Food Allergens - The Big 8 is Now The Big 9
Six to eight percent of children and three percent of adults are allergic to food. Allergies cause immune system responses that can have severe consequences for some people, even in the presence of small amounts of an allergen.
Currently, there is no cure for food allergies. Thus, people must avoid food products that trigger allergic reactions altogether.
However, many products available in the market contain potential allergens, and consumers need to know if the foods they choose could cause allergic reactions. Therefore, food manufacturers must identify foods or ingredients from major food allergens on packaged foods to protect their consumers and avoid product recalls.
Food Recalls in the U.S.
From 2017 to 2021, the Food and Drug Administration (FDA) announced 1,095 food and beverage recalls. About 46% of these notifications were related to undeclared allergens, the leading cause of food recalls. These numbers are concerning since allergic consumers rely on manufacturers to label products correctly for allergens.
The prevalence of recalls underscores the importance of proper food allergen identification and labeling. Not only does food allergen labeling prevent illness and save lives, but the practice also prevents unnecessary expenses for food manufacturers. A recall can cost $10 million, depending on the product.
“The Big 9” Allergens
Although more than 160 foods can cause allergies, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) identified eight principal food allergens. Known as "The Big 8" allergens, they account for 90% of allergic reactions to food. In 2021, a new food joined the list of major allergens, turning "The Big 8" into "The Big 9."
“The Big 8” allergens identified since 2004 are:
- Milk
- Eggs
- Fish
- Shellfish
- Tree nuts
- Peanuts
- Wheat
- Soybean
Sesame joined the Big 8 allergens following the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of April 2021. As a result, from January 1, 2023 onward, products containing sesame must be included in manufacturers’ allergen monitoring and labeling plans.
Food Safety 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 requirements. Key aspects include:
- Manufacturers must identify the name of the allergen source on the label of foods or ingredients that contain a "major food allergen."
- Manufacturers must cite the name of the food source if the usual name of an ingredient doesn't identify the allergen. For example, a label may indicate "flour (wheat)" to identify an allergen.
- 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, it's necessary to specify the type or species.
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.
What Happened in the Industry With FSMA?
The FDA Food Safety Modernization Act (FSMA) aims to prevent foodborne illnesses and significant public health and economic problems. With this rule, food facilities had to develop a safety plan to prevent or minimize identified hazards, including:
- Food allergen controls – documented procedures for controlling allergen cross-contamination and ensure adequate labeling.
- Sanitization controls – processes to ensure sanitary conditions to minimize or prevent hazards such as food allergens, among others.
- Written recall plan – clear steps that the manufacturer will take if an allergen is identified.
FSMA emphasized the importance of food safety and implemented science-based regulatory standards that resulted in safer food for consumers all over the country. Moreover, the proposed Food Traceability Rule will promote a more efficient action against foodborne illness outbreaks by ensuring that food producers maintain records associated with different Critical Tracking Events (CTEs).
Allergen Testing and Labeling
Due to the many ingredients that trigger allergies and the potential severe health consequences for consumers, manufacturers need to ensure they label food products accurately. In addition, manufactures typically produce several different food items at their facilities and there is a major risk accidental introduction of allergens. Comprehensive product testing is necessary to identify all potential allergens, sources cross contamination and to validate cleaning and line change procedures. Eurofins consulting, auditing, and testing services can help your company comply with federal laws while keeping your consumers informed and safe.
Our capabilities include the testing for the allergens that currently require labeling in the U.S. as well as sesame and other targets that are relevant outside the U.S. Contact us to partner with us for food allergen testing services!
