Scientific Documents

Plant Stanols and Plant Sterols and Blood LDL-Cholesterol - Scientific Opinion of the Panel on Dietetic Products Nutrition and Allergies on a request from the European Commission and a similar request from France in relation to the authorization procedure for health claims on plant stanols and plant sterols and lowering/reducing blood LDL-cholesterol pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Summary (68 KB)

Opinion (126 KB)

Summary

Following a request from the European Commission and a similar request from France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver a scientific advice in relation to the authorisation procedure for health claims on plant stanols and plant sterols and lowering/reducing blood cholesterol pursuant to Article 14 of Regulation (EC) No 1924/2006.

The quantities of plant sterols/plant stanols in this opinion are expressed as equivalent weights of free (unesterified) stanols and sterols.
Over 80 randomised, controlled trials have investigated the effect of plant sterols/plant stanols added to a wide range of food formats on blood concentrations of LDL-cholesterol. A number of meta-analyses on these trial has shown that plant sterols/plant stanols lower LDL-cholesterol in a dose-dependent manner with the effect appearing to taper off at daily intakes greater that about 2g. The efficacy for lowering LDL-cholesterol is similar for plant sterols and plant stanols.

The Panel notes that 1.5 - 1.9 g and 2.0 - 2.4 g plant sterols/plant stanols per day was observed to lower blood LDL-cholesterol by an average of 8.5 % and 8.9 %, respectively. The Panel concludes that for an intake of 1.5 - 2.4 g/d an average reduction of between 7 and 10.5 % can be expected. The Panel considers that such a reduction is of biological significance in terms of reduced risk of coronary heart disease. 

The Panel concludes that the blood LDL cholesterol lowering effect is usually established within the first 2 - 3 weeks and can be sustained by a continued consumption of plant sterols/stanols. This effect has been shown up to 85 weeks.

The Panel concludes that while plant sterols/stanols added to foods such as margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts and cheese have been shown consistently to lower blood LDL-cholesterol, the efficacy of plant sterols/stanols added to other food formats is less well established.