ELI: http://data.europa.eu/eli/reg/2024/1003/oj 1/3COMMI SSION REGUL ATION (EU) 2024/1003 
of 4 Apr il 2024
amending Regulation (EU) 2023/915 as regards maximum levels for the sum of 
3-monochlor propanediol (3-MCPD) and 3-MCPD fatty acid esters in infant formul ae, follow-on 
formulae and food for special medical pur poses intended for infants and young children and young 
child formulae 
(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 (EU) 2023/915 (2)sets maximum levels for certain contaminants, including for the sum of 
3-monochloropr opanediol (3-MCPD) and 3-MCPD fatty acid esters in food.
(2) When the maximum 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) 2020/1322 (3), it was stipulat ed 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 Safe ty Author ity (‘the Author ity’) concluded that the presence of 3-MCPD esters and 
glycidyl esters in certain foodstuffs was a health concer n, in particular in foods for infants and young children (4).
(4) Maximum 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 intende d for infants and young children and 
young child formulae were established by Regulation (EU) 2020/1322 and these maximum levels were integrat ed in 
Regulation (EU) 2023/915.
(5) Recent occur rence data from controls performed by Member State s and available in the Author ity’s database of the 
sampli ng years 2020-2022 indicate that lower levels of 3-MCPD and 3-MCPD fatty acid esters in infant formulae, 
follo w-on formulae and food for special medical purposes intended for infants and young children and young child 
formulae can already be achi eved followi ng good practices. Theref ore, those maximum levels should be lowered to 
ensure a high level of human health prot ection.
(6) Regulation (EU) 2023/915 should theref ore be amended according ly.
(7) To enable economic operat ors to prepare for the new rules introduced by this Regulation, it is appropr iate to provid e 
for a reasonable time until the new maximum levels apply . It is also appropr iate to provide for a transitional period 
for food lawfully placed on the mark et before the date of application of this Regulation.
(1)OJ L 37, 13.2.1993, p. 1.
(2)Commission Regulation (EU) 2023/915 of 25 Apr il 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 Sept ember 2020 amending Regulation (EC) No 1881/2006 as regards maximum levels 
of 3-monochloropropanediol (3-MCPD), 3-MCPD fatty acid esters and glycidyl fatty acid esters in certain foods (OJ L 310, 24.9.2020, 
p. 2).
(4)EFSA CONT AM Panel (EFSA Panel on Contaminants in the Food Chain), 2018. Scientif ic Opinion on the update of the risk assessment 
on 3-monochlorop ropane diol and its fatty acid esters (EFSA Journal 2018;16(1):5083, 48 pp.,https://doi.org/10.2903/j. 
efsa.2018.5083 ).
Offi cial Jour nal  
of the European Union EN 
L series    
2024/1003  5.4.2024ELI: http://data.europa.eu/eli/reg/2024/1003/oj 2/3(8) 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
Annex I to Regulation (EU) 2023/915 is amended in accordance with the Annex to this Regulation.
Article 2
Food listed in the Annex, lawfully placed on the mark et before 1 Januar y 2025 , may remain on the mark et 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.
It shall apply from 1 Januar y 2025 .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 Apr il 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 5.4.2024 EN  ELI: http://data.europa.eu/eli/reg/2024/1003/oj 3/3ANNEX 
In Annex I to Regulation (EU) 2023/915, section 5, entr y 5.3.3 is replaced by the follo wing:
‘5.3.3 Infant formulae, follow-on formulae and food for special medical purposes intended for infants and 
young children(3) and young-c hild formulae(4)The maximum level applies to the product as 
placed on the market.
5.3.3.1 placed on the market as powder 80
5.3.3.2 placed on the market as liquid 12’OJ L, 5.4.2024 EN