylated starch. |
Novel fibre: |
Resistant potato starch or |
Obtained from raw potato tubers using conventional physical procedures (without chemical modification).. |
Traditional fibre |
Resistant wheat starch or |
Obtained from wheat starch through a chemical modification using phosphorylating agents leading to the formation of a cross-linked phosphorylated starch. |
Novel fibre: |
| Syrup (fibre) | ||
Corn syrup (fibre) |
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.
|
Novel fibre: |
| 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: |
Polysaccharide complex (glucomannan, xanthan gum, sodium alginate) |
PGX®/PolyGlycopleX® (InovoBiologic). |
Novel fibre: |
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: |
Wheat flakes, starch-reduced |
Obtained from the amylolytic digestion of milled wheat kernel used for ethanol production. |
Novel fibre: |
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
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