EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/11114/2011 Rev. 2 (POOL/E4/2011/11114/11114R2-
EN.doc) 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
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) 
  
EN 1   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
refusing to authorise certain he alth 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 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 deliver  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 Yakult Europe B.V., submitted pursuant to 
Article 13(5) of Regulation (EC) No 1924/ 2006, the Authority was required to deliver 
an opinion on a health claim re lated to the effects of live Lactobacillus casei strain 
Shirota and maintenance of the upper respir atory 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 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2010; 8(10):1860.  
EN 2   EN 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 Me mber States received the scientific 
opinion from the Authority, whic h 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 ef fect. 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 Piimandusühi stu 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 
HarmonyTM 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 
HarmonyTM brand comprising probiotic Lactobacillus plantarum  TENSIATM helps to 
maintain the cardio-vascular system/h eart health throu gh 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, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of 
Lactobacillus plantarum  TENSIATM in the semi-hard Edam-type "heart cheese" of 
HarmonyTM 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 ar e 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 relationshi ps 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 benefi t from the transitional period provided 
for in that Article. 
(10) In order to ensure that this Regulation is fully complied with, both food business 
operators and the national competent authorit ies should take the necessary actions to 
ensure that, at the latest six months follo wing 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 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 measures  provided for in this Regulation.  
                                                 
3 The EFSA Journal 2011; 9(2):1981.  
EN 3   EN (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 claims listed in the Annex to this Regulation shall not  be included in the 
Union list of permitted claims as provided fo r in Article 13(3) of Regulation (EC) No 
1924/2006. 
2. However, products bearing these health cl aims 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 six months after that date.  
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 
 José Manuel BARROSO 
 The President  
EN 4   EN ANNEX  
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  
TENSIA
TM  Regular consumption (at least 
three weeks) of 50 g/day  
Südamejuust ("heart cheese") of Harmony
TM 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-
00950