EN    EN    
  EUROPEAN COMMISSION   
Brussels, XXX  
SANCO/12827/2011 
(POOL/E4/2011/12827/12827 -EN.doc)  
[…](2011) XXX draft   
  
COMMISSION REGULATION (EU) No …/..  
of XXX  
refusing to authorise certain health claims  made on foods, ot her than those referrin g to 
the reduction   of disease risk and to child ren'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-2011-00120)4. The claim proposed by the applicant was worded as follows: 
"Appl'In® contributes to decrease  glycaemic response in women".  
(10) On 6 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) The health claim related to "hypo-caloric sn acks (KOT products)" is a health 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 pe riod laid down in Ar ticle 28(6) of that 
Regulation. However, as the applicati on was not made before 19 January 2008, the 
requirement provided for in point (b) of Article 28(6) is not fulfilled, and the transitional period laid down in th at Article is not applicable.  
(12) The health claims related to IPP and VPP and to Appl'In® 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 pe riod laid down in Ar ticle 28(5) of that 
Regulation. However, as the Authority conc luded that cause and effect relationships 
                                                
 
3 The EFSA Journal 2011; 9(9):2380. 
4 The EFSA Journal 2011; 9(10):2383. EN 4   EN have not been established between the foods and the claimed effects, the claims do not 
comply with Regulation (EC) No 1924/2006, a nd therefore they may not benefit from 
the transitional period provided for in that Article. 
(13) 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.  
(14) 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 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 "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