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

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2012;10(7):2810 [13 pp.].
doi
10.2903/j.efsa.2012.2810
Panel members at the time of adoption
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen for the preparatory work on this scientific opinion.

Possible conflict of interest
One member 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
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands following an application by Health Concern B.V.
Question Number
EFSA-Q-2009-00237
EFSA-Q-2011-01114
Adopted
27 June 2012
Published
17 July 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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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®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.

Summary

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 scope of the application was proposed to fall under a health claim referring to disease risk reduction.

The food constituent that is the subject of the health claim (originally for Claim Serial No 0314_NL and after clarification for Claim Serial No 0239_NL) is “plant sterols in combination with Cholesternorm®mix”. The food, which is the subject of the claim, 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 Panel considers that the food constituent, a combination of plant sterols (free and in esterified form) and Cholesternorm®mix, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect.

The claimed effect is “plant sterols together with the Cholestemorm@mix of cholesterol lowering ingredients lowers LDL-cholesterol”. The target population proposed by the applicant is individuals who wish to reduce their blood cholesterol levels. The Panel considers that 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.

No information on the literature search strategy used to identify the body of pertinent scientific data for the scientific substantiation of the claim has been provided by the applicant. The Panel considers that the criteria and process used by the applicant for the identification and selection of data is unclear, may be subject to bias, and does not allow an evaluation of whether the totality of the scientific evidence, which may be pertinent for the scientific substantiation of the claim, has been provided.
The applicant provided seven published human intervention studies on plant sterols and stanols and one unpublished human intervention study (claimed to be proprietary) on plant sterols in combination with Cholesternorm®mix on blood cholesterol concentrations for the scientific substantiation of the claim.

In the randomised, double-blind, placebo-controlled parallel study which investigated the effect of the combination of plant sterols and Cholesternorm®mix on blood cholesterol concentrations, 54 healthy male subjects were randomised to consume daily either intervention or control spreads for six weeks. The Panel notes that even though the applicant was requested during the validation period to provide the full study report, only a summary report was submitted. The Panel also notes that the composition of the control spread, which contained around twice the amount of alpha-linolenic acid and of linoleic acid than the intervention spread as well as a comparable amount of fibres, did not allow conclusions to be drawn on an effect of the combination of plant sterols and Cholesternorm®mix on blood cholesterol concentrations and that there is uncertainty whether the study was properly randomised. The Panel also notes that only per protocol analysis was presented, that baseline values and repeated measures were not taken into account in the analysis, that a requested re-analysis of data was not presented by the applicant and that the set of raw data provided was incomplete. The Panel considers that owing to the major methodological limitations of this study no conclusions can be drawn from this study for the scientific substantiation of the claim.

The Panel notes that none of the human intervention studies provided on plant sterols and stanols alone investigated dose ranges in line with the proposed conditions of use and considers that these studies do not provide any additional information to the Panel’s previous evaluations of claims on plant sterols and stanols and maintenance/reduction of blood LDL-cholesterol concentrations, which have been assessed with favourable outcomes.

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.

The Panel concludes that 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.

Keywords
Plant sterols, Cholesternorm®mix, blood cholesterol, LDL-cholesterol, health claims
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Number of Pages
13