EFSA claims on a supplement label — what is allowed and what is not

A supplement label carries two kinds of statements side by side: claims that are formally permitted, and claims that suggest they are permitted but are not. For a consumer that difference is usually invisible — both look equally official, both are marked with a * or an asterisk, both appear in the same font size as the product name.

This article explains what the EFSA rules involve, what the difference is between approved and non-approved claims, and how you as a reader can tell where a shop stays within the rules and where it does not.

The Regulation — in brief

In 2006 the European Regulation EC 1924/2006 came into force, with one aim: to allow only scientifically substantiated health claims on foods and food supplements in the EU. Since 2012 (Regulation EU 432/2012) there has been a definitive list of permitted health claims — the EFSA Health Claim Register — with around 250 approved claims for specific nutrients and botanical ingredients.

The NVWA (the Dutch Food and Consumer Product Safety Authority) enforces these rules in the Netherlands and can compel supplement suppliers to change their texts, recall products, or face an administrative fine for breaches.

Three categories — what is the difference

1. EFSA-approved health claims — permitted, may appear on the label

Examples:

• "Vitamin C contributes to the normal function of the immune system"
• "Magnesium contributes to a reduction of tiredness and fatigue"
• "Vitamin D contributes to the maintenance of normal bones"

Conditions for being allowed to use the claim:

1. The claim must come exactly from the EFSA register — the literal wording, or a paraphrase approved by EFSA. No creative rewriting into "boost your immune system".
2. The product must contain at least 15% of the Reference Intake (RI) per daily dose of the vitamin or mineral concerned. Below that threshold the claim may not be used, even if the ingredient appears on the ingredient list.
3. The claim must be clearly linked to the specific ingredient — not to the product as a whole.

2. Claims "pending European authorisation" — not permitted

This is where it gets slippery. In the years after 2012, thousands of submitted claims were rejected by EFSA or parked as "on-hold" — above all claims about botanical ingredients (herbs, mushrooms). For years the Dutch supplement industry made use of a lull in enforcement by carrying those claims anyway, with an asterisk and the text:

"Health claim pending European authorisation"

The legal reality: that is not a permitted claim status. "Pending" effectively means: this claim did not pass the scientific assessment, or was withdrawn by the applicant. The Regulation has no intermediate category between "permitted" and "not permitted".

Recent shift: since 2023 the NVWA has been structurally stricter in enforcing against these "pending" claims. Webshops and producers are increasingly written to with a demand to remove such claims within 30 days. What was a grey area until 2022 has become a red zone in 2025–2026.

3. Claims that are not permitted at all — disease and treatment claims

Not permitted on a food supplement under any circumstances:

• "Cures…", "treats…", "prevents…" — links the product to a disease
• "Clears up your migraine" / "helps with depression" / "regulates your blood sugar" — a direct or indirect reference to disease
• Before-and-after photos that suggest a disease
• "Clinically proven" without being able to hand that clinical evidence to the regulator

A food supplement is by definition not a medicine. The moment a claim addresses a disease, the product falls legally under medicines legislation — a far heavier requirement (registration, assessment of efficacy, clinical trials, and so on).

The limits of the system — what EFSA approval does not mean

It is tempting to read the EFSA list as "this is what science knows about nutrients". That is not correct. The EFSA list is what has been approved on the basis of dossiers submitted as applications — not what is biochemically established.

A few concrete examples to make that difference tangible:

L-Glutamine — appears in every university biochemistry textbook (Lehninger, Stryer, Berg-Tymoczko) as one of the most studied amino acids. The main energy substrate for enterocytes and immune cells, a regulator of the acid-base balance, a precursor of glutathione. Decades of clinical research into intestinal permeability, post-operative recovery and sports performance. Number of EFSA-approved claims for L-Glutamine: zero. Not because the work does not exist, but because no applicant has submitted a dossier that met the EFSA criteria for exclusive clinical outcomes.

Caffeine — extensively researched since 1819. EFSA recognises two health claims: increased alertness and increased concentration at ≥75 mg per daily dose, plus a performance claim at ≥3 mg/kg body weight for endurance sport. At the same time, other well-substantiated caffeine effects — lipolysis, adenosine receptor antagonism, dopamine modulation — are not included in the register. Not because they do not exist, but because the specific EFSA requirement (causal relationship, population, dose-response model) differs from what the pharmacological literature describes as action.

Taurine — an endogenous sulfonic acid amino acid, a precursor of bile acids, an osmoregulator, a modulator of GABA receptors. Present in every physiology textbook. No EFSA-approved claim.

The difference is not a scientific gap — it is a bureaucratic filter. The EFSA procedure requires an applicant (usually a manufacturer or a trade association) to invest time and money in a dossier that meets precise methodological requirements. For patent-free substances without a commercial sponsor that is economically unattractive: who pays for a claim that every competitor is then free to use?

What this means for the label reader

A good label names this difference honestly. The legal reality is: on the label, only the approved EFSA claims, linked to correctly dosed ingredients. Away from the label — in product dossiers, practitioner fact sheets, personal consultations — the broader context may (and should) be explained. That is the legislation as intended: marketing strict, individual advice free.

