COMMI SSION REGUL ATION (EU) 2020/1322 
of 23 September 2020 
amending Regulation (EC) No 1881/2006 as regards maximum levels of 3‐monochloropropanediol 
(3-MCPD), 3-MCPD fatty acid ester s and glycidyl fatty acid esters in certain foods 
(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 Council Regulation (EEC) No 315/93 of 8 Febr uary 1993 laying down Community procedures for 
contaminants in food (1), and in particular Article 2(3) thereof, 
Whereas: 
(1) Commission Regulation (EC) No 1881/2006 (2) sets maximum levels for certain contaminants in foodstuffs. In the 
Annex to this Regulation maximum levels are established for 3-monochloropropanediol (3-MCPD) and glycidyl 
fatty acid esters. 
(2) On 21 November 2017, the Scientific Panel on Contaminants in the Food Chain (‘the CONT AM Panel’) of the 
European Food Safety Auth ority adopt ed a scientific opinion (3) on an update of the its assessment of the risks for 
human health related to the presence of 3-monochloropr opanediol (‘3-MCPD’) and its fatty acid esters in food 
published in 2016 (4), in view of the scientifi c diverge nce identified concer ning the establishment of the tolerable 
daily intake (TDI) in the Joint FAO/WHO Exper t Committ ee on Food Additives and Contaminants repor t(5). 
(3) The CONT AM Panel established an update d group TDI of 2 μg/kg body weight per day for 3-MCPD and its fatty acid 
esters. It note d that this TDI is not exceeded in the adult population. However , a slight exceedance of the TDI was 
obser ved in case of the high consumers of the younger age groups and in particular in case of infants receiving 
formula only . 
(4) 3-MCPD and its fatty acid esters are processing contaminants formed during the refinement process of vegetable oils. 
It is theref ore appropr iate to establish maximum levels for the presence of 3-MCPD and its fatty acid esters in 
veget able oils and fats placed on the mark et for the final consumer or for use as an ingredient in food. As virgin 
olive oils do not contain glycidyl fatty acid esters, 3-MCPD and its fatty acid esters, it is appropr iate that neither 
these new maximum levels for 3-MCPD and its fatty acid esters or the existing maximum level for glycidyl fatty acid 
esters apply to virgin oils 
(5) However , given the possible health concer n for infants and young children, it is appropr iate to establish a stricter 
maximum level for vegetable oils and fats, destined for the production of baby food and of processed cereal-based 
food for infants and young children. 
(6) In order to exclude any possible health concer ns as regar ds infants and young children, in particular taking into 
account the possible exposure to 3-MCPD and its fatty acid esters of infants solely fed on infant formula, it is 
appropr iate to establish specif ic strict maximum levels, depending on whether they are sold in powder or liquid 
form, for infant formula, follow-on formula and food for special medical purposes intende d for infants and young 
children. 
(1)OJ L 37, 13.2.1993, p. 1. 
(2)Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs 
(OJ L 364, 20.12.2006, p. 5). 
(3)EFSA CONT AM Panel (EFSA Panel on Contaminants in the Food Chain), 2018. Scientific opinion on the update of the risk assessment 
on 3-monochloropropanediol and its fatty acid esters. EFSA Journal 2018;16(1):5083, 48 pp. https://doi.org/10.2903/j. 
efsa.2018.5083 
(4)EFSA CON TAM Panel (EFSA Panel on Contaminants in the Food Chain), 2016. Scientific opinion on the risks for human health related 
to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food. EFSA 
Journal 2016;14(5):4426, 159 pp. doi:10.2903/j.efsa.2016.4426. 
(5)Safet y evaluation of certain contaminants in food. WHO Food Additives Series, No. 74, 2018. Toxicological Monographs 19 bis of the 
83rd meeting. 
http://apps.who.int/ir is/bitstream/handle/10665/276868/9789241660747-eng.pdf?ua=1 EN Offi cial Jour nal of the European Union L 310/2                                                                                                                                           24.9.2020   (7) Given that the slight exceedance of the TDI was obser ved in high consumers of the younger age groups and not only 
in infants receiving formula only , it is appropr iate to apply the same strict level to young child formula given that 
these formula are also consumed by the children younger than 3 years. In addition, it is appropr iate to establish the 
existing maximum level for glycidyl fatty acid esters for infant formula and follo w on formula also for young child 
formula. 
(8) Further more, it has recently become evident by scientific publications and occur rence data received, that also fish oil 
and oils from other mar ine organisms can contain high levels of glycidyl fatty acid esters and 3-MCPD and its fatty 
acid esters. In order to ensure a high level of human health prote ction, it is appropr iate to establish a maximum 
level for glycidyl fatty acid esters and 3-MCPD and its fatty acid esters in fish oil and oils from other mar ine 
organisms. 
(9) Food business operat ors should be grant ed enough time to adapt their production processes and theref ore it is 
appropr iate that the maximum levels for 3-MCPD and its fatty acid esters and the new maximum levels of glycidyl 
esters in young child formula and fish oil and oils from other mar ine organisms only apply from 1 Januar y 2021. 
Further more, it is appropr iate to allow products not compl ying with the maximum levels for 3-MCPD and its fatty 
acid esters and placed on the mark et before that date to remain on the mark et until their date of minimum 
durability or use-by-dat e. However , given that glycidyl fatty acid esters are genoto xic carcinog ens, and consequently 
their presence is a higher risk for public health, products not complying with the new maximum levels for glycidyl 
fatty acid esters and placed on the mark et before 1 Januar y 2021 should only be allowed to remain on the mark et 
for a limite d period of time. 
