Scientific Opinion on the substantiation of a health claim related to the consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat and a two-fold greater reduction in blood LDL-cholesterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006

plant stanols, plant stanol esters, LDL-cholesterol, saturated fat, diet, health claims
First published in the EFSA Journal
8 April 2013
Adopted
21 March 2013
Type
Scientific Opinion

Abstract

Following an application from McNeil Nutritionals and Raisio Nutrition Ltd, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to the consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat and a two-fold greater reduction in blood LDL-cholesterol concentrations compared to the consumption of a diet low in saturated fat alone. The food that is the subject of the health claim, plant stanol esters, is sufficiently characterised. The applicant provided five human intervention studies for the scientific substantiation of the claim. The Panel notes that the design of the studies submitted did not allow an evaluation of the quantitative effects of diets low in saturated fat per se on blood LDL-cholesterol concentrations. Therefore, the effect of consuming 2 g/day plant stanols as part of a diet low in saturated fat relative to the effect of consuming a diet low in saturated fat alone cannot be determined on a quantitative basis. The Panel considers that the evidence provided by the applicant does not establish that the consumption of 2 g/day of plant stanols (as plant stanol esters) as part of a diet low in saturated fat results in a two-fold greater reduction in LDL-cholesterol concentrations compared with consuming a diet low in saturated fat alone. A claim on plant stanol esters and reduction of blood LDL-cholesterol concentrations (irrespective of the background diet) has already been authorised in the European Union.

Panel members at the time of adoption

Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.
Panel on Dietetic Products, Nutrition and Allergies
Contact
nda [at] efsa.europa.eu
doi
10.2903/j.efsa.2013.3160
EFSA Journal 2013;11(4):3160
Question Number
On request from
the Competent Authority of the United Kingdom following an application by McNeil Nutritionals and Raisio Nutrition Ltd
Competing interests
Two members of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests