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Canada's Regulatory System for Foods with Health Benefits - An Overview for Industry

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Agriculture and Agri-Food Canada is committed to helping industry bring innovative food products to market. Currently, to address consumers' growing interest in health, the sector is focused on developing foods with enhanced nutritional value and functional properties. This fact sheet is a starting point for companies wanting to promote the health benefits of their products. It will help you better understand and navigate Canada's food regulatory system and point you to important resources.


The Food and Drugs Act

The Food and Drugs Act (FDA) is the primary legislation governing the safety and nutritional quality of food sold in Canada. Its scope includes food labelling, advertising and claims; food standards and compositional requirements; fortification; foods for special dietary uses; food additives; chemical and microbial hazards; veterinary drug residues; packaging material; and pesticides. The role of the FDA is to protect the public against health hazards and fraud from the sale of food (including beverages), drugs, medical devices and cosmetics.

Federal government departments have complementary roles in the development, enforcement and interpretation of policies and guidance based on the FDA and its regulations:

Core principle of the Food and Drugs Act

A key underlying premise of the FDA is to enable consumers to make informed food choices based on information that is truthful and not misleading. All advertising and all statements on food packages are subject to subsection 5(1) of the FDA, which states:

"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."

Food manufacturers and importers are responsible for ensuring that their products are accurately positioned in the marketplace and comply with Canadian legislation. Nutrition and health claims are voluntary; however, if they are made, they must comply with applicable regulations or guidelines including conditions for use. As more food products are being promoted for their health benefits, industry must continue to ensure that all advertising and label claims are scientifically validated and provide meaningful information to the consumer.

Regulatory modernization

The federal government is streamlining the way regulations are administered while continuing to protect the health and safety of Canadians. This includes recent amendments to the FDA to allow new tools called "Marketing Authorizations" and "Incorporation by Reference", which improve the efficiency of implementing science-based decisions. For example, these tools could be applied to approve a new or modified health claim or a new application for a food additive, allowing their use in the marketplace once the science has been substantiated. It will be important for industry to keep up-to-date on new procedures and tools. See the Resources, including e-mail notification lists.

Food and natural health product classification

The FDA categorizes consumed products as either foods or drugs; drugs include the subcategory of natural health products (NHPs). The regulatory requirements are different depending on how the product is classified.

Some products, such as beverages with added vitamins, minerals or amino acids, as well as products making certain health claims, have previously been able to gain market access as NHPs under the NHPR. To resolve the confusion about which regulatory framework is appropriate, Health Canada outlined principles in a guidance document, Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats. Products are classified as foods or as NHPs on a case-by-case basis and consideration is given to public health and safety. Four key criteria are used to make decisions: product composition, product representations, product format, and public perception and history of use.

In accordance with the classification guidance document, Health Canada determined that most food-like NHP products fit the regulatory definition of a food and therefore is transitioning them to the food regulatory framework, mainly through the issuance of Temporary Marketing Authorization Letters (TMALs). The transition process was initiated in early 2012, starting with caffeinated energy drinks and moving to additional categories (e.g. beverages, conventional foods, powders). Health Canada's Natural Health Products Directorate no longer accepts NHP applications for products that are represented, packaged and sold as foods.

Food labelling in Canada

Mandatory nutrition facts table

Most pre-packaged food products sold in Canada require a Nutrition Facts table on their label.

Other mandatory information is required on food labels. The CFIA's Guide to Food Labelling and Advertising, Chapters 5 and 6, provides details to assist manufacturers with nutrition labelling requirements. CFIA also offers other Food Labelling and Advertising information, including an interactive tool that depicts food labelling requirements.

Dietary fibre

The Policy for Labelling and Advertising of Dietary Fibre-Containing Food Products, released in February 2012, affects the declaration of both dietary fibre and energy in the Nutrition Facts table. This policy aligns Canada with international standards on the definition of dietary fibre.

Food allergen labelling

New regulations on food allergen labelling came into force on August 4, 2012 for all pre-packaged foods sold in Canada. Specific priority food allergens, gluten sources and added sulphites must be declared on food labels, either in the list of ingredients or immediately following the list of ingredients using the format "Contains: [common name of allergen]." Mustard is a new priority allergen.

Priority food allergens in Canada

The foods or protein derived from the foods listed below are priority food allergens:

Gluten sources need to be declared when a food contains gluten protein or modified gluten protein from barley, oats, rye, triticale, or wheat (including kamut and spelt). Health Canada's position on gluten-free claims restricts label statements to products containing less than 20 parts per million (ppm) of any gluten protein, including protein fractions.

