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FARE Blog March 20, 2018

This Blog Post May Contain: Food for Thought About Precautionary Allergen Labeling

If you’re managing food allergies, you’ve probably encountered precautionary allergen labeling. After you’ve carefully read the ingredients list and any “Contains” statement, you might also find suggestions that other ingredients – allergens – are hiding in the package.


If you’re managing food allergies, you’ve probably encountered precautionary allergen labeling. After you’ve carefully read the ingredients list and any “Contains” statement, you might also find suggestions that other ingredients – allergens – are hiding in the package:

“May contain…”

“May contain traces of…”

“Manufactured in a facility that processes…”

“Made on shared equipment with…”

What do these warnings mean? Do the different wordings represent different amounts of possible allergen, or different likelihoods of allergen cross-contact? Is a product that lacks a warning safer than a product that carries a warning? A 2018 clinical commentary review in the Journal of Allergy and Clinical Immunology: In Practice highlights how confusing these precautionary allergen labels can be and suggests a more standardized and regulated approach.

As food allergy prevalence and awareness increased during the past two decades, governments first made recommendations for allergen labeling and later established regulations and laws that mandate the labeling of certain allergens. These laws apply to intentional ingredients. Among foods that are regulated by the U.S. Food and Drug Administration (FDA), the labeling of eight major allergens is regulated by the Food Allergen Labeling and Consumer Protection Act (FALCPA).

By contrast, precautionary labels that warn about unintentional inclusion of allergens are voluntary and not regulated. Laws do not require these statements or govern how they are worded. FDA advises only that precautionary allergen labeling “should not be used as a substitute for adhering to current Good Manufacturing Practices” and “must be truthful and not misleading.”

In North America, the wording of precautionary labeling is not based on the amount of allergen present. This is widely misunderstood in the food allergy community. A 2016 FARE-funded study found that 37 percent of consumers managing food allergy assume that the wording of precautionary allergen labels reflects the risk of allergen cross-contact. Forty-one percent of the survey respondents reported that they sometimes or always buy foods “manufactured in a facility that also processes” allergen, whereas only 11 percent bought products that “may contain” allergen.

The 2018 commentary review presents data from analytical surveys of products from the U.S., Australia and various European countries. These surveys included foods both with and without precautionary allergen labeling. These comparisons reveal several key points:

  • Some products without precautionary labeling do contain detectable allergen. For processed foods typically made on shared equipment, foods that aren’t labeled with an allergen precaution are almost as likely to contain detectable food allergen as are foods that carry a warning label.
  • Many products with precautionary allergen labeling do not contain detectable allergen. Among processed foods that carry precautionary labels, products manufactured in continental Europe are more likely to contain detectable allergen than are products manufactured in the UK, Ireland, Australia or the U.S.
  • Dark chocolate frequently contains traces of milk, regardless of whether it carries a precautionary label. This is because the same equipment is often used to manufacture dark and milk chocolates, and cleaning the equipment with water could encourage the growth of bacteria. The commentary recommends that individuals with milk allergy avoid dark chocolate unless they know that the products are made on dedicated, milk-free equipment.
  • Oats and oat products that aren’t labeled as gluten-free frequently contain gluten proteins from a top eight allergen – wheat – or from the related grains, barley and rye. This reflects agricultural processing practices in which cereal crops are comingled.
  • As the technology for detecting allergens improves, more and more foods will be found to contain detectable levels of allergens. Foods that are positive for detectable allergen when tested using one brand of test kit can yield negative results, with no allergen detected, when tested with a different kit.

Like precautionary allergen labeling, “free-from” labeling is voluntary and often misunderstood by consumers. The commentary notes that in many countries (including the U.S.), packaged foods bearing a gluten-free label are required to contain less than 20 parts gluten per million, although some packaged foods that are labeled gluten free have been found to exceed this threshold. Members of the food allergy community should know that other free-from labels, such as “peanut free,” “nut free” or “dairy free,” are not regulated or associated with specific allergen thresholds. There is no requirement that foods with free-from labeling be made on dedicated equipment or in a dedicated facility. And, remarkably, the regulated term “non-dairy” applies to some products that contain milk ingredients. For example, many non-dairy creamers contain caseinate, a milk protein that consumers with milk allergy should avoid. FARE recommends that consumers contact the manufacturer if they are unsure about the contents of any packaged food.

Avoiding foods with precautionary allergen labeling can add to the challenges of food allergy management by costing more time and money while further limiting choices. This makes unnecessary warning labels burdensome. As a result, many people managing food allergies ignore some or all precautionary allergen labeling, including a majority of young adults, according to a 2006 U.S. survey. In a 2010 Canadian survey, 8 percent of 651 individuals who reported reactions to packaged food indicated that the package included precautionary allergen labeling. The recent review mentions a fatality in Poland, reported to result from reaction to a chocolate bar with precautionary labeling for peanut. While tragedies like this are rare, FARE is aware of at least one other fatality in the past several years reportedly attributed to cross-contact.

Still, with the exception of dark chocolate for milk-allergic individuals, the 2018 commentary does not take a position on whether individual allergy patients should avoid products that carry precautionary labels for their allergens. This differs from advice offered by FARE. Your Food Allergy Field Guide, FARE’s resource for newly diagnosed patients, notes that most allergists recommend against consuming foods with precautionary allergen labeling. FARE concurs with this opinion.

The 2018 commentary review explains and recommends the global adoption of a risk-based approach to precautionary labeling developed by the non-governmental Allergen Bureau in Australia and New Zealand. The VITAL (Voluntary Incidental Trace Allergen Labeling) program is a collaboration between scientists and food manufacturers. VITAL uses clinical data from oral food challenges to calculate population thresholds (also called Reference Doses), levels of allergen to which less than 5 percent (or 1 percent, high-quality data permitting) of allergic individuals are predicted to react. The consensus study published in 2016 by the National Academies of Sciences, Engineering and Mathematics recommends the development of a similar approach in the U.S.

As stated in a June 2016 press release, FARE has recommended to the FDA that it not establish a threshold for any food allergen unless the FDA is in possession of reliable scientific data that clearly identifies a quantity of the allergen that is so small that it will not cause an allergic reaction in even the most sensitive individuals, and also a reliable analytical method for determining compliance with the threshold that can be easily used by food companies and the FDA.

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