New allergen rules came into effect August 4, 2012, changing the rules on required disclosure on labelling of priority allergens, as well as gluten sources. As part of the regulatory amendments, the definition of "gluten" was revised. The Food and Drug Regulations (FDR) in Section B.24.018, now states that:
It is prohibited to label, package, sell or advertise 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, referred to in the definition "gluten" in subsection B.01.010.1(1).
The FDR specifies the meaning of "gluten" in Section B.01.010.1(1) as:
(a) any gluten protein from the grain of any of the following cereals or the grain of a hybridized strain created from at least one of the following cereals:
(iv) triticale, or
(v) wheat, kamut or spelt; or
(b) any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the cereals referred to in subparagraphs (a)(i) to (v) or the grain of a hybridized strain referred to in paragraph (a). (gluten)
In June, 2012, both the Canadian Food Inspection Agency (CFIA) and Health Canada released statements on "Gluten Free" claims. The CFIA enforcement policy can be found at: http://www.inspection.gc.ca/food/labelling/other-requirements/gluten-free-claims/eng/1340194596012/1340194681961; the Health Canada “Position on Gluten-Free Claims” can be found at: http://www.hc-sc.gc.ca/fn-an/securit/allerg/cel-coe/gluten-position-eng.php.
Health Canada Position
The Health Canada; position explains the circumstances in which a food may be labelled as "gluten free", as well as the labelling requirements for intentionally added gluten, stating that:
"Based on the available scientific evidence, Health Canada considers that gluten-free foods, prepared under good manufacturing practices, which contain levels of gluten not exceeding 20 ppm as a result of cross-contamination, meet the health and safety intent of B.24.018 when a gluten-free claim is made.
Based on the enhanced labelling regulations for allergens and gluten sources, any intentionally added gluten sources, even at low levels (e.g. wheat flour as a component in a seasoning mixture which makes up a small proportion of the final food), must be declared either in the list of ingredients or in a "Contains" statement. In these cases, a gluten-free claim would be considered false and misleading. If, however, a manufacturer using a cereal-derived ingredient includes additional processing steps which are demonstrated to be effective in removing gluten, then the food may be represented as gluten-free."
In terms of the scientific evidence, relevant to the level of tolerance, Health Canada has explained its position as follows:
"While additional evidence is being gathered to support the establishment of a regulatory 20 ppm threshold for Gluten free claims, including the development of an accepted standard reference material for Gluten, Health Canada is of the position that at levels not exceeding 20 ppm of gluten as a result of cross-contamination, when Good Manufacturing Practices are followed, a claim suggesting the food is gluten-free would not pose a health risk to individuals with celiac disease and would meet the intent of B.24.018 of the FDR. This would be in keeping with the availability of validated methods (and their associated limitations, as outlined above), and would be consistent with the approach being taken internationally."
CFIA Compliance and Enforcement Statement
The CFIA has signalled that it considers a 20 ppm level of gluten as the enforcement level for products labelled "gluten free", where the gluten is present by virtue of cross-contamination:
"Any gluten that is present due to cross-contamination in a food labelled gluten-free should be as low as reasonably achievable and must not surpass 20 ppm of gluten, a level that is considered protective for the majority of people with Celiac disease.
Manufacturers and importers of gluten-free foods are expected to make every reasonable effort to minimize gluten present through cross-contamination. In instances where the gluten is present due to cross contamination at a level of less than 20 ppm in the food, the CFIA will follow up with the manufacturer or importer regarding the presence of gluten in the product. These manufacturers and importers should have good manufacturing/importing practices (GMP/GIP) in place to achieve the lowest levels of gluten possible to avoid cross-contamination. However, based on Health Canada's position, enforcement action on products containing less than 20 ppm gluten as a result of cross-contamination will not include a recall of the product, nor a request to remove the gluten-free claim.
In all instances, regardless of source, if more than 20 ppm of gluten is present in a food labelled as gluten-free, the product may be in violation of the FDR Section B.24.018 and/or Section 5.1 of the Food and Drugs Act (FDA) and, on the basis of a health risk assessment provided by Health Canada, subject to appropriate enforcement action by the CFIA, which may include the possibility of recall."