COMMISSION DECISION
of 13 December 2010
amending Decision 2009/980/EU as regards the conditions of use of an authorised health claim on the effect of water-soluble tomato concentrate on platelet aggregation
(notified under document C(2010) 8828)
(Only the English text is authentic)
(Text with EEA relevance)
(2010/770/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the functioning of the European Union,
Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Articles 18(4) and 19 thereof,
Having consulted the European Food Safety Authority,
Having consulted the Member States,
Whereas:
(1)
Following the opinion of the European Food Safety Authority (EFSA), hereinafter referred to as the Authority, on the effects of Water-Soluble Tomato Concentrate (WSTC) I and II on the blood platelet activity in healthy people (Question No EFSA-Q-2009-00229) (2), the health claim stating that Water-Soluble Tomato Concentrate (WSTC) I and II ‘helps maintain normal platelet aggregation, which contributes to healthy blood flow’ was authorised by Commission Decision 2009/980/EU (3). Pursuant to Article 16(4) of Regulation (EC) No 1924/2006, Decision 2009/980/EU included the following condition of use of that health claim: ‘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)’.
(2)
In that context, the applicant, Provexis Natural Products Ltd., submitted on 31 March 2010 an application for the modification of the authorisation of the relevant health claim pursuant to Article 19 of Regulation (EC) No 1924/2006. The modification concerns an extension of the conditions of use accompanying the authorised health claim, allowing in particular its use in food supplements.
(3)
The Authority was required to deliver an opinion on the modification of the conditions of use of the health claim as proposed by the applicant. On 23 July 2010, the Commission and the Member States received a scientific opinion from the Authority (Question No EFSA-Q-2010-00809) (4) which concluded that on the basis of the data submitted, a cause and effect relationship had been established between the consumption of WSTC I and II in food supplements, such as powder sachets, tablets and capsules, and the claimed effect.
(4)
Taking into account the scientific opinion of the Authority, and in order to extend the use of the health claim to foods other than those already authorised, it is therefore necessary to amend its conditions of use.
(5)
Decision 2009/980/EU should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
In the Annex to Decision 2009/980/EU, the text in the forth column (Conditions of use of the health claim), is replaced by the following:
‘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’.
Article 2
This Decision is addressed to Provexis Natural Products Ltd., Thames Court, 1 Victoria Street, Windsor, Berkshire, SL4 1YB, United Kingdom.
Done at Brussels, 13 December 2010.