Scientific Opinion on the substantiation of a health claim related to Eye qTM and working memory pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Vifor Pharma (Potters) submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Eye qTM and working memory. Eye qTM is a combination of eicosapentaenoic acid, docosahexaenoic acid, and gamma-linolenic acid, and is sufficiently characterised regarding the content of these polyunsaturated fatty acids. The improvement of working memory is considered beneficial for children’s development and health. Six human intervention studies were identified by the applicant as being pertinent to the health claim, three of which did not report any measures of working memory. Two of the studies were conducted in children with either developmental coordination disorder or showing severe symptoms of attention deficit hyperactivity disorder. The sixth was a randomised, placebo-controlled intervention reporting a statistically significant difference between the Eye qTM and control group in relation to verbal working memory. There were no data indicating a dose-response relationship between Eye qTM consumption and working memory outcomes in healthy children. There were no other data (from experimental or observational studies) presented on this combination of fatty acids in the target population in order to corroborate the findings, and the evidence provided did not establish a biologically plausible mechanism by which the combination of docosahexaenoic acid, eicosapentaenoic acid, and gamma-linolenic acid in Eye qTM could exert the claimed effect in the target population. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the intake of Eye qTM and the improvement of working memory