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

Revised May 2017

Bureau of Nutritional Sciences
Food Directorate
Health Products and Food Branch

Table of Contents

• Purpose
• 1.0 Background
• 2.0 Definition of dietary fibre
• 3.0 Energy value
• 4.0 Physiological effects
• 5.0 Requirement for novel fibre sources
• 6.0 Labelling and claims
• 7.0 Methods of analysis
• 8.0 Mailing directions and contact information
• References

Purpose

This document updates the 2012 Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products to reflect a major change in the requirements for recognizing a product as a dietary fibre source. In 2014, Health Canada’s Food Directorate deemed that premarket approval of novel fibre sources was not mandatory. This more flexible approach was conveyed to stakeholders during informal meetings and via correspondence in response to inquiries and this update makes that information more widely available. In addition, one of the four recognized physiological effects of fibre—related to glucose metabolism—has been slightly reworded for clarification and the list of analytical methods has been updated. The structure of the document has also been modified in order to differentiate policy text from explanatory note and to make the relevant information more accessible to the reader.

1.0 Background

In 1985, the Canadian Department of National Health and Welfare adopted the dietary fibre definition developed by its Expert Advisory Committee on Dietary Fibre:

“Dietary fibre consists of the endogenous components of plant material in the diet, which are resistant to digestion by enzymes produced by humans. They are predominantly non-starch polysaccharides and lignin and may include, in addition, associated substances” (Health and Welfare Canada, 1985).

In 1988, as new products were isolated from plants, Health Canada published the Guideline Concerning the Safety and Physiological Effects of Novel Fibre Sources and Food Products Containing Them, which expanded on the 1985 definition and confirmed that non-starch polysaccharides of plant origin would be considered as novel sources of fibre if they met the following definition:

“Novel Fibre or Novel Fibre Source means a food that is manufactured to be a source of dietary fibre, and

• that has not traditionally been used for human consumption to any significant extent, or
• that has been chemically processed, e.g., oxidized, or physically processed, e.g., very finely ground, so as to modify the properties of the fibre contained therein, or
• that has been highly concentrated from its plant source” (Health Canada, 1988).

In the 2000s, a number of countries and scientific bodies recognized a wide range of substances as dietary fibre based on their chemical nature and their physiological properties, regardless of their origin (American Association of Cereal Chemists (AACC), 2001; Food Standards Australia New Zealand (FSANZ), Standard 1.2.8; Institute of Medicine (IOM), 2001; Agence Française de Sécurité Sanitaire des Aliments (AFSSA), 2002; European Commission, 2008; Codex, 2009; European Food Safety Authority (EFSA), 2010). These products include, for example, non-digestible oligosaccharides, resistant starch, and other modified and synthetic substances. However, some of these fibre-like products were not considered to be dietary fibre according to the 1985 Canadian definition. The current international trend in defining dietary fibre is to specify the basic chemical features and resistance to digestion in addition to requiring that a fibre have physiological effects. This approach does not typically limit dietary fibre to plant sources.

In 2010, in light of positions taken on dietary fibre by the U.S. Food and Nutrition Board of the Institute of Medicine and the Codex Alimentarius Commission, and taking into account advances in scientific knowledge about dietary fibre and food industry innovation, Health Canada’s Food Directorate developed a proposal for a revised dietary fibre definition and a more accurate fibre energy value. The purpose of these changes was to bring Canada up to date with international standards regarding the use of dietary fibre in foods.

A consultation document was posted on Health Canada’s website for stakeholder feedback between December 9, 2010 and February 7, 2011. Fifty-one comments were received from industry associations, food companies, consultants, universities and not-for-profit organizations. In general, respondents supported the revised fibre definition and the proposed energy value of 2 kcal (8 kJ)/g. However, some respondents made suggestions regarding an expanded list of physiological effects for fibre as well as the implementation of a more flexible premarket review process.

In 2012, the Food Directorate released the Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products aimed at informing food manufacturers and suppliers of fibre ingredients about the latest policy on the recognition and labelling of ingredients with respect to dietary fibre. A positive list of dietary fibre sources was subsequently developed. This List of Dietary Fibres Reviewed and Accepted by Health Canada’s Food Directorate has since been regularly updated with new products.

2.0 Definition of dietary fibre

In 2012, Health Canada adopted the following definition:

“Dietary fibre consists of:

1. carbohydrates with a DP^{Footnote 1} of 3 or more that naturally occur in foods of plant origin and that are not digested and absorbed by the small intestine; and
2. accepted novel fibres.

Novel fibres are ingredients manufactured to be sources of dietary fibre and consist of carbohydrates with a DP 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.”

