Nutrition and Health Claim Guide for food supervisors and food business operators

222 functional claims approved for food marketing

The European Commission has adopted a Regulation that approves 222 functional claims, i.e. claims referred to in Article 13.1 of the Regulation on Nutrition and Health Claims, for use in the marketing of foodstuffs. Claims rejected from the list of authorised claims may no longer be used in the marketing of foodstuffs.

Commission Regulation (EC) No 432/2012 authorising functional claims will came into force on 14 June 2012. This is the first batch of authorised Article 13(1) health claims and it mainly comprises claims related to vitamins, minerals, various fatty acids and fibres as well as certain other substances and foods. Article 13(1) health claims refer to claims that describe the effect that a nutrient or some other substance has on growth, development and the functions of the body, on psychological and behavioural functions, or on slimming and weight control.

In addition to the Regulation, the Commissioning has published in the Union's Register of Claims a list of the Article 13.1 claims that were not authorised. Claims were rejected for the following reasons:

  • the cause-effect relationship had not been shown
  • the substance was not sufficiently characterised
  • the claim was related to the prevention, treatment or cure of a human disease
  • the claim was not related to a beneficial physiological effect
  • the claim was too general in nature or not specific enough, or
  • there was not enough evidence to establish cause-effect

A transition period of 6 months was granted for the removal of non-authorised health claims from food labelling, advertising and other marketing materials. The transition period ended in mid-December 2012.

The lists of authorised and non-authorised Article 13(1) claims will later be supplemented with claims associated with other substances. Some claims on which EFSA has issued a favourable opinion are still awaiting the final decision. Around 1,500 claims related to substances of plant origin are still under the review process. Claims currently under review may be used in accordance with the provisions of the Regulation on nutrition and health claims until the European Commission passes a decision on the authorisation or rejection of the claim involved.

It is recommended that he wording approved by the European Commission be used for the health claims. Wording other than that presented for the claim in the Regulation can also be used in food marketing, if the claim is likely to have the same meaning for the consumer. A link to the general principles regarding the flexibility of wording adopted jointly by the member states is provided on the right-hand side of the page. It should also be pointed out that claims are not product-specific, but all operators in the food sector can use the authorised claims in the marketing of their own products, provided the conditions for the use of the claim are fulfilled and the compulsory supplementary statements required for such use are provided.

In addition to Article 13(1) health claims, the Regulation on Nutrition and Health Claims also covers Article 13(5) health claims based on newly developed scientific evidence and/or for which protection of proprietary data is requested, as well as Article 14 health claims referring to reduction of disease risk and to children's development and health. These claims may not be used until the claim has been authorised through a Commission Regulation.