Precautionary allergen labelling

“May contain” is voluntary food information under Article 36, not an Annex II ingredient

Direct answer. In the consolidated text of Regulation (EU) No 1169/2011, CELEX 02011R1169-20250401 (EN, 01.04.2025; reference line 02011R1169 — EN — 01.04.2025 — 004.001), Article 36 is titled “Applicable requirements.” Article 36(2) says food information provided on a voluntary basis shall not mislead the consumer, as referred to in Article 7; shall not be ambiguous or confusing for the consumer; and shall, where appropriate, be based on the relevant scientific data. Article 36(3)(a) requires the Commission to adopt implementing acts on the application of those requirements to “information on the possible and unintentional presence in food of substances or products causing allergies or intolerances.” Commission Notice 2022/C 355/01 (CELEX 52022XC0916(01)) says that information may be provided on a voluntary basis, and that harmonised provisions are pending. This page did not find an adopted implementing act for Article 36(3)(a). This page is not legal advice.

EU Food Info Guard (Shopify App Store · Write a review): “Review allergen, ingredient, nutrition, net quantity, origin, operator, and storage gaps before food product display.” The 14 Annex II names are a separate list. A “may contain” line is not that ingredient list.

Related: FibreLedger Textile Labels — EU fibre composition uses Annex I names.

Free check first: EU food label particulars checklist runs in your browser and sends nothing. Paste food-label text and see which particulars it mentions.

Checklist before you add “may contain”

Article 36(2) and Article 36(3)(a)

Article 36(2) says: “Food information provided on a voluntary basis shall meet the following requirements: (a) it shall not mislead the consumer, as referred to in Article 7; (b) it shall not be ambiguous or confusing for the consumer; and (c) it shall, where appropriate, be based on the relevant scientific data.”

Article 36(3) says the Commission shall adopt implementing acts on the application of the requirements referred to in paragraph 2 to the following voluntary food information, and point (a) is: “information on the possible and unintentional presence in food of substances or products causing allergies or intolerances.” The article then says those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). Points (b), (c), and (d) of the same paragraph are other voluntary-information cases. This page is point (a).

Commission Notice 2022/C 355/01

The notice is titled “Commission Notice on the implementation of food safety management systems covering Good Hygiene Practices and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses.” It is OJ C 355, 16.9.2022, CELEX 52022XC0916(01). Section 3.7, Allergens, says: “According to Regulation (EU) No 1169/2011 mandatory labelling only applies where allergenic products or substances have been intentionally added as ingredients or processing aids. Information on the possible and unintentional presence in food of substances or products causing allergies or intolerances may be provided on a voluntary basis (6) (Article 36 of Regulation (EU) No 1169/2011, paragraph 3, point a)). Voluntary information provided to the consumers has to comply with the provisions of Article 36 of the Regulation. In particular, such voluntary information must not be misleading ambiguous or confusing for the consumer; and must, as appropriate, be based on the relevant scientific data. Pending the adoption of such harmonised provisions, food business operators are responsible to ensure that such information when provided is not misleading, ambiguous or confusing for consumers.”

The next paragraph says: “Precautionary allergen labelling (PAL), should only be used where a preventive strategy cannot be efficiently implemented and the product may present a risk to allergic consumers. Precautionary allergen labelling is a separate statement next to the list of ingredients and should be based on the findings of an appropriate risk assessment, conducted by the food manufacturer, to evaluate the possible and unintended presence of allergens. Allergens (potentially) present in the product via cross-contamination should not be included in the list of ingredients as they are not intentionally added and are no part of the formula of the product. Such labelling should never be used as an alternative to preventive measures.” The punctuation and the words “are no part” are the notice’s. An allergen named in the ingredients but missing from the declared list is a different gap. Showing the declared list on the product page is a theme-block job.

United Kingdom

GOV.UK, Precautionary allergen labelling (PAL), says: “If you’ve identified a risk of potential allergen cross-contamination which cannot be controlled, you should use precautionary allergen labelling (PAL) to warn consumers.” It says you can use wording such as “may contain milk” or “not suitable for people with a nut allergy,” and: “You should not use general statements such as ‘may contain allergens’.” It says not to use PAL in combination with a free-from statement for the same allergen, and not as a substitute for food hygiene and safety practices. It also says: “If you use PAL when no genuine risk to the consumer has been identified, you could be misleading consumers and therefore breaking food law.” The page tells businesses to contact the Food Standards Agency hypersensitivity team. The former Food Standards Agency URL food.gov.uk/business-guidance/precautionary-allergen-labelling redirects to GOV.UK food labelling.

The FSA technical guidance on GOV.UK, paragraph 24, says: “A Precautionary Allergen Label (PAL) is a statement that food businesses can choose to apply to food products where there is an unavoidable risk of allergen cross-contamination. It is commonly seen as ‘may contain allergen x’ or ‘not suitable for someone with x allergy’ on food products.” Paragraph 23 of that guidance points voluntary statements to Chapter V of the Food Information to Consumers Regulation, including the rule that they must not mislead consumers or be ambiguous or confusing.

What this page is not

Related pages

Not legal advice. Confirm Article 36 on the live consolidated text, and section 3.7 of Commission Notice 2022/C 355/01, before you treat a “may contain” line as voluntary information or as an ingredient. The app reviews gaps in the food information you enter.