G/SPS/N/EU/497  
 
26 July 2021  
(21-5803) 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:  Commission Regulation (EU) 2021/1156 of 13 July 2021 
amending Annex II t o 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 steviol 
glycosides (E 960) and rebaudioside M produced via enzyme modification of steviol 
glycosides from Stevia  (Text with EEA relevance) . Language(s):  English, French and 
Spanish . Number of pages:  14 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4825_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4825_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4825_00_s.pdf  
6. Description of content:  The text aims at updating the current authorisation of the food 
additive steviol glycosides (E 960) and to authorise rebaudioside M produced via enzyme 
modification of steviol glycosides from Stevia in the European Union. The Annex to 
Regulation No 231/2012 (specifications for food additives) is amended accordingly, in  line 
with the conclusion of the evaluation of the safety of this food additive by the European 
Food Safety Authority (EFSA), which concluded that the new additive does not raise safety 
concern at the same proposed uses and use levels as steviol glycosides  (E 960). In the 
interest of clarity and coherence, the currently authorised food additive 'steviol glycosides 
(E 960)' is renamed as 'Steviol glycosides from Stevia (E 960a)'and 'rebaudioside  M 
produced via enzyme modification of steviol glycosides from S tevia' is assigned E 960c(i) 
as an E -number. As those food additives may be regulated combined, a new group for 
steviol glycosides, including both of them, is inserted in Part C of Annex II to Regulation 
(EC) No 1333/2008, and all entries for steviol glyco sides (E 960) in Part E of Annex II to 
that Regulation are replaced accordingly, while maintaining the currently applicable uses 
and maximum level for authorised uses and use levels.  
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.   G/SPS/N/EU/497  
 
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  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?  
[X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from th e 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
The Safety of the amendment of the specifications for steviol glycosides (E 960) as a food 
additive related to rebaudioside M produced via enzyme ‐catalysed bioconversion of purified 
stevia leaf extract (European Food Safety Authority, EFSA Journal 2019;17(10):5867, 
https://www.efsa.europa.eu/en/efsajournal/pub/5867  (avail able in English)  
10. Proposed date of adoption (dd/mm/yy) : 13 July 2021  
Proposed date of publication (dd/mm/yy) : 14 July 2021  
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 18 -month period).  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
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