How to Use Health Claims for Food Supplements in the EU
Health claims—the mystery or bureaucracy
One of the most confusing—and heavily regulated—aspects of dietary supplement marketing in the EU is health claims.
These claims influence buyer decisions and affect product approval, labeling, and advertising.
However, stringent EU legislation as well as national restrictions limit their legal use.
In this article, BF‑EssE outlines how to use approved health claims, the distinction between stable and unstable claims, and the dangers of depending on so-called "on-hold" Article 13(1) claims.
These claims influence buyer decisions and affect product approval, labeling, and advertising.
However, stringent EU legislation as well as national restrictions limit their legal use.
In this article, BF‑EssE outlines how to use approved health claims, the distinction between stable and unstable claims, and the dangers of depending on so-called "on-hold" Article 13(1) claims.
We'll also demonstrate how, depending on the market, language, or platform, a claim that is legally permissible in the EU could still result in your product being flagged.
What Are Health Claims?
Under EU Regulation (EC) No 1924/2006, a health claim is any message that links a nutrient or substance to a health benefit — for example:
- “Vitamin D contributes to the maintenance of normal bones”
- “Vitamin D treats osteoporosis” (→ forbidden, medical claim)
- -1-
Approved Article 13(1) claims
General, well-established effects (e.g., “Vitamin C supports the immune system”) - -2-
Article 14 claims
Disease risk reduction or children's development (e.g., “Plant sterols reduce blood cholesterol”) - -3-
Article 13(5) claims
Based on newly developed science or proprietary data
The so-called "on-hold" health claims, which are based on botanicals or compounds that are still undergoing EFSA review, are used by several supplement brands.
Unstable Claims: Article 13.1 “On-Hold” List
These are part of the Article 13.1 on-hold list, and while they are technically allowed for now, they are not officially approved.
We call these claims “”unstable”—because they can be changed, rejected, or banned at any time once the EU Commission finalizes their position.
Risk summary:
We call these claims “”unstable”—because they can be changed, rejected, or banned at any time once the EU Commission finalizes their position.
Risk summary:
- Can be used under national interpretation
- May not be accepted on Amazon or by strict national authorities
- Often blocked during cross-border sales, especially in Germany, Denmark, or Nordic markets
-
4222 - Valeriana officinalis (Valerian) - Mental health:
Helps to maintain a natural sleep/helps maintain normal
quality of sleep/helps you cope calmly with the stress of a
busy lifestyle -
4269 - Ginko biloba leaf - Brain circulatory system
Ginko biloba can help the maintenance of the proper brain performance in elderly people -
2636 - extract of Passion flower (Passiflora incarnata) - herbal sedative
Helps to induce calm rest and sleep
Helps to calm down after the argument and excitedness recommended to people feeling week and fatigued helps to induce relaxation
ndaclaims13 database of heath claims
3 types of health claims by status— Published, on hold, Withdrawn in database
Theoretically: Yes — and practically: Yes.
Published health claims are approved by the European Commission based on EFSA's positive scientific opinion and are listed in the EU Register of Nutrition and Health Claims.
You can use them if:
Published health claims are approved by the European Commission based on EFSA's positive scientific opinion and are listed in the EU Register of Nutrition and Health Claims.
You can use them if:
- The claim is used exactly as written
- The ingredient and form match EFSA’s evaluation (e.g., magnesium citrate)
- The product provides the minimum effective dose (if required)
- In practice, these are safe to use.
- Accepted across all EU member states
- Recognized by most major e-commerce platforms (e.g., Amazon, eBay)
- Low regulatory risk when used correctly
Can You Use Published (Approved) Health Claims ?
Theoretically: Yes.
Some EU countries allow their use with caution if:
Some EU countries allow their use with caution if:
- The claim is truthful and not misleading
- The ingredient is traditionally recognized
- The product does not treat or prevent disease
In practice: It's risky.
- Enforcement differs by country
- Online platforms (like Amazon) may apply stricter rules
- Claims might be removed, or your product delisted without warning
No.
Withdrawn or rejected health claims have been either
Withdrawn or rejected health claims have been either
- Scientifically disproven by European Food Safety Authority (EFSA)
- Voluntarily withdrawn by the applicant
- Rejected by the European Commission after review
- The claim was formally rejected (published in Official Journal)
- The claim contradicts scientific consensus
- The wording implies a benefit that isn’t approved
Can You Use On-Hold Claims?
In practice: Using withdrawn claims is non-compliant and dangerous.
- Can lead to product suspension or fines
- National authorities may issue a warning and penalties.
- Online platforms often auto-flag such products
Can You Use Withdrawn or Rejected Health Claims?
National Rules Override EU Flexibility
Even with EU-wide regulations, each country may set national limits on health claims and active ingredient dosages.
This creates a regulatory minefield, especially for brands trying to sell across borders.
Example: Melatonin
Key takeaway: Even if a claim is allowed in the EU, you must still check national rules and platform-specific policies.
This creates a regulatory minefield, especially for brands trying to sell across borders.
Example: Melatonin
- EU-approved claim: “Melatonin helps reduce the time it takes to fall asleep.”
- Minimum effective dose for the claim: 1 mg per serving
- But every country sets its own rules for what is legally allowed in a food supplement:
Country | Maximum Allowed Dose | Market Notes |
Latvia | 1.99 mg | Official national limit |
Lithuania | 1.0 mg | Stricter interpretation |
Germany | 1.99 mg | Allowed under food law |
Amazon.de | 0.5 mg | Platform restriction (not legal) |
Spain | >2 mg | Some products allowed at higher dose |
Key takeaway: Even if a claim is allowed in the EU, you must still check national rules and platform-specific policies.
Best Practices When Using Health Claims
- Use only approved EFSA claims, word-for-word
- Check ingredient form and minimum dosage
- Avoid “curative” or medical language
- For botanicals or on-hold claims, add disclaimer (e.g. “Traditional use”) and check national interpretation
- Always verify label and marketing for each country separately
Frequently Asked Questions About EFSA and Health Claims
A health claim is any statement that links a nutrient or substance to a health benefit, as defined by EU Regulation (EC) No 1924/2006.
Example: “Vitamin C contributes to the normal function of the immune system.”
Example: “Vitamin C contributes to the normal function of the immune system.”
On-hold claims are typically linked to botanicals still under EFSA review. You can use them in some EU countries, but they are legally unstable and may be rejected at any time.
No. Approved health claims must be used verbatim. Any modification, simplification, or exaggeration may render the claim illegal.
You can search the EU Register of Nutrition and Health Claims online or consult regulatory experts like BF‑Esse for compliant wording matched to your formulation.
EFSA provides the scientific opinion, but final approval comes from the European Commission, which publishes the approved claims in the Official Journal of the EU.
Yes — but only through a formal application process.
You cannot simply write your own health claim on packaging or in marketing — even if it’s based on real data — unless it has been scientifically reviewed and approved.
You cannot simply write your own health claim on packaging or in marketing — even if it’s based on real data — unless it has been scientifically reviewed and approved.
How BF‑Esse Helps You Stay Compliant
Contact BF‑EssE’s regulatory team for tailored support.
Contact BF‑EssE’s regulatory team for tailored support.
At BF‑Esse, we:
- Match ingredients to legal claims
- Review your label for claim compliance
- Guide you through country-specific limits
- Help you avoid delisting or rejection due to unapproved claims
Useful link list:
1. Additives in Food – EU Business Portals.
2. EU Regulation (EC) No 1333/2008 on Food Additives
3. Nutrition and Health Claims – EU Business Portal
4. General Rules on Food Labelling – EU Business Portal
5. Regulation (EC) No 1924/2006 on Nutrition and Health Claims
6. EFSA: Article 14 Health Claims (Disease Risk Reduction & Children)
7. EFSA: Article 13 Health Claims (General Function Claims)
8. Downloadable Article 13.1 database of on-hold botanical claims
2. EU Regulation (EC) No 1333/2008 on Food Additives
3. Nutrition and Health Claims – EU Business Portal
4. General Rules on Food Labelling – EU Business Portal
5. Regulation (EC) No 1924/2006 on Nutrition and Health Claims
6. EFSA: Article 14 Health Claims (Disease Risk Reduction & Children)
7. EFSA: Article 13 Health Claims (General Function Claims)
8. Downloadable Article 13.1 database of on-hold botanical claims
Disclaimer
The information provided on this page is for informational purposes only and does not constitute legal or regulatory advice. While BF‑Esse makes every effort to ensure accuracy and compliance with current Latvian and EU regulations, businesses are responsible for conducting their own due diligence and consulting with the relevant authorities or legal advisors where necessary. The Latvian Food and Veterinary Service (PVD) is the official body overseeing food supplement notifications in Latvia.