EN    EN  
 EUROPEAN  
COMMISS IO N 
Brussels, XXX   
SANTE/10462/2015 
(POOL/E4/2015/10462/10462-EN.doc) 
[…](2015) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
authorising a health claim made on foods, other than those referring to the reduction of 
disease risk and to children's development and health and amending 
Regulation (EU) No 432/2012 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
authorising a health claim made on foods, ot her than those referring to the reduction of 
disease risk and to children's de velopment and health and amending 
Regulation (EU) No 432/2012 
(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 foods1, and in 
particular Article 18(4) thereof,  
Whereas: (1) Regulation (EC) No 1924/2006 provides that 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) Pursuant to Article 13(3) of Regulati on (EC) No 1924/2006, Commission Regulation 
(EU) No 432/2012
2 was adopted, which establishes a list of permitted health claims 
made on foods other than those referring to the reduction of diseas e risk and to 
children's development and health. 
(3) Regulation (EC) No 1924/2006 provid es that applicati ons for authorisations of health 
claims are to 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 (EFS A), hereinafter referred to as 
'the Authority', for a scientific assessment, as well as to the Commission and the Member States for information. 
(4) The Commission is to decide on the authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) In order to stimulate innovation, health cl aims which are based on newly developed 
scientific evidence and/or which include a request for the protection of proprietary 
data shall undergo an accele rated type of authorisation. 
(6) Following an application from BENEO-Orafti S.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 the scientific 
                                                
 
1 OJ L 404, 30.12.2006, p. 9. 
2 Commission Regulation (EU) No 432/2012 of 16 Ma y 2012 establishing a list of permitted health 
claims made on foods, other than those referring to the reduction of disease risk and to children's 
development and health (OJ L 136, 25.5.2012, p. 1).  
EN 3   EN substantiation of a health claim related to native chicory inulin and maintenance of 
normal defecation by increasing stool fr equency (Question No EFSA-Q-2014-004033). 
The claim proposed by the applicant was worded, inter alia , as follows: 
“Orafti®Inulin improves bowel function”.  
(7) On 9 January 2015, the Commissi on and the Member States received the scientific 
opinion from the Authority whic h concluded that on the basi s of the data presented a 
cause and effect relationship had been esta blished between the c onsumption of native 
chicory inulin, a non-fractionated mixture of  monosaccharides (< 10%), disaccharides, 
inulin-type fructans and i nulin extracted from chicory with a mean degree of 
polymerisation ≥ 9, and maintenance of normal defecation by increasing stool 
frequency. Accordingly, a health claim refl ecting this conclusion should be considered 
as complying with the requirements of Regulation (EC) No 1924/2006 and should be 
included in the Union list of permitted cl aims, established by Regulation (EU) No 
432/2012. 
(8) The Authority indicated in its opinion that the one study claimed as proprietary4 by the 
applicant was required to establish conditi ons of use for this specific claim.  
(9) All the justifiable information provided by the applicant has been assessed by the 
Commission and it is considered that the requirements laid down in Article 21(1) of Regulation (EC) No 1924/2006 are fulfilled fo r the study claimed as proprietary. 
Accordingly, the scientific data and other information included in that study may not 
be used for the benefit of a subsequent a pplicant for a period of five years from the 
date of entry into force of this Regul ation, under the conditions laid down in 
Article 21(1) of Regulation (EC) No 1924/2006. 
(10) One of the objectives of Regulation (EC) No  1924/2006 is to ensure that health claims 
are truthful, clear and reliable  and useful to the consumer, and that the wording and the 
presentation are taken into account in that respect. Ther efore, where the wording of 
claims used by the applicant has the same  meaning for consumers as that of an 
authorised health claim, because they dem onstrate the same relationship that exists 
between a food category, a food or one of it s constituents and health, these claims 
should be subject to the same conditions of use as those listed in the Annex to this 
Regulation. 
(11) In accordance with Article 20 of Regula tion (EC) No 1924/2006, the Register of 
nutrition and health claims containing all au thorised health claims should be updated 
in order to take into account this Regulation. 
(12) Since the applicant claims prot ection of proprietary data, it is  considered appropriate to 
restrict the use of this clai m in favour of the applicant fo r a period of five years. 
However, the authorisation of this claim rest ricted for the use of an individual operator 
should not prevent other applicants from a pplying for authorisation to use the same 
claim in case the application is based on da ta and studies other than those protected 
under Article 21 of Regulation (EC) No 1924/2006. 
(13) The comments from the applicant rece ived 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. 
                                                
 
3 EFSA Journal 2015;13(1):3951. 
4 Schulz A and Schön C, 2012. Effect of consumption of inulin on bowel motor function in subjects with 
constipation (unpublished study report).  
EN 4   EN (14) Regulation (EU) No 432/2012 should therefore be amended accordingly. 
(15) The Member States have been consulted, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claim set out in the Annex to this Regulation shall be included in the 
Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006. 
2. The use of the health claim referred to in th e first paragraph shall be restricted to the 
applicant for a period of five years from the date of entry into force of this 
Regulation. After the expiry of that pe riod, that health claim may be used, in 
conformity with the conditions applying to it, by any food business operator. 
Article 2 
The scientific data and other information includ ed in the application, which are claimed by the 
applicant as proprietary and w ithout the submission of which the health claim could not have 
been authorised are restricted for use for the be nefit of the applicant for a period of five years 
from the date of entry into force of this  Regulation under the co nditions laid down in 
Article 21(1) of Regulation (EC) No 1924/2006. 
Article 3 
The Annex to Regulation (EU) No 432/2012 is ame nded in accordance with the Annex to this 
Regulation. 
Article 4 
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