For the consumer this means: a product with few claims is not by definition weaker. A product with many claims is not by definition stronger. And a claim that is missing — on an L-Glutamine or taurine supplement, for instance — says nothing about what the substance does, only about who was prepared to submit the dossier.

A practical example — a berberine product under the microscope

Suppose you read this text on a product package:

"Berberine 500 — for a healthy blood sugar level and cholesterol\ Berberine supports normal stomach function, the urinary tract, the liver and the immune system\ Berberine stimulates the activation of AMP kinase*\ * Health claim pending European authorisation"

What do you see here? Four different health claims for one botanical ingredient, all four without EFSA approval, all four covered by the same asterisk. It is exactly the kind of stacking the NVWA now actively enforces against. The label breaches the Regulation on four points at once — and the asterisk disclaimer does not rescue that legally.

What would be allowed on such a label? A factual description of the ingredient — which plant, which part of the plant, which standardised extract, which dose per capsule. Possibly some traditional context ("traditionally used in Chinese herbal medicine") — without any claim about action or outcome.

What the label says about the shop

How a brand handles EFSA rules says something about its company culture. Three patterns worth noticing:

Pattern 1 — strictly EFSA-compliant

The label carries only approved claims, linked to ingredients that pass the 15% RI threshold. For botanical ingredients: no claim about action, only a factual description. This often comes with a line such as "for an explanation of how it works, consult your practitioner" — exactly what the legislation allows.

Pattern 2 — stacked "pending" claims

Asterisks and disclaimers right across the label. Usually with big claims about action on the front and the disclaimer in small print on the back. Legally fragile; as a brand signal it suggests the shop is aiming more at sales than at compliance.

Pattern 3 — outright disease claims

"Clears up migraine", "helps with ADHD", "cures gut complaints". You do not come across this much any more in legitimate Dutch webshops — it has become too risky administratively — but outside the established market (the Bol marketplace, foreign drop-shippers) it still occurs regularly. You can categorically leave these products alone.

A reading guide for the consumer

What you can check on a label in 30 seconds:

1. Is there a claim about action? Look for verbs: supports, contributes to, stimulates, helps with.
2. Is that claim linked to a vitamin or a mineral? Then it is probably EFSA-approved, provided the dose is right.
3. Is that claim linked to a herb or a botanical substance? Then it is almost never EFSA-approved. An asterisk disclaimer saying "pending" does not make it permitted after all.
4. Are disease names mentioned? Stop reading and put the jar back.
5. Does it state, per ingredient, how much you get per daily dose — not only per capsule? That says something about whether the manufacturer is thinking about EFSA-compliant communication.
6. Is the dose honest? An EFSA claim requires ≥15% RI per daily dose. A vitamin that shows off 2% RI on the label may formally carry no claim — although that is regularly breached.

What you cannot deduce from the label

• How well it is absorbed (quality of the form, presence of fillers)
• How fresh the product is, how well it has been stored, how long it keeps under normal use
• Whether the stated dose in the capsule is actually reached (analytical certainty)
• Whether the effect — for you specifically — has any added value

For those questions you need information from beyond the label: certificates of analysis, production context, and possibly guidance from a professional.

What a good brand does for its customers

• Uses EFSA-compliant claims — so less spectacular on the front, but verifiable
• States how much an ingredient delivers per daily dose (and not only "per capsule")
• Mentions upper limits (UL) where relevant — with zinc, vitamin D and vitamin A, for example
• Describes botanical ingredients factually only, without any claim about action
• Runs a customer service that answers questions about how something works, instead of smuggling that explanation onto the label

When and how to call in a professional

EFSA-compliant communication is conservative — which means that a great deal of clinically interesting research on herbal extracts and specific applications may not appear on the label, while an orthomolecular practitioner or a doctor may explain the current evidence in a personal consultation. That is not a back door; it is exactly how the legislation is intended: marketing strict, individual advice free.

For anyone who wants to know more than the label allows: a consultation with an orthomolecular practitioner or an integrative GP gives you that room. In addition, scientific databases (PubMed, Examine.com, NutriCertify) are accessible sources for the confident reader.

Vitarium therapeutic editorial team

For our range, EFSA compliance is not a minimum requirement but a choice. We would rather carry fewer claims on a product and explain what an ingredient factually does and does not do — even though that makes the product page less spectacular than a competitor who does stack "pending" claims. In practice that translates into three characteristics you will find in our PDPs: transparency about the daily dose (not only per capsule), factual herb descriptions without any claim about action, and extensive safety information where the product category deserves it. For anyone who wants a deeper explanation of a specific field of application, our LVC5 multivitamin and Immuvir Lysine complex remain readable examples of what a compliant PDP can look like in practice.

This article is informative and is not legal or medical advice. For specific questions about supplement claims or choices: consult an orthomolecular practitioner or an integrative doctor. Official sources: the NVWA and the EFSA Health Claim Register.

Sources: Regulation (EC) No 1924/2006 on nutrition and health claims made on foods · Regulation (EU) No 432/2012 (list of permitted health claims) · NVWA annual enforcement reports on food supplements 2023–2025 · EFSA Health Claim Register (available online).