EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11727/2016 
(POOL/E2/2016/11727/11727 -EN.doc) 
D048378/04  
[…](2017) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) 1881/2006 as regards maximum levels of glycidyl fatty acid 
esters in vegetable oils and fats, infant formula, follow -on formula and foods for special 
medical purposes intended for infants and young children    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Regulation (EC) 1881/2006 as regards maximum levels of glycidyl fatty acid 
esters in vegetable oils and fats, infant formula, follow -on formula and foods for special 
medical purposes intended for infants and young children  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Council Regulation (EEC) No  315/93 of 8  February 1993 laying down 
Community procedures for contaminants in food1, and in particular Article  2(3) thereof,  
Whereas:  
(1) Commission Regulation (EC) No  1881/20062 sets maximum levels for certain 
contaminants in foodstuffs.  
(2) In May of 2016, t he Scientific Panel on Contaminants in the Food Chain (CONTAM) 
of the European Food Safety Authority ( 'the Authority' ) adopted a  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 food3. 
(3) In view of the updated guidance of its Scientific Committee on the use o f the 
benchmark dose approach in risk assessment4, the Authority has decided to re -open 
the assessment of 3 -MCPD and its fatty acid esters, following a detailed analysis of 
the divergence s in opinion s, concerning that contaminant, between the Joint 
FAO/WHO  Expert Committee on Food Additives5 and the Authority. Therefore it is 
appropriate to wait for the outcome of the assessment of 3 -MCPD and its acid esters 
before taking appropriate regulatory measures.  
(4) Glycidyl fatty acid esters are food contaminants foun d at highest levels in reﬁned 
vegetable oils  and fats . Glycidyl fatty acid esters are hydrolysed in glycidol  in the 
gastrointestinal tract.  
(5) The Authority  concluded that glycidol is a genotoxic and carcinogenic compound. In 
view of the genotoxic and carcinogenic potential of glycidol, the Authority applied a 
margin of exposure ( 'MoE ') approach. Scenarios of exposure for infants, toddlers and 
other children ranging from 12800 to 4900 and in infants receiving only formula diet 
resulted in a MoE of about 5500 to 2100. The Authority considered that a  MoE lower 
                                                 
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 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  
4 Minutes of the 82nd Plenary meeting of the Scientific Committee held on 13 -14 February 2017. 
Available at https://www.efsa.europa.eu/sites/default/files/event/170213 -m.pdf  
5 Joint FAO/WH O Expert  Committee  on Food Additives, Eighty -third meeting , Rome, 8 –17 November 
2016 , Summary and Conclusions. Available at http://www.fao.org/3/a -bq821e.pdf   
EN 3   EN than 25000 is of health concern . It is therefore appropriate to establish a maximum 
level  for the presence of glycidyl fatty acid esters in vegetable oils and fats placed  on 
the market for the final consumer or for use as an ingredient in food. Because of the 
health concern for infants, toddlers and young children  it is appropriate to establish a 
stricter maximum level for vegetable oils and fats destined for the productio n of baby 
food and processed cereal -based food for infants and young children.  
(6) In order to exclude any possible health concerns as regards infants, toddlers and young 
children, in particular, taking into account the possible exposure to glycidyl esters of 
infants solely fed on infant formula, it is appropriate to establish a specific  strict 
maximum level for infant formula, follow -on formula and food for special medical 
purposes intended for infants and young children. However there is a need to further 
reduce the presence of glycidyl fatty acid esters in infant formula, follow -on for mula 
and food for special medical purposes intended for infants and young children and 
therefore it is necessary to review the maximum levels once a reliable method of 
analysis is available to analyse stricter  level s in view of ensuring an effective 
enforc ement of these levels.  
(7) Food business operators should be granted enough time to adapt their production 
processes.  
(8) Regulation (EC) No 1881/2006 should therefore be amended accordingly.  
(9) The measures provided for in this Regulation are in accordance with th e opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to Regulation (EC) No  1881/2006 is amended in accordance with the Annex to 
this Regulation.  
Article 1  
Foodstuffs listed in the Annex to this Regulation that were lawfully placed on the market 
before the entry into force of this Regulation may remain on the market until [OPOCE please 
insert precise date – this is 6 months after the date of entry into force of this Regulation]  
Article 2 
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  
 Jean -Claude J UNCKER