EU Health Claims Under Regulation (EC) No 1924/2006: Why Most Supplement Brands Are Getting Their Labels Wrong

A supplement brand had its French distribution stalled last year — not because the formulation failed safety testing or the GMP certificate had lapsed. The ingredient profile was solid, the product information file was in order, and the lab results were clean. The problem was a single sentence on the front panel: “supports heart health.” Three words that don’t appear anywhere on the EU Register of authorized health claims under Regulation (EC) No 1924/2006. The distributor flagged it, the brand rewrote the label, and roughly 11 days and a considerable reprint bill later, the product shipped. That was a best-case outcome. We’ve seen brands face sustained DGCCRF investigations for the same category of phrasing — with penalties that made label reprints look like a minor inconvenience.

The EU’s health claims framework is one of the most misunderstood pieces of food law in operation today. It’s not conceptually complex, but the gap between what brands believe is permitted and what the regulation actually authorizes is wider than most realize until they’re already in trouble. And the French market, where the DGCCRF operates as one of the most active enforcement bodies in the EU, is not where you want to discover that gap.

What Regulation (EC) No 1924/2006 Actually Governs

The regulation entered into force on 1 January 2007 and applies to all nutrition and health claims made on food products — including food supplements — sold anywhere in the EU. Its scope is broader than most brands initially assume. It covers the physical label, yes, but also websites, social media posts, product brochures, and any promotional material directed at consumers. If you’re selling into the EU market, it applies to you whether you’re manufacturing in Marseille or in Montreal.

The regulation distinguishes between two fundamentally different types of statements. Nutrition claims describe the presence, absence, or reduced level of a nutrient — “high in vitamin C” or “low in saturated fat.” Health claims assert or imply a relationship between a food substance and health. “Calcium contributes to normal muscle function” is a health claim. So is “helps maintain normal energy levels.” And so — critically — is “supports your immune system,” even when that language feels vague or generic to a marketing team.

Any health claim made on a product must appear on the EU Register of Authorized Nutrition and Health Claims. If it isn’t on that list, word for word or close enough to satisfy the relevant competent authority, it’s not a legal claim to make. There’s no category of “generally recognized” health claims that exists outside the Register. That’s a common misconception, especially among brands entering from the US market, where the structure/function claim framework under DSHEA works very differently.

The Article 13 Split: General Function Claims and the Long Shadow of the Botanicals

Within Regulation 1924/2006, health claims are authorized through different pathways depending on their type. The two that matter most for supplement brands in practice are Article 13.1 and Article 13.5.

Article 13.1 claims cover well-established, general function health claims. These were collected from EU member states in 2008, reviewed by the European Food Safety Authority (EFSA), and consolidated into Commission Regulation (EU) No 432/2012, which took effect in December 2012. That regulation authorized approximately 222 health claims for nutrients — vitamins, minerals, fatty acids, and a handful of other substances. Counting subsequent amendments and nutrition claims together, the full EU Register today contains over 2,400 authorized entries.

Article 13.5 claims apply to new or proprietary health claims not covered by the general list. A brand that wants to use one submits a full application to EFSA through the European Commission, supported by a scientific dossier demonstrating that the claimed effect is real and substantiated. EFSA issues a scientific opinion; if positive, the Commission may authorize the claim by amending the Regulation. The process typically takes 3 to 5 years from submission to authorization — when it goes smoothly — and the science compilation alone routinely costs north of €200,000.

Then there’s the botanical situation, which has been an open regulatory wound since 2010. Botanical and herbal ingredients — turmeric, ashwagandha, valerian, ginkgo biloba, and hundreds of others — were placed “on hold” pending further EFSA evaluation, because the traditional use evidence supporting most botanical health claims didn’t meet EFSA’s scientific substantiation standard. More than 15 years later, those claims remain pending. Brands selling botanical food supplements in the EU are operating in genuine regulatory grey territory, and member states handle that grey zone differently. France has consistently taken a stricter enforcement posture than many other EU countries — a practical reality that shapes how any supplement brand targeting the French market needs to approach its labels.

Why Exact Wording Is Non-Negotiable — and Where Brands Consistently Stumble

This is where most non-conformities originate. The EU Register doesn’t license a concept — it authorizes specific, defined wording. “Zinc contributes to normal cognitive function” is authorized. “Zinc supports brain health” is not, even though most consumers would consider those statements equivalent. The regulation permits adaptation of authorized wording to aid consumer comprehension, but “adaptation” has a narrow practical meaning. You can rephrase slightly for clarity; you cannot substitute a non-authorized formulation and expect it to hold up under inspection.

