April 30, 2025

Chemical 3-MCPD in infant formula


U.S. Food & Drug Administration, MD
Source: Food Addit Cntrl Pt A Chem Anal Cntrl Expo Risk Assess, Jan 2020

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Vegetable seed oils are added to infant formula to provide important fatty-acid nutrients. During the refining process of seed oils, they are heated to 400 degrees F to remove unpleasant odors. However, this process inadvertantly creates the two chemicals 3-MCPD and glycidol. 55 commercial samples of infant formula were tested for these contaminants. Levels of 3-MCPD reached 5.13 ug g-1 in samples and glycidol reached 6.14 ug g-1. As these chemicals are known to be carcinogenic and/or genotoxic, their presence in formula is of concern as infants have reduced brain and body defenses compared to older children and adults.
ABSTRACT
Fatty acid esters of 3-monochloropropanediol (3-MCPD), 2-monochlorpropanediol (2-MCPD), and glycidol are process-induced chemical contaminants found in refined vegetable oils. Due to their toxicological properties, there is potential concern regarding exposure to these compounds, particularly for formula-fed infants where refined edible oils are the primary fat source in commercial infant formulas.

In order to assess exposure, 55 commercial oil samples, specifically intended for use in infant formula, were collected in 2015 from various infant formula manufacturers in the United States and analysed using a LC-MS/MS direct detection method. At the time of collection, there were no validated methods for the analysis of MCPD and glycidyl esters in infant formula.

Therefore, analysis of these commercial oil samples served as an alternative for confirming the presence of these ester contaminants in infant formula. Bound 3-MCPD and glycidol concentrations in these oils ranged from below the limit of quantitation (< LOQ) to 5.13 µg g-1 and < LOQ to 6.14 µg g-1, respectively. Highest ester concentrations were observed in palm olein samples. Concentrations of bound 3-MCPD and glycidol in the commercial oils were consistent with previously published occurrence studies at the time, suggesting that oils used in the manufacture of infant formula were similar (or processed in a similar manner) as refined oils marketed directly to consumers in 2015.

In order to determine if conditions during infant formula production impact the presence of 3-MCPD and glycidyl esters in the finished products, concentrations in oils were compared to concentrations in finished infant formula collected at approximately the same time. The comparison revealed that conditions used in the manufacture of infant formula likely initiate the destruction or conversion of glycidyl esters to other compounds, resulting in lower amounts of bound glycidol in the final product relative to the concentrations originally present in the refined oils.