Autorité européenne de sécurité des aliments (EFSA)

Danacol® and blood cholesterol Scientific substantiation of a health claim related to a low fat fermented milk product (Danacol®) enriched with plant sterols/stanols and lowering/reducing blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Question nº: EFSA-Q-2008-779

Résumé  (0.1Mb)

Avis  (0.2Mb)

Summary

Following an application from Danone France, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to “phytosterols” 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 reduction of a disease risk.

The food constituent that is subject of the proposed claim is a low fat fermented milk product (Danacol®) enriched with plant sterols/stanols (phytosterols). The active ingredients, the phytosterols esters, are of plant oil origin and are a mixture of β-sitosterol ≤ 80 %, campesterol ≤ 40 %, stigmasterol ≤ 30 %, β-sitostanol ≤ 15 %, campestanol ≤ 5 %, brassicasterol ≤ 3 % and other phytosterols ≤ 3 %. The phytosterols are esterified with fatty acids of vegetable origin. Data from published Danacol studies indicate a content of approximately 75 - 80 % β-sitosterol and 8.4 - 10 % campesterol. This profile is comparable to a mixture of phytosterols of a previous health claim application assessed by the European Food Safety Authority. The Panel considers that the phytosterols 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 target population are adults with mildly raised LDL blood cholesterol concentration.

The Panel considers that the claimed effect of lowering LDL-cholesterol is beneficial to human health.

The application contains 23 publications, 19 controlled human studies, 1 uncontrolled human study, and 3 meta-analyses on the LDL-cholesterol lowering effect of phytosterols. In addition, the applicant provided 2 unpublished meta-analyses.

On the basis of the data presented, a biological significant LDL-cholesterol lowering effect can be achieved by a daily intake of 1.6 g phytosterols added to low fat fermented milk products. The size of the effect is comparable to that of plant sterols and plant stanols added to foods such as margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts and cheese, as discussed in the EFSA opinion on plant sterols/stanols and lowering/reducing blood LDL-cholesterol.

The Panel concludes that a cause and effect relationship has been established between the dietary intake of phytosterols and lowering of LDL-cholesterol.

The Panel considers that the following wording reflects the available scientific evidence: “Phytosterols have been shown to lower/reduce blood cholesterol. High blood cholesterol is a risk factor in the development of coronary heart disease”.

The Panel considers that phytosterols should be consumed only by people who need and want to lower their blood cholesterol and that patients on cholesterol-lowering medication should only consume the product under medical supervision.

---

[1] For citation purposes: Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies on a request from Danone France related to the scientific substantiation of a health claim on phytosterols and lowering/reducing blood cholesterol and reduced risk of (coronary) heart disease. The EFSA Journal (2009) 1177, 1-12.