The European Food Safety Authority Publishes Guidance and further Assessment of Health Claims

The European Food Safety Authority’s (“EFSA”) has published two additional guidance documents for applicants who want to submit health claims for approval in the EU. The latest documents give advice on the scientific requirements for the substantiation of health claims related to physical performance and functions of the nervous system. They are the last two in a series of six which have already covered claims concerning gut and immune function, antioxidants and cardiovascular health; weight management; and bone, joints and oral health.

Because of the scientific and technical complexity of health claims, EFSA has devoted considerable effort to the development of guidance to support the industry in the submitting of applications. The general guidance covers issues such as the selection of suitable studies for the substantiation of claims, the wording of claims, the extent to which specific food needs to be characterized, and claims regarding beneficial physiological effects. All of the guidance documents have been subject to public consultation and revised to take into account the comments received.

In addition, EFSA has also completed its further assessment on the “general function” of health claims following the submission of additional data by the Member States. After finishing its evaluations in June 2011, and having published a total of 341 opinions covering 2758 claims, the European Commission and the Member States agreed that a limited number of the claims would be eligible for further assessment by EFSA. Ultimately, only two of the claims were considered to be substantiated, i.e. those covering prunes and normal bowel function, and alpha-cyclodextrin with the effect of lowering the rise of blood glucose after meals.

Roschier, Attorneys Ltd. - Finland