EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/967/2023 
(POOL/A1/2023/967/967 -EN.docx)  
[…](2023) 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)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  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 foods1, 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 Commi ssion in accordance with that 
Regulation and included in the Union  list of permitted health claims.  
(2) Article 18 of the Regulation (EC) No 1924/2006 also provides that applications for 
authorisation of health claims must 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 European Food Safety Authority (‘the Authority ’) 
for a scientific assessment as well as to the Commission and other Member States for 
information . 
(3) Following the receipt of an application, the Authority is to deliver an opinion on the 
health claim concerned  within five months . 
(4) The Commission is to decide on the authorisation of the health clai m taking into 
account the opinion delivered by the Authority.  However,  in accordance with Article 
17 of the Regulation (EC) No 1924/2006,  in that consideration the Commission must 
take into account also  other legitimate factors relevant to the matter .  
(5) Following an application from BENEO  GmbH , submitted pursuant to Article 18(1) of 
Regulation (EC) No 1924/2006  for a health claim within the meaning of Article 13(5) , 
the Authority was required to deliver an opinion on a health claim related to 
isomaltulose an d its contribution to the normal energy -yielding metabolism  (Question 
No EFSA -Q‐202 1‐00073). The claim proposed by the applicant was worded as 
follows: ‘Consumption of foods/drinks containing isomaltulose (PalatinoseTM) 
replacing other sugars contributes to normal energy -yielding metabolism yet via a 
slower hydrolysis ’. Upon a request from the Authority according to which the 
contribution of glycaemic carbohydrates (including isomaltulose) to energy -yielding 
metabolism does not depend on the rate of hydrol ysis to glucose, the scope of the 
scientific evaluation was restricted to the contribution of isomaltulose  as a source of 
                                                 
1 OJ L 404, 30.12.2006, p. 9.   
EN 2  EN glucose to normal energy -yielding metabolism  with the  agreement of the applicant . 
The target population is the general population.  
(6) On 15 September  2021, the Authority  adopted a scientific opinion2 on that claim , in 
which the Authority concluded that, on the basis of the data presented,  a cause -and-
effect relationship has been established between the consumption of isomaltulose and 
the contribution to normal energy -yielding metabolism . However, since the 
contribution to energy -yielding metabolism is not specific to isomaltulose but applies  
to all energy containing macronutrients (i.e. carbohydrates, proteins, and lipids) which  
supply  the body with metabolisable energy and that any amount of those 
macronutrients would contribute to the claimed effect,  the Authority could not  set 
conditions of use for this claim . 
(7) Pursuant to Articles 6(1) and 13(1) of Regulation (EC) No 1924/2006 , health cl aims 
shall be based on generally accepted scientific evidence. According to Regulation 
(EC) No 1924/2006 , health claims must also be truthful, clear, reliable and useful to 
the consumer in choosing a healthy diet.  In this respect also Article 5(2) require s that 
the health claim can only be made if the average consumer can be expected to 
understand the beneficial effects as expressed in the claim. Authorisation may 
legitimately be withheld if health claims do not comply with other general and specific 
requi rements of Regulation (EC) No 1924/2006, even in the case of a favourable 
scientific assessment by the Authority. Health claims inconsistent with generally 
accepted nutrition and health principles should not be made. In this particular case , the 
use of such a health claim would convey a conflicting and confusing message to 
consumers . Isomaltulose is a disaccharide that consists of one glucose and one 
fructose molecule and therefore such health claim would  encourage consumption of 
sugars for which, on the basis of generally accepted scientific  advice,  national and 
international authorities inform the consumer that  their intake should be reduced.   
(8) Therefore, a health claim as described above does not comply with point (a)  of the 
second paragrap h of Article 3  of Regulation (EC) No 1924/2006, which provides that 
the use of nutrition and health claims should not be ambiguous or misleading . 
Furthermore, even if the concerned health claim was to be authorised only under 
specific conditions of use and /or accompanied by additional statements or warnings, it 
would not be sufficient to alleviate the confusion of the consumer, and consequently it 
should not be authorised for inclusion in the Union list of permitted health claims . 
That conclusion is also is in line with Commission Regulation (EU) 2015/83 , which 
contains the same finding concerning glucose and the contribution to energy yielding 
metabolism . 
(9) The comments of the applicant  received by the Commission pursuant to Article 16(6) 
of Regulation (EC ) No 1924/ 2006 , have been considered when  adopting  this 
Regulation.  
(10) The Member States have been consulted  in the context of the  working group meeting 
on nutrition and health claims  of 11 July 2022 . 
(11) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
                                                 
2 EFSA Journal 2021;19( 10):6849. 
3 Commission Regulation (EU) 2015/8 of 6 January 2015 refusing to authorise certain health claims 
made on foods, other than those referring to the reduction of disease risk and to children's development 
and health ( OJ L 3, 7.1.2015, p. 6 ).  
EN 3  EN HAS ADOPTED THIS REGULATION:  
Article 1  
The health claim set out in the Annex to this Regulation shall not be includ ed in the Union list 
of permitted health claims as provided for in Article 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 Europea n Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN