EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/11528/2013 
(POOL/E4/2013/11528/11528-EN.doc) […](2013) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
authorising a health claim made on foods, ot her than those referring to the reduction of 
disease risk and to children's development and health and amending Commission 
Regulation (E U) No 432/2012 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
authorising a health claim made on foods, ot her than those referring to the reduction of 
disease risk and to children's developm ent and health and amending Commission 
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 foods
1, and in 
particular Article 18(4) thereof, 
Whereas: (1) Regulation (EC) No 1924/2006 provides that health claims made on food 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 established 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 al so provides that applications for authorisations of 
health claims areto 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. 
                                                
 
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 (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 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 suga r beet fibre on the increase of faecal bulk 
(Question No EFSA-Q-2011-00972)3. The claim proposed by the applicant was 
worded as follows: "Sugar beet fibre increases faecal bulk".  
(7) On 8 December 2011, the Commission and the Me mber States received the scientific 
opinion from the Authority which concluded th at on the basis of the data presented, a 
cause and effect relationship had been esta blished between the consumption of sugar 
beet fibre and the claimed effect. Acco rdingly, a health claim reflecting this 
conclusion should be considered as comply ing with the requirements of Regulation 
(EC) No 1924/2006 and should be included in  the Union list of permitted claims, 
established by Commission Regulation (EU) No 432/2012. 
(8) 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 its  constituents and health, they should be 
subject to the same conditions of use as t hose listed in the Anne x to this Regulation. 
(9) 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. 
(10) 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 measur es provided for in this Regulation. 
(11) Regulation (EU) No 432/2012 should therefore be amended accordingly. 
(12) The Member States have been consulted, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claim set out in the Annex to this Regulati on shall be included in  the Union list of 
permitted claims as provided for in Artic le 13(3) of Regulation (EC) No 1924/2006.  
                                                 
3 The EFSA Journal 2011;9(12):2468. EN 4   EN Article 2 
The Annex to Regulation (EU) No 432/2012 is ame nded in accordance with the Annex to this 
Regulation. 
Article 3 
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   
In the Annex to Regulation (EU) No 432/2012, the following entry is inserted in an alphabetical order:  
Nutrient, 
substance, food or 
food category Claim Conditions of use of the claim Conditions and/or 
restrictions of use of 
the food and/or 
additional statement 
or warning EFSA Journal 
number Relevant entry 
number in the 
Consolidated List 
submitted to EFSA 
for its assessment 
Sugar beet fibre Sugar beet fibre contributes to 
an increase in faecal bulk The claim may be used only for 
food which is high in that fibre as 
referred to in the claim HIGH FIBRE as listed in the Annex to 
Regulation (EC) No 1924/2006.  
2011;9(12):2468