Allergen-free, gluten-free and cross contamination statements
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.
- 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 Facts table (NFt) still apply when a food is represented as "gluten-free". For information regarding exemptions from nutrition labelling requirements, see Reasons for losing the exemption.
For more information on gluten-free claims, please see Health Canada's position on gluten-free claims.
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 & triticale – 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.
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.
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 CFIA will object to the use of a "gluten-free" claim on beers produced from one of these grains [B.01.010.1(1), FDR]. 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. No part of this statement shall be emphasized or repeated anywhere on the label. When beer labels bear claims such as "crafted to remove gluten," "deglutenized," "deglutinized" or any equivalent statements that emphasize the removal of gluten from the product, they imply that the beer is either "low in gluten" (which is a non-permitted claim) or "gluten-free." These types of claims may lead consumers to believe that gluten has been removed to a safe level when current analytical testing methods may not be able to detect gluten protein fragments still present in beer after additional processing has occurred.
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 CFIA do 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.
Gluten-free and vodka
Vodka distilled from gluten containing grains
It is the position of Health Canada and the CFIA that vodka made from gluten containing grains and processed by fractional distillation are considered "specially processed or specially formulated" to remove gluten, and therefore meet the intent of Division 24 of the FDR in protecting the health and safety of people with Celiac disease.
A gluten-free claim can be made on vodka distilled from gluten-containing grains if the following conditions are met:
- the residual gluten protein level in the finished product is less than 20 ppm and the manufacturer or importer has available documentation showing that the gluten protein in the finished product is less than 20 ppm
- the product meets the requirements for Division 24 of the Food and Drug Regulations (FDR) with regards to vodka that have been either specially processed or formulated to remove gluten
Flavoured vodka may not qualify for the claim as flavouring preparations and other ingredients added after the distillation may be derived from gluten-containing grains and would therefore not meet the second criterion listed above.
Qualifying statements are not required for gluten-free claims on vodka and could be considered misleading to consumers if they create a false impression that all vodkas, including flavoured vodkas, are gluten-free [6(1), SFCA; 5(1), FDA]. For more information on CFIA's guidance on accompanying qualifiers, see the policy on false uniqueness under Negative claims pertaining to the absence or non-addition of a substance.
Vodka distilled from non-gluten containing material of agricultural origin
A gluten-free claim can be made on vodka fractionally distilled from non-gluten containing material of agricultural origin (definition) as long as good manufacturing practices have been followed to reduce the inadvertent presence of gluten levels below 20 ppm. These vodkas are considered "specially formulated" according to Division 24 of the FDR and do not contravene section B.24.018 of the FDR. Nonetheless, documentation should be available to prove that the finished product is in fact gluten-free (i.e., below 20 ppm).
It is the manufacturer’s responsibility to ensure that their products will not present a health risk to consumers, particularly products marketed to individuals with special dietary needs. Regulated parties are also responsible for ensuring that sufficient testing and processing controls are in place to consistently produce gluten-free products, like vodka, that meets all regulatory requirements when making a gluten-free claim.
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