On supplement labels in the European Union, manufacturers and brand owners are required to clearly list the fourteen recognised allergens if they are present as ingredients in the product. Allergen legislation for food supplements is governed by the same EU regulations as other foodstuffs, which means that the rules are binding across the entire European market. In this article, we answer the most frequently asked questions about how these rules work in practice.
Which allergens must be listed on a supplement label?
Under European Regulation (EU) No 1169/2011 on the provision of food information to consumers, you are required to list fourteen specific allergens if they are present in the product as an ingredient or a processed component. This requirement also applies in full to food supplements in powder or other forms.
The fourteen mandatory allergens are:
- Cereals containing gluten (wheat, rye, barley, oats, spelt, kamut)
- Crustaceans
- Eggs
- Fish
- Peanuts
- Soya beans
- Milk (including lactose)
- Nuts (almonds, hazelnuts, walnuts, cashew nuts, pecans, Brazil nuts, pistachios, macadamia nuts)
- Celery
- Mustard
- Sesame seeds
- Sulphur dioxide and sulphites (at concentrations exceeding 10 mg/kg or 10 mg/litre)
- Lupin
- Molluscs
This is particularly relevant for supplements, as commonly used ingredients such as whey protein (milk), soya protein (soya) and certain protein blends may contain several of these allergens. Every allergen present as an ingredient must be listed without exception, regardless of the quantity.
How should allergens be listed and displayed on a label?
Allergens must be clearly distinguished from the rest of the list of ingredients on the supplement label. This is achieved by using a different font, a different style or a different background colour, so that the allergen immediately stands out to the consumer.
In practice, this almost always means that the allergen in bold is listed in the ingredients list. For example, it reads: “Ingredients: protein blend (meadow, soya), cocoa, sweetener.” The use of bold type for the allergen is sufficient to meet the legal requirement, provided the contrast is clear enough.
In addition to the visual markings, there are also rules governing their placement:
- Allergens are listed in the ingredients list on the packaging
- If there is no list of ingredients, a separate statement must be included reading “Contains [name of allergen]”
- The text must be legible and must not be obscured by small fonts or colours with low contrast
- The information must be provided in the language of the country of sale
For supplements sold in several EU countries, this means that multilingual labels or country-specific labels are required in order to comply with allergen legislation in each individual country.
What are the rules regarding ‘may contain traces of’ labelling?
The statement “may contain traces of [allergen]” is not a legal requirement, but is a voluntary precautionary measure that manufacturers may include where there is a genuine risk of unintentional cross-contamination during production. There is no harmonised legislation in the EU that sets these thresholds.
Although this statement is voluntary, its use does entail certain responsibilities. A manufacturer who includes the phrase “may contain traces of nuts” on a label must be able to substantiate this with a risk analysis or an HACCP-based food safety plan. Adding it arbitrarily, or using it as a standard precautionary measure without a factual risk assessment, is not permitted and may be misleading.
Practical guidelines for the “may contain traces of” statement:
- Only use this statement if there is a demonstrable risk of cross-contamination, for example due to shared production areas or equipment
- Support this statement with an allergen risk analysis as part of your food safety plan
- Do not use vague wording such as “may contain allergens” without specifying which allergen
- Check regularly whether the information is still up to date in the event of changes to the production process
In the food supplements industry, where shared production lines for different product types are common, a thorough allergen risk assessment is therefore not a luxury but an essential part of responsible labelling.
What happens if allergen information is missing or incorrect?
If allergen information is missing from a supplement label or is demonstrably incorrect, this may lead to enforcement action by the competent national food authorities, such as the NVWA in the Netherlands. The consequences can range from an official warning to a mandatory product recall and, in serious cases, to administrative fines.
In addition to the legal and financial consequences, there are also commercial and reputational risks. A product recall due to a missing allergen declaration is costly and can seriously damage the trust of retailers and consumers. For B2B brand owners who distribute products through supermarkets or large retailers, this may also have contractual consequences.
The most common errors on supplement labels relating to allergens are:
- Allergens that are present in the formulation but are not shown in bold or listed
- Outdated labels that have not been updated following a change to the recipe or raw materials supplier
- Incorrect translations of allergen names on multilingual labels
- The absence of allergen labelling on products without a full list of ingredients
Regular label audits and an up-to-date food safety plan are therefore essential for anyone placing supplements on the European market.
Do the same allergen requirements apply to all EU countries?
The fourteen mandatory allergens and the rules on visual labelling have been harmonised under European Regulation (EU) No 1169/2011 and apply in the same way across all EU Member States. This means that the basic requirements for allergen labelling in the Netherlands, Belgium, Germany, France and all other EU countries are identical.
However, there are national nuances that warrant attention. Although the substantive requirements are uniform, each EU country requires that the information on the label be provided in that country’s official language. A food supplement sold in both the Netherlands and Germany therefore requires a label containing allergen information in both Dutch and German, or two separate country-specific labels.
Different rules apply outside the EU. Following Brexit, the United Kingdom has introduced its own version of allergen legislation, which largely corresponds to the EU rules but may differ in certain details. When exporting to markets outside Europe, it is always necessary to consult the specific national legislation of the country in question.
