   
  
G/SPS/N/EU/558  
 
25 April 2022  
(22-3262) 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 the Annex to 
Commission Regulation (EU) No 231/2012 laying down specifications for food additives 
listed in Annexes II and III to Regulat ion (EC) No 1333/2008 of the European Parliament 
and of the Council as regards the presence of ethylene oxide in food additives (Text with 
EEA relevance) . Language(s):  English . Number of pages:  6 
https://members.wto.org/crnattachments/2022/SPS/EEC/22_3022_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_3022_01_e.pdf  
6. Description of content:  The text revises the part of the EU specifications of food 
additives related to ethylene oxide. Currently, Regulation (EU) No 231/2012 provides that 
ethylene oxide may not be used for sterilizing purposes in food additives. However, there 
is no quantified limit for the presence of ethylene oxide regarding all food addi tives. 
Recently, in the European Union, there have been several notifications concerning findings 
of ethylene oxide in particular in a number of food additives used for the manufacture of a 
variety of foodstuffs. However, it is difficult to establish wheth er the presence of ethylene 
oxide results from its use in the sterilization of the food additives in breach of Regulation 
No 231/2012 or from any other reason.  
In order to avoid those difficulties and to ensure a high level of protection of human 
health, i t is therefore appropriate to lay down that the presence of ethylene oxide, 
irrespective of its origin, is not authorized for all food additives. For this purpose, a 
maximum limit for residues of ethylene oxide specific for food additives should be set out  
at the limit of quantification in those products, that is, at the validated lowest residue 
concentration, which can be currently quantified and reported by routine monitoring with 
validated control methods. This corresponds to maximum limit of 0.1 mg/kg o f ethylene 
oxide (sum of ethylene oxide and 2 -chloro -ethanol expressed as ethylene oxide) applicable 
to all authorized food additives.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/pla nt pest or disease, [  ] protect territory from 
other damage from pests.   G/SPS/N/EU/558  
 
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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, 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 standard:  Ethylene oxide is a substance of concern as regards 
carcinogenicity, mutagenicity and toxicity for reproduction. The food additive specifications 
developed by JECFA do not contain any general limit for ethylene oxide. The generally 
applicable limit addressing the presence of ethylene oxide in food additives, irrespective of  
its origin, proposed for the EU specifications is a follow up to the recent findings of 
ethylene oxide in a number of food additives and it intends to ensure a high level of 
protection of human health.  
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : Foreseen for August 2022.  
Proposed date of publication (dd/mm/yy) : Foreseen for August 2022.  
11. Proposed date of entry into force: [  ] Six months from date of publicat ion, 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) : 24 June 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 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  
 