Featured Course
Food Labelling Regulations Training
Practical Food Labelling Regulations Training covering EU 1169/2011, allergens, nutrition declarations, claims, traceability, and Spain/EU compliance.
EU allergen labelling requirements oblige prepacked foods to identify any Annex II allergen used and still present in the finished product. The allergen source must be clearly emphasised within the ingredients list. A separate “contains” statement is generally unnecessary, while precautionary “may contain” wording must not replace effective allergen controls.
Regulation (EU) No 1169/2011 on the provision of food information to consumers is the principal EU legislation governing allergen declarations on food labels. For prepacked foods, allergen information is normally provided through the ingredients list rather than through a separate warning box.
The rules apply to ingredients and processing aids listed in Annex II, or derived from an Annex II substance, when they were used in manufacture and remain present in the finished product, even in an altered form. The European Commission’s allergen guidance helps businesses and national authorities interpret these requirements consistently.
What are the 14 allergens that must be labelled?
Key takeaway: EU law identifies 14 categories of substances or products whose presence must be clearly declared when the relevant legal conditions are met.
The 14 Annex II allergen categories are:
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Cereals containing gluten: wheat, including spelt and khorasan wheat, rye, barley, oats and their hybridised strains
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Crustaceans
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Eggs
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Fish
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Peanuts
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Soybeans
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Milk, including lactose
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Nuts: almonds, hazelnuts, walnuts, cashews, pecan nuts, Brazil nuts, pistachio nuts and macadamia or Queensland nuts
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Celery
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Mustard
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Sesame seeds
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Sulphur dioxide and sulphites at concentrations above 10 mg/kg or 10 mg/litre, expressed as total sulphur dioxide
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Lupin
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Molluscs
The law requires the particular cereal or nut to be identified. A label should therefore say wheat, barley, almond or cashew, rather than relying only on broad terms such as “gluten” or “nuts”. EFSA also identifies these 14 categories as the allergens that must be indicated when used as ingredients in food sold in the EU.
Annex II contains specific exemptions for certain derived ingredients where the relevant conditions are met. Food businesses should therefore check the current consolidated legislation and supplier specification rather than treating a simplified allergen poster as the complete legal text. The current consolidated version of Regulation 1169/2011 has applied since 1 April 2025.
For deeper information about allergenic ingredients, cross-contact controls and staff communication, see Food Allergen Awareness Training.
How do you label allergens on prepacked food?
Key takeaway: State the allergen’s legally recognised source within the ingredients list and make it visually distinct from the surrounding ingredients.
For most prepacked food, the allergen declaration follows this process:
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Obtain an approved and current specification for every ingredient.
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Identify ingredients, additives, processing aids and compound ingredients derived from Annex II substances.
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Confirm whether each relevant substance remains present in the finished food.
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name the allergen source clearly in the ingredients list.
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Emphasise the allergen source using a distinct typesetting treatment.
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Check artwork against the approved recipe and specification before printing.
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Repeat the assessment whenever a recipe, supplier or ingredient changes.
Regulation 1169/2011 requires prepacked foods to carry a list of ingredients and to declare any Annex II ingredient or processing aid that remains present in the finished product.
A compliant example might read:
Ingredients: oat flakes, sugar, sunflower oil, almonds, dried fruit, milk powder, salt.
For a compound ingredient:
Ingredients: pasta [durum wheat semolina, egg], tomato, cheese (milk), olive oil.
The declaration must identify the source that consumers need to recognise. For example:
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Whey powder should identify milk.
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Soya lecithin should identify soya or soybeans.
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Fish gelatine should identify fish, unless a specific Annex II exemption applies.
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Spelt flour should make wheat clear.
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Tahini should identify sesame.
The exact ingredient-list order, compound-ingredient format and quantitative ingredients declaration are separate technical issues. See food ingredients list rules for the rules on descending weight, QUID and additives.
Do allergens have to be in bold?
Key takeaway: Bold type is common, but EU law requires clear emphasis through typesetting; it does not prescribe bold as the only permitted method.
