The requirements regarding allergen labelling have been tightened in recent years, and the European rules will continue to be strictly enforced in 2026. For companies marketing food supplements, all fourteen recognised allergens must be clearly and distinctly stated on the label, without exception. In this article, we answer the most frequently asked questions about allergen labelling, so that you know exactly what is expected of you.
What changes apply to the labelling of allergens on packaging?
The basic rules for allergen labelling are set out in the European Regulation on the provision of food information to consumers (EU 1169/2011). The core principle remains unchanged: the fourteen major allergens must always be clearly visible, legible and distinct in the list of ingredients. In 2026, increasing attention will be paid to the enforcement of “may contain” labelling and the requirements relating to allergen control in the production environment.
National regulatory authorities, including the NVWA in the Netherlands, are carrying out increasingly stringent checks on the accuracy of labels. Incomplete or misleading allergen information is leading to more frequent product recalls and fines. Furthermore, companies exporting products within Europe must take into account the language requirements of each country: allergen information must be available in the language of the country of sale.
A significant development is the growing focus on cross-contamination. Whereas “may contain” statements used to be added on a voluntary basis, regulators now expect you to substantiate such a statement with a documented risk analysis. It is no longer sufficient to use a standard text on the label without this being underpinned by an actual assessment of production risks.
Which products are covered by the new allergen regulations?
Allergen legislation applies to all pre-packaged foodstuffs placed on the market in the European Union, including food supplements in powder form, capsules and tablets. This means that protein shakes, pre-workout supplements, meal replacements and functional blends are all subject to the same rules as regular foodstuffs.
There are no exceptions for supplements based on their form or marketing. Products sold as sports nutrition or health supplements are also foodstuffs within the meaning of the law and must be fully compliant. This applies to products sold both via online shops and through high-street retailers.
Products manufactured in a shared production environment deserve particular attention. If products containing nuts, gluten or milk are also produced in the same room or on the same equipment, that risk must be assessed and communicated. Failure to provide such a statement when the risk is present is considered a breach.
How should allergens be listed correctly on a supplement label?
Allergens must be included in the list of ingredients and must be visually distinguished from the other ingredients. In practice, this means highlighting them in bold, a different colour or a different font size. The information must be legible and must not be hidden in small print or a cluttered layout.
The fourteen mandatory allergens are:
- Gluten (wheat, rye, barley, oats, spelt)
- 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
- Lupin
- Molluscs
In addition to the mandatory listing in the ingredients list, you can include a separate allergen statement, such as “Contains: milk, soya”. This is not mandatory but is considered clear and helpful by consumers. What is mandatory, however, is that the statement is consistent with the actual composition of the product. Any change to the recipe requires an immediate update to the label.
What are the risks of incorrect or missing allergen labelling?
Incorrect or missing allergen labelling poses serious risks, both to consumers and to your business. For people with an allergy or intolerance, consuming an unlabelled allergen can lead to severe, sometimes life-threatening reactions. From a business perspective, the consequences are legal, financial and damaging to reputation.
The most immediate consequence is a compulsory recall. The NVWA can remove a product from the market if the labelling is incorrect, and you are obliged to actively inform consumers. A recall is costly and significantly damages confidence in your brand, particularly in the supplements market where health and safety are paramount.
In addition, administrative fines may be imposed. In the event of repeated infringements or infringements that pose a direct risk to consumers, the supervisory authority may take further enforcement measures. In serious cases, criminal liability may also apply, particularly where there is evidence of negligence.
How do you check whether your current labels are still compliant?
A label assessment begins by comparing the current formulation with the information on the label. For each ingredient, check whether it contains a recognised allergen or is derived from an allergen, and whether this is correctly and clearly indicated in the list of ingredients. Repeat this process every time the formulation is changed, even if the change appears minor.
When carrying out the check, follow these steps:
- Draw up an up-to-date list of ingredients for all raw materials, including additives and flavourings.
- Check each raw material to see whether it contains any allergens, including as a by-product or carrier.
- Compare the findings with the current labelling and identify any discrepancies.
- Assess the production environment for risks of cross-contamination and document this.
- Have the label assessed by a professional with knowledge of EU labelling legislation.
- Keep all documentation as part of your quality system.
It is advisable to carry out this check at least once a year, and always when changing suppliers or altering a formula. Keep a record of the version history of your labels so that, in the event of an inspection, you can demonstrate when and why changes were made.
Who is responsible for allergen labelling on private-label products?
