EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/10436/2013 
(POOL/E4/2013/10436/10436-EN.doc) 
[…](2013) 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 2   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 authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from Ceprodi KOT, 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  "hypo-caloric snacks  (KOT products)" on 
reduction of adipocyte size at the abdominal level in the context of a low-calorie diet 
(Question No EFSA-Q-2011-00016)
2. The claim proposed by the applicant was 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2011; 9(9):2381.  
EN 3   EN worded as follows: "Contributes to reduce th e adipocytes size at the abdominal level, 
in the context of a low-calorie diet".  
(6) On 30 September 2011, the Commi ssion 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 
"hypo-caloric snacks (KOT products)" and a be neficial physiological effect related to 
the reduction of subcutaneous adipocyte size at the abdominal level. Accordingly, as 
the claim does not comply with the re quirements of Regulat ion (EC) No 1924/2006, it 
should not be authorised. 
(7) Following an application from Valio 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 the effects of isol eucyl-prolyl-proline (IPP) and valyl-prolyl-
proline (VPP) on maintenance of normal blood pressure (Question No EFSA-Q-
2011-00121)3. The claim proposed by the applicant was worded as follows: "Peptides 
IPP and VPP help to maintain normal blood pressure".  
(8) On 30 September 2011, the Commi ssion 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 IPP 
and VPP 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. 
(9) Following an application from Diana Naturals, 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 th e effects of Appl'In® polyphe nolic apple extract powder 
(Malus domestica ) on reduction of post-prandial glycaemic responses (Question No 
EFSA-Q-2011-00190)4. The claim proposed by the applicant was worded as follows: 
"Appl'In® contributes to decrease  glycaemic response in women".  
(10) On 5 October 2011, 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 
Appl'In® 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. 
(11) 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 the consumption of coffee C21 and reduction of spontaneous 
DNA strand breaks (Question No EFSA-Q-2011-00783)
5. The claim proposed by the 
applicant was worded as follows: "Regular consumption of Coffee C21 contributes to 
the maintenance of DNA integrity in cells of the body"  
(12) On 5 December 2011, 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 
                                                 
3 The EFSA Journal 2011; 9(9):2380. 
4 The EFSA Journal 2011; 9(10):2383. 
5 The EFSA Journal 2011; 9(12):2465.  
EN 4   EN 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. 
(13) Following an application from Kao Corporation,  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 diacylglycerol (DAG) oil and reduction of body 
weight (Question No EFSA-Q-2011-00751)6. The claim proposed by the applicant 
was worded as follows: "Substituting your us ual vegetable oil with DAG oil helps in 
the management of body weight through weight loss"  
(14) On 5 December 2011, 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 
DAG oil (as a replacement of triacylglycerol oils) 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. 
(15) Following an application from Giuliani S.p.A.,  submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006 a nd including a request for protection of proprietary 
data, the Authority was require d to deliver an opinion on a health claim related to the 
effects of spermidine and prolongation of the growing phase (anagen) of the hair cycle 
(Question No EFSA-Q-2011-00896)7. The claim proposed by the applicant was 
worded as follows: "Spermidine prolongs th e growing phase (anagen) of the hair 
cycle".  
(16) On 7 December 2011, the Commission and the Me mber States received the scientific 
opinion from the Authority, whic h concluded that on the basi s of the data presented, 
the claimed effect is related to pathological  conditions leading to the shortening of the 
anagen phase of hair growth and relates thus to the treatment of a disease.  
(17) Regulation (EC) No 1924/2006 complements th e general principles of Directive 
2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the 
approximation of the laws of the Member St ates relating to the labelling, presentation 
and advertising of foodstuffs8. Article 2(1)(b) of Direct ive 2000/13/EC provides that 
the labelling shall not attri bute to any foodstuff the propert y of preventing, treating or 
curing a human disease, or refer to such pr operties. Accordingly, as the attribution of 
medicinal properties to foods is prohibite d, the claim related to the effects of 
spermidine should not be authorised. 
(18) Following an application from Clasado 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 the effects of galacto-oligosaccharides from Bimuno® (Bimuno® GOS) and reducing gast ro-intestinal discomfort (Question No EFSA-Q-
2011-00401)
9. The claim proposed by the applicant was worded as follows: "Regular 
                                                 