You also cannot combine claims in ways that imply something the individual authorizations don’t cover. “Vitamin D for strong bones and immunity” bundles two separate authorized claims — one for maintenance of normal bones, one for normal immune function — and both conditions of use must be satisfied independently. If either isn’t met, neither can be used.

The most persistent mistake in the compliance reviews we conduct is a brand citing an EFSA scientific opinion as the regulatory basis for a claim. An EFSA opinion is a scientific assessment — it’s input to the Commission’s decision-making, not an authorization in itself. The authorization only exists once a Commission Regulation or Decision formally adds the claim to the Register. I have reviewed product files where brands held a positive EFSA opinion from 2013 and had been using the associated claim for more than a decade. That opinion was never followed by a Commission authorization. Every label they had printed in that period carried an unauthorized claim.

How DGCCRF Enforcement Works in Practice

In France, the Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes — DGCCRF — is the primary enforcement body for food supplement labeling and health claims compliance. The agency runs targeted inspection campaigns on food supplements every two to three years, with results published on its website. Its most recent sector survey found labeling irregularities or unauthorized claims in more than 40% of sampled products. That figure is broadly consistent with EU-wide data, but France’s follow-through on enforcement is notably more active than the EU average.

DGCCRF inspectors examine the physical product label, the brand’s French-language website, and any French-language promotional content. They buy products online. They cross-reference claims against the EU Register and against the national transposition framework — principally Decree No 2006-352, which implements Directive 2002/46/EC on food supplements in France, along with subsequent Arrêtés governing botanical ingredients, vitamins, and minerals. An unauthorized claim on a landing page carrying a French translation is just as enforceable as one on a physical label in a pharmacy.

The typical enforcement path starts with an administrative notice — an injonction — requiring the operator to correct the non-conformity within a set timeframe, typically 30 days. If the brand fails to respond or the violation is repeated, the agency escalates to administrative financial penalties or, in cases of deliberate consumer deception, to criminal referral. For non-EU brands selling into France online, DGCCRF has worked with customs authorities to flag repeat offenders at the border. The days when a non-French domain provided effective cover are well behind us.

How to Verify Your Claims Before the Label Goes to Print

Getting this right is methodical work, not guesswork. Here’s the process we follow in pre-launch regulatory reviews:

1. Start from the EU Register, not from your marketing brief. The EU Register of Authorized Nutrition and Health Claims, maintained by the European Commission, is the only authoritative source. Search every ingredient you’re labeling for health purposes, and document which claims are authorized, which were rejected, and which are on hold.

2. Map every claim on the draft label and website to a Register entry. If a statement doesn’t have a direct, current entry, it cannot appear — including indirect claims. Imagery, product names, or descriptions that imply a health benefit fall within the definition of a health claim under Article 2(2)(5) of the regulation.

3. Check the conditions of use for every authorized claim. Authorized claims almost always carry conditions: minimum amounts per serving, specific food categories, or mandatory accompanying statements. Vitamin C’s contribution to normal immune function, for example, requires the product to provide at least 15% of the reference intake per 100 ml or per portion.

4. Establish your member-state position for any botanical ingredients. Because botanical health claims are suspended at EU level, you need to understand how each market where you’re distributing treats them nationally. In France, the DGCCRF’s operational guidance indicates that traditional use claims for botanicals may be used under specific conditions tied to the Arrêté on botanical substances — but that window is narrower than it sounds and changes with enforcement priorities.

5. Have a qualified regulatory professional review and sign off before print. Responsibility for claims compliance sits with the food business operator under Regulation 1924/2006. That means someone with genuine regulatory competence — not a general legal counsel unfamiliar with food law, and not a freelance copywriter — needs to have reviewed and approved the label before it goes to a printer.

The Most Expensive Mistake Is Also the Most Avoidable

Unauthorized health claims are the most commonly cited non-conformity in DGCCRF food supplement audits, and they’re almost entirely preventable. A thorough pre-launch claims review costs a fraction of what a label reprint, product hold, or enforcement response typically runs. And unlike many regulatory risks, this one has a clear, publicly searchable reference point: the EU Register tells you exactly what is and isn’t authorized.

If you’re developing a supplement line for the EU market or adapting a product already successful in North America, don’t assume the claims framework translates. It doesn’t. US structure/function claims authorized under DSHEA have almost no direct equivalents in the EU Register. Starting the mapping process early — against the actual Register, not against competitor labels you’ve seen in-market — remains the single most efficient investment a supplement brand can make before the label reaches final design.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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