EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2172 
(POOL/E2/2022/2172/2172 -EN.docx) 
D088018/03  
[…](2023) 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 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)    
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 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)  
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) and Article 
14 thereof,  
Having regard to Regulation  (EC) No 1331/2008 of the European Parliament and of the 
Council of 16 December 2008 es tablishing a common authorisation procedure for food 
additives, food en zymes and food flavourings2, and in particular Article 7(5) thereof,  
Whereas:  
(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives 
approved for use in foods  and their conditions of use.  
(2) Commission Regulation (EU) No 231/20123 lays down specifications for food 
additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.  
(3) The Union lists of food additives and the specifications may be updated  in accordance 
with the common procedure referred to in Article 3(1) of Regulation (EC) No 
1331/2008 , either on the initiative of the Commission or following an application.  
(4) Glycerol (E 422), polyglycerol esters of fatty acids (E 475) and polyglycerol 
polyricinoleate (E 476) are substances authorised in accordance with Annex es II and 
III to Regulation (EC) No 1333/2008.  
(5) On 15 March 2017, the Authority issued a scientific opinion on the re -evaluation of 
glycerol (E 422) as a food additive4, which concluded that there was no need for a 
numerical acceptable daily intake and that the food additive was of no safety concern 
for the reported uses. The Authority recommended some modifications to the 
specifications for E 422 set out in Regulation (EU) No  231/2012 an d that more 
information on the uses and use levels is made available to the Authority.  
                                                 
1 OJ L 354, 31.12.2008, p. 16.  
2 OJ L 354, 31.12.2008, p. 1. 
3 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food 
additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and 
of the Council (OJ L 83, 22.3.2012, p. 1).  
4 EFSA Journal 2017;15( 3):4720.   
EN 2  EN (6) On 23 November 2018 , the Commission launched a public call for technical data on 
the food additive glycerol (E 422), targeting the data needs identified  by the Authori ty. 
(7) Following the data submission  by interested business operators , the Commission 
requested the Authority to provide a scientific opinion to confirm that the technical 
data provided by interested business operators adequately support ed an amendment to 
the specifications for the food additive glycerol (E 422) to bring them in line with 
current standards, as recommended by the Authority.  
(8) In its scientific opinion adopted on 18 May 20225, the Authority concluded that the 
current specifications for glycerol (E 422) were to be adapted in particular 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 
deleting the test for the presence of acrolein, by including a maximum limit for 
acrolein  and by modifying the definition of glycerol (E 422).  
(9) It is therefore appropriate to amend the specifications for glycerol (E 422).  The 
definition of the food additive should be amended to restrict it to the manufacturing 
processes for which data were assessed by the Authority.  The current maximum limits 
for toxic elements  should be reduced in accordance with the scientific opinion of the 
Authority, taking into  account the  currently  achievable levels by the application of 
good manufacturing practices. The identification method for glycerol based on 
acrolein formation during heating should be deleted considering that the content of 
glycerol in  E 422 is to be determined by an appropriate analytical method. The test for 
the presence of acrolein should be deleted and a maximum numerical limit for acrolein  
should be included in accordance with the scientific opinion of the Authority and 
taking into  account the level which is currently achievable by the application of good 
manufacturing practices.  
(10) Considering  that the Authority did not identify an immediate health concern linked to 
the presence of toxic elements  and acrolein , it is appropriate to all ow during a 
transitional period the use of the food additive  glycerol (E 422)  lawfully placed on the 
market before  the date of  the entry into force of this Regulation.  
(11) For the same reasons, it is appropriate that foods containing the food additive glycerol  
(E 422)  that has been lawfully placed on the market before  the date of entry into force 
of this Regulation  may continue  to be placed on the market during a transitional period 
and to remain on the market  until their date of minimum durability or ‘use-by-date’. 
(12) On 20 December 2017, the Authority issued a scientific opinion on the re-evaluation  
of polyglycerol esters of fatty acids (E 475) as a food additive6, which concluded that 
there was no need for a numerical acceptable daily intake and that the food additive 
was of no safety concern at the reported uses and use levels. The Authority 
recommended some modifications to the specifications for E 475 set out in Regulation 
(EU) No 231/2012.  
