G/SPS/N/EU/733  
1 March 2024  
(24-1950) 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 and 
Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council 
as regards the food additives tartar ic acid (L(+) -) (E 334), sodium tartrates (E 335), 
potassium tartrates (E 336), sodium potassium tartrate (E 337) and calcium tartrate 
(E 354) (Text with EEA relevance) . Language(s):  English . Number of pages:  16 
https://members.wto.org/crnattachments/2024/SPS/EEC/24_01786_00_e.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_01786_01_e.pdf  
6. Description of content:  The text revises the conditi ons of use of the authorized food 
additives tartaric acid (L(+) -) (E 334), sodium tartrates (E 335), potassium tartrates 
(E 336), sodium potassium tartrate (E 337) and calcium tartrate (E 354). These food 
additives are currently authorized for use at quant um satis  and included in Group I, 
in Annex II, Part C of Regulation (EC) No 1333/2008, which covers food additives, other 
than colours and sweeteners, with an 'acceptable daily intake not specified' or for which 
the most recent risk assessment concluded th at 'there is no need for a numerical 
acceptable daily intake'. In addition, tartaric acid (L(+) -) (E 334), sodium tartrates 
(E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337) and calcium 
tartrate (E  354) are authorized for use in speci fic food categories with a numerical 
maximum level or at quantum satis . 
The European Food Safety Authority (EFSA) re -evaluated these food additives in 2020 and 
established a group acceptable daily intake (ADI) of 240 mg/kg bw per day, expressed as 
tartaric  acid, for tartaric acid -tartrates (E 334 - 337 and E 354). Following the EFSA 
re-evaluation, it is appropriate to remove those food additives from Group I, create a new 
group for them, review their conditions of use and establish numerical maximum use 
levels. 
In order to allow for a smooth transition, the text lays down a transitional period for food 
business operators to adapt to the new more stringent conditions of use.  
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/733  
 
- 2 - 
 
  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, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international stand ard: In the Codex General Standard for Food Additives (GSFA), there 
are provisions for L(+) -Tartaric acid (INS 334), Sodium L(+) -tartrate (INS 335(ii)), 
Potassium sodium L(+) -tartrate (INS 337) but not for potassium tartrate and calcium 
tartrate. Moreover,  there are differences in the authorized conditions of use.  
9. Other relevant documents and language(s) in which these are available:   
− EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings  
https://www.efsa.europa.eu/en/efsajournal/pub/6030  
− Scientific Opinion on the re -evaluation of L(+) -tartaric acid(E 334), sodium tartrates 
(E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium 
tartrate (E 354) as food additives. EFSA Journal 2020; 18(3):6030, 58 pp.  
https://doi.org/10.2903/j.efsa.2020.6030  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : Foreseen for Q2 2024.  
Proposed date of publication (dd/mm/yy) : Foreseen for Q2 2024.  
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 t he 
notification and/or (dd/mm/yy) : 30 April 2024  
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 A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  
13. Text(s) avail able 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 A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu