How do US and EU allergen labelling rules differ?

The United States requires nine major food allergens to be declared, either within the ingredient list or in a "Contains" statement next to it (section 403(w) of the Federal Food, Drug, and Cosmetic Act). The European Union requires fourteen, and they must be emphasised within the ingredient list itself, for example in bold (Article 21 and Annex II of Regulation (EU) No 1169/2011). Celery, mustard, lupin, molluscs, sulphites, barley, rye and oats are declared as allergens only in the EU. The US also requires the species of fish and crustacean shellfish to be named.

Where the rules come from

United States. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) defines "major food allergen", and section 403(w) (21 U.S.C. 343(w)) sets the labeling requirement. Both were added by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA, Public Law 108-282, enacted 2 August 2004), for food labeled on or after 1 January 2006. The FASTER Act of 2021 (Public Law 117-11, signed 23 April 2021) added sesame as the ninth allergen. That change applies to food introduced or delivered for introduction into interstate commerce on or after 1 January 2023.

The requirement sits in the statute, not in 21 CFR Part 101. FDA's current interpretation is its final guidance Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5) ("Edition 5"), announced on 6 January 2025 (Federal Register notice, 7 January 2025). The guidance is non-binding.

European Union. Article 9(1)(c) of Regulation (EU) No 1169/2011 makes allergen information mandatory. It covers any ingredient or processing aid listed in Annex II, or derived from one, that is still present in the finished product "even if in an altered form". Article 21 sets out how it is shown, and Annex II lists the fourteen allergens, as amended by Delegated Regulation (EU) No 78/2014 and Delegated Regulation (EU) 2024/2512. The 2024 amendment excludes from the mustard entry the emulsifiers E 470a, E 471 and E 477 made with behenic acid from mustard seed (at least 85 % pure, obtained after two distillation steps); it applies from 1 April 2025. Commission Notice 2017/C 428/01 gives the Commission's reading.

The nine US allergens and the fourteen EU allergens

Annex II also lists exceptions, among them wheat-based glucose syrups and maltodextrins, fully refined soybean oil and fat, isinglass used to fine beer and wine, and lactitol. The sulphite threshold is calculated on the product as ready for consumption or as reconstituted according to the manufacturer's instructions.

Master comparison: US and EU allergen labelling

How a US declaration works

Section 403(w)(1) offers two methods; a label may use either or both.

• Contains statement. "Contains", with a capital C (Edition 5, D.7), followed by the food sources, printed immediately after or next to the ingredient list: "Contains: milk, egg, peanuts". If used, it must name every major allergen in the food, including those already named in the list (Edition 5, D.1 and D.6). It is reserved for the major allergens (D.10).
• Within the ingredient list. The source follows the ingredient in parentheses: "whey (milk)". This is not needed where the ingredient's name already uses the source ("nonfat dry milk") or the source name appears elsewhere in the list. The exception is a source name that appears only in the name of an ingredient that is not a major food allergen, such as highly refined soybean oil (§ 403(w)(1)(B)(ii)).

Section 403(w)(2) requires the specific type of tree nut and the species of fish or crustacean shellfish; "tree nuts" or "fish" alone does not comply. In the ingredient list FDA expects the name from its Seafood List; a "Contains" statement may use a generic name such as "salmon" (Edition 5, C.6).

Edition 5 also settles several definitions:

• Tree nuts (Table 1). Twelve: almond, black walnut, Brazil nut, California walnut, cashew, filbert/hazelnut, heartnut/Japanese walnut, macadamia nut/bush nut, pecan, pine nut/pinon nut, pistachio and walnut (English, Persian). Tree nuts not in Table 1 (coconut is not a Table 1 item) must still appear in the ingredient list by common name (21 CFR 101.4), but not in the "Contains" statement (C.8).
• Milk and eggs. Milk from domesticated cows, goats, sheep or other ruminants; eggs from domesticated chickens, ducks, geese, quail and other fowl. Name a non-cow or non-chicken source: "goat milk", "duck egg" (C.1–C.4).
• Sesame in spices. Sesame in a blend declared as "spices" must still appear, as "spices (sesame)" or "Contains sesame" (B.5).

