G/SPS/N/EU/666  
21 July 2023  
(23-4994) Page: 1/3 
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 additives nitrites 
(E 249 -250) and nitrates (E 251 -252) (Text with EEA relevance) . Language(s):  English . 
Number of pages:  49 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_11184_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_11184_01_e.pdf  
6. Description of content:  The text revises the conditi ons of use and the EU specifications 
of the authorised food additives potassium nitrite (E 249), sodium nitrite (E 250), sodium 
nitrate (E 251) and potassium nitrate (E 252). Nitrites and nitrates are food additives 
authorised in the European Union used as  a preservative to secure, in conjunction with 
other factors, the microbiological safety of foods. At the same time, the presence of 
nitrites and nitrates in foods can give rise to the formation of nitrosamines some of which 
are carcinogenic. The European Food Safety Authority (EFSA) in its 2017 scientific opinions 
re-evaluating the safety of nitrites and nitrates as food additives concluded that their 
respective Acceptable Daily Intake values (ADIs) were not exceeded from food additive 
uses; however the AD Is would be exceeded if all sources of dietary exposure were to be 
considered together. In addition, EFSA considered that there was some concern for the 
overall exposure to nitrosamines present in food, which was also confirmed by the recent 
scientific opi nion on the risks to public health related to the presence of nitrosamines in 
food (2023).  
Following the EFSA re -evaluation of nitrites and nitrates as food additives, it is appropriate 
to reduce the maximum amounts of nitrites and nitrates that may be add ed to foods to 
keep the level of nitrosamines potentially formed due to that use as low as possible, while 
ensuring microbiological safety. It is also appropriate to amend the specifications and 
lower the existing maximum permitted limits for lead, mercury  and arsenic in nitrites and 
nitrates additives.  
In order to allow for a smooth transition, the text lays down transitional periods for food 
business operators to adapt to the new more stringent conditions of use and specifications.  G/SPS/N/EU/666  
 
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  7. Objective and ratio nale: [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?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  The food additive specifications of potassium nitrite (E 249), 
sodium nitrite (E 250), sodium nitrate (E 251) and potassium nitrate (E 252) developed by 
JECFA do not contain maximum limits for arsenic and mercury. The maxim um limit for lead 
in the specifications developed by JECFA is higher (2 mg/kg) than in the revised 
EU specifications.  
In the Codex General Standard for Food Additives (GSFA, CODEX STAN 192 -1995), there 
are provisions for nitrites (INS 249, 250) and nitrite s (INS 251, 252) however limited to 
certain standardised products only resulting from the alignment between the GSFA and 
Codex Commodity standards. The Codex work on the food additive provisions for nitrites 
and nitrates has not been completed and has been  postponed until consensus is reached 
on a reporting basis for the nitrate residual provisions pending the advise of CCMAS 
(Codex Committee on Methods of Analysis and Sampling), see REP21/FA, paras 139 -141. 
9. Other relevant documents and language(s) in which these are available:   
− EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Alicja 
Mortensen, Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit 
Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott,  Ursula Gundert -Remy, 
Claude Lambré, Jean -Charles Leblanc, Oliver Lindtner, Peter Moldeus, Pasquale 
Mosesso, Agneta Oskarsson, Dominique Parent -Massin, Ivan Stankovic, Ine Waalkens -
Berendsen, Rudolf Antonius Woutersen, Matthew Wright, Piet van den Brandt, Cristina 
Fortes, Leonardo Merino, Fidel Toldrà, Davide Arcella, Anna Christodoulidou, José 
Cortinas Abrahantes, Federica Barrucci, Ana Garcia, Fabiola Pizzo, Dario Battacchi, 
Maged Younes, 2017. Scientific Opinion on the re -evaluation of potassium nitrite 
(E 249) and sodium nitrite (E 250) as food additives. EFSA Journal 2017;15(6):4786, 
157 pp. 
https://www.efsa.europa.eu/en/efsajournal/pub/4786  
− EFSA Panel o n Food Additives and Nutrient Sources added to Food (ANS), Alicja 
Mortensen, Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit 
Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert -Remy, 
Claude Lambré, Jean -Charles Lebla nc, Oliver Lindtner, Peter Moldeus, Pasquale 
Mosesso, Agneta Oskarsson, Dominique Parent -Massin, Ivan Stankovic, Ine Waalkens -
Berendsen, Rudolf Antonius Woutersen, Matthew Wright, Piet van den Brandt, Cristina 
Fortes, Leonardo Merino, Fidel Toldrà, Davide Arcella, Anna Christodoulidou, Federica 
Barrucci, Ana Garcia, Fabiola Pizzo, Dario Battacchi, Maged Younes, 2017. Scientific 
Opinion on the re -evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) 
as food additives. EFSA Journal 2017;15(6):478 7, 123 pp.  
https://www.efsa.europa.eu/en/efsajournal/pub/4787  
− EFSA Panel on Contaminants in the Food Chain (EFSA CONTAM Panel), Dieter Schrenk, 
Margherita Bignami, Laurent Bodin, James Kevin Chipman, Jesús del Mazo, Christer 
Hogstrand, Laurentius (Ron) Hoogenboom, Jean -Charles Leblanc, Carlo Stefano 
Nebbia, Elsa Niel sen, Evangelia Ntzani, Annette Petersen, Salomon Sand, Tanja G/SPS/N/EU/666  
 
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  Schwerdtle, Christiane Vleminckx, Heather Wallace, Benigni Romualdo, Cristina Fortes, 
Stephen Hecht, Marco Iammarino, Olaf Mosbach -Schulz, Francesca Riolo, Anna 
Christodoulidou, Bettina Grasl -Kraupp, 2023. Scientific Opinion on the risk assessment 
of N-nitrosamines in food. EFSA Journal 2023;21(3):7884, 278 pp.  
https://www.efsa.europa.eu/en/efsajournal/pub/7884  
(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 6, 24, 36 and 48 months).  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation  of the 
notification and/or (dd/mm/yy) : 19 September 2023  
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) 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 A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu