G/SPS/N/EU/254  
 
19 April 2018  
(18-2464) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member: EUROPEAN UNION  
If applicable, name of local government involved:  
2. Agency responsible: European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable): Food products  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Draft Commission Regulation 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) . Language(s): English.  Number 
of pages: 12 
https://members.wto.org/crnattachments/2018/SPS/EEC/18_2137_00_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_2137_01_e.pdf  
6. Description of content: The text removes octyl gallate  (E 311) and dodecyl gallate 
(E 312) from the Union list of authorised food additives in Regulation (EC) No 1333/2008, 
since due to the absence of appropriate toxicological data it is not possible to assess the 
risk posed by the use of these substances as a food additive to human health. Therefore, 
the inclusion  of these substances in the Union list of authorised food additives can no 
longer be justified. Annexes II and III to Regulation (EC) No 1333/2008 (authorised uses 
and use levels for food additives) and the Annex to Regulation (EU) No 231/2012 
(specificati ons for food additives) are amended accordingly.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.  
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Codex General Stan dard For Food Additives – 
Codex  Stan 192 -1995 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  G/SPS/N/EU/254  
 
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  [X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:  
9. Other relevant documents and language(s) in which these are available:  
 Scientific Opinion on the re -evaluation of octyl gallate  (E 311) as a food additive 
(European Food Safety Authority, EFSA Journal 2015;13(10):4248  
https://www.efsa.europa.eu/en/efsajournal/pub/4248  
 Scientific Opinion on the re -evalua tion of dodecyl gallate (E 312) as a food additive 
(European Food Safety Authority, EFSA Journal 2015;13(5):4086  
https://www.efsa.europa.eu/en/efsajournal/pub/4086   
10. Proposed date of adoption (dd/mm/yy) : August 2018  
Proposed date of publication (dd/mm/yy) : August 2018  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days after publication in the Official Journal of the European Union.  
[ ] Trade facilitating measure  
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 18 June 2018  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:  
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu