What are the 8 foods that must be identified by law? A Guide to US Allergen Labeling

According to the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, eight specific food groups were recognized as the 'major food allergens' in the U.S.. These are the 8 foods that must be identified by law due to their potential to cause serious and life-threatening allergic reactions in a large portion of the population.

Quick Summary

This article examines the original eight major food allergens required by U.S. law, detailing each one and exploring the legislation that mandated clear labeling for consumer safety.

Key Points

• The 'Big 8' are the foundation: Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans were the original eight major allergens identified by US law.

• FALCPA revolutionized labeling: The Food Allergen Labeling and Consumer Protection Act of 2004 mandated clear, plain-language labeling for the 'Big 8' to protect consumers.

• Sesame joined the list: The FASTER Act of 2021 added sesame as the ninth major allergen in the US, mandating its inclusion on food labels starting in 2023.

• Label reading is crucial: Consistent and careful reading of ingredient lists and 'Contains' statements is the primary method for allergic individuals to ensure food safety.

• Regulations vary internationally: Different countries, like the EU, have expanded their lists of mandatory allergens beyond the US 'Big 9', complicating global food trade.

The Historical Context: The 'Big 8' Allergens

For nearly two decades, U.S. food labeling law focused on eight principal food allergens, responsible for roughly 90% of food-related allergic reactions. These eight items, often referred to as the 'Big 8,' were the cornerstone of the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, which mandated clear, plain-language identification on packaged foods. Understanding these original eight is essential for grasping the history and evolution of food safety regulations.

Milk

Dairy is a common and potent allergen, particularly in infants and young children. A milk allergy involves the body's immune system reacting to proteins found in milk from cows, sheep, and other mammals. It is distinctly different from lactose intolerance, which is a digestive issue. The proteins in milk, including casein and whey, can be hidden in many processed foods, requiring strict avoidance for allergic individuals. Manufacturers must list milk as an ingredient, even if it's part of a composite ingredient like whey powder or casein.

• Common sources: Milk, cheese, butter, yogurt, cream, whey, casein, lactose.

Eggs

Egg allergy is another common childhood allergy, though many children outgrow it before adulthood. The allergic reaction is triggered by proteins in either the egg whites or yolks. Like milk, egg proteins are used in a wide variety of processed and baked goods, making clear labeling critical. Some individuals may be able to tolerate eggs when they are baked into a food, but this should only be done under a doctor’s supervision. For most, strict avoidance of all forms of egg is necessary.

• Common sources: Eggs, mayonnaise, meringue, pasta, baked goods, sauces, dressings.

Fish

Allergies to finned fish are more common in adults than in children and can be severe. A person can be allergic to a specific type of fish, such as cod or tuna, or to multiple species. Because fish proteins can be potent, and cross-contact is a significant risk, FALCPA mandated that fish be clearly labeled. This includes fish used in ingredients like fish sauce or Worcestershire sauce. It is important to note that a fish allergy is distinct from a shellfish allergy.

• Common sources: Salmon, tuna, cod, halibut, fish sauces, surimi, sushi.

Crustacean Shellfish

Shellfish, specifically crustaceans like shrimp, crab, and lobster, are a leading cause of allergic reactions in older children and adults. Reactions can be severe and require immediate medical attention. FALCPA specifically identified crustacean shellfish, but it is important to distinguish this from molluscan shellfish (e.g., oysters, clams), which are not part of the original Big 8 and were not required to be labeled under FALCPA.

• Common sources: Shrimp, crab, lobster, crayfish, prawn, krill.

Tree Nuts

Tree nut allergies are often severe and persistent throughout a person's life. The term 'tree nut' covers a wide variety of nuts, including almonds, walnuts, pecans, and cashews. A person can be allergic to one type of tree nut or multiple types, and cross-contact is a major concern in manufacturing. FALCPA requires the specific type of tree nut to be identified on the label, providing crucial information for individuals who might be able to tolerate some tree nuts but not others.

• Common sources: Almonds, walnuts, pecans, cashews, hazelnuts, pistachios, macadamia nuts, nut butters, baking mixes.

Peanuts

Peanuts are one of the most common food allergens, and reactions can be extremely serious, often involving anaphylaxis. Despite their name, peanuts are legumes, not tree nuts, and FALCPA recognized them as a separate and significant allergen. Due to the high prevalence and severity of peanut allergies, strict avoidance and clear labeling are paramount. Peanut protein can be found in a surprising number of processed foods, flavorings, and sauces.

• Common sources: Peanuts, peanut butter, peanut oil (unless highly refined), sauces, candies, baked goods.

Wheat

Wheat allergy affects a significant portion of the population and is different from celiac disease, which is an autoimmune disorder triggered by gluten. FALCPA required the declaration of wheat as a major allergen, covering not only wheat flour but also ingredients derived from it, such as wheat starch and vital wheat gluten. This information is crucial for those who must avoid wheat for health reasons.

• Common sources: Breads, pasta, cereals, baked goods, soy sauce, thickeners, coatings.

Soybeans

Soy allergies are most prevalent in infants and young children but are often outgrown. As a legume, soybeans are widely used in food manufacturing, appearing in ingredients like tofu, soy milk, edamame, and various flavorings. The FALCPA requirements ensure that soy protein, a common hidden allergen, is always identified on food labels. A notable exception is highly refined soy oil, which is not considered a major allergen because the refining process removes the allergenic protein.

• Common sources: Soybeans, soy sauce, tofu, soy milk, edamame, vegetable oil (if not highly refined).

