The 14 Allergens: Allergen Labelling Rules and Best Practices

The Essentials: 14 Allergens, 1 Threshold, 2 Exceptions

Which 14 Allergens Are Mandatory Under EU 1169/2011?

Annex II of Regulation (EU) No 1169/2011 lists 14 allergens that must be declared whenever they are present in a food:

1. Cereals containing gluten (wheat, rye, barley, oats, spelt, kamut) and products thereof
2. Crustaceans and products thereof
3. Eggs and products thereof
4. Fish and products thereof (with the exception of fish gelatine used as a carrier in vitamin preparations)
5. Peanuts and products thereof
6. Soybeans and products thereof (with the exception of fully refined soybean oil)
7. Milk and products thereof (including lactose)
8. Nuts (almonds, hazelnuts, walnuts, cashew nuts, pecan nuts, Brazil nuts, pistachio nuts, macadamia nuts) and products thereof
9. Celery and products thereof
10. Mustard and products thereof
11. Sesame seeds and products thereof
12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre (expressed as SO₂)
13. Lupin and products thereof
14. Molluscs (snails, mussels, squid) and products thereof

Two allergens deserve extra attention in practice. Sulphites are the only allergen with a quantitative threshold (10 mg/kg), which means they only have to be declared above that limit. For nuts and cereals containing gluten, you must name the specific species where possible: "almonds" and "wheat" instead of "nuts" and "gluten".

How Do You Emphasise Allergens in the Ingredient Declaration?

Article 21(1)(b) of EU 1169/2011 requires allergens in the ingredient declaration to 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". The Commission Notice 2017/C 428/01 fills this in concretely: bold text, underlining, capital letters and a different background colour are all permitted, as long as the contrast is clearly visible to an average consumer.

A concrete example: "water, sugar, wheat flour, sunflower oil, salt, egg, herbs".

Two rules that manufacturers regularly forget:

• Every occurrence must be emphasised, not just the first mention. If wheat appears twice in the list (for example as "wheat flour" and later as "wheat starch"), both are emphasised. The legislation says "emphasised" without limiting it to the first mention.
• The specific name must be given, not just the overarching category. "Flour" is not enough. You must write "wheat flour" so it is clear that it contains gluten.

When Is "May Contain" Allowed on the Label?

Only after a substantiated quantitative risk assessment. Precautionary allergen labelling, known as PAL, produces a "may contain nuts" or "produced in a facility that also processes peanuts" statement on the label. The older wording "may contain traces" is used less in modern QRA practice, because "traces" wrongly suggests that it is always about microscopic quantities. A QRA can in fact demonstrate measurable contamination well above "traces". In the Netherlands, PAL statements have only been permitted since 1 January 2026 after a quantitative risk assessment (QRA) via the VITAL framework, according to the Q&A on PAL published by the national food safety authority (in the Netherlands the NVWA). The same VITAL framework applies in other EU markets, but enforcement can differ per member state; check the position of your competent authority. PAL without a QRA is technically a violation in the Netherlands, even though it feels safe.

PAL as a safety net protects nobody and buries the real warnings in noise. PAL as a substantiated warning tells an allergic consumer exactly where the risk lies. A consumer who reads "may contain" on everything eventually starts ignoring it — and misses precisely the products where the warning is justified.

The QRA compares the total allergenic contamination in the product (from supplier data plus production line contamination) with the reference dose per allergen. That reference dose is the amount at which 95% of allergic consumers still have no reaction. If the Hazard Quotient (HQ, the risk value) is higher than 1, the risk is real and PAL must go on the label.

Two allergens work differently from the rest under PAL:

• Sulphites fall outside the QRA system. They have a fixed legal threshold of 10 mg/kg SO₂, independent of VITAL reference doses. Exceed the threshold and it goes on the label; below it, it doesn't. See the sulphites article for the details.
• Cereals containing gluten get an extra limit of 20 ppm per individual cereal plus a cap on the sum of all contaminated cereals combined. The 20 ppm threshold itself comes from Codex Alimentarius Standard 118-1979 (protecting coeliac patients against total gluten exposure). The cap per individual cereal is written into VITAL 3.1.6 as "whichever is lower". The sum-cap across multiple contaminated cereals was explicitly laid down for the Netherlands in the Dutch authority's Q&A on PAL (July 2025), but the medical rationale is universal; Eclarion therefore applies the sum-cap in all three standards (NL ED05, VITAL 3, VITAL 4). If wheat contributes 15 ppm and rye 12 ppm, the sum is 27 ppm, well above the 20 ppm cap. In the PAL statement you must name both cereals specifically.

