Q.01

How should allergens be labelled on food in the UK?

Across the UK, food businesses must declare 14 named allergens whenever they are used as an ingredient or processing aid and are still in the finished food. How you do that depends on the type of food. Prepacked food and food prepacked for direct sale (PPDS) need the allergens emphasised in a full ingredients list on the label. Loose food can be covered by written or spoken information. The legal basis is Regulation (EU) No 1169/2011 on food information to consumers (FIC). It applies as assimilated law in Great Britain and as EU law in Northern Ireland, and the Food Information Regulations 2014 (with separate versions for Wales and Northern Ireland) enforce it (FSA technical guidance, para. 1).

Approach: I read the EU FIC text and the FSA's guidance in the datasets, then the current FSA guidance on GOV.UK (England, Wales and Northern Ireland) and Food Standards Scotland's PPDS page. I could not open the GB assimilated text on legislation.gov.uk, so GB legal wording below comes from FSA guidance, and the article quotes come from the EU text, which is the version that applies in Northern Ireland.

The 14 allergens (FIC Annex II)

  1. Cereals containing gluten (wheat, including spelt and khorasan wheat, rye, barley, oats)
  2. Crustaceans
  3. Eggs
  4. Fish
  5. Peanuts
  6. Soybeans
  7. Milk, including lactose
  8. Tree nuts: almonds, hazelnuts, walnuts, cashews, pecans, Brazil nuts, pistachios and macadamia nuts
  9. Celery
  10. Mustard
  11. Sesame
  12. Sulphur dioxide and sulphites at more than 10 mg/kg or 10 mg/litre as total SO2, calculated on the food as ready to eat or as made up by the maker's instructions
  13. Lupin
  14. Molluscs

Some highly processed derivatives are exempt, for example wheat-based glucose syrups, fully refined soybean oil, and whey or nuts used to make alcoholic distillates [1]. Declaring these is mandatory under Article 9(1)(c) [2]. The same 14 are on the FSA's list (FSA allergen guidance).

Prepacked food (Article 21)

  • Where: allergens "shall be indicated in the list of ingredients", with a clear reference to their Annex II name.
  • How: the allergen name "shall be emphasised through a typeset that clearly distinguishes it from the rest of the list", for example font, style or background colour [3].
  • Every time: the FSA says allergens "must be emphasised each time they appear in the ingredients list" (FSA).
  • Unfamiliar names: these need a pointer to the allergen, such as "tahini (sesame)", "whey (milk)" or "spelt (wheat)". For gluten, it is the cereal that must be emphasised, not the word "gluten" (technical guidance, paras 29-30, 47, 42).
  • No ingredients list (for example drinks over 1.2% alcohol): use "contains" followed by the Annex II name.
  • Name of the food: no extra declaration is needed if the name clearly refers to the allergen [3].
  • No repeat "Contains" box: where there is an ingredients list, the FSA says the FIC does not allow a voluntary "Contains: wheat, egg and milk" statement that repeats it (para. 71).
  • Small packs: if the largest surface is under 10 cm², the ingredients list can be left off, but allergens must still be declared on the pack with "Contains…" (para. 56).
  • Font size: an x-height of 1.2 mm or more is required where the labelling surface is 80 cm² or more (para. 55).

Prepacked for direct sale (PPDS, "Natasha's Law")

  • What it is: food packed by the same business, on the same premises or site (or for its own market stall or mobile outlet), before it is offered for sale. Examples are sandwiches, deli pizzas, rotisserie chicken, and burgers made by a butcher on site.
  • What the label needs: the name of the food and a full ingredients list, with allergens emphasised every time they appear, for example in bold, capitals, a contrasting colour or underlined (paras 94, 101).
  • Start date: these rules took effect in all four UK nations on 1 October 2021 (para. 92). Food Standards Scotland confirms the same rules for Scotland (FSS PPDS).
  • What is not PPDS: food packed after the customer orders, which counts as non-prepacked, and food packed by one business and sold by another, which counts as fully prepacked (FSA PPDS introduction).

