Occurrence and risk assessment of glycidyl and 3-monochloropropanediol esters in infant formulas marketed in Taiwan. 2024

Chen Liu, and Shang-Ta Wang, and Choon-Hui Tan, and Zih-Ee Lin, and Wei-Ju Lee
Master Program in Food Safety, Taipei Medical University, Taipei, ROC.

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.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
D010938 Plant Oils Oils derived from plants or plant products. Oils, Plant,Oils, Vegetable,Plant Oil,Vegetable Oil,Vegetable Oils,Oil, Plant,Oil, Vegetable
D011208 Powders Substances made up of an aggregation of small particles, as that obtained by grinding or trituration of a solid drug. In pharmacy it is a form in which substances are administered. (From Dorland, 28th ed) Powder
D011409 Propylene Glycols Derivatives of propylene glycol (1,2-propanediol). They are used as humectants and solvents in pharmaceutical preparations. Propanediols,Glycols, Propylene
D004952 Esters Compounds derived from organic or inorganic acids in which at least one hydroxyl group is replaced by an –O-alkyl or another organic group. They can be represented by the structure formula RCOOR’ and are usually formed by the reaction between an acid and an alcohol with elimination of water. Ester
D005506 Food Contamination The presence in food of harmful, unpalatable, or otherwise objectionable foreign substances, e.g. chemicals, microorganisms or diluents, before, during, or after processing or storage. Food Adulteration,Adulteration, Food,Adulterations, Food,Contamination, Food,Contaminations, Food,Food Adulterations,Food Contaminations
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000073878 Palm Oil Nutritive oil extracted from the fleshy mesocarp of the fruit of the African palm tree, Elaeis guineensis. Palmolein,Oil, Palm
D000517 alpha-Chlorohydrin A chlorinated PROPANEDIOL with antifertility activity in males used as a chemosterilant in rodents. alpha-Chlorhydrin,3-Chloro-1,2-propanediol,3-Chloropropanediol,3-MCPD,3-Monochloropropane-1,2-diol,Glycerol alpha-Monochlorohydrin,U-5897,3 Chloro 1,2 propanediol,3 Chloropropanediol,3 Monochloropropane 1,2 diol,Glycerol alpha Monochlorohydrin,U 5897,U5897,alpha Chlorhydrin,alpha Chlorohydrin,alpha-Monochlorohydrin, Glycerol
D013624 Taiwan Country in eastern Asia, islands bordering the East China Sea, Philippine Sea, South China Sea, and Taiwan Strait, north of the Philippines, off the southeastern coast of China. The capital is Taipei. The alternate country name is Republic of China. Formosa,Republic of China

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