EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10967/2016 
(POOL/E1/2016/10967/10967 -EN.doc) 
D047296/01  
[…](2016) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
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  
(Text with EEA relevance)   EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
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  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Havi ng 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 , as defined in 
that Regulation, are prohibited unless they are authorised by the Commission in 
accordance with that Regulation and included in a list of permitted claim s. 
(2) Regulation (EC) No 1924/2006 also 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 European 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 Authority is to deliver an opinion on the health claim concerned.  
(4) The Commission is to decide on the authorisation of health claims taking into account 
the opinion delivered by the Authority.  
(5) Following an application from Ecopharma BVBA , 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 Fabenol® Max, a standardised aqueous extract from 
Phaseolus vulgaris  L., and the reduction of the absorption of carbohydrates (Question 
No EFSA -Q-2015 -001232). The claim proposed by  the applicant was worded as 
follows: “ Fabenol® Max reduces the absorption of carbohydrates ”. 
(6) On 23 February 201 6, the Commission and the Member States received the scient ific 
opinion from the Authority , which noted that the claimed effect was not sufficie ntly 
defined and that the applicant did not provide any further information as requested by 
the Authority. Therefore , on the basis of the data presented, the Authority concluded  
that a cause and effect relationship had not been established between the cons umption 
of Fabenol® Max and the claimed effect. Accordingly, as the claim does not comply 
with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.  
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 201 6;14(2):4401 .  EN 3   EN (7) Following an application from DSM Nutritional Products , 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 docosahexaenoic acid (DHA) and improvement 
of memory function ( Question No EFSA -Q-2015-004563). The claim proposed by the 
applicant was  worded as follows: “ DHA contributes to improved memory function ”. 
(8) On 2 May 2016, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded that , on the basis of the data p resented , a 
cause and effect relation ship ha d not been established between the consumption of 
DHA and the claimed  effect. Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised.  
(9) Following an application from  Tate & Lyle PLC , submitted pursuant to Article 13(5) 
of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinio n on 
a health claim related to Polydextrose and normal defecation  (Question No EFSA -Q-
2015-005504). The claim proposed by the applicant wa s worded as follows: 
“Polydextrose contributes to an improved bowel function by increasing stool bulk ”. 
(10) On 25 May 2016 , the Commission and the Member States received the scientific 
opinion from the Authority, which concluded that , on the basis of the data presented , a 
cause and effect relationship ha d not been established between the consumption of 
polydextrose and the claimed effect . Accordingly, as the claim does not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised . 
(11) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,   
HAS ADOPTED THIS REGULATION:  
Article 1  
The health claims listed in the Annex to this Regulation shall not be inc luded in the Union list 
of permitted 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 European Un ion. 
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  
                                                 
3 EFSA Journal 201 6;14(5):4455 . 
4 EFSA Journal 201 6;14(5):4480 .