EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1984 Rev1 
(POOL/E2/2023/1984/1984 -R1-EN.docx  
D092106/02  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) 2023/915 as regards maximum levels for the sum of 3 -
monochlorpropanediol (3 -MCPD) and 3 -MCPD fatty acid esters in infant formulae, 
follow -on formulae and food for special medical purposes intended for infants and 
young children and  young child formulae  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) 2023/915 as regards maximum levels for the sum of 3 -
monochlorpropanediol (3 -MCPD) and 3 -MCPD fatty acid esters in infant formulae, 
follow -on formulae and food for special medical purposes intended for infants and 
young children and  young child formulae  
(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 conta minants in food1, and in particular Article  2(3) thereof,  
Whereas:  
(1) Commission Regulation (E U) 2023/9152 sets maximum levels for certain 
contaminants , including for the sum of 3 -monochlor opropanediol (3 -MCPD) and 3 -
MCPD fatty acid  esters  in food.  
(2) When the m aximum levels for the sum of 3 -monochloropropanediol (3 -MCPD) and 3 -
MCPD fatty acid esters in infant formulae, follow -on formulae and food for special 
medical purposes intended for infants and young children and young child formulae 
were established  by Commission Regulation (EU) 2020/13223, it was stipulated that 
those maximum levels are to be reviewed in view of lowering  them within 2 years 
from the date of application  of that Regulation .   
(3) In 2018  the European Food Safety Authority (‘ the Authority’ ) concluded that the 
presence of 3 -MCPD esters and glycidyl esters in certain foodstuffs was a health 
concern, in particular in foods for infants and young children4.  
(4) Maximum levels for the sum of 3 -monochlor opropanediol (3 -MCPD) and 3 -MCPD 
fatty acid esters in infant formulae, follow -on formulae and food for special medical 
purposes intended for infants and young children and young child formulae were 
established by Commission Regulation (EU) 2020/1322 and these maximum levels 
were integrated i n Commission Regulation (EU) 2023/915 . 
(5) Recent occurrence data  from controls performed by Member States and available in 
the Authority’s  database  of the sampling years 2020 - 2022  indicate that lower levels 
 
1 OJ L 37, 13.2.1993, p. 1.  
2 Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants 
in food and repealing  Regulation (EC) No 1881/2006 (OJ L 119, 5.5.2023, p. 103).  
3 Commission Regulation (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 
esters and glycidyl fatty ac id esters in certain foods (OJ L 310, 24.9.2020, p. 2) . 
4 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   
EN 2  EN of 3-MCPD and 3 -MCPD fatty acid esters in  infant formulae, follow -on formulae and 
food for special medical purposes intended for infants and young children and young 
child formulae  can already be achieved  following good practices . Therefore, th ose 
maximum levels should be lowered to ensure a high level of human health protection.  
(6) Regulation (E U) 2023/915  should therefore be amended accordingly.  
(7) To enable economic operators to prepare for the new rules introduced by this 
Regulation, it is appropriate to provide for a reasonable time until the new maximum 
levels apply . It is also appropriate  to provide for a transitional period for food lawfully 
placed on the market before the date of application of this Regulation .  
(8) The measures provided for in this Regulation are in accordance with the opinion of t he 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex I to Regulation (E U) 2023/915  is amended in accordance with the Annex to this 
Regulation.  
Article 2   
Food listed in the Annex , lawfully placed on the market before 1 January 2025, may remain 
on the market  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 Jo urnal of the European Union.  
It shall apply from 1 January 2025.  
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