The UK Food Standards Agency (FSA) has proposed to set a limit for ethylene oxide in all food additives in line with EU regulations and is seeking stakeholder feedback. In addition, the public consultation on ethylene oxide was made alongside a call for comment on several regulated product applications, specifically: four novel food authorizations, a food additive authorization extension, two new production methods for existing authorized food additives, and the removal of authorization for 22 flavorings.
Ethylene oxide is considered a contaminant in food by FSA, and when it is detected as a residue, FSA and Food Standards Scotland (FSS) investigate individual incidents and assess the risk on a case-by-case basis. In recent years, there has been a string of incidents regarding the presence of ethylene oxide and its breakdown product 2-chloro-ethanol in a wide range of food commodities across the UK and the EU, often linked to locust bean gum, guar gum, xanthan gum, and calcium carbonate. In response, the EU set a limit of 0.1 milligrams per kilogram (mg/kg) for ethylene oxide in all food additives in September 2022.
UK investigations suggest the incidents are due to changes in the manufacturing processes for some food additives that have resulted in unavoidable contamination, not as a result of a deliberate misuse.
In line with the EU, FSA is proposing a limit of 0.1 mg/kg for ethylene oxide across all food additives, which the agency says is considered low-risk to human health by toxicologists. The same limit has been set in pesticide legislation.
FSA/FSS will continue to manage the risks associated with food additives containing unacceptably high levels of ethylene oxide. A product withdrawal would be required for any noncompliant food additive with levels above 0.1 mg/kg. FSA and FSS should be informed if a food additive is contaminated with ethylene oxide above 0.1 mg/kg, and if any amount of ethylene oxide (including below 0.1 mg/kg) has been detected in infant formula.
Regulated Product Applications
FSA/FSS are recommending that four novel foods are safe and that their applications should be approved. These foods include barley rice protein, cetylated fatty acids, a mixture of lacto-N-fucopentaose I and 2'-fucosyllactose (to be used as a source of human-identical milk oligosaccharides, a component found in human breast milk), and 3-fucosyllactose from Escherichia coli strain K-12 DH1 (to be used as a source of human-identical milk oligosaccharides).
Also available for public consultation is the extension of a food additive authorization for the emulsifier polyglycerol polyricinoleate, the approval of new production methods for steviol glycosides (non-nutritive sweeteners), and the removal of 22 food flavorings from the domestic list of approved substances (which are unapproved for use in the EU as of September 2022). The flavorings are not widely used by the UK flavorings industry, and therefore industry decided not to provide the information required to support their reevaluation.