EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10466/2015 
(POOL/E4/2015/10466/10466-EN.doc) 
[…](2015) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
authorising certain health claims 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 certain health claims 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) 
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 Regula tion (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 t hose referring to the reductio n of disease risk and to 
children’s development and health.  
(3) 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 (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 Roquettes Frères, 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 Nutriose
® which should replace fermentable carbohydrates in 
foods or beverages in order to obtain the claimed effect, i.e. maintenance of tooth 
mineralisation by reducing tooth demine ralisation (Question No EFSA-Q-2013-
                                                 
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 000403). The claim proposed by th e applicant was worded as follows: "Frequent 
consumption of sugars contributes to tooth demineralisation. Consumption of 
food/drinks containing Nutriose® instead of sugar may help maintain tooth 
mineralisation by decreasing tooth demineralisation". 
(7) On 26 July 2013, the Commission and the Member States received the scientific 
opinion from the Authority which concluded that the characteristic which is most 
relevant to the claimed effect (i.e. not lo wering plaque pH be low 5.7 during and up to 
30 minutes after consumption) is not uni que to the food subject to the claim4, but 
common to other non-fermentable car bohydrates (e.g. pol yols, D-tagatose, 
isomaltulose, and polydextrose). The Author ity added that a claim on sugar replacers 
xylitol, sorbitol, mannitol, maltitol, lac titol, isomalt, erythritol, D-tagatose, 
isomaltulose, sucralose and polydextrose a nd maintenance of tooth mineralisation by 
decreasing tooth deminerali sation had already been as sessed with a favourable 
outcome5. The Authority concluded that a cause  and effect relationship had been 
established between the consumption of f oods or beverages containing fermentable 
carbohydrates at an exposure fre quency of four or more tim es daily and an increased 
tooth demineralisation, and that the consum ption of foods or beverages containing 
non-fermentable carbohydrates  instead of fermentable carbohydrates may maintain 
tooth mineralisation by decrea sing tooth demineralisation, pr ovided that such foods or 
beverages do not lead to de ntal erosion. Accordingly, a he alth 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 Regulation (EU) No 432/2012. 
(8) Following an application from Beneo-Orafti SA, 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 fructo-oligosacchar ides (FOS) from inulin and a reduction of 
post-prandial glycaemic responses (Question No EFSA-Q-2013-006156). The claim 
proposed by the applicant was worded, inter alia,  as follows: “Consumption of 
foods/drinks containing oligofructose from ch icory instead of sugars induces a lower 
blood glucose rise”. 
(9) On 10 January 2014, the Commission and the Member States received the scientific 
opinion from the Authority which noted that th e characteristic which is most relevant 
to the claimed effect (i.e. reduction of pos t-prandial glycaemic responses by replacing 
sugars in foods and beverages) is not  unique to FOS but common to other non-
digestible carbohydrates (e.g. non-starch pol ysaccharides, resistant oligosaccharides, 
resistant starch) because, si milar to FOS, non-digestible carbohydrates are resistant to 
hydrolysis and absorption in the small inte stine and therefore do not contribute to post-
prandial glycaemia. The Authority also noted  that a claim related to sugar replacers 
and reduction of post-prandial glycaemic responses had already been assessed by the 
Authority with a favourable outcome7.The Authority concluded that on the basis of the 
data presented, a cause and effect relati onship has been established between the 
consumption of foods or beverages contai ning non-digestible carbohydrates instead of 
                                                 
