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How are potential health risks of Ethylene Oxide affecting regulation?
May 31st 2022

How are potential health risks of Ethylene Oxide affecting regulation?


By Sarah O’Brien and Walt Brandl

Edited by Todd Napolitano and Kristen Rowell

Following a recent crisis in the European Union, regulatory agencies in the U.S. and abroad are working to understand the potential health risks of Ethylene Oxide (EtO) as well as establish limits for human consumption. In fact, EPA has determined that EtO can pose risks to human health. Accordingly, EPA’s pesticide registration review of EtO focused on mitigating EtO’s impact on human health and issued specific, detailed mitigation measures in 2021. Nevertheless, the problem is growing, particularly in the spice industry. The more we look for Ethylene Oxide, the more we are finding it.

Ethylene Oxide is a small molecule used as a surface disinfectant and a medical instrument sterilant as well as a pesticide and fumigant. In the US and Canada, Ethylene Oxide is registered for use in herbs and spices, typically at a maximum residue limit of 7 ppm. Its primary degradation product, 2-chloroethanol, has a limit of 940 ppm. EtO is commonly used in the spice industry to reduce microbial contamination post-harvest and in storage. There are practical advantages of using Ethylene Oxide. A true gas, it does not require wet application on dried products.  EtO is also an effective sterilant at low temperatures, so there is no required heating that may degrade temperature-sensitive products. The end result is better color and flavor retention and, it is hoped, greater consumer acceptance of natural seasoning products.

Why, then, is this proven established anti-microbial pathogen inactivator banned in the European Union and why is there intense pressure to ban it in the U.S. and Canada?  Well, here’s the bad news. Ethylene oxide is a Class 1 carcinogen, mutagen, and reproductive toxin. Although it dissipates relatively rapidly after application, it also diffuses readily into many food products where it can bind or react to form other toxic compounds, most commonly 2-chlorethanol after reacting with native chloride.

EPA is taking this very seriously. Maximum limits for EtO and 2-chlorethanol in the EU vary from 0.2 ppm in food additives down to 0.01 ppm in baby foods. Several recalls involving a variety of products, most notably sesame seeds and most recently thickeners made from locust bean in ice cream have occurred. Now, both FDA and Health Canada are formally reviewing the use of ethylene oxide and associated MRLs.

Given the mounting scrutiny, resulting health concerns, and consumers’ growing demand for “clean” food choices, one can expect the limits will be lowered drastically in North America. To support these regulatory developments, Mérieux NutriSciences has a dedicated methodology to make accurate determinations of ethylene oxide and 2-chlorethanol down to 0.01 ppm to provide maximum information and be compliant with the lowest regulations globally.

Learn more about how Mérieux NutriSciences can assist you with regulatory compliance.

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