Scientific Opinion on the substantiation of a health claim related to ♀EFAX™ and reduction of menstrual discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Nutrilinks Sarl submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to ♀EFAX™ and reduction of menstrual discomfort. The food, ♀EFAX™, which is standardised pure krill oil and is the subject of the health claim, is sufficiently characterised. The claimed effect, reduction of menstrual discomfort, is a beneficial physiological effect. No human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. A cause and effect relationship has not been established between the consumption of ♀EFAX™ and reduction of menstrual discomfort.