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What are the allergens for Labelling?

4 min read

According to the FDA, nine major food allergens account for over 90% of food allergies in the U.S., making it critical to understand what are the allergens for labelling to ensure consumer safety. For individuals with food allergies, accurate and clear labelling is not just a convenience, but a life-saving necessity.

Quick Summary

This guide details the specific allergens requiring mandatory labelling under US and EU regulations. It covers how to read ingredient lists for allergens, understand precautionary statements like 'may contain,' and prevent cross-contact. Adherence to these guidelines protects consumers with food allergies and is vital for food business compliance.

Key Points

  • US vs. EU Allergens: The US mandates labelling for nine major allergens, while the EU requires declaration of 14, including additional items like celery, mustard, and lupin.

  • Clear Labelling is Mandatory: Regulations in both regions require that allergens be clearly identified, often emphasized within the ingredient list or in a separate 'Contains' statement.

  • Read Every Label: Consumers should always read food labels for allergens, even for familiar products, as ingredients and manufacturing processes can change unexpectedly.

  • Precautionary Statements Vary: Voluntary 'may contain' labels are unregulated and can indicate different levels of cross-contact risk; they should not be ignored by sensitive individuals.

  • Prevent Cross-Contact: Simple measures like thorough handwashing, using separate utensils, and dedicated cooking areas are crucial for preventing cross-contact at home and in food preparation.

  • Cooking Doesn't Eliminate Allergens: Unlike bacteria, heat does not destroy food allergens, so foods that have come into contact with an allergen cannot be made safe by cooking.

In This Article

Food allergies are a growing public health concern, with varying regulations across different regions designed to protect consumers by mandating clear allergen labelling. Understanding the specific allergens that must be declared is crucial for both consumers reading labels and manufacturers ensuring compliance. The most recognized lists come from the United States and the European Union, which define a set of major allergens that must be clearly indicated on packaged food.

Global Standards for Allergen Labelling

Different regulatory bodies have established lists of priority allergens based on prevalence and severity of reactions in their respective populations. While the core allergens overlap, there are notable differences in the specific items included in mandatory declarations.

The US Nine Major Allergens

In the United States, the Food Allergen Labeling and Consumer Protection Act (FALCPA) originally identified eight major food allergens. This list was updated by the FASTER Act of 2021 to include a ninth. These nine are:

  • Milk: A common allergen, especially in children, found in dairy products, whey, and casein.
  • Eggs: Derived from chickens and other fowl, used in many baked goods, sauces, and dressings.
  • Fish: Includes specific finfish like bass, flounder, and cod. The specific type must be named.
  • Crustacean Shellfish: Prawns, crabs, and lobsters. This does not include molluscan shellfish.
  • Tree Nuts: A group of nuts including almonds, walnuts, pecans, cashews, and Brazil nuts. The specific nut must be named.
  • Peanuts: A legume, distinct from tree nuts, known for causing severe allergic reactions.
  • Wheat: A common grain containing gluten, used in bread, pasta, and many processed foods.
  • Soybeans: A legume used in products like tofu, soy sauce, and lecithin.
  • Sesame: Added as the ninth major allergen, effective January 1, 2023, found in tahini, spices, and baked goods.

The EU's 14 Allergens

The European Union requires the labelling of a broader list of 14 allergens, which is enforced by Regulation (EU) 1169/2011. This list includes the core US allergens plus additional items considered significant public health risks:

  • Cereals containing gluten: Wheat (including spelt, Khorasan wheat), rye, barley, and oats.
  • Crustaceans: Prawns, crabs, and lobsters.
  • Eggs: Chicken eggs and eggs from other birds.
  • Fish: All species of fish.
  • Peanuts: The same as the US list.
  • Soybeans: The same as the US list.
  • Milk: The same as the US list.
  • Nuts: Includes almonds, hazelnuts, walnuts, cashews, pecans, Brazil nuts, pistachios, and macadamia nuts. Products made from these are also covered.
  • Celery: Includes celeriac and products derived from celery.
  • Mustard: All mustard seeds and products.
  • Sesame seeds: The same as the US list.
  • Sulphur dioxide and sulphites: Added when they exceed 10mg/kg or 10mg/litre, common as a preservative.
  • Lupin: A legume used in flour and other products.
  • Molluscs: Mussels, oysters, squid, etc.

Labelling Requirements and How to Read Labels

Allergen information must be presented clearly and conspicuously on packaged food. The most common methods include emphasizing the allergen within the ingredient list or providing a separate 'Contains' statement.