Explanatory note

The substances in part 1 of this definition are all edible plant materials that have a history of use as food and have been processed or cooked using conventional processes. They include the fibre in whole or parts of fruits, vegetables, pulses, seeds, nuts, cereals, legumes, etc. Some types of starches resistant to digestion by endogenous human enzymes (resistant starch or RS) are also considered naturally occurring dietary fibre sources: RS1 or physically inaccessible starch as found in coarsely ground or chewed cereals, legumes and grains; and RS3 or retrograded starch created during normal processing (cooking and chilling) of starchy foods. Ungelatinized starch granules as found in raw potatoes and green bananas are considered type 2 RS. However, they cannot be considered as fibre sources in food products that are eaten cooked since, once cooked, they become digestible due to moist heat-induced gelatinization.

Some minor substances, such as lignin, waxes, cutin, suberin, phytate and tannin, although not carbohydrates, are an integral part of dietary fibre and are intricately tied to the plant polysaccharides, often serving as chemical cross-links between various components and increasing resistance to digestion in the small intestine. These substances, as well as some proteic fractions, are not separated from the polysaccharides in some gravimetric methods (Lee et al., 1992; Prosky et al., 1992, 1994). Therefore, they are included in the definition of dietary fibre when they are part of the plant cell wall matrix, but they cannot be defined as dietary fibre if they are isolated and introduced into a food.

Substances in part 2 of the definition include, for example, substances obtained from agricultural crop by-products and from raw plant materials not usually considered as food (hull, straw, etc.), substances of animal (chitin), fungal (yeast beta-glucan) or bacterial origin (xanthan gum), chemically modified substances (modified cellulose, partially hydrolyzed beta-glucan or guar gum), oligosaccharides (fructo-, galacto- and isomalto-oligosaccharides), synthetic products (polydextrose), etc. Novel fibre sources also include starch-derived products, for instance, digestion-resistant maltodextrins and some types of digestion-resistant starches such as high amylose starch (RS2), starches that have been chemically modified to resist digestion (RS4) and starch-lipid complexes (RS5).

In contrast to Health Canada’s previous position on novel fibre (Health Canada, 1988), fine grinding is not a factor in determining whether a product is a novel fibre source. Health Canada considers that very fine particle size does not represent a risk for human health since toxicological data from humans and animals have provided no evidence of any adverse pathology associated with the intestinal persorption of microcrystalline cellulose of particle size as small as 5 µm (European Commission, 1997; World Health Organization (WHO), 1998). Processed fibre sources have an average particle size much greater than 5 µm. In addition, the data reviewed by Health Canada of various novel fibre sources, as well as literature data (Brodribb and Groves, 1978; Jenkins et al., 1999), support the conclusion that fine particle dietary fibre materials can be effective fecal bulking agents. It has also been shown that reducing particle size improves fibre fermentability (Jenkins et al., 1999; Stewart and Slavin, 2009).

3.0 Energy value

Health Canada considers the energy value for carbohydrate that is not digested in the small intestine, but is fully fermented in the large intestine, to be 2 kcal (8 kJ)/g. This is the general value to use for all unavailable carbohydrate, including soluble and insoluble dietary fibre, in the absence of specific values. This value also applies to inulin for which the previously calculated value was 2.2 kcal (9.2 kJ)/g.

Products with energy values lower than 2 kcal (8 kJ)/g, which have already been accepted by Health Canada based on scientific evidence, may carry a label declaration of these specific caloric values. Thus, the energy value of the fibre portion of wheat bran is 0.6 kcal (2.5 kJ)/g and the wheat bran itself (containing around 40 % of fibre) has an energy value of 2.4 kcal (10 kJ)/g. As well, polydextrose, an accepted fibre source under the new definition, has an energy value of 1 kcal (4 kJ)/g given that it is only partially fermentable (Auerbach et al., 2007).

For food manufacturers wishing to declare an energy value lower than 2 kcal (8 kJ)/g, Health Canada requires substantiation with evidence obtained from a properly designed human balance study. Animal experimentations and in vitro fermentation techniques are optional and would be considered as supporting information.

Explanatory note

In Canada, until 2012, a caloric value of 4 kcal (17 kJ)/g was applied to the fibre portion of a product, unless a specific energy value was available for the fibre source and had been approved by Health Canada. However, advances in scientific knowledge indicate that an energy value of 2 kcal (8 kJ)/g for dietary fibre more accurately reflects its metabolizable energy in mixed diets (Brown et al., 1998).

