COMMISSION REGULATION (EU) No 1171/2011  
of 16 November 2011  
refusing to authorise certain health claims made on foods, other than those referring to the 
reduction of disease risk and to children’s development and health  
(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(5) 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 Yakult Europe BV, 
submitted pursuant to Article 13(5) of Regulation (EC) 
No 1924/2006, the Authority was required to deliver an 
opinion on a health claim related to the effects of live  
Lactobacillus casei  strain Shirota and maintenance of the 
upper respiratory tract defence against pathogens by 
maintaining immune defences (Question No EFSA-Q- 
2010-00137) (  2 ). The claim proposed by the applicant 
was worded, inter alia, as follows: ‘Daily consumption 
of live  Lactobacillus casei  strain Shirota as present in a fermented milk product helps maintain the upper 
respiratory tract defences by helping to support 
immune functions’.  
(6) On 18 October 2010, the Commission and the Member 
States received the scientific opinion from the Authority, 
which concluded that on the basis of the data presented, 
a cause and effect relationship had not been established 
between the consumption of  Lactobacillus casei  strain 
Shirota 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.  
(7) Following an application from Piimandusühistu E-Piim 
(Dairy Cooperative E-Piim), submitted pursuant to 
Article 13(5) of Regulation (EC) No 1924/2006, the 
Authority was required to deliver an opinion on a 
health claim related to the effects of  Lactobacillus 
plantarum  TENSIA  TM in the semi-hard Edam-type ‘heart 
cheese’ of Harmony  TM and maintenance of normal blood 
pressure (Question No EFSA-Q-2010-00950) (  3 ). The 
claim proposed by the applicant was worded as 
follows: ‘Regular consumption (at least three weeks) of 
50 g/day Südamejuust (“heart cheese”) of Harmony  TM 
brand comprising probiotic  Lactobacillus plantarum  
TENSIA  TM helps to maintain the cardio-vascular 
system/heart health through reduction of blood pressure/ 
symbol of heart’.  
(8) On 14 February 2011, the Commission and the Member 
States received the scientific opinion from the Authority, 
which concluded that on the basis of the data presented, 
a cause and effect relationship had not been established 
between the consumption of  Lactobacillus plantarum  
TENSIA  TM in the semi-hard Edam-type ‘heart cheese’ of 
Harmony  TM 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.  
(9) The health claims subject to this Regulation are health 
claim as referred to in point (a) of Article 13(1) of 
Regulation (EC) No 1924/2006 and may benefit from 
the transitional period laid down in Article 28(5) of 
that Regulation. As the Authority concluded that cause 
and effect relationships have not been established 
between the foods and the claimed effects, the claims 
do not comply with Regulation (EC) No 1924/2006, 
and therefore they may not benefit from the transitional 
period provided for in that Article.EN L 299/4 Official Journal of the European Union 17.11.2011  
( 1 ) OJ L 404, 30.12.2006, p. 9.  
( 2 ) The EFSA Journal 2010; 8(10):1860.  (  3 ) The EFSA Journal 2011; 9(2):1981.(10) In order to ensure that this Regulation is fully complied 
with, both food business operators and the national 
competent authorities should take the necessary actions 
to ensure that, at the latest 6 months following the entry 
into force of this Regulation, products bearing the health 
claims listed in its Annex are no longer present on the 
market.  
(11) 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.  
(12) 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 claims listed in the Annex to this Regulation 
shall not be included in the Union list of permitted claims as 
provided for in Article 13(3) of Regulation (EC) No 1924/2006.  
2. However, products bearing these health claims placed on 
the market or labelled prior to the date of entry into force of 
this Regulation may remain on the market for a maximum 
period of 6 months after that date.  
Article 2  
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, 16 November 2011.  
For the Commission  
The President  
José Manuel BARROSOEN 17.11.2011 Official Journal of the European Union L 299/5ANNEX  
Rejected health claims  
Application – Relevant provisions of Regulation 
(EC) No 1924/2006  Nutrient, substance, food or food category  Claim  EFSA opinion reference  
Article 13(5) health claim based on newly developed 
scientific evidence and/or including a request for the 
protection of proprietary data  Live  Lactobacillus casei  strain Shirota  Daily consumption of live  Lactobacillus casei  strain Shirota as present in a 
fermented milk product helps maintain the upper respiratory tract defences 
by helping to support immune functions  Q-2010-00137  
Article 13(5) health claim based on newly developed 
scientific evidence and/or including a request for the 
protection of proprietary data  Lactobacillus plantarum  TENSIATM Regular consumption (at least three weeks) of 50 g/day Südamejuust (‘heart 
cheese’) of HarmonyTM brand comprising probiotic  Lactobacillus plantarum  
TENSIATM helps to maintain the cardio-vascular system/heart health through 
reduction of blood pressure/symbol of heart  Q-2010-00950EN L 299/6 Official Journal of the European Union 17.11.2011