How an EU declaration works

Article 21(1) requires the allergen to appear in the list of ingredients "with a clear reference to the name of the substance or product as listed in Annex II", and to be emphasised so that it clearly stands out, for example by bold, capitals, underlining or a background colour (Article 21(1)(b) leaves the method to the business; Notice, point 15).

The Commission Notice (2017/C 428/01) adds:

• Cereals. Name the cereal: wheat, rye, barley or oats. "Spelt" or "khorasan" needs a reference to wheat, e.g. "wheat (spelt)". "Gluten" may be added but does not replace the cereal name (points 8–11).
• Nuts. The Annex II list is exhaustive (point 6). Name the nut in derived ingredients too: "flavourings (almond)" (point 13).
• Compound ingredients. Emphasise allergens inside them too (point 17).
• No voluntary repetition. Allergen information may not be repeated outside the list as "contains …", in symbols or in text boxes (point 27).

Where there is no list of ingredients, the label uses "contains" followed by the Annex II name (Article 21(1), second subparagraph), for example on foods exempt under Article 19, or on beer and spirit drinks above 1.2% alcohol by volume (Article 16(4)). Wine has needed a list of ingredients since 8 December 2023; where that list is given only electronically, the allergens must still appear on the label as "contains" followed by the Annex II name (Regulation (EU) No 1308/2013, Article 119(1)(i) and (5)(c), as amended by Regulation (EU) 2021/2117).

For food sold without prepackaging, allergen information stays mandatory (Article 44(1)(a)), and each Member State may decide how it is provided (Article 44(2)).

Precautionary "may contain" labelling

Neither market has a harmonised rule.

• United States. Section 403(w) does not address advisory statements. A "may contain" statement must be truthful and not misleading (§ 403(a)(1)) and does not replace good manufacturing practice under 21 CFR Part 117 (Edition 5, D.12 and D.15). FDA advises against "may contain milk" alongside a milk ingredient or a "milk-free" claim (D.13–D.14).
• European Union. Precautionary statements are voluntary information and must not mislead or confuse (Article 36(2)). Article 36(3)(a) foresees implementing acts on the "possible and unintentional presence" of allergens; the Commission's page still lists them as to be adopted. The Commission's February 2026 factsheet (Allergen labelling in the EU: Ensuring consumer safety, 23 February 2026) says such statements should rest on a risk assessment. Check the current status before relying on this.

One label for both markets: the gotchas

1. EU-only allergens. Celery, mustard, lupin, molluscs, sulphites above the threshold, and barley, rye and oats must be emphasised for the EU. They do not belong in a US "Contains" statement (Edition 5, D.10).
2. "Contains" against emphasis. A US "Contains" box below an emphasised EU list is the repetition the Commission says is not permitted (Notice, point 27). The US box is optional, so one list can serve both: name the source in the list (§ 403(w)(1)(B)), emphasise every Annex II allergen (Article 21(1)(b)), and leave out the box. For example: "wheat flour, whey (milk), cod (fish), mustard seed". This works only if every major allergen, including any in processing aids, is named in the list (Edition 5, D.8).
3. Different species lists. The US needs the species of fish and crustacean. Our reading of Article 21(1)(a) is that the EU label should refer to "fish" or "crustaceans", e.g. "cod (fish)", which serves both; the Commission Notice gives no example for fish. Pine nut, black walnut, California walnut and heartnut are US major allergens but not on the EU's exhaustive list, which names walnut as Juglans regia only. The EU names Corylus avellana and Macadamia ternifolia; FDA covers Corylus spp. and Macadamia spp.
4. Refined oils. Highly refined peanut oil is exempt in the US but must be emphasised as peanut in the EU, where only fully refined soybean oil and fat is excepted.
5. Sulphites. The EU threshold is more than 10 mg/kg or 10 mg/litre as total SO₂. In the US, sulfites are not a major allergen: added sulfites are listed as ingredients, and incidental sulfites must be declared at 10 ppm or more (21 CFR 101.100(a)(4)).
6. Milk and eggs. FDA refers to ruminants and domesticated fowl; the Commission reads Annex II as covering milk from farmed animals and eggs from all farmed birds (Notice, point 6).

Common mistakes

How RegaaS checks this

RegaaS applies FD&C Act §§ 201(qq) and 403(w), added by FALCPA and amended by the FASTER Act (the nine major food allergens, in the ingredient list or a "Contains" statement, cited to the statute), and Regulation (EU) No 1169/2011, including emphasis of the fourteen listed allergens within the ingredient list. A label for both markets can be reviewed against each market's rules. Each finding cites its provision, is marked on the label image and comes with suggested text; the report states which provisions were applied and when (rule set reviewed 10 September 2026).

Every rule applied gets one of four results: Compliant, Needs review, Potential risk or Not applicable. Where the information provided is not enough to decide, or the case is borderline, RegaaS marks the rule Needs review and refers it to regulatory staff instead of reaching a conclusion. Each Potential risk shows where the issue is on the label, the provision and the version in force, and a suggested revision. Whether a finding stands, and what to do about it, is decided by regulatory staff. When a provision is amended, RegaaS identifies the products already reviewed against it so they can be checked again.

The same "Contains" line would be correct on the US label, because mustard and barley are not major food allergens under § 201(qq).

What this guide does not cover

RegaaS reports the following as out of scope:

• meat, poultry and egg products regulated by USDA FSIS, and most alcoholic beverages regulated by TTB;
• EU food supplements;
• EU "gluten-free" statements (Implementing Regulation (EU) No 828/2014) and lactose statements;
• Member State language requirements;
• Great Britain, which has had its own food information regime since EU exit (Northern Ireland applies EU rules), and Switzerland;
• US state requirements.

This guide also does not cover national measures for non-prepacked food under Article 44(2), or allergen controls in the plant under 21 CFR Part 117.

A RegaaS report is a documented review against the provisions above. It is not legal advice, and it does not replace sign-off by a qualified regulatory professional.

Frequently asked questions

How many allergens must be declared in the US and in the EU? Nine in the US (FD&C Act § 201(qq)) and fourteen in the EU (Annex II to Regulation (EU) No 1169/2011).

Is sesame a major allergen in the US? Yes. The FASTER Act of 2021 made sesame the ninth major food allergen, for food introduced into interstate commerce on or after 1 January 2023.

Can I put a "Contains" statement on an EU label? Only where the food has no list of ingredients (Article 21(1), second subparagraph). Otherwise allergens are emphasised within the list, and the Commission's view is that they should not be repeated in a "contains" line.

Do allergens have to be in bold on a US label? No. Section 403(w) requires the food source to be named in the ingredient list or in a "Contains" statement. It does not require typographic emphasis.

Is "may contain" labelling mandatory? No. It is voluntary in both markets and must not mislead. The EU implementing act foreseen by Article 36(3)(a) of Regulation (EU) No 1169/2011 has not yet been adopted.

Is coconut a tree nut allergen? Not under FDA's January 2025 guidance, whose Table 1 lists twelve tree nuts without coconut. It is not on the EU's exhaustive nut list in Annex II point 8 either.

Primary sources

• 21 U.S.C. 321(qq), definition of major food allergen
• 21 U.S.C. 343(w), major food allergen labeling requirements
• Public Law 108-282, Title II: FALCPA (2004)
• Public Law 117-11: FASTER Act of 2021
• FDA, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), January 2025
• 21 CFR 101.100, food exemptions from labeling
• Regulation (EU) No 1169/2011 on the provision of food information to consumers
• Commission Delegated Regulation (EU) No 78/2014
• Commission Delegated Regulation (EU) 2024/2512
• Regulation (EU) No 1169/2011, consolidated text of 1 April 2025
• Regulation (EU) No 1308/2013, Article 119 (wine labelling)
• Commission Notice 2017/C 428/01 on allergen information
• European Commission, voluntary food information