EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11793/2016 ANNEX 
(POOL/E2/2016/11793/11793 -EN 
ANNEX.docx)  D073140/03  
[…](2021) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) …/…  
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of 
the Council as regards the inclusion of 3 -(1-((3,5 -dimethylisoxazol -4-yl)methyl) -1H-
pyrazol -4-yl)-1-(3-hydroxybenzyl)imidazolidine -2,4-dione i n the Union list of flavouring 
substances  
  
EN 1  EN ANNEX  
In Annex I , Part A, Section 2, Table 1 to Regulation (EC) No 1334/2008 t he following entry concerning FL  No 16.127 is inserted, after entry 16.126 : 
" 
16.127 3-(1-((3,5 -dimethylisoxazol -4-
yl)methyl) -1H-pyrazol -4-yl)-1-(3-
hydroxybenzyl)imidazolidine -2,4-dione  1119831 -25-2 2161  at least 99%, assay (HPLC/ 
UV) Restrictions of use as a 
flavouring substance: 
 
In categor y 1.4, – not 
more than 4 mg/kg   
In categor y 1.8,– not 
more than 8 mg/kg   
In categor y 3 – not 
more than 4 mg/kg  
In category 5.1. – not 
more than 15 mg/kg  
In category 5.2. – not 
more than 16 mg/kg  
In category 5.3. – not 
more than 30 mg/kg 
In category 5.4 – not 
more than 15 mg/kg 
In ca tegory 6.3. – not 
more than 25 mg/kg 
In category 12.1.  – not 
more than 75 mg/kg 
In category 12.2.  – not 
more than 100 mg/kg 
In category 12.3.  – not 
more than 25 mg/kg 
In category 12.4.  – not 
more than 25 mg/kg 
In category 12.5.  – not 
more than 4 mg/kg  
In category 13.2. – not  EFSA   
EN 2  EN more than 4 mg/kg  
In categor y 13.3, – not 
more than 4 mg/kg  
In category 14.1.4 – not 
more than 4 mg/l (for 
dairy based drinks 
only)  
In categor y 14.1.5 . – 
not more than 8 mg/kg  
In categor y 15.1. – not 
more than 20 mg/kg 
In category 16. – not 
more than 4 mg/l (for 
dairy based deserts 
only) 
" 