Summary
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There have been many recalls and removal of food products from the market worldwide over recent years due to presence of residues of ethylene oxide detected in them;
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Ethylene oxide is a man-made organic compound which exists in the form of a colourless and flammable gas with a sweet odour at room temperature and pressure. It is generally used in sterilisation of food products to destroy possible bacterial growth;
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The International Agency for Research on Cancer (IARC), a specialised research agency of the World Health Organization (WHO), has classified ethylene oxide as a Group 1 substance, i.e. “proven to be carcinogenic to humans”. Consumption of food containing residues of ethylene oxide over an extended period of time can increase health risks;
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The food industry has the responsibility to ensure that the food products for sale meet the hygiene and food safety requirements and that they are safe for human consumption;
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The Municipal Affairs Bureau (IAM) has already published the “Food Recall Guidelines”. The food industry has the responsibility to adhere to the Guidelines and cooperate with IAM when undertaking recalls of food products and their removal from the market. They also ought to take the initiative to recall food products that may pose risk to food safety and remove them from the market, and notify IAM about the information about the recalled products as well as the details and progress of the recall;
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As for the general public, it is advisable to maintain a balanced diet so as to avoid excessive intake of certain substances due to selective eating.
Introduction
In recent years, there have been many recalls worldwide of food products containing residues of ethylene oxide and their removal from the market, including internationally renowned branded food products that are commonly found in the local market. Between 2020 and 2022, IAM of Macao issued a total of 17 food alerts for relevant incidents, with the majority of them concerning recalls of food products found to contain residues of ethylene oxide, as notified by the regions in the European Union. The raw materials containing residues of ethylene oxide used in food production is the prime cause behind the presence of ethylene oxide in those food products, and the residues existed in trace amounts in the downstream or finished products. Recently, ethylene oxide was detected in instant noodles imported by neighbouring regions, which was followed by recall and removal of the affected instant noodles from the market initiated by the authorities of these regions. So, what is ethylene oxide and why has it become a concern, all of sudden, in recent years?
Origin and Health Risks of Residues of Ethylene Oxide in Food
Ethylene oxide is a man-made organic compound which exists in the form of a colourless and flammable gas with a sweet odour at room temperature and pressure. It is used in the production of polyester polymers as a coolant and antifreeze, as a fumigant for sterilisation of medical equipment, and is naturally present in most tobacco products. As far as food is concerned, ethylene oxide is primarily used for pest control and sterilisation in agricultural products and dried food, and prevention of serious food-borne diseases caused by salmonella and E. coli, among others. Nevertheless, ethylene oxide has been proven to be carcinogenic to the human body, and some countries and regions have already prohibited its use in food products.
IARC, a specialised research agency of WHO, has classified ethylene oxide as a substance “carcinogenic to humans” (Group 1). Studies have shown that ethylene oxide has neurotoxic, reproductive-toxic, genotoxic and carcinogenic effects in experimental animals. Since ethylene oxide degrades in the atmosphere after being applied in food products, the residual amounts of ethylene oxide present in food are minimal and unlikely to pose acute hazards under normal food consumption. However, ingestion of food containing residues of ethylene oxide over an extended period of time can increase health risks.
Regulatory Actions Taken Worldwide and by Macao
Currently, the Codex Alimentarius Commission has not established a standard for ethylene oxide in food, and the European Union cannot derive a health-based reference value for ethylene oxide since it is a carcinogen. Moreover, the food safety regulations and standards in relation to ethylene oxide vary across countries and regions, based on local realities:
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The United States and Canada allow the use of ethylene oxide in certain types of foods (e.g. spices, sesame seeds, and dried vegetables), provided that the amounts used are within the established maximum residue levels;
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China and the Taiwan region prohibit the use of ethylene oxide in food;
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Australia and New Zealand have banned the use of ethylene oxide in food sold locally since 2003;
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In addition to prohibiting the use of ethylene oxide as a food additive, the European Union has established the maximum residue levels for ethylene oxide and its metabolites in food additives listed in relevant annexes, regardless of its origin.
