G/SPS/N/EU/645  
22 June 2023  
(23-4289) 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 Annex II 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 the food additive stearyl 
tartrate (E  483) (Text with EEA relevance) . Language(s):  English . Number of pages:  6 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10482_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10482_01_e.pdf  
6. Description of content:  The text removes the authorisation to use stearyl tartrate 
(E 483) in foods based on the recent scientific opinion from the European Food Safety 
Authority (EFSA) concluding that the safety of stearyl tartrate (E  483) could not be 
assessed.  
In order to allow for a smooth transition, the text lays down that foods that contain stearyl 
tartrate (E  483) used in accordance with the rules applicable before the date of application 
of the Regulation may continue to be marketed until their date of minimum durability or 
'use-by date'.  
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 Standard for Food Additives – 
Codex  Stan 192 -1995 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, c hapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  G/SPS/N/EU/645  
 
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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:  
EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), Younes M, Aquilina G, 
Castle L, Engel K -H, Fowler P, Frutos Fernandez MJ, Fürst P, Gürtler R, Gundert -Remy U, 
Husøy T, Mennes W, Shah R, Waalkens -Berendsen DH, Wölfle D, Boon P, Tobback P, 
Wright M, Rin con AM, Tard A and Moldeus P, 2020. Re -evaluation of stearyl tartrate 
(E 483) as a food additive. EFSA Journal 2020;18(3):6033, 18 pp  
https://doi.org/10.2903/j.efsa.2020.6033  
https://www.efsa.europa.eu/en/efsajournal/pub/6033  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : Foreseen for Q3 2023.  
Proposed date of publication (dd/mm/yy) : Foreseen for Q3 2023.  
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 (with 
transitional provisions for a six -month period).  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 21 August 2023  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Add ress, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
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 Foo d Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu