EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/1829  
(POOL/E2/2022/1829/1829 -EN.docx) 
D088133/03  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 231/2012 as regards specifications for mono - and 
diglycerides of fatty acids (E 471)  
 
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) No 231/2012 as regards specifications for mono - and 
diglycerides of fatty acids (E  471) 
 
(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 additive s1, and in particular Article 14 thereof,  
Whereas:  
(1) Commission Regulation (EU) No 231/20122 lays down specifications for food 
additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.  
(2) The specifications for food additives  may be updated in accordance with the common 
procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the  
European Parliament and of the Council3, either on the initiative of the Commission or 
following an application  from a Member State or an interested party .  
(3) Mono - and diglycerides of fatty acids (E 471) is a substance authorised in a variety of 
foods in accordance with Annexes II and III to Regulation (EC) No 1333/2008.  
(4) On 26 September 2017, the Authority issued a scientific opinion on the re-evaluation  
of mono - and diglycerides of fatty acids (E 471) as food additive s4, which concluded 
that there was no need for a numerical acceptable daily intake and that the food 
additive was of no safety concern when used in food for the general populati on. The 
Authority considered that the uses in food for infants under the age of 1 6 weeks would 
require a specific risk assessment. The Authority recommended some modifications to 
the specifications for food additive E 471 set out  in Regulation (EU) No 231/ 2012.  
(5) Following th e publication of that scientific opinion, as part of the re -evaluation of the 
safety of food additives permitted in food category 13.1 (food for infants and young 
children) of Annex II to Regulation (EC) No 1333/2008 , the Commission requ ested 
the Authority to address the data gaps  specified in the recommendations of th at 
scientific opinion . 
                                                 
1 OJ L 354, 31.12.2008, p. 16.  
2 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).  
3 Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 
establishing a common authorisation procedure fo r food additives, food enzymes and food flavourings 
(OJ L 354, 31.12.2008, p. 1 ). 
4 EFSA Journal 2017;15(11):5045.   
EN 2  EN (6) On 29 November 2018, the Authority launched a public call for technical and 
toxicological data on food additive E 471. This allowed the interested par ties to 
provide the requested information for completing its risk assessment  of E 471 as a 
food additive in food for all population groups and to assess the safety of its use in 
food for infants below 16 weeks of age.  
(7) In 2020, there was a RASFF  notification concerning findings of high levels of 
genotoxic and carcinogenic  glycidyl fatty acids esters  (expressed as glycidol ) in the 
food additive E 471 used in the production of a bread spread . On the basis of th at 
notification and pending the recomm endations of the Authority  for the setting of 
maximum limits for glycidyl fatty acids esters in the food additive, follow -up actions 
were undertaken on the basis of Article 14 of Regulation (EC) No 178/2002 of the 
European Parliament and of the Council5. A broad concentration range and high levels 
of glycidyl esters  (expressed as  glycidol ) were detected in commercial samples of the 
food additive analysed by the industry in response to the call for data during the same 
period.  
(8) Considering that  the food additive E 471  is authorised at quantum  satis in food 
categories  for which the setting of maximum level s for the presence of glycidyl fatty 
acids esters  is envisaged  or is already in place , maximum  levels  for glycidyl fatty acids 
esters  (expresse d as glycidol ) in food additive  E 471  should be established to avoid the 
placing on the market of unsafe food.  
(9) In its scientific opinion adopted on 30 September 20216, the Authority concluded that 
there is no reason for a safety concern when the food additive E 471 is used in food 
categories 13.1.1 (infant formulae) and 13.1.5.1 (dietary foods for infants for special 
medical purposes and special formulae for infants) of Annex II to Regulation (EC) No 
1333/2008 and in accordance with  Annex III  to th at Regulation . The Authority 
recommended adapting the current specifications for mono - and diglycerides of fatty 
acids (E 471), in particular by reducing the maximum limits for toxic elements and 
including maximum limits for impurities and constituent s of safety concern.  
(10) In light of the Authority’s recommendation  and the maximum levels for certain 
contaminants in foods  as laid down in  Regulation (EU) 2023 /…7, it is therefore 
appropriate to amend the specifications for mono - and diglycerides  of fatty a cids (E 
471). 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 compliant with the 
specifications of the food additive E 422. A maximum content of erucic acid should be 
established in the current entry ‘assay’ for mono - and diglycerides of fatty acids (E 
471). The current maximum limits for arsenic, lead, mercury and cadmium should be 
reduced and maximum limits for the sum of 3 -monochloropropane  diol (3 -MCPD) an d 
3-MCPD fatty acid esters (expressed as 3 -MCPD), and glycidyl fatty acids esters 
(expressed as glycidol) should be established in accordance with the opinion of the 
Authority. In order to exclude high exposure to tho se impurities and components of 
concern  resulting from the consumption of food containing the food additive E  471 by 
vulnerable consumers , it is necessary to establish stricter maximum limits for erucic 
                                                 
