EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006.

EFSA Publication; Inge Tetens

doi:10.2903/j.efsa.2012.2810

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006.

EFSA Publication, Inge Tetens

1 Citation (Scopus)

Abstract

Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations. The food which is the subject of the health claim is a combination of plant sterols (free and in esterified form) and Cholesternorm®mix and provides at the levels of the proposed conditions of use around 0.52 g plant sterols, 0.95 g linoleic acid, 0.13 g alpha-linolenic acid and 0.13 g pectins per day. The combination of plant sterols and Cholesternorm®mix, which is the subject of the claim, is sufficiently characterised in relation to the claimed effect. Reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of coronary heart disease. The Panel notes that no evidence was provided that plant sterols or constituents other than plant sterols in Cholesternorm®mix, which have a role in the claimed effect, could reasonably be expected to have an effect on blood LDL-cholesterol concentrations at the proposed conditions of use. The Panel notes that no human interventions studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. A cause and effect relationship has not been established between the consumption of a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations at the proposed conditions of use.

Original language	English

Publisher	European Food Safety Authority
DOIs	https://doi.org/10.2903/j.efsa.2012.2810
Publication status	Published - 2012
Externally published	Yes

Access to Document

10.2903/j.efsa.2012.2810

Cite this

Publication, EFSA., & Tetens, I. (2012). EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006. European Food Safety Authority. https://doi.org/10.2903/j.efsa.2012.2810

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006. / Publication, EFSA; Tetens, Inge.

European Food Safety Authority, 2012.

Research output: Book/Report › Report › Research › peer-review

Publication, EFSA & Tetens, I 2012, EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006. European Food Safety Authority. https://doi.org/10.2903/j.efsa.2012.2810

Publication EFSA, Tetens I. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006. European Food Safety Authority, 2012. doi: 10.2903/j.efsa.2012.2810

Publication, EFSA ; Tetens, Inge. / EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006. European Food Safety Authority, 2012.

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abstract = "Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 a combination of plant sterols and Cholesternorm{\textregistered}mix and reduction of blood LDL-cholesterol concentrations. The food which is the subject of the health claim is a combination of plant sterols (free and in esterified form) and Cholesternorm{\textregistered}mix and provides at the levels of the proposed conditions of use around 0.52 g plant sterols, 0.95 g linoleic acid, 0.13 g alpha-linolenic acid and 0.13 g pectins per day. The combination of plant sterols and Cholesternorm{\textregistered}mix, which is the subject of the claim, is sufficiently characterised in relation to the claimed effect. Reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of coronary heart disease. The Panel notes that no evidence was provided that plant sterols or constituents other than plant sterols in Cholesternorm{\textregistered}mix, which have a role in the claimed effect, could reasonably be expected to have an effect on blood LDL-cholesterol concentrations at the proposed conditions of use. The Panel notes that no human interventions studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. A cause and effect relationship has not been established between the consumption of a combination of plant sterols and Cholesternorm{\textregistered}mix and reduction of blood LDL-cholesterol concentrations at the proposed conditions of use.",

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N2 - Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations. The food which is the subject of the health claim is a combination of plant sterols (free and in esterified form) and Cholesternorm®mix and provides at the levels of the proposed conditions of use around 0.52 g plant sterols, 0.95 g linoleic acid, 0.13 g alpha-linolenic acid and 0.13 g pectins per day. The combination of plant sterols and Cholesternorm®mix, which is the subject of the claim, is sufficiently characterised in relation to the claimed effect. Reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of coronary heart disease. The Panel notes that no evidence was provided that plant sterols or constituents other than plant sterols in Cholesternorm®mix, which have a role in the claimed effect, could reasonably be expected to have an effect on blood LDL-cholesterol concentrations at the proposed conditions of use. The Panel notes that no human interventions studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. A cause and effect relationship has not been established between the consumption of a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations at the proposed conditions of use.

AB - Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations. The food which is the subject of the health claim is a combination of plant sterols (free and in esterified form) and Cholesternorm®mix and provides at the levels of the proposed conditions of use around 0.52 g plant sterols, 0.95 g linoleic acid, 0.13 g alpha-linolenic acid and 0.13 g pectins per day. The combination of plant sterols and Cholesternorm®mix, which is the subject of the claim, is sufficiently characterised in relation to the claimed effect. Reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of coronary heart disease. The Panel notes that no evidence was provided that plant sterols or constituents other than plant sterols in Cholesternorm®mix, which have a role in the claimed effect, could reasonably be expected to have an effect on blood LDL-cholesterol concentrations at the proposed conditions of use. The Panel notes that no human interventions studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. A cause and effect relationship has not been established between the consumption of a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations at the proposed conditions of use.

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