About 30,000 individuals require emergency treatment, and 150 die every year because of allergic reactions to food. 

Presently, there’s no cure for food allergies, and individuals must avoid allergy-inducing foods to avoid life-threatening situations. 

To ensure the safety of such individuals, the FDA conducts regular inspections at food facilities and has laid down strict allergen labeling requirements. 

Failing to comply with these requirements will lead to product recalls and other negative consequences.

Unfortunately, you have a packed schedule and don’t have the time to pore over tones of reading material to understand labeling requirements. 

That’s why we’ve created a simple guide that’ll help you bypass lengthy texts and jargon. It’s concise, skips the legalese, and helps you find the answers you’ve been looking for.

We’ve based all the information in this guide based on the latest FDA regulations.

Major Allergens

According to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the term major allergens refers to the eight foods and their protein derivatives that cause more than 90% of food allergies and severe reactions in the USA. 

So, any packaged food containing the following allergens must declare the ingredients on its label to warn its consumers. 

Note: 

Sesame has been recognized as the 9th major food allergen recently.

But we’re omitting it from the list above, as the change becomes effective only on January 1st, 2023, and you don’t have to label it as a major allergen until then. 

Detailed List of Major Allergens

The following subsections will give you a detailed list of foods considered major allergens under each category. 

1. Fish & Crustacean Shellfish

The term crustacean shellfish refers to shellfish with a soft shell (prawns, lobsters, etc.) and doesn’t include molluscan shellfish (oysters, clams, mussels, etc.)

There are numerous edible fishes and shellfishes, we’ve included only common species in the lists below. 

You may refer to the FDA’s seafood list for the complete set of related ingredient names.

2. Tree Nuts

The FALCPA considers the following foods as “tree nuts” and the list may also include nuts not used in foods for the sake of comprehensiveness. 

3. Wheat

Wheat refers to any plant species of the genus Triticum, and it includes the following grains:

Exemptions

The FALCPA applies to most packaged food products, but you’re exempted from making a declaration if your product is:

• A raw agricultural commodity like fresh fruits or vegetables. 
  

• Not pre-packaged with a label. This includes foods wrapped or placed in containers upon the consumer’s request or at the point of purchase. 
  

• Highly refined oil made from the foods listed above or a product derived from these oils.
  

Note: If your products aren’t regulated by the FALCPA, i.e. meat products, poultry, egg, and alcoholic beverages, check out the allergen regulations laid down by the relevant organizations. 

Other Allergenic Substances

In addition to identifying eight major allergens, the FDA has also identified more than 160 substances that cause adverse reactions and pose significant health risks to individuals. 

This section lists other allergenic substances that require specific labeling according to the FALCPA. 

1. Gluten

Gluten is a group of proteins in certain grains like wheat, barley, and rye. It triggers the immune response that leads to the damage of the lining surrounding the small intestine in people who have celiac disease. 

Such damage will cause malnutrition and leave them at a high risk of developing life-threatening diseases like cancers in the long term. 

That’s why the FDA has laid down stringent standards and labeling regulations for “gluten-free” products. 

2. Color & Food Additives

Substances that impart color to foods, drugs, cosmetics, or the human body are called color additives. They’re found in your fruit punch and add vibrancy to your bland morning cereal.

Although most color additives are very safe when used properly, some individuals can have allergic reactions to certain color additives. 

FD&C Yellow No. 5 (tartrazine) is widely found in beverages, desserts, and processed vegetables. It may cause symptoms like hives and itching in some individuals, so you must identify it on the labels of your food products. 

Color additives derived from carmine or cochineal extracts may lead to *anaphylaxis and must be declared on food labels. 

Food additives like sulfiting agents cause asthma in some individuals. So, you must declare them if their concentration exceeds 10 million parts per million of sulfur dioxide present in the food.

*life-threatening allergic reaction that is characterized by nausea, vomiting, breathing difficulties, and shock.

