EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10219/2018 ANNEX CIS Rev. 
1 (POOL/E2/2018/10219/10219R1 -EN 
ANNEX CIS.doc)  
[…](2018) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) .../...  
amending Annexes II and III to Regulation (EC) No 1333/2008 of the European 
Parliament and of the Council and the Annex to Commission Regulation (EU) No 
231/2012 as regards octyl gallate (E 311) and dodecyl gallate (E 312 )   
EN 1  EN ANNEX  
(1) Annex II to Regulation (EC) No 1333/2008 is amended as follows:  
(a) in Part B, in Table 3: Additives other than colours and sweeteners,  the entr ies for the food additive s E 311 octyl gallate and E 312 
dodecyl gallate are deleted ; 
(b) in Part C, in Table 5: Other additives that may be regulated combined, point (k) “E 310 -320: Gallates, TBHQ and BHA” is replaced by 
the following:   
'(k) E 310–320: Propyl gallate, TBHQ and BHA  
E-number  Name  
E 310  Propyl gallate  
E 319  Tertiary -butyl hydroquinone (TBHQ)  
E 320  Butylated hydroxyanisole (BHA)  
'  
(c) Part E is amended as follows:  
1) In category 01.5 (Dehydrated milk as defined by Directive 2001/114/EC), the entry concerning food additives E 310 -320 
(Gallates, TBHQ and BHA) is replaced by the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) only milk powder for vending mach ines 
'  
EN 2  EN 2) In category 02.1 (Fats and oils essentially free from water (excluding anhydrous milkfat)) , the entry concerning food additive s E 
310-320 (Gallates, TBHQ and BHA , individually or in combination ) is replaced by the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) (41)  only fats and oils for the professional 
manufacture of heat - treated foods; 
frying oil and frying fat (excluding olive 
pomace oil) and lard, fish oil, beef, 
poultry and sheep fat  
' 
3) In category 02.2.2 (Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liqu id 
emulsions), the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA , individually or in combination ) is replaced 
by the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) (2)  only frying fat  
' 
4) In category 04.2.5.4 (Nut butters and nut spreads) , the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) is  
replaced by the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) (41)  only processed nuts  
' 
5) In category 04.2.6 (Processed potato products), the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) is  
replaced by the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  25 (1) only dehydrated potatoes   
EN 3  EN ' 
6) In category 05.3 (Chewing gum), the entry concerning food additives E 310 -321 (Gallates, TBHQ, BHA and BHT ) is replaced by 
the following:  
' 
 E 310 -321 Propyl gallate, TBHQ, BHA and BHT  400 (1)  
' 
7) In category 06.3 (Breakfast cereals) , the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) is  replaced by the 
following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) (13)  only precooked cereals  
' 
8) In category 06.7 (Pre -cooked or processed cereals), the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) is  
replaced by the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) only pre -cooked cereals  
' 
9) In category 07.2 (Fine bakery wares), the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) is  replaced by 
the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) only cake mixes  
'  
EN 4  EN 10) In category 08.3.1 (Non -heat–treated meat products), the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) 
is replaced by the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) (13)  only dehydrated meat  
' 
11) In category 08.3.2 (Heat –treated meat products), the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) is  
replaced by the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) (13)  only dehydrated meat  
' 
12) In category 12.2.2 (Seasonings and condiments), the entry concerning food additives E 310 -321 (Gallates, TBHQ, BHA and BHT ) 
is replaced by the following:  
' 
 E 310 -321 Propyl gallate, TBHQ, BHA and BHT  200 (1) (13)   
' 
13) In category 12.5 (Soups and broths), the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) is  replaced by the 
following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) (13)  only dehydrated soups and broths  
'  
EN 5  EN 14) In category 12.6 (Sauces), the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) is  replaced by the 
following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) (13)   
' 
15) In category 15.1 (Potato -, cereal -, flour - or starch -based snacks), the entry concerning food additives E 310 -320 (Gallates, TBHQ 
and BHA) is  replaced by the following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) only cereal -based snack foods  
' 
16) In category 15.2 (Processed nuts), the entry concerning food additives E 310 -320 (Gallates, TBHQ and BHA) is  replaced by the 
following:  
' 
 E 310 -320 Propyl gallate, TBHQ and BHA  200 (1) (13)   
' 
17) In category 17.1 (Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewa ble 
forms), the entry concerning food additives E 310 -321 (Gallates, TBHQ, BHA and BHT ) is replaced by the following:  
' 
 E 310 -321 Propyl gallate, TBHQ, BHA and BHT  400 (1)  
'  
EN 6  EN 18) In category 17.2 (Food supplements supplied in a liquid form), the entry concerning food additives E 310 -321 (Gallates, TBHQ, 
BHA and BHT ) is replaced by the following:  
' 
 E 310 -321 Propyl gallate, TBHQ, BHA and BHT  400 (1)  
' 
19) In category 17.3 ( Food supplements supplied in a syrup -type or chewable form ), the entry concerning food additives E 310 -321 
(Gallates, TBHQ, BHA and BHT ) is replaced by the following:  
' 
 E 310 -321 Propyl gallate, TBHQ, BHA and BHT  400 (1)  
'  
EN 7  EN (2) Annex III to Regulation (EC) No 1333/2008 is amended as follows:  
(a) in Part 4 ( Food additives including carriers in food flavourings) , the entr ies concerning food additives E 310, E 311, E 312, E 319 and E 
320 are replaced by the following:  
' 
E 310  
 
 
 
E 319  
 
 
 
E 320  Propyl gallate  
 
 
 
Tertiary -butyl 
hydroquinone (TBHQ)  
 
 
Butylated 
hydroxyanisole (BHA)  Essential oils  1 000 mg/kg (propyl 
gallate, TBHQ and BHA, 
individually or in  
combination) in the 
essential oils  
Flavourings other than 
essential oils  100 mg/kg 1(1) ( propyl 
gallate)  
200 mg/kg (1) (TBHQ and 
BHA, individually or in 
combination) in 
flavourings  
' 
(b) in Part 4 ( Food additives including carriers in food flavourings) , the footnote (1) is replaced by the following:  
' 
(1) Proportionality rule: when combinations of propyl gallate, TBHQ, and BHA are used, the individual levels must be reduced 
proportionally.  
'