(13) On 23 November 2018 , the Commission launched a public  call for technical data on 
the food additive polyglycerol esters of fatty acids (E 475), targeting the data needs 
identified  by the Authority . 
                                                 
5 EFSA Journal 202 2;20(6):7353.  
6 EFSA Journal 2017;15(12):5089 .  
EN 3  EN (14) Following the data submission by interested business operators, the Commission 
requested the Authority to provid e a scientific opinion to confirm that the technical 
data provided by interested business operators adequately support ed an amendment to 
the specifications for the food additive polyglycerol esters of fatty acids (E 475) to 
bring them in line with current standards, as recommended by the Authority.  
(15) In its scientific opinion adopted on 1 April 20227, the Authority concluded that the 
current specifications for polyglycerol esters of fatty acids (E 475) were to be adapted 
in particular by reducing the maximum limits  for toxic elements , by including 
maximum limits for impurities and constituents of safety  concern  and by modifying 
the definition of polyglycerol esters of fatty acids (E 475).  
(16) It is therefore appropriate to amend the specifications for polyglycerol esters of fatty 
acids (E 475). The definition of the food additive should be amended in order to 
restrict the use of glycerol for the production of the food additive to glycerol compl iant 
with the specifications for the food additive (E 422). The current maximum limits for 
toxic elements  should be reduced and maximum limits for the sum of 3 -
monochloropropanediol (3 -MCPD) and 3 -MCPD fatty acid esters (expressed as 3 -
MCPD), glycidyl fatt y acid esters (expressed as glycidol) and erucic acid should be 
established in accordance with the scientific opinion of the Authority and taking into 
account the level which is  currently achievable by the application of good 
manufacturing practices.  
(17) As ne w manufacturing techniques resulting in the production of the food additive 
polyglycerol esters of fatty acids (E 475) with lower levels of glycidyl fatty acid esters 
(expressed as glycidol) are being implemented, it is appropriate to provide the 
manufactu rers of food additives with a transitional period to reach a maximum level of 
5 mg/kg for glycidyl fatty acid esters (expressed as glycidol ) in the food additive (E  
475). However, given that glycidyl fatty acid esters are genotoxic and carcinogenic, an 
intermediate maximum level of 10 mg/kg for glycidyl fatty acid esters (expressed as 
glycidol ) should apply from the date of entry into force of this Regulation.  
(18) Considering  that the Authority did not identify an immediate health concern linked to 
the presenc e of toxic elements , 3-monochloropropanediol (3 -MCPD), 3 -MCPD fatty 
acid esters , erucic acid  and glycidyl fatty acid esters , it is appropriate to allow  during a 
transitional period  the use of the food additive  polyglycerol esters of fatty acids (E 
475) lawfully placed on the market before the date of entry into force of this 
Regulation  and to allow foods containing such food additive, to continue to be placed 
on the market for the same transitional period and to remain on the market until their 
date of minimum durability or ‘use -by-date’.  
(19) For the same reasons  and considering its reduced content of glycidyl fatty acid esters , 
the food additive polyglycerol esters of fatty acids (E 475) legally placed on the 
market after the date of entry into force of thi s Regulation and complying with the 
reduced intermediate maximum level for glycidyl fatty acid esters  (expressed as 
glycidol)  should be allowed to be used  until the exhaustion 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 EFSA Journal 202 2;20(5):7308.   
EN 4  EN (20) On 24 March 2017, the Authority issued a scientific opinion on the re-evaluation  of 
polyglycerol polyricinoleate (E 476) as a food additive8. The Authority concluded that 
the data set gave reason to increase the acceptable daily intake to 25 mg/kg bw per 
day. The Authority recommended some modifications to the specifications for E  476 
set out  in Regulation (EU) No 231/2012.  
(21) On 23 November 201 8, the Commission launched a public call for technical data on 
the food additive polyglycerol polyricinoleate (E 476 ), targeting the data needs 
identified  by the Authority . 
(22) On 18 March 2020, an application was submitted for the authorisation of the use of 
polyglycerol polyricinoleate (E 476) as an emulsifier in edible ices for fat and oil 
emulsion of water -in-oil type and emulsified sauces with a fat content of more than 20 
%. The application was subsequently made available to the Member States by the 
Commi ssion pursuant to Article 4 of Regulation (EC) No 1331/2008.  
