Following an application from UNILEVER PLC (United Kingdom) and UNILEVER N.V. (Netherlands), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to “Plant sterols and lowering/reducing blood cholesterol and reducing the risk of coronary heart disease”.
The scope of the application was proposed to fall under a health claim referring to a reduction of a disease risk.
In the context of this application, the term plant sterols (present as free sterols or esterified) refers specifically to plant sterols from natural sources with a composition as specified in the Commission Decisions authorising the placing on the market of food products with added plant sterols under Regulation (EC) No 258/97. The Panel considered that the plant sterols for which the health claim is proposed have been sufficiently characterised.
Elevated low-density lipoprotein (LDL) blood cholesterol is one recognised risk factor for coronary heart disease (CHD). CHD is an important cause of mortality and morbidity. Lowering LDL-cholesterol by dietary intervention has been shown to reduce the risk of coronary heart disease. The Panel considers that the claimed effect of lowering LDL-cholesterol is beneficial to human health.
The applicant has provided evidence supporting the cholesterol-lowering effect of plant sterols added to fat-based foods such as fat spreads and low-fat foods such as milk and yoghurt. A meta-analysis of 41 trials showed that an intake of 2 – 2.4 g/day of sterols added to margarine (or to mayonnaise, olive oil or butter in 7 trials) reduced average LDL-cholesterol by 8.9%. The applicant also provided a still unpublished meta-analysis showing that an average intake of 2.15 g/day of plant sterols when added to fat-based foods or low-fat foods such as milk and yoghurt lowers LDL-cholesterol by 8.8%. On the basis of the data presented, a clinically significant LDL-cholesterol effect of about 9% can be achieved by a daily intake of 2 – 2.4 g of phytosterols in an appropriate food (e.g. plant sterols added to fat-based foods and low-fat foods such as milk and yoghurt). The magnitude of the cholesterol-lowering effect may differ in other food matrices. The Panel concludes that a cause-effect relationship has been established between the consumption of plant sterols and lowering of LDL cholesterol, in a dose-dependent manner.
With respect to the association of LDL-cholesterol lowering with reduction in the risk of coronary heart disease the Panel considers that there is evidence that the risk of CHD can be reduced by cholesterol-lowering therapy including dietary intervention strategies. However, there are no studies demonstrating that plant sterols have an impact on population-based CHD morbidity and mortality rates.
The Panel considers that products to which phytosterols are added should be consumed only by people who need and want to lower their blood cholesterol and that patient on cholesterol- lowering medication should only consume the product under medical supervision.
The Panel discussed the wording proposed by the applicant and considers that the following wording reflects the available scientific evidence: “Plant sterols have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease".