Health Claims for Supplements in the EU: What Your Label Can Say

“Builds muscle”, “boosts your immune system”, “burns fat”. Phrases like these fill supplement marketing, but in the European Union the label leaves no room for creativity: you may only use the health claims that have been authorised, and every other mandatory element of the label is regulated down to the millimetre. This guide explains what your brand can and cannot say on a food supplement label in the EU and in Spain.

What is a health claim?

In the EU, a supplement brand may only use, on its label and in its advertising, the health claims authorised in the EU register under Regulation EC 1924/2006, tied to a specific ingredient and dose; everything else (medical claims, “fat burner”, invented promises) is prohibited and penalised.

A health claim is any statement that states or suggests a relationship between a food, or one of its components, and health. “Magnesium contributes to a reduction of tiredness and fatigue” is a health claim. So is a bicep icon next to the word “muscle”, because the Regulation does not only govern text: it covers any commercial message or representation, including images and trademarks, that suggests an effect on health.

Regulation (EC) 1924/2006 on nutrition and health claims made on foods reversed the previous logic: instead of banning misleading statements case by case, it established a positive-list system. Every claim is prohibited unless it has been expressly authorised.

The EU register of authorised claims

The European Commission maintains a public register of health claims listing the authorised claims (and the rejected ones). Each entry in the register specifies three things:

1. The nutrient or substance the claim refers to (not the product: the effect belongs to vitamin C, not to “your formula”).
2. The wording of the claim, which may be adapted slightly as long as it has the same meaning for the consumer.
3. The conditions of use: the minimum amount of the nutrient the product must provide in order to use the claim, and in some cases additional warnings.

This last point is the one most brands overlook. It is not enough for your formula to contain “a bit of” vitamin C: it must provide it in a sufficient amount under the register’s conditions (at the very least, the product must qualify as a “source of” that nutrient under the legislation). If your product contains a token 5 mg of magnesium, you cannot use the magnesium claim.

When a claim is used, the Regulation additionally requires accompanying statements such as the importance of a varied and balanced diet and a healthy lifestyle, and the quantity of the food and pattern of consumption required to obtain the claimed effect.

Authorised claims you can actually use (real examples)

These are some of the most useful authorised claims for sports supplements, as they appear in the EU register:

Notice the pattern: the claim always names the ingredient, never the product or the brand, and uses cautious verbs (“contributes to”) about normal bodily functions. There is no authorised claim that promises extraordinary results.

There is also a second route, disease risk reduction claims (Article 14 of the Regulation), but these require specific authorisation following a scientific evaluation by EFSA and are very rare in sports supplements.

What you are not allowed to say on the label

Medical claims: cure, treat, prevent

This is the absolute red line. No food, and a food supplement is a food, may claim the property of preventing, treating, or curing a human disease. “Prevents colds”, “relieves joint pain”, “fights anxiety”, or “regulates blood sugar” are illegal medical claims on a supplement, no matter how much supporting literature you believe you have.

”Fat burner”, “detox”, and other marketing classics

“Fat burner”, “boosts your metabolism”, “eliminates toxins”, “natural anti-inflammatory”: none of these appear as authorised claims in the EU register. It does not matter that competitors use them or that consumers expect them: if they are not in the register, they cannot appear on the label, on the website, or on the brand’s social media (the Regulation covers all commercial communication).

Botanicals: the “on hold” claims

Claims about plants and botanical extracts (ashwagandha, ginseng, turmeric, green tea…) are in a transitional situation: most have been pending evaluation (“on hold”) for years. In the meantime they may be used provisionally under the operator’s responsibility, provided they comply with the Regulation’s general principles (truthfulness, scientific substantiation, no medicinal properties). It is a grey area best navigated with regulatory advice, because interpretation varies between Member States and an authority can demand the claim’s removal.

The risk of being reclassified as a medicine

There is a risk even bigger than the fine: the product being deemed a medicine by presentation. If the name, label, leaflet, or advertising present the supplement as though it had therapeutic properties, the authority can reclassify it as a medicinal product, at which point marketing it without a marketing authorisation is illegal at its root, with immediate withdrawal from the market. We cover this in more detail in the guide to the AESAN notification for food supplements.

Mandatory labelling for a food supplement

Besides controlling what you say voluntarily, the legislation dictates what you must say. The general rules are in Regulation (EU) 1169/2011 on food information to consumers, and the supplement-specific ones in Royal Decree 1487/2009 (which transposes Directive 2002/46/EC in Spain).

And one requirement that surprises brands importing pre-labelled products: in Spain, the mandatory label information must be at least in Spanish. A label written only in English, however compliant it may be in Ireland, is not legal on the Spanish market.

What you want to say vs. what you can say

The legal version is less flashy, granted. But it is the only one that does not expose your brand to penalties, product withdrawal, and entire packaging runs in the bin.

Penalties: what a non-compliant label can cost you

In Spain, food safety and nutrition infringements are penalised under Law 17/2011:

• Minor infringement: up to €3,000
• Serious infringement: €3,001 to €60,000
• Very serious infringement: more than €60,001 and possible product withdrawal from the market

On top of the fine comes the real cost of non-compliance: relabelling or destroying the affected stock, redesigning the packaging, halting sales while it is corrected, and the reputational damage with distributors and platforms, which increasingly audit labelling before listing a product.

The role of the GMP manufacturer: review before you print

The cheapest way to comply is not to get it wrong in the first place, and that is where a GMP-certified manufacturer makes the difference. In a serious contract manufacturing project, the regulatory review of the label is part of the process before anything goes to print:

• Claim verification: every claim on the final artwork is checked against the EU register and against the formula’s actual doses.
• Formula–label reconciliation: ensuring the amounts declared per daily dose match the production specifications and that each claim’s conditions of use are met.
• Mandatory statements: a full checklist against Regulation 1169/2011 and RD 1487/2009, including highlighted allergens and warnings.
• Languages and markets: adapting the label to each destination country (language, local statements, ingredient restrictions).

At Akumal we review the claims and labelling of every project before printing, as part of the same regulatory support we provide for the AESAN notification.

Request a regulatory consultation before designing your label: validating claims on paper takes minutes; correcting them once the product is packaged costs an entire batch.