EFSA Further Assesses Health Claims and Publishes Guidance

The latest guidance documents give advice on the scientific requirements for the substantiation of health claims related to functions of the nervous system, including psychological functions and those related to physical performance.

8 Aug 2012 --- EFSA has reached two significant milestones in its work on health claims. The Authority’s Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) has published two additional guidance documents for applicants who want to submit health claims for approval in the EU, and has also completed its further assessment of “general function” health claims following submission of additional data by Member States.

The latest guidance documents give advice on the scientific requirements for the substantiation of health claims related to functions of the nervous system, including psychological functions and those related to physical performance. They are the last two in a series of six which has already covered claims related to gut and immune function; antioxidants and cardiovascular health; weight management; and bone, joints and oral health.

Specific issues addressed in the documents include: which claimed effects are considered to be beneficial physiological effects, and which studies/outcome measures are appropriate for the substantiation of function claims and disease risk reduction claims.

Because of the scientific and technical complexity of health claims, EFSA has devoted considerable effort to the development of guidance to support industry in submitting applications to the Authority. In 2007 it published guidance on the preparation and presentation of applications, followed two years later by guidance on the general principles employed by the NDA Panel in assessing scientific substantiation for health claims; the latter document has since been revised twice. 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 a food needs to be characterized; and claimed effects which are considered beneficial physiological effects.

All of the guidance documents, which are based on the NDA Panel’s experience of evaluating claims, have been subject to public consultation and revised to take into account the comments received.

EFSA finalized its evaluations of all general function claims, other than those related to botanicals, in June 2011, having published a total of 341 opinions covering 2,758 claims. The European Commission and the Member States agreed that a limited number of these claims would be eligible for further assessment by EFSA, based on additional data submitted by Member States. These included 74 claims related to micro-organisms, which the Panel initially considered to be not sufficiently characterized and 17 claims for which the NDA Panel concluded in its initial assessment that there was insufficient evidence to establish a cause and effect relationship between the consumption of the food and the claimed effect.

Two of the claims were, after further assessment, considered to be substantiated: these were those covering prunes and normal bowel function; and alpha-cyclodextrin and a lower rise in blood glucose after meals. Using EFSA’s scientific advice, the Commission has already adopted a list of 222 approved general function claims for use in the European Union. EFSA will continue to assess health claim applications under the individual authorization procedure.