Ethylene oxide (EO) is an alkylating agent used to sterilise a variety of healthcare products, such as single-use medical products, through gas chromatography. EO leaves residue on whatever it is used due to the nature of the material or type of packaging used for products. Ethylene Oxide i.e. ETO is a colorless, flammable gas. ETO is widely used as a sterilizer to reduce the microbial load as it disrupts cellular metabolism and reproductive processes of microorganisms. Being gaseous, It penetrates breathable packaging, making contact with all accessible surfaces of the product to deliver the required sterility assurance level (SAL).Sterilization process kills yeasts, molds, vegetative bacteria, spore formers and allows food manufacturers, producers, distributors to extend its shelf-life. It also allows the food processors to store and distribute the products safely. Whenever food is sterilized with Ethylene Oxide and is not aerated properly, Ethylene Oxide generally remains as a residue. This leads to the formation of highly toxic compounds such as 2-Chloroethanol (2-CE), Ethylene Chlorohydrin (ECH) and Ethylene Glycol (EG) . ETO and its breakdown products are carcinogenic and can cause severe organ damage. Ethylene oxide testing is the process by which chemical and technological methodology, such as nitrogen washes and extended aeration and heat treatment, is used to detect the presence of EO in these products.
BENEFITS OF ETHYLENE OXIDE TESTING:
Ethylene oxide residual analysis on products before they are sent for distribution in the market has several benefits, including the protection of your brand’s reputation, as well as the prevention of financial losses due to product recalls.
Ethylene oxide residual testing is vital to ensure the health of consumers, as exposure to ETO can cause several issues such as nausea, irritation to the eyes, and an increased risk of cancer.
We offer to test food matrices for ETO contamination using the GC-MS technique in our laboratory.
Across European Union, Ethylene Oxide residues are regulated in compliance with:
- (EU) 2020/1540 – regulations for Ethylene Oxide monitoring
- (EU) 2021/2246 – regulations for increase of official controls and emergency measures for entry of goods having Ethylene Oxide
- (EU) 2019/1793 – Sesame seeds originating in India
- (EU) 2015/868 – Maximum residual limits (MRLs) for ETO and 2-CE in different foods / Agriculture Commodities ranging from 0.02 to 0.1 mg/kg
- (EC) No 396/2005 – Maximum residue level of 0.05 mg/kg
EU has proposed separate Maximum residual limits (MRLs) for ethylene oxide and its primary metabolite 2-chloroethanol in different food and agriculture commodities ranging from 0.02 to 0.1 mg/kg (Commission Regulation (EU) 2015/868.
We offer to test food matrices for ETO contamination using the GC-MS technique in our laboratory. Products we test : Spices, Oilseeds, Tea, Cereals, Pulses, Fruits, Vegetables, Guar Gum, Bakery products, Processed foods, Agriculture products, Ayush and by product, Nutraceutical all food groups, raw materials and Organic products at an LOQ level – 0.01mg/kg.