COMMISSION REGUL ATION (EU) 2018/1481 
of 4 Oct ober 2018 
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) 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 
on food additives (1), and in particular Article 10(3) and Article 14 thereof, 
Whereas: 
(1)  Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives appro ved for use in foods 
and their conditions of use. 
(2)  Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food 
additives, food enzymes, food flavouri ngs, nutr ients and their conditions of use. 
(3)  Commission Regulation (EU) No 231/2012 (2) lays down specifi cations for food additives that are listed in 
Annex es II and III to Regulation (EC) No 1333/2008. 
(4)  Octyl gallat e (E 311) and dodecyl gallat e (E 312) are substances author ised as antio xidants in a variety of foods, 
as well as in food flavourings, in accordance with Annexes II and III to Regulation (EC) No 1333/2008. 
(5)  Article 32(1) of Regulation (EC) No 1333/2008 provides that all food additives that were already permitted in 
the Union before 20 Januar y 2009 are subject to a new risk assessment by the European Food Safety Author ity 
(‘the Author ity’). 
(6)  For that purpose, a program for the re-evaluation of food additives is laid down in Commission Regulation (EU) 
No 257/2010 (3). Pursuant to Regulation (EU) No 257/2010 the re-evaluation of antio xidants had to be 
compl eted by 31 December 2015. 
(7)  On 5 May 2015 the Auth ority delivered a Scientific Opinion on the re-evaluation of dodecyl gallat e (E 312) as 
a food additive (4). The opinion stated that there was a lack of adequate toxicological data on dodecyl gallat e. 
Consequently the Auth ority was not able to conf irm the safety of dodecyl gallat e as a food additive and 
concluded that the present group Acceptable Daily Intak e (ADI) for prop yl gallate (E 310), octyl gallat e (E 311) 
and dodecyl gallat e (E 312) should no long er be valid. The opinion stated that a sufficient toxicological database 
would be required for an adequat e assessment of the safety of dodecyl gallat e as a food additive. 
(8)  On 1 October 2015 the Author ity delivered a Scientifi c Opinion on the re-evaluation of octyl gallat e (E 311) as 
a food additive (5). The opinion state d that there was a lack of adequate toxicological data on octyl gallate. 
Consequently the Author ity was not able to conf irm the safety of octyl gallat e as a food additive and concluded 
that the present group ADI for prop yl gallat e (E 310), octyl gallate (E 311) and dodecyl gallat e (E 312) should no 
long er be valid. The opinion state d that a sufficient toxicological database would be required for an adequate 
assessment of the safety of octyl gallate as a food additive. 5.10.2018 L 251/13 Official Jour nal of the European Union EN     
(1)OJ L 354, 31.12.2008, p. 16. 
(2)Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to 
Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1). 
(3)Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up the program for the re-evaluation of approved food additives in 
accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (OJ L 80, 26.3.2010, 
p. 19). 
(4)EFSA Jour nal 2015;13(5):4086. 
(5)EFSA Jour nal 2015;13(10):4248. (9)  On 30 May 2017 the Commission launched a public call for scientifi c and technological data on prop yl gallat e 
(E 310), octyl gallat e (E 311) and dodecyl gallate (E 312) (1), targeting the data needs identif ied in the Scientifi c 
Opinions on the re-evaluation of those substances as food additives. However , no business operator committed to 
provid ing the request ed toxicological data for octyl gallate (E 311) and dodecyl gallat e (E 312). Without those 
data the Author ity cannot complet e the re-evaluation of the safety of octyl gallat e and dodecyl gallate as food 
additives and consequently it cannot be determined whether those substances still fulfil the conditions pursuant 
to Article 6(1) of Regulation (EC) No 1333/2008 for inclusion in the Union list of appro ved food additives. 
(10)  It is theref ore appropr iate to remove octyl gallat e (E 311) and dodecyl gallate (E 312) from the Union list of 
appro ved food additives. 
(11)  Pursuant to Article 10(3) of Regulation (EC) No 1333/2008, the Union list of approved food additives shall be 
amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European 
Parliament and of the Council (2). 
