The Problem
2- and 3-monochloropropanediol esters (2-MCPDE and 3-MCPDE) and glycidyl esters (GE) are impurities that form at high temperatures during the oil refining process. During digestion, 2-MCPDE, 3-MCPDE and GE are hydrolysed to 2- and 3-monochloropropanediol (2-MCPD and 3-MCPD) and glycidol.
3-MCPD is categorised as a possible carcinogen and glycidol a probable carcinogen.1, 2 Glycidol is considered more harmful and potentially genotoxic. Given the widespread use of edible or refined oils in food products (e.g. infant formula) and pharmaceuticals (e.g. lipid-based drug products), these impurities pose a potential health risk to consumers.
The Actions
Following the discovery of these impurities, international food safety and regulatory bodies have set tight tolerable daily intake levels. The Food and Drug Administration (FDA) has referred to provisional tolerable daily intake (TDI) levels for 3-MCPD at 4 μg/kg body weight/day and for glycidol at 2 μg/kg body weight/day set by JECFA.3, 4 The European Food Safety Authority (EFSA) has set a TDI for 3-MCPD at 2 μg/kg body weight/day.5, 6 A higher risk has been identified in younger age groups, especially infants. Surveys have been conducted globally to monitor these contaminants in several products.
The Challenge
Method development and validation need to be tailored to the product. Choosing a suitable test method based on the impurity (e.g. free and/or bound 2-MCPD, 3-MCPD and glycidol) of interest is critical.7 The analysis of MCPD, glycidol and their fatty acid esters in product matrices is extremely complex, involving time-consuming sample extraction, purification, and derivatisation processes. Furthermore, sensitive instruments that can detect low concentrations (e.g. 0.01 ppm for infant formula and infant drug products) are required to assess these impurities, adding to the challenge.
What We Offer
PharmSky can provide comprehensive analytical services to test for MCPDs and glycidol, utilising both internationally recognised methods and unique in-house analytical approaches. Our team offers guidance on method selection, sampling techniques, and assistance in interpreting test outcomes. Our tailored method development services enable trace-level quantification (LOQ = 10 ppb) of MCPDs and glycidol compounds in various refined oils and complex matrices. At PharmSky, our expertise helps facilitate clients’ development of safe products whilst enabling them to meet regulatory expectations.
References
- International Agency for Research on Cancer. 2013. IARC monographs on the evaluation of carcinogenic risks to humans. Some chemicals present in industrial and consumer products, food and drinking-water.101:349–374.
- International Agency for Research on Cancer. 2000. IARC monographs on the evaluation of carcinogenic risks to humans. Some industrial chemicals. 77:469–486.
- https://www.fda.gov/food/process-contaminants-food/3-monochloropropane-12-diol-mcpd-esters-and-glycidyl-esters
- Joint FAO/WHO Expert Committee on Food Additives. 2017. Evaluation of certain contaminants in food. Eighty-third report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, No.1002. https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/6456
- European Food Safety Authority Panel on Contaminants in the Food Chain. 2016. Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food. EFSA Journal. 14(5):4426. https://doi.org/10.2903/j.efsa.2016.4426
- European Food Safety Authority Panel on Contaminants in the Food Chain. 2018.Scientific opinion on the update of the risk assessment on 3-monochloropropane diol and its fatty acid esters. EFSA Journal. 16(1):5083. https://doi.org/10.2903/j.efsa.2018.5083
- American Oil Chemists’ Society. AOCS Official Method Cd 29a-13, Cd 29b-13, Cd 29c-13, Cd 29f-2021; International Organization for Standardization. ISO 18363-1:2015, ISO 18363-2:2018, ISO 18363-3:2017, ISO 18363-4:2021
