Scientific Opinion on the substantiation of a health claim related to 3 g/day plant stanols as plant stanol esters and lowering blood LDL-cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006

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

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.


Following an application from Raisio Nutrition Ltd, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to 3 g/day plant stanols as plant stanol esters per day and lowering blood LDL-cholesterol by 12 % and reduced risk of (coronary) heart disease. The applicant has further requested that the minimum duration to obtain the effect be stated to be one to two weeks, and that the claims be authorised for an extended range of foods, including yellow fat spreads, dairy products, cheese, rye bread, oatmeal, fermented soy milk based products (drinkable and spoonable yoghurt-type products), and oat based milk drinks. The applicant provided an unpublished meta-analysis with 18 randomised, controlled human studies on the LDL-lowering efficacy of plant stanol esters at intakes between 2.7 to 3.3 g per day plant stanols. On the basis of the data presented, the Panel concludes that plant stanol esters at a daily intake of 3 g plant stanols (range 2.7 g to 3.3 g) in matrices approved by Regulation (EC) No 376/2010 (yellow fat spreads, dairy products, mayonnaise and salad dressings) lowers LDL-cholesterol by 11.4 % (95% CI: 9.8 – 13.0), that the minimum duration required to achieve the maximum effect of plant stanol esters on LDL-cholesterol lowering is two to three weeks, and that while plant stanol esters added to foods such as margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol levels, the size of the cholesterol-lowering effect of plant stanols added to other food formats is less well established.

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):2692
Question Number
On request from
Competent Authority of Finland following an application by Raisio Nutrition Ltd