COMMI SSION REGUL ATION (EU) 2023/1428 
of 7 July 2023
amending the Annex to Regulation (EU) No 231/2012 as regards mono- and digly cerides of fatty 
acids (E 471) 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on 
food additives (1), and in particular Article 14 thereof,
Whereas:
(1) Commission Regulation (EU) No 231/2012 (2)lays down specific ations for food additives that are listed in Annex es 
II and III to Regulation (EC) No 1333/2008.
(2) The specifi cations for food additives may be updat ed in accordance with the common procedure refer red to in 
Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (3), either on the 
initiative of the Commission or followi ng an application from a Member State or an inter ested party.
(3) Mono- and diglycerides of fatty acids (E 471) is a substance author ised in a variety of foods in accordance with 
Annex es II and III to Regulation (EC) No 1333/2008.
(4) On 26 Sept ember 2017 , the Auth ority issued a scientifi c opinion on the re-evaluation of mono- and diglycerides of 
fatty acids (E 471) as food additives (4), which concluded that there was no need for a numer ical acceptable daily 
intake and that the food additive was of no safety concer n when used in food for the general population. The 
Authority considered that the uses in food for infants under the age of 16 weeks would require a specific risk 
assessment. The Author ity recommended some modifi cations to the specifi cations for food additive E 471 set out 
in Regulation (EU) No 231/2012.
(5) Following the publication of that scientifi c opinion, as part of the re-evaluation of the safety of food additives 
permitted in food categor y 13.1 (food for infants and young children) of Annex II to Regulation (EC) 
No 1333/2008, the Commission request ed the Author ity to address the data gaps specifi ed in the 
recommendations of that scientific opinion.
(6) On 29 November 2018 , the Author ity launched a public call for technical and toxicological data on food additive E 
471. This allowed the inter ested parties to provid e the requested information for compl eting 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.
(1)OJ L 354, 31.12.2008, p. 16.
(2)Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specificat ions 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 
author isation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
(4)EFSA Journal 2017;15(11):5045.EN Offi cial Jour nal of the European Union L 175/6 10.7.2023  (7) In 2020, there was a RASFF notifi cation concer ning findings of high levels of genoto xic 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 that notificati on and pending the recommendations of the Authority for the setting of maximum limits for 
glycidyl fatty acids esters in the food additive, follow-up actions were under take n on the basis of Article 14 of 
Regulation (EC) No 178/2002 of the European Parliament and of the Council (5). A broad concentration range and 
high levels of glycidyl esters (expressed as glycidol) were detected in commercial sam ples of the food additive 
analysed by the industr y in response to the call for data during the same period.
(8) Consider ing that the food additive E 471 is author ised at quantum satis in food catego ries for which the setting of 
maximum levels for the presence of glycidyl fatty acids esters is envisag ed or is already in place, maximum levels for 
glycidyl fatty acids esters (expressed as glycidol) in food additive E 471 should be established to avoid the placing on 
the mark et of unsaf e food.
(9) In its scientifi c opinion adopt ed on 30 Sept ember 2021 (6), the Auth ority concluded that there is no reason for a 
safety concer n when the food additive E 471 is used in food catego ries 13.1.1 (infant formulae) and 13.1.5.1 
(dietar y 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 that Regulation. The Author ity recommended adaptin g 
the current specifi cations for mono- and diglycerides of fatty acids (E 471), in particular by reducing the maximum 
limits for toxic elements and including maximum limits for imp urities and constituents of safety concer n.
(10) In light of the Author ity’s recommendation and the maximum levels for certain contaminants in foods as laid down 
in Commission Regulation (EU) 2023/915 (7), it is theref ore appropr iate to amend the specifications for mono- and 
diglycerides of fatty acids (E 471). The definition of the food additive should be amended in order to restr ict 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 cont ent of erucic acid should be established in the current entr y ‘assa y’ for mono- and diglycerides 
of fatty acids (E 471). The current maximum limits for arsenic, lead, mercur y and cadmium should be reduced and 
maximum limits for the sum of 3-monochloropropane diol (3-MCPD) and 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 Author ity. In order to excl ude high exposure to those impur ities and compo nents of concer n resulting from 
the consum ption of food containing the food additive E 471 by vulnerable consumers, it is necessar y to establish 
stricter maximum limits for erucic 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 children (8). Those maximum limits 
take into account the level which is currently reasonably achi evable by the application of good manuf actur ing 
practices.