Where Does Allergen Labelling Usually Go Wrong?

Incomplete Supplier Data

Suppliers don't always provide complete allergen information. The absence of an allergen in the supplier specification does not mean it isn't in there. Explicitly request an allergen declaration per raw material and update it with every composition change from the supplier. For "may contain" you need contamination values in mg/kg from the supplier, not just a status.

Allergens Missed in Compound Ingredients

The classic: a dressing contains mustard via the vinegar fraction, but you only entered "dressing" as an ingredient. Break every compound ingredient down until the allergens become visible in the underlying composition. In recipe management this happens via a nested bill of materials in which sub-ingredients carry their own allergen profile.

Unjustified "May Contain" Statements

Some companies put "may contain nuts" on every product by default as a safety net. That is not legally permitted without a quantitative risk assessment, and it devalues the warning for the people who genuinely need to watch out for it. An allergic consumer who reads "may contain" everywhere eventually starts ignoring it.

Outdated Allergen Information After a Recipe Change

Your supplier swaps a raw material, you adjust the recipe, but the label lags behind. Without linked data between recipe and label, this happens structurally. A recipe management system in which allergens automatically flow through to the label prevents this drift.

How Do You Manage Allergens in Eclarion?

In Eclarion you record the allergen status per raw material in four states: Free from, May contain, Contains and Unknown. Each of the 14 mandatory allergens plus additional special allergens (such as lactose, chicken, coriander) is recorded separately per raw material.

Eclarion calculates the allergen status of the end product automatically from the bill of materials. Per allergen, the highest risk status of all ingredients wins: Contains ranks above May contain, which in turn ranks above Free from. Unknown means the data has not yet been entered and is treated as "still to be verified", not as "free from".

For "May contain" statements, Eclarion performs the PAL assessment: per allergen and per product, the system compares the total contamination (from supplier data plus production line contamination) with the reference dose per chosen standard. You can choose between three standards: NL ED05 (Dutch Government Gazette 2024), VITAL 3 (conservative, ED01-based) and VITAL 4 (international, ED05-based). If the Hazard Quotient is higher than 1, Eclarion shows that a PAL statement is needed. For cereals containing gluten, the 20 ppm cap per cereal plus the sum-cap applies on top of that.

Two exceptions that Eclarion handles differently: sulphites have their own threshold calculation (10 mg/kg, not via HQ), and nuts are assessed per specific species (almonds, hazelnuts, walnuts, and so on) because the legislation requires naming the specific species in the PAL statement.

Frequently Asked Questions

Is "May Contain Traces" the Same as "May Contain"?

Legally, both terms are equivalent and both refer to precautionary allergen labelling. In modern QRA practice, "may contain" is preferred, because "traces" weakens the warning: it suggests it is always about microscopic quantities, while a quantitative risk assessment can in fact demonstrate measurable contamination well above "traces". Eclarion uses "May contain" as the status name in the application, and it is also the wording that regulators use in recent Q&A guidance.

Do I Also Have to Declare Allergens on Non-Prepacked Products?

Yes. For products sold loose (bakery, butcher, caterer), allergen information must also be available, for example on a sign, in a menu or on request from staff. The statement doesn't have to be on the product itself, but it must not be missing. Article 44 of EU 1169/2011 leaves member states room for their own implementation; enforcement is handled by the competent authority in each member state.

Which Allergens Are Most Often Overlooked?

The allergens that get missed most often almost always arrive via compound ingredients where the QA manager only entered the main ingredient. Three classics: sulphites (hidden in potato products, dried fruit and wine vinegar), mustard (hidden in dressings, marinades and sauces) and celery (hidden in stocks and seasoning mixes). Always break compound ingredients down until the allergens become visible at the lowest level.

What Happens During an Audit if My Allergens Aren't Properly Documented?

During an inspection, the competent authority asks you to demonstrate that the allergen status per raw material has been verified and recorded. Merely claiming "free from" for an allergen without a source or calculation is insufficient. A finding usually leads to a warning; repeated findings lead to a fine or a mandatory correction of labels already on the market. For a recall of labelled products, the costs are considerably higher than the time it takes to record the information properly up front.

Do I Have to Name the Specific Cereal, or Is "Gluten" Enough?

If you know which cereal it is, name it specifically (wheat, rye, barley, oats, spelt or kamut). Only if the specific species is genuinely unknown may you use "cereals containing gluten" as a collective term. For PAL statements, enforcement is strict: name the specific cereal that contributes to the risk threshold, so that consumers who tolerate one cereal but not another can make an informed choice.