How to Identify Allergens

  • Check the Ingredient List: Look for allergens listed in parentheses after an ingredient's common name, e.g., 'whey (milk)' or 'flavourings (almond)'. European rules require the allergen to be emphasized (e.g., in bold or underlined) wherever it appears in the ingredient list.
  • Find the 'Contains' Statement: In the US, manufacturers often provide a summary statement, usually near or below the ingredient list, that begins with 'Contains:' followed by the list of major allergens present.
  • Don't Rely on 'Free From' Claims Alone: Claims like 'vegan' or 'dairy-free' are useful but should not replace careful label reading, as they don't guarantee the absence of all allergens, especially due to potential cross-contact.

Navigating Precautionary Allergen Labelling (PAL)

Beyond mandatory labelling, manufacturers may use voluntary precautionary statements like 'may contain' or 'manufactured on shared equipment'. These warnings are not regulated and are used to inform consumers of potential cross-contact risks.

Understanding PAL

  • Voluntary and Unregulated: The FDA does not regulate the use of PAL statements, so they can be inconsistent and confusing.
  • Indicates Risk: The presence of a PAL statement means that despite all efforts to prevent cross-contact, there remains a risk that trace amounts of an allergen could be present in the final product.
  • 'May Contain' vs. 'Shared Equipment': Research has shown there is no consistent difference in the level of allergen residue associated with different types of PAL statements. A 'shared facility' statement can carry as much risk as a 'may contain' statement.

Avoiding Allergen Cross-Contact

Cross-contact occurs when a food allergen is unintentionally transferred to another food, potentially making it unsafe for a person with allergies. Unlike cross-contamination with bacteria, cooking will not destroy allergens.

Preventing Cross-Contact at Home

  • Wash Thoroughly: Clean hands, surfaces, utensils, and cutting boards with soap and hot water. Hand sanitizers are often ineffective at removing allergen residue.
  • Prepare Separately: Always prepare allergen-free meals first. Keep food and utensils separate throughout the cooking process.
  • Dedicated Equipment: Consider using separate sets of utensils, pans, or cutting boards for allergy-safe food. This is particularly important for severely allergic individuals.
  • Label and Store Securely: Use clear labels and store allergy-safe foods in separate, sealed containers to prevent accidental contact in cupboards or refrigerators.

Comparison of US and EU Allergen Lists

Allergen US (9 Major) EU (14 Major)
Milk
Eggs
Fish
Crustacean Shellfish
Tree Nuts
Peanuts
Wheat
Soybeans
Sesame
Celery
Mustard
Lupin
Molluscs
Sulphur Dioxide/Sulphites

Conclusion

Understanding what the allergens for labelling are, and adhering to strict labelling rules, is fundamental for protecting consumer health. Regulatory lists, such as the US's nine major allergens and the EU's 14, provide a critical framework. For consumers, vigilance in reading every label every time is essential, especially when relying on voluntary 'may contain' statements. For businesses, implementing robust allergen management protocols and ensuring clear, accurate labelling is a legal and ethical responsibility. Given the potential for severe reactions, the continuous focus on clear communication and careful prevention of cross-contact remains paramount for food safety worldwide.

For more detailed information on US regulations, visit the FDA's official food allergies page.

Frequently Asked Questions

The most common food allergens vary slightly by region. In the US, the nine major allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. The EU adds celery, cereals with gluten, lupin, molluscs, mustard, and sulphites to its mandatory list.

You should check the ingredient list, where allergens are often emphasized (e.g., in bold or italics) or listed in parentheses. Many products also have a 'Contains' statement near the ingredient list that summarizes all present major allergens.

A 'may contain' statement is a voluntary advisory warning from the manufacturer indicating that there is a risk of unintentional cross-contact with an allergen. These statements are unregulated, and sensitive individuals should consider them a potential risk.

No. While sometimes used interchangeably, cross-contact specifically refers to the transfer of an allergen, whereas cross-contamination typically refers to the transfer of bacteria. A key difference is that cooking does not eliminate allergens transferred via cross-contact.

No, cooking and heat do not destroy food allergens. If a food item has been exposed to an allergen, even in a trace amount through cross-contact, it remains unsafe for someone with that allergy.

A food allergy is an immune system response to a protein in food and can be life-threatening. A food intolerance is a digestive system issue and is generally not life-threatening. Allergen labelling regulations are in place to protect those with true food allergies.

No. 'Gluten-free' regulations address gluten, a protein in wheat and other grains. While many wheat-allergic individuals also need to avoid gluten, a 'gluten-free' product can still contain other non-gluten wheat proteins that can cause an allergic reaction. Always check the full ingredient list for wheat.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.