(12)  Article 3(1) of Regulation (EC) No 1331/2008 provi des that the Union list of food additives may be updat ed 
either on the initiative of the Commission or followi ng an application. 
(13)  Theref ore, Annexes II and III to Regulation (EC) No 1333/2008 and the Annex to Regulation (EU) No 231/2012 
should be amended by deleting octyl gallate (E 311) and dodecyl gallat e (E 312) from the Union list of author ised 
food additives since due to the absence of appropr iate toxicological data their inclusion in the list can no long er 
be justif ied. 
(14)  It is appropr iate to provide for a transitional period during whic h foods containing octyl gallat e (E 311) and/or 
dodecyl gallate (E 312) that have been lawfully placed on the mark et before the entr y in force of this Regulation 
may continue to be mark eted. 
(15)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Annex es II and III to Regulation (EC) No 1333/2008 are amended in accordance with the Annex to this Regulation. 
Article 2 
In the Annex to Regulation (EU) No 231/2012, the entr ies for food additives octyl gallate (E 311) and dodecyl gallat e 
(E 312) are delet ed. 
Article 3 
Foods containing octyl gallat e (E 311) and/or dodecyl gallate (E 312) that have been lawfully placed on the mark et 
before the entr y into force of this Regulation may continue to be mark eted until 25 Apr il 2019. 
Article 4 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 5.10.2018 L 251/14 Official Jour nal of the European Union EN     
(1)http://ec.europa.eu/f ood/safety/f ood_impro vement_agents/additives/re-evaluation_en. 
(2)Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common author is­
ation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1). This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 4 October 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  5.10.2018 L 251/15 Official Jour nal of the European Union 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 additives E 311 octyl 
gallate and E 312 dodecyl gallat e are delet ed; 
(b)  in Part C, in Table 5: Other additives that may be regulate d combined, point (k) ‘E 310-320: Gallates, TBHQ and 
BHA ’ is replaced by the following: 
‘(k)  E 310–320: Prop yl gallate, TBHQ and BHA 
E-number Name 
E 310 Prop yl gallat e 
E 319 Tertiary-butyl hydroquinone (TBHQ) 
E 320 Butylated hydro xyanisole (BHA)’  
(c)  Part E is amended as follows:  
1. In categor y 01.5 (Deh ydrate d milk as defined by Directive 2001/114/EC), the entr y concer ning food 
additives E 310-320 (Gallates, TBHQ and BHA) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) only milk powder for vending 
machines’   
2. In categor y 02.1 (Fats and oils essentially free from water (excluding anhydrous milkfat)), the entr y 
concer ning food additives E 310-320 (Gallates, TBHQ and BHA, individually or in combination) is replaced 
by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) (41) only fats and oils for the profes ­
sional manufacture of heat- treat ­
ed foods; frying oil and frying fat 
(excluding olive pomace oil) and 
lard, fish oil, beef, poultr y and 
sheep fat’   
3. In catego ry 02.2.2 (Other fat and oil emulsions including spreads as defined by Council Regulation (EC) 
No 1234/2007 and liquid emulsions), the entr y concer ning food additives E 310-320 (Gallates, TBHQ and 
BHA, individually or in combination) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) (2) only frying fat’   
4. In categor y 04.2.5.4 (Nut butters and nut spreads), the entr y concer ning food additives E 310-320 (Gallates, 
TBHQ and BHA) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) (41) only processed nuts’   
5. In categor y 04.2.6 (Processed potat o products), the entr y concer ning food additives E 310-320 (Gallate s, 
TBHQ and BHA) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 25 (1) only dehydrat ed potatoes’   
6. In catego ry 05.3 (Chewing gum), the entr y concer ning food additives E 310-321 (Gallates, TBHQ, BHA and 
BHT) is replaced by the followi ng:  
‘E 310-321 Prop yl gallat e, TBHQ, BHA and 
