Scientific Opinion on the substantiation of a health claim related to <em>Opti</em><sub>EFAX</sub>™ and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Abstract

<p>Following an application from Nutrilinks Sarl, submitted for authorisation of a claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, 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 <em>Opti</em>_EFAX&trade; and maintenance of normal blood LDL-cholesterol concentrations. The food that is the subject of the health claim, <em>Opti</em>_EFAX&trade;, which is standardised pure krill oil, is sufficiently characterised in relation to the claimed effect. The claimed effect, maintenance of normal blood LDL-cholesterol concentrations, is a beneficial physiological effect. The target population proposed by the applicant is the general population. No human studies have been provided from which conclusions could be drawn for the scientific substantiation of the claim. A cause and effect relationship has not been established between the consumption of <em>Opti</em>_EFAX&trade; and maintenance of normal blood LDL-cholesterol concentrations.</p>

Keywords

• OptiEFAX™
• krill oil
• LDL
• cholesterol
• health claims