Non-prepacked (loose) food and catering

  • Legal basis: allergen information stays mandatory under FIC Article 44(1)(a). The method of providing it is left to national measures [4].
  • Methods: businesses "must supply allergen information for every item that contains any of the 14 allergens". This can be written (menu, chalkboard, information pack) or spoken, as long as a written notice in a clearly visible position tells customers how to get it (FSA). The technical guidance links this to Regulation 5(4) of the Food Information Regulations (para. 81).
  • Buffets: give the information for each item separately, not for the buffet as a whole.

Distance selling (online, phone)

  • Allergen information must be available free of charge before the purchase is completed and when the food is delivered (technical guidance, paras 72, 86-88).
  • For PPDS food sold this way, the full ingredients list requirement does not apply; Article 14 of the FIC governs instead (para. 104).

"May contain" (precautionary allergen labelling)

  • This labelling is voluntary under FIC Article 36. It must not mislead, and it must not be ambiguous or confusing [5].
  • When to use it: the FSA says it should only be used where a risk assessment has found an unavoidable cross-contamination risk that cannot be controlled.
  • Wording: it should name the specific allergen ("may contain milk"). Generic wording such as "may contain allergens" is not acceptable (GOV.UK PAL guide).
  • Peanuts: "May contain nuts" does not cover peanuts (technical guidance, para. 38).
  • Combinations: do not pair "may contain" with a "free from" claim for the same allergen. It can sit alongside a "vegan" label, or alongside "gluten-free" (which means no more than 20 mg/kg gluten) (paras 67-69, 31).

Differences between the nations

  • England, Wales and Northern Ireland: the FSA guidance covers all three.
  • Northern Ireland: the EU text of Regulation 1169/2011 applies. Under the Windsor Framework, GB public-health standards can apply to prepacked retail goods moved through the Northern Ireland Retail Movement Scheme (NIRMS) (FSA).
  • Scotland: Food Standards Scotland publishes its own guidance and applies the same PPDS requirements.

Enforcement

Local authorities enforce these rules. Breaking the allergen requirements in Regulation 10 of the Food Information Regulations is a criminal offence, and on conviction the fine can be unlimited (technical guidance, paras 107-108).

Q.02

When should food labels say may contain?

Only put "may contain" on a label when a risk assessment has found a real risk of cross-contamination with a specific allergen that you can't control through measures such as segregation and cleaning. The statement is voluntary under UK law. If you do use it, it must not be misleading, ambiguous or confusing.

Approach: I checked the text of Regulation (EU) No 1169/2011 on food information to consumers (FIC) in the datasets. The datasets don't hold the FSA's guidance on precautionary allergen labelling (PAL), so that comes from FSA pages on GOV.UK and from Food Standards Scotland.

Legal basis

  • "May contain" is voluntary information under FIC Article 36. Article 36(2) says such information "shall not mislead the consumer", "shall not be ambiguous or confusing for the consumer" and "shall, where appropriate, be based on the relevant scientific data."
  • Article 36(3)(a) names "the possible and unintentional presence in food of substances or products causing allergies or intolerances" as an area where the Commission "shall adopt implementing acts" [5].
  • Article 7 also applies: food information "shall not be misleading" and "shall be accurate, clear and easy to understand" [6].

When to use it (FSA, England, Wales and Northern Ireland)

  • The trigger: the FSA's best-practice guidance says PAL "should only be provided… if an unavoidable risk of allergen cross-contamination has been identified following a risk assessment that cannot be sufficiently controlled through controls, such as segregation and cleaning" (technical guidance, para. 25).
  • Why it matters: PAL is voluntary, but to avoid supplying food that could be deemed unsafe, businesses "should" give accurate information about the risk of allergens being present unintentionally (para. 25).
  • What it is not: PAL is no substitute for good hygiene and safety practice. Using it where no real risk has been identified is misleading and breaks food information law (GOV.UK PAL guide).
  • Supplier warnings: pass on any PAL you get from ingredient suppliers to the final consumer, "unless your risk assessment supersedes that information" (GOV.UK).
  • Review: reassess your PAL statements, especially when you change suppliers or manufacturing processes.

