These limits were arrived at based on estimates of how much infants would be exposed to, according to levels of 3-MCPDE’s and GE’s measured in infant formulas on the market.
Part of those estimates appears in the latest FDA report in 20208, analyzing a total of 222 different brands of infant formulas from 4 manufacturers, from 2013-16 and 2017-2019.
The study determined the average levels of 3-MCPDE and GE across all products. which formulas contained these contaminants, or what the individual levels were, they showed that 3-MCPDE was from could be up to 0.95 mcg/g, and GE could be up to 0.37 mcg/g of formula. Based on an average amount of formula powder per day (~100g) and average baby weight (~3.5kg), this means a baby could get approximately 27 µg /day of 3-MCPDE and 10.5 µg /day for GE. For 3-MCPDE, this is higher than all maximum limits.
This graph shows an approximation of what levels a baby would consume, based on the average amounts of 3-MCPD measured in the products over the two periods. The red line is the EFSA limits. Some companies have shown a drop in that time, but others haven’t.