EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10768/2021 
(POOL/E1/2021/10768/10768 -EN.docx)  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise a health claim made on foods and referring to the reduction of 
disease risk  
(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 C ommission.    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise a health claim made on foods and referring to the reduction of 
disease risk  
(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 ma de on foods1, and in 
particular Article 17(3) 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 the Union  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 ’’). 
(3) Following the receipt of an application , the Authority is to inform without delay the 
other M ember States and the Commission,  and 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 Anxioﬁt Ltd. , submitted pursuant to Article 14 (1), point 
(a), of Regulation (EC) N o 1924/2006, the Authority was required to deliver an 
opinion on the scientific substantiation of a  health claim related to Anxioﬁt -1 and  the 
reduction of subthreshold and mild anxiety (Question No EFSA -Q-2020 -00032 ). The 
claim proposed by the applicant wa s worded as follows: " Anxioﬁt -1 has been shown 
to ameliorate subthreshold and mild anxiety. Subthreshold and mild anxiety are risk 
factors in the development of anxiety disorders and depression ". 
(6) The Commission, the Member States and the applicant received  the scientif ic opinion2 
on that claim from the Authority , which concluded  that, on the basis of the data 
presented, the scientific evidence had  been insufficient to establish a cause and effect 
relationship between the consumption of Anxiofit -1 and the reduction of subthreshold 
and mild anxiety . 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.  
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2020;18 (10):6264   
EN 2  EN (7) The measures provided f or 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 set out  in the Annex to this Regulation shall not be included in the Union list 
of permitted claims as provided for in Article 14(1) 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.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER L EYEN