Allergen-Free, Gluten-Free and Precautionary Statements

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Table of Contents

Overview

All aspects of food labels and advertisements are considered in the overall impression attributed to food products. Allergen-free, gluten-free and precautionary statements that appear on food labels or advertisements contribute toward this overall impression. For this reason these types of claims are also subject to the General Principles for Labelling and Advertising.

If a food-allergen or gluten source is present in a prepackaged product that is required to carry a label, it must be declared on the label. This does not include cases where the presence of food allergens or gluten is a result of cross-contamination. Refer to List of Ingredients and Allergens for more information.

Gluten-Free Claims

A gluten-free claim is any representation in labelling or advertising that states, suggests or implies that a food is free of gluten. In order for a food to be represented as "gluten-free", it must comply with section B.24.018 of the Food and Drug Regulations (FDR). Claims to the effect that a food does not contain an ingredient or substance must be factual and not misleading.

Section B.24.018 of the FDR prohibits the labelling, packaging, advertising or sale of a food in a manner likely to create an impression that it is a gluten-free food if the food contains any gluten protein or modified gluten protein, including any gluten protein fraction, from wheat, oats, barley, rye, triticale or their hybridized strains.

Examples:

  • Battered fish that is formulated to use batter and other ingredients that do not contain gluten, and processed in such a way to meet the specifications of FDR B.24.018, may be labelled "gluten-free".
  • Rice flour, which is a food that in the absence of specific processing controls may be cross-contaminated with gluten, may be represented as "gluten-free" when it meets the specifications of FDR B.24.018

Although Health Canada's regulatory requirements for "gluten-free" foods do not refer to any specific threshold for gluten in products represented as "gluten-free", Health Canada considers that levels of gluten protein below 20 ppm generally do not represent health risks to consumers with celiac disease. The Canadian Food Inspection Agency (CFIA) has published a position on the Compliance and Enforcement of Gluten-Free Claims that reflects the Health Canada position, and takes into account whether gluten is present due to intentional addition or to cross-contamination.

There are no regulatory requirements prescribing that dedicated facilities must be used in the production of gluten-free foods. Regulated parties are responsible for ensuring that sufficient processing controls are in place to consistently produce gluten-free foods that meet all regulatory requirements.

A gluten-free claim is not considered to be a representation about particular nutritional or health-related properties on its own. Any exemptions from displaying a Nutrition Fact Table still apply when a food is represented as "gluten-free". For information regarding exemptions from nutrition labelling requirements, see Reasons for Losing the Exemption.

Gluten-Free versus Wheat-Free

A "gluten-free" claim cannot be used interchangeably with a "wheat-free" claim. Gluten can be present in products that do not contain wheat. Gluten is present in wheat (including spelt and kamut), oats, barley, rye and triticale. Individuals with a wheat allergy react to wheat gluten proteins, as well as other proteins present in wheat. Individuals with celiac disease, an autoimmune disorder among genetically susceptible individuals, experience adverse symptoms when exposed to gluten from any of the sources listed above. "Gluten-free" claims must follow the requirements outlined above.

Products with "wheat-free" claims must follow the requirements in "(Naming the Food Allergen)-Free" Claims. For more information on wheat allergies, refer to Wheat – one of the ten priority food allergens.

Gluten-Free and Oats

Health Canada has published a position indicating that the majority of people with celiac disease can tolerate uncontaminated oats, which are oats that have been specially produced to ensure they do not contain more than 20 ppm of gluten from wheat, rye, barley, or their hybridized strains. In order to facilitate the ability for individuals to clearly identify uncontaminated oats, Health Canada has created a Marketing Authorization that allows gluten-free oats, and foods made using gluten-free oats as ingredients, to be labelled as 'Gluten Free'. The criteria for gluten-free oats to carry this claim and requirements regarding how gluten-free oats are declared on labels are outlined in Health Canada's guidance document on Gluten-free labelling claims for products containing specially produced "gluten-free oats".

