The statement ‘may contain traces of’ may only be used if there is a realistic and demonstrable risk of unintentional cross-contamination with an allergen during production. This statement is not a non-binding precautionary measure and must not be used to avoid liability without actual evidence of that risk. In this article, we answer the most frequently asked questions about allergen legislation for supplements.
When is the ‘may contain traces of’ statement mandatory?
The ‘may contain traces of’ statement is not a legal requirement, but is strongly recommended where a risk assessment shows that accidental cross-contamination with an allergen is a realistic possibility. European allergen legislation does require manufacturers to protect consumers from unintended exposure to allergens, but does not prescribe the exact wording.
What the law does require, however, is that allergens added intentionally must always be clearly stated on the label. Where an allergen is not intentionally added but may nevertheless be present due to shared production lines, storage areas or equipment, ‘precautionary allergen labelling’ (PAL) applies. EU Regulation 1169/2011 on the provision of food information to consumers forms the legal basis for this.
The decision to include the claim must always be supported by a documented risk analysis. Without such support, the claim is not only legally vulnerable but also misleading to consumers.
What is the difference between cross-contamination and deliberate allergens?
Intentional allergens are ingredients that are deliberately added to a product and must always be listed in the ingredients list. Cross-contamination is the unintentional presence of an allergen resulting from shared production environments, equipment or raw materials. This distinction is fundamental to the correct application of allergen legislation.
A protein powder containing milk whey includes milk as an intentional allergen. This is stated in the list of ingredients. If the same production line is also used for a product containing nuts, and cleaning is not entirely sufficient to remove nut residues, there is a risk of potential cross-contamination with nuts. This cross-contamination is then communicated via a PAL statement.
This distinction is also legally relevant. Deliberately added allergens must always be listed, regardless of the quantity. In the case of cross-contamination, listing is only justified if the presence of the allergen is actually possible on the basis of demonstrable production risks.
How do you determine whether cross-contamination poses a realistic risk?
You determine whether cross-contamination poses a realistic risk by carrying out a systematic risk analysis based on your production process, raw material flows and cleaning procedures. In doing so, you should consider which allergens are present in the facility, how production lines are configured and how effective the cleaning is, as demonstrated by evidence.
Specific factors to include in the analysis include:
- Which allergens are processed elsewhere in the production facility?
- Whether shared equipment or means of transport are used
- Whether raw materials are stored in the same room as allergenic products
- Whether cleaning validations demonstrate that allergen residues are effectively removed
- Whether suppliers of raw materials use PAL declarations themselves
An HACCP-based approach provides the appropriate methodology for this. By identifying critical control points and validating cleaning protocols, you can substantiate whether a PAL declaration is justified or, conversely, unnecessary. Documentation of this analysis is essential in the event of an inspection by the NVWA.
Can you use the phrase ‘may contain traces of’ as a precautionary measure without any evidence?
No, you must not use the ‘may contain traces of’ statement as a general precautionary measure without a demonstrable risk. This is considered misleading labelling and contravenes European food information legislation. The statement must always be supported by a documented risk analysis.
In practice, it still happens that manufacturers include this statement as a matter of course to limit their liability, without any actual risk of cross-contamination having been identified. This is problematic for two reasons. Firstly, the statement loses its informative value for consumers with allergies, who are then left unsure as to which warnings are to be taken seriously and which are not. Secondly, it is not legally tenable if it is not based on a risk assessment.
The NVWA and European regulatory authorities are applying increasingly strict standards for PAL claims. An unsubstantiated claim may lead to enforcement action or mandatory relabelling. The rule of thumb is simple: no evidence of risk means no claim.
Which allergens must be listed on supplements?
Supplements placed on the market in the EU must carry mandatory labelling for fourteen major allergens if these have been deliberately added as ingredients. This also applies to supplements and sports nutrition products, which are covered by the general food information legislation.
The fourteen mandatory allergens under EU Regulation 1169/2011 are:
- Gluten (wheat, rye, barley, oats and spelt)
- Crustaceans
- Eggs
- Fish
- Peanuts
- Soya beans
- Milk (including lactose)
- Nuts (such as almonds, hazelnuts, walnuts and cashew nuts)
- Celery
- Mustard
- Sesame seeds
- Sulphur dioxide and sulphites
- Lupin
- Molluscs
In supplements, milk is a common allergen due to whey proteins. Soya and gluten are found in plant-based protein blends and functional mixes. These allergens must be highlighted in the ingredients list, for example by printing them in bold or underlining them, so that they are immediately noticeable to consumers with an allergy.
What are the consequences of incorrect allergen labelling on your product?
Incorrect allergen labelling can lead to serious legal, financial and reputational consequences. In the worst-case scenario, this can result in a product recall, fines from regulatory authorities and liability for allergic reactions in consumers. For B2B parties, it can also lead to a breach of contract with retailers or distributors.
The most common consequences are:
- Product recall: If an undeclared allergen is found in a product, a recall is mandatory. This entails significant costs and damage to the company’s reputation.
- Enforcement by the NVWA: The Netherlands Food and Consumer Product Safety Authority may impose fines, withdraw products from the market or require the publication of details of infringements.
