Abstract
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 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 Opti EFAX™ and maintenance of normal blood HDL‐cholesterol concentrations. The food that is the subject of the health claim, Opti EFAX™, which is standardised pure krill oil, is sufficiently characterised in relation to the claimed effect. The claimed effect, maintenance of normal blood HDL‐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 Opti EFAX™ and maintenance of normal blood HDL‐cholesterol concentrations.
Keywords: OptiEFAX™, krill oil, HDL, cholesterol, health claims
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Scientific Opinion on the substantiation of a health claim related to Opti EFAX ™ and maintenance of normal blood HDL‐cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2012;10(7):2803. [8 pp.]. doi: 10.2903/j.efsa.2012.2803.
Panel members: Carlo Agostoni, Jean‐Louis Bresson, Susan Fairweather‐Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser‐Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Correspondence: nda@efsa.europa.eu
Acknowledgement: The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean‐Louis Bresson, Susan Fairweather‐Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen for the preparatory work on this scientific opinion.
Adoption date: 27 June 2012
Published date: 17 July 2012
Question number: EFSA‐Q‐2012‐00340
On request from: Competent Authority of Belgium following an application by Nutrilinks Sarl
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