EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10929/2015 CIS 
(POOL/E4/2015/10929/10929-EN 
CIS.doc) […](2015) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise a health claim 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 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise a health claim 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(4) thereof, 
Whereas: (1) Pursuant to Regulation (EC) No 1924/2006 hea lth claims made on food are prohibited 
unless they are authorised by the Commissi on 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', for a scientific assessment, as well as to the Commission and the Member States for information.  
(3) The Commission is to decide on the authoris ation of health claims taking into account 
the opinion delivered by the Authority. In so me cases, the scientific risk assessment 
alone cannot provide all the information on which a risk management decision should 
be based and therefore ot her legitimate factors rele vant to the matter under 
consideration should also be taken into account. 
(4) Following an application from Oy Karl F azer AB, 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 high-fibre s ourdough rye bread and a reduction of post-
prandial glycaemic responses (Question No EFSA-Q-2014-00012
2). The claim 
proposed by the applicant was worded as follows: “Consumption of high-fibre sourdough rye bread contributes to a reduc tion of glycaemic response accompanied 
with a decreased insulin re sponse after a meal”. Upon request of the Authority, the 
applicant specified that as regards the claimed effect high-fibre sourdough rye bread 
should be compared with glucose. 
(5) On 8 October 2014, the Commissi on and the Member States received the scientific 
opinion from the Authority, whic h concluded on the basis of the data presented that a 
                                                
 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2014;12(10):3837. EN 3   EN cause and effect relationship had been esta blished between the consumption of almost 
any food and a reduction of post-prandial bl ood glucose responses as compared with 
glucose. 
(6) Pursuant to Articles 6(1) and 13(1) of Regulation (EC)  No 1924/2006 health claims 
need to be based on generally accepted sc ientific evidence. Authorisation may be 
legitimately withheld if health claims do not  comply with other general and specific 
requirements of Regulation (EC) No 1924/ 2006, even in the case of a favourable 
scientific assessment by the Authority. The Au thority noted in its scientific opinion 
that, when comparable amounts of av ailable carbohydrates from different 
carbohydrate-containing foods are tested, almost any carbohydrate-containing food 
would induce a reduction of pos t-prandial blood glucose re sponses compared with the 
blood glucose responses elicited by the consum ption of glucose. In addition, it noted 
that foods containing low amounts of car bohydrates or no avai lable carbohydrates 
would also induce lower post-prandial blood glucose responses when compared with 
glucose.  
(7) Regulation (EC) No 1924/2006 defines ‘claim’ as any me ssage or representation 
which states, suggests or implies that a food has particular charac teristics. A claim on 
high-fibre sourdough rye bread and post-prandial glycaemic  responses would suggest 
that high-fibre sourdough rye bread has par ticular characteristics in relation to the 
reduction of post-prandial glycaemic responses  when compared with glucose, while in 
fact almost all foods have that  effect. Point (a) of the sec ond paragraph of Article 3 of 
Regulation (EC) No 1924/2006 provides that th e use of health claims shall not be 
misleading. A claim suggesting that a part icular food possesses certain beneficial 
properties when in fact almost all foods possess such properties would be misleading.  
(8) In the light of the above, the claim on the consumption of high-fibre sourdough rye 
bread and the reduction of post-prandial glycaemic responses does not comply with 
the requirements of Regulation (EC) No  1924/2006 and should therefore not be 
included in the list of permitted health claims.  
(9) The comments from the applicant receiv ed 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. 
(10) The Member States have been consulted, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claim set out in the Annex to this Re gulation shall not be incl uded in the Union list 
of permitted claims as provided for in Ar ticle 13(3) of Regulation (EC) No 1924/2006. 
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. EN 4   EN Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER