Scientific Opinion on the substantiation of a health claim related to OPC Plus and reducing the risk of chronic venous insufficiency by increasing microcirculation pursuant to Article 14 of Regulation (EC) No 1924/2006
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
Acknowledgment
The Panel wishes to thank the members of the Working Group on Claims for the preparatory work on this scientific opinion: 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.
Contact
nda@efsa.europa.eu
Following an application from GP International Holding B.V. submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to OPC Plus and reducing the risk of chronic venous insufficiency by increasing microcirculation. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The food that is the subject of the health claim is OPC Plus, which contains 40 mg oligomeric procyanidins (OPC) and 40 mg berry-blend per capsule. The Panel considers that OPC Plus is sufficiently characterised with respect to OPC extracted from grape (Vitis vinifera L.) seeds. The claimed effect is “OPC improves venous microcirculation and increases capillary resistance and therefore may reduce the risk of chronic venous insufficiency (CVI)”. The target population is males and females over 30 years of age. The Panel considers that the evidence provided does not establish that improving the “alterations in the venous microcirculation” is a beneficial physiological effect by reducing the risk of chronic venous insufficiency. No human intervention studies using OPC extracted from grape seeds have been provided. The Panel concludes that a cause and effect relationship has not been established between the consumption of OPC Plus and reducing the risk of chronic venous insufficiency by increasing microcirculation.
© European Food Safety Authority, 2010
Following an application from GP International Holding B.V. submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to OPC Plus and reducing the risk of chronic venous insufficiency by increasing microcirculation.
The scope of the application was proposed to fall under a health claim referring to disease risk reduction.
The food that is the subject of the health claim is OPC Plus, which contains 40 mg oligomeric procyanidins (OPC) and 40 mg berry-blend per capsule. The capsule also contains inulin (338 mg). The manufacturing process has been described. The Panel notes that no information has been provided regarding the berry-blend in the OPC Plus capsules. The Panel considers that the food, OPC Plus, which is the subject of the health claim, is sufficiently characterised with respect to OPC extracted from grape (Vitis vinifera L.) seeds.
The claimed effect is “OPC improves venous microcirculation and increases capillary resistance and therefore may reduce the risk of chronic venous insufficiency (CVI)”. The target population is males and females over 30 years of age. The Panel notes that “alterations” in the venous microcirculation (i.e., venous microangiopathy) is a consequence rather than a cause of (or a risk factor for) CVI. The Panel considers that the evidence provided does not establish that improving the “alterations in the venous microcirculation” is a beneficial physiological effect by reducing the risk of chronic venous insufficiency.
The Panel notes that no human intervention studies using OPC extracted from grape (Vitis vinifera L.) seeds have been provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of OPC Plus and reducing the risk of chronic venous insufficiency by increasing microcirculation.
OPC Plus, oligomeric procyanidins, berries, microcirculation, risk reduction, health claims
