Scientific Opinion on the substantiation of a health claim related to isolated soy protein 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
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.

EFSA Journal
EFSA Journal 2012;10(2):2555 [17 pp.].
doi
10.2903/j.efsa.2012.2555
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
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of Belgium following an application by ENSA/EUVEPRO/SPA
Question Number
EFSA-Q-2011-00784
Adopted
18 January 2012
Published
2 February 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Following an application from the European Natural Soyfood Manufacturers Association (ENSA), the European Vegetable Protein Federation (EUVEPRO) and the Soya Protein Association (SPA), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to isolated soy protein (ISP) and reduction of blood LDL-cholesterol concentrations, referring to disease risk reduction. The food constituent that is the subject of the health claim, ISP (as defined by the applicant), is sufficiently characterised in relation to the claimed effect. A reduction of blood LDL-cholesterol concentrations is a beneficial physiological effect. A reduction in blood LDL-cholesterol concentrations reduces the risk of CHD. In weighing the evidence, the Panel took into account that under similar conditions four randomised controlled trials (RCTs) reported an effect of ISP on blood LDL/non-HDL cholesterol concentrations, whereas 14 RCTs did not report such an effect, and another RCT showed no consistent effects. The Panel also took into account that most of these RCTs were at high risk of bias, that differences in the results obtained between trials appear unrelated to the dose of ISP used, to sample size or to study duration, and that the evidence provided in support of a possible mechanism was not convincing. A cause and effect relationship has not been established between the consumption of ISP (as defined by the applicant) and a reduction in blood LDL-cholesterol concentrations.

Keywords
Isolated soy protein, ISP, blood cholesterol, LDL-cholesterol, health claims
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Number of Pages
17