(23) Polyglycerol polyricinoleate (E 476) is capable of producing  stable water -in-oil 
emulsions with smaller droplet sizes that can be frozen to produce soft, creamy, edible 
ices requiring less energy in the manufacturing process and having enhanced stability 
in the frozen supply chain. It allows the use of  low saturate d fats and oils and lower 
amounts of sugar s in edible ices. The level of polyglycerol polyricinoleate (E 476) 
needed to achieve the intended technological function is 4000 mg/kg.  
(24) Polyglycerol polyricinoleate (E 476) also enables oil reduction in emulsified  sauces 
(e.g. mayonnaise or salad dressings) without having the negative effect on mouthfeel. 
The currently authorised maximum level of 4000 mg/kg is not sufficient for products 
with a fat content of more than 20 %. The level of use of polyglycerol polyric inoleate 
(E 476) needed to achieve the intended technological function in products with a fat 
content of more than 20  % is 8000 mg/kg.  
(25) Following the data submission by interested business operators in response to the 
public call for technical data and the submission of the application on the extension of 
use of polyglycerol polyricinoleate  (E 476), the Commission requested the Authority 
to provide a scientific opinion to confirm that the technical data provided by interested 
business operators adequately su pport ed an amendment to the specifications for the 
food additive polyglycerol polyricinoleate  (E 476) to bring them in line with current 
standards, as recommended by the Authority .  
(26) In its scientific opinion adopted on 30 March 20229, the Authority conclud ed that the 
proposed extension of use would not give rise to a safety concern. The Authority also 
concluded that the current specifications for polyglycerol polyricinoleate  (E 476) were 
to be adapted in particular by reducing the maximum limits for toxic e lements , by 
including maximum limits for impurities of safety concern  and by modifying the 
definition of polyglycerol polyricinoleate  (E 476).  
(27) It is therefore appropriate to authorise polyglycerol polyricinolate  (E 476) in food 
category 03 ‘Edible ices’ at a maximum level of 4000 mg/kg, increase the authorised 
maximum level in food category 12.6 ‘Sauces’ to 8000 mg/kg for emulsified sauces 
with a fat content of 20 % or more  and amend its specifications in light o f the 
Authority’s scientific opinion . The definition of the food additive should be amended 
in order to restrict the use of glycerol for the production of the food additive to 
                                                 
8 EFSA Journal 2017;15( 3):4743.  
9 EFSA Jour nal 202 2;20(5):7294.   
EN 5  EN glycerol compliant with the specifications for the food additive (E 422). The cu rrent 
maximum limits for toxic elements  should be reduced and 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) should be 
established in accordance with the scientific opinion of the Authority and taking into  
account the level which is  currently achievable by the application of good 
manufacturing practices.  
(28) Considering that the Authority did not identify an immediate health concern linked t o 
the presence of toxic elements, 3-monochloropropanediol (3 -MCPD) , 3-MCPD fatty 
acid esters  and glycidyl fatty acid esters , it is appropriate to allow during a transitional 
period the use of the food additive polyglycerol polyricinolate (E 476) lawfully p laced 
on the market before the date of entry into force of this Regulation . 
(29) For the same reasons, it is appropriate that foods containing the food additive 
polyglycerol polyricinolate (E 476) that has been lawfully placed on the market before 
the date of entry into force of this Regulation  may continue  to be placed on the market 
during a transitional period and to remain on the market until their date of minimum 
durability or ‘use -by-date’ . 
(30) Regulation s (EC) No 1333/2008 and (EU) No 231/2012 should therefor e be amended 
accordingly.  
(31) 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 amende d in accordance with Annex I to this 
Regulation.  
Article 2  
The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this 
Regulation.  
Article 3  
The food additive glycerol (E 422) that has been lawfully placed on the market before …  
[date of the entry into force of this Regulation ] and that does not comply with the maximum 
limits for arsenic, lead, mercury, cadmium or acrolein applicable from … [ date of  the entry 
into force of this Regulation ] may be added to food in accordance with Annexes II and III to 
Regulation (EC) No 1333/2008 until … [6 months after the date of entry into force of this 
Regulation ]. 