Regular oats not meeting the criteria of the Marketing Authorization would continue to be included in the list of gluten grains in section B.01.010.1(1) of the Food and Drug Regulations. Therefore, "gluten-free" claims are not permitted on regular oats or products containing these oats.

For more information, see Health Canada's Position on the Introduction of Oats to the Diet of Individuals Diagnosed with Celiac Disease (CD).

Gluten-Free and Canary Seed

Health Canada has issued a novel food decision permitting the sale of glabrous (hull) varieties of brown and yellow coloured canary seed (Phalaris canariensis L.). Canary seed itself does not contain gluten and may be represented as gluten-free if it meets the requirements outlined above. However, canary seed does contain other proteins that may be similar to those proteins responsible for wheat allergies. For this reason, Health Canada requires canary seed and foods containing canary seed to be labelled with a statement to the effect that the product "may not be suitable for people with wheat allergy." Please note that this statement should not be used when the food also contains wheat as an ingredient; in this situation, the addition of wheat must be declared in accordance with allergen labelling requirements. For more information see Health Canada's Information for Wheat-Allergic Individuals - Canary Seed.

Quantitative Statements

There is no prohibition against making quantitative statements about the amount of gluten in a food, such as "contains less than 5 ppm gluten". Such statements must be truthful and not misleading, and as such, the actual level in a food must not exceed the declared level. The method of analysis used to generate a quantitative value must be appropriate for the product involved. For example, R5 Enzyme Linked Immunosorbent Assay (ELISA) type gluten methods are not suitable for hydrolyzed, fermented or enzymatic processed food products.

Low Gluten or Reduced Gluten Claims

"Low gluten" or "reduced gluten" claims are not acceptable in Canada, including in relation to foods containing less than 20 ppm of gluten. These claims are considered to be misleading, as consumers with celiac disease may be led to believe that these foods are safe to consume, while medical advice recommends a gluten-free diet.

Gluten-Free Beer

Made from Gluten Containing Grains

It is the manufacturer's responsibility to ensure that their products will not represent a health risk to consumers, particularly those marketed to individuals with special dietary needs. Based on a position provided by Health Canada that there is uncertainty around the complete removal of gluten from beer or beer-like products made using barley, oats, rye, triticale, wheat or their hybridized strains, the CFIAwill object to the use of a "gluten free" claim on beers produced from one of these grains [B.01.101.1(1)]. Although additional processing steps in the beer making process can be taken to remove gluten, results from currently available analytical testing methods for gluten, including ELISA tests, are not sufficient to substantiate a 'gluten free' claim on these products.

However, Health Canada and the CFIA do not object to the use of the statement "This product is fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten". In this case manufacturers must be prepared to provide evidence to substantiate their claim, including a detailed description of the method used to remove gluten from the product, appropriate gluten assay results for the finished product, and the name and the manufacturer of the assay.

Made from Non-Gluten Containing Grains

It is the manufacturer's responsibility to ensure that their products will not represent a health risk to consumers, particularly those marketed to individuals with special dietary needs. Health Canada and the CFIAdo not object to the use of a "gluten free" claim on a beer-like product derived from a non-gluten grain if it meets the requirements outlined for "gluten free" claims. This includes ensuring that all ingredients used in the manufacture of the product are gluten free and that there is no cross-contamination with gluten containing ingredients during processing.

Fortification of Gluten-Free Foods

Section D.03.003 of the FDR allows the fortification of gluten-free foods that:

  • are foods for special dietary use – meaning foods that have been specially processed or formulated to meet the requirements of B.24.018 of the FDR;
  • do not have a standard prescribed in the Regulations, and
  • are not advertised to the general public

The intent of this regulation is to allow flour replacements such as soy flour to be fortified. Foods that are inherently "gluten-free" may not be fortified under this provision, even if they are unstandardized.

Examples:

  • It is acceptable to fortify gluten-free crackers to replace the nutrients that would have been in enriched wheat flour, when wheat ingredients are replaced with a gluten-free substitute. Crackers are not standardized foods.
  • Although it is possible to label a salad dressing product as a "gluten-free" food when it processed and formulated to replace any gluten ingredients and components provided for in the standard (FDR B.07.042), salad dressing may not be fortified since it is a standardized food.

