What Regulation (EC) No 1924/2006 covers
Regulation (EC) No 1924/2006 governs every nutrition and health claim made for a food supplement in the EU. This includes the label, the presentation and advertising. A claim may appear only if the Regulation permits it and the product meets its conditions of use. Those conditions are expressed in the units of Regulation (EU) No 1169/2011. Converting vitamin D from IU to mcg is therefore part of claim compliance, not only of labelling.
The Regulation applies to claims in commercial communications about foods delivered as such to the final consumer. Food supplements are foods, so it applies to them. It works alongside Directive 2002/46/EC and Regulation (EU) No 1169/2011, not in place of them.
Types of claim and how each becomes usable
| Claim type | Legal basis | How it becomes usable |
|---|---|---|
| Nutrition claim | Article 8 and the Annex | Only claims listed in the Annex, under the conditions set there |
| General function health claim | Article 13(1) | Inclusion in the Union list of permitted claims under Article 13(3), adopted by Commission Regulation (EU) No 432/2012 as amended |
| Claim based on newly developed science or proprietary data | Article 13(5) | Individual authorisation through the procedure in the Regulation |
| Article 14 claim | Article 14: risk-reduction claims and claims referring to children’s development and health | Individual authorisation following an EFSA opinion |
Medicinal claims fall outside this system entirely. Article 7(3) of Regulation (EU) No 1169/2011 prohibits food information that attributes to a food the property of preventing, treating or curing a human disease. Article 6 of Directive 2002/46/EC repeats that prohibition for food supplements.
General conditions every claim must meet
Article 3 sets general principles. A claim must not be false, ambiguous or misleading. It must not encourage excess consumption of a food. It must not state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.
Article 5 sets conditions on the presence, quantity and form of the substance the claim refers to. For vitamins and minerals, the significant-amount rule and the nutrient reference values (NRVs) are in Annex XIII, Part A, of Regulation (EU) No 1169/2011. The quantity must be judged on the amount reasonably expected to be consumed, which for a supplement is generally taken to be the recommended daily portion.
Article 10(2) lists information that must accompany a health claim. Article 10(3) allows a reference to general, non-specific benefits only when a specific authorised claim accompanies it. Article 12 bans certain claims outright, including those referring to recommendations of individual doctors or health professionals.
The EU Register of nutrition and health claims
The EU Register of nutrition and health claims is the practical starting point. It lists permitted nutrition claims and authorised health claims with their conditions of use and any restrictions. It also records claims that have been refused, with the reason.
Treat the Register as an information tool. The legally binding text is the regulation that authorised each claim, published in EUR-Lex. Check that act before you finalise a label.
To use the Register for a product:
- Search by nutrient or substance, not by ingredient form.
- Read the conditions of use and any restriction or warning attached to the claim.
- Record the authorised wording and the date and act of authorisation.
- Note any claim status that is not “authorised” and treat it as unusable until confirmed.
Check with the competent authority of each target market how far authorised wording may be adapted, including any national guidance on this.
Claims, nutrients and the form you buy
Authorised claims for vitamins and minerals are generally made for the nutrient, not for a particular salt or ester. The form itself must still be permitted in food supplements under Annex II of Directive 2002/46/EC. Our guide to permitted vitamin and mineral forms covers that list.
The condition of use depends on the amount of nutrient in the daily portion, not on the mass of the compound. A mineral salt therefore needs elemental-content arithmetic before you can tell whether a claim is open to you. The elemental content calculator does this from molar mass.
For substances other than vitamins and minerals, the position differs. Many claims for botanical substances may still be pending evaluation and handled under the transitional rules in Article 28 of the Regulation. National approaches can differ, so check with the competent authority of each target market.
Units on a claimed label: vitamin D IU to mcg and vitamin E IU to mg
For food supplements, Annex I of Directive 2002/46/EC sets the units for vitamins A and D in µg and for vitamin E in mg. The declared amount and the claim condition are compared in those units. An amount specified in international units must be converted first.
For vitamin D, IU and µg are linked by a single fixed factor for cholecalciferol and ergocalciferol. For vitamin E, the factor depends on the form: natural or synthetic, free tocopherol or ester. The vitamin unit converter applies the correct factor for each form.
Whether IU may also appear on an EU label, alongside the mandatory unit, should be confirmed for each market. The labelling guide covers declaration of amounts.
Claims and the novel food regulation
Regulation (EU) 2015/2283 controls foods and ingredients not consumed to a significant degree in the EU before 15 May 1997. Authorised novel foods appear in the Union list in Implementing Regulation (EU) 2017/2470.
The two systems are separate. An authorised health claim does not authorise a novel ingredient. A novel food authorisation does not authorise a claim. A Union list entry may also set its own labelling requirements, which apply alongside any claim. See the novel food status guide.
Claims and the food supplements directive 2002/46/EC
Directive 2002/46/EC defines food supplements and lists the vitamins and minerals, and their forms, that may be used. Article 6 sets the name of the product and the mandatory label statements. These apply whether or not the label carries a claim.
A claim does not change maximum levels. Those are set nationally, and the maximum levels guide explains how they differ between member states.
What a manufacturer must do before using a claim
- Confirm that each ingredient is permitted: Annex II of Directive 2002/46/EC, novel food status and national rules for other substances.
- Find the claim in the Register and confirm it in the authorising act in EUR-Lex.
- Calculate the nutrient per daily portion in the Annex XIII unit and check it meets the condition of use.
- Check the amount against the national maximum level in each target market.
- Add the information Article 10(2) requires and check the Article 12 restrictions.
- Check national notification requirements for food supplements in each market.
- Keep the analytical evidence behind the declared amounts on file.
For step 7, SoleChem sends the specification sheet and certificate of analysis with its quote. These documents describe the material’s identity and composition. They do not carry or substantiate claims.
Who enforces the rules
Competent authorities in each member state enforce Regulation (EC) No 1924/2006 on their market. Interpretation of wording, treatment of claims not yet evaluated and notification procedures differ between them. A label accepted in one member state is not automatically accepted in another.