Allergen labelling rules for UK food and US packaged food
UK allergen labelling requires ingredient emphasis. May contain warnings address cross-contact. Check separate catering, delivery and US label rules.
For UK prepacked food, allergen labelling must identify relevant Annex II allergens in the ingredients list and make their names stand out. A separate "may contain" warning concerns unintended cross-contact, not an allergenic ingredient deliberately used in the recipe. They are separate decisions: Article 21 governs ingredient declarations, while FSA guidance addresses precautionary warnings.
Loose food, food prepacked for direct sale and online orders need separate checks. For FDA-regulated US packaged food, both the major-allergen list and declaration format differ. Don't approve one label for both markets without reviewing those differences. The relevant starting points are FSA business guidance and FDA's food-allergy guidance.
Former EU food-information legislation operates as assimilated law in GB and as directly applicable EU law in Northern Ireland. For NI, check the applicable EU text rather than assuming the GB wording applies unchanged. Some retail movements into Northern Ireland follow specific arrangements, so check FSA business guidance before treating a GB label as enough. FSA best-practice guidance explains the GB and NI distinction.
Identify and emphasise ingredient allergens
Article 21 requires a clear reference to the relevant Annex II allergen name. Typesetting must make that name stand out from the other ingredients, for example by font, style or background colour. Bold is one permitted method. For England, Wales and Northern Ireland, FSA says to emphasise the allergen each time it appears in the ingredients list. Food Standards Scotland confirms the same emphasis for prepacked food in Scotland. Where several ingredients come from the same allergen, make the source clear for each relevant ingredient. See Article 21 and FSA's labelling instructions.
The 14 Annex II categories are cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk including lactose, specified nuts, celery, mustard, sesame, sulphur dioxide and sulphites more than the stated threshold, lupin and molluscs. This is a legal declaration list, not every food capable of causing an allergy.
Name the cereal or specified nut. "Gluten" or an undifferentiated "nuts" does not supply that detail. The specified nuts are almonds, hazelnuts, walnuts, cashews, pecans, Brazil nuts, pistachios and macadamia or Queensland nuts. Coconut is not among them. For sulphites, the threshold is more than 10 mg/kg or 10 mg/litre, expressed as total SO₂. Calculate it for food ready for consumption or reconstituted according to instructions. These details come from Annex II.
Check derivatives against the actual exemption text. Annex II exempts fully refined soybean oil and fat, and specified wheat glucose syrups, subject to its qualifications. Those exemptions do not cover every oil or syrup. A formulation review should use Annex II itself, rather than a blanket rule about ingredients derived from allergens.
Where no ingredients list is required, Article 21 specifies "contains" followed by the relevant allergen name, unless the food's name clearly refers to that substance or product. That route does not let a separate Contains box replace an otherwise required ingredients list. Check the conditions in Article 21.
When should precautionary allergen labelling be used?
FSA recommends precautionary allergen labelling only after a risk assessment identifies cross-contact that risk-management actions cannot remove. It is voluntary information about unintended presence. It should not replace good food hygiene or safety practices. The FSA guidance sets out the recommended assessment process. Do not treat each recommended step as a separate statutory duty.
Use a specific warning, such as "may contain" followed by the relevant allergen. Blanket "may contain allergens" wording is not appropriate. Voluntary information must not mislead or be ambiguous or confusing. Nor should a label combine "free from milk" with "may contain milk". These points appear in the FSA precautionary allergen labelling guidance, which applies to England, Wales and Northern Ireland.
During artwork approval, keep the ingredient decision separate from the cross-contact decision. An intentional allergenic ingredient still needs its Article 21 declaration. A "may contain nuts" warning cannot repair that omission, and it does not remove the need to assess and control cross-contact under the FSA's recommended approach.
Give allergen information for non-prepacked food
Loose food still needs allergen information, but the communication route differs from a prepacked ingredients list. In England, the operator can give allergen information by any chosen means, including orally, for non-prepacked food and food packed at the customer's request. A notice that customers can ask staff is required when that information is given orally. It can be a readily discernible notice, menu, ticket or label where the customer chooses the food. This route excludes PPDS and distance sales under England's regulation 5.
Scotland and Northern Ireland have their own oral-information provisions. Those provisions also require visible signposting when staff give the information orally. FSA's business guidance also covers Wales. An England-only instrument is not the legal basis for every UK nation.
FSA's best-practice guidance, published 24 February 2025, recommends easily available written information supported by a conversation. It applies to England, Wales and Northern Ireland, excludes PPDS and does not change the minimum legal requirement. Written information is the recommendation, not a new UK-wide written-menu law. The guidance expressly distinguishes best practice from law.
Keep PPDS separate
Prepacked for direct sale, or PPDS, food needs a food name and full ingredients list with allergens emphasised. Put those particulars on the packaging or an attached label. The applicable provisions include statutory qualifications, so do not treat a guidance summary as the whole rule. See FSA business guidance and Food Standards Scotland's PPDS guidance.
Don't assume that food packed after a customer's order is PPDS. Establish the sales category before choosing the label route. England's regulation 5A and the Scottish equivalent set out the packaging requirements and exclude sales by distance communication.
Check information before purchase and at delivery
Distance sales require allergen information before the purchase is completed and at delivery. Article 14's pre-purchase exception for date marking is not an exception for allergen information. Check Article 14 when reviewing online or telephone ordering.
For non-prepacked delivery, FSA recommends written information at both stages. That is best practice, rather than a universal statutory requirement to use writing. Do not automatically transfer the face-to-face PPDS packaging rule to distance sales.
Check US allergy labeling separately
FDA-regulated packaged food has nine major allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame requirements took effect on 1 January 2023. The UK list cannot be converted simply by deleting five categories: its cereal and shellfish categories differ. Use FDA's list for this review.
| Label decision | UK prepacked food | FDA-regulated US packaged food |
|---|---|---|
| Ingredient allergen declaration | Emphasise the relevant Annex II name in the ingredients list. | Use source-identifying ingredient names, parenthetical sources or an adjacent Contains statement. |
| Separate Contains statement | Does not replace an otherwise required ingredients list. | If used, must cover all relevant major allergens. |
| Cross-contact warning | FSA recommends a risk assessment and controls before PAL. | Voluntary statements must be truthful and not misleading, and should not replace current good manufacturing practices. |
Sources: Article 21, FSA PAL guidance and FDA food-allergy information.
A US label does not always need a new Contains statement: ingredient names may already identify the required sources. Relevant tree-nut types and fish or Crustacean species must also be identified. FDA's label-reading guidance covers that check. FDA's FAQ, with relevant entries updated 26 March 2025, says coconut is no longer a tree nut treated as a major food allergen, but coconut still belongs in the ingredients list unless an exemption applies. See the FDA allergen FAQ. This comparison covers FDA-regulated packaged food, not US restaurant rules or every product-specific regime.
Before approving the label
Use these checks during artwork approval, alongside the applicable rules:
- Confirm the market and sales category before selecting the declaration format.
- Check the formulation against the applicable allergen list and exact derivative exemptions.
- Review each allergen occurrence in the artwork, not just a separate warning box.
- Keep the cross-contact assessment and resulting warning decision together.
- Check how customers receive information before purchase and at delivery.
RegAffairs AI's answer on allergen labelling provides a starting point for checking the source texts.