Regulation (EC) No 396/2005 on pesticide residues lays down the maximum residue levels (MRL) for ethylene oxide. In addition, Regulation (EU) 231/2012 laying down specifications for food additives, notes that ethylene oxide may not be used for sterilising purposes in food additives. This Regulation additionally sets a purity limit of not more than 0.2 mg/kg for ethylene oxide in some additives.
During 2021, ethylene oxide residues have been detected in additives and in food manufactured from them for which no MRLs have been set. On 4 October 2021, the European Commission held a meeting to discuss the regulatory and technical aspects of ethylene oxide. The meeting held that a maximum level of 0.1 mg/kg can be applied to ethylene oxide residues in additives to ensure that ethylene oxide has not been used for sterilising purposes contrary to Regulation (EU) 231/2012.
Applicable maximum levels
MRLs for ethylene oxide mean the definition set under (EC) No 396/2005 (sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide) except for the purity requirements laid down in Regulation (EU) 231/2021.
Food, additives and food made of ingredients containing ethylene oxide residues exceeding the MRL or maximum levels agreed upon must be withdrawn from the market and recalled from consumers.
The MRLs of ethylene oxide residues listed below are applied on the basis of the legislation in force and the summary record of the meeting published on 12 October 2021.
Unprocessed food
- The MRLs laid down in Annex II of (EC) No 396/2005 are applied to unprocessed food.
Additives
- An MRL of 0.1 mg/kg applies to food additives.
- Raw materials used for the manufacture of additives must comply with the MRLs laid down in the Pesticide residue regulation.
- An MRL of 0.2 mg/kg (for pure ethylene oxide) applies to additives that are subject to the purity requirement laid down in Regulation (EU) 231/2012. The additives are E 431-436, E 1209 and E 1521.
Composite food
- For food comprising more than one raw ingredient for which the ethylene oxide content is not known, an MRL of 0.02 mg/kg applies.
- Where a raw material is known to be non-compliant, by way of derogation from the previous point, the content of the end product is irrelevant since it is considered to be non-compliant on the basis of the content of the raw material.
- Where the exact composition of a food manufactured from several raw materials is known, processing factors may be applied to determine the content of the raw material in accordance with Article 20 of (EC) No 396/2005. Where the dilution factors for processing are not known for ethylene oxide and 2-chloroethanol in the process concerned, the default factor 1 is used.
Baby food
- An MRL of 0.01 mg/kg applies to baby food and, where possible, laboratories with this analytical accuracy are used for the testing of baby food
- Where an additive with an ethylene oxide content above 0.1 mg/kg or other non-compliant raw material has been used in a baby food, the end product is non-compliant irrespective of the ethylene oxide content of the end product.
Food supplements
- For food supplements, including capsules used in their preparation, an MRL of 0.1 mg/kg applies.
- Where a raw material is known to be non-compliant, by way of derogation from the previous point, the content of the end product is irrelevant since it is considered to be non-compliant on the basis of the content of the raw material.