This is supported by experts consulted by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization which held an Expert Consultation on Carbohydrates in Human Nutrition in 1997 (FAO/WHO, 1998) and a Technical Workshop on Food Energy - Methods of Analysis and Conversion Factors in 2002 (FAO, 2003). Both expert consultations recommended that, for nutritional and labelling purposes, the energy value should be set at 2 kcal (8 kJ)/g for carbohydrates that reach the colon. It was also indicated that 70 percent of the fibre in traditional foods can be assumed to be fermentable. The recommended energy value was based on studies published by Livesey (1990) and Livesey and Elia (1995).

Some jurisdictions such as Australia and New Zealand, Japan and the European Union have adopted the energy value of 2 kcal (8 kJ)/g for dietary fibre (FSANZ, Schedule 11; Goldring, 2004; European Commission, 2008).

However, in the U.S.A, the calorie calculation is different. In May 2016, the U.S. Food and Drug Administration (FDA) released a final rule aimed at amending its labelling regulations for foods. The Electronic Code of Federal Regulations, Title 21, § 101.9(c)(1)(i)(C)), has been amended to require that a general factor of 2 kcal (8 kJ) /g be used for soluble non-digestible carbohydrates (the previous energy value for soluble fibre being 4 kcal (17 kJ) /g). Although no exceptions were provided, the FDA stated that considerations could be made for changing the caloric value of a soluble non-digestible carbohydrate when the difference in energy value is significant and when the FDA determines that the evidence is established by science (FDA, 2016).

4.0 Physiological effects

Health Canada considers that the physiological effects of dietary fibre listed below are acceptable as physiological effects of novel fibre sources. Dietary fibre:

1. improves laxation or regularity by increasing stool bulk;
2. reduces blood total and/or low-density lipoprotein cholesterol levels;
3. reduces post-prandial blood glucose and/or insulin levels, or increases sensitivity to insulin^{Footnote 2};
4. provides energy-yielding metabolites through colonic fermentation.

This list is not exhaustive and other effects attributable to dietary fibre may be recognized by Health Canada as science evolves. It is understood that a specific dietary fibre source is not expected to demonstrate all recognized fibre effects since each effect will depend on the physico-chemical characteristics of the fibre source.

Explanatory note

In this list, "providing energy-yielding metabolites through colonic fermentation" has been added as a fourth effect to the list of the three well established physiological effects of dietary fibre previously accepted by Health Canada (Health Canada, 1997). Traditionally, the large intestine was seen as an organ responsible for water and electrolyte absorption as well as providing a mechanism for the disposal of waste products of digestion. It is now well established that the large intestine is also a major site of bacterial fermentation not only of non-digestible carbohydrate, but also of protein escaping digestion in the small intestine, sloughed epithelial cells and mucins. Bacteria are present in the human colon at 10¹⁰ to 10¹¹ colony forming units/g wet weight with over 400 species identified in human feces (Topping and Clifton, 2001). The major end products of colonic fermentation are short chain fatty acids (SCFA), primarily acetate, propionate and butyrate. While carbohydrates remain the major source of substrate for colonic SCFA production in a normal western diet, protein can also contribute significantly. Cummings (1997) estimated that 20–60 g of carbohydrate and 5–20 g of protein are available to the colonic microflora on a daily basis.

From the host's view point, this metabolic activity is important given that 95% of SCFA generated in the colon are absorbed and metabolised by the host (Cummings and Macfarlane, 1991; Topping and Clifton, 2001). It is reported that in individuals consuming western diets, the energy provided by SCFA is about 5–10% of the basal energy requirement (McNeil, 1984; McBurney and Thompson, 1989; Cummings, 1997).

Short chain fatty acids can be used as an energy source either by colonic mucosal epithelial cells (Scheppach, 1994; Marsman and McBurney, 1995; Clausen and Mortensen, 1995; Scheppach et al., 1996) or when they are absorbed into the circulation (Cummings, 1981; Scheppach et al., 1991). There is evidence that colonocytes are specifically adapted to utilize butyrate (Marsman and McBurney, 1995) and, in cells and tissue sections from normal subjects, as well as in vivo, butyrate stimulates cell proliferation (Sakata, 1987; Bartram et al., 1993; Scheppach et al., 1995).

The U.S. Food and Nutrition Board of the Institute of Medicine considers fermentation to be one of the physiological effects affected by the fibre properties and indicates that butyrate is the preferred energy source for colon cells. In addition, they emphasize that foods rich in hemicelluloses and pectins, such as fruits and vegetables, contain dietary fibre that is more completely fermentable than foods rich in celluloses, such as cereals. Resistant starch was identified as being highly fermentable (IOM, 2005).

