EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10461/2015 
(POOL/E4/2015/10461/10461-EN.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 in the first subparag raph of 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 InQpharm Europe Ltd., submitted pursuant to Article 
13(5) of Regulation (EC) No 1924/2006, the Au thority was required to deliver an 
opinion on a health claim related to a standa rdised aqueous extract from white kidney 
bean ( Phaseolus vulgaris L.) and reduction of body wei ght (Question No EFSA-Q-
2013-00973
2). The claim proposed by the applicant was worded as follows: “Helps to 
reduce body weight”. 
(6) On 16 July 2014, the Commission and the Member States received the scientific 
opinion from the Authority, which conc luded that the evidence provided was 
insufficient to establish a cause and effect relationship between the consumption of the 
standardised aqueous extract from white kidney bean ( Phaseolus vulgaris L.) and 
reduction of body weight. 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 Natural Altern ative International, Inc. (NAI), submitted 
pursuant to Article 13(5 ) of Regulation (EC) No  1924/2006, the Authority was 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2014;12(7):3754.  
EN 3   EN required to deliver an opinion on a health claim related to beta-alanine and increase in 
physical performance during short-duration,  high-intensity exer cise (Question No 
EFSA-Q-2013-009743). The claim proposed by the applicant was worded as follows: 
“Beta-alanine increases performance during short-duration high intensity exercise”. 
(8) On 16 July 2014, the Commission and the Member States received the scientific 
opinion from the Authority, wh ich concluded that a cause and effect relationship had 
not been established between the consumption of beta-alanine and increase in physical 
performance during short-duration, high-inte nsity exercise. Accordingly, as the claim 
does not comply with the requirements of Regulation (EC) No 1924/2006, it should 
not be authorised. 
(9) Following an application from Federación Nacional de Industrias Lácteas (FeNIL), 
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 fat-free yogurts and fermented milks complying with the specifica tions “fat free”, “low in sugars”, “high 
protein”, “source of calcium” and “source of vitamin D” for nutrition claims and 
reduction of body and visceral fat while main taining lean body mass in the context of 
an energy-restricted diet (Question No EFSA-Q-2014-00126
4). The claim proposed by 
the applicant was worded as follows: “Fat-free yogurts a nd fermented milks with live 
yogurt cultures, with ad ded vitamin D, and with no adde d sugars, help to reduce body 
and visceral fat in the context of an energy-restricted diet”. 
(10) On 7 January 2015, the Commissi on and the Member States received the scientific 
opinion from the Authority, wh ich concluded that a cause and effect relationship had 
not been established between the consump tion of fat-free yogurts and fermented milks 
with live yogurt cultures complying with the sp ecifications “fat free”, “low in sugars”, 
“high protein”, “source of calcium” and “sour ce of vitamin D” for nutrition claims and 
reduction of body and visceral fat while main taining lean body mass in the context of 
an energy-restricted diet. In that opini on, the Authority also noted that no human 
studies from which conclusions could be draw n for the scientific substantiation of the 
claim were provided by the applicant. Accord ingly, 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 Federación Nacional de Industrias Lácteas (FeNIL), 
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 fat-free yogurts and fermented milks with live yogurt cultures complying with the specificatio ns “fat free”, 
“low in sugars”, “high prot ein”, “source of calcium” a nd “source of vitamin D” for 
nutrition claims and maintenance of lean body mass in the cont ext of an energy-
restricted diet (Que stion No EFSA-Q-2014-00127
5). The claim proposed by the 
applicant was worded as follows: “Fat-free yogurts and fermented milks with live yogurt cultures, with added vita min D, and with no added suga rs, help to ma intain lean 
body mass (muscle and bone) in the contex t of an energy-restricted diet”. 
(12) On 7 January 2015, the Commissi on and the Member States received the scientific 
opinion from the Authority, wh ich concluded that a cause and effect relationship had 
not been established between the consump tion of fat-free yogurts and fermented milks 
with live yogurt cultures complying with the sp ecifications “fat free”, “low in sugars”, 
“high protein”, “source of calcium” and “sour ce of vitamin D” for nutrition claims and 
                                                
 
3 EFSA Journal 2014;12(7):3755. 
4 EFSA Journal 2015;13(1):3948. 
5 EFSA Journal 2015;13(1):3949.  
EN 4   EN maintenance of lean body mass in the context of an energy-restricted diet. In that 
opinion, the Authority also not ed that no human studies fr om which conclusions could 
be drawn for the scientific substantiation of the claim we re provided by the applicant. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
(13) Following an application from Avesthagen Limited, submitted pursuant to Article 
13(5) of Regulation (EC) No 1924/2006, the Au thority was required to deliver an 
opinion on a health claim rela ted to Teestar™, a fenugreek seed extract standardised 
by its content of galactomannan, and a reducti on of post-prandial glycaemic responses 
(Question No EFSA-Q-2014-001536). The claim proposed by the applicant was 
worded as follows: “Teestar™ lowers blood glucose levels”. 
(14) On 8 January 2015, the Commissi on and the Member States received the scientific 
opinion from the Authority, wh ich concluded that a cause and effect relationship had 
not been established between the consump tion of Teestar™, a fenugreek seed extract 
standardised by its conten t of galactomannan, and a reduction of post-prandial 
glycaemic responses. In that opinion, the Auth ority also noted that in the absence of 
evidence for an effect of Teestar™ on post-prandial glycaemic responses in humans, animal studies on potential mechanisms do  not provide support for the scientific 
substantiation of the claim.  Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(15) 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. 
(16) 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 
                                                
 
6 EFSA Journal 2015;13(1):3952.