The EFSA approves health claims on the basis of scientific evidence. A claim is only authorised if there are sufficient clinically substantiated studies demonstrating that a substance has a specific, measurable effect on human health. For companies marketing supplements, knowing which claims have been approved is essential to remaining compliant and communicating credibly. In this article, we answer the most frequently asked questions about health claims, the approval process and what this means for private-label products.
Which health claims have been approved by the EFSA?
Approved health claims are listed in the EU register of authorised claims, based on Regulation (EC) No 1924/2006. The EFSA has assessed hundreds of claims and issued a favourable opinion on some of them. Well-known examples include claims relating to vitamin C and the immune system, calcium and strong bones, and magnesium and normal muscle function.
The approved claims are divided into two categories: Article 13 claims (general functional claims, such as the effects of vitamins and minerals) and Article 14 claims (claims relating to the reduction of disease risk or claims aimed at children). Article 13 claims are most relevant to supplement brands, as they relate to the day-to-day effects of substances in the body.
Important to note: not every claim submitted has been approved. The EFSA has also published an extensive list of rejected claims, including many relating to plant extracts and herbal preparations. These so-called ‘botanicals’ fall into a special category where the assessment is still ongoing or where insufficient evidence was available.
How does the authorisation process work at EFSA?
The EFSA’s approval process for a health claim begins with the submission of a scientific dossier. The EFSA then assesses whether the available evidence is sufficiently robust and consistent to demonstrate a causal link between a nutrient and a health benefit. This process can take several years.
The steps in the approval process are as follows:
- Submission of an application to the European Commission, including a comprehensive scientific dossier.
- Scientific assessment by the EFSA, with panels of independent experts assessing the evidence for quality, relevance and consistency.
- Publication of the opinion by the EFSA, with a positive or negative opinion on the claim.
- Decision of the European Commission, which transposes the opinion into a legally binding regulation.
- Inclusion in the EU register, after which the claim may be officially used on products that meet the specified conditions.
It is not possible to simply “make up” a claim yourself and use it, provided you sound credible. Any health claim you make on a supplement must correspond word for word to an approved wording in the EU register, including the associated conditions of use, such as minimum daily doses.
What is the difference between a health claim and a nutrition claim?
A nutritional claim refers to the nutritional composition of a product, such as “high in protein” or “low in sugar”. A health claim goes further and establishes a link between a nutrient and a health benefit, such as “contributes to normal muscle function.” The distinction is legally relevant because different rules apply to each type.
Nutrition claims are regulated in the Annex to Regulation (EC) No 1924/2006 and are subject to fixed thresholds. For example, a product may only be described as “high in protein” if at least 20% of its energy value comes from protein. These claims are relatively straightforward to use, provided you meet the quantitative requirements.
Health claims are more complex. They require not only that the substance be present in a significant quantity, but also that the claim correspond exactly to an approved wording. You must therefore not paraphrase or offer your own interpretation of a scientific effect. The exact wording from the EU register is binding.
What claims are you allowed to use on private-label supplements?
For private-label supplements, you may only use health claims that have been approved and included in the EU register. In addition, the product must comply with the specific conditions of use associated with each claim, such as a minimum amount of the active ingredient per daily portion.
There are plenty of options for commonly used supplement categories. Here are a few examples of permitted claims:
- Protein products: “Protein helps build and maintain muscle mass” (provided there is at least 15 g of protein per portion).
- Pre-workout supplements containing caffeine: “Caffeine helps improve concentration and alertness” (at 75 mg of caffeine per serving).
- Vitamin D: “Vitamin D helps maintain healthy bones and teeth.”
- Magnesium: “Magnesium helps reduce tiredness and fatigue.”
- Zinc: “Zinc contributes to the normal functioning of the immune system.”
When drafting your label, it is advisable to always consult the EU register and use the exact wording. Even minor differences in wording can result in a non-compliant claim. If you are working with a manufacturing partner that offers support with food safety and labelling compliance, that party can help to organise this properly.
What happens if you use an unauthorised health claim?
The use of an unauthorised health claim constitutes a breach of European food legislation and may result in enforcement measures by the Netherlands Food and Consumer Product Safety Authority (NVWA). These measures range from a warning or a fine to the mandatory withdrawal of the product from the market.