Article 21 requires the allergen name to be emphasised through a typesetting method that clearly distinguishes it from the rest of the ingredients list. Businesses may use:
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Bold type
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CAPITAL LETTERS
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A contrasting typeface
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A distinct background
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Another clear and consistently applied typesetting treatment
The method must remain legible in the final printed artwork. It should not depend on a subtle colour difference that may disappear under poor lighting, low-quality printing or colour-vision limitations.
Good example
Ingredients: flour (WHEAT), water, cheese (MILK), yeast and salt.
Weak example
Ingredients: flour (wheat), water, cheese (milk), yeast and salt.
In the weak version, “wheat” and “milk” are not visually differentiated from the surrounding text.
A recurring operational problem in pre-print reviews is technically correct allergen data becoming ineffective during artwork production. Font substitution, reduced contrast, line wrapping or copying text between packaging formats can remove the intended emphasis. The finished production artwork—not only the formulation spreadsheet—must therefore be checked.
What if the food has no ingredients list?
Key takeaway: Where EU rules do not require an ingredients list, the allergen must normally be declared using “contains” followed by the relevant Annex II substance.
Some foods are exempt from carrying an ingredients list. When an ingredients list is not provided, the allergen indication should use the word “contains” followed by the name of the allergen, unless the name of the food itself clearly refers to the relevant substance.
Examples include:
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Contains: sulphites
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Contains: milk
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Contains: egg and mustard
A separate “contains” box is not a substitute for emphasising allergens in an ingredients list where an ingredients list is required. The primary legal declaration remains the emphasised allergen source within that list.
Businesses should also avoid declarations that are unnecessarily repetitive, ambiguous or inconsistent. For example, an ingredients list that emphasises milk but a separate panel that states “contains dairy” introduces different terminology and may confuse consumers.
What is PPDS labelling in the EU?
Key takeaway: “Prepacked for direct sale” food is excluded from the EU definition of prepacked food and is handled through Article 44 and national implementing rules.
Regulation 1169/2011 defines prepacked food as food placed in packaging before being offered for sale where the contents cannot be altered without opening or changing the packaging. However, the definition specifically excludes food packed on the sales premises at the consumer’s request and food prepacked for direct sale.
For EU purposes, these products fall within the Article 44 framework for non-prepacked food. Allergen information is mandatory, but Member States may determine:
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How the information must be provided
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Whether it must be written or may be provided verbally
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What signs or notices must accompany verbal information
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Whether additional mandatory particulars are required
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The required form and presentation of the information
The European Commission confirms that Article 44 covers food sold without prepackaging, food packed at the consumer’s request and food prepacked for direct sale.
Country variations
“PPDS” is widely used as a defined regulatory category in the United Kingdom, where national rules require affected products to carry the food name, a full ingredients list and emphasised allergens. Those UK requirements should not be presented as a harmonised EU rule. EU businesses must check the implementing requirements in each Member State where the product is sold.
For a broader explanation of food sold loose or packed at the point of sale, see labelling non-prepacked and loose foods.
How should “may contain” statements be used?
Key takeaway: Precautionary allergen labelling should communicate a genuine residual cross-contact risk, not compensate for incomplete specifications or weak controls.
Statements such as “may contain peanuts” or “may contain traces of milk” are forms of precautionary allergen labelling. They address possible unintended presence rather than allergens deliberately used as ingredients.
Under Article 36, voluntary food information must not mislead consumers, be ambiguous or confusing, and should be based on relevant scientific data where appropriate.
A responsible process should therefore include:
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Identifying possible cross-contact routes
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Reviewing shared equipment, storage, rework and production sequencing
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Applying cleaning, segregation and supplier controls
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Assessing whether a meaningful residual risk remains
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Using precautionary wording only where justified
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Reviewing the decision after recipe, equipment or supplier changes
Precautionary wording must not replace the mandatory declaration of an intentionally used allergen. A product containing peanut as an ingredient cannot declare only “may contain peanuts”.
It should also not become a default statement applied to every product manufactured on a site. Excessive warnings reduce their practical value and may unnecessarily restrict food choices for people with allergies.
The Codex Alimentarius Code of Practice on Food Allergen Management for Food Business Operators provides voluntary international good practice for managing allergen risks. Codex texts are not automatically binding law; they must be implemented through applicable legislation or regulatory systems to become enforceable.
What about non-prepacked and loose foods?
Key takeaway: Allergen information remains mandatory, but the permitted method of communication depends heavily on national rules.
For food offered without prepackaging, packed at the consumer’s request or prepacked for direct sale, EU law requires information about Annex II allergens used in the product. Other particulars may also become mandatory under national measures.
Depending on the country and type of business, allergen information may be provided through:
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A product label
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A menu
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A shelf ticket
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A display sign
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A written allergen matrix
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Verbal communication supported by a prominent notice and accessible written records
Businesses serving more than one Member State should not assume that a process accepted in one country will satisfy another country’s implementing rules.
This distinction also protects the cluster’s scope: the present article explains on-pack allergen declaration mechanics. Detailed kitchen controls, staff questioning, recipe communication and cross-contact prevention belong within operational allergen management.
A practical pre-print allergen label check
Key takeaway: The final label should be checked against the approved recipe, current supplier data and actual production process before artwork approval.
Use this checklist before releasing packaging:
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Every ingredient has a current approved specification.
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All Annex II allergens and allergen-derived ingredients have been identified.
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Compound ingredients have been expanded where required.
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The specific cereal or nut is named.
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Allergens are clearly distinguished in the ingredients list.
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The emphasis remains visible at the final printed size.
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“Contains” wording is used only where appropriate.
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Any “may contain” statement is supported by a documented risk assessment.
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The label matches the current recipe and production process.
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Supplier, recipe and packaging changes trigger a fresh review.
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Translated labels preserve the same allergen meaning and emphasis.
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National requirements have been checked for each destination market.
The broader mandatory-particulars review should also cover the food name, QUID, net quantity, date marking, storage instructions, business details, origin where applicable and nutrition declaration. See the mandatory food label information checklist.
Strengthen allergen labelling competence
Key takeaway: Training should connect legal requirements with recipe control, supplier specifications, artwork approval and change management.
Anyone who writes, reviews or approves food labels should understand how Regulation 1169/2011 applies to ingredients, allergens, compound ingredients and voluntary warnings.
The Food Labelling Regulations Training is designed to help product developers, technical teams, quality personnel, packaging teams and managers understand the controls needed to produce clearer and more reliable food labels.
Featured Course
Food Labelling Regulations Training
Practical Food Labelling Regulations Training covering EU 1169/2011, allergens, nutrition declarations, claims, traceability, and Spain/EU compliance.
Training supports competent decision-making, but it does not guarantee compliance or replace product-specific legal advice, supplier verification or review of national requirements.
Sources and Methodology
Key takeaway: This article is based primarily on binding EU legislation, official European Commission guidance and recognised international good practice.
The article was prepared using:
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The current consolidated version of Regulation (EU) No 1169/2011
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The European Commission’s mandatory food-information guidance
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The Commission Notice on substances or products causing allergies or intolerances
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European Food Safety Authority information on food allergens
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Codex Alimentarius food-labelling and allergen-management texts
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Current official UK guidance solely for the country-comparison section
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Search-intent analysis and practical label-review good practice
Principal sources consulted:
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Regulation (EU) No 1169/2011, particularly Articles 2, 21, 36 and 44 and Annex II.
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European Commission: Mandatory food information.
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European Commission: Guidance on allergens.
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EFSA: Food allergens.
- Codex CXC 80-2020: Code of Practice on Food Allergen Management for Food Business Operators.
Professional limitation: This article provides general guidance and is not legal advice. Product-specific legislation and national rules may impose additional requirements. Businesses should consult the competent authority or qualified adviser for the markets in which their food is sold.
Frequently Asked Questions
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How do you label allergens on food?
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What are the 14 allergens that must be labelled?
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Do allergens have to be in bold?
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Is a separate “contains” box required?
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What is PPDS labelling?
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Can allergens be declared only in a “may contain” statement?
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