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

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 The results of one unpublished study showed that the three water-soluble tomato concentrate formulations reduced platelet aggregation as compared to the corresponding control and baseline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)