Health Canada does not specify fortification levels, nor specific nutrients that may be added to gluten-free foods that may be fortified. However, as a general rule, fortification of gluten-free foods should be done to achieve levels of enrichment equivalent to those required in flour, and corresponding to the amount of flour replaced. Companies that are considering fortification beyond the nutrients and amounts permitted for flour should contact Health Canada for advice. Over-fortification that poses a health risk may be subject to enforcement action by the CFIA.

A product is considered to be a food for special dietary use with respect to the absence of gluten when it is a type of food that could otherwise contain gluten, due to product formulation or cross-contamination, but for which the manufacturing process or formulation has been modified to remove the gluten. Foods that are inherently gluten-free are not considered foods for special dietary use for this purpose.

Advertising of Gluten-Free Foods to the General Public

Gluten-free foods fortified according to the provisions of section D.03.003 of the FDR may not be advertised to the general public. These fortified foods may be sold at retail but may not be advertised by the store or the manufacturer to the general public. They may be advertised in magazines, newsletters and other materials targeted to individuals with celiac disease and/or to those who are on gluten-restricted diets.

Note: Other foods labelled as gluten-free (those that are not fortified or those fortified in accordance with FDR D.03.002) may be advertised to the general public.

Food Allergen Precautionary Statements

A food allergen precautionary statement is a declaration on the label of a prepackaged food of the possible inadvertent presence of an allergen in the food. Precautionary statements are made by food manufacturers and importers on a voluntary basis and are appropriate when, despite all reasonable measures, the inadvertent presence of allergens in food is unavoidable. Precautionary statements are not a substitute for Good Manufacturing Practices.

Precautionary labelling must not be used when an allergen or allergen-containing ingredient is deliberately added to a food – in such cases, mandatory food allergen and gluten declaration is required.

Like all labelling statements, precautionary statements are subject to subsection 5(1) of the Food and Drugs Act (FDA) and must be truthful and not misleading.

There are no regulations stipulating the wording and location of precautionary statements. However, for consistency in interpretation and understanding, Health Canada and the CFIA recommend that food manufacturers and importers use only the following precautionary statement on food labels:

"may contain [X]"

where X is the name by which the allergen is commonly known. This is a recommendation and industry best practice.

Additionally, it is a best practice to place precautionary statements in the location on the label where the affected consumers will be looking for allergen information. Therefore, precautionary statements are best placed after any allergen "contains" statement, or if there isn't one, immediately after the list of ingredients.

For more information on precautionary statements please see Health Canada's Use of Food Allergen Precautionary Statements on Prepackaged Foods.

Precautionary Labelling of Food Ingredients

Health Canada has published information for Canadians with mustard allergy that clarifies that it is not a requirement to carry over precautionary labelling on ingredient labels to the label of end food products made with those ingredients. This is a manufacturer or importer's decision, made in consideration of whether the end product poses a potential health risk to an allergic consumer. While the Health Canada information above was developed for mustard which may be inadvertently present in cereal grain flours, the same principles may be used to assess whether other precautionary allergen statements should be carried over to the end food product.

Regulated parties are responsible for the safety of their products, including addressing potential risks associated with the presence of allergens. Options to achieve this may include (but are not limited to);

  • Putting production system or process controls in place,
  • Performing sampling of end product for allergen presence,
  • Working with suppliers on ingredient specifications, and
  • Carrying over precautionary labelling to final products intended to be sold at retail.

During inspections, CFIA inspectors may request information from manufacturers or importers to demonstrate how potential health risks to allergic consumers are being addressed.

Allergen-Free Claims

"(Naming the Food Allergen)-Free" Claims

Manufacturers making a negative statement or claim pertaining to the absence of food allergen sources such as "(naming the food allergen)-free" and "contains no (naming the food allergen)", must ensure there is absolutely no amount of the named food allergen source present in the product, whether through intentional or inadvertent means.

