3 MCPD and GE Testing
What is 3-MCDPDE?
3-monochloropropane-1, 2-diol esters (3-MCPDE) and glycidyl esters (GE) are common impurities that form during the oil refinement process. During digestion, 3-MCPDE and GE break down to 3-monochloropropane-1, 2-diol (3-MCPD) and glycidol, respectively, both of which are potentially toxic. The highest concentrations typically occur in refined palm oil and palm olein oil however, 3-MCPDE and GE are also found in other refined vegetable oils (such as safflower, coconut, sunflower, and soybean oils) and refined marine oils (such as fish oils). The wide application of refined oils leads to high potential exposure to these impurities in common foods made from these oils (e.g., mayonnaise, spreads, infant food), and pharmaceuticals (e.g., lipid-based drug products), therefore posing a health risk.
International food safety and regulatory bodies have set tight limits for these impurities. The Food and Drug Administration (FDA) has established 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. The European Food Safety Authority (EFSA) has set a TDI for 3-MCPD at 2 μg/kg body weight/day and for glycidol at 0.6 μg/kg body weight/day. A higher risk has been identified in younger age groups, especially infants. Of particular concern is infant formula where refined vegetable oils are a major component (20-30% by weight) due to nutritional needs.
In the last decade, there has been a global effort to monitor these impurities. For instance, the FDA has monitored and tested 3-MCPDE and GE in various foods in 2013-2016, 2017-2019, and 2021-2023. Similar surveys were conducted in Europe, Australia and New Zealand on infant formula.
MCPDE and GE Analysis
Analysis of MCPDE and GE in product matrices can be extremely complex, involving time-consuming sample extraction, purification, and derivatisation processes, coupled with low detection requirements (e.g. to 0.01 ppm level for infant formula). Given these challenges, method development and validation is typically customised to the product.
In addition, calculating and interpreting free and bound 3-MCPD and glycidol is a multifaceted process. PharmSky can provide comprehensive analytical services for these compounds, 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
Our tailored method, including analytical testing and 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 pharmaceutical regulatory expectations.
Why Choose PharmSky To Partner With?
PharmSky can provide comprehensive analytical services for these compounds, 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.
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Frequently Asked Questions
3-MCPD is categorised as a possible carcinogen and glycidol a probable carcinogen. 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.
Analysis of MCPDE and GE in product matrices can be extremely complex, involving time-consuming sample extraction, purification, and derivatisation processes, coupled with low detection requirements (e.g. to 0.01 ppm level for infant formula). Given these challenges, method development and validation is typically customised to the product. In addition, calculating and interpreting free and bound 3-MCPD and glycidol is a multifaceted process.
Extraction from the sample matrix, derivatisation, spiking with an internal standard and analysis by GC-MS/MS.
Quantitation limits are dependent on the sample matrix. Typical quantitation limits of 10 ppb for Glycidol and 2-MCPD, and 20 ppb for 3-MCPD have been achieved.
The analytical method has been validated according to ICH guidelines.
