The European Commission is to change the rules around the presence of ethylene oxide in food additives.

A revision was made because of the challenge in enforcing the current law because of a lack of clarity on the source of ethylene oxide in food additives. In the EU, use of the chemical to disinfect food is not permitted.

The problem started in September 2020 with sesame seeds from India. In 2020, most Rapid Alert System for Food and Feed (RASFF) alerts related to sesame seed products, but in 2021 and 2022 a variety of items were reported, including locust bean gum, guar gum and xanthan gum from Turkey, food supplements and spices. 

There have been at least six meetings at the European level with countries expressing concern about how the issue has been handled. The ethylene oxide incident is the biggest food recall operation in EU history, according to the 2021 Alert and Cooperation Network report.

Closing gap in current law
The EU position is that products containing the additive locust bean gum that contain ethylene oxide need to be withdrawn or recalled to protect the consumer. It has led to thousands of recalls. One recent example is contaminated General Mills Häagen-Dazs ice cream that was distributed to about 80 countries.

Current EU rules state that ethylene oxide may not be used for sterilizing purposes in food additives. However, there is no quantified limit for its presence in all additives. A limit of not more than 0.2 mg/kg of ethylene oxide is set for some additives treated with the substance.

There have been hundreds of RASFF notifications reporting findings of ethylene oxide in a number of food additives used to make a variety of foodstuffs.

Based on those reports and information from official controls by member states, the EU Commission established measures for goods of non-animal origin entering the region from certain countries to protect public health due to the risk of contamination.

However, enforcement has raised problems, because it is difficult to establish whether the presence of ethylene oxide is from use in the sterilization of food additives or because of other reasons.

Tighter controls for additives
To avoid these difficulties, the EU Commission said it was appropriate to say the presence of ethylene oxide, irrespective of origin, is not authorized for food additives.

A maximum limit for residues of ethylene oxide for food additives should be set at the limit of quantification. This means the lowest residue concentration which can currently be quantified and reported by routine monitoring with validated control methods.

The new rules state that no residue above 0.1 mg/kg of ethylene oxide — sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide — shall be present in food additives listed in EU legislation, including mixtures of food additives.

The regulation, which applies beginning in September, was backed by the Novel Food and Toxicological Safety of the Food Chain section of the Standing Committee on Plants, Animals, Food and Feed in March.

The maximum level may also be re-examined in the future, based on technological progress in achieving lower limits of quantification by routine methods of analysis by laboratories in the European Union.

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