EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/12134/2015 
(POOL/E4/12134/12134-EN.doc) 
D043609/01 […](2016) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise certain health claims ma de 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 SmithKline Beecham Limited, 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 caffeine and increased alertness (Question 
No EFSA-Q-2013-00399
2). The claim proposed by the applicant was worded as 
follows: “caffeine helps to increase alertness”. 
(6) On 21 February 2014, the Commission and the Member States received the scientific 
opinion from the Authority. In  its opinion, the Authority recalled that a claim on 
caffeine and increased alertness in the ge neral adult population for products containing 
at least 75 mg of caffeine per serving had already been assessed by the Authority with 
a favourable outcome3. In the present applic ation, the app licant proposed th at, in order 
to bear the claim, a product should contain a dose of caffeine of at least 40 mg per 
serving. The Authority considered that the scientific substantiation of this claim 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2014;12(2):3574.  
3 EFSA Journal 2011;9(4):2054.  
EN 3   EN related to doses of caffein e between 40 mg per serving4 and 75 mg per serving5, and 
concluded that, on the basis of the data pr esented, a cause and e ffect relationship had 
not been established between the consump tion of caffeine and increased alertness 
under the conditions of use proposed by the appl icant. Further, the Authority reiterated 
its previous conclusion that, in order to b ear the claim, a product should contain at 
least 75 mg caffeine per serving. Accord ingly, as the claim, under the proposed 
conditions of use, does not comply with  the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
(7) Following an application from BASF SE and Stepan Lipid Nutrition, 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 an equimolar mixture 
(marketed under the trade names Clarinol® and Tonalin®) of the two conjugated 
linoleic acid (CLA) isomers c9,t11 and t 10,c12, and contribution to a reduction in 
body fat mass (Question No EFSA-Q-2014-005806). The claim proposed by the 
applicant was worded as follows: “Consumption of Clarinol® or Tonalin® contributes 
to a reduction in body fat mass”. 
(8) On 8 January 2015, the Commissi on and the Member States received the scientific 
opinion from the Authority, which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had not been established between the consumption of an 
equimolar mixture of the CLA isomers c 9,t11 and t10,c12, marketed under the trade 
names of Clarinol® and Tonalin®, 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) Following an application from Synbiotec S.r.l., 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 SYNBIO®, a combination of Lactobacillus rhamnosus  
IMC 501® and Lactobacillus paracasei  IMC 502®, and maintenance of normal 
defecation (Question No EFSA-Q-2014-005677). The claim proposed by the applicant 
was worded as follows: “SYNBIO® persists in the intestinal tract and favours the 
natural regularity contributing to maintain  and improve human in testinal well-being”. 
(10) On 13 May 2015, the Commission and the Member States re ceived the scientific 
opinion from the Authority, which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had not been  established between the consumption of 
SYNBIO® and maintenance of normal defecatio n. Accordingly, as the claim does not 
comply with the requirements of Regul ation (EC) No 1924/2006, it should not be 
authorised. 
(11) Following an application from WILD-V alencia SAU, 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 a FRUIT UP®, a carbohydrate extract from 
carob pods ( Ceratonia siliqua  L.), and a reduction of post-prandial blood glucose 
responses (Question No EFSA-Q-2014-004058). The claim proposed by the applicant 
                                                 
4 Minimum effective dose proposed by the applicant. 
5 Minimum effective dose proposed by EFSA. 
6 EFSA Journal 2015;13(1):3953. 
7 EFSA Journal 2015;13(5):4095. 
8 EFSA Journal 2015;13(5):4098.  
EN 4   EN was worded as follows: “FRUIT UP® reduces post-prandial blood glucose responses 
compared to high-glycaemic carbohydrates”. 
(12) On 13 May 2015, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had not been  established between the consumption of 
FRUIT UP® and a reduction of post-prandial gl ycaemic responses over and above the 
well-established effect of fructose9 on reducing post-prandial glycaemic responses 
when replacing glucose in foods. The Author ity also stated that no effect had been 
observed when FRUIT UP® was compared with sucrose. 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 Nerthus ApS, 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 a combination of  pomegranate pomace extract (standardised by 
its content of punicalagins) and greater ga langal rhizome powder (standardised by its 
content of acetoxychavicol acetate) and an increase in the number of motile 
spermatozoa in semen (Question No EFSA-Q-2014-0056610). The claim proposed by 
the applicant was worded as follows: “A combination of standardised pomegranate pomace extract and greater galangal rhizom e powder increases the number of motile 
spermatozoa in semen”. 
(14) On 13 May 2015, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had not been established between the consumption of the 
combination of pomegranate pomace extr act (standardised by its content of 
punicalagins) and greater galangal rhizome powder (standardised by its content of 
acetoxychavicol acetate) and the claimed eff ect. Accordingly, as the claim does not 
comply with the requirements of Regul ation (EC) No 1924/2006, it should not be 
authorised. 
(15) Following an application from Lallemand Health Solutions, 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 Bifidobacterium bifidum  CNCM I-3426 and 
defence against pathogens in the upper re spiratory tract (Question No EFSA-Q-2014-
00673
11). The claim proposed by the applicant was worded as follows: 
“Bifidobacterium bifidum  CNCM I-3426 increases the proportion of healthy days by 
maintaining normal immune function in h ealthy adults during everyday life events 
such as moderate stress”. 
(16) On 13 May 2015, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had not been  established between the consumption of B. 
bifidum CNCM I-3426 and defence against pathoge ns in the upper respiratory tract. 
                                                 
9 EFSA Journal 2011;9(6):2223. A health claim relating to fructose was authorised by Commission 
Regulation (EU) No 536/2013 of 11 June 2013 amending Regulation (EU) No 432/2012 establishing a 
list of permitted health claims made on foods other th an those referring to the reduction of disease risk 
and to children’s development and health (OJ L 160 of 12.6.2013, p. 4). 
10 EFSA Journal 2015;13(5):4097. 
11 EFSA Journal 2015;13(5):4094.  
EN 5   EN Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
(17) Following an application from Tchibo GmbH, 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 coffee C21, a coffee standard ised by its content of 
caffeoylquinic acids, trigonelline and N- methylpyridinium, and reduction of DNA 
damage by decreasing spontaneous DNA st rand breaks (Question No EFSA-Q-2014-
0062412). The claim proposed by the applicant was worded as follows: “Regular 
consumption of coffee C21 contributes to th e maintenance of DNA in tegrity in cells of 
the body’. 
(18) On 13 May 2015, the Commission and the Member States re ceived the scientific 
opinion from the Authority, which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had not been  established between the consumption of 
coffee C21 and the claimed effect. Accordingl y, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(19) 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. 
(20) 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 
                                                
 
12 EFSA Journal 2015;13(5):4099.