 
EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10138/2022 ANNEX 
(POOL/E1/2022/10138/10138 -EN 
ANNEX.docx)  
[…](2022) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) …/…  
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    
EN 1  EN ANNEX  
Rejected health claims  
 Application – Relevant provisions of 
Regulation (EC) No 1924/2006  Nutrient, substance, food or food category  Claim  EFSA opinion 
reference  
Article 13(5) health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  Beta‐glucans sourced from oats and/or barley, 
incorporated into ready‐to‐eat breakfast cereals  
manufactured  via pressure cooking (i.e. either by 
batch cooking or extrusion), and present at a level 
of at least 1.3 g per 25 g available carbohydrate in 
the ready‐to‐eat cereal  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  Q‐2020‐000447   
Article 13(5) health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  Affron®, aqueous  saffron extract, with the sum of 
crocins and safranal concentration > 3.5% and 
dextrin as inert carrier  Affron® contributes to maintain a 
healthy mood by reducing the negative 
traits of depressive and anxiety 
feelings  Q-2020 -00617  
Article 13(5) health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  MegaNatural®-BP grape seed extract made entirely 
of California -grown grapes containing biologically 
active constituents: total phenolics (90 –93%), gallic 
acid (≥ 2%) and catechin and epicatechin (≥ 5%). 
The distribution of phenolic compounds in the 
MegaNatural®-BP is on average 9% monomers, 
69% oligomers and 22% polymers  MegaNatural®-BP helps maintain 
healthy b lood pressure  Q-2020 -00718  
Article 13(5) health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  Frutalose® chicory oligofructose  Frutalose® chicory oligofructose 
contributes to regular b owel function 
by increasing stool frequency  
(And three other alternative wordings)  Q-2020 -00631  