Scientific Opinion on the modification of the authorisation of a health claim related to water-soluble tomato concentrate and helps to maintain a healthy blood flow and benefits circulation pursuant to Article 13(5) of Regulation (EC) No 1924/2006 following a request in accordance with Article 19 of the Regulation (EC) No 1924/2006

water soluble tomato concentrate, platelet aggregation, clotting time, adults, conditions of use, health claims
First published in the EFSA Journal
23 July 2010
Adopted
9 July 2010
Type
Scientific Opinion

Abstract

Following an application from Provexis Natural Products Limited submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on a request for modification of the authorisation of a health claim related to water-soluble tomato concentrate and platelet aggregation. The modification concerns an extension of the authorised health claim to additional proposed conditions of use for powdered single-serve sachets, tablets, and capsules. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data. The Panel considers that the food constituents, water-soluble tomato concentrate I and II (i.e., in powder sachets, tablets and capsules), which are the subject of the claim are sufficiently characterised. The results of one unpublished study showed that the three water-soluble tomato concentrate formulations reduced platelet aggregation as compared to the corresponding control and baseline values, with no significant differences between the three formulations. The Panel concludes that a cause and effect relationship has been established between the consumption of water-soluble tomato concentrate I and II (corresponding to the specifications provided by the applicant) and a reduction in platelet aggregation under the new conditions of use proposed by the applicant (i.e., consumed as powder, tablets or capsules). © European Food Safety Authority, 2010

Substances

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.
Panel on Dietetic Products, Nutrition and Allergies
Contact
nda [at] efsa.europa.eu
doi
10.2903/j.efsa.2010.1689
EFSA Journal 2010; 8(7):1689
Question Number
On request from
Provexis Natural Products Limited