Plant Sterols and Stanols and Blood Cholesterol


Plant stanols, plant sterols, phytosterols, coronary heart disease, LDL-cholesterol
First published in the EFSA Journal
16 May 2012
26 April 2012
Scientific Opinion

Following an application from Unilever PLC and Unilever NV, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of an application to modify the conditions of use of an authorised Article 14 claim related to 1.5 - 3.0 g plant sterols/stanols per day and lowering blood LDL-cholesterol by 7 - 12 % and reduced risk of (coronary) heart disease. The applicant has further requested that the minimum duration to obtain the effect be one to two weeks. The applicant provided a published systematic review and meta-analysis that evaluated the comparative efficacy of plant sterols and plant stanols for lowering blood LDL-cholesterol in healthy and hypercholesterolaemic subjects and an unpublished meta-analysis on 27 randomised controlled human studies on the LDL-lowering efficacy at a dose range between 2.6 and 3.4 g per day. On the basis of the data presented, the Panel concludes that plant sterols and stanol esters at daily intakes ranging from 1.5 to 3.0 g plant sterols/stanols in matrices approved by Regulation (EC) No 376/2010 (yellow fat spreads, dairy products, mayonnaise and salad dressings) have a similar efficacy on blood LDL-cholesterol lowering, that plant sterols and stanol esters at a daily intake of 3 g (range 2.6 g to 3.4 g) plant sterols/stanols in matrices approved by Regulation (EC) No 376/2010 lower LDL-cholesterol by 11.3 % (95 % CI: 10.0 - 12.5), and that the minimum duration required to achieve the maximum effect of plant sterols and stanols on LDL-cholesterol lowering is two to three weeks.

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
nda [at]
EFSA Journal 2012;10(5):2693 [15 pp.].
Question Number
On request from
Competent Authority of the United Kingdom following an application by Unilever PLC
Competing interests
Two members 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