A combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations

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Article
Plant sterols, Cholesternorm®mix, blood cholesterol, LDL-cholesterol, health claims
First published in the EFSA Journal
17 July 2012
Adopted
27 June 2012
Type
Scientific Opinion
Abstract

Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations. The food which is the subject of the health claim is a combination of plant sterols (free and in esterified form) and Cholesternorm®mix and provides at the levels of the proposed conditions of use around 0.52 g plant sterols, 0.95 g linoleic acid, 0.13 g alpha-linolenic acid and 0.13 g pectins per day. The combination of plant sterols and Cholesternorm®mix, which is the subject of the claim, is sufficiently characterised in relation to the claimed effect. Reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of coronary heart disease. The Panel notes that no evidence was provided that plant sterols or constituents other than plant sterols in Cholesternorm®mix, which have a role in the claimed effect, could reasonably be expected to have an effect on blood LDL-cholesterol concentrations at the proposed conditions of use. The Panel notes that no human interventions studies were 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 a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations at the proposed conditions of use.

Panel members at the time of adoption
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.
Panel on Dietetic Products, Nutrition and Allergies
Contact
nda [at] efsa.europa.eu
doi
10.2903/j.efsa.2012.2810
EFSA Journal 2012;10(7):2810 [13 pp.].
On request from
Competent Authority of the Netherlands following an application by Health Concern B.V.
Competing interests
One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests
Print on demand
Number of Pages
13