EFSA Health Claims: How to Get Your Supplement Claim Approved

The EU Register of authorised health claims contains approximately 250 approved claims. EFSA has evaluated over 4,000 claim applications since Regulation (EC) No 1924/2006 came into force. The rejection rate is approximately 80%. Understanding why most claims fail — and what the successful ones have in common — is essential for any supplement brand targeting the EU market.

What Is the EU Health Claims Regulation?

Regulation (EC) No 1924/2006 on nutrition and health claims made on foods governs all health claims used on food products, including food supplements, in the EU. Under this regulation, a health claim is any statement that suggests a relationship between a food or one of its constituents and health.

Health claims are divided into three categories:

Article 13 claims (general function claims): Claims about the role of a nutrient in normal growth, development, and body functions. These were evaluated in bulk during the initial implementation of the regulation. The EU Register contains the approved Article 13 claims — approximately 250 claims for vitamins, minerals, and a small number of other substances.

Article 14 claims (disease risk reduction and children’s development claims): Claims that a food or ingredient reduces the risk of a disease, or claims relating to children’s development and health. These require individual authorisation through EFSA evaluation.

Botanical claims: Claims for botanical ingredients (herbs, plant extracts) are in a special category — they were placed “on hold” during the initial evaluation and have not been systematically evaluated. Brands can use botanical claims that were used before the regulation came into force, provided they comply with national rules, but the legal status of these claims is uncertain.

How Does the EFSA Health Claim Evaluation Process Work?

For new Article 14 claims (disease risk reduction claims), the authorisation process works as follows:

1. Application submission: The applicant submits a dossier to the competent authority of an EU member state (in France, ANSES handles the initial submission). The dossier is then forwarded to EFSA.

2. EFSA evaluation: EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA Panel) evaluates the scientific evidence. The evaluation typically takes 12 to 18 months.

3. EFSA opinion: EFSA issues a scientific opinion — either positive (the evidence supports the claim) or negative (the evidence does not support the claim).

4. Commission authorisation: If EFSA’s opinion is positive, the European Commission adds the claim to the EU Register of authorised health claims through a Commission Regulation. This step typically takes an additional 12 to 18 months.

Total timeline: 3 to 5 years from application to authorisation (if successful).

What Evidence Does EFSA Require?

EFSA’s scientific standard for health claim evaluation is high — significantly higher than FDA’s standard for structure/function claims under DSHEA.

EFSA requires:

Characterisation of the food/substance: The substance making the claim must be clearly defined and characterised. For botanical extracts, this means specifying the plant species, plant part, extraction method, and active constituent profile. Vague descriptions (“herbal extract”) are not acceptable.

Substantiation of the claimed effect: The evidence must demonstrate a cause-and-effect relationship between consumption of the substance and the claimed health effect. EFSA uses a hierarchy of evidence:

• Systematic reviews and meta-analyses of randomised controlled trials (highest quality)
• Individual randomised controlled trials
• Observational studies (lowest quality for establishing causality)

Relevance of the evidence: The studies must be conducted in the target population (e.g., healthy adults, not patients with a disease) at the dose and form of the substance as used in the supplement.

Consistency of the evidence: Multiple independent studies should reach consistent conclusions. A single positive study is generally insufficient.

Why Do Most Health Claim Applications Fail?

The 80% rejection rate reflects several systematic problems:

Insufficient clinical evidence: Many applications rely on in vitro studies, animal studies, or observational data. EFSA requires human clinical trial data demonstrating the claimed effect in healthy subjects at the dose and form of the substance as marketed.

Poorly characterised substance: Applications for botanical extracts frequently fail because the extract is not sufficiently characterised. EFSA cannot evaluate the safety or efficacy of an extract that is described only as “standardised to 5% active compound” without specifying the plant species, plant part, extraction solvent, and full constituent profile.

Claim not substantiated by the evidence: The evidence may demonstrate a health effect, but not the specific effect claimed. For example, evidence that a substance reduces blood pressure does not substantiate a claim that it “maintains normal blood pressure” in healthy subjects with normal blood pressure.

Studies conducted in patients, not healthy subjects: EFSA evaluates claims for use in healthy populations. Studies conducted in patients with a disease do not substantiate claims for healthy subjects.

Dose mismatch: The dose used in the supporting studies must match the dose in the supplement as marketed. Studies conducted at doses that are not achievable through normal supplement use do not substantiate claims at lower doses.

The Botanical Claims Situation

The “on hold” status of botanical health claims is one of the most practically significant regulatory gaps in EU supplement law. Hundreds of health claims for botanical ingredients — including widely used herbs like echinacea, valerian, ginkgo, and milk thistle — have been submitted but not evaluated.

The current position is:

• Botanical claims that were in use before the regulation came into force may continue to be used under national rules (member state discretion)
• France, Germany, and other member states have different national positions on which botanical claims are permitted
• EFSA has not committed to a timeline for evaluating botanical claims

For brands selling botanical supplements in the EU, this means:

• Claims for vitamins and minerals: use only authorised claims from the EU Register
• Claims for botanical ingredients: check national rules in each target market; consult a regulatory specialist

Using Authorised Health Claims Correctly

Even for authorised claims, the regulation specifies exact conditions of use. The claim must be used:

• In the exact wording authorised (or equivalent wording that conveys the same meaning to consumers)
• Only for the specific substance at the specific amount that was the basis for the authorisation
• Only in products that contain the substance at the level required to achieve the claimed effect (the “significant amount” as defined in the regulation)
• With the required accompanying information (e.g., “Calcium is needed for the maintenance of normal bones” must be accompanied by information about the importance of a varied diet)

Brands that use authorised claim wording but apply it to products that don’t meet the conditions of use are non-compliant — even if the claim itself is on the authorised list.

At Care Europe, we advise supplement brands on EU health claims compliance, including claim audit against the EU Register, national botanical claim rules, and EFSA application strategy for new claims. Contact us at [email protected].