Added sulphites need to be declared when directly added to a food, or when the total amount of added sulphites in the food is 10 parts per million or more.

Additional guidance on allergen labelling is available from Health Canada's Food Allergen Labelling web page and CFIA's Enhanced Labelling Regulations for Food Allergens web page.

Precautionary statements

A precautionary statement should only be used when, despite all reasonable measures, the inadvertent presence of an allergen in food is unavoidable. Furthermore, it should not be used unless there is a real risk of the allergen being present in the food. The policy on The Use of Food Allergen Precautionary Statements on Prepackaged Foods recommends that industry use only one set of wording on food labels: "May contain [common name of allergen]".

Foods with added vitamins and minerals

The FDR (Part D) controls the addition of vitamins and mineral nutrients by prescribing which foods may contain added nutrients, and the nutrients and levels allowed; additions not listed in the regulations are prohibited.

However, manufacturers may request that Health Canada allow for the addition of vitamins and mineral nutrients to foods where not currently permitted.

Novel foods, novel fibres and food additives

Novel foods, novel fibres and food additives require a pre-market safety assessment by Health Canada before they can be sold in Canada. Prior to making a submission, industry is encouraged to contact Health Canada's Submission Management and Information Unit (SMIU) to clarify the regulatory requirements.

Novel foods are products that do not have a history of safe use as a food, foods resulting from a process not previously used for food, or foods that have been modified by genetic manipulation (also known as genetically modified foods, GM foods, genetically engineered foods or biotechnology-derived foods).

Novel fibres are ingredients manufactured to be sources of dietary fibre. They are synthetically produced or obtained from natural sources that have no history of safe use as dietary fibre or have been processed so as to modify the properties of the fibre. Fine grinding is no longer a factor in determining whether a product is a novel fibre source. Accepted novel fibres have at least one physiological effect demonstrated by generally accepted scientific evidence. Once a novel fibre source has been accepted by Health Canada, it is considered to be a dietary fibre and should be declared on food package labels as dietary fibre.

Food additives are any substances added to a food for a specific function during manufacturing or processing that become a part of the food or affect the food's characteristics (specific exclusions are outlined in the FDR). Pre-market approval is required for new food additives that are not already regulated in the FDR, and for proposed new uses of an existing food additive.

Submissions for novel foods, novel food processes, food additives and food processing aids that have a demonstrated capacity to enhance microbiological food safety may be given priority.

Nutrition claims permitted in Canada

Several types of nutrition-related claims and declarations can be made in Canada. Many of these relate to the nutrients or nutrient content. For the purposes of food labelling and advertising, Health Canada considers a substance to be a nutrient if it is recognized as such by the United States (U.S.) Institute of Medicine (IOM) of the National Academies. Canada is a participant on IOM committees.

Nutrient content claims

Nutrient content claims describe the quantity of energy or of a nutrient in a food. Only those claims listed in the FDR are permitted. For each claim, the regulations prescribe the compositional criteria, the wording, the reference amount, and any additional labelling requirements.

Quantitative declaration of nutrients and non-nutrients

Simple label declarations of the amount of a food ingredient, component, or food constituent present in a food may be made on a voluntary basis provided the information is truthful and not misleading.

Composition and quality claims

Claims can be made about the composition, quality, or origin of products—such as "organic" or "natural"—as long as they are truthful, not misleading, and in compliance with other regulatory requirements.

Nutrient function claims

Nutrient function claims describe the well-established roles of energy or known nutrients in a food that are essential for the maintenance of good health or for normal growth and development.

Health claims permitted in Canada

A health claim is any representation in labelling or in advertising that states, suggests, or implies that a relationship exists between consumption of a food or food constituent (including an ingredient in the food), and health. Health claims may be stated explicitly with words, or implied through symbols, graphics, logos or other means such as a name, trademark or seal of approval.

Health claims are grouped into several categories based on how they are regulated and evaluated: general health claims, function claims, disease risk reduction claims and therapeutic claims.

All health claims must be truthful and not misleading, and substantiated with scientific evidence before they appear on food product labels or in advertising. For a summary of the types of health claims permitted in Canada, along with requirements for pre-market approval and scientific substantiation, see the table, A Summary of Health Claim Requirements in Canada.

General health claims

General health claims promote health through healthy eating or provide dietary guidance. These claims do not refer to a specific product or to a health effect, disease, or health condition.

An example of acceptable general health claims is:

Function claims

Function claims are health claims that describe the specific beneficial effects that the consumption of foods or food constituents has on the normal functions or biological activities of the body associated with health or performance.