6 The EFSA Journal 2011; 9(12):2469. 
7 The EFSA Journal 2011; 9(12):2466. 
8 OJ L 109, 6.5.2000, p. 29.  
9 The EFSA Journal 2011; 9(12):2472.  
EN 5   EN daily consumption of 1.37 g galacto-oli gosaccharides from Bimuno® may reduce 
intestinal discomfort".  
(19) On 8 December 2011, 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 
Bimuno® GOS and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (E C) No 1924/2006, it should not be authorised. 
(20) Following an application from Nordic Sugar A/S.,
 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 sugar beet fibre and decreasing intenstinal transit time (Question No EFSA-Q-2011-00971)
10. The claim proposed by the 
applicant was worded as follows: "Sugar beet  fibre decreases intenstinal transit time".  
(21) On 8 December 2011, 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 
sugar beet fibre and the claimed effect. Accordingly, as the claim does not comply 
with the requirements of Regulation (E C) No 1924/2006, it should not be authorised. 
(22) The health claim related to the effects of  spermidine and prolongation of the growing 
phase (anagen) of the hair cycle, is a hea lth claim attributing me dicinal properties to 
the food subject to the claim and is  therefore prohibited for foods. 
(23) The health claims related to "hypo-cal oric snacks (KOT products)" and to 
diacylglycerol (DAG) oil are hea lth claims as those referred to in point (c) of Article 
13(1) of Regulation (EC) No 1924/2006 which are subject to the transitional period 
laid down in Article 28(6) of  that Regulation. However, as  the applications were not 
made before 19 January 2008, the requirement  provided for in point (b) of Article 
28(6) of that Regulation is not fulfilled, and therefore those claims may not benefit 
from the transitional period provided for in that Article. 
(24) The other health claims subject to this Regul ation are health claims as referred to in 
point (a) of Article 13(1) of Regulation (EC) No 1924/2006, which are subject to the 
transitional period laid down in  Article 28(5) of that Regul ation until the adoption of 
the list of permitted health claims provided that they comply with that Regulation.  
(25) The list of permitted health claims has been established by Commission 
Regulation(EU) No 432/2012 and is applicab le since 14 Decem ber 2012. As regards 
claims referred to in Article 13(5) of  Regulation (EC) No 1924/2006 for which the 
evaluation by the Authority or consideration by the Commission has not been 
completed by 14 December 2012 and which by virtue of this Regulation are not included in the list of permitted health cl aims, it is appropriate to provide for a 
transitional period during which they may still be used, in order to allow both food business operators and the competent national authorities to adapt to the prohibition of 
such claims.  
                                                
 
10 The EFSA Journal 2011; 9(12):2467.  
EN 6   EN (26) 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.  
(27) 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, the health claims referred to in  paragraph 1 used prior to the entry into 
force of this Regulation, may continue to  be used for a maximum period of six 
months after the entry into  force of this Regulation. 
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  José Manuel BARROSO  
EN 7   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 "Hypo-caloric 
snacks (KOT 
products)" Contributes to reduce the 
adipocytes size at the abdominal 
level, in the context of a low-
calorie diet  Q-2011-
00016 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Isoleucyl-prolyl-
proline (IPP) and 
valyl-prolyl-
proline (VPP)  Peptides IPP and VPP help to 
maintain normal blood pressure  Q-2011-
00121 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Appl'In® 
polyphenolic 
apple extract powder ( Malus 
domestica )  Appl'In® contributes to decrease 
glycaemic response in women Q-2011-
00190 
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Coffee C21  Regular consumption of Coffee 
C21 contributes to the maintenance of DNA integrity in 
cells of the body  Q-2011-
00783 
Article 13(5) health 
claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Diacylglycerol 
(DAG) oil  Substituting your usual 
vegetable oil with DAG oil helps in the management of 
body weight through weight loss Q-2011-
00751  
EN 8   EN Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Spermidine Spermidine prolongs the 
growing phase (anagen) of the 
hair cycle  Q-2011-
00896 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Bimuno® 
(Bimuno® GOS)  Regular daily consumption of 
1.37 g galacto-oligosaccharides 
from Bimuno® may reduce 
intestinal discomfort Q-2011-
00401 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Sugar beet fibre  Sugar beet fibre decreases 
intenstinal transit time Q-2011-
00971