Article 13 Health Claims Approved by EFSA

06 May 2011

Amy Williams

European Regulation 1924/2006 addresses the use of health and nutritional claims when marketing foods. The Regulation entered into force in January 2007 and Article 13 provided that the central regulatory body, the European Food Safety Authority (EFSA), would consider claims put forward by the competent authorities of the Member States, in order to produce a list of approved health claims which have sufficient scientific basis and are worded so as to be understood by the average consumer.

A health claim is defined in the Regulation as any claim that "states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health". Article 13 specifically excludes claims relating to the reduction of disease risk and childhood development (which are dealt with under Article 14). However, the EFSA will examine all health claims referring to growth, development and the functioning of the body, as well as behavioural effects and weight-loss. These are known as "general function" health claims.

The description of the health benefit of a claim must be truthful, clear, reliable and useful to a consumer in choosing a healthy diet and the role of the nutrient or substance should be carefully considered. The wording of health claims should also be considered in light of the Article 10 requirements that additional labelling may be required in cases where certain foods should not be consumed by certain members of the population or where excess consumption may have negative health consequences. 

Over 44,000 general health claims were submitted by the Member States and these were consolidated into 4637  main claims for consideration by the EFSA. Each proposal included the scientific basis for the relationship between the food and the health claim, as well as some proposals for the wording of each claim.

The EFSA's evaluation of the claims is ongoing, with 80% of the general health claims now having been reviewed. It is intended that this stage will be completed by June 2011. In April 2011, the fourth batch of approved claims was released, with successful claims including the relationship between walnuts and improved function of blood vessels; the antioxidant effects of polyphenols found in olive oil on so-called "bad" cholesterol; and the effect of caffeine on alertness and physical endurance. The EFSA has approved just 20% of the claims which it has considered so far and has put its assessment of botanical claims relating to substances such as echinacea, ginseng and green tea on hold, to be considered once the list of general health claims is completed.

The final list of approved claims will be recommended by the EFSA for enactment by the EU Commission. Until this time, the current domestic legislation relating to health claims must be complied with. Although there has not previously been an official list of health claims in the UK, there has been a requirement that claims are not misleading and that they have sufficient scientific basis. However, once the Community list is produced, claims which are not included on this list must not be used in the UK or elsewhere in the Community.


European Food Safety Authority (EFSA) and UK Food Standards Agency (FSA) websites