BHT 400 (1)’   5.10.2018 L 251/16 Official Jour nal of the European Union EN     7. In cate gory 06.3 (Breakf ast cereals), the entr y concer ning food additives E 310-320 (Gallates , TBHQ and 
BHA) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) (13) only precooked cereals’   
8. In categor y 06.7 (Pre-cooke d or processed cereals), the entr y concer ning food additives E 310-320 (Gallate s, 
TBHQ and BHA) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) only pre-cooked cereals’   
9. In catego ry 07.2 (Fine bake ry wares), the entr y concer ning food additives E 310-320 (Gallate s, TBHQ and 
BHA) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) only cake mixes’   
10. In categor y 08.3.1 (Non-heat–treated meat products), the entr y concer ning food additives E 310-320 
(Gallate s, TBHQ and BHA) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) (13) only dehydrat ed meat’   
11. In categor y 08.3.2 (Heat–treate d meat products), the entr y concer ning food additives E 310-320 (Gallates , 
TBHQ and BHA) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) (13) only dehydrat ed meat’   
12. In categor y 12.2.2 (Seasonings and condiments), the entr y concer ning food additives E 310-321 (Gallate s, 
TBHQ, BHA and BHT) is replaced by the following:  
‘E 310-321 Prop yl gallat e, TBHQ, BHA and 
BHT 200 (1) (13)’    
13. In cate gory 12.5 (Soups and broths), the entr y concer ning food additives E 310-320 (Gallates , TBHQ and 
BHA) is replaced by the followi ng:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) (13) only dehydrat ed soups and 
broths’   
14. In catego ry 12.6 (Sauces), the entr y concer ning food additives E 310-320 (Gallate s, TBHQ and BHA) is 
replaced by the following:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) (13)’    
15. In catego ry 15.1 (Potato-, cereal-, flour - or starch-based snacks), the entr y concer ning food additives E 310- 
320 (Gallates, TBHQ and BHA) is replaced by the follo wing:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) only cereal-based snac k foods’   
16. In categor y 15.2 (Processed nuts), the entr y concer ning food additives E 310-320 (Gallates, TBHQ and BHA) 
is replaced by the following:  
‘E 310-320 Prop yl gallat e, TBHQ and BHA 200 (1) (13)’   5.10.2018 L 251/17 Official Jour nal of the European Union EN     17. In categor y 17.1 (Food supplements supplied in a solid form including capsules and tablets and similar 
forms, excluding chewable forms), the entr y concer ning food additives E 310-321 (Gallates, TBHQ, BHA 
and BHT) is replaced by the followi ng:  
‘E 310-321 Prop yl gallat e, TBHQ, BHA and 
BHT 400 (1)’    
18. In catego ry 17.2 (Food supplements supplied in a liquid form), the entr y concer ning food additives E 310- 
321 (Gallates, TBHQ, BHA and BHT) is replaced by the followi ng:  
‘E 310-321 Prop yl gallat e, TBHQ, BHA and 
BHT 400 (1)’    
19. In catego ry 17.3 (Food supplements supplied in a syrup-type or chewable form), the entr y concer ning food 
additives E 310-321 (Gallates, TBHQ, BHA and BHT) is replaced by the followi ng:  
‘E 310-321 Prop yl gallat e, TBHQ, BHA and 
BHT 400 (1)’    
(2) Annex III to Regulation (EC) No 1333/2008 is amended as follows: 
(a)  in Part 4 (Food additives including carriers in food flavouri ngs), the entr ies concer ning food additives E 310, 
E 311, E 312, E 319 and E 320 are replaced by the follo wing: 
‘E 310 Prop yl gallate Essential oils 1 000 mg/kg (prop yl gallate, TBHQ and 
BHA, individually or in combination) in 
the essential oils E 319 Tertiary-butyl hydroquinone (TBHQ) 
E 320 Butylated hydro xyanisole (BHA) Flavourings other 
than essential oils 100 mg/kg (1) (prop yl gallate) 
200 mg/kg (1) (TBHQ and BHA, individu ­
ally or in combination) in flavouri ngs’  
(b)  in Part 4 (Food additives including carriers in food flavouri ngs), the footnote (1) is replaced by the followi ng: 
‘(1)  Propor tionality rule: when combinations of prop yl gallate, TBHQ, and BHA are used, the individual levels 
must be reduced propor tionally .’  5.10.2018 L 251/18 Official Jour nal of the European Union EN