EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
SANCO/10117/2012 
[…](2012) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
on the authorisation of a health claim made on foods and referring to the reduction of 
disease risk 
(Text with EEA relevance) 
 EN 1   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
on the authorisation of a health claim made  on foods and referring to the reduction of 
disease risk 
(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 17(3) thereof, 
Whereas: (1) Pursuant to Regulation (EC) No 1924/ 2006 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) Regulation (EC) No 1924/2006 al so provides that applications for authorisations of 
health claims may 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'. 
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Comm ission thereof, and to deli ver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from Cargil l Incorporated, submitted pursuant to 
Article 14(1)(a) of Regulation (EC) No  1924/2006 and requesting the protection of 
proprietary data fo r one meta-analysis
2 and for information pertaining to the 
production process of barl ey "betafiber" (BarlivTM), the Authority was required to 
deliver an opinion on a health claim related to the effects of barley beta-glucans and 
lowering of blood cholesterol and reduced  risk of (coronary) heart disease (Question 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2  Harland JI, 2011 (unpublished); Meta-analysis of the effects of barley beta-glucan on blood lipids.  EN 2   EN No EFSA-Q-2011-00798)3. The claim proposed by the applicant was worded as 
follows: "Barley beta-glucan has been shown to lower/reduce blood cholesterol. Blood 
cholesterol lowering may reduce the ri sk of (coronary) heart disease".  
(6) On the basis of the data presented, the Au thority concluded in its opinion received by 
the Commission and the Member States on 8 December 2011 that a cause and effect 
relationship had been established between th e consumption of barley beta-glucans and 
lowering of blood LDL-cholesterol concen trations. Accordingly, a health claim 
reflecting this conclusion should be consider ed as complying with the requirements of 
Regulation (EC) No 1924/2006, and should be in cluded in the Union list of permitted 
claims. The meta-analysis and informati on pertaining to the production process of 
barley "betafiber" (BarlivTM), claimed by the applicant as proprietary, were not 
considered necessary by the Authority fo r reaching its conclusi on. It is therefore 
considered that the requirement laid down in point (c) of Article 21(1) of Regulation (EC) No 1924/2006 is not fulfilled and accord ingly, protection of proprietary data 
should not be granted.  
(7) Following an application from Valens Int. d.o.o., submitted pursuant to 
Article 14(1)(a) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects of barley beta-glucans and 
lowering of blood cholesterol and reduced  risk of (coronary) heart disease (Question 
No EFSA-Q-2011-00799)
4. The claim proposed by the applicant was worded as 
follows: "Barley beta-glucan has been shown to reduce blood cholesterol. Blood 
cholesterol lowering may reduce th e risk of  heart disease". 
(8) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 8 December 2011 that a cause and effect 
relationship had been established between th e consumption of barley beta-glucans and 
lowering of blood LDL-cholesterol concen trations. Accordingly, a health claim 
reflecting this conclusion should be consider ed as complying with the requirements of 
Regulation (EC) No 1924/2006, and should be in cluded in the Union list of permitted 
claims.  
(9) Article 16(4) of Regulation (EC) No 1924/2006 provides that an opinion in favour of 
authorising a health claim should include certain particulars.  Accordingly, those 
particulars should be set out in  the Annex to this Regulatio n as regards the authorised 
claim and include, as the case may be, the revised wording of the claim, specific 
conditions of use of the claim, and, where a pplicable, conditions or restrictions of use 
of the food and/or an additional statement or  warning, in accordance with the rules laid 
down in Regulation (EC) No 1924/2006 and in line  with the opinions of the Authority.  
(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 wording and 
presentation are taken into account in that  respect. Therefore where the wording of 
claims has the same meaning for consumers as  that of an authorised health claim, 
because they demonstrate the same relationship that exists between a food category, a food or one of its constituents and healt h, they should be subject to the same 
conditions of use indicated in the Annex to this Regulation.  
                                                
 
3 The EFSA Journal (2011); 9(12):2470. 
4 The EFSA Journal (2011); 9(12):2471. EN 3   EN (11) The comments from the applicants and th e members of the public received by the 
Commission pursuant to Article 16(6) of  Regulation (EC) No 1924/2006 have been 
considered when setting the measur es provided for in this Regulation. 
(12) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council have opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claim listed in the Annex to th is Regulation may be made on foods on the 
European Union market in compliance with  the conditions laid down in that Annex. 
2. The health claim referred to in paragraph 1 shall be included in the Union list of 
permitted claims as provided for in Artic le 14(1) of Regulation (EC) No 1924/2006. 
Article 2 
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  José Manuel BARROSO    
EN 4   EN  
Application 
– Relevant 
provisions 
of 
Regulation 
(EC) No 
1924/2006 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 EFSA opinion 
reference 
Cargill Incorporated, acting through Cargill Health and Nutrition, c/o Cargill R&D Centre Europe, Havenstraat 84, B-1800 Vilvoorde, Belgium Q-2011-00798 
Article 
14(1)(a) health claim referring to a reduction of a disease riskValens Int. d.o.o., 
Kidričeva ulica 24b, 
SI-3000 Celje, Slovenia Barley beta-
glucan  Barley beta-glucan 
has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease Information shall be given to the 
consumer that the beneficial effect is obtained with a daily intake of 3 g of barley beta-glucan.  
The claim can be used for foods 
which provide at least 1 g  of barley 
beta-glucan  per quantified portion.   
Q-2011-00799 
     
 ANNEX  
Permitted health claim