V0137 and ‘a reduced loss of cognitive function’: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
Following an application from Pierre Fabre Medicament, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to V0137, a ‘DHA-enriched fish oil’, and ‘helps to slow the age-related cognitive decline in domains such as memory and executive function’. The food, V0137, which is the subject of the health claim, is sufficiently characterised. The Panel considers that a reduced loss of cognitive function is a beneficial physiological effect. The applicant submitted five human studies for the substantiation of the health claim, four of which were carried out with foods other than V0137. No conclusions could be drawn from these four studies for the scientific substantiation of the claim. The remaining study was a multicentre, randomised, placebo-controlled, 3-years parallel trial in 1,680 subjects of at least 70 years and at risk of cognitive decline. The subjects were distributed to the four following study groups: (i) V0137 + multidomain intervention (MDI; physical and cognitive exercise, nutrition recommendations); (ii) V0137 without MDI; (iii) placebo + MDI; (iv) placebo without MDI. The primary endpoint of the study was a change in cognitive function, as assessed by a composite cognitive score. There were no statistically significant differences between the study groups for changes in the composite cognitive score at 36 months. The Panel concludes that a cause and effect relationship has not been established between the consumption of V0137 and a reduced loss of cognitive function.