5 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1) . 
6 EFSA Journal 2021;19(11):6885 . 
7 Commission Regulation (EU) 2023 /…of … on maximum levels for certain contaminants in food and 
repealing Regulation (EC) No 1881/2006 (OJ L x, xxxxxx, p. x).   
EN 3  EN acid and the sum of 3-monochloropropanediol (3 -MCPD) and 3 -MCPD fatty acid 
esters (expressed  as 3-MCPD)  applicable for foods for infants and young children8. 
Those maximum limits take into  account the level which is currently reasonably 
achievable by the application of good manufacturing practices.   
(11) As new manufacturing techniques resulting in th e production of mono - and 
diglycerides of fatty acids (E 471) with lower levels of glycidyl fatty acid esters 
(expressed as glycidol) are being implemented, it is appropriate to provide the 
manufacturers of this food additive  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  471. However,  given that glycidyl fatty acid esters have a genotoxic and 
carcinogenic  potential , an intermediate maximum level of 10 mg/kg for glycidyl fatty 
acid esters (expressed as gl ycidol) sh ould apply from the date of the entry into force of 
this Regulation  except for uses in food for infants and young children.  
(12) Considering that the Authority did not identify an immediate health concern li nked to 
the presence of toxic elements, erucic acid , the sum of 3 -monochloropropanediol (3 -
MCPD) and 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 mono - and 
diglycerides of fatty acids E 471, 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 during  the transitional period and to remain on the  
market until their date of minimum durability or ‘use by date’.  However, in light of the 
vulnerability of infant s and young children, the food additive  mono - and diglycerides 
of fatty acids (E 471) not complying with the maximum level for glycidyl fatty acid 
esters  set out in this Regulation for  use in foods for infants and young children should  
not be 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 wer e 
lawfully placed on the market  already before that date .  
(13) For the same reasons  and considering its reduced contents of glycidyl fatty acid esters , 
the food additive mono - and diglycerides of fatty acids (E 471)  complying with the 
reduced intermediate maxi mum 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 o f minimum durability or ‘use -by-date’.  
(14) Regulation (EU) No 231/2012 should therefore be amended accordingly.  
(15) The measures provided for in this regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
                                                 
8 As defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 
2013 on food intended for infants and  young children, food for special medical purposes, and total diet 
replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 
96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European 
Parlia ment and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 
(OJ L 181, 29.6.2013, p. 35).   
EN 4  EN HAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to Regulation (EU) No 231/2012 is amended in accordance with the Annex to this 
Regulation.  
Article 2  
The food additive mono - and diglycerides of fatty acids (E 471) that has been lawfully placed 
on the market be fore … [ date of the entry into force of this Regulation ] and that does not 
comply with the maximum limit s for arsenic, lead, mercury, cadmium, 3 -
monochloropropanediol (3 -MCPD) and 3 -MCPD fatty acid esters (expressed as 3 -MCPD) , or 
erucic acid  applicable fr om … [ 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 and 
Regulation (EU) 2023 /… until … [6 months after the date of entry into force of this 
Regulation ]. 
The food additive mono - and diglycerides of fatty acids (E 471) 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 glycidyl fatty acids esters (express ed as glycidol ) 
applicable from … [ date of  the entry into force of this Regulation ] may be added to food, 
except for foods for infants and young children, in accordance with Annexes II and III to 
Regulation (EC) No 1333/2008 and Regulation (EU) 2023 /… until … [6 months after the 
date of entry into force of this Regulation ]. 
Foods c ontaining the food additive mono - and diglycerides of fatty acids (E 471)  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 limit s for  arsenic, lead, mercury, cadmium, 3 -
monochloropropanediol (3 -MCPD) and 3 -MCPD fatty acid esters (expressed as 3 -MCPD)  or  
erucic acid  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 ’.  
Foods, except foods for infants and young children,  containing the food additive mono - and 
diglycerides of fatty acids (E 471)  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 limit s 
for glycidyl fatty acids este rs (expressed as glycidol ) applicable from … [ date of  the entry into 
force of this Regulation ] may continue to be placed on the market until … [6 months 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’.  
Foods  for infants and young children  lawfully placed on the market before … [ date of the 
entry into force of this Regulation ] and containing the food additive mono - and diglycerides 
of fatty acids (E 471) that does not comply  with the maximum limits glycidyl fatty acids 
esters  (expressed as glycidol ) applicable from … [date of  the entry into force of this 
Regulation ] may continue to be marketed until their date of minimum durability or ‘use -by 
date’ .  
The food additive mono - and digl ycerides of fatty acids (E 471)  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  
EN 5  EN months after the date of entry into force of this Regulation ] may be added to food , except 
foods for infants and young children,  in ac cordance with Annexes II and III to Regulation 
(EC) No 1333/2008 until the exhaustion of stocks . 
Foods , except  food for infants and young children , containing the food additive mono - and 
diglycerides of fatty acids (E 471)  that has  been lawfully placed on the market after … [date 
of the entry into force of this Regulation ] and up to … [6 month s after the date of entry into 
force  of this Regulation ] and that does not comply with the maximum limits for glycidyl fatty 
acids esters (exp ressed as glycidol ) applicable from … [6 months after the date of 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 ’.  
Article 3  
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