How to list allergens on a label?

October 30, 2025 •

3 min read

A recent study found that nearly 60% of people with food allergies have had a reaction due to unclear or mislabeled food packaging. For food manufacturers, retailers, and distributors, knowing precisely how to list allergens on a label is not just a legal obligation but a critical responsibility that protects public health. This comprehensive guide breaks down the complex rules and provides clear, actionable steps for ensuring accurate labeling.

Quick Summary

This guide details how to list allergens on a label correctly, covering legal requirements from different regions, formatting rules for ingredients, and proper use of precautionary statements. It provides a roadmap for ensuring full regulatory compliance and consumer safety.

Key Points

Understand Regional Laws: Comply with regulations like the U.S. FALCPA (with the addition of sesame) and the EU's 14 mandatory allergens.
Emphasize Allergens Clearly: Use bolding or other contrasting text styles to highlight allergens within the ingredients list every time they appear.
Use a 'Contains' Statement: Include a separate, consolidated 'Contains' summary statement near the ingredients list for added clarity.
Implement Cross-Contact Controls: Manage allergens through segregation, dedicated equipment, and supplier verification to prevent accidental contamination.
Use Precautionary Statements Responsibly: Apply 'May Contain' warnings only when a real and unavoidable cross-contact risk is identified through a risk assessment.
Provide Clear Information: Ensure all product labels, whether for pre-packaged or direct-sale items, have complete and easy-to-read allergen information.

Understanding Regional Allergen Labeling Laws

Navigating allergen labeling requires a solid grasp of the regulations specific to your target market, as rules vary significantly between regions like the United States and the European Union.

United States Regulations: FALCPA and the FASTER Act

In the U.S., the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 mandates that food labels clearly state the name of the food source for any major allergen present. The FASTER Act of 2021 updated the original list of eight major allergens, adding a ninth.

The nine major U.S. food allergens are:

Milk
Eggs
Fish
Crustacean shellfish
Tree nuts
Peanuts
Wheat
Soybeans
Sesame

European Union Regulations: EU Food Information for Consumers (EU FIC)

EU Regulation (EU) No 1169/2011, or EU FIC, governs allergen information in the EU. It requires the declaration of 14 specific allergens, which must be emphasized within the ingredients list whenever they appear.

The 14 EU mandatory allergens are:

Celery
Cereals containing gluten
Crustaceans
Eggs
Fish
Lupin
Milk
Molluscs
Mustard
Peanuts
Sesame seeds
Soybeans
Sulphur dioxide and sulphites (at levels >10 ppm)
Tree nuts

Proper Formatting and Placement on Labels

Allergens must be prominently displayed. In both the U.S. and EU, emphasis within the ingredients list is crucial. A common method is bolding. The source must be specified for ingredients derived from an allergen, e.g., Whey (milk). A separate "Contains" statement summarizing allergens is often used immediately after the ingredients list in the U.S.. Precautionary Allergen Labeling (PAL), like "may contain [allergen]", addresses cross-contact risk but should only be used after a thorough assessment and is not a substitute for proper controls.

How to Manage Cross-Contact

Minimizing unintended allergen contamination is vital. Key preventive measures include segregating ingredients, using dedicated equipment (or implementing rigorous cleaning), verifying ingredient specifications with suppliers, and providing staff training.

Comparison of Allergen Labeling Regulations


Feature	United States (FALCPA + FASTER Act)	European Union (EU FIC)
Governing Act	Food Allergen Labeling and Consumer Protection Act (FALCPA) and FASTER Act	EU Food Information for Consumers (EU FIC)
Mandatory Allergens	9 major allergens	14 mandatory allergens
Ingredients List Declaration	Can be in parentheses or summarized in a 'Contains' statement	Must be emphasized (e.g., bolded) every time it appears in the ingredients list
'Contains' Statement	Optional, but commonly used for a summary	Optional, but used in some regional contexts and for certain products
Precautionary Statements ('May Contain')	Voluntary, but should be truthful and not misleading. Not a substitute for Good Manufacturing Practices.	Voluntary, should only be used when cross-contact risk is unavoidable after all measures are taken.
PPDS Foods	Labeling requirements typically apply to prepackaged foods.	Explicit rules for pre-packaged for direct sale (PPDS) foods, requiring full labeling.

Conclusion

Accurate and transparent allergen labeling is a cornerstone of food safety and consumer trust. By adhering to strict regional regulations like FALCPA and EU FIC, and implementing robust cross-contact prevention measures, food businesses can protect sensitive consumers and avoid costly recalls. Clear formatting, proper declaration within the ingredients list, and responsible use of precautionary statements are all critical steps in ensuring a safe food supply chain. Consistent and reliable labeling gives consumers the confidence to make informed, safe dietary choices.

For more detailed guidance on specific regulations, refer to authoritative sources like the U.S. Food and Drug Administration (FDA) or the Food Standards Agency in the UK.

Frequently Asked Questions

Following the FASTER Act of 2021, the U.S. recognizes nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.

No, the EU mandates the declaration of 14 specific allergens under its Food Information for Consumers (EU FIC) regulation, which includes some not on the U.S. list, such as celery, mustard, and lupin.

No, these are voluntary statements used to inform consumers of an unavoidable cross-contact risk after all possible preventative measures have been taken.

Allergens should be emphasized through a distinct font style, such as bolding, or by using a contrasting color. The specific allergen source must be clearly identified.

Natasha's Law is a UK regulation that requires full ingredient and allergen labeling on foods pre-packaged for direct sale (PPDS). It was introduced to address the risks associated with foods prepared and packaged on-site.

Yes, for products like alcoholic beverages that may not have a full ingredients list, allergens still must be declared, often by preceding the allergen name with the word 'contains'.

No, a 'Contains' statement is not always mandatory. Consumers should always read the full ingredients list to verify the presence of allergens, as the list is the most complete source of information.