EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10138/2022 
(POOL/E1/2022/10138/10138 -EN.docx)  
[…](2022) 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 Commi ssion in accordance with that 
Regulation and included in the Union  list of permitted health claims.  
(2) Regulation (EC) No 1924/2006 also provides that applications for authorisation 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 Member States and the Commission, and to deliver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authorisation of the health claim taking into 
account the opinion delivered by the Authority.  
(5) Following an application from Nestl é S.A., 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 beta‐glucans sourced from oats 
and/or barley in ready‐to‐eat  breakfas t cereal s manufactured via pressure cooking and 
to the reduction of blood glucose rise after consumption (Question No EFSA -Q‐2020‐
000447). The claim proposed by the applicant was worded as follows: ‘Consumption 
of beta‐glucans from oats and/or barley in a ready‐to‐eat breakfast cereal contributes to 
a reduction of the blood glucose rise after that meal ’.  
(6) On 8 April 2021, the Commission and the Member States  received the scientific 
opinion2 on that claim from the Authority, which concluded that, on the basis of the 
data presented, the effect of beta -glucans in reducing post -prandial blood glucose 
responses is well established. However, the evidence provided had been insufficient to 
establish an effect  on reduction of post‐prandial glycaemic responses at doses of 1.3 g 
beta‐glucans per 25 g of available carbohydrate incorporated into ready‐to -eat 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2021;19(4):6493.   
EN 2  EN breakfast cereals manufactured by pressure cooking (i.e. either batch cooking or 
extrusion), as requested by the applicant. 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 health claims, it should not be authorised.  
(7) Following an application from Pharmactive Biotech Products, S.L. , 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 Affron® and the contribution to the maintenance  of a healthy mood  (Question No 
EFSA -Q-2020 -00617 ). The  claim  proposed by the applicant was worded as follows: 
‘Affron® contributes to maintain a healthy mood by reducing the negative traits of 
depressive and anxiety feelings’ . 
(8) On 6 July 2021 , the Commission and the Member States received the scientific 
opinion3 on that claim from the Authority, which concluded that, on the basis of the 
data presented, the evidence provided had been insufficient to establish a cause and 
effect relationship between the consumption of Affron® and increase in positive mood . 
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  health  claims , it 
should not be authorised.  
(9) Following an application from Praline i Cokolada j.d.o.o.,  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 MegaNatural®-
BP grape seed extract and the maintenance of normal blood pres sure (Question No 
EFSA -Q-2020 -00718). The claim proposed by the applicant was worded as follows: 
‘MegaNatural®-BP helps maintain healthy blood pressure’.  
(10) On 9 August 2021, the Commission and the Member States received the scientific 
opinion4 on that claim from the Authority, which concluded that, on the basis of the 
data presented, the evidence provided had been insufficient to establish a cause and 
effect relationship between the consumption of MegaNatural®-BP, a grape seed extract 
standardised for total p henolics, gallic acid and the sum of catechin and epicatechin 
content, and maintenance of normal blood pressure. 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 p ermitted  health  claims, it should not be authorised.  
(11) Following an application from Sensus B.V. (Royal Cosun) , 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 Frutalose® and 
the maintenance of normal defecation  (Question No EFSA -Q-2020 -00631). The claim 
proposed by the applicant was worded as follows: ‘Frutalose® chicory oligofructose 
contributes to regular bowel function by increasing stool frequency’ . The applicant 
also provided three alternative wordings  for the claim . 
(12) On 12 August 20 21, the Commission and the Member States received the scientific 
opinion5 on that claim from the Authority, which concluded that, on the basis of the 
data presented, the evidence provided was insufficient to establish a cause and effect 
relationship between the consumption of Frutalose® and the maintenance of normal 
defecation under the proposed conditions of use . Accordingly, as the health claim does 
                                                 
3 EFSA Journal 2021;19(7):6669 . 
4 EFSA Journal 2021;19(8):6776 . 
5 EFSA Journal 2021;19(8 ):6775.  
EN 3  EN not comply with the requirements of Regulation (EC) No 1924/2006  for the inclusion 
in the Union list of permitted  health  claims,  it should not be authorised.  
(13) The comments by Nestl é S.A. on the Authority’s opinion on  the health claim relating 
to beta‐glucans sourced from oats and/or barley in ready‐to‐eat  breakfast  cereal s 
manufactured via pressure cooking and to the reduction of blood glucose rise after 
consumption (Question No EFSA -Q‐2020‐000447 ), received by the Commission 
pursuant to Article 16(6) of Regulation (EC) No 1924/ 2006 , have been considered 
when  adopting  this Regulation.  
(14) 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 claims listed in the Annex to this Regulation shall not be included in the Union list 
of permitted health 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 U nion. 
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