A function claim must not refer directly or indirectly to the treatment, mitigation or prevention of any disease, disorder or abnormal physical state, or of their symptoms. It also may not refer directly or indirectly to correcting or restoring abnormal functions or to modifying organic functions beyond the normal physiological effects of food.

Examples of acceptable function claims include:

Disease risk reduction claims and therapeutic claims

Disease risk reduction claims highlight a specific relationship between a food, a food constituent, or the characteristics of a diet and a reduced risk of developing a diet-related disease or condition. For example, "[naming the food or food constituent] may reduce the risk of cardiovascular disease". Any food that meets the criteria may carry the claim using the prescribed wording for the claim.

Since 2003, Health Canada has allowed disease risk reduction claims that reflect five substantiated relationships:

Therapeutic claims highlight the therapeutic effect of a food, food constituent or diet, including restoring, correcting, or modifying body functions. For example, "[naming the food or food constituent] lowers blood cholesterol". The composition of a food that carries the claim must contribute to a healthy dietary pattern as outlined in the conditions for use.

Health Canada has authorized the use of therapeutic claims on the following food–health relationships:

If a disease risk reduction or a therapeutic claim associates a food as a treatment, preventative or cure for any of the diseases referred to in Schedule A of the Food and Drugs Act, then a regulatory amendment is needed. Otherwise a regulatory amendment may not be required before the claim can be used.

Probiotic claims are claims about live microorganisms in foods which, when administered in adequate amounts, may confer a health benefit (e.g. "promotes regularity" and "improves nutrient absorption and aids in digestion"). Pre-market consultation is recommended for new probiotic claims as there are specific requirements for the safety, quality (stability) and labelling of such food products. The type of claim available will be determined by the scientific evidence.

A Summary of Health Claim Requirements in Canada
Type of ClaimPre-Market ApprovalScientific Substantiation

All Health Claims

  • Any representation in labelling or in advertising that states, suggests, or implies that a relationship exists between consumption of a food, or an ingredient in the food, and health
  • Applies to symbols, graphics, logos, trademarks or seals of approval as well as words
  • All claims must be supported by scientific evidence in a systematic, comprehensive and transparent manner

Nutrient Function Claims

  • Describe well-established roles of energy or nutrients that are essential for maintenance of good health or for normal growth and development
  • Pre-market notification is not required for accepted nutrient function claims listed in GFLA* Chapter 8 (Section 8.6)
  • New nutrient function claims will be considered only for nutrients with established recommended intakes and if the function reflects consensus among authoritative scientific bodies

General Health Claims

  • Broad statements on healthy eating patterns or dietary guidance
  • Do not refer to a health effect, disease, or health condition
  • Pre-market notification is not normally required
  • Statements that imply "healthy choice" or the use of a logo or symbol are subject to review and must not be false, misleading or deceptive

Function Claims

  • Link the consumption of a food or a food constituent with normal body functions or biological activities
  • Based on the role that the food or food constituent plays when consumed at levels consistent with normal dietary patterns
  • A list of acceptable function claims and conditions for use is maintained in GFLA* Chapter 8 (section 8.5)
  • Pre-market notification is recommended for new function claims
  • Evidence should be available upon request

Disease Risk Reduction and Therapeutic Claims

  • Link a food, food constituent, or dietary characteristic to a reduced risk of developing a diet-related disease or condition (e.g. heart disease) or highlight a therapeutic effect, including restoring, correcting, or modifying body functions (e.g. lowering cholesterol)
  • Food must contribute to a healthy dietary pattern
  • The health effect is based on food's normal use as part of the diet
  • A list of claims reviewed by Health Canada for scientific validity is published on Health Canada's Health Claim Assessments web page
  • Conditions of use and prescribed wording apply
  • If a claim associates a food as a treatment, preventative or cure for any of the diseases referred to in Schedule A of the FDA, then a regulatory amendment is needed prior to use
  • If the claim is not subject to Schedule A, then a regulatory amendment may not be required before the claim can be used
* GFLA = CFIA's Guide to Food Labelling and Advertising

Resources

Food regulatory issues division

Health claims, food labelling and advertising

Food additives and novel foods

Food and natural health product classification

Food allergen labelling and gluten-free claims

Health Canada submission management and information unit

Health Canada Submission Management and Information Unit

Email notification lists

Contact us

To learn more about policy and regulatory issues affecting Canada's food industry, visit the Food Processing Innovation and Regulations web collection or contact the Sector Development and Analysis Directorate at aafc.sdad-ddas.aac@canada.ca.


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