EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10068/2022 
(POOL/E2/2022/10068/10068 -EN.docx)                     
D080872/03  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council as regards the use of ascorbic acid (E 300), sodium ascorbate (E301) and 
calcium ascorbate (E302) in tuna  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council as regards the use of ascorbic acid (E 300), sodium ascorbate (E301) and 
calcium ascorbate (E302) in tuna  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the 
Council of 16 December 2008 on food additives1, and in particular Article 10(3)  thereof,  
Whereas:  
(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives 
approved for use in food and  their conditions of use.  
(2) That list may be updated in accordance with the common procedure referred to in 
Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the 
Council2, either on the initiative of the Commission or following an application.  
(3) Pursuant to Annex II to Regulation (EC) No 1333/2008, ascorbic acid (E 300 ), sodium 
ascorbate  (E 301 ) and calcium ascorbate ( E 302) (‘the food additives’) are currently 
authorised as food additives in, among other categories, category   09.1.1 ‘unprocessed 
fish’ and category   09.2 ‘Processed fish and fishery products including molluscs and 
crustaceans’ , at quantum satis . The Scientific Committee on Food considered their use 
as antioxidants acceptable. The  European Food Safety Authority (‘the Authority ’) in 
its scientific opinion re -evaluating the safety of the food additives3 confirmed that 
there is no safety concern for their use as food additives at the reported uses and use 
levels  and that there is no need for a numerical acceptable daily intake. Such a 
conclusion means that the substance is of a very low safety concern, there is reliable 
information for exposure and toxicity and there is a low probability of adverse health 
effects in humans at doses that do not induce nutritional imbalance  in animals . 
Currently, no maximum numerical level is laid down for those food additives and they 
are to be used in accordance with good manufacturing practice, at a level not higher 
than what is necessary to achieve the intended purpose and provided the c onsumer is 
not misled .   
(4) In unprocessed fish, antioxidants  are used to slow down discoloration of fish flesh and 
rancidity  development . In unprocessed tuna , consumers link freshness to the naturally 
red colour  of fresh tuna flesh . 
                                                 
1 OJ L 354, 31.12.2008 , p. 16.  
2 Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 
establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 
354, 31.12.2008, p. 1 ). 
3 EFSA Journal 2015;13(5):4087, 124 pp.   
EN 2  EN (5) Thawed tuna loins  markete d as ‘fresh ’ tuna are to be obtained  from tuna frozen below 
– 18°C after fishing (‘fresh tuna’),  whereas other thawed tuna loins  is to be used only 
for canning  (‘tuna for canning’),  in accordance with  Regulation (EC) No 853/2004  of 
the European Parliament and of the Council4. The use of the food additives in tuna for 
canning in high amounts to  artificially  restore  the colour of fresh tuna flesh gives an 
opportunity to deceptively market that tuna for canning as fresh tuna,  selling it at a 
higher price,  misleading the consumers about the product and exposing them to the 
risk of histamine poisoning . 
(6) Such use of the food additives, however,  does not comply with the general conditions 
for inclusion and use of food additives in the Union lists  and with the quantu m satis  
principle.  
(7) Following food fraud  investigations under Regulation (EC) No 2017 /625 of the 
European Parliament and of the Council5, competent authorities regularly report cases 
where tuna loins sold as fresh are found to contain the food additives in amounts 
higher than those considered by those competent authorities as necessary to achieve 
the typical antioxidant effect on fresh tuna . On the basis of this, the competent  
authorities suspect  that the food additives are being used on tuna for canning  to restore  
their colour and place  them on the market as fresh.  
(8) As it is for the national competent authorities to establish that the quantum satis  
principle has not been complied with and this may be difficult, the Member States, and 
in particula r Spain, have  requested the Commission to lay down an appropriate 
maximum level for the use of the food  additives as antioxidants in thawed tuna sold as 
fresh tuna (unprocessed) or marinated  tuna (processed).  
(9) In the interest of legal c ertain ty, and to ensu re a high level of consumer protection and 
fair practices in food trade , it is therefore appropriate to set a maximum level of use in 
tuna of the additives in food categories 0 9.1.1 and 09.2 in Part E of Annex II to 
Regulation (EC) No 1333/2008 . 
(10) The maximum level should allow to maintain the current levels of legitimate use 
following good manufacturing practices . On the basis of the information provided by 
the industry to the Authority in view of the re-evaluati on of the safety of the food 
additives , a maximum level of 300 mg/kg is considered appropriate. This level is the 
highest use level  reported by the industry, as lis ted in the Authority’s  scientific 
opinion .   
(11) The Commission has been made aware of studies carried out by the fish industry and 
the opinion of one competent authority  which conclude d that the use of  900 mg/kg of 
the food additives  is necessary  to control oxidation in tuna loins  maintained  below 4°C 
for ten days. However, in light of the information available, and in particular of the 
fact that official controls carried out by some other competent authorities showed that 
                                                 
4 Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying 
down specific hygiene rules for food of animal origin  (OJ L 139, 30.4.2004, p. 55 ). 
5 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on animal 
health and wel fare, plant health and plant protection products, amending Regulations (EC) No 999/2001, 
(EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 
2016/429 and (EU) 2016/2031 of the European Parliament and of the Cou ncil, Council Regulations (EC) No 
1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC 
and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European 
Parliament and of the Counc il, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 
96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC  (OJ L 95, 7.4.2017, p. 1 ).  
EN 3  EN a shelf -life of ten days may be  achieved for thawed tuna  with a treatment at 300 mg/kg  
without it changi ng the initial colour , the level of 300 mg/kg appears to be  sufficient to 
achieve the desired antioxidant  effect.  
(12) Setting a maximum level for the use of ascorbic acid (E 300), sodium ascorbate (E 
301) and calcium ascorbate (E302) as antioxidants in tuna i s not liable to have an 
effect on human health. Therefore, under Article 3(2), second subparagraph, of 
Regulation (EC) No 1331/2008, it is not necessary to seek the opinion of the 
Authority.  
(13) Annex II to Regulation (EC) No 1333/2008 should therefore be ame nded accordingly.  
(14) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this 
Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and direct ly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN