LegalizeCommission Regulation (EU) 2026/1825 of 29 July 2026 amending Regulation (EU) 2023/915 as regards maximum levels of 3-monochloropropanediol (3-MCPD), 3-MCPD fatty acid esters and glycidyl fatty acid esters in certain foods
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| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2026/1825 | 30.7.2026 |
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 food [^ntr1-L_202601825EN.000101-E0001], and in particular Article 2(3) thereof,
Whereas:
- (1) Commission Regulation (EU) 2023/915 [^ntr2-L_202601825EN.000101-E0002] sets maximum levels for certain contaminants in foodstuffs.
- (2) The Scientific Panel on Contaminants in the Food Chain (‘the CONTAM Panel’) of the European Food Safety Authority adopted on 3 March 2016 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 food [^ntr3-L_202601825EN.000101-E0003]. On 21 November 2017, the CONTAM Panel adopted a scientific opinion on an update of its assessment of the risks for human health related to the presence of 3-monochloropropanediol (‘3-MCPD’) and its fatty acid esters in food [^ntr4-L_202601825EN.000101-E0004]. The CONTAM Panel concluded that the presence of glycidyl esters in food is of health concern and the presence of 3-MCPD and its fatty acid esters is of health concern in certain exposure scenarios and population groups.
- (3) Maximum levels for glycidyl fatty acid esters, expressed as glycidol, and for the sum of 3-MCPD and 3-MCPD fatty acid esters, expressed as 3-MCPD have been established for vegetable oils and fats, fish oils and oils from other marine organisms in Regulation (EU) 2023/915. Considering the health concern for infants and young children, specific maximum levels for infant formulae, follow-on formulae and food for special medical purposes intended for infants and young children and young child formulae have also been established in that Regulation.
- (4) A specific lower level was established for vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children. At the time of adoption of Regulation (EU) 2023/915, no maximum levels for glycidyl fatty acid esters and for the sum of 3-MCPD and 3-MCPD fatty acid esters were established for baby food and processed cereal-based food for infants and young children due to the lack of occurrence data.
- (5) In the meantime, the occurrence data on glycidyl fatty acid esters, 3-MCPD and 3-MCPD fatty acid esters have become available for baby food and processed cereal-cereal based food for infants and young children. It is therefore appropriate to establish maximum levels in these foods on the basis of those data. Furthermore, the maximum levels for vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children should be lowered to ensure consistency with the maximum levels for baby food and processed cereal-based food for infants and young children taking into account their typical vegetable oil content.
- (6) High levels of glycidyl fatty acid esters and the sum of 3-MCPD and 3-MCPD fatty acid esters have been found in compound food containing vegetable oils and difficulties were experienced to assess compliance with Article 3 of Regulation (EU) 2023/915. To ensure effective enforcement, it is necessary to establish additional provisions as regards the application of maximum levels for glycidyl fatty acid esters and the sum of 3-MCPD and 3-MCPD fatty acid esters in compound food containing vegetable oils. As there is evidence that additional contamination of coated fish and meat with 3-MCPD and 3-MCPD fatty acid esters as the consequence of frying occurs, but the factors of such formation are for the moment undetermined. Since the determination of such factors is necessary to apply good practices to mitigate that contamination and to establish appropriate maximum levels for 3-MCPD and 3-MCPD fatty acid esters in these foods as low as reasonably achievable, maximum levels should not be set out as regards those foods pending that determination, which is not expected before 2027.
- (7) There has been some confusion as to which maximum level of 3-MCPD and 3-MCPD fatty acid esters is applicable to refined olive oil. It is therefore appropriate to clarify in the remarks regarding the maximum level for other vegetable oils and fats, fish oils and oils from other marine organisms that the maximum level is also applicable to refined olive oil.
- (8) For the control of the presence of glycidyl fatty acid esters, indirect methods of analysis are routinely used by official control laboratories. Recent research has found that with the use of these indirect methods, 3-monobromopropanediol (3-MBPD) fatty acid esters and 3-monoiodopropanediol (3-MIPD) fatty acid esters are determined together with glycidyl esters due to analytical conversions, particularly in the case of marine oils. It is therefore appropriate to explicitly provide that the maximum levels for glycidyl esters include also the compounds 3-MBPD and 3-MIPD.
- (9) Regulation (EU) 2023/915 should therefore be amended accordingly.
- (10) To enable economic operators to prepare for the new maximum levels for baby food and processed cereal-cereal based food for infants and young children and the lowered maximum level for vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children, it is appropriate to provide for a reasonable time until the new maximum levels apply.
- (11) Taking into account that baby food and processed cereal based food for infants and young children have a long shelf life, it is appropriate that these foods that were lawfully placed on the market before the date of application of the maximum level for these foods are allowed to remain on the market.
- (12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) 2023/915 is amended as follows:
- (1) Article 10(1) is amended as follows:
- (a) the introductory phrase is replaced by the following:
‘Food lawfully placed on the market prior to the dates referred to in points (a) to (r) may remain on the market until their date of minimum durability or use-by date:’;
- (b) the following point (r) is added:
- ‘(r) 1 January 2027 as regards the maximum levels for sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD set out in points 5.3.2 and 5.3.4 of Annex I and the maximum levels for glycidyl fatty acid esters set out in points 5.4.2 and 5.4.4. of Annex I.’;
- (2) Annex I is amended in accordance with the Annex to 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, 29 July 2026.
For the Commission
The President
Ursula VON DER LEYEN
[^ntr1-L_202601825EN.000101-E0001]: OJ L 37, 13.2.1993, p. 1, ELI: http://data.europa.eu/eli/reg/1993/315/oj.
[^ntr2-L_202601825EN.000101-E0002]: 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, ELI: http://data.europa.eu/eli/reg/2023/915/oj).
[^ntr3-L_202601825EN.000101-E0003]: 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. https://doi.org/10.2903/j.efsa.2016.4426.
[^ntr4-L_202601825EN.000101-E0004]: Scientific opinion on the update of the risk assessment on 3-monochloropropanediol and its fatty acid esters. EFSA Journal 2018;16(1):5083, 48 pp. https://doi.org/10.2903/j.efsa.2018.5083.
ANNEX
In Annex I to Regulation (EU) 2023/915, Section 5, subsections 5.3 ‘Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD’ and 5.4 ‘Glycidyl fatty acid esters, expressed as glycidol’, are replaced by the following:
| ‘5.3 | Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD | Maximum level (μg/kg) | Remarks |
| For the sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, maximum levels refer to lower bound concentrations, which are calculated on the assumption that all the values below the limit of quantification are zero. | |||
| 5.3.1 | Vegetable oils and fats, fish oils and oils from other marine organisms except products listed in 5.3.2 placed on the market for the final consumer or for use as an ingredient in food falling within the following categories: | Except virgin olive oils (7). | |
| 5.3.1.1 | oils and fats from coconut, maize, rapeseed, sunflower, soybean, palm kernel and olive oils (composed of refined olive oil and virgin olive oil) (7). and mixtures of oils and fats with oils and fats only from this category | 1 250 | Except virgin olive oils (7). |
| 5.3.1.2 | other vegetable oils and fats, fish oils and oils from other marine organisms and mixtures of oils and fats with oils and fats only from this category | 2 500 | Including refined olive oil (7) and pomace olive oils (7). |
| 5.3.1.3 | mixtures of oils and fats from products listed in 5.3.1.1 and 5.3.1.2 | - | The oils and fats used as ingredients for the mixture shall comply with the maximum level established for the oil and fat. Therefore, the level of the sum of 3-MCPD and 3-MCPD fatty acid esters, expressed as 3-MCPD in the mixture, shall not exceed the level calculated in accordance with Article 3(1), point (c). In case the quantitative composition is not known by the competent authority and the food business operator, not producing the mixture, the level of the sum of 3-MCPD and 3-MCPD fatty acid esters, expressed as 3-MCPD in the mixture shall in any case not exceed 2 500 μg/kg. |
| 5.3.2 | Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children (3) | 750 500 as from 1 January 2027 | When the product is a mixture of different oils or fats of the same or of different botanical origins, the maximum level applies for the mixture. The oils and fats used as ingredients for the mixture shall comply with the maximum level established for the oils and fats in point 5.3.1. |
| 5.3.3 | Infant formulae, follow-on formulae and food for special medical purposes intended for infants and young children (3) and young-child 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 | |
| 5.3.4. | Baby food (3) Processed cereal based food for infants and young children (3) | 50 as from 1 January 2027 | The maximum level applies to the product as placed on the market. |
| 5.3.5 | Compound food containing more than 5 % fat and containing added vegetable oils and fats and/or fish oils and/or oils from other marine organisms except — products listed in 5.3.3 and 5.3.4 — pre-fried and fried coated meat and fish | The maximum levels refer to the fat content. The fat content is as declared on the label or in case the labelled fat content is not available, as extracted for analysis. | |
| 5.3.5.1. | Containing only oils and fats listed in 5.3.1.1. | 1 250 μg/kg fat | |
| 5.3.5.2. | Containing only oils and fats listed in 5.3.1.2. | 2 500 μg/kg fat | |
| 5.3.5.3. | Containing mixtures of oils and fats referred to in 5.3.1.3. | The oils and fats used as ingredients for the mixture shall comply with the maximum level established for the oils and fats. Therefore, the level of the sum of 3-MCPD and 3-MCPD fatty acid esters, expressed as 3-MCPD in the mixture, shall not exceed the level calculated in accordance with Article 3(1), point (c). In case the quantitative composition is not known by the competent authority and the food business operator, not producing the mixture, the level of the sum of 3-MCPD and 3-MCPD fatty acid esters, expressed as 3-MCPD in the mixture shall in any case not exceed 2 500 μg/kg. | |
| --- | --- | --- | --- |
| 5.4 | Glycidyl fatty acid esters, expressed as glycidol | Maximum level (μg/kg) | Remarks |
| The maximum level refers to the sum of glycidyl esters, 3-MBPD fatty acid esters and 3-MIPD fatty acid esters. | In case of use of a direct method to determine glycidyl esters, for the sum of glycidyl esters, 3-MBPD fatty acid esters and 3-MIPD fatty acid esters, maximum levels refer to lower bound concentrations, which are calculated on the assumption that all the values below the limit of quantification are zero. | ||
| 5.4.1 | Vegetable oils and fats, fish oils and oils from other marine organisms placed on the market for the final consumer or for use as an ingredient in food except products listed in 5.4.2 | 1 000 | Except virgin olive oils (7). |
| 5.4.2 | Vegetable oils and fats, fish oils and oils from other marine organisms destined for the production of baby food and processed cereal-based food for infants and young children (3) | 500 250 as from 1 January 2027 | When the product is a mixture of different oils or fats of the same or of different botanical origins, the maximum level applies for the mixture. The oils and fats used as ingredient for the mixture shall comply with the maximum level established for the oils and fats in point 5.4.1. |
| 5.4.3 | Infant formulae, follow-on formulae and food for special medical purposes intended for infants and young children (3) and young-child formulae (4) | The maximum level applies to the product as placed on the market. | |
| 5.4.3.1 | placed on the market as powder | 50 | |
| 5.4.3.2 | placed on the market as liquid | 6,0 | |
| 5.4.4 | Baby food (3) Processed cereal based food for infants and young children (3) | 25 As from 1 January 2027 | The maximum level applies to the product as placed on the market. |
| 5.4.5 | Compound food containing more than 5 % fat and containing added vegetable oils and fats and/or fish oils and/or oils from other marine organisms except products listed in 5.4.3. and 5.4.4. | 1 000 μg/kg fat | The maximum level refers to the fat content. The fat content is as declared on the label or in case the labelled fat content is not available, as extracted for analysis.’ |
ELI: http://data.europa.eu/eli/reg/2026/1825/oj
ISSN 1977-0677 (electronic edition)
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