EFSA Seeks Comment on Cognitive Health Claim Substantiation

October 31, 2011

The draft guidance states that claims referring to “mental performance,” “mental health,” “mental well-being,” “emotional balance,” “relaxation,” and “serenity” are too general.

The European Food Safety Authority (EFSA; Parma, Italy) is seeking public comment on scientific requirements for health claims related to neurological and psychological function. Comments are due by December 16, 2011.

In its draft guidance, EFSA lays out its current view on criteria, including which studies/outcome measures are appropriate for the substantiation of claims related to function and disease-risk reduction, for categories such as long-term maintenance of cognitive function, cognitive development in infants and small children, attention, memory, mood, stress, and sleep.

EFSA notes, “This draft guidance has been drawn from scientific opinions of the NDA Panel on such health claims. Thus, this guidance represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. It is not intended that the document will include an exhaustive list of beneficial effects and studies/outcome measures that are acceptable.”

Of note, the draft guidance states:

  • In its evaluation, the NDA Panel considers that where a health claim relates to a function/effect that may be associated with a disease, subjects with the disease are not the target population for the claim, for example, Alzheimer disease patients. Applications for claims that specify target groups other than the general (healthy) population are the subject of ongoing discussions with the Commission and Member States with regard to their admissibility.

  • Claims referring to “mental performance,” “mental health,” “mental well-being,” “emotional balance,” “relaxation,” “serenity” have been proposed. These terms are too general and cannot be assessed. Hence, the Panel considers that they are not sufficiently defined for a scientific evaluation.

Nutritional Outlook thanks Harry Rice, PhD, for the tip.