Ethylene oxide in food: update on the current residue situation

EU decides on maximum residue level for ethylene oxide of 0.1 mg/kg in food additives

Aug 2022 (update). With the publication in the Official Journal of the European Union on 11 August 2022, Regulation (EU) No 231/2012 will change with regard to ethylene oxide: According to the new version, a maximum content of ethylene oxide of 0.1 mg/kg (sum of ethylene oxide and 2-chloroethanol) may not be exceeded in additives listed in Annex II and III of Regulation (EC) No 1333/2008. The Regulation shall enter into force on 1 September 2022.

Background, legal requirements and current analytical developments

Sept 2021 (update). Since the autumn of 2020, the demand for ethylene oxide analysis has increased significantly worldwide. Initially, the focus was on sesame imported from India and products made from it. In the meantime, however, it has become apparent that ethylene oxide can be a relevant issue in various value chains. Within the last weeks, products that contained locust bean gum (E410) as an ingredient were in the focus and many public recalls resulted in this. The demands on laboratory capacity, method development and validation are correspondingly high.

In order to meet the greater demand for analysis, the Eurofins laboartory network for Food and Feed testing in Germany has significantly increased its capacity for the analysis of ethylene oxide and 2-chloroethanol in recent months. As part of the capacity expansion, extensive investments were made in laboratory equipment. Thus, the turnaround time has been significantly reduced.

Background on the increased demand for ethylene oxide analysis

In August 2020, positive ethylene oxide findings were detected for the first time in sesame seed from India and products made from it. A corresponding notification via the European Rapid Alert System for Food and Feed (RASFF) led to a high number of analyses – at that time mainly limited to the product group sesame seed (incl. products).

In Germany, the use of ethylene oxide in food is banned since 1981 (read more about fumigants in the food sector here). The use is also not allowed in the European Union. As a result, maximum residue levels are at a very low level.

In October 2020, the EU Commission issued the Implementing Regulation (EU) 2020/1540 requiring 50% of sesame originating from India to be tested for ethylene oxide. In the course of this, Eurofins Food & Feed Testing laboratories in Germany took comprehensive measures to adapt the analytical capacity to the market requirements.

Health assessment by the German Federal Institute for Risk Assessment (BfR)

In its Statement No. 056/2020 in December 2020, the BfR addressed the health risks associated with exposure to ethylene oxide and updated it in September 2021 with Statement No. 024/2021.

According to the BfR, sesame seeds are a mutagenic and carcinogenic chemical, so residues are undesirable. As long as the maximum residue levels in the products are met, there is no concern that the maximum recommended intake levels will be exceeded in children or adults, even if sesame seeds are consumed regularly.

Analysis of ethylene oxide and analysable matrices

Ethylene oxide is analysed by GC-MS or GC-MS/MS. The result is reported expressed as the sum of ethylene oxide and 2-chloroethanol, according to the residue definition. Depending on the method, a distinction between 2-chloroethanol and ethylene oxide is possible. The limit of quantification is 0.01 mg/kg for all available methods.

At the Eurofins Food & Feed Testing laboratories in Germany, a large number of matrices have already been validated and can be analysed accordingly. In addition to spices, sesame seeds and other oilseeds, the method is also available for cereal products (including thickeners such as locust bean gum and guar gum) as well as ice cream, yogurt and similar dairy products. Other product groups are currently under development.

Do you have questions or would like to have your products tested?

We are your reliable partner for the analysis of ethylene oxide at the high quality level known in the industry. Please contact us for further details or if the product group you are interested in is not currently being analysed. Our expert Kathrin Maiwald or your personal account manager looking forward to your enquiry.