How to word it

  • Name the allergen: for example "may contain milk" or "not suitable for people with a nut allergy". Don't use vague wording such as "may contain allergens" (GOV.UK).
  • Peanuts: write "May contain peanuts", not "May contain nuts", because peanuts are legumes. Where there are mixed risks, use wording like "May contain peanuts and pistachio (nuts)" (para. 38).

Combining it with other claims

  • "Free from": don't put a "free from" claim and "may contain" on the same product for the same allergen (para. 67).
  • "Vegan": a "vegan" label and "may contain" can appear together (para. 68).
  • "Gluten-free": "gluten-free" (gluten below 20 mg/kg) can sit alongside "may contain wheat". The FSA notes that such a product is suitable for people with coeliac disease but may be a risk for people with an allergy to non-gluten cereal proteins (para. 69).

Loose food and catering

PAL doesn't have to be on a label. It can be given in other ways, such as staff telling customers or signs on the premises (GOV.UK).

Scotland

Food Standards Scotland takes the same line. It says "may contain" statements should only be used "after a meaningful risk assessment has been performed and there is considered to be a significant and real risk", and that using PAL "when there is not a real risk could be considered to be misleading food information" (FSS online allergen training, module 4).

On wording: the law itself says "shall" (no misleading, ambiguous or confusing information). The FSA's rule on when to use PAL is best-practice guidance, worded as "should".

Q.03

How do US allergen labelling rules differ?

The US declares fewer allergens than the UK (9 "major food allergens" against 14) and declares them in a different way. The UK requires the allergen to be emphasised in the ingredients list and does not allow a repeat "Contains" box. US law asks for either a "Contains" statement next to the ingredients list or the food-source name in brackets after the ingredient, and says nothing about bold or other emphasis. "May contain" is voluntary in both countries, but no US statute or regulation governs it.

Approach: For the US I used the FD&C Act (21 U.S.C. 321 and 343, 2023 US Code edition), current 21 CFR Parts 101 and 117, FSIS directives and guidelines, the FDA Food Code 2026 and FDA's guidance catalogue, plus FDA pages on fda.gov. I could not open the PDFs of FDA's Edition 5 allergen Q&A guidance or the draft CPG 555.250, so FDA's current positions come from its web FAQ. I did not check state laws, or TTB rules for alcoholic drinks.

1. Which allergens must be declared

USUK
List9: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, sesame [7]14 (FIC Annex II)
Not on the US listcelery, mustard, lupin, molluscs, sulphites
Gluten cerealsOnly wheat is a major allergen. FSIS says gluten "is not a 'Big 9' major food allergen" [8]All cereals containing gluten
SesameAdded by the FASTER Act, for food entering interstate commerce on or after 1 January 2023 [9] (Food Code Annex text)Already on the list
  • Derived ingredients: an ingredient containing protein from one of the nine is itself a major food allergen. The exceptions are highly refined oils (and ingredients derived from them) and ingredients granted an exemption [7].
  • Tree nuts (January 2025): FDA's Edition 5 guidance removed coconut, beech nut, butternut, chestnut, chinquapin, cola/kola nut, ginkgo nut, hickory nut, palm nut, pili nut, shea nut and lichee nut from its tree nut list (FDA FAQ).
  • Milk and eggs: these now cover milk from cows, goats, sheep or other ruminants, and eggs from chickens, ducks, geese, quail and other fowl. The label names the animal, for example "Contains milk, goat milk" (same FAQ). FSIS has updated its directive to match [8].
  • No compliance deadline: FDA says the January 2028 uniform compliance date does not apply to these changes, and labels should be updated "as soon as practicable" (same FAQ).

2. How allergens are declared on packaged food

Under 21 U.S.C. 343(w)(1), food is misbranded unless it uses one of two methods [10]:

  • (A) "Contains" statement: the word "Contains" followed by the food source, printed "immediately after or is adjacent to" the ingredients list, in type no smaller than that list.
  • (B) Brackets in the ingredients list: the food source in parentheses after the ingredient, for example whey (milk). This is not needed if the ingredient's name already uses the food source, or the food source appears elsewhere in the list.

