G/SPS/N/EU/629  
24 March 2023  
(24-2134) 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 as regards 
the use of polyglycerol polyricinoleate  (E 476) and the Annex to Commission Regulation 
(EU) No 231/2012 as regards specifications for glycerol (E 422), polyglycerol esters of 
fatty acids (E 475) and polyglycerol polyricinoleate (E 476) (Text with EEA relevance) . 
Language(s):  English . Number of pages:  16 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_8435_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_8435_01_e.pdf  
6. Description of content:  The text revises the EU specifications of the authorised food 
additives glycerol (E 422), polyglycerol esters of fatty acids (E 475) and, polyglycerol 
polyricinoleate (E 476) and authorises an extension of use of polyglycerol polyricinoleate 
(E 476) based on the recent scientific opinions from the European Food Safety Authority 
(EFS). For glycerol (E 422), the current specifications are adapted by reducing the 
maximum limits for toxic elements (arsenic, lead, mercury and cadmium), by deleting the 
identification method based on acrolein formation during heating, by delet ing the test for 
the presence of acrolein, by including a maximum limit for acrolein and by modifying the 
definition of glycerol (E 422). For polyglycerol esters of fatty acids (E 475), the current 
specifications are adapted by reducing the maximum limits for toxic elements, by including 
maximum limits 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 polygl ycerol esters of fatty acids (E 475). For 
polyglycerol polyricinoleate (E 476), the current specifications are adapted by reducing the 
maximum limits for toxic elements, by including maximum limits for the sum of 
3-monochloropropanediol (3 -MCPD) and 3 -MCPD  fatty acid esters (expressed as 3 -MCPD) 
and glycidyl fatty acid esters (expressed as glycidol) and by modifying the definition of 
polyglycerol polyricinoleate (E 476).  
The text also authorises the use of polyglycerol polyricinolate (E 476) in food categor y 03 
'Edible ices' at a maximum level of 4 ,000 mg/kg and in food category 12.6 'Sauces' at an 
increased maximum level of 8 ,000 mg/kg for emulsified sauces with a fat content of 20% 
or more.  G/SPS/N/EU/629  
 
- 2 - 
 
  In order to allow for a smooth transition, the text lays down that  the use of the food 
additives glycerol (E 422), polyglycerol esters of fatty acids (E 475) and polyglycerol 
polyricinolate (E 476) lawfully placed on the market before the date of the entry into force 
of this Regulation is allowed during a transitional pe riod 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'. The food additive polyglycerol esters  of fatty acids (E 475) 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 exha ustion of stocks and foods 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'.  
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 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 glycerol (E 422) developed by 
JECFA do not contain maximum levels for arsenic, mercury, cadmium and acrolein.  
For polyglycerol esters of fatty acids (E 475), the food additive specificati ons by JECFA 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.  
For polyglycerol p olyricinoleate (E 476), the food additive specifications by JECFA 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) 
and glycidyl fatty acid esters (ex pressed as glycidol).  
In the Codex General Standard for Food Additives (GSFA), Polyglycerol polyricinolate 
(E 476) is currently authorised authorised in food category 3 'Edible ices, including sherbet 
and sorbet' at a maximum level of 5000 mg/kg and in foo d categories 12.6.1. 'Emulsified 
sauces and dips (e.g. mayonnaise, salad dressing, onion dip)' and 12.6.3. 'Mixes for 
sauces and gravies' at a maximum level of 5000 mg/kg.  
9. Other relevant documents and language(s) in which these are available:   
− EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), Younes M, Aquilina G, 
Castle L, Engel K, Fowler P, Frutos Fernandez MJ, Gundert -Remy U, Gürtler R, Husøy 
T, Manco M, Mennes W, Moldeus P, Passamonti S, Shah R, Waalkens -Berendsen I, 
Wölfle D, W right M, Cheyns K, Mirat M, Rincon AM and Fürst P, 2022. Scientific Opinion 
on the follow -up of the reevaluation of glycerol (E 422) as a food additive. 
EFSA Journal 2022;20(6):7353, 18 pp.  
https://d oi.org/10.2903/j.efsa.2022.7353  
https://www.efsa.europa.eu/en/efsajournal/pub/7353  
− EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), Younes M, Aquilina G, 
Castle L, Engel K, Fowler P, Frutos Fernandez MJ, Gundert -Remy U, Gürtler R, Husøy G/SPS/N/EU/629  
 
- 3 - 
 
  T, Manco M, Mennes W, Moldeus P, Passamonti S, Shah R, Waalkens -Berendsen I, 
Wölfle D, W right M, Cheyns K, Mirat M, Rincon AM and Fürst P, 2022. Scientific Opinion 
on the follow -up of the reevaluation of polyglycerol esters of fatty acids (E 475) as a 
food additive. EFSA Journal 2022;20 (5):7308, 21 pp.  
https://doi.org/10.2903/j.efsa.2022.7308  
https://www.efsa.europa.eu/en/efsajournal/pub/7308  
− EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), Younes M, Aquili na G, 
Castle L, Engel K, Fowler P, Frutos Fernandez MJ, Gundert -Remy U, Gürtler R, Husøy 
T, Manco M, Mennes W, Moldeus P, Passamonti S, Shah R, Waalkens -Berendsen I, 
Wölfle D, Wright M, Cheyns K, Mirat M, Rincon AM, Tard A and Fürst P, 2022. Scientific 
Opinion on the follow -up of the reevaluation of polyglycerol polyricinoleate (E 476) as 
a food additive. EFSA Journal 2022;20(5):7294, 30 pp.  
https://doi.org/10.2903/j.efsa.2022.7294  
https://www.efsa.europa.eu/en/efsajournal/pub/7294  
(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 pr ovisions 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 May 2023  
Agency or authority designated to handle comments: [X]  National N otification 
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  
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 o ther body:   
European Commission  
DG Health and Food Safety, Unit A4 -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