EN   EN  
 
 EUROPEAN  
COMMISSIO N   
Brussels, XXX   
SANTE/10642/2021 
(POOL/E1/2021/10642/10642 -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 1  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 DuPont Nutrition Biosciences ApS , submitted pursuant  
to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related Biﬁdobacterium animalis  subsp. lactis  Bi-07 (Bi -07) and the contribution to increasing 
lactose digestion (Question No EFSA -Q-2020- 00024). The  claim proposed by the 
applicant was worded as follows: ‘ Bifidobacterium animalis  subsp. lactis  Bi-07 
contributes to the improvement of lactose digestion in individuals who have difficulty 
digesting lactose’.  
(6) The Commission , the Member States  and the applicant  received the scientific opinion
2 
on that claim from th e Authority, which concluded that, on the basis of the data 
presented,  a cause and effect relationship has not been established between the 
consumption of Biﬁdobacterium animalis  subsp. lactis  Bi-07 and a  beneﬁcial 
physiological effect (i.e. the improvemen t of symptoms of lactose maldigestion) in 
individuals with lactose maldigestion . Accordingly, as the health claim does not 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2020;18(7):619 8.  
EN 2  EN 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.  
(7) Following an application from Tchibo GmbH, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on 
the scientiﬁc substantiation of a health claim related to Coffee C21 and the protection 
of DNA from s trand breaks (Question No EFSA -Q-2019- 00423). The claim proposed 
by the applicant was worded as follows: ‘regular consumption of Coffee C21 contributes to the maintenance of DNA integrity in cells of the body’.  
(8) The Commission , the Member States  and the applicant  received the scientific opinion
3 
on that claim from the Authority, which concluded that, on the basis of the data 
presented, a cause and effect relationship has not been established between the 
consumption of Coffee C21 and the protection of DNA from strand breaks . 
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) Following an applica tion from  NattoPharma ASA, submitted pursuant to Article 13(5) 
of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on 
the scientific substantiation of  a health claim related to MenaQ7® and the maintenance 
of the elastic proper ties of the arteries ( Question No EFSA -Q-2019 -00229 ). The claim 
proposed by the applicant was worded as follows:  ‘MenaQ7®, vitamin K2 as 
menaquinone -7, improves arterial stiffness’.  
(10) The Commission , the Member States  and the applicant  received the scientific opinion4 
on that claim from the Authority, which concluded that, on the basis of the data presented,  a cause and effect relationship has not been established between the 
consumption of MenaQ7
® and the maintenance of the elastic pro perties of the arteries . 
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.  
(11) The comments from DuPont Nutrition Bioscie nces ApS  and Tchibo GmbH  received 
by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006, have 
been considered when adopting  this Regulation.  
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standi ng 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 twentieth day following that of its publication in 
the Official Journal of the European Union.  
                                                 
3 EFSA Journal 2020;18(3):6055.  
4 EFSA Journal 2020;18(1):5949.   
EN 3  EN This Regulation shall be binding in its entirety and directly applicable in all Member Sta tes. 
Done at Brussels,  
 For the Commission 
 The President  
 Ursula VON DER LEYEN