There has been increased news and awareness over the last few years about impurities in nutrient milk formulas for infants and children, which may pose a health and safety issue.

During routine testing, trace amounts of two main types of chemicals have been identified^[1] and measured^[2], called (1) 3-monochloro-1,2-propanediol (3-MCPD) esters (3-MCPDE’s), and (2) glycidyl esters (GE’s).

3-MCPDE’s and GE’s originate from the natural plant oils used in milk formulas, during the steps of making a formula (product formulation) so they are often called “byproducts”.

These chemicals have been known about for decades in food industry applications. When milk formulas are manufactured, all the main ingredients, including the milk proteins, carbohydrates and oils are blended in large batches before they are packaged into tins.

To do this, the ingredients must be heated to higher temperatures to dry them out. The end result is a stable powder that is easier to package and easier to dissolve, with a longer product life in shelf storage. When the oils are heated, they produce very small amounts of 3-MCPDE’s and GE’s, which ultimately end up in the powdered formula.

Results from non-human research studies³ have shown that 3-MPCDE’s and GE’s can be absorbed by the gut, and may have some toxic effects in different areas, including the kidneys and reproductive system.

At this stage, there is no human evidence of these effects. Some recent research has reported that humans are able to absorb and break down 3-MCPD⁴, but what the specific actions are remains unknown.

The fact that these byproducts are detectable in infant formulas has prompted food authorities in the US and Europe to establish safety limits on 3-MPCDE’s and GE’s. Unfortunately, not all countries have their own safety limits.

For those who like stats, here are some of those limits:

Tolerable limits

• For 3-MCPDE
  • World Health Organization (WHO): 4 µg/kg body weight/day⁵
  • European Food Safety Authority (EFSA): 2 µg/kg body weight/day​⁶

Maximal levels

• For 3-MCPDE: European Union Regulation EU-2018/290: 20 µg/kg body weight/day
• For GE: European Union Regulation EU-2018/290: 50 µg/kg body weight/day⁷

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.

The risk of 3-MCPDE’s and GE’s remains an important consideration for nutrient milk formulas. Especially for infants and toddlers who are using them as a sole source of nutrition, and for extended durations. As awareness grows, more widespread testing in line with the safety limits will hopefully mean safer formulas our newest generation.

We prefer not to take any chances with your little stars’ safety, so we voluntarily test every single batch of all our infant and toddler formulas for 3-MCPDE’s and GE’s, using an accredited lab in Australia.

We do not release any product to the market until we have the results confirming that they are safe for consumption and meet accepted safety limits.