COMMISSION REGULATION (EU) No 1160/2011  
of 14 November 2011  
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)  
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 also provides that appli ­
cations 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 European Food Safety Authority (EFSA), hereinafter 
referred to as ‘the Authority’.  
(3) Following receipt of an application the Authority is to 
inform without delay the other Member States and the 
Commission thereof, and to deliver an opinion on the 
health claim concerned.  
(4) The Commission is to decide on the authorisation of 
health claims taking into account the opinion delivered 
by the Authority.  
(5) Following an application from CreaNutrition 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 related 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 balanced diet can actively 
lower/reduce blood LDL (low-density lipoprotein) and 
total cholesterol’.  (6) On the basis of the data presented, the Authority 
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 beta-glucan and 
lowering of blood LDL-cholesterol concentrations. 
Accordingly, a health claim reflecting this conclusion 
should be considered as complying with the requirements 
of Regulation (EC) No 1924/2006, and should be 
included 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 Regu ­
lation 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 applicable, 
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 health, they should be subject to the 
same conditions of use indicated in the Annex to this 
Regulation.  
(9) Following an application from HarlandHall Ltd (on behalf 
of the Soya Protein Association, the European Vegetable 
Protein Federation and the European Natural Soyfood 
Manufacturers Association), 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 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 protein has been 
shown to lower/reduce blood cholesterol; blood 
cholesterol lowering may reduce the risk of (coronary) 
heart disease’.EN L 296/26 Official Journal of the European Union 15.11.2011  
( 1 ) OJ L 404, 30.12.2006, p. 9.  
( 2 ) EFSA Journal  2010; 8(12):1885.  (  3 ) EFSA Journal  2010; 8(7):1688.(10) On the basis of the data presented, the Authority 
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 established between 
the consumption of soy protein and the claimed effect. 
Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it 
should not be authorised.  
(11) Following an application from Danone France, 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 
Actimel®, a fermented milk product containing  Lactoba ­
cillus casei  DN-114 001 and yoghurt symbiosis on the 
reduction of the presence of  Clostridium difficile  toxins in 
the gut (Question No EFSA-Q-2009-00776) (  1 ). The 
claim proposed by the applicant was worded as 
follows: ‘Fermented milk containing the probiotic  Lacto ­
bacillus 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 Authority 
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 cause 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 the claim does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be auth ­
orised.  (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 measures provided 
for in this Regulation.  
(14) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal 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 
Article 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 Article 14(1) of Regulation (EC) No 1924/2006.  
Article 3  
This Regulation shall enter into force on the 20th day following 
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, 14 November 2011.  
For the Commission  
The President  
José Manuel BARROSOEN 15.11.2011 Official Journal of the European Union L 296/27  
( 1 ) EFSA Journal  2010; 8(12):1903.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 1 g of oat beta glucan per 
quantified portion.  Q-2008-681  
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-2009-00776EN L 296/28 Official Journal of the European Union 15.11.2011