With respect to recalls of food products containing residues of ethylene oxide over the recent years, the prime cause behind is the use of raw materials, seasonings, and food additives in food production that are originated in various countries, such as spices used in ice cream, sesame seeds in bread, and locust bean gum added to baked desserts. Ethylene oxide could be allowed as a sterilising agent for food in the countries of origin of the raw materials and the amounts of ethylene oxide used are within the local permissible levels. However, when these raw materials are exported to other countries for further processing or are used to produce downstream products, they may not be allowed for use or sale in the imported countries for the levels of residual ethylene oxide in them may have exceeded the established permissible levels of the imported countries, thus failing to comply with the food safety requirements of these countries.
The Municipal Affairs Bureau (IAM) closely monitors latest food recalls across the globe and collects useful information concerning the recalls through its regularised food monitoring system, which includes recalls involving harmful substances in food. IAM also adopts a series of preventive and control measures according to the degree and extent of food hazard, such as issuing food alerts, and order a recall and removal from sale of the implicated food products on the market to safeguard the food safety of the public of Macao. In addition, food producers and dealers have the responsibility to ensure that the food they supply is hygienic, safe, and suitable for human consumption. When the food products they produce or sell pose, or may pose, a risk to food safety, they have an obligation to report it to IAM and recall the implicated products. IAM has published the “Food Recall Guidelines”, whose details are provided in the webpage on “Trade Guidelines” of the website of “Food Safety Information”.
Advice for the Industry and the Public
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The food industry have the responsibility to ensure that the food products and food materials they produce and market meet the hygiene and food safety requirements, and that they are safe for human consumption;
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The food industry should buy hygienic and quality food and food materials that are suitable for human consumption from reputable suppliers;
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The food industry have the responsibility to comply with a food recall order and remove the implicated food products from the shelves. When they learn through suppliers or other channels that the food products they sell may pose a risk to food safety, they should take the initiative to recall the implicated food products, remove them from sale and inform IAM about the information of the recalled food products, as well as the details and progress of the food recall;
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In case of a food recall, anyone in possession of the recalled food product should not eat the product, regardless of whether the product has expired or is spoiled. Wrap up the product properly before discarding it;
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The public should maintain a balanced diet to avoid excessive intake of certain substances due to selective eating;
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If there is any doubt about the safety, hygiene condition or quality of a food product, do not buy or eat it.
References:
1. “Food Recall Guidelines” (GL 003 DSA 2015), Municipal Affairs Bureau, January 2022.
https://www.foodsafety.gov.mo/file?p=foodsafetyinfo/returnGuideLine/637771665073272.pdf
2. “Ethylene Oxide in Food”, Centre for Food Safety of the Hong Kong SAR Government, 23 December 2022.
https://www.cfs.gov.hk/english/committee/files/TCF_79/TCF79_A1.pdf
3. Health risk of ethylene oxide in food （German Federal Institute for Risk Assessment）, 2 June 2022.
https://www.bfr.bund.de/cm/349/health-risk-of-ethylene-oxide-in-food.pdf
4. COMMISSION REGULATION (EU) 2022/1396 of 11 August 2022（Official Journal of the European Union）, 11 August 2022.
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1396&qid=1660311679482&from=en
5. Ethylene oxide（Food Standards Australia New Zealand）, 24 February, 2021.
https://www.foodstandards.gov.au/consumer/chemicals/Pages/Ethylene-oxide.aspx
6. Frequent Additional Questions about Ethylene Oxide (EtO) （United States Environment Protection Agency）, 11 April 2023.
7. ETHYLENE OXIDE（International Agency for Research on Cancer）, 28 October 2022.
https://monographs.iarc.who.int/wp-content/uploads/2018/06/mono100F-28.pdf
8. MRL Database（Government of Canada）, 1 March 2021.
https://pest-control.canada.ca/pesticide-registry/en/mrl-search.html
9. § 180.151 Ethylene oxide; tolerances for residues.（Code of Federal Regulations, USA）, 15 June 2021.
https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180/subpart-C/section-180.151
10. Ethylene Oxide, Environmental Health Research Center of the Taiwan region, 28 October 2022.
http://nehrc.nhri.org.tw/toxic/toxfaq_detail_mobile.php?id=62
BRR 007 DAR 2023
