EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10221/2016 
(POOL/E1/2016/10221/10221-EN.doc) 
D045163/01 […](2016) 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) 
  
EN 2   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 made on foods
1, 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 a list of permitted claims. 
(2) Regulation (EC) No 1924/2006 al so 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 Eu ropean Food Safety Authority (EFS A), hereinafter referred to as 
'the Authority'. 
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Comm ission thereof, and to deli ver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from Anxiofit Ltd. and ExtractumPharma Co Ltd, submitted 
pursuant to Article 14(1)(a) of Regulat ion (EC) No 1924/2006, the Authority was 
required to deliver an opinion on a health cl aim related to Anxiofit-1 and reduction of 
subthreshold and mild anxiety (Question No EFSA-Q-2015-00006
2). The claim 
proposed by the applicant was 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 a nxiety disorders and depression”. 
(6) On 8 January 2016, the Commissi on and the Member States received the scientific 
opinion from the Authority, which concluded th at, on the basis of the data presented, 
the scientific evidence is insufficient to establish a cause and effect relationship 
between the consumption of Anxiofit-1 an d reduction of subthreshold and mild 
                                                
 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2016;14(1):4365.  
EN 3   EN anxiety. Accordingly, as the claim does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
(7) The measure provided for in this Regulati on is in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claim listed in the Annex to this Regulation shall not be included in the Union list 
of permitted claims as provided for in Ar ticle 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  Jean-Claude JUNCKER