The Challenges of Allergen-Free Claims on Labels

Consumer desires for simple, less processed, “natural” food products have led to the current increased popularity of “clean label” foods. Part of this trend includes the use of “free-from” labeling, pertaining to genetically modified components, gluten, allergens, or other attributes.

While generally appealing, free-from allergen claims can be particularly challenging because these foods especially appeal to consumers with food allergies who are at risk of suffering adverse reactions if these label claims are false or misleading. Free-from allergen claims, with the exception of gluten free, have no regulatory basis for, or even industry consensus on, what “allergen free” actually means. The potential for immediate, severe health impacts from incorrect allergen labels raises the bar for decisions about using such claims.

Because free-from allergen claims are not regulated, food companies may voluntarily choose to use such label statements. Sometimes, application of such claims is simple, e.g., canned tomato paste is probably, and always has been, peanut free and gluten free. But, if breaded tomato products are made in a shared facility with the tomato paste, then the decision becomes more complex. Our goal is not to advocate for or against the use of free-from allergen claims but instead to raise awareness of the issues that must be examined as the use of such claims is considered.

Food Allergy

Food allergy prevalence estimates vary but could be as high as 10% in the U.S., EU, Canada, Australia, and New Zealand. The prevalence of food allergies is unknown in many other parts of the world but is likely growing worldwide. Food allergy is typically controlled by avoidance, with many countries requiring the labeling of major allergenic foods by law. The lists of major allergenic foods vary among countries, but it is important to note that the allergenic foods that require labeling are not the only foods that may be allergenic. In the U.S., labeling of the “Big 8” allergenic foods is commonly thought to cover 90% of all food allergies in the country. Legislation requires labeling the presence of particular identified foods in a defined fashion but does not give guidance for indicating absence, or free-from-type claims. One exception is gluten free, which does have a regulatory definition. Gluten-free foods have been marketed for decades before the establishment of the regulatory definition, while other terms that have also been used for decades, such as “dairy free,” have no regulatory definition. However, recent dietary trends have precipitated a rise in the use of free-from-type claims for food allergens, including gluten free and dairy free.

Free-From Claims for Food Allergens

A number of free-from claims have gained in popularity in the U.S., EU, and elsewhere. Some claims are more definitive than others. Here, we list examples of some claims that are found in the marketplace, along with a few observations. Although such label claims are not regulated, they must not be false or misleading.

Free-from (specific allergen) (e.g., ‘peanut free’). Given the need, under law and regulation, that certain allergens be labeled, the free-from claim implies additional precautions were taken to ensure the allergen indicated is not present. While the degree of care needed to support a free-from claim is not specified, prudent precautions might include assurance or testing to indicate that no ingredients contain the allergen, an absence of cross-contact risk if the allergen exists in the manufacturing facility, and the lack of agricultural comingling with the allergen.

Allergen free or free from allergens. In the absence of other information, these terms imply the absence of any risk of allergic reaction from any source. In current practice, corporate definitions might be restricted to absence of any major allergen, such as free of the Big 8. As discussed above, many foods not on the Big 8 list of allergens may cause allergic reactions. Thus, a corporate definition of the meaning of allergen free is recommended. Generic allergen-free claims are not allowed in Canada.