EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/10207/2011 Rev. 1 (POOL/E4/2011/10207/10207R1-
EN.doc) 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
on the authorisation and refusal of authorisation of certain health claims 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 and refusal of authorisat ion of certain health claims 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 (EFSA ), 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 authorisa tion of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from CreaN utrition AG, 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 relate d to the effects of oat beta-glucan on 
lowering blood cholesterol (Question No EFSA-Q-2008-681)
2. The claim proposed 
by the applicant was worded as follows: "The inclusion of oat beta-glucan as part of a 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal (2010); 8(12):1885.  
EN 2   EN balanced diet can actively lower/reduce bl ood LDL (low-density lipoprotein) and total 
cholesterol". 
(6) 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 2010 that a cause and effect 
relationship had been established between the consumption of oat beat-glucan 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.  
(7) 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 Annex I 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.  
(8) 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.  
(9) Following an application from HarlandHall L.t.d. (on behalf of the Soya Protein 
Association, the European Vegetable Prot ein Federation and the European Natural 
Soyfood Manufacturers Association), subm itted 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 soy protein on the reduction of blood cholesterol 
concentrations (Question No EFSA-Q-2009-00672)
3. The claim proposed by the 
applicants was worded as follows: "Soy prot ein has been shown to  lower/reduce blood 
cholesterol; blood cholesterol lowering ma y reduce the risk of  (coronary) heart 
disease". 
(10) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 30 July 2010 that a cause and effect 
relationship had not been esta blished between the consump tion of soy protein and the 
claimed effect. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised.  
(11) Following an application from Danone Fran ce, 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 th e effects of Actimel®, a fermented milk product containing 
Lactobacillus casei DN-114 001 and yoghurt symbiosis on the reduction of the 
presence of Clostridium difficile toxins in the gut (Question No EFSA-Q-2009-
                                                 
3 The EFSA Journal 2010; 8(7):1688.  
EN 3   EN 00776)4. The claim proposed by the applicant was worded as follows: "Fermented 
milk containing the probiotic Lactobacillus casei DN-114001 and yogurt symbiosis 
decreases presence of Clostridium difficile toxins in the gut (of susceptible ageing 
people). Presence of Clostridium difficile toxins is associated with the incidence of 
acute diarrhoea ". 
(12) 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 2010 that the evidence provided is insufficient to establish a ca use and effect relationship between the 
consumption of Actimel®
 and reduction of the risk of C. difficile diarrhoea by 
reducing the presence of C. difficile toxins. Accordingly, as th e claim does not comply 
with the requirements of Regulation (EC)  No 1924/2006, it should not be authorised.  
(13) The comments from the applicants and the 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. 
(14) 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 Annex I to this 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 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 
The health claims listed in Annex II to this Regulation shall not be included in the Union list 
of permitted claims as provided for in Ar ticle 14(1) of Regulation (EC) No 1924/2006. 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
                                                 
4 The EFSA Journal 2010 8(12):1903.  
EN 4   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 José Manuel BARROSO  The President  
EN 5   EN ANNEX I  
Permitted health claim 
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 
Article 14(1)(a) health claim referring to a reduction of a disease risk CreaNutrition 
AG, Business Park, 6301 Zug, Switzerland Oat beta-
glucan Oat 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 oat beta-glucan.  
The claim can be used for 
foods which provide at least 1g of oat beta glucan per quantified portion.   Q-2008-681 
  
EN 6   EN ANNEX II  
Rejected health claims 
Application – Relevant provisions 
of Regulation (EC) No 1924/2006 Nutrient, substance, food or food 
category Claim EFSA opinion reference 
Article 14(1)(a) health claim 
referring to a reduction of a disease risk Soy protein Soy protein has been shown to 
lower/reduce blood cholesterol; blood cholesterol lowering may reduce the risk of (coronary) heart disease Q-2009-00672 
Article 14(1)(a) health claim 
referring to a reduction of a disease risk ACTIMEL® Lactobacillus casei  
DN-114 001 plus yoghurt symbiosis Fermented milk containing the probiotic 
Lactobacillus casei  DN-114 001 and 
yoghurt symbiosis decreases presence of Clostridium difficile  toxins in the gut (of 
susceptible ageing people). Presence of Clostridium difficile  toxins is associated 
with the incidence of  acute diarrhoea. Q-2009-00776