- Liability: In the event of an allergic reaction resulting from incorrect or missing labelling, the manufacturer or brand owner may be held liable for damages.
- Loss of retail partners: Supermarkets and major retailers have strict purchasing requirements. A labelling breach can result in a product being removed from the range.
Accurate allergen labelling is therefore not only a legal obligation, but also a business necessity for anyone who is serious about marketing supplements.
How MixMasters helps with allergen legislation and labelling compliance
Accurate allergen labelling starts with a well-organised production process and a robust food safety plan. We provide our customers with comprehensive support in this area, from risk analysis right through to the final label.
What we specifically offer in the field of allergen management and compliance:
- An HACCP-based food safety plan, drawn up in collaboration with specialist consultants
- Allergen management as part of our BRCGS-certified production processes
- Support in drawing up accurate product specifications and label information
- Traceability of raw materials, so that the risks of cross-contamination are transparent and verifiable
- Guidance on translating risk analyses into specific PAL entries
Do you want to be sure that your range of supplements complies with all the requirements of allergen legislation? Take a look at our food safety and compliance services or get in touch for a no-obligation chat about your product.
Frequently Asked Questions
How often should I review my allergen risk assessment?
Your risk analysis must be reviewed whenever there is a relevant change to your production process, such as the introduction of new raw materials, the modification of production lines or changes to cleaning procedures. It is also recommended that the analysis be reviewed at least once a year, even if there have been no immediate changes. For BRCGS certification, periodic review of allergen risk analyses is a formal requirement.
Do the allergen regulations also apply if I have my supplements manufactured by a contract manufacturer?
Ja, als merkhouder blijf jij eindverantwoordelijk voor de juistheid van de allergeneninformatie op jouw label, ook als de productie wordt uitbesteed. Je bent verplicht om van je loonproducent volledige en aantoonbare informatie te ontvangen over allergenenrisico’s in hun productieomgeving. Leg dit contractueel vast en vraag altijd om actuele productspecificaties en risicoanalyses als onderbouwing voor je labelkeuzes.
What should I do if a raw material from my supplier already has a PAL entry?
Als een grondstof van je leverancier zelf al een ‘kan sporen bevatten van’-vermelding draagt, moet je beoordelen of dat risico ook doorwerkt in jouw eindproduct. In de meeste gevallen is het dan gerechtvaardigd om dezelfde PAL-vermelding op jouw label op te nemen, mits je dit documenteert in je risicoanalyse. Neem contact op met je leverancier voor aanvullende technische specificaties, zodat je een onderbouwde beslissing kunt nemen in plaats van de vermelding klakkeloos over te nemen.
Have any threshold levels been set for the amount of allergen that may be present in the event of cross-contamination?
At present, there are no legally established thresholds for unintentional allergen contamination within the EU. The European Food Safety Authority (EFSA) is working on the scientific basis for reference doses, but harmonised standards have not yet been enshrined in legislation. Until this is the case, any detectable presence of an allergen resulting from cross-contamination must be communicated via a PAL declaration, regardless of the quantity.
Can I use a 'free from' claim on my supplement, such as 'gluten-free' or 'lactose-free'?
Ja, maar alleen als je product aantoonbaar voldoet aan de wettelijke criteria voor die claim. Voor ‘glutenvrij’ geldt bijvoorbeeld dat het product maximaal 20 mg gluten per kilogram mag bevatten, conform EU-verordening 828/2014. Een ‘vrij van’-claim en een gelijktijdige PAL-vermelding voor hetzelfde allergeen zijn in principe tegenstrijdig en juridisch kwetsbaar. Zorg er dus voor dat je reinigingsvalidaties en testresultaten de claim ondersteunen voordat je deze op het label plaatst.
What common mistakes do you spot in the allergen labelling on supplement labels?
De meest voorkomende fouten zijn: het ontbreken van visuele benadrukking van allergenen in de ingrediëntenlijst (vetgedrukt of onderstreept is verplicht), het gebruik van PAL-vermeldingen zonder onderliggende risicoanalyse, en het niet updaten van labels na een wijziging in grondstoffenleverancier of productielocatie. Ook zien we regelmatig dat allergenen worden vermeld onder een niet-gangbare naam, zoals ‘caseïne’ in plaats van ‘melk’, wat niet voldoet aan de transparantievereisten van EU-verordening 1169/2011.
What is the difference between BRCGS certification and compliance with allergen legislation?
Wettelijke naleving is de minimumverplichting die voortvloeit uit EU-wetgeving, zoals verordening 1169/2011, en geldt voor iedere fabrikant die voedingsmiddelen of supplementen op de markt brengt. BRCGS-certificering gaat verder dan dat: het is een internationaal erkende voedselveiligheidsstandaard die gestructureerde allergenenbeheerprogramma’s, audits en continue verbetering vereist. Een BRCGS-gecertificeerde producent biedt daarmee een aantoonbaar hoger niveau van allergenenbeheersing, wat ook door retailers en internationale afnemers steeds vaker als inkoopvereiste wordt gesteld.
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