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Allergen Labeling on Food Products

Publication Number: P3551
View as PDF: P3551.pdf

The Food Allergen Labeling and Consumer Protection Act (FALCPA), which took effect on January 1, 2006, requires food manufacturers to use common names to identify major allergens. Allergen declaration is required on products regulated by the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and state regulatory authorities (e.g., Mississippi Department of Agriculture and Commerce, Mississippi State Department of Health, Mississippi Department of Marine Resources). Additionally, FALCPA’s labeling requirements extend to cottage food products and foods packaged by retail or foodservice establishments.

Food allergies are a serious public health concern that affects adults and children of all ages. Food allergies affect 32 million Americans and are reportedly increasing in prevalence. There is no cure for food allergies. True food allergies are immune-mediated systemic allergic reactions to certain foods that can cause serious illness or death. Although more than 160 foods have been identified to cause food allergies in sensitive individuals, the “big eight” most common food allergens account for 90 percent of all food allergies. In the U.S., only these eight most common food allergens are subject to FALCPA labeling requirements.

Major Food Allergens

In the United States, there are eight major food allergens, also known as the “big eight.” These eight foods and their components (including major ingredient sub-ingredients) are considered to be major food allergens under FALCPA and must be declared on food product labels. Note that major food allergens (as discussed on pages 20–24 of the FDA Labeling Guide), even if they are present only in trace amounts, must be declared. They include:

  1. Milk
  2. Eggs
  3. Fish

    The specific species of fish must be declared (e.g., bass, cod, flounder). See Guidance for Industry: The Seafood List.

  4. Crustacean Shellfish

    The specific species must be declared (e.g., crab, lobster, shrimp). See Guidance for Industry: The Seafood List.

  5. Tree Nuts

    The specific type of nut must be declared (e.g., almonds, pecans, walnuts). See Guidance for Industry: Questions and Answers Regarding Food Allergens (scroll down for a list of tree nuts).

  6. Wheat
  7. Peanuts
  8. Soy

Labeling

If your food product contains any of the major eight food allergens, they must be declared on the product label. Here, we will look at sugar cookies as an example using the ingredients listed below. Ingredients must be listed in descending order of predominance by weight, meaning the ingredient that is used the most by weight is listed first, next most used is listed as second, and so forth.

Ingredient

Sub-ingredients

Enriched flour

wheat flour, malted barley, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid

Sugar

 

Partially hydrogenated cottonseed oil

 

High fructose corn syrup

 

Whey

 

Eggs

 

Vanilla

 

Natural and artificial flavoring

 

Salt

 

Leavening

sodium acid pyrophosphate, monocalcium phosphate

Lecithin

 

Mono- and diglycerides

 

You have two options for listing allergens on product labels.

Option 1. Include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major food allergen does not appear elsewhere in the ingredient statement for another allergenic ingredient. In the sugar cookie example, wheat, milk, eggs, and soy are specifically stated and listed within the ingredients, so an additional “contains” statement is not required.

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OR

Option 2. Place the word “Contains,” followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in a type size that is no smaller than that used for the ingredient list.

Image description in text.

 

Food Recalls

There are three recall classes for food products, and they are categorized according to the level of hazard involved (Table 1). Undeclared allergens are one of the leading causes of food recalls in the United States in both FDA- and USDA-regulated products. Undeclared allergens are a Class I recall, which means they are required to be recalled due the seriousness of the hazard.

Table 1. Recall classification.

Class I

Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II

Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III

Products that are unlikely to cause any adverse health reaction but that violate FDA or USDA labeling or manufacturing laws. Examples include: a minor container defect or lack of English labeling on a retail food.

Allergens in Ingredients

Allergens may be in several ingredients used in product formulations. It is important to review, assess, and include major ingredients and their sub-ingredients on product labels. Undeclared allergen recalls are often a result of new ingredients, new suppliers, misprinted labels, products in the wrong package, product reformulation, and ingredient reformulation.

Always read food labels carefully and watch for hidden allergens in your product ingredients. Hidden allergens are ingredients derived from or containing major food allergens with common names that may be unfamiliar to consumers. Table 2 lists foods associated with common allergens. Note: This is not a comprehensive list.

Table 2. Common foods and ingredients that may contain allergens.

Allergens

Common Foods and Ingredients

Peanuts

Chili

Chocolate

Crumb toppings

Graham cracker crust

Hydrolyzed plant protein

Hydrolyzed vegetable protein

Mole sauce

Peanut flavoring (natural and artificial)

Fried foods

Ethnic foods: African, Asian, Chinese, Indian, Indonesian, Thai, Vietnamese, Mexican

Tree nuts

Black walnut hull extract (flavoring)

Natural nut extract

Nut distillates/alcoholic extracts

Nut oils (e.g., walnut oil, almond oil)

Walnut hull extract (flavoring)

Grated/shredded coconut

Wheat

Baking mixes (most)

Crackers

Cream sauces

Enriched flour

Farina

Gravy

Graham flour

Modified food starch

Salad dressings (some)

Soy sauce

Vegetable gum

Vegetable starch

Milk

Almond butter

Butter

Calcium caseinate

Casein/caseinate

Lactose/lactoalbumin

Margarine with milk solids

Milk

Milk chocolate

Nonfat milk solids

Sodium caseinate

Whey

Eggs

Albumin

Binder

Coagulant

Emulsifier

Globulin

Lecithin

Livetin

Lysozyme

Mayonnaise

Ovalbumin

Ovamucin

Ovovitelin

Salad dressings (some)

Vitelin

Fish

Barbecue sauce

Caesar salad and Caesar dressing

Bouillabaisse

Caponata (eggplant relish)

Imitation or artificial fish or shellfish (surimi, also known as “sea legs” or “sea sticks,” is made from fish)

Worcestershire sauce (anchovies)

Shellfish

Bouillabaisse

Cuttlefish ink (crab or clam extract)

Fish stock

Glucosamine

Seafood flavoring

Imitation or artificial fish, crab, or lobster

Surimi, also known as “sea legs” or “sea sticks,” is made with fish, not shellfish.

Soy

Margarines

Meat substitutes

Pan release (cooking spray)

Soy

Soybeans

Soy flour/soy milk/soy nuts

Soy protein isolate (can be found in many seasonings)

Soy sauce

Tamari (soy) sauce

Tempeh

Teriyaki sauce

Texturized vegetable protein

Tofu

Vegetable gum

Vegetable starch

*This is not a comprehensive list.

Resources and References

Food and Drug Administration (FDA). Food Labeling Guide. https://www.fda.gov/files/food/published/Food-Labeling-Guide-%28PDF%29.pdf

Food and Drug Administration (FDA). Guidance for Industry: Questions and Answers Regarding Food Allergens (Edition 4). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-allergens-edition-4

Food and Drug Administration (FDA). Guidance for Industry: The Seafood List. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-seafood-list

United States Department of Agriculture – Food Safety and Inspection Service (USDA FSIS). Compliance Guidelines Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control, and Declaration through Labeling. https://www.fsis.usda.gov/wps/wcm/connect/f9cbb0e9-6b4d-4132-ae27-53e0b52e840e/Allergens-Ingredients.pdf?MOD=AJPERES

MSU Extension Publications

P3545 Labeling Mississippi Cottage Food Productshttp://extension.msstate.edu/publications/labeling-mississippi-cottage-food-products

P2920 Basic Labeling Requirements for Food Products Entering Commercehttp://extension.msstate.edu/publications/publications/basic-labeling-requirements-for-food-products-entering-commerce

P3542 Developing a Food Recall Plan. http://extension.msstate.edu/publications/developing-food-recall-plan

This material is based upon work supported by USDA/NIFA under Award Number 2018-70027-28585.


Publication 3551 (12-20)

By Courtney A. Crist, PhD, Assistant Extension Professor, Food Science, Nutrition, and Health Promotion.

Copyright 2020 by Mississippi State University. All rights reserved. This publication may be copied and distributed without alteration for nonprofit educational purposes provided that credit is given to the Mississippi State University Extension Service.

Produced by Agricultural Communications.

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