EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
SANCO/10116/2012 
[…](2012) 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 authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) 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)
2. 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"  
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2011; 9(12):2465.  
EN 2   EN (6) On 6 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 
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. 
(7) 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)3. 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"  
(8) On 6 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. 
(9) 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)4. The claim proposed by the applicant was 
worded as follows: "Spermidine prolongs th e growing phase (anagen) of the hair 
cycle".  
(10) 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. Pursuant to 
Directive (EC) No 2000/135 and in particular its Arti cle 7(3), it is a fundamental 
requirement that food information shall not  attribute to any food the property of 
preventing, treating or curing a human di sease, nor refer to such properties. 
Accordingly, the claim should not be authorised. 
(11) 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 Bimuno® (Bimuno® GOS) and reducing gastro-intestinal discomfort (Question No EFSA-Q-2011-00401)
6. The claim proposed by 
the applicant was worded as follows: "Re gular daily consumption of 1.37 g galacto-
oligosaccharides from Bimuno® may reduce intestinal discomfort".  
                                                 
3 The EFSA Journal 2011; 9(12):2469. 
4 The EFSA Journal 2011; 9(12):2466. 
5  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 States relating to the labelling, presentation and advertising of 
foodstuffs, OJ L 109, 6.5.2000, p. 29.  
6 The EFSA Journal 2011; 9(12):2472.  
EN 3   EN (12) 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. 
(13) 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)
7. The claim proposed by the 
applicant was worded as follows: "Sugar beet  fibre decreases intenstinal transit time".  
(14) 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. 
(15) Four health claims subject to this Regulati on are health claims as referred to in point 
(a) of Article 13(1) of Regulation (EC) No 1924/2006 and may, in principle, benefit 
from the transitional period laid down in Article 28(5) of that Regulation. However, as 
the Authority concluded that cause and effect  relationships 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 no t benefit from the transitional period 
provided for in that Article.  
(16) The health claim related to di acylglycerol (DAG) oil is a heal th claim as referred to in 
point (c) of Article 13(1) of Regulation (EC) No 1924/ 2006 and may, in principle, 
benefit from the transitional period laid down in Article 28(6) of that Regulation. 
However, as the application was not made  before 19 January 2008, the requirement 
provided for in point (b) of Article 28(6) of that Regulat ion is not fulfilled, and the 
transitional period laid down in th at Article is not applicable.  
(17) 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, 
the health claims listed in its  Annex are no longer used.  
(18) 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.  
(19) 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,   
                                                 
7 The EFSA Journal 2011; 9(12):2467.  
EN 4   EN 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 5   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 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 
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