3. Sesame

More than 300,000 Americans suffer an allergic reaction from sesame and may prove to be fatal even if it’s ingested only in small quantities.

That’s why the Food Allergy Safety, Treatment, Education, and Research (FASTER) act has declared it a major allergen, effective from 2023. 

Until then, you’re exempt from listing sesame as an ingredient in natural spices and flavorings. But a voluntary declaration in parentheses following the spice or flavor can potentially save the lives of your consumers.

Allergen Labeling Requirements

This section explains how to declare allergens on a food package and answers some of the most pressing questions on the labeling requirements. 

1. Allergen Declaration

You can declare major allergens in your label in one of the following ways:

1. Include the food source of a major food allergen in parentheses following the ingredient’s name
Here’s an example of a correct allergen declaration:

Ingredients: Whey (milk), lecithin (soy), and flour (wheat)

Note: If the common name of an ingredient includes the name of the major food allergen, you needn’t include the food source of the major allergen in parentheses. For example, buttermilk. 

2. Use a “Contains” statement immediately after or next to the ingredient list to declare major allergens. 

This statement must always begin with a capital “C" and the usage of punctuations and bold-lettering is optional. Here’s an example of a correct allergen declaration with a “Contains” statement:

CONTAINS WHEAT, SOY, AND MILK

Note: If your product is manufactured in a facility where it might be exposed to traces of other major allergens due to cross-contact or contamination, you must issue an advisory statement like:

MAY CONTAIN TRACES OF TREE NUTS

Declaration of Allergens from Food Groups

The table below shows the procedure for the declaration of ingredients from the three allergen food groups, i.e. Tree nuts, fish, and crustacean shellfish.

2. Placement of Information

Ingredient lists and allergens appear on the Principal Display Panel (PDP) or Information Panel (IP). 

3. Type Size 

As allergens are declared immediately after the list of ingredients or with it, they must be no less than 1/16” in height. 

Note: The letter height is the equivalent of a lowercase or uppercase “O.”

Frequently Asked Questions Regarding Allergen Labeling Requirements

1. Are single-ingredient foods containing major allergens exempt from the FALCPA?

No. Single-ingredient foods that are major allergens or contain proteins derived from them must identify the food source (eg. all-purpose wheat flour) or use a “Contains” statement to list allergens.

Note: 

1. If you’re using a “Contains” statement, place it immediately above the manufacturers, distributors, or packers statement. 

2. If the single-ingredient food is intended for further manufacturing, place the “Contains” statement on the PDP. 

2. Can singular terms be substituted for plural terms in the declaration and still satisfy FALCPA requirements?

Yes, you may use singular terms like almond, pecan, or walnut for different types of tree nuts and still satisfy the labeling requirements of FALCPA.

3. Can I use synonyms for the term “soybean”?

“Soy,” “Soya,” and “Soybean” are acceptable synonyms and satisfy FALCPA’s labeling requirements. 

However, you must stick to using “soybeans” if your product is made of soy (e.g., soy sauce) or contains soy as a component of a multi-component ingredient (e.g., tofu)

Exemption from Allergen Declaration

You may file a petition with the Secretary to exempt your ingredients from the allergen labeling requirements. 

Once the petition is filed, the Secretary must post it publicly within 14 days and approve or deny it within 180 days of its receipt, unless there’s an agreement for mutual extension of time. 

In your petition, you must provide scientific evidence and describe the analytical method used to prove that your product doesn’t contain allergenic protein and adversely affect human health. 

Note: You’re exempt from filing a petition if:

• You’ve already filed a notification that shows your product doesn’t contain any allergenic proteins.
  
• The Secretary has already approved your ingredient as non-allergenic under a pre-market or notification program. 
  

Wrapping Up

You must list major food allergens with the ingredient list and make voluntary declarations wherever possible. To contest the declaration of allergen, you must submit a petition or notification to the Secretary with scientific proof for the absence of allergenic proteins. Products exempted from declaration include highly refined oils made from allergens and raw commodities like fresh fruits and vegetables. 

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