Health Canada thus concluded that dietary fibre acts as a substrate for the bacterial community of the large intestine and, through the action of this community, provides energy-yielding nutrients such as SCFA to the colon epithelial cells as well as to other organs of the body. In this way, the mere fact that a dietary fibre is fermentable and produces energy for the host makes it a nutrient similarly to digestible carbohydrates that have no other function than to provide energy.

The evidence required by Health Canada to support the production of energy-yielding metabolites through the colonic fermentation of dietary fibre includes both in vivo and in vitro studies. Depending on what is known about the physico-chemical characteristics of the product, the types of studies required could include:

1. Human or animal studies demonstrating that the product is not digested and absorbed in the small intestine (for example, human breath gas evolution, ileal excreta collected from colectomized animals);
2. In vitro fermentation studies providing an estimate of SCFA and gas production;
3. Human or animal feces analysis showing fibre disappearance and confirming that part or all of the fibre has been broken down in the large intestine.

Health Canada would also consider other validated applicable methods.

Fibre fermentation in other jurisdictions

France was the first jurisdiction to recognize the stimulation of colonic fermentation as a physiological property of dietary fibre (AFSSA, 2002). In 2008, this property (fermentability by colonic microflora) was adopted by the European Commission as one of the physiological effects of dietary fibre (European Commission, 2008). In addition, in 2010, the Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority (EFSA) identified short-chain fatty acid production in the colon by undigested oligosaccharides as one of the fibre-like effects (EFSA, 2010).

In the 2016 U.S. FDA's final rule on nutrition labelling, a dietary fibre definition was provided, and isolated and synthetic non-digestible carbohydrates (corresponding to the Canadian novel fibre category) are required to demonstrate a physiological effect that is beneficial to human health, such as attenuation of postprandial blood glucose concentration; attenuation of blood cholesterol concentration; and improved laxation. The FDA considers colonic fermentation and short chain fatty acid production to be processes that may be associated with a physiological endpoint, rather than physiological endpoints themselves. Health Canada agrees that currently there is no demonstrated health outcome associated with fibre fermentation which is seen only as a physiological effect typical of a nutrient (production of energy).

5.0 Requirements for novel fibre sources

5.1 Demonstration of safety

The safety of a novel fibre source must be established before it may be used as an ingredient in foods.

1. If a novel fibre source is not a "Novel Food" as defined in Division 28 of the Food and Drug Regulations, its sale is still subject to Section 4 of the Food and Drugs Act and its use in food must not lead to a violation of this section.
2. If a novel fibre source is a "Novel Food," subject to notification under Division 28 of the Food and Drug Regulations, a novel food premarket application must be completed and submitted to the Food Directorate for approval as a novel food.

5.2 Demonstration of physiological effect

Manufacturers and importers must be able to disclose the evidence substantiating that their novel fibre source has at least one of the four physiological effects of fibre identified in Part 4 of this policy, so that the product can be considered as an accepted dietary fibre. In the absence of such evidence, it would be considered misleading to declare the ingredient as a source of fibre. A guideline (Guideline Concerning the Safety and Physiological Effects of Novel Fibre Sources and Food Products Containing Them, Health Canada) is available to assist food manufacturers and importers in preparing their evidence.

5.3 Voluntary submission

A manufacturer or seller of novel fibres may request, voluntarily, an assessment by the Food Directorate's Bureau of Nutritional Sciences. This assessment is conducted on a case-by-case basis and will result in the issuance of a letter of opinion about the acceptability of this novel fibre for use as fibre source in foods for sale in Canada. Such dietary fibres are added to the List of Dietary Fibres Reviewed and Accepted by Health Canada's Food Directorate. This positive list that includes generic and brand name fibre products assessed by Health Canada is regularly updated and made available to the public.

Explanatory note on relevant regulations

Manufacturers and importers of foods to be sold in Canada must comply with all relevant food legislation and regulations. Fibre declaration and content claims on a food label are subject to regulatory oversight by the Canadian Food Inspection Agency (CFIA). Like all food ingredients, the use of a dietary fibre source is governed by Sections 4 and 5, Part I of the Food and Drugs Act and by Division 28, Part B of the Food and Drug Regulations:

• Section 4.(1): No person shall sell an article of food that
  1. has in or on it any poisonous or harmful substance; or
  2. is unfit for human consumption.
• Section 5.(1): No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.
• Division 28.002.(1): No person shall sell or advertise for sale a novel food unless the manufacturer or importer of the novel food
  1. has notified the Director in writing of their intention to sell or advertise for sale the novel food; and
  2. has received a written notice from the Director under paragraph B.28.003(1)(a) or subsection B.28.003(2).

