EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10890/2015 CIS 
(POOL/E4/2015/10890/10890-EN 
CIS.doc) […](2015) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
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 2   EN COMMISSION REGULATION (EU) …/… 
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', for a scientific assessment, as well as to the Commission and the Member States for information.  
(3) The Authority is to deliver an opini on 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 E-piim  production Ltd, 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 Lactobacillus plantarum  TENSIA
® in the semi-
hard Edam-type 'heart cheese' of Ha rmony™ and maintenance of normal blood 
pressure (BP) (Question No EFSA-Q-2014-000972). The claim proposed by the 
applicant was worded as follows: “Regular, at least for eight week consumption of 
50 g/day Lactobacillus plantarum TENSIA® comprising Südamejuust (English 
translation: Heart cheese) of the Harm ony™ brand helps to ma intain the cardio-
vascular system/heart health through reduc tion of blood pressure/Symbol of heart”. 
(6) On 1 October 2014, the Commissi on 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 TENSIA® in the semi-hard Edam-type 'heart cheese' of 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2014;12(10):3842. EN 3   EN Harmony™ and maintenance of normal blood pressure. 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 British Specialist Nutrition Association Ltd, 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 car bohydrate solutions and 
maintenance of physical performance during endurance exercise (Question No EFSA-
Q-2014-000583). The claim proposed by the app licant was worded as follows: 
“carbohydrate solutions contribute to the maintenance of endurance performance during prolonged endurance exercise”. Upon request of the Authority, the applicant 
specified that the food that is the subject of  this claim relates to  carbohydrate solutions 
that do not include electrolytes and that , as regards the claimed effect, carbohydrate 
solutions should be compared to wa ter or water-electrolyte solutions. 
(8) On 1 October 2014, the Commissi on 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 
carbohydrate solutions and ma intenance of physical performance during endurance 
exercise as compared to water or water-elect rolyte solutions. Accordingly, as the claim 
does not comply with the requirements of Regulation (EC) No 1924/2006, it should 
not be authorised. 
(9) The comments from the applicants r eceived by the Comm ission pursuant to 
Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the 
measures provided for in this Regulation. 
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,   
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claims listed in the Annex to this Regulation shall not be in cluded in the Union list 
of permitted claims as provided for in Ar ticle 13(3) 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  Jean-Claude JUNCKER 
                                                
 
3 EFSA Journal 2014;12(10):3836.