4 Food Allergens Proposed to Be Added to the Mandatory Labelling of Foods List

In a new study, investigators identified 8 foods frequently involved in food-induced anaphylaxis that are not currently listed in the European regulation and proposed 4 that should be added to the list: goat’s and sheep’s milk, buckwheat, peas-lentil, and pine nut.1

Other identified food allergens included alpha-gal, kiwi, beehive products, and apple. The investigators proposed adding only 4 foods to the list, given their frequency, severity, recurrence, and potential for hidden exposure.

“In our series of nearly 3,000 food anaphylaxis cases, 413 were caused by one of these eight ‘emerging food allergens’ without mandatory labelling, with 2 deaths,” said corresponding author Dominique Sabouraud-Leclerc, MD, of CHU Reims, in France.2"We therefore believe it is time to review the list of the 14 foods with mandatory labelling to include at least the most severe of these emerging food allergens."

Anaphylaxis, a potentially life-threatening allergic reaction, has a global incidence between 50 and 112 episodes per 100,000 person-years, with an estimated lifetime prevalence of 0.3 – 5.1%.3 The Allergy & Asthma Network stated that 1 in 20 Americans have experienced anaphylaxis, and approximately 225 Americans die from anaphylaxis each year.4

The Food Allergen Labeling and Consumer Protection Act of 2024 identified 8 foods as major food allergens, including milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. More recently, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law in 2021, declaring sesame as the 9th major food allergen. The US Food & Drug Administration (FDA) requires labeling for all major food allergens.5

When it comes to Europe, the European Food Safety Authority (EFSA) requires 14 food allergens to be labeled: cereals containing gluten (wheat, rye, barley, oats), crustaceans (crabs, prawns, lobsters), eggs, peanuts, soybeans, milk, nuts (almonds, hazelnuts, walnuts, cashews, pecan nuts, brazil nuts, pistachio nuts, macadamia/Queensland nut), celery, mustard, sesame seeds, Sulphur dioxide and sulphites used as a preservation (10 mg/kg or 10 mg/L), lupin, and molluscs (mussels, oysters, squid, snails).6

Investigators, led by Sabouraud-Leclerc and Delphine Mariotte, both from the Allergy-Vigilance Network in France, analyzed food-induced anaphylaxis cases reported to the Allergy Vigilance Network from 2002 to 2023.1 The team assessed the frequency, severity, recurrence, and potential presence in hidden form to determine which allergens should be added to EFSA’s list. They considered emerging food allergens involved in ≥ 1 anaphylaxis case that are not currently on the EFSA food allergen list.

After exclusion criteria, the study included 413 cases of anaphylaxis. The following 8 foods induced anaphylaxis: goat and sheep milk (2.8%), buckwheat (2.4), peas and lentils (1.8%), alpha-gal (1.7%), pine nut (1.6%), kiwi (1.5%), beehive products (1%), and apple (1%).1

“Eight foods or food groups not included in the [Mandatory Labelling of Foods] list were responsible for 1% or more of all [food-induced anaphylaxis] recorded by the [Allergy-Vigilance Network] from 2002 to 2023,” investigators wrote.1 “Their frequency is higher than that of the two least frequent [Mandatory Labelling of Foods], mustard and sulphites.”

Severe reactions, defined as Ring grades 3 and 4, were reported with goat and sheep milk (46.8% and 4.8%, respectively), resulting in 2 deaths. Severe reactions were also reported with buckwheat (46.5% and 1.4%), peas-lentil (20% and 1.8%), and alpha-gal (54% and 8%). Allergens with hidden exposures and leading to recurrent reactions included goat and sheep milk (15.5% and 56%, respectively), buckwheat (16.9% and 49.3%), peas-lentil (9% and 7.3%), and pine nut (4.1% and 12.2%).1

Grade 3 reactions were reported with pine nut (49%), kiwi (54.5%), beehive products (33.3%), and apple (46.7%).1

Based on these findings, investigators proposed that goat’s and sheep’s milk, buckwheat, peas-lentil, and pine nuts should be added to the European Mandatory Labelling of Foods list.1

“This need for better labelling does not seem as relevant for the other four [emerging food allergens],” investigators wrote.1 “Because of its severity, the case of alpha-gal could be discussed, but it is difficult to imagine how to include it in the [Mandatory Labelling of Foods list]; moreover, apart from a few exceptions, foods containing alpha-gal are well known and easy to identify, which is also the case for kiwi, beehive products, and apple, consumed in their native form, without hidden presence in our series.”

References

1. Sabouraud-Leclerc D, Mariotte D, Bradatan E, et al. Food Anaphylaxis: Eight Food Allergens Without Mandatory Labelling Highlighted by the French Allergy-Vigilance Network. Clin Exp Allergy. Published online August 20, 2025. doi:10.1111/cea.70130

2. Cardona V, Ansotegui IJ, Ebisawa M, et al. World allergy organization anaphylaxis guidance 2020. World Allergy Organ J. 2020;13(10):100472. Published 2020 Oct 30. doi:10.1016/j.waojou.2020.100472

3. Anaphylaxis Statistics. Allergy & Asthma Network. https://allergyasthmanetwork.org/anaphylaxis/anaphylaxis-statistics/. Accessed August 20, 2025.

4. Food Allergies. US Food & Drug Administration. https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/food-allergies. Accessed August 20, 2025.

5. Safe2Eat. European Food Safety Authority. April 22, 2025. https://www.efsa.europa.eu/en/safe2eat/food-allergens. Accessed August 20, 2025.

6. Should additional food allergens have mandatory labelling due to anaphylaxis risk? EurekAlert! August 20, 2025. https://www.eurekalert.org/news-releases/1094947. Accessed August 20, 2025.

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