(11) As new manuf actur ing techniques resulting in the 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 appropr iate to provi de 
the manufacturers of this food additive with a transitional period to reac h a maximum level of 5 mg/kg for glycidyl 
fatty acid esters (expressed as glycidol) in the food additive E 471. Howe ver, given that glycidyl fatty acid esters have 
a genot oxic and carcinogenic poten tial, an intermediate maximum level of 10 mg/kg for glycidyl fatty acid esters 
(expressed as glycidol) should apply from the date of the entr y into force of this Regulation excep t for uses in food 
for infants and young children.
(5)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 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) 2023/915 of 25 Apr il 2023 on maximum levels for certain contaminants in food and repealing 
Regulation (EC) No 1881/2006 (OJ L 119, 5.5.2023, p. 103).
(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 Parliament 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 Offi cial Jour nal of the European Union 10.7.2023 L 175/7  (12) Consider ing that the Author ity did not identify an immediate health concer n linked to the presence of toxic 
elements, erucic acid, the sum of 3-monochloropr opanediol (3-MCPD) and 3-MCPD fatty acid esters and glycidyl 
fatty acid esters, it is appropr iate 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 entr y into force of this Regulation 
and to allow foods containing such food additive to continue to be placed on the mark et during the transitional 
period and to remain on the mark et until their date of minimum durability or ‘use by date’. Howe ver, in light of the 
vulnerability of infants and young children, the food additive mono- and diglycerides of fatty acids (E 471) not 
compl ying 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 allowe d to be added to such foods after the date of entr y into force of this 
Regulation and the mark eting of those foods should be allowed only if they were lawfully placed on the mark et 
already before that date.
(13) For the same reasons and consider ing its reduced cont ents of glycidyl fatty acid esters, the food additive mono- and 
diglycerides of fatty acids (E 471) complying with the reduced interm ediat e maximum level for glycidyl fatty acid 
esters (expressed as glycidol) should be allowed to be used until the exhaustion of stoc ks and foods containing such 
food additive should be allowed to be placed on the market and to remain on the mark et until their date of 
minimum durability or ‘use-by-dat e’.
(14) Regulation (EU) No 231/2012 should theref ore be amended according ly.
(15) The measures provid ed for in this regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
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 mark et before 30 July 
2023 and that does not compl y with the maximum limits for arsenic, lead, mercur y, cadmium, 3-monochloropr opanediol 
(3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD), or erucic acid applicable from 30 July 2023 may be added 
to food in accordance with Annexes II and III to Regulation (EC) No 1333/2008 and Regulation (EU) 2023/915 until 
30 Januar y 2024 .
The food additive mono- and diglycerides of fatty acids (E 471) that has been lawfully placed on the mark et before 30 July 
2023 and that does not comply with the maximum limits for glycidyl fatty acids esters (expressed as glycidol) applicable 
from 30 July 2023 may be added to food, excep t for foods for infants and young children, in accordance with Annexes II 
and III to Regulation (EC) No 1333/2008 and Regulation (EU) 2023/915 until 30 Januar y 2024 .
Foods containing the food additive mono- and diglycerides of fatty acids (E 471) that has been lawfully placed on the 
mark et before 30 July 2023 and that does not compl y with the maximum limits for arsenic, lead, mercur y, cadmium, 
3-monochloropr opanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD) or erucic acid applicable from 
30 July 2023 may continue to be placed on the mark et until 30 Januar y 2024 and may continue to be mark eted until their 
date of minimum durability or ‘use-b y date’.
Foods, excep t 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 30 July 2023 and that does not comply with the maximum limits 
for glycidyl fatty acids esters (expressed as glycidol) applicable from 30 July 2023 may continue to be placed on the mark et 
until 30 Januar y 2024 and may continue to be market ed until their date of minimum durability or ‘use-by date’.EN Offi cial Jour nal of the European Union L 175/8 10.7.2023  Foods for infants and young children lawfully placed on the market before 30 July 2023 and containing the food additive 
mono- and diglycerides of fatty acids (E 471) that does not compl y with the maximum limits glycidyl fatty acids esters 
(expressed as glycidol) applicable from 30 July 2023 may continue to be mark eted until their date of minimum durability 
or ‘use-by date’.
