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 The results of one unpublished study showed that the three water-soluble tomato concentrate formulations reduced platelet aggregation as compared to the corresponding control and baseline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). © European Food Safety Authority, 2010

© European Food Safety Authority, 2010

Following an initial application from Provexis Natural Products Limited, submitted in 2009 pursuant to Article 13(5) of Regulation (EC) No 1924/2006, and subsequently to the opinion adopted by the Panel on Dietetic Products, Nutrition and Allergies on a health claim related to the effects of water-soluble tomato concentrate (WSTC) I and II on the blood platelet activity, the Commission Decision was adopted on 17 December 2009 authorising a health claim related to “water-soluble tomato concentrate (WSTC) I and II helps maintain normal platelet aggregation, which contributes to healthy blood flow”.

In April 2010, Provexis Natural Products Limited submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 a request in accordance with Article 19 of the afore-mentioned Regulation for modification of the authorisation of the health claim related to water-soluble tomato concentrate (WSTC) I and II helps maintain normal platelet aggregation, which contributes to healthy blood flow.

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.

As a consequence, the Panel on Dietetic Products, Nutrition and Allergies, in the present opinion, addresses only whether the conditions of use for the authorised claim could be extended to powdered single-serve sachets, tablets, and capsules.

The Panel considers that the food constituents, WSTC I and II (i.e., in powder sachets, tablets and capsules), which are the subject of the claim, are sufficiently characterised.

The Panel considers that the bioavailability of potentially active compounds in WSTC, when administered as powder, tablets or capsules, would not be different from that observed in other food matrices for which the health claim has been authorised (i.e., fruit juices, flavoured drinks or yogurt drinks) as long as these are easily dissolved in water.

One unpublished study addressed the acute effects of different forms of the tomato extract on platelet aggregation. The study was a double-blind placebo-controlled, randomised crossover design with three interventions (corresponding to 3 g WSTC I (syrup), WSTC II 150 mg (powder) produced at ambient temperature, and WSTC II 150 mg (powder) produced at 65°C) and one control. All test and control materials were administered in capsules with hydroxypropyl methylcellulose as food matrix together with 200 mL of water. The results showed that the three WSTC formulations reduced platelet aggregation (ADP agonist) as compared to the corresponding control and baseline values, with no significant differences between the three formulations. The responses to collagen 2 mg/L were also significant for all three formulations, whereas the response to collagen 5 mg/L was significant only for WSTC I. Thromboxane A2 generation (measured by the concentration of the stable metabolite thromboxane B2) was significantly reduced by the three formulations for ADP and both collagen concentrations. No changes were observed in plasma soluble P-selectin, a marker of platelet activation. This study indicated that the biological activity of both forms of WSTC (I and II) administered in capsules is comparable to equivalent doses provided in fruit juice.

The Panel concludes that a cause and effect relationship has been established between the consumption of water-soluble tomato concentrate (i.e., WSTC I and II corresponding to the specifications provided by the applicant) and the reduction in platelet aggregation under the new conditions of use proposed by the applicant (i.e., consumed as powder, tablets or capsules).

In order to achieve the claimed effect, 3 g WSTC I or 150 mg WSTC II as powder, tablets or easily dissolved capsules with at least 200 mL of liquid should be consumed daily. The target population is adults between 35 and 70 years of age. The Panel considers that there is no basis to restrict the conditions of use to this age range in the adult population.

water soluble tomato concentrate, platelet aggregation, clotting time, adults, conditions of use, health claims