3 EFSA Journal 2013;11(7):3329. 
4 i.e. 85 % resistant dextrin, with an average degree of polymerisation from 12 to 25, and less than 0.5 % 
of mono- and disaccharides, which is relevant for the claimed effect (i .e. not lowering plaque pH below 
5.7 during and up to 30 minutes after consumption). 
5 EFSA Journal 2011;9(4):2076. 
6 EFSA Journal 2014;12(1):3513. 
7 EFSA Journal 2011;9(4):2076.  
EN 4   EN sugars and a reduction of post-prandial gl ycaemic responses as compared to sugar-
containing foods or beverages. Accordingly, a health claim reflecting that 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 claims, established by 
Regulation (EU) No 432/2012.  
(10) Following an application from Olygose, 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 AlphaGOS® and a reduction of post-prandial glycaemic 
responses (Question No EFSA-Q-2014-000448). The claim proposed by the applicant 
was worded as follows: “Consumption of  foods or drinks containing AlphaGOS® 
instead of sugar induces a lower blood glucos e rise after their c onsumption compared 
to sugar-containing foods or drinks”. 
(11) On 8 October 2014, the Commissi on and the Member States received the scientific 
opinion from the Authority which noted that th e characteristic which is most relevant 
to the claimed effect (i.e. reduction of pos t-prandial glycaemic responses by replacing 
sugars in foods and beverages) is not unique to α-galacto-oligosaccharides ( α-GOS) 
but is common to other non-di gestible carbohydrates (e.g. no n-starch polysaccharides, 
resistant starch) because, similar to α-GOS, non-digestible car bohydrates are resistant 
to hydrolysis and absorption in the small in testine and therefore do not contribute to 
post-prandial glycaemia. In that opinion, th e Authority also noted that a claim on non-
digestible carbohydrates and reduction of  post-prandial glycaemic responses had 
already been assessed by the Aut hority with a favourable outcome9 and concluded that 
a cause and effect relationship had been es tablished between the consumption of foods 
or beverages containing non-di gestible carbohydrates and a reduction of post-prandial 
glycaemic responses as compared with sugar-containing foods or beverages. Accordingly, a health claim reflecting th is conclusion should be considered as 
complying with the requirements of Re gulation (EC) No 1924/2006 and should be 
included in the Union list of permitted claims established by Regulation (EU) No 
432/2012. 
(12) Following an application from Roquette It alia S.P.A., submitted pursuant to Article 
13(5) of Regulation (EC) No 1924/2006, the Au thority was required to deliver an 
opinion on a health claim related to Nutriose
®06 and a reduction of post-prandial 
glycaemic responses (Question No EFSA-Q-2014-0007310). The claim proposed by 
the applicant was worded as follows: "Consumption of foods/drinks containing 
Nutriose®06 instead of high gly caemic carbohydrates induce s a lower blood glucose 
rise after their consumption compared to high glycaemic carbohydrates-containing foods/drinks".  
(13) On 8 October 2014, the Commissi on and the Member States received the scientific 
opinion from the Authority in which it noted  that the characteristic which is most 
relevant to the claimed effect (i.e. reduc tion of post-prandial glycaemic responses by 
replacing glycaemic carbohydrates in foods a nd beverages) is the non-digestibility of 
the resistant dextrin contained in the food subject to the claim
11. The Authority also 
considered that this characteristic, which is relevant to the claimed effect, is not unique to resistant dextrin but is common to other non-digestible  carbohydrates (e.g. non-
                                                
 
8 EFSA Journal 2014;12(10):3838. 
9 EFSA Journal 2014;12(1):3513. 
10 EFSA Journal 2014;12(10):3839. 
11 i.e. 85 % resistant dextrin with an average degree of polymerisation of 12-25, and less than 0.5 % 
mono- and disaccharides.  
EN 5   EN starch polysaccharides and resistant oli gosaccharides) because, similar to resistant 
dextrin, non-digestible carbohydrates are resi stant to hydrolysis and absorption in the 
small intestine and therefore do not contribut e to post-prandial glycaemia. In that 
opinion, the Authority noted that a clai m on non-digestible carbohydrates and 
reduction of post-prandial glycaemic res ponses had already b een assessed by the 
Authority with a favourable outcome12 and it concluded that a cause and effect 
relationship had been established between the consumption of foods or beverages 
containing non-digestible carbohydrates, and a reduction of post-prandial glycaemic 
responses as compared with foods or be verages containing glycaemic carbohydrates. 
Accordingly, a health claim reflecting th is conclusion should be considered as 
complying with the requirements of Re gulation (EC) No 1924/2006 and should be 
included in the Union list of permitted claims established by Regulation (EU) No 
432/2012. 
(14) 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. 
(15) 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. 
(16) The comments from one of the applicants  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. 
(17) Regulation (EU) No 432/2012 should therefore be amended accordingly. 
(18) The Member States have been consulted, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claims set out in the Annex to this Regulation shall be included in the Union list of 
permitted claims as provided for in Artic le 13(3) of Regulation (EC) No 1924/2006.  
Article 2 
The Annex to Regulation (EU) No 432/2012 is ame nded in accordance with the Annex to this 
Regulation. 
                                                 
12 EFSA Journal 2014;12(1):3513.  
EN 6   EN Article 3 
This Regulation shall enter into  force on the twentieth day follo wing 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