How this compares with the UK:

  • Emphasis: the statute sets no bold or other emphasis rule. The UK requires emphasis.
  • "Contains" box: this is the main US method. The UK does not allow one that repeats the ingredients list.
  • Specific names: for tree nuts, fish and Crustacean shellfish, the label "means the name of the specific type of nut or species", for example almond, cod or shrimp (343(w)(2)).
  • Flavourings, colourings and incidental additives: these are subject to the allergen rules even where other provisions exempt them from ingredient labelling (343(w)(4)). This overrides the 21 CFR 101.100(a)(3) incidental-additive exemption [11].
  • Raw agricultural commodities: these are outside 343(w).

3. Exemptions

The UK has a fixed list of exempt derivatives in FIC Annex II. The US instead has a case-by-case route [10]:

  • Petition (343(w)(6)): the petitioner must show the ingredient "does not cause an allergic response that poses a risk to human health". FDA has 180 days to decide, or the petition is deemed denied.
  • Notification (343(w)(7)): the evidence must show the ingredient does not contain allergenic protein. The ingredient can be marketed 90 days after FDA receives the notification, unless FDA objects.
  • FDA publishes inventories of the petitions and notifications it has received [12][13].

4. "May contain" (precautionary labelling)

  • FDA (no rule): section 403(w) does not address advisory statements. They are voluntary and "there is no uniform rule that governs what they mean" (FDA FAQ; FDA consumer update).
  • FDA (combinations): FDA says not to put a "may contain" statement next to a "Contains" statement or a "free" claim for the same allergen (same FAQ). This is like the UK's "free from" rule.
  • FSIS (meat, poultry, egg products): "may contain" or "Produced in a plant that uses peanuts" statements "may only be used in cases where establishments show that adequate SSOPS cannot effectively eliminate the cross contact issue". They are "not acceptable" as a replacement for poor sanitation procedures [14]. This is close to the UK's risk-assessment approach, though it is guidance rather than law.
  • Cross-contact controls: these are handled in manufacturing law, not labelling law. Facilities under 21 CFR Part 117 must have food allergen controls, including labelling the finished food so it is not misbranded under 403(w) [15]. They must also protect food from "allergen cross-contact" [16].

5. Gluten-free claims

  • Limit: both countries use 20 ppm. In the US, "gluten-free" requires any unavoidable gluten to be below 20 ppm (below 20 mg/kg) [17].
  • Wheat on a gluten-free food: this is a US-specific rule. If a gluten-free food declares "wheat", the word must carry an asterisk linking to: "The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods" [18].
  • States: states may not set different gluten-free rules [19].

6. Loose food, retail and food service

The US has no federal statutory equivalent of the UK's PPDS rule or of FIC Article 44. In the datasets, the retail rules come from FDA's model Food Code 2026. I did not check which states and localities have adopted this edition.

  • Unpackaged food: the permit holder "shall notify CONSUMERS by written notification of the presence of MAJOR FOOD ALLERGENS as an ingredient in unPACKAGED FOOD items" [9]. The UK allows this information to be given orally.
  • Food packaged at the establishment: the label must give the food source of each major food allergen.
  • Staff training: the person in charge must ensure employees are trained in food allergy awareness [20].

7. Two regulators

FDA covers most food. USDA FSIS covers meat, poultry and egg products under its own laws, which require all ingredients to be declared. FSIS accepts a "Contains: milk, wheat gluten, soy" statement as voluntary [14]. FSIS inspectors check labels against formulations monthly for the Big 9 and gluten. Undeclared allergens can lead FSIS to request a voluntary recall [8].

Practical consequences for a UK product sold in the US

  • New label wording: a UK label with emphasised allergens and no "Contains" box needs either a "Contains" line or the bracketed food-source names.
  • Species names: tree nuts, fish and crustaceans must be named by species. Goat or sheep milk and non-chicken eggs must name the animal.
  • The five extra UK allergens: the US allergen rules do not cover celery, mustard, lupin, molluscs or sulphites. Each ingredient still has to appear in the ordinary ingredients list (FDA FAQ).
Q.04