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Allergens

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Food Safety
What are food allergens?

A food allergen is a protein that triggers a physical reaction (sometimes severe or even fatal) in a person with that food allergy. The proteins that cause allergic reactions occur naturally in the food, and are not a contaminant.

Unlike many pathogens, allergens cannot be removed through cooking.

An estimated 2 percent of adults and 5 percent of infants and young children in the United States have some kind of food allergy, according to the FDA. About 30,000 individuals receive emergency room treatment for allergic reactions to food, of which 150 people die.1

For an allergen to be removed, the food must be specially refined. For example, highly refined soybean oil no longer contains any soy protein, and so it should not cause an allergic reaction in someone with a soy allergy.2

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Top 8 Allergens in the US

Nearly any food can cause an adverse reaction, but eight major allergens account for 90 percent of all food allergies.3 These eight allergens, covered by FALCPA, include:

  1. Milk
  2. Eggs
  3. Fish
  4. Shellfish
  5. Tree nuts (e.g., almonds, walnuts, pecans)
  6. Peanuts
  7. Wheat
  8. Soybeans

By January 1, 2023, sesame seeds will also need to be labelled as an allergen as well, and will be added to the major allergens list.

Relevance & Regulation

Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 to minimize health risks associated with food allergens. This law applies to all packaged foods sold in the United States that fall under the Federal Food, Drug, & Cosmetic Act. This does not include meat, poultry, or egg products.4 It also does not include foods regulated by the Alcohol and Tobacco Tax and Trade Bureau, including wine, beer, and distilled spirits.3

Under FALCPA, food manufacturers must label food products for allergens if an ingredient is one of eight common allergen, or if the food contains protein from a major allergen. Manufacturers can either include the allergen in parentheses in the list of ingredients, or to list the allergens after the list of ingredients.5

How to establish an Allergen Control Program

Food processors can establish an allergen control program to prevent unintentional allergens from being introduced into a product. A control program must consider every step in the process.1

  • In the purchasing stage, facilities should evaluate all raw materials for the presence of allergens.
  • The receiving stage should confirm that the product is identical to the product ordered. Ingredient declarations and other statements should be reviewed and confirmed.
  • Storage, scheduling, and handling should be coordinated to prevent the introduction of unwanted allergens into a product.
  • Packaging should include procedures to prevent the use of incorrect or obsolete packaging.

References

  1.  Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), Public Law 108-282, Title II, SEC. 202. FINDINGS, 21 USC 343 note. https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106187.htm
  2.  “Allergens.” Food Safety and Sanitation. Chapter 4. AIB International. Webinar. Accessed 15 Jan. 2018.
  3.  “Food Allergy Overview.” Types of Allergies. American College of Allergy, Asthma & Immunology. 2014. http://acaai.org/allergies/types/food-allergy
  4.  “Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004.” Guidance & Regulation. 4th ed. U.S. Food and Drug Administration, 8 Nov. 2017. https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/allergens/ucm059116.htm
  5. “Food Allergen Labeling And Consumer Protection Act of 2004 Questions and Answers.” Guidance & Regulation. U.S. Food and Drug Administration, 18 July, 2006. https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106890.htm