I’m sure you’ve seen an allergen statement on the back of a food package. Something that starts with “Contains” or “Made in a facility that processes.” Allergies are widespread and can be fatal, so today I’ll delve into the regulations and labeling requirements for them.

First off, what exactly is an allergen? It’s a typically harmless substance that triggers an immune system response. Responses range in severity from mild itchiness to fatal anaphylaxis, and usually occur within seconds or minutes after exposure.  When it comes to food, an allergen can be an ingredient or an ingredient that contains a protein derived from something else. Allergens are almost always proteins, so it’s unlikely that you’ll find someone allergic to sugars or fats.

As for policy, the Food Allergen Labeling and Consumer Protection Act (FALCPA) was passed in 2004 and requires the labeling of major allergens in food that contains two or more ingredients. This obviously doesn’t include raw produce, cuts of meat, or much of the food found in the perimeter of a grocery store.

This requirement is carried out by the FDA, the default agency in charge of food safety regulations. Labeling is mandated for eight major allergens: cow’s milk, eggs, fish, shellfish, peanuts, tree nuts, wheat, and soybeans. It’s voluntary for anything else.

While this may seem like a simple list, there are nuances which make it more complicated. Milk, eggs, peanuts, wheat, and soybeans are pretty straightforward. However, fish, shellfish, and tree nuts refer to food groups rather than specific ingredients and so have further clarifications.

For each of these three categories, the species or specific type must be declared. Fish and shellfish must be labeled with the common market name, which can be found on the Seafood List. Shellfish is further categorized into Crustacean and Molluscan. Crustacean shellfish, like lobster and shrimp, must be labeled. Molluscan shellfish, like oysters and mussels, are not considered major allergens and are exempt. The Seafood List designates Crustaceans, so if you have an allergy, you can always take a look and see if labeling is required. Like fish and shellfish, tree nuts must be labeled with their common name, which can be found here. Most people are allergic to specific tree nuts, like cashews or pecans, but not all of them.

Food manufacturers have two options on how to label these allergens. They can simply be in the ingredient list or they can be in a “Contains” statement, which can’t be in smaller font than the ingredients. Statements starting with “May contain” or “Processed in a facility that processes” are advisory statements that are not regulated by FALCPA. Some food manufacturers voluntarily put this on the label because unintended cross-contact can cause allergic reactions.

The FDA doesn’t have a threshold or lower limit for allergens. This means that an allergen must be labeled if it can be detected, regardless of processing method and even at low levels that may not elicit an allergic response.

The 8 major allergens account for 90% of all food allergies, though more than 170 foods can cause allergic reactions. With such a high number, it’s not feasible to mandate labeling of all possible allergens. As you can probably guess, labeling is not consistent worldwide. Canada, the EU, Australia, and New Zealand mandate labeling of gluten, Molluscan shellfish, sesame, and sulfite in addition to the eight mentioned above. Much of Central and South America require labeling of gluten and sulfites in addition to the major 8. Japan requires labeling of seven known allergens and recommends the disclosure of an additional 20.

Allergen labeling requirements are constantly being revisited, with this year as no exception. The FDA is considering regulations on labeling for sesame. The agency is taking comments until the end of the year. I’ll post the comment link in the Important Dates section as well.

Image by: Brett Hondow


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Superb post but I was wondering if you could write a little more on this subject? I’d be very thankful if you could elaborate a little bit further. Cheers!

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