Foods containing the food additive glycerol (E 422) that has been lawfully placed on the 
market before … [ date of the entry into force of this Regulation ] and that does not comply 
with the maximum limits for arsenic, lead, mercury, cadmium or acrolein applicable from … 
[date of  the entry into force of this Regulation ] may continue to be placed on the market until  
… [6 month s after t he date of entry into force of this Regulation ] and may continue to be 
marketed until their date of minimum durability or ‘use-by date ’.   
EN 6  EN The food additive polyglycerol esters of fatty acids (E 475) that has been lawfully placed on 
the market before … [ date of the entry into force of this Regulation ] and that does not comply 
with the maximum limits for arsenic, lead, mercury, cadmium, the sum of 3 -
monochloropropanediol (3 -MCPD) and 3 -MCPD fatty acid esters (expressed as 3 -MCPD), 
erucic acid  or glycidyl fatt y acids esters (expressed as glycidol ) applicable from … [ date of  
the entry into force of this Regulation ] may be added to food in accordance with Annexes II 
and III to Regulation (EC) No 1333/2008 until … [6 months after the date of entry into force 
of this Regulation ]. 
Foods containing the food additive polyglycerol esters of fatty acids (E 475) that has been 
lawfully placed on the market before … [ date of the entry into force of this Regulation ] and 
that does not comply with the maximum limits arsenic,  lead, mercury, cadmium, the sum of 3 -
monochloropropanediol (3 -MCPD) and 3 -MCPD fatty acid esters (expressed as 3 -MCPD), 
erucic acid  or for glycidyl fatty acids esters (expressed as glycidol ) applicable from … [ date 
of the entry into force of this Regulati on] may continue to be placed on the market until  … [6 
month s after the date of entry into force of this Regulation ] and may continue to be marketed 
until their date of minimum durability or ‘use-by date ’.  
The food additive polyglycerol esters of fatty ac ids (E 475) that has been lawfully placed on 
the market after … [ date of the entry into force of this Regulation ] and up to … [ 6 months 
after the date of entry into force of this Regulation ] and that does not comply with the 
maximum limits for glycidyl fatty acids esters (expressed as glycidol ) applicable from … [ 6 
months after the date of  the entry into force of this Regulation ] may be added to food in 
accordance with Annexes II and III to Regulation (EC) No 1333/2008 unt il the exhaustion of 
stocks . 
Foods containing the food additive polyglycerol esters of fatty acids (E 475) that has been has 
been lawfully placed on the market  after … [ date of the entry into force of this Regulation ] 
and up to … [ 6 months after the date o f entry into force of this Regulation ] and that does not 
comply with the maximum limits for glycidyl fatty acids esters (expressed as glycidol ) 
applicable from … [ 6 months after the date of  the entry into force of this Regulation ] may 
continue to be placed  on the market and may continue to be marketed until their date of 
minimum durability or ‘use by date’.  
The food additive polyglycerol polyricinoleate (E 476) that has been lawfully placed on the 
market before … [ date of the entry into force of this Regula tion] and that does not comply 
with the maximum limits for arsenic, lead , mercury, cadmium , the sum of 3 -
monochloropropanediol (3 -MCPD) and 3 -MCPD fatty acid esters (expressed as 3 -MCPD)  or 
glycidyl fatty acids esters (expressed as glycidol ) applicable from … [ date of  the entry into 
force of this Regulation ] may be added to food in accordance with Annexes II and III to 
Regulation (EC) No 1333/2008 until … [6 months after the date of entry into force of this 
Regulation ]. 
Foods containing the food additive polyglycerol polyricinoleate (E 476) that has been 
lawfully placed on the market before … [ date of the entry into force of this Regulation ] and 
that does not comply with the maximum limits for arsenic, lead, mercury, cadm ium, the sum 
of 3-monochloropropanediol (3 -MCPD) and 3 -MCPD fatty acid esters (expressed as 3 -
MCPD)  or glycidyl fatty acids esters (expressed as glycidol ) applicable from … [ date of  the 
entry into force of this Regulation ] may continue to be placed on the market until  … [6 
month s after the date  of entry into force of this Regulation ] and may continue to be marketed 
until their date of minimum durability or ‘use-by date ’.  
EN 7  EN Article 4  
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 directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN