COMMISSION REGUL ATION (EU) 2018/290 
of 26 Febr uary 2018 
amending Regulation (EC) No 1881/2006 as regards maximum levels of glycidyl fatty acid esters in 
vegetabl e oils and fats, infant formula, follow-on formula and foods for special medical pur poses 
intended for infants and young children 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d 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. 
(2)  In May of 2016, the Scientifi c Panel on Contaminants in the Food Chain (Contam) of the European Food Safety 
Author ity (‘the Author ity’) adopt ed a scientifi c opinion on the Risks for human health related to the presence of 
3- and 2-monochlor opropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food (3). 
(3)  In view of the update d guidance of its Scientific Committ ee on the use of the benc hmark dose approach in risk 
assessment (4), the Author ity has decided to re-open the assessment of 3-MCPD and its fatty acid esters, followi ng 
a detailed analysis of the diverge nces in opinions, concer ning that contaminant, between the Joint FAO/WHO 
Exper t Committ ee on Food Additives (5) and the Author ity. Theref ore it is appropr iate to wait for the outcome of 
the assessment of 3-MCPD and its fatty acid esters before taking appropr iate regulatory measures. 
(4)  Glycidyl fatty acid esters are food contaminants found at highest levels in refined vegetable oils and fats. Glycidyl 
fatty acid esters are hydrolysed into glycidol in the gastroint estinal tract. 
(5)  The Author ity concluded that glycidol is a genoto xic and carcinog enic compound. In view of the genoto xic and 
carcinog enic potential of glycidol, the Auth ority applied a margin of exposure (‘MoE’) approac h. Scenar ios of 
exposure for infants, toddlers and other children resulted in a MoE ranging from 12 800 to 4 900 and for 
infants receiving only formula diet in a MoE of about 5 500 to 2 100. The Author ity considered that a MoE 
lower than 25 000 is of health concer n. It is theref ore appropr iate to establish a maximum level for the presence 
of glycidyl fatty acid esters in vege table oils and fats placed on the mark et for the final consumer or for use as an 
ingredient in food. Because of the health concer n for infants, toddlers and young children it is appropr iate to 
establish a stricter maximum level for veget able oils and fats destined for the production of baby food and 
processed cereal-based food for infants and young children. 
(6)  In order to excl ude any possible health concer ns as regar ds infants, toddle rs and young children, in particular , 
taking into account the possible exposure to glycidyl fatty acid esters of infants solely fed on infant formula, it is 
appropr iate to establish a specifi c strict maximum level for infant formula, follo w-on formula and food for 
special medical purposes intended for infants and young children. Howe ver there is a need to further reduce the 
presence of glycidyl fatty acid esters in infant formula, follo w-on formula and food for special medical purposes 27.2.2018 L 55/27 Official Jour nal of the European Union EN     
(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)Scientific opinion on the risks for human health relate d 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 
(4)Minutes of the 82nd Plenar y meeting of the Scientif ic Committee held on 13-14 Febr uary 2017. Available at https://www .efsa.europa. 
eu/sit es/default/files/event/170213-m.pdf 
(5)Joint FAO/WHO Exper t Committee on Food Additives, 83rd meeting, Rome, 8–17 November 2016, Summar y and 
Conclusions. Available at http://www .fao.org/3/a-bq821e.pdf intende d for infants and young children and theref ore it is necessar y to review the maximum levels once 
a reliable method of analysis is available to analyse stricter levels in view of ensur ing an effective enforcement of 
these levels. 
(7)  Food business operators should be grant ed enough time to adapt their production processes. 
(8)  Regulation (EC) No 1881/2006 should theref ore be amended according ly. 
(9)  The measures provi ded 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 (EC) No 1881/2006 is amended in accordance with the Annex to this Regulation. 
Article 2 
Foodstuffs listed in the Annex to this Regulation that were lawfully placed on the mark et before the entr y into force of 
this Regulation may remain on the mark et until 19 September 2018. 
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 State s. 
Done at Brussels, 26 Febr uary 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  27.2.2018 L 55/28 Official Jour nal of the European Union EN     ANNEX 
In the Annex to Regulation (EC) No 1881/2006, Section 4: 3-monochloropropa ne-1,2-diol (3-MCPD) is replaced by the 
follo wing: 
‘Section 4: 3-monochloropropanediol (3-MCPD) and glycidyl fatty acid esters 
Foodstuffs (1) Maximum level 
(µg/kg) 
4.1 3-monochloropropanediol (3-MCPD)  
4.1.1 Hydrolysed vege table prot ein (30) 20 
4.1.2 Soy sauce (30) 20 
4.2 Glycidyl fatty acid esters expressed as glycidol  
4.2.1. Vegetable oils and fats placed on the market for the final consumer or for 
use as an ingredient in food with the excep tion of the foods referred to in 
4.2.2 1 000 
4.2.2. Vegetable oils and fats destined for the production of baby food and pro­
cessed 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 (powder) (3) (29) 75 until 30.6.2019 
50 as from 1.7.2019 
4.2.4 Infant formula, follow-on formula and foods for special medical purposes 
intended for infants and young children (liquid) (3) (29) 10,0 until 30.6.2019 
6,0 as from 1.7.2019’   27.2.2018 L 55/29 Official Jour nal of the European Union EN