EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10219/2018 CIS Rev. 1 
(POOL/E2/2018/10219/10219R1 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 EUROPEAN CO MMISSION,  
Having regard 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 additives1, 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 
approved 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 us e in food additives, food enzymes, food flavourings, nutrients and their 
conditions of use.  
(3) Commission Regulation (EU) No 231/20122 lays down specifications for food 
additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.  
(4) Octyl gallate (E 311) and dodecyl gallate (E 312)  are substances authorised as 
antioxidants 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 1333/20 08 provides that all food additives that 
were already permitted in the Union before 20 January 2009 are subject to a new risk 
assessment by the European Food Safety Authority (‘the Authority’).  
(6) For that purpose, a program for the re -evaluation of food addi tives is laid down in 
Commission Regulation (EU) No 257/20103. Pursuant to Regulation (EU) 
No 257/2010 the re -evaluation of antioxidants had to be completed by 31 December 
2015.  
(7) On 5 May 2015 the Authority delivered a Scientific Opinion on the re -evaluati on of 
dodecyl gallate (E 31 2) as a food additive4. The opinion stated that there was a lack of 
adequate toxicological data on dodecyl gallate . Consequently the Authority was not 
                                                 
1 OJ L 354, 31.12.2008, p. 16 . 
2 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down s pecifications 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 Journal 2015;13(5):4086 .  
EN 2  EN able to confirm the safety of dodecyl gallate  as a food additive and concl uded  that the 
present group Acceptable Daily Intake (ADI) for propyl gallate (E 310), octyl gallate 
(E 311) and dodecyl gallate (E 312) should no longer be valid . The opinion stated that 
a sufficient toxicological database would be required for an adequate ass essment of the 
safety of dodecyl gallate as a food additive.  
(8) On 1 October 2015 the Authority delivered a Scientific Opinion on the re -evaluation 
of octyl gallate (E 311) as a food additive5. The opinion stated that there was a lack of 
adequate toxicologica l data on octyl gallate . Consequently the Authority was not able 
to confirm the safety of octyl gallate  as a food additive and concluded that the present 
group ADI for propyl gallate (E 310), octyl gallate (E 311) and dodecyl gallate (E 312) 
should no longer be valid . The opinion stated that a sufficient toxicological database 
would be required for an adequate assessment of the safety of octyl gallate as a food 
additive.  
(9) On 30 May 2017  the Commission launched a public call for scientific and 
technologi cal data on propyl gallate (E 310), octyl gallate (E 311) and dodecyl gallate 
(E 312)6, targeting the data needs identified in the Scientific Opinions on the re -
evaluation of those substances as food additives. However, no business operator 
committed to pr oviding the requested toxicological data for octyl gallate (E 311) and 
dodecyl gallate (E 312) . Without those data the Authority cannot complete the re -
evaluation of the safety of octyl gallate and dodecyl gallate as food additive s and 
consequently it cann ot be determined whether th ose substances still fulfil the 
conditions pursuant to Article 6(1) of Regulation (EC) No 1333/2008 for inclusion in 
the Union list of approved food additives.  
(10) It is therefore appropriate to remove octyl gallate (E 311) and dodec yl gallate (E 312) 
from the Union list of approved 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 133 1/2008 of the European Parliament and of the Council7. 
(12) Article 3(1) of Regulation (EC) No 1331/2008 provides that the Union list of food 
additives may be updated either on the initiative of the Commission or following an 
application.  
(13) Therefore, 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 gallate (E 312) from the Union list of authorised food additives since due 
to the absence of appropriate to xicological data their inclusion in the list can no longer 
be justified.  
(14) It is appropriate to provide for a transitional period during which foods containing 
octyl gallate (E 311) and/or dodecyl gallate (E 312) that have been lawfully placed on 
the market before the entry in force of this Regulation may continue to be marketed.  
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
                                                 
5 EFSA Journal 2015;13(10):4248 . 
6 http://ec.europa.eu/food/safety/food_improvement_agents/additives/re -evaluation_en . 
7 Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 
establishing a common authorisation procedure for food additives, food enzy mes and food flavourings 
(OJ L 354, 31.12.2008, p. 1).   
EN 3  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes 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 entries for food additives octyl gallate 
(E 311) and dodecyl gallate (E 312) are delete d. 
Article 3  
Foods containing octyl gallate (E 311) and/or dodecyl gallate (E 312) that have been lawfully 
placed on the market before the entry into force of this Regulation may continue to be 
marketed until 6 months after the entry into force of this Regulation . (OPOCE to insert the 
exact date )  
Article 4  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER