EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/12060/2014 
(POOL/E4/2014/12060/12060-EN.doc) 
[…](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
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 amendi ng Regulation (EU) 
No 432/2012 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
authorising a health claim made on foods, ot her 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) 
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 Article 18(4) and 19 thereof,  
Whereas: (1) Regulation (EC) No 1924/2006 provides that health claims made on foods are 
prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims. 
(2) Pursuant to Article 13(3) of Regulati on (EC) No 1924/2006, Commission Regulation 
(EU) No 432/2012
2 was adopted, which establishes a list of permitted health claims 
made on foods other than those referring to the reduction of diseas e risk and to 
children's development and health. 
(3) Regulation (EC) No 1924/2006 provid es that applicati ons for authorisations of health 
claims are to be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid 
applications to the Eu ropean Food Safety Authority (EFS A), hereinafter referred to as 
'the Authority', for a scientific assessment, as well as to the Commission and the Member States for information. 
(4) The Commission is to decide on the authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) In order to stimulate innovation, health cl aims which are based on newly developed 
scientific evidence and/or which include a request for the protection of proprietary 
data shall undergo an accele rated type of authorisation. 
(6) Following an application from Barry Callebaut Belgium NV submitted pursuant to 
Article 19(1) of Regulation (EC) No 1924/ 2006 and including a re quest for protection 
of proprietary data, the Authority wa s required to deliver an opinion on the 
modification of the authorisation of health claim “cocoa flavanols help maintain the 
                                                
 
1 OJ L 404, 30.12.2006, p. 9. 
2 Commission Regulation (EU) No 432/2012 of 16 Ma y 2012 establishing a list of permitted health 
claims made on foods, other than those referring to the reduction of disease risk and to children's 
development and health (OJ L 136, 25.5.2012, p. 1.).  
EN 3   EN elasticity of blood vessels, whic h contributes to normal blood flow”. That health claim 
was authorised, pursuant to Article 13( 5) of Regulation (EC) No 1924/2006, by 
Commission Regulati on (EU) No 851/20133. The applicant requested an extension of 
the authorised conditions of use of the claim to a high-flavanols (HF) cocoa extract to be consumed in capsules, tablets or a dded to “other foods, including beverages”. 
(7) On 5 May 2014, the Commission and the Member States received a scientific opinion 
from the Authority (Question No EFSA-Q-2013-00832)
4 which concluded that on the 
basis of the data submitted, a cause and effect relationship had been established 
between the consumption of cocoa flavanols in the HF cocoa extract (i.e. in capsules 
or tablets) and the claimed effect. 
(8) The Authority indicated in its opinion that its conclusions could not  have been reached 
without considering one human interven tion study claimed by the applicant as 
proprietary.5  
(9) All the justifiable information provided by the applicant has been assessed by the 
Commission and it is considered that the requirements laid down in Article 21(1) of Regulation (EC) No 1924/2006 are fulfilled fo r the study claimed as proprietary. 
Accordingly, the scientific data and other information included in that study may not 
be used for the benefit of a subsequent a pplicant for a period of five years from the 
date of entry into force of this Regul ation, under the conditions laid down in 
Article 21(1) of Regulation (EC) No 1924/2006. 
(10) One of the objectives of Regulation (EC) No  1924/2006 is to ensure that health claims 
are truthful, clear and reliable  and useful to the consumer, and that the wording and the 
presentation are taken into account in that respect. Ther efore, where the wording of 
claims used by the applicant has the same  meaning for consumers as that of an 
authorised health claim, because they dem onstrate the same relationship that exists 
between a food category, a food or one of its  constituents and health, they should be 
subject to the same conditions of use as t hose listed in the Anne x to this Regulation. 
(11) In accordance with Article 20 of Regula tion (EC) No 1924/2006, the Register of 
nutrition and health claims containing all au thorised health claims should be updated 
in order to take into account this Regulation. 
(12) Since the applicant claims prot ection of proprietary data, it is  considered appropriate to 
restrict the use of this clai m in favour of the applicant fo r a period of five years. 
However, the authorisation of this claim rest ricted for the use of an individual operator 
should not prevent other applicants from a pplying for authorisation to use the same 
claim in case the application is based on da ta and studies other than those protected 
under Article 21 of Regulation (EC) No 1924/2006. 
(13) The comments from the applicant rece ived by the Commission pursuant to 
Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the 
measures provided for in this Regulation. 
(14) Regulation (EU) No 432/2012 should therefore be amended accordingly. 
                                                
 
3 Commission Regulation (EU) No 851/2013 of 3 September 2013 authorising certain health claims 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 (OJ L 235, 4.9.2013, p. 3). 
4 EFSA Journal 2014;12(5):3654. 
5 ProDigest, 2012. Pharmacokinetic study to assess th e bioavailability of the cocoa flavanol epicatechin 
from different matrices. ProDigest Report nr. PD-2015009/C1-11.  
EN 4   EN (15) The Member States have been consulted, 
HAS ADOPTED THIS REGULATION: 
Article 1 
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 th e 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 pe riod, that health claim may be used, in 
conformity with the conditions applying to it, by any food business operator. 
Article 2 
The scientific data and other information incl uded in the application, which is claimed by the 
applicant as proprietary and w ithout the submission of which the health claim could not have 
been authorised is restricted for use for the be nefit of the applicant fo r a period of five years 
from the date of entry into force of this  Regulation under the co nditions laid down in 
Article 21(1) of Regulation (EC) No 1924/2006. 
Article 3 
The Annex to Regulation (EU) No 432/2012 is ame nded in accordance with the Annex to this 
Regulation. 
Article 4 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President 
 Jean-Claude JUNCKER