EFSA NDA Panel (EFSA Panel on Dietetic Products, Nut rition and Allergies ) , 2013. Scientific Opinion on the substantiation of a health claim related to the c onsum ption of 2 g/day of plant stanols (as plant stanol ester s ) as part of a diet low in saturated fat and a two - fold greater reduction in blood LDL - chol esterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006

EFSA Publication; Inge Tetens

doi:10.2903/j.efsa.2013.3160

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nut rition and Allergies ) , 2013. Scientific Opinion on the substantiation of a health claim related to the c onsum ption of 2 g/day of plant stanols (as plant stanol ester s ) as part of a diet low in saturated fat and a two - fold greater reduction in blood LDL - chol esterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006

EFSA Publication, Inge Tetens

1 Citationer (Scopus)

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.
© European Food Safety Authority, 2013

Originalsprog	Engelsk

Forlag	European Food Safety Authority
DOI	https://doi.org/10.2903/j.efsa.2013.3160
Status	Udgivet - 1 apr. 2013
Udgivet eksternt	Ja

Emneord

Plant stanols
Plant stanol esters
LDL-cholesterol
Saturated fat
Diet
Health claims

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Citationsformater

Publication, EFSA., & Tetens, I. (2013). EFSA NDA Panel (EFSA Panel on Dietetic Products, Nut rition and Allergies ) , 2013. Scientific Opinion on the substantiation of a health claim related to the c onsum ption of 2 g/day of plant stanols (as plant stanol ester s ) as part of a diet low in saturated fat and a two - fold greater reduction in blood LDL - chol esterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006. European Food Safety Authority. https://doi.org/10.2903/j.efsa.2013.3160

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nut rition and Allergies ) , 2013. Scientific Opinion on the substantiation of a health claim related to the c onsum ption of 2 g/day of plant stanols (as plant stanol ester s ) as part of a diet low in saturated fat and a two - fold greater reduction in blood LDL - chol esterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006. / Publication, EFSA; Tetens, Inge.

European Food Safety Authority, 2013.

Publikation: Bog/antologi/afhandling/rapport › Rapport › Forskning › peer review

Publication, EFSA & Tetens, I 2013, EFSA NDA Panel (EFSA Panel on Dietetic Products, Nut rition and Allergies ) , 2013. Scientific Opinion on the substantiation of a health claim related to the c onsum ption of 2 g/day of plant stanols (as plant stanol ester s ) as part of a diet low in saturated fat and a two - fold greater reduction in blood LDL - chol esterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006. European Food Safety Authority. https://doi.org/10.2903/j.efsa.2013.3160

Publication EFSA, Tetens I. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nut rition and Allergies ) , 2013. Scientific Opinion on the substantiation of a health claim related to the c onsum ption of 2 g/day of plant stanols (as plant stanol ester s ) as part of a diet low in saturated fat and a two - fold greater reduction in blood LDL - chol esterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006. European Food Safety Authority, 2013. doi: 10.2903/j.efsa.2013.3160

Publication, EFSA ; Tetens, Inge. / EFSA NDA Panel (EFSA Panel on Dietetic Products, Nut rition and Allergies ) , 2013. Scientific Opinion on the substantiation of a health claim related to the c onsum ption of 2 g/day of plant stanols (as plant stanol ester s ) as part of a diet low in saturated fat and a two - fold greater reduction in blood LDL - chol esterol concentrations compared to the consumption of a diet low in saturated fat alone pursuant to Article 14 of Regulation (EC) No 1924/2006. European Food Safety Authority, 2013.

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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.",

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AB - 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.

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