Ethylene oxide: stricter regulation

The rules concerning the presence of the controversial substance ethylene oxide in additives were tightened on 1 September 2022. This decision was taken by the European Commission to simplify enforcement of the substance.

To properly understand this blog, we'd first like to clarify a few key concepts:

• Additives are substances deliberately added to food to simplify the manufacturing process or improve appearance, taste or shelf life. For example, preservatives in food.
• A residue is the substance that remains after a chemical reaction, separation process or mechanical treatment.

What is ethylene oxide and what is it used for?

Ethylene oxide (EtO) is a chemical substance used in third countries, i.e. countries that are not EU members, as a disinfectant on seeds, herbs, fibres and other agricultural products.

The substance has carcinogenic (cancer-causing), mutagenic (damages genetic material) and teratogenic (toxic to reproduction) effects. Because of its harmful nature, using ethylene oxide to disinfect additives is not permitted in the EU.

What caused confusion in the previous regulation?

Although using ethylene oxide to disinfect additives is not permitted in the EU, the substance has been detected since September 2020 in various foods, particularly food additives, including locust bean gum (E 410). Locust bean gum is often used in ice cream and bakery products.

The reason for this lies in the unclear regulation that applied at the time. Regulation (EU) No 231/2012, which sets out the specifications and purity criteria for food additives, previously set no maximum residue level for ethylene oxide.

However, there was a maximum level of 0.2 mg/kg for food additives in which ethylene oxide is used during their production.

It was therefore difficult to determine the origin of the presence of ethylene oxide:

• Ethylene oxide used to disinfect food additives (no maximum level set);
• or ethylene oxide used during the production process of food additives (a set maximum level of 0.2 mg/kg).

Clarification and new regulation were needed.

What does the new regulation cover?

To simplify enforcement, the Commission decided to set a maximum residue level for ethylene oxide in food additives of 0.1 mg/kg at the limit of quantification in those products. This means the lowest concentration of a substance that can reliably be measured using standard tests is used as the reference point. This new regulation has been in force since 1 September 2022.

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