Commission Regulation (EU) 2015/539 of 31 March 2015 authorising a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health and amending Regulation (EU) No 432/2012 Text with EEA relevance
1. The health claim set out in the Annex to this Regulation shall be included in the Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.
2. The use of the health claim referred to in the first paragraph shall be restricted to the applicant for a period of five years from the date of entry into force of this Regulation. After the expiry of that period, that health claim may be used, in conformity with the conditions applying to it, by any food business operator.
The scientific data and other information included in the application, which are claimed by the applicant as proprietary and without the submission of which the health claim could not have been authorised are restricted for use for the benefit of the applicant for a period of five years from the date of entry into force of this Regulation under the conditions laid down in Article 21(1) of Regulation (EC) No 1924/2006.
The Annex to Regulation (EU) No 432/2012 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
In the Annex to Regulation (EU) No 432/2012, the entry for cocoa flavanols is replaced by the following:
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
EFSA Journal number
Relevant entry number in the Consolidated List submitted to EFSA for its assessment
‘Cocoa flavanols
Cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow ( ***** )
( ****** )
Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 200 mg of cocoa flavanols.
The claim can be used only for cocoa beverages (with cocoa powder) or for dark chocolate which provide at least a daily intake of 200 mg of cocoa flavanols with a degree of polymerisation 1-10. ( ***** )
The claim can be used only for capsules or tablets containing high-flavanol cocoa extract which provide at least a daily intake of 200 mg of cocoa flavanols with a degree of polymerisation 1-10. ( ****** )
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2012;10(7):2809 ( ***** )
2014;12(5):3654 ( ****** )
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( ***** ) Authorised on 24 September 2013 restricted to the use of Barry Callebaut Belgium NV, Aalstersestraat 122, B-9280 Lebbeke-Wieze, Belgium, for a period of five years.
( ****** ) Authorised on 21 April 2015 restricted to the use of Barry Callebaut Belgium NV, Aalstersestraat 122, B-9280 Lebbeke-Wieze, Belgium, for a period of five years.’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