The NVWA actively monitors the supplements market and checks whether claims on labels comply with the applicable regulations. Products that feature unauthorised claims are considered non-compliant, regardless of whether the claim is factually correct or appears scientifically plausible.
In addition to legal risks, there are also commercial implications. Retailers and buyers are increasingly demanding proof of compliance before adding a product to their range. A product with dubious label claims may be rejected or removed from the shelves, resulting in a direct loss of turnover.
Another thing you should avoid is implicit health claims: claims that do not literally mention a health benefit, but which do give the consumer that impression. The NVWA also assesses claims on the basis of the overall impression a product makes, including its name, images and marketing texts.
How MixMasters helps with health claims and label compliance
We understand that the regulations governing health claims can be complex and time-consuming, particularly if you are looking to launch a new supplement on the market. That is why we offer our clients practical support in the areas of food safety and label compliance:
- HACCP-based food safety plan which is specifically tailored to your product range and market launch.
- Accurate product information on the label, including verification of claims against the EU register.
- BRCGS certification, an internationally recognised food safety standard which demonstrates that our production processes are controlled and auditable.
- Support from concept to production, with compliance being an integral part of the development process rather than a mere footnote.
This ensures that your private-label supplement complies with European regulations from day one, without you having to wade through all the legislation yourself. Would you like to know how we can make your product compliant and ready for the market? Contact us and we’re happy to help you find a solution.
Frequently Asked Questions
May I translate or adapt an approved health claim to suit my own brand language?
No, the exact wording from the EU register is binding and must not be paraphrased, even if you believe that an alternative formulation conveys the same meaning. You may, however, translate the claim into another official EU language, provided that the translation corresponds accurately to the authorised version. Always consult the official EU register to verify the correct translation for each language before placing it on your label.
Do the same health claim rules apply to online marketing and social media as well?
Yes, the rules set out in Regulation (EC) No 1924/2006 apply not only to physical labels, but also to all commercial communications, including websites, social media, advertisements and email campaigns. The NVWA assesses claims based on the overall impression a brand makes, so even an Instagram post or product description in an online shop can be classified as a non-compliant health claim. You should therefore ensure that your marketing team is aware of the same compliance guidelines as your labelling team.
What should I do if I want to launch a supplement containing an ingredient for which there is not yet an approved claim?
If no authorised health claim is available for a specific ingredient, you may not claim any health benefits for that ingredient. You may, however, name the ingredient and provide factual, neutral information without suggesting a causal link to a health effect. An alternative is to position your product on the basis of the approved ingredients in the formula, and to ensure that any communication regarding the non-approved ingredient remains strictly factual.
How do I know if my daily dose meets the criteria for a specific health claim?
Every approved health claim in the EU register is subject to specific conditions of use, including a minimum amount of the active substance per daily portion. You can consult these conditions directly via the official EU register on the European Commission’s website. It is strongly recommended that you have your supplement’s formula assessed by a manufacturing partner or regulatory specialist who is familiar with these threshold values, so that you can be sure that the claim on your product is actually applicable.
Are there any common mistakes to avoid when using health claims on private-label products?
One of the most common mistakes is to use a claim that appears scientifically plausible but does not correspond exactly to an approved wording in the EU register. In addition, many brands underestimate the risk of implicit claims: product names, images or slogans that suggest a health benefit without stating this explicitly. A third common mistake is using a claim without checking whether the dosage in the product meets the relevant minimum requirements.
What is the difference between a 'pending' botanical claim and a rejected claim?
Botanicals fall into a separate category for which the European Commission has temporarily suspended the assessment process, meaning that these claims have not yet been officially approved but have not been definitively rejected either. In practice, many Member States adopt a policy of tolerance towards botanicals with a history of use, but this varies from country to country and offers no legal certainty. To ensure a safe market launch, it is advisable not to use botanical claims until official approval has been granted, unless you have sought legal advice on the specific situation in your target market.
How often are the authorised health claims in the EU register updated, and how can I keep up to date with any changes?
The EU register is updated periodically when the European Commission publishes new regulations based on EFSA opinions. There is no fixed update frequency, so it is important to actively monitor the register or subscribe to updates via the European Commission’s or EFSA’s website. For private label brands, it is practical to entrust this responsibility to a regular manufacturing partner or compliance specialist who keeps track of changes and informs you in good time if a claim on which your product is based is amended or withdrawn.
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