How MixMasters helps with allergen compliance on supplement labels
Accurate allergen labelling on a supplement label is not only a legal requirement, but also forms part of a broader food safety policy that must be verifiable and auditable. We support our customers in this regard in several ways:
- HACCP-based food safety plan: In collaboration with specialist consultants, we draw up a food safety plan tailored specifically to your product range, including an allergen risk analysis for all raw materials used and shared production lines.
- BRCGS certification: Our production site is BRCGS-certified, an internationally recognised standard that covers, amongst other things, allergen management, traceability and quality management. This provides you, as a brand owner, with added assurance during audits by retailers or certification bodies.
- Label support: Our team advises on the information required by law to appear on the label, including the correct presentation and listing of allergens in accordance with EU regulations.
- Transparency regarding raw materials: As we use our own raw materials, we can guarantee full traceability and consistent allergen status for each batch.
Whether you’re an established brand looking for a reliable manufacturing partner or want to launch a new range of supplements, we’ll ensure your product complies with current allergen legislation. Take a look at our full range of services or get in touch to discuss how we can ensure your range of supplements is compliant and ready for the market.
Frequently Asked Questions
Do I need to have my label re-approved if I change my raw materials supplier?
Ja, een wisseling van grondstoffenleverancier kan invloed hebben op de allergeenstatus van je product, zelfs als de formulering zelf niet verandert. Een nieuwe leverancier kan andere productieomstandigheden hebben, waardoor er nieuwe kruisbesmettingsrisico’s ontstaan of juist wegvallen. Het is daarom verplicht om bij elke wijziging in de toeleveringsketen een nieuwe allergeenrisicoanalyse uit te voeren en je label indien nodig bij te werken voordat je het product opnieuw op de markt brengt.
Does the allergen labelling requirement also apply to supplements that I sell exclusively online?
Yes, the requirements set out in EU Regulation 1169/2011 apply in full to supplements sold via online channels. For online sales, the mandatory food information, including allergen information, must be available on the product page before the purchase is completed, and the physical packaging must also contain the correct allergen labelling upon delivery. The absence of allergen information on an online shop page is considered a breach of the same legislation that applies to physical retail outlets.
What should I do if an ingredient is both a functional ingredient and an allergen, such as soya lecithin?
In dat geval gelden beide verplichtingen tegelijkertijd: het ingrediënt moet worden vermeld in de ingrediëntenlijst én het allergene bestanddeel moet visueel worden gemarkeerd, doorgaans vetgedrukt. Dus ‘sojalecithine’ wordt weergegeven als ‘sojalecithine’, waarbij het woord ‘soja’ vetgedrukt is om de aanwezigheid van het allergeen soja direct zichtbaar te maken. Zelfs als sojalecithine in een kleine hoeveelheid als technologisch hulpstof wordt gebruikt, vervalt de allergeenverplichting niet.
How should I deal with allergens in 'own-brand' products that I have manufactured by a third party?
Als merkhouder van een private label product ben jij eindverantwoordelijk voor de juistheid van de labelinformatie, ook al wordt de productie uitbesteed aan een contract manufacturer. Het is essentieel dat je van je productiepartner volledige en actuele allergeendocumentatie ontvangt, inclusief specificaties van alle gebruikte grondstoffen en een overzicht van mogelijke kruisbesmettingsrisico’s op de productielocatie. Leg deze verantwoordelijkheden contractueel vast en voer periodieke audits uit om te borgen dat de informatie op je label altijd overeenkomt met de werkelijke productiesituatie.
Are there any plans to tighten EU allergen legislation for supplements in the future?
De Europese Commissie evalueert de allergeenwetgeving periodiek en kan de lijst van verplichte allergenen uitbreiden als wetenschappelijk bewijs daartoe aanleiding geeft. Zo wordt lupine relatief recent aan de lijst toegevoegd en staat sesam in sommige internationale markten al langer prominent vermeld. Voor supplementfabrikanten is het raadzaam om de ontwikkelingen rondom de ‘Farm to Fork’-strategie en eventuele herzieningen van Verordening 1169/2011 actief te volgen, zodat je labelstrategie tijdig kan worden aangepast zonder dure herdrukken of productterugroepacties.
Can I use a single multilingual label for sales in several EU countries, or do I need separate labels?
A multilingual label is permitted and is widely used in practice by supplement brands operating in several EU countries. The condition is that the mandatory information, including allergen declarations, must be included in full and correctly in the official language of each country where the product is sold. Bear in mind that multilingual labels can quickly become complex and confusing; a clear layout in which the languages are clearly separated from one another is not only legally advisable, but also essential for the consumer’s ability to read the information.
What is the difference between listing an allergen in the ingredients list and a separate 'Contains' statement, and when should I use which one?
De vermelding in de ingrediëntenlijst met visuele markering (vetdruk) is de standaardmethode en vereist dat het allergeen als onderdeel van de ingrediëntenopsomming herkenbaar is gemarkeerd. De aparte ‘Bevat [naam allergeen]’-vermelding is uitsluitend bedoeld voor situaties waarin er geen ingrediëntenlijst aanwezig is op de verpakking, wat bij de meeste supplementen zelden het geval zal zijn. Gebruik nooit beide methoden door elkaar voor hetzelfde product, want dit kan verwarring wekken bij consumenten en is niet in lijn met de geest van de wetgeving.
English 
Dutch 
German 
French