Regulation

Nutrition & health claims regulation

Regulation (EC) No 1924/2006 governs what can be said about food, including food supplements, in relation to nutrition and health. Only nutrition claims listed in its Annex, and health claims authorised by the European Commission (generally following scientific assessment by EFSA), may be used, subject to transitional arrangements for claims still pending.

The instrument

Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (NHCR) is directly applicable in all EU Member States. It applies to nutrition and health claims made in commercial communications — on labels, in advertising, on the seller's website — relating to foods supplied to the final consumer, including foods supplied in mass catering. Food supplements are a category of food and are within scope.

Two key principles underpin the regulation: claims must not mislead the consumer, and they must be based on generally accepted scientific evidence. The European Food Safety Authority (EFSA) is the body that provides the scientific assessment.

What is a nutrition or health claim

A "nutrition claim" (Article 2(4)) is any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the energy it provides, contains in reduced or increased proportions, or does not provide; or due to the nutrients or other substances it contains, contains in reduced or increased proportions, or does not contain. Permitted nutrition claims are listed in the Annex to the Regulation (for example, "low fat", "source of fibre", "high in vitamin C").

A "health claim" (Article 2(5)) is any claim which states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Health claims are further subdivided by the procedural article under which they are authorised: 13(1) and 13(5) for "function" claims, and 14 for disease-risk reduction claims and claims related to children's development and health.

Article 13 general function claims

Article 13(1) covers health claims that describe the role of a nutrient or substance in growth, development and functions of the body, or psychological and behavioural functions, or reference to slimming or weight-control. The original Article 13 list was built from claims submitted by Member States and assessed in successive batches by EFSA. Authorised Article 13(1) claims are listed in Commission Regulation (EU) No 432/2012 and subsequent amendments.

An authorised Article 13(1) claim takes a specific wording, attached to specific conditions of use. For example, claims for vitamins and minerals are authorised in connection with specific nutrient functions, and may be used only on foods that contain a minimum significant amount of the nutrient as defined in EU food law.

Article 13(5) new-evidence claims

Article 13(5) applies to health claims based on newly developed scientific evidence or for which protection of proprietary data is requested. Such claims undergo an EFSA scientific opinion and then a Commission authorisation procedure; if authorised, they are added to the EU Register.

Article 14 disease-risk reduction and children's claims

Article 14 covers two categories of claim:

• Reduction of disease-risk claims: any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease.
• Claims referring to children's development and health.

Both types of claim are subject to individual authorisation following an EFSA opinion. Examples of authorised reduction-of-disease-risk claims include certain claims for plant sterols and stanols in relation to blood cholesterol, and certain claims for calcium and vitamin D in relation to bone mineral loss in post-menopausal women (each with detailed conditions of use).

Note that a reduction-of-disease-risk claim is not the same as a claim to treat, prevent or cure a disease. Attributing to a food the property of preventing, treating or curing a human disease is prohibited by Article 7(3) of Regulation (EU) No 1169/2011, and such a claim may also lead to the product being regarded as a medicinal product by presentation.

The EU Register

The EU Register of nutrition and health claims is maintained by the European Commission. It lists all authorised and rejected claims, the conditions of use of each authorised claim, and the regulation under which each entry was authorised. The Register is the operational reference for what may and may not be said about a food: any claim used in commercial communication should be traceable to an entry in the Register.

Botanicals on hold

A large number of claims relating to botanical substances (plant-based ingredients) submitted under the Article 13 procedure were placed "on hold" pending further Commission deliberation. Under transitional arrangements, these claims have continued to be usable subject to national-law conditions. The Commission has periodically signalled its intention to address the backlog; as of writing, the on-hold status remains the operative arrangement for many botanical claims.

Practical effect in parapharmacy

For a parapharmacy retailing food supplements, the practical consequence of Regulation 1924/2006 is that every health claim on a product label, on shelf signage, on a website description or in advertising must correspond to an authorised claim in the EU Register, used in the conditions defined for that claim. Generic phrasing that goes beyond an authorised claim — "supports immunity" without the specific nutrient and the specific authorised wording — is a regulatory exposure. Claims that imply prevention, treatment or cure of disease are prohibited for foods and may lead to the product being regarded as a medicinal product.

Frequently asked questions

What is the difference between Article 13 and Article 14 claims?

Article 13 covers general function claims, such as the role of a nutrient in growth or body functions. Article 14 covers disease risk-reduction claims and claims about children's development and health, which need individual authorisation.

Does EFSA authorise health claims?

No. EFSA assesses the scientific substantiation. Authorisation is decided by the European Commission together with the Member States, and authorised claims are listed in the EU Register.

Can a food supplement claim to prevent or cure a disease?

No. Food law prohibits attributing to a food the property of preventing, treating or curing a human disease. The only exception is an authorised Article 14 claim about reducing a risk factor.

What does "on hold" mean for botanical claims?

Many claims on plant substances submitted for the Article 13 list were never assessed to a conclusion. Under transitional rules they may continue to be used, under the operator's responsibility, pending a decision.

Last reviewed: October 2026.