EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10024/2020 
(POOL/E1/2020/10024/10024 -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 are included in the list of permitted claims.  
(2) With regard to health claims on reduction of disease risk, Article 15 of Regulation 
(EC) No 1924/2006 provides that applications for authorisations of health claims shall 
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'.  
(3) Follo wing receipt of an application , the Authority is to inform without delay the other 
Member States and the Commission thereof, 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 Han-Biotech GmbH  submitted  via the competent 
authority of Germany  pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, 
the Authority was required to deliver an opin ion on a health claim related to 
Symbiosal® and the lowering of blood pressure and a reduced risk of hypertension  
(Question No EFSA -Q-2018 -00002 ). The claim proposed by the applicant was worded 
as follows: " ‘Symbiosal®’ has been shown to lower the rising o f blood pressure when 
used as a replacement of traditional table salt. The rising of blood pressure is a risk 
factor for high  blood pressure (hypertension) ". 
(6) On 25 July 2018 , the Commission and the Member States received the scientif ic 
opinion from the Authority2, which concluded that on the basis of the data presented a  
cause and effect relationship has  not been established between the consumption of  
‘Symbiosal® ’ and lowering of blood pressure . Accordingly, as the health claim does 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2018;16(7):5364 .  
EN 2  EN not comply with the r equirements of Regulation (EC) No 1924/2006, it should not be 
authorised.  
(7) The comments from the applicant received by the Commission pursuant to Article 
16(6) of Regulation (EC) No 1924/2006 have been considered when setting out the 
measure provided for in  this Regulation.  
(8) The measure s 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 listed 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 followi ng 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 LEYEN