LegalizeCommission Decision of 17 December 2009 authorising a health claim on the effect of water-soluble tomato concentrate on platelet aggregation and granting the protection of proprietary data under Regulation (EC) No 1924/2006 of the European Parliament and of the Council (notified under document C(2009) 10113) (Text with EEA relevance)
Article 1
The health claim set out in the Annex to this Decision shall be included in the Community list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.
Article 2
The scientific data and other information included in the studies identified in the Annex to this Decision shall be restricted for use for the benefit of the applicant for a period of 5 years from the date of authorisation under the conditions laid down in Article 21(1) of Regulation (EC) No 1924/2006.
Article 3
This Decision is addressed to Provexis Natural Products Ltd, Thames Court, 1 Victoria Street, Windsor, Berkshire, SL4 1YB, United Kingdom.
ANNEX
| Applicant — Address | Nutrient, substance, food or food category | Claim | Conditions of use of the claim | Conditions and/or restrictions of use of the food and/or additional statement or warning | Proprietary data restricted for use for the benefit of the applicant | EFSA opinion reference |
|---|---|---|---|---|---|---|
| Provexis Natural Products Ltd, Thames Court, 1 Victoria Street, Windsor, Berkshire, SL4 1YB, United Kingdom | Water-Soluble Tomato Concentrate (WSTC) I and II | Water-Soluble Tomato Concentrate (WSTC) I and II helps maintain normal platelet aggregation, which contributes to healthy blood flow | Information to the consumer that the beneficial effect is obtained with a daily consumption of 3 g WSTC I or 150 mg WSTC II in up to 250 ml of either fruit juices, flavoured drinks or yogurt drinks (unless heavily pasteurised) or with a daily consumption of 3 g WSTC I or 150 mg WSTC II in food supplements when taken with a glass of water or other liquid | 1. O’Kennedy, N., Crosbie, L., van Lieshout M., Broom J.I., Webb, D.J., Duttaroy, A.K., 2003a. Persistence of the antiplatelet effect of a single dose of WSTC equivalent to 2 fresh tomatoes over a 24-hour timecourse. REC No 02/0269 2. O’Kennedy et al. 2003b. A 42-day randomised, controlled and double-blinded crossover study to evaluate effects of daily WSTC consumption on platelet function, coagulation and some baseline CVD risk markers. REC No 03/0177. 3. O’Kennedy et al. 2005. Effects of overconsuming Sirco®, a one-a-day fruit juice drink containing 12g/L WSTC, on platelet function in healthy subjects. REC No 05/S0802/77. 4. O’Kennedy et al. 2006c. A pilot study to compare the antiplatelet effects of WSTC in healthy subjects, after consumption in two different food matrices. REC No 06/S0802/60. 5. O’Kennedy et al. 2007. A randomised, controlled and double-blinded crossover study to compare the antiplatelet effects of three different formats of WSTC in healthy humans. REC No 07/S0801/13. 6. Song, V., Sheddon, A., Horgan, G. and O’Kennedy, N. Anticoagulatory and anti-inflammatory activities of WSTC in platelets and endothelial cells. Manuscript for submission; 2008. 7. Zhang, F., Song, V., Neascu, M., Crosbie, L., Duncan, G., Horgan, G., de Roos, B. and O’Kennedy, N. Flow cytometric and proteomic studies examining the effects of WSTC on platelet function in vitro. Unpublished, 2007/2008. | Q-2009-00229 |
OJ L 404, 30.12.2006, p. 9.
The EFSA Journal (2009) 1101, pp. 1-15.
[^E0003]: (3) O’Kennedy, N., Crosbie, L., Whelam, S., Luther, V., Horgan, G., Broom, J.I., Webb, D.J., Duttaroy, A.K., Effects of tomato extract on platelet function: a double-blinded crossover study in healthy humans, The American Journal of Clinical Nutrition, 2006, Vol. 84, pp. 561-569 and O’Kennedy N., Crosbie, L., van Lieshout, M., Broom, J.I., Webb, D.J., Duttaroy, A.K., Effects of antiplatelet components of tomato extract on platelet function in vitro and ex vivo: a time-course cannulation study in healthy humans. The American Journal of Clinical Nutrition, 2006, Vol. 84, pp. 570-579.
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