The food additive mono- and diglycerides of fatty acids (E 471) that has been lawfully placed on the market after 30 July 
2023 and up to 30 Januar y 2024 and that does not comply with the maximum limits for glycidyl fatty acids esters 
(expressed as glycidol) applicable from 30 Januar y 2024 may be added to food, excep t foods for infants and young 
children, in accordance with Annex es II and III to Regulation (EC) No 1333/2008 until the exhaustion of stoc ks.
Foods, excep t 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 mark et after 30 July 2023 and up to 30 Januar y 2024 and that does not 
compl y with the maximum limits for glycidyl fatty acids esters (expressed as glycidol) applicable from 30 Januar y 2024
may continue to be placed on the mark et and may continue to be mark eted until their date of minimum durability or ‘use 
by date’.
Article 3
This Regulation shall enter into force on the twentieth day followi ng 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, 7 July 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 10.7.2023 L 175/9  ANNEX 
In the Annex to Regulation (EU) No 231/2012, the entr y for food additive E 471 MONO- AND DIGL YCERIDES OF FATTY 
ACIDS is replaced by the followi ng:
‘E 471 MONO- AND DIGL YCERIDES OF FATTY ACIDS
Synonyms
Def inition Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and 
tri-est ers of fatty acids occur ring in food oils and fats. They may contain small 
amounts of free fatty acids and glycerol.
Glycerol used for the manufacture of mono- and diglycerides of fatty acids should 
compl y with the specifi cations for E 422.
E 471 shall be produced from fats and oils compl ying with Union food safety 
requirements for edible fats and oils.
Einecs
Chemical name
Chemical formula
Molecular weight
Assa y Content of mono- and di-este rs: not less than 70 %
Content of erucic acid, including erucic acid bound in the mono/dig lyceride:
Not more than 0,2 % (only if added to food for infants and young children)
Not more than 0,5 % (for all uses excep t for foods intended for infants and young 
children)
Descr iption The product varies from a pale yellow to pale brown oily liquid to a whit e or slightly 
off-white hard waxy solid. The solids may be in the form of flakes , powders or small 
beads.
Identif ication
Infrared absor ption spectr um Characte ristic of a partial fatty acid ester of a poly ol
Test for glycerol Passes test
Test for fatty acids Passes test
Solubility Insoluble in water , soluble in ethanol and toluene at 50 °C
Purity
Water cont ent Not more than 2 % (Kar l Fischer method)
Acid value Not more than 6
Free glycerol Not more than 7 %
Polyg lycerols Not more than 4 % diglycerol and not more than 1 % higher polyg lycerols both 
based on total glycerol cont ent
Arsenic Not more than 0,1 mg/kg
Lead Not more than 0,1 mg/kg
Mercur y Not more than 0,1 mg/kgEN Offi cial Jour nal of the European Union L 175/10 10.7.2023  Cadmium Not more than 0,1 mg/kg
Sum of 3-monochloropropanediol 
(3-MCPD) and 3-MCPD fatty acid 
esters, expressed as 3-MCPDNot more than 0,75 mg/kg (only if added to food for infants and young children)
Not more than 2,5 mg/kg (for all uses excep t for foods intended for infants and 
young children)
Glycidyl esters of fatty acids, 
expressed as glycidolFrom 30 July 2023 until 30 Januar y 2024 , not more than 5 mg/kg if added to food 
for infants and young children) and not more than 10 mg/kg for all other uses.
From 30 Januar y 2024 , not more than 5 mg/kg for all uses.
Total glycerol Not less than 16 % and not more than 33 %
Sulphate d ash Not more than 0,5 % determined at 800 ± 25 °C
Soap —
Purity criteria apply to the additiv e free of sodium, potassium and calcium salts of fatty acids, howe ver these substances may be present up 
to a maximum level of 6 % (expr essed as sodium oleate)’.EN Offi cial Jour nal of the European Union 10.7.2023 L 175/11