Health claim means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Health claims are divided into the following categories.
Article 13 health claims (= functional claims):
- claims that refer to the role of a nutrient or other substance in growth, development and the functions of the body
- claims that refer to psychological and behavioural functions
- claims that describe slimming or weight control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet.
Article 14 health claims
- claims that refer to the reduction of disease risk (=risk factor)
- claims that refer to children's development and health.
System for authorisation of health claims
Health claims may only be used in the labelling, advertising or other presentation of foodstuffs provided the claims have been authorised and they are included in the lists of permitted claims referred to in Articles 13 and 14.
The establishment of the authorisation system started with the member states submitting to the Commission by 31 January 2008 national lists of Article 13(1) health claims for evaluation.
The European Food Safety Authority EFSA assesses the scientific substantiation for health claims and the wording of the claim. EFSA's opinion is not a health claim decision, but the decision is made under a Commission Regulation. After discussions between the Commission and the member states the claim is either authorised or rejected under a Commission Regulation.
The Commission takes a decision on each health claim as soon as EFSA has issued its opinion. An up-to-date list of the authorised and rejected health claims is provided on the Commission's web site.
The authorised Article 13(1) health claims – i.e., the Regulation (EU) No. 432/2012 on functional health claims – has applied since 14 December 2012. This means that Article 13(1) health claims rejected by the European Commission may not be used after said date in labelling or marketing foods.
Until EFSA has issued its opinion, health claims referred to in Article 13(1) of the Regulation on nutrition and health claims may be used under the responsibility of the food business operator, provided the claims are in conformity with the conditions set out in the Regulation on nutrition and health claims and in national regulations.
Health claims substantiated by newly developed scientific evidence or health claims that include a request for protection of proprietary data may be included in the list by a separate application. For more information, refer to health claim applications.
- Register of claims submitted to EFSA for evaluation
- Authorised and non-authorised health claims on Commission's web site