From Big 8 to Big 9 and Beyond: Ensuring Food Safety Through Proper Allergen Testing and Labeling

Published Date :
Tuesday, Feb 25, 2025
Tags :
Allergens
Food
Beverages

Eight percent of children under age five and four percent of adults are allergic to food1. Food allergies trigger immune system responses that can have severe consequences, even in the presence of small amounts of an allergen. For individuals with food allergies, avoiding allergens entirely is crucial, making accurate food testing and labeling by manufacturers essential. The correct identification of allergens ensures consumer safety and prevents life-threatening reactions.

Food recalls in the U.S.

From 2017 to 2021, the Food and Drug Administration (FDA) announced 1,095 food and beverage recalls. Of these, approximately 46% were due to undeclared allergens, making them the leading cause of food recalls2.  The high incidence of allergen-related recalls highlights the necessity of stringent allergen identification and labeling protocols. Proper labeling not only protects consumers but also helps manufacturers avoid costly recalls, which can amount to up to $10 million for an incident3.

The “Big 8” allergens

Although more than 160 foods can cause allergic reactions, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) identified eight principal food allergens4, collectively known as the “Big 8" allergens. These account for 90% of allergic reactions to food:

  • Milk 
  • Eggs 
  • Fish 
  • Shellfish 
  • Tree nuts 
  • Peanuts 
  • Wheat 
  • Soybean

The “Big 8” becomes the “Big 9” allergens

In 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act recognized sesame as a major food allergen, expanding the "Big 8" allergens list to the "Big 9." As of January 1, 2023, manufacturers must label products containing sesame to comply with federal regulations5.

Tree nut allergen classification and updates

In 2025, the FDA issued a final guidance for industry on the food allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act (edition 5)6. This revision identifies the listing of tree nuts that the FDA considers as major food allergens. This includes: 

  • Almond 
  • Black walnut 
  • Brazil nut 
  • California walnut 
  • Cashew 
  • Filbert/Hazelnut 
  • Heartnut/Japanese walnut 
  • Macadamia nut/Bush nut 
  • Pecan 
  • Pine nut/Pinon nut 
  • Pistachio 
  • Walnut

Of special note in this edition is the removal of coconut from the “tree nut allergen” list, and the specific addition of pine nut.

Food safety labeling requirements

All packaged foods and dietary supplements regulated under the Federal Food, Drug, & Cosmetic Act labeled after January 1, 2006, must comply with FALCPA's food allergen labeling requirements4. Key regulations include: 

  • Manufacturers must identify the name of the allergen source on the label of foods or ingredients that contain a "major food allergen." 
  • If an ingredient name does not explicitly indicate the allergen, manufacturers must provide clarification to cite the name of the food source (e.g., “flour (wheat)”).  
  • The "Contains" statement on the label must include the word "Contains," followed by the names of all major allergens in the product. For example, "Contains wheat, milk, and eggs." 
  • For nuts, fish, and crustaceans, the specific type or species must be specified.

It's important to note that manufacturers do not have to declare a spice, color, or flavoring that is not a major allergen. Also, manufacturers can label ingredients that are not major allergens using their common or usual name without specifying the allergen source.   

Food allergens and FSMA compliance

The FDA Food Safety Modernization Act (FSMA) reinforces the importance of food allergen control. FSMA mandates that food facilities implement food safety plans to prevent or minimize risks associated with foodborne hazards, including: 

  • Food allergen controls – documented procedures for controlling allergen cross-contamination and ensure adequate labeling. 
  • Sanitization controls – processes to maintain sanitary conditions to reduce allergen contamination risks. 
  • Written recall plan – clear steps that the manufacturer will take if an allergen is identified. 

FSMA strengthens food safety standards, ensuring consumer protection and reducing health risks associated with allergen exposure. The proposed Food Traceability Rule further enhances food safety by requiring record-keeping for Critical Tracking Events (CTEs)7.

Allergen testing and labeling for the Big 9 allergens and beyond

Given the serious health implications of allergen exposure, manufacturers must implement rigorous allergen testing and labeling practices. Food production facilities often handle multiple ingredients, increasing the risk of cross-contact. Comprehensive product testing is crucial to: 

  • Identify all potential allergens present
  • Detect cross-contamination sources
  • Validate cleaning and equipment changeover procedures

At Eurofins Food & Feed Testing, we provide industry-leading consulting, auditing, and testing services to help manufacturers comply with U.S. allergen labeling laws. Our expertise covers testing for the Big 9 allergens and additional allergen targets relevant outside the U.S.  

Contact us today to ensure your food products meet federal allergen safety standards while keeping your consumers safe.

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Additional resources

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References

  1. Mayo Foundation for Medical Education and Research. 2025. Food allergy. Available at: https://www.mayoclinic.org/diseases-conditions/food-allergy/symptoms-causes/syc-20355095 Accessed 17 February 2025. 
  2. The Food Industry Association. 2021. FDA Recalls 2017-2020. Available at: https://www.fmi.org/docs/default-source/food-safety/fs21--fda-recall-report_1-13-21_v2_.pdf?sfvrsn=19c8d6d_2 Accessed 17 February 2025. 
  3. Food Safety Magazine. 2025. Recall: The Food Industry’s Biggest Threat to Profitability. Available at: https://www.food-safety.com/articles/2542-recall-the-food-industrys-biggest-threat-to-profitabilityecall:
  4. The Food Industry's Biggest Threat to Profitability | Food Safety Accessed 17 February 2025. 
    The United States Food and Drug Administration. 2022. Food Allergen Labeling and Consumer Protection Act of 2024 (FALCPA). Public Law 108-282, Title II. Available at: https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/food-allergen-labeling-and-consumer-protection-act-2004-falcpaling and Consumer Protection Act of 2004 (FALCPA) | FDA Accessed 17 February 2025. 
  5. FoodSafety.gov. 2025. The Food Allergy Safety, Treatment, Education, and Research Act of 2021. Available at: https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/food-allergen-labeling-and-consumer-protection-act-2004-falcpa Accessed 17 February 2025. 
  6. The United States Food and Drug Administration. 2025. Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5). Available at: https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/food-allergen-labeling-and-consumer-protection-act-2004-falcpa Accessed 17 February 2025. 
  7. The United States Food and Drug Administration. 2024. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. Available at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods?utm_medium=email&utm_source=govdelivery#:~:text=The%20proposed%20rule%20would%20require,a%20firm's%20traceability%20program%20records  Accessed 17 February 2025.