(10) Regulation (EC) No 1881/2006 should theref ore be amended according ly. 
(11) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The Annex to Regulation (EC) No 1881/2006 is amended in accordance with the Annex to this Regulation. 
Article 2 
Fish oils and oils from other mar ine organisms referred to in point 4.2.1 and 4.2.2 of the Annex to Regulation (EC) 
No 1881/2006 and young child formula refer red to in point 4.2.3 and 4.2.4 of that Annex that were lawfully placed on 
the mark et before 1 Januar y 2021 may continue to be mark eted until 30 June 2021. 
Foodstuffs listed under point 4.3 of the Annex to Regulation (EC) No 1881/2006 that were lawfully placed on the market 
before 1 Januar y 2021 may continue to be market ed 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, 23 Septembe r 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 24.9.2020                                                                                                                                           L 310/3   ANNEX 
In the Annex to Regulation (EC) No 1881/2006, Section 4 ‘3-monoc hloropropanediol (3‐MCPD) and glycidyl fatty acid 
esters’ is replaced by the followi ng: 
‘Section 4: 3-monochlor opropanediol (3-MCPD), 3-MCPD fatty acid esters and glycidyl fatty acid esters                                                              
Foodstuffs (1) Maximum level (μg/kg) 
4.1 3-monochloropropanediol (3-MCPD)  
4.1.1 Hydrolysed vegetable protein (30) 20 
4.1.2 Soy sauce (30) 20 
4.2 Glycidyl fatty acid ester s, expressed as glycidol  
4.2.1. Vegetable oils and fats, fish oils and oils from other mar ine organisms placed on 
the mark et for the final consumer or for use as an ingredient in food, with the 
excep tion of the foods refer red to in 4.2.2 and of virgin olive oils  (*) 1 000 (***) 
4.2.2. Vegetable oils and fats, fish oils and oils from other mar ine orga nisms destined for 
the production of baby food and processed cereal-based food for infants and 
young children (3) 500 (***) (******) 
4.2.3 Infant formula, follow-on formula and foods for special medical purposes 
intended for infants and young children (3) (29) and young-c hild formula (29)  (**) 
(powder) 50  (***) 
4.2.4 Infant formula, follow-on formula and foods for special medical purposes 
intended for infants and young children (3) (29) and young-ch ild formula (29) (**) 
(liquid) 6,0 (***) 
4.3 Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid ester s, 
expressed as 3-MCPD (****)  
4.3.1. Vegetable oils and fats, fish oils and oils from other mar ine organisms placed on 
the market for the final consumer or for use as an ingredient in food falling within 
the follo wing catego ries, with the excep tion of the foods refer red to in 4.3.2 and 
of virgin olive oils (*): 
— oils and fats from coconut, maize, rapeseed, sunf lower, soybean, palm kern el 
and olive oils (com posed of refined olive oil and virgin olive oil) (*) and 
mixtures of oils and fats with oils and fats only from this catego ry, 1 250 
— other vegetable oils (including pomace olive oils (*)), fish oils and oils from 
other mar ine organisms and mixtures of oils and fats with oils and fats only 
from this catego ry, 2 500 
— mixtures of oils and fats from the two abovementioned categor ies.  —  (*****) 
4.3.2. Vegetable oils and fats, fish oils and oils from other mar ine orga nisms destined for 
the production of baby food and processed cereal-based food for infants and 
young children (3) 750 (******) 
4.3.3 Infant formula, follow-on formula and foods for special medical purposes 
intended for infants and young children (3) (29) and young-c hild formula (29)  (**) 
(powder) 125 (*******) 
4.3.4 Infant formula, follow-on formula and foods for special medical purposes 
intended for infants and young children (3) (29) and young-ch ild formula (29) (**) 
(liquid) 15 (*******) EN Offi cial Jour nal of the European Union L 310/4                                                                                                                                           24.9.2020   (*) As defined in Part VIII of Annex VII to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 
December 2013 establishing a common organisation of the markets in agricultural products and repealing Council 
Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671). 
(**) “Young-ch ild formula” refers to milk -based drinks and similar prot ein-based products intended for young children. These 
products are outside the scope of Regulation (EU) No 609/2013 (Repor t from the Commission to the European Parliament 
and the Council on young-ch ild formulae (COM(2016) 169 final) https://eur -lex.europa.eu/legal-cont ent/EN/TXT/PDF/? 
uri=CELEX:52016DC0169&qid=1559628885154&from=EN). 
(***) For fish oil and oils from other mar ine organisms and young-child formula, the maximum levels shall apply from 1 Januar y 2021. 
(****) The maximum levels shall apply from 1 Januar y 2021. 
(*****) The oils and fats used as ingredient for the mixture shall comply with the maximum level established for the oil and fat. 
Theref ore, the level of the sum of 3-monoc hloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD in 
the mixture, shall not exceed the level calculated in accordance with Article 2(1)(c) of Regulation (EC) No 1881/2006. In case 
the quantitative composition is not known for the compet ent author ity and the food business operat or, not producing the 
mixture, the level of the sum of 3-MCPD and 3-MCPD fatty acid esters, expressed as 3-MCPD in the mixture shall in any case 
not exceed 2 500 μg/kg. 
(******) When the product is a mixture of different oils or fats of the same or of different botanical origins, the maximum level applies 
for the mixture. The oils and fats used as ingredient for the mixture shall compl y with the maximum level established for the 
oil and fat in point 4.3.1. 
(*******) Maximum level to be reviewed in view of loweri ng within 2 years from the date of application.’   EN Offi cial Jour nal of the European Union 24.9.2020                                                                                                                                           L 310/5