The Legislation: A Closer Look at FALCPA

The Food Allergen Labeling and Consumer Protection Act of 2004 revolutionized food labeling in the U.S. by moving beyond a simple ingredient list. Before FALCPA, allergens could be hidden under generic terms like 'natural flavoring' or 'spices'. The law required that a food label must identify the food source name of any major food allergen in a clear, plain-English manner. This can be done in one of two ways: either in parentheses following the ingredient name (e.g., 'Whey (Milk)') or in a separate 'Contains' statement at the end of the ingredient list (e.g., 'Contains: Milk, Wheat'). FALCPA's passage was a significant win for consumer safety, providing a consistent and easily understandable format for allergen information.

From the Big 8 to the Big 9: The Addition of Sesame

While the original FALCPA focused on the Big 8, the landscape of food allergy regulation changed in 2021 with the passage of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act. This law declared sesame as the ninth major food allergen in the U.S., effective January 1, 2023. Previously, sesame could be listed under generic terms, making it difficult for allergic individuals to avoid. The FASTER Act mandates that sesame now be clearly and specifically identified on all food labels, protecting an estimated 1.6 million Americans with sesame allergies. The evolution from the Big 8 to the Big 9 demonstrates a commitment to refining food safety laws as new data emerges about allergen prevalence.

Comparison of Allergen Labeling: US vs. EU

To understand the global perspective, it is useful to compare the US regulations with those in the European Union. The lists of mandatory allergens differ, and the method of presentation also varies. This comparison highlights why international food trade requires manufacturers to be vigilant about regional compliance.

Feature	United States (FALCPA/FASTER Act)	European Union (EU FIC)
Number of Allergens	9 (Milk, Egg, Fish, Shellfish, Tree Nuts, Peanuts, Wheat, Soybeans, Sesame)	14 (Includes celery, cereals with gluten, crustaceans, eggs, fish, lupin, milk, molluscs, mustard, peanuts, sesame, soybeans, sulfur dioxide, tree nuts)
Specifics	Requires identification of specific tree nuts and fish types.	Requires identification of specific cereals containing gluten, but less detail on fish or molluscs.
Voluntary Labeling	Precautionary Allergen Labeling (PAL) is voluntary (e.g., 'May Contain').	PAL is not mandated but often used, though EU guidance does not specifically regulate it.
Hidden Allergens	Mandates declaration in spices, flavorings, and colorings.	Strong rules to prevent allergens from being hidden in composite ingredients.

How Consumers Can Protect Themselves

For individuals with food allergies or intolerances, careful label reading is the single most important step for safety. Always check the ingredient list for the specific allergen you need to avoid. The 'Contains' statement is a helpful summary, but it is wise to confirm with the full ingredient list, especially as ingredients and manufacturing processes can change. Even for foods purchased frequently, reading the label every time is recommended. Awareness of cross-contact risks is also important. Some labels include precautionary statements like 'May contain,' which, while not a substitute for proper allergen control, serve as an additional warning. When in doubt, it is always best to contact the manufacturer for clarification.

Conclusion

The historical legal requirement to identify the original 8 foods was a landmark achievement in consumer protection. Over time, evolving knowledge of food allergies led to legislative changes, including the addition of sesame in the U.S. and more comprehensive lists in other parts of the world. Clear, consistent, and legally mandated allergen labeling empowers individuals with allergies to make informed decisions and live safer lives. While the 'Big 8' formed the foundation, the current 'Big 9' standard reflects a more complete understanding of public health needs. As food science and global trade continue to evolve, so too will the regulations that protect vulnerable consumers.

FoodAllergy.org provides excellent resources for managing food allergies and understanding labels.

Frequently Asked Questions

Why did the US law expand from 8 to 9 foods?

The US law expanded from the original 'Big 8' to the 'Big 9' with the addition of sesame in 2023 under the FASTER Act. This change was based on growing evidence of sesame allergy prevalence and the severity of reactions, leading to a recognized public health need for mandatory labeling.

Is a milk allergy the same as lactose intolerance?

No, a milk allergy is an immune system reaction to milk proteins (casein and whey), which can be severe. Lactose intolerance is a digestive issue caused by the inability to process the sugar (lactose) in milk and is not life-threatening.

Does highly refined peanut oil need to be labeled as an allergen?

Under US law, highly refined oils derived from major allergens, such as peanut or soy oil, are not required to be labeled as an allergen. The refining process is considered to remove the allergenic protein.

What is the difference between fish and shellfish allergens?

Fish refers to finned fish (e.g., cod, salmon). Shellfish are divided into crustaceans (e.g., shrimp, crab) and mollusks (e.g., clams, oysters). The original US law focused only on crustacean shellfish, while later legislation and practices have clarified and expanded requirements for both categories.

What if an allergen is part of a flavoring or spice?

The FALCPA and subsequent laws made it mandatory to declare major food allergens even if they are part of a generic ingredient like 'natural flavor' or 'spice.' The food source must be clearly identified, for example, 'natural flavoring (contains milk)'.

Are 'May Contain' warnings legally required?

Precautionary Allergen Labeling (PAL) like 'May Contain' statements are voluntary warnings issued by manufacturers to indicate potential cross-contact. They are not legally required by the FDA but are used as a risk management tool.

How should I read a food label for allergies?

Always read the full ingredient list carefully, even for products you buy often. The 'Contains' statement is a helpful summary, but changes can occur. For packaged foods, allergen information is required to be clear and prominent.

What should I do if I suspect an unlabeled allergen caused a reaction?

If you experience a severe allergic reaction, seek immediate medical attention. You can also report the incident to the FDA to help track potential mislabeling and prevent future incidents.