In the case of private-label products, the legal responsibility for labelling lies with the party whose name and address appear on the label, the so-called “food business operator” (FBO). In most cases, this is the client – the brand selling the product under its own name – rather than the manufacturing partner. This distinction is crucial and is frequently misunderstood in practice.
As a brand or company marketing a private-label supplement, you are therefore ultimately responsible for the accuracy of the allergen information on the label. This also applies if production is fully outsourced. You may contractually assign part of this responsibility to the manufacturer, but the legal liability remains with the food business operator.
A reliable production partner does, however, play an essential supporting role in this regard. That partner must be transparent about the raw materials used, the production environment and any risks of cross-contamination. Good cooperation and clear communication between the manufacturer and the client form the basis for a compliant label. Always ensure that you set out in writing what information the manufacturer is to provide and that you verify this yourself before the label is approved.
How MixMasters helps with allergen labelling and compliance
We understand that allergen legislation can be complex, particularly if, as a brand or business owner, you do not deal with food safety on a daily basis. In our role as a manufacturing partner, we actively support our customers in complying with labelling regulations. We do this in the following ways:
- Transparent raw material specifications: We provide full specifications for every raw material, including allergen information and origin, so that you can draw up your label correctly.
- HACCP-based food safety plan: We operate in accordance with a documented food safety plan that identifies the risks of cross-contamination and sets out control measures.
- BRCGS certification: Our production site is BRCGS-certified, which means that allergen management, traceability and production hygiene are systematically assessed and audited.
- Support with label design: We can advise on the information required by law to appear on the label, including the correct labelling of allergens.
- Working with compliance consultants: In collaboration with external consultants, we help you draw up a food safety plan tailored to your specific product range and market.
Would you like to know how we can make your range of supplements compliant and ready for the market? Take a look at our private label manufacturing services or Please contact us directly for a no-obligation chat.
Frequently Asked Questions
Do I need to have my label re-approved if I change my raw material supplier?
Yes, changing suppliers can affect the allergen profile of your product, even if the ingredient is the same on paper. Request a full raw material specification from each new supplier and compare it with the previous version to check for allergens, cross-contamination risks and the production environment. If there are any discrepancies, the label must be amended before the product goes back into production.
What is the difference between 'Contains' and 'May contain traces of', and when should I use which statement?
‘Contains’ is used when an allergen is actually an ingredient or is derived from one, and is a legal requirement. ‘May contain traces of’ (or ‘may contain’) is intended for unintentional cross-contamination that occurs during production; it is voluntary but must be supported by a documented risk assessment. You must not, therefore, use this statement as a precautionary measure without there being a demonstrable and genuine risk in the production environment.
Do the same allergen regulations apply if I only sell my supplements online?
Yes, European allergen legislation makes no distinction between online and in-store sales. When selling via an online shop, allergen information must be available before the purchase is made, so that consumers can make an informed choice. This means that the information must be clearly visible on the product page, not just on the physical packaging that the customer receives later.
How often should I have an allergen audit or label assessment carried out?
An annual assessment is the absolute minimum, but in practice it is advisable to schedule an audit whenever there is a change to the formulation, raw materials, suppliers or production site. Companies operating under a quality management system such as BRCGS or ISO 22000 usually have a structured audit cycle that automatically covers this. Always keep version-dated documentation of each review as evidence in the event of an inspection by the NVWA.
What should I do if I discover that my current label is missing an allergen or lists it incorrectly?
Stop selling the product in question immediately and consult a labelling or food safety specialist to assess the severity of the non-compliance. Depending on the risk to consumers, it may be necessary to launch a voluntary recall and proactively inform the NVWA. The sooner you act and the more transparently you communicate, the greater the chance of limiting reputational and legal damage.
Are there any specific rules regarding font size or typeface when highlighting allergens on a label?
The legislation does not prescribe a specific font or minimum font size for highlighted allergens, but it does stipulate that the information must be clearly legible and visually distinguishable from the other ingredients. In practice, bold type is the most commonly used and accepted format. Additionally, ensure that the general minimum font size for label information (1.2 mm x-height) is adhered to, as required by EU Regulation 1169/2011.
As a small business owner or start-up, can I also access support with allergen labelling, or is that reserved for large companies only?
Allergen compliance is a legal obligation that applies to every business, regardless of size, but support is certainly also available to small brands and start-ups. Many private label manufacturers, including specialist firms such as MixMasters, also offer smaller clients access to raw material specifications, food safety plans and labelling advice. Moreover, investing in correct labelling from day one is always cheaper than having to deal with a recall or a fine later on.
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