G/SPS/N/EU/632  
24 April 2023  
(23-2914) 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 Regulation (EU) 
No 231/2012 as regards specifications for mono - and diglycerides of fatty acids (E 471) 
(Text with EEA relevance) . Langua ge(s):  English . Number of pages:  6 + 4  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_9231_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_9231_01_e.pdf  
6. Description of content:  The text revises the EU specifications of the authorised food 
additives mono - and diglycerides of fatty acids (E 471) based on the recent scientific 
opinion from the European Food Safety Authority (EFSA). The current specifications are 
adapted by reducing the maximum limits for toxic elements, by including maximum limi ts 
for the sum of 3 -monochloropropanediol (3 -MCPD) and 3 -MCPD fatty acid esters 
(expressed as 3 -MCPD), glycidyl fatty acid esters (expressed as glycidol) and erucic acid 
and by modifying the definition of mono - and diglycerides of fatty acids (E 471).  
In order to allow for a smooth transition, the text lays down that the use of the food 
additives mono - and diglycerides of fatty acids (E 471), lawfully placed on the market 
before the date of the entry into force of this Regulation is allowed during a transit ional 
period of six months. Foods containing such food additives may continue to be placed on 
the market during the same transitional period and may remain on the market until their 
date of minimum durability or 'use -by-date'. However, in light of the vuln erability of 
infants and young children, the food additive mono - and diglycerides of fatty acids (E 471) 
not complying with the maximum level for glycidyl fatty acid ester set out in this 
Regulation for use in foods for infants and young children should no t allowed to be added 
to such foods after the date of entry into force of this Regulation and the marketing of 
those foods should be allowed only if they were lawfully placed on the market already 
before that date.  
The food additive mono - and diglycerides of fatty acids (E 471) legally placed on the 
market after the date of entry into force of this Regulation and complying with the reduced 
intermediate maximum level for glycidyl fatty acid esters (expressed as glycidol) is allowed 
to be used until the exhau stion of stocks and foods, except food for infants and young 
children, containing such food additive should be allowed to be placed on the market and 
to remain on the market until their date of minimum durability or 'use -by-date'.  G/SPS/N/EU/632  
 
- 2 - 
 
  7. Objective and rationa le: [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, 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:  The food additive specifications of mono - and diglycerides of 
fatty acids (INS 471) defined by JECFA (Monograph 1, 2006) do not contain maximum 
levels for arsenic, mercury, cadmium, the sum of 3 -monochloropropanediol (3 -MCPD) and 
3-MCPD fatty acid esters (expressed as 3 -MCPD), glycidyl fatty acid esters (expressed as 
glycidol) and erucic acid.  
9. Other relevant documents and language(s) in which these are available:  
Scientific  opinion on the re -evaluation of mono - and digly cerides of fatty acids (E471) as 
food additive in foods for infants below 16 weeks of age and follow -up of their 
re-evaluation as food additives for uses in foods for all population groups. 
EFSAJournal2021;19(11):6885,44pp.  
https://doi.org/10.2903/j.efsa.2021.6885  (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 a six -month period) . 
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 23 June 2023  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax nu mber 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@e c.europa.eu  G/SPS/N/EU/632  
 
- 3 - 
 
  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