Allergen labelling rules for chocolate

An allergen used as an ingredient must be declared by law. A “may contain” warning is voluntary in every jurisdiction read here, and its presence or absence has been measured to predict very little. This page keeps the two apart.

4 jurisdictionsRead in the legal textNot advice

Three different things

Legal requirement: What a statute or regulation requires. Read here in the text itself.
Voluntary practice: What a business may choose to say. The law does not require it, and usually attaches conditions if it is said.
Manufacturing control: What a manufacturer does on the production line. The law may require that it be done; it does not say how.

If you have a food allergy, this page cannot tell you what is safe for you. It describes rules and measurements. Decisions about what to eat belong with you and your clinician.

United Kingdom, under the regulation it inherited from the European Union

Regulation (EU) No 1169/2011, Annex II. 14 substances or products.

The list

Cereals containing gluten (wheat, rye, barley, oats)
Crustaceans
Eggs
Fish
Peanuts
Soybeans
Milk, including lactose
Nuts: almonds, hazelnuts, walnuts, cashews, pecans, Brazil nuts, pistachios, macadamia nuts
Celery
Mustard
Sesame seeds
Sulphur dioxide and sulphites above 10 mg/kg or 10 mg/litre
Lupin
Molluscs

The rules

Legal requirement. A listed substance used as an ingredient must appear in the ingredient list by the name in the annex, and that name must be “emphasised through a typeset that clearly distinguishes it from the rest of the list of ingredients, for example by means of the font, style or background colour”. (source 1)
Legal requirement. The annex exempts a few highly processed derivatives by name, among them fully refined soybean oil and fat, and lactitol. Lecithin made from soya is not among the exemptions, which is why it is declared as soya on a chocolate label. (source 1)
Voluntary practice. The regulation treats “information on the possible and unintentional presence in food of substances or products causing allergies or intolerances” as voluntary food information. It sets no wording and no threshold for it. (source 1)
Legal requirement. Voluntary information is still bound by three conditions: it “shall not mislead the consumer”, it “shall not be ambiguous or confusing for the consumer”, and it “shall, where appropriate, be based on the relevant scientific data”. (source 1)

Not read: The European Union's own consolidated text was not opened on the day: EUR-Lex refused automated access. The annex above is the United Kingdom's version of the same regulation, which records its last amendment to this list as a 2013 delegated regulation. The Food Standards Agency's guidance pages on precautionary labelling could not be retrieved as text and are not quoted.

United States

Federal Food, Drug, and Cosmetic Act, section 403(w). 9 major food allergens.

The list

Milk
Eggs
Fish
Crustacean shellfish
Tree nuts
Peanuts
Wheat
Soybeans
Sesame

The rules

Legal requirement. The nine major food allergens must be declared. Sesame became the ninth under an act signed on 23 April 2021, with effect from 1 January 2023. (source 2)
Legal requirement. A label may not say “tree nuts” in general: the statute “requires that the specific type of tree nut be declared (e.g., almonds, pecans, walnuts)”. (source 3)
Voluntary practice. Advisory statements such as “may contain” are, in the agency's words, “not required by law”. The labelling section of the statute “does not address the use of allergen advisory statements”. (source 3)
Legal requirement. If one is used, it “is not a substitute for adherence to current good manufacturing practices or food allergen preventive controls and must be truthful and not misleading”. (source 3)
Manufacturing control. Manufacturers covered by the preventive controls rule (21 CFR part 117) must have “written procedures in place to control allergen cross-contact between products that contain allergens and those that are not supposed to contain them”. The rule requires the control and leaves the method to the facility. (source 2)

Canada

Food and Drug Regulations, B.01.010.1. 11 food allergens, with gluten sources and added sulphites declared alongside.

The list

Almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios or walnuts
Peanuts
Sesame seeds
Wheat or triticale
Eggs
Milk
Soybeans
Crustaceans
Molluscs
Fish
Mustard seeds

The rules

Legal requirement. A food allergen is defined as “any protein from any of the following foods, or any modified protein that includes any protein fraction derived from” them, and its source must be shown either in the ingredient list or in a “Contains” statement. (source 4)
Voluntary practice. A cross-contamination or precautionary statement is described as “a declaration on the label of a prepackaged product that alerts consumers of the possible presence of an allergen in the food”. The agencies recommend one form of words only, “May contain: [X]”. (source 4)
Legal requirement. Such statements “are subject to subsection 5(1) of the Food and Drugs Act (FDA) and must be truthful and not misleading”. (source 4)

Australia and New Zealand

Australia New Zealand Food Standards Code, as changed by Proposal P1044. Not read in the Code itself.

The rules

Legal requirement. Requirements developed as “Plain English Allergen Labelling” came into force on 25 February 2024. Allergen information must be declared “in a specific format and location on food labels”, “using simple, plain English terms in bold font”. (source 5)

Not read: The list of foods that must be declared, and whatever the Code says about precautionary statements, were not read in the Code. The agency's pages for consumers and businesses returned “not found” on the day. No list is given here in their place.

Internationally

There is no international law on precautionary labels. An expert committee convened by two United Nations agencies has reported on it, and the Codex committee on food labelling is considering the result.

An expert committee convened by the FAO and WHO “unanimously agreed that current PAL systems used in many countries needed to be improved as they were neither uniform nor informative and were not consistently risk based”. (source 6)
It found that current approaches “led to widespread PAL that diminished information and value for consumers”, and agreed that a reference dose for each priority allergen was a valid basis for deciding when an unintended presence should be communicated. (source 6)

How allergens get into chocolate

Two routes, which the law treats differently. An ingredient is declared. Cross-contact, the unintended carry-over from another product made on the same equipment, is where the voluntary warning comes in.

