Occurrence and risk assessment of glycidyl and 3-monochloropropanediol esters in infant formulas marketed in Taiwan

Abstract

Glycidyl esters (GEs) and 3-monochloropropanediol esters (3-MCPDEs) are process contaminants commonly found in refined edible oils which are often added to infant formulas. The Taiwan Food and Drug Administration (TFDA) launched regulations for GEs in infant formulas that went into effect on 1 July 2021. To investigate levels of GEs and 3-MCPDEs in infant formula powder, 45 products were sampled and analysed during 2020–2021. The contents of GEs and 3-MCPDEs in formulas of different brands significantly varied, but their concentrations in all of the formulas complied with European Union (EU) regulations. Infant formulas containing palm oil had significantly higher 3-MCPDE levels in both extracted oils and milk powder than those without palm oil. Concentrations of GEs and 3-MCPDEs in infant formula powder and extracted oils were significantly lower in products from Europe than those from Australia and New Zealand. Infants aged 0–1 years in Taiwan who consumed only infant formula showed a margin of exposure (MoE) exceeding 25,000. Mean consumer exposures to 3-MCPDEs stayed below the tolerable daily intake (TDI), while high exposures at the 95th percentile (P95) exceeded the TDI by 1.7-fold. Herein, we present the changing trends in the risk assessment results of infant formula across various countries in the decade. Implementation of regulations and mitigation strategy effectively reduced the risk of infants being exposed to GEs and 3-MCPDEs through infant formula.

Keywords:

• Processing contaminant
• palm oil
• margin of exposure
• tolerable daily intake
• EU regulation
• TFDA

Acknowledgments

The authors acknowledge the technical support provided by Taipei Medical University Core Facility.

CRediT authorship contribution statement

Chen Liu: investigation. Shang-Ta Wang: resources. Choon-Hui Tan: resources. Zih-Ee Lin: formal analysis. Wei-Ju Lee: conceptualisation, supervision, writing original draft, reviewing, editing, and funding acquisition.

Disclosure statement

The authors declare that there are no conflicts of interest.

Additional information

Funding

The authors acknowledge the National Science and Technology Council for providing a research grant (no. 108-2320-B-038-016-MY3).