G/SPS/N/EU/256  
 
26 April 2018  
(18-2635) 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 the Annex to 
Commission Regulation (EU) No 231/2012 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 as regards spe cifications for certain sorbitan esters (E 491 Sorbitan 
monostearate, E 492 Sorbitan tristearate and E 495 Sorbitan monopalmitate) (Text with 
EEA relevance) . Language(s): English.  Number of pages: 5 
https://members.wto.org/crnattachments/2018/SPS/EEC/18_2241_00_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EE C/18_2241_01_e.pdf  
6. Description of content: The text amends the specifications for E 491 Sorbitan 
monostearate, E 492 Sorbitan tristearate and E 495 Sorbitan monopalmitate as a follow -up 
to an application and safety evaluation performed by EFSA. The Annex to Regulation (EU) 
No 231/2012 (specifications for food additives) is amended accordingly.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territ ory 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 r elevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the G/SPS/N/EU/256  
 
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  international standard: The draft removes the congealing range from the specifications 
and introduces another analytical method, gas chro matography, whereas the other 
parameters remain the same.  
9. Other relevant documents and language(s) in which these are available: Scientific  
Opinion on the re -evaluation of sorbitan monostearate (E 491), sorbitan tristearate 
(E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan 
monopalmitate (E 495) when used as food additives. EFSA Journal 2017;15(5):4788, 
56 pp. 
https://www.efsa.europa.eu/ en/efsajournal/pub/4788   
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) : 25 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 Froissar t 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