Scientific Opinion on the modification of the authorisation of a health claim related to plant sterol esters and lowering blood LDL‐cholesterol; high blood LDL‐cholesterol is a risk factor in the development of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006, following a request in accordance with Article 19 of Regulation (EC) No 1924/2006

摘要

Following an application from SANOFI‐AVENTIS FRANCE, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the modification of the authorisation of a health claim related to plant sterol esters and lowering blood LDL‐cholesterol (high blood LDL‐cholesterol is a risk factor in the development of (coronary) heart disease), pursuant to Article 14 of Regulation (EC) No 1924/2006. The applicant requested an extension of the conditions of use to powder supplements to be diluted in water at a dose of 2 g per day, which would lower blood LDL‐cholesterol concentrations by “5.4‐8.1 %” after six weeks of daily consumption. Plant sterol esters are sufficiently characterised. Lowering blood LDL‐cholesterol concentrations is a beneficial physiological effect and elevated blood LDL‐cholesterol concentration is a risk factor for coronary heart disease. The target population is subjects who need and want to lower their blood cholesterol. In weighing the evidence, the Panel took into account that only one human intervention study showed a reduction in blood LDL‐cholesterol concentrations after six weeks of consuming 2 g/day of plant sterol esters in powder, the large uncertainty surrounding the estimates of this effect, and that the results of that study have not been replicated in other studies. The Panel reiterates its previous conclusion that, while plant sterols added to foods such as margarine‐type spreads, mayonnaise, salad dressings, and dairy products have been shown consistently to lower blood LDL‐cholesterol concentrations in a large number of studies, the effective dose of plant sterols (as powder diluted in water) needed to achieve a given magnitude of effect in a given timeframe cannot be established with the data provided.