G/SPS/N/EU/568  
 
23 May 2022  
(22-3951) 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 to 
Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards 
the use of ascorbic acid (E  300), sod ium ascorbate (E  301) and calcium ascorbate (E  302) 
in tuna (Text with EEA relevance) . Language(s):  English . Number of pages:  6 
https://members.wto.org/crnattachments/2022/SPS/EEC/22_3611_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_3611_01_e.pdf  
6. Description of content:  The proposal sets, in the interest of legal certainty, a maximum  
level for the use of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate 
(E302) which applies only for tuna in food categories 09.1.1 "Unprocessed fish" and 
09.2 "Processed fish and fishery products including molluscs and crustaceans" in  Part E of 
Annex II to Regulation (EC) No 1333/2008. The use of those food additives in tuna 
intended for canning in high amounts to artificially restore the colour of fresh tuna flesh 
does not comply with the general conditions for inclusion and use of fo od additives in the 
Union list and with the quantum satis  principle. On the basis of the information provided 
by the industry to the European Food Safety Authority in view of the re -evaluation of the 
safety of the food additives and official controls carri ed out by some competent authorities, 
a maximum level of 300 mg/kg is considered appropriate. The maximum level allows to 
maintain the current levels of legitimate use following good manufacturing practices.  
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 Commissio n (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) :  G/SPS/N/EU/568  
 
- 2 - 
 
  [ ] 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 standard:  The measure sets a maximum level considered as appropriate to 
achieve the typical antioxidant effect on fresh tuna for three food additives of a very low 
safety concern. Currently, those food additives are to be used in accordance w ith good 
manufacturing practice, at a level not higher than what is necessary to achieve the 
intended purpose and provided the consumer is not misled.  
9. Other relevant documents and language(s) in which these are available:  
Scientific  opinion re-evaluating the safety of ascorbic acid (E 300), sodium ascorbate 
(E 301) and calcium ascorbate (E 302) (European Food Safety Authority, EFSA Journal 
2015;13(5):4087 ), https://www.efsa.eu ropa.eu/en/efsajournal/pub/4087  (available in 
English)  
10. Proposed date of adoption (dd/mm/yy) : Foreseen for September 2022  
Proposed date of publication (dd/mm/yy) : Foreseen for September 2022  
11. Proposed date of entry into force: [  ] Six months from d ate 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) : 22 July 2022  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
avail able) 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 Foo d 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