Response to comments on the 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

Question number: EFSA-Q-2012-00732
Issued: 29 August 2012
Report (0.2 Mb)

Abstract

No abstract available

Summary

Following a request from the European Commission, EFSA was asked to review the scientific comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims 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 pursuant to Article 14 of Regulation (EC) No 1924/2006.

Comments submitted to EFSA via the European Commission Services originated from the applicant (Raisio Nutrition Ltd.).

EFSA has reviewed the comments and shared them with the chair of the NDA Panel and the chair of the NDA Working Group on Claims.

In its opinion adopted on 26 April 2012, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded 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. The comments received do not change the conclusions of the NDA Panel.


Published: 4 September 2012