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Are You Focused on Allergens? Regulators Are



In our November 7th newsletter, we discussed the manslaughter conviction of two U.K. food business managers for the death of a teen who died from an allergic reaction to food from their restaurant which contained peanut protein – after having informed them of her nut allergy. As just one of at least three recent food allergy-related deaths in the U.K., the government is requesting public comment on “amending allergen information provisions contained within domestic food information legislation for food prepacked for direct sale (PPDS foods).”


The U.K. is proposing four options for response by March 29: one non-regulatory and three regulatory:

  1. Promote best practices in allergen communication by encouraging businesses and consumers to review their allergen knowledge, skills and actions.

  2. Mandate “ask the staff” about allergens labels; when asked, staff would have to provide allergenic information in writing before the food was purchased.

  3. Mandate PPDS labels to include the name of the food and intentional allergenic ingredients.

  4. Mandate PPDS labels have the name of the food and all ingredients, with allergens (or processing aids derived from them still present in food) emphasized (e.g., in a bold).

It is an area on which U.S. food facilities should keep a close eye. Should any of the mandated options be selected for implementation, the U.S. may consider following. While the Food Allergen Labeling and Consumer Protection Act (FALCPA) requires that food labels list ingredients which contain one or more of the major food allergens, the law does not apply to restaurant foods or those “placed in a wrapper or container in response to a consumer's order - such as the paper or box used to provide a sandwich ordered by a consumer.” Additionally, while “FDA advises consumers who are allergic to particular foods to ask questions about ingredients and preparation when eating at restaurants or any place outside the consumer's home,” the U.S. currently has no requirement for any of the proposed U.K. options. In the U.S., risks at the restaurant level are significant and have certainly led to lawsuits against restaurant chains.


Other allergen areas over which the industry should keep watch are those of additions to the regulated list of major allergens, along with any potential threshold determinations.

Currently the U.S. has only 8 allergens that must be declared by law, as opposed to the 10 of Canada and 14 of the U.K. and E.U.:


  • Big 8 Allergens. In the U.S., eight foods, and any ingredient that contains protein derived from one or more of them, are designated as “major food allergens' by FALCPA and must be declared on the label are: Milk; Eggs; Fish (e.g., bass, flounder, cod); Crustacean shellfish (e.g., crab, lobster, shrimp); Tree nuts (e.g., almonds, walnuts, pecans); Peanuts; Wheat; Soybeans

  • Big 10 Allergens. Health Canada requires food manufacturers to clearly label products if they contain one of the government’s priority allergens: peanut; tree nuts; soy; wheat; egg; milk; seafood (shellfish, fish, and crustaceans); sesame; sulphites; and mustard. All priority allergens must be listed on the ingredient list of pre-packaged food, both domestic and imported.

  • Big 14 Allergens. In the European Union and United Kingdom, 14 allergens must be declared: celery; cereals containing gluten (including wheat [such as spelt and Khorasan], rye, barley and oats); crustaceans (such as prawns, crabs and lobsters); eggs; fish; lupin; milk; molluscs (such as mussels and oysters); mustard; tree nuts (including almonds, hazelnuts, walnuts, brazil nuts, cashews, pecans, pistachios and macadamia nuts); peanuts; sesame seeds; soybeans; sulphur dioxide and sulphites (at a concentration of more than ten parts per million). This applies also to the additives, processing aids and any other substances which are present in the final product.

FDA reasoning is that “the eight major food allergens identified by FALCPA account for over 90 percent of all documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.” However, manufacturers who sell internationally need to know the labeling laws of other countries, and all food suppliers should be aware of both consumer advocacy and government agency focused on the adding of allergens, (e.g., gluten and sesame) and the establishing of thresholds.


  • Gluten has long been a focus with FDA and is unique in having a regulatory tolerance level. FDA has held public meetings as far back as 2005, which included an evaluation of FDA's draft report, "Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food." to help FDA develop a regulation to define and permit the voluntary use on food labeling of the term "gluten-free" In 2013, FDA issued a final rule defining “gluten-free” for food labeling.

  • More recently, in October 2018, FDA issued a request for information on the prevalence and severity of sesame allergies in the U.S. for possible regulation require sesame to be labeled as an allergen on packaged foods. Sesame is not currently considered a major allergen and, in some cases, is exempt from being listed by name in the ingredients. The comment period closed in late December, so it will be interesting to follow the outcome.


The establishing of thresholds of major food allergens does not, however, seem to have received as much focus, as the most recent FDA information on the topic is a Q&A written in 2005, with the page last updated in October 2018. In answer to the question whether FDA will establish a threshold level for any allergen, the response remains “FDA may consider a threshold level for one or more food allergens. In the findings from the original report, FDA states that an approach based on statutory exemption could potentially be used to set a single threshold level for proteins derived from any of the major food allergens, but it “might yield thresholds that are unnecessarily protective of public health compared to thresholds established using the safety assessment-based approach or the risk assessment-based approach.” Confirming or requiring that would, however, require additional data and reevaluation as new knowledge, data, and risk assessment tools become available.


What it means to you.

What are the take-aways from all this? I’d say the top consideration is that allergens continue to be a major focus – around the world. With deaths resulting from undeclared allergens – which also is regularly the top reason for food recalls in the U.S. – governments are making their detection and declaration a key focus. Which means you must too. Additionally, with no established threshold, tolerance continues to be “zero tolerance.”


My advice: Consider allergens to be as high risk as pathogens. Require full supplier disclosure; test and hold; check and double check labels; recall immediately if needed; and stay aware of FDA guidance, rulings, and notices on anything allergenic. And subscribe to this e-newsletter for continued information or contact TAG for assistance or consultation.


About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

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