Allergens in chocolate, as an ingredient and by cross-contact
Allergen	As an ingredient	By cross-contact	Measured in
Milk	Milk powder or milk fat in milk and white chocolate, and in many fillings. An ingredient, declared as one.	The best measured case. Dark chocolate made on equipment that also makes milk chocolate picks milk up from the line, and in one survey milk was found in a third of dark bars whose label did not mention it.	Bedford et al. 2017; Zhang et al. 2024
Peanuts	Whole, as paste or as praline in filled and inclusion bars.	Found in bars that did not list peanuts in two surveys, at very different rates by place of manufacture and by year.	Vadas and Perelman 2003; Bedford et al. 2017
Tree nuts	Hazelnut above all (gianduja, praline, spreads), then almond, pistachio and others. Each jurisdiction lists the nuts it means, and the lists differ: Canada's includes pine nuts, the list read for the United Kingdom does not.	Reference doses have been estimated for hazelnut. No survey of tree nut traces in chocolate was read for this page.	Allen et al. 2014
Soy	Almost always as lecithin, the emulsifier. Declared as soya where soybeans are listed.	No measurement was read for this page.	No study read
Wheat and other gluten cereals	Not in plain chocolate. Present through wafer, biscuit, cereal or malt inclusions and fillings.	Possible wherever such products share a line with plain chocolate. Wheat was one of the four allergens in a British study of unintended presence; no chocolate-specific figure was read.	Remington et al. 2015
Sesame	In halva, tahini and seeded inclusions. Listed in all three jurisdictions whose lists were read, and in the United States only since 1 January 2023.	No measurement was read for this page.	No study read
Egg	In some fillings, nougats and baked inclusions. Not in plain chocolate.	A reference dose has been estimated, and egg recovery from chocolate has been studied as a testing problem. No survey in chocolate was read.	Allen et al. 2014; Khuda et al. 2015

What “may contain” tells you, and what it does not

It is not required. So its absence is not a statement that an allergen is absent. In a survey of dark chocolate sold in the United States, a third of bars whose label did not mention milk contained it.
Its wording carries no scale. “May contain”, “traces of” and “made in a facility that also handles” are not grades of risk defined anywhere in the texts read here. In the same survey the type of statement did not predict the amount of milk.
It does not excuse the manufacturer. In the United States it “is not a substitute for adherence to current good manufacturing practices”; in Britain and Canada it must not mislead.
“Dairy free” and “vegan” are different claims again. They are claims about what the product is, and in the survey some bars carrying them contained milk. Whether a vegan claim implies anything about allergens is not settled by any text read for this page.
Chocolate is hard to clean out of a line. Factories avoid water for good reason, and cleaning without it leaves residue that the next batch picks up. That is the mechanical reason dark chocolate so often carries milk.

The studies behind these statements, with their limits, are in allergens in chocolate. For reading a label, see chocolate allergen labels and the label decoder, which recognises allergen wording and is explicitly not an allergen check.

Looked for and not read

Nothing on this page rests on any of these. They are listed so the gaps are visible.

The Codex Code of Practice on Food Allergen Management for Food Business Operators (CXC 80-2020): The Codex document service returned a web page in place of the file, as it did in the previous session.
The Food Standards Agency's guidance on precautionary allergen labelling: The pages could not be retrieved as text. A search engine's summary of them is not a reading, so nothing is quoted.
The European Union's current consolidated text of Regulation (EU) No 1169/2011: EUR-Lex refused automated access on the day. The United Kingdom's version was read in its place and is labelled as such.
Health Canada's own page on allergen labelling, and the allergen list in the Australia New Zealand Food Standards Code: The pages returned errors. Canada's list is taken from the Canadian Food Inspection Agency, which quotes the regulation.
Any jurisdiction beyond these four: Not attempted. One review read for the research pages reports that about a hundred countries regulate allergens as ingredients.

Sources

Regulation (EU) No 1169/2011 on the provision of food information to consumers, Articles 21 and 36 and Annex II, as it applies in Great Britain. Read on legislation.gov.uk, latest available revised version. www.legislation.gov.uk/eur/2011/1169/annex/II
US Food and Drug Administration. Food Allergies. Read on fda.gov. www.fda.gov/food/nutrition-food-labeling-and-critical-foods/food-allergies
US Food and Drug Administration. Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry. January 2025. Read on the guidance document, as a PDF. www.fda.gov/media/117410/download
Canadian Food Inspection Agency. List of ingredients and allergens on food labels; Allergens and gluten (industry labelling tool). Read on inspection.canada.ca. inspection.canada.ca/en/food-labels/labelling/industry/list-ingredients-and-allergens
Food Standards Australia New Zealand. Proposal P1044: Plain English Allergen Labelling. Read on foodstandards.gov.au. www.foodstandards.gov.au/food-standards-code/proposals/P1044PlainEnglishAllergenLabelling
FAO and WHO. Risk assessment of food allergens, part 3: review and establish precautionary labelling in foods of the priority allergens. Meeting report. 2023. Read on the World Health Organization's publication page, which carries the report's summary. www.who.int/publications/i/item/9789240072510

Current as of 9 October 2026. Labelling law changes; check the instrument itself before relying on any of this. All data.