6.0 Labelling and claims

In Canada, the amount of dietary fibre contained in a food is one of the 13 core nutrients that must be declared in the Nutrition Facts table (Food and Drug Regulations, item 10 of the table following B.01.401). The amount of dietary fibre naturally occurring in plant foods is included as part of the total dietary fibre declaration in the Nutrition Facts table as per the new definition and using methodologies identified in Part 7 – Methods of analysis. The amount of dietary fibre from novel fibre sources can also be included in the total fibre declaration provided that the legal agents:

1. are able to disclose the scientific evidence substantiating the safety and fibre physiological effect of their ingredients upon request by the Canadian Food Inspection Agency, or
2. have received a No Objection letter from the Food Directorate’s Bureau of Nutritional Sciences for their ingredients to be used as fibre sources, or
3. are using fibres that are on the List of Dietary Fibres Reviewed and Accepted by Health Canada’s Food Directorate.

Explanatory note on relevant regulations

The amount of both soluble and insoluble fibre may be declared separately as additional information (Food and Drug Regulations, items 10 and 11 of the table following B.01.402). The energy value of 2 kcal (8 kJ)/g must be included in the caloric declaration.

Health Canada no longer requires a product which has evidence to demonstrate a fibre physiological effect in one food matrix (for example, a solid) to have the effect demonstrated in another matrix (for example, a liquid); it will be permitted to be labelled as dietary fibre in all unstandardized foods with the exception of infant formula unless otherwise specified. The addition of dietary fibre ingredients is not permitted in standardized foods unless a provision is made in the Food and Drug Regulations.

The content claims “source of fibre”, “high source of fibre” and “very high source of fibre” can be made for foods containing, respectively, a minimum of 2, 4, or 6 grams of dietary fibre per serving (Food and Drug Regulations, Table following B.01.513, items 41-43). Comparative claims about the amount of dietary fibre may be made under the conditions described in item 44 of that table. “More fibre” claims are not restricted to fibre from the same source. Claims comparing the qualities of one fibre-containing food to another are considered misleading because of the substantial differences in chemical nature and physiological effects among dietary fibre ingredients.

When a health claim is made about a beneficial effect of a specific dietary fibre source, like all health claims, it requires substantiation on a case-by-case basis and is subject to conditions of use. Generally, a health claim about a specific food ingredient must be supported by the totality of relevant evidence related to that food ingredient. Detailed information on the substantiation of health claims can be found in the Guidance Documents for Preparing Health Claims Submissions. 

7.0 Methods of analysis

In consultation with the CFIA, Health Canada proposes a list of appropriate analytical methods for dietary fibre in Tables 1 (general methods) and 2 (specific methods), in part adapted from recommendations made by the Codex Committee on Methods of Analysis and Sampling (2012). These methods, as well as other equivalent and validated methods, are considered acceptable to quantify fibre.

Explanatory note

For assessing compliance, the CFIA uses the AOAC 2009.01 method. This method is seen as effective for measuring the total dietary fibre content of most foods and its variability is similar to that of other dietary fibre analytical procedures. Furthermore, this method eliminates issues of double accounting when certain fibre fractions such as resistant starch, polydextrose and inulin are measured by a combination of general and specific methods in each of which these fibres may be partially or completely quantified (Figure 1).

However, Health Canada and CFIA understand that some specific fibre components may not be adequately quantitated by the AOAC 2009.01 method. In those cases, manufacturers or importers are advised to work with the CFIA in order to determine which analytical method should be used and what amount of fibre should be declared.

Figure 1. Schematic representation of dietary fibre components measured, and not measured, by AOAC Official Methods 985.29 and 991.43.

8.0 Mailing directions and contact information

8.1 Submission to Health Canada

Voluntary submissions for novel fibre sources, consisting of two hard copies and one CD-ROM, should be addressed to:

Submission Management and Information Unit
Food Directorate, Health Products and Food Branch, Health Canada
251, Sir Frederick Banting Driveway, Room E224
Postal Locator 2202E
Ottawa, Ontario, Canada, K1A 0K9

Submissions of less than 20 pages may be sent electronically to the following address in addition to, but not in place of, hard copies: smiu-ugdi@hc-sc.gc.ca

8.2 Contact for questions

Manufacturers and importers who are considering the use of novel fibre sources and require further guidance on the fibre policy 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
Postal Locator  2203E
Ottawa, Ontario, Canada, K1A 0K9
Email address: fibre@hc-sc.gc.ca

Questions about food health claims should be forwarded to: healthclaims-allegationssante@hc-sc.gc.ca

Questions about mandatory pre-market notification of novel foods should be forwarded to: Novelfoods-alimentsnouveaux@hc-sc.gc.ca 

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