These claims are permitted on foods that have been specially formulated or are processed under special conditions to ensure the absence of the named food allergen source that may be present in a similar food. The presence of that food allergen source may be in similar products through:

  • addition via ingredients or multi-generational ingredients; and/or
  • cross contamination despite good manufacturing practices

Regulated parties may be asked by the CFIA to demonstrate that production systems or process controls are in place to substantiate that the claim does not mislead the consumer as to the safety of the food for consumers for whom the consumption of the named allergen would pose a potential health risk.

See Negative Claims Pertaining to the Absence or Non-Addition of a Substance for more information on claims like dairy-free and lactose-free.

Allergen-Free Claims in Conjunction with Precautionary Labelling

It is not acceptable for a "(naming the allergen)-free" claim to be used in conjunction with a "may contain (naming the same allergen)" statement on the same product. The combination of these two claims is considered to be misleading as to the composition of the food. Furthermore, it is not possible for both statements to be truthful on a single product.

There may be situations where both a "(naming the allergen)-free" statement and other types of precautionary statements (other than the "may contain" statement could be truthful at the same time. For example, it is possible that both a "soy-free" claim and "produced in a facility that also processes soy" statement could be true for a single product. In such situations, it is important to note that in no way does a precautionary allergen statement or other similar types of statements reduce a regulated party's responsibility for the accuracy of a "(naming the allergen)-free" claim. A false or inaccurate "(naming the allergen)-free" claim may be subject to enforcement action by the CFIA, regardless of whether a precautionary statement is also present.

The use of a "gluten-free" claim in conjunction with a "may contain wheat" statement, while possibly factual, should be done with caution. It is understood that "may contain wheat" could alert individuals with a wheat allergy to the presence of low levels of wheat in a gluten-free food. However, manufacturers must ensure that the product contains no intentionally added gluten sources and less than 20 ppm of gluten as a result of cross-contamination on a consistent basis, and that the other criteria for "gluten-free" claims outlined above are also met. In this instance, manufacturers are encouraged to use the statement "may contain less than 20ppm of wheat". For information on Gluten-Free claims, refer to Gluten-Free Claims.

General "Allergen-Free" or "No Allergens" claims

General claims stating only "Allergen Free" or "No Allergens" are considered to be too broad in nature and are therefore not acceptable. The list of potential food allergen sources is not restricted to the list of priority food allergens identified by Health Canada. There are over 200 food proteins that can cause adverse reactions to some segments of the population. Therefore, it is likely to create an erroneous impression to state that a product is free of allergens.

"(Naming the Food Allergen Source)-Free" Symbols

Any representation (statement, image or advertising) that states, suggests or implies that a food allergen source is not present when it is present would be considered false and misleading information under subsections 5.(1) of the Food and Drugs Act and 7.(1) of the Consumer Packaging and Labelling Act. (Naming the food allergen source)-free symbols or representations are interpreted to be the same as making a "(naming the food allergen source)-free" claim. Therefore, the same requirements apply when using such symbols or images.

It is important that such symbols or images indicate what is absent in the product. It is recommended that clarifying text, such as a "(naming the food allergen)-free" statement, accompany the symbol to ensure the symbol or image is not misinterpreted.

Wheat-Free Claims on Products Containing Canary Seed

Health Canada has issued a novel food decision permitting the sale of glabrous (hull) varieties of brown and yellow coloured canary seed. Canary seed contains proteins that may be similar to those proteins responsible for wheat allergies. For this reason, Health Canada states that it would be inappropriate for canary seed, or food containing canary seed, to carry a wheat-free claim. For more information see Health Canada's Information for Wheat-Allergic Individuals - Canary Seed.

"Does Not Contain Nuts" Claims on Products Containing Coconut

Products containing coconut can declare "does not contain tree nuts or peanuts". Coconut must be declared in the list of ingredients as per general labelling requirements.

Additional Information

Information Letters/Policy Updates

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