EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10124/2019 CIS 
(POOL/E2/2019/10124/10124 -EN 
CIS.docx)  
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of 3 -
monochloropropane diol (3 -MCPD), 3 -MCPD fatty acid esters and glycidyl fatty acid 
esters in certain foods  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of 3 -
monochloropropane diol (3 -MCPD), 3-MCPD fatty acid esters and glycidyl fatty acid 
esters in certain foods  
(Text with EEA relevance)  
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. In the Annex to this Regulatio n maximum levels are 
established for 3 -monochloropropane diol (3 -MCPD) and glycidyl fatty acid esters , 
when used in foodstuffs.  
(2) On 21 November 2017, the Scientific Panel on Contaminants in the Food Chain ( ʽthe 
CONTAM  Panelʼ) of the European Food Safety Authority adopted a scientific 
opinion3 on an update of the its assessment of the risks for human health related to the 
presence of 3 -monochloropropane diol ( ʽ3-MCPDʼ) and its fatty acid esters in food 
published in 20164, in view of the scientific divergen ce identified concerning the 
establishment of the tolerable daily intake (TDI) in the Joint FAO/WHO Expert 
Committee on Food Additives and Contaminants  report5.  
(3) The CONTAM Panel established an updated group TDI of 2 µg/kg b ody weight per 
dayfor 3 -MCPD and its fatty acid esters . It noted that this TDI is not exceeded in the 
adult population. However, a  slight exceedance of the TDI was  observed in case of the 
high consumers of the younger age groups and in particular in case of infants receiving 
formula o nly.  
                                                 
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 CONTAM Panel (EFSA Panel on Contaminants in the Food Chain),  2018. Scientific opinion on 
the update of the risk assessment on 3 -monochloropropane diol and its fatty acid esters. EFSA Journal 
2018;16(1):5083, 48 pp. https://doi.org/10.2903/j.efsa.2018.5083  4 EFSA CONTAM 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  
4 EFSA CONTAM 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  Safety evaluation of certain contaminants in food. WHO Food Additives Series, N o. 74, 2018 . 
Toxicological Monographs 19 bis of the 83rd meeting.   
http://apps.who.int/iris/bitstream/handle/10665/276868/9789241660747 -eng.pdf?ua=1   
EN 2  EN (4) 3-MCPD and its fatty acid esters are processing contaminants formed during the 
refinement process of vegetable oils. It is therefore appropriate to establish  maximum 
level s for the presence of 3-MCPD and its fatty acid esters in vegetable oils and f ats 
placed on the market 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 appropriate that neither these new maximum level s for 3 -MCPD and it s 
fatty acid esters or the existing maximum level for glycidyl fatty acid esters  apply to 
virgin oils  
(5) However, g iven the possible health concern for infants and young children , it is 
appropriate 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 concerns as regards i nfants 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 appropriate to establish specific 
strict maximum level s, depending on whether they are sol d in powder or liquid form,  
for infant formula, follow -on formula and food for special medical purposes intended 
for infants and young children.  
(7) Given that the slight exceedance of the TDI was observed in high consumers of the 
younger age groups and not o nly in infants receiving formula only, it is appropriate 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 appropriate to 
establish the existing maximum  level for glycidyl fatty acid esters for infant formula 
and follow on formula  also for young child formula.  
(8) Furthermore , it has recently become evident by scientific publications and occurrence 
data received, that also fish oil and oils from other marine 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 protection, it is appropriate 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 marine o rganisms .  
(9) Food business operators should be granted enough time to adapt their production 
processes  and therefore it is appropriate 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 marine organisms   only apply  from 1 January 2021 .. 
Furthermore, it is appropriate to allow  products not complying with the maximum 
levels for 3-MCPD and its fatty acid esters  and placed on the market before that date 
to may remain on the market until their date of minimum durability or use -by-date. 
However, given  that glycidyl fatty acid esters are genotoxic carcinogens, and 
consequent ly 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 market 
before 1 January 2021 should only be allowed to remain on the market for a limited 
period of time.  
(10) Regulation (EC) No 1881/2006 should therefore be amended accordingly.  
(11) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,   
EN 3  EN 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 2  
Fish oil s and oils from other marine 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 referred to in point 4.2.3 
and 4.2.4 of that Annex that were lawfully placed on the market before 1 January 2021 may 
continue to be  market ed 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 January 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 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