EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12330/2020 
(POOL/E1/2020/12330/12330 -EN.docx)  
[…](2021) 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)  
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 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,  
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 Commission in accordance with that 
Regulation and included in a list of permitted claims.  
(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 ( ‘'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 analyze & realize GmbH , 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 GlycoLite™ and t he reduction of  body weight 
(Question No EFSA -Q‐2018‐00611). The claim proposed by the applic ant was worded 
as follows: “ GlycoLite™  helps to reduce body weight ”.  
(6) The Commission, the Member States and the applicant received the scientific opinion2 
on that claim from the Authority, which concluded that , on the basis of the data 
presented,  the evidence provided has been insufficient to establish a cause and effect  
relationship between the consumption of an aqueous extract from white kidney bean 
(Phaseolus vulgaris  L.) standardised by its in vitro  α-amylase inhibitory activity 
(GlycoLiteTM) and a reduction of body weight  either under energy restriction or when 
eating ad libitum . Accordingly, as the health claim does not comply with the 
requirements of R egulation (EC) No 1924/2006  for the inclusion in the Union list of 
permitted claims , it should not be authorised.  
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2019;17(6):5715 .  
EN 3  EN (7) Following an application from BioGaia AB , submitted pursuan t to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to orodispersible lozenges containing a combination of 
Lactobacillus reuteri  DSM 17938 and Lactobacillus reuteri  ATCC PTA 5289 an d 
normal gum function  (Question No EFSA -Q-2019 -00383 ). The claim proposed by the 
applicant was worded as follows: “ Lozenges containing Lactobacillus reuteri  DSM 
17938 and Lactobacillus reuteri  ATCC PTA 5289 support normal gum function ”.  
(8) The Commission, th e Member States and the applicant received the scientific opinion3 
on that claim from the Authority , which concluded that , on the basis of the data 
presented, the evidence provided has been  insufficient to establish a cause and effect 
relationship between the consumption of orodispersible lozenges containing a 
combination of Lactobacillus reuteri  DSM 17938 and Lactobacillus reuteri  ATCC 
PTA 5289 and the maintenance of normal gum function.  Accordingly, as the  health  
claim does not comply with the requirements of Regulation (EC) No 1924/2006  for 
the inclusion in the Union list of permitted claims , it should not be authorised.  
(9) The comments from  analyze & realize GmbH  received by the Commission pursuant to 
Article 16(6)  of Regulation (EC) No 1924/2006 , have been considered when adopting 
this Regulation.  
(10) 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 claim s listed in the Annex to this Regulation shall not be included 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 twenti eth 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  
 Ursula VON DER LEY EN 
                                                 
3 EFSA Journal 2020;18(3):6004.