Occurrence of 3-monochloropropane-1,2-diol (3-MCPD) esters and glycidyl esters in infant formulas from Germany. 2021

Jessica K Beekman, and Samanta Popol, and Michael Granvogl, and Shaun MacMahon
Center for Food Safety and Applied Nutrition, United States Food and Drug Administration, Maryland, United States.

Fatty acid esters of 3-monochloropropane-1,2-diol (3-MCPD), 2-monochloropropanediol-1,3-diol (2-MCPD), and glycidol are heat-induced processing contaminants formed during the deodorisation step of edible oil refining. Because these compounds are potentially carcinogenic and/or genotoxic, their presence in refined oils and fats and foods containing these oils/fats poses possible health concerns. In particular, formula-fed infants may be exposed to these compounds due to their presence in commercial infant formulas. For this reason, in 2018, the European Union established maximum limits for glycidyl esters in oils/fats and infant formulas and recently, as of January 2021, implemented regulations for the sum of free 3-MCPD and 3-MCPD fatty acid esters as well. This work involved the analysis of 3-MCPD and glycidyl ester contents in 45 infant formula products purchased from German supermarkets in 2019. The data produced in this study showed that average contaminant concentrations across all manufacturers were exceptionally low, with 100% of the products analysed falling below the current EU regulation for glycidyl esters in powdered formulas and 96% of the products analysed meeting the recently implemented regulation for the sum of free and bound 3-MCPD. In addition, a comparison of the 2019 data set to occurrence data collected for German formulas purchased in 2015 showed that average bound 3-MCPD and glycidol concentrations have decreased (from 0.094 to 0.054 µg g-1 and from 0.010 to 0.006 µg g-1, respectively), likely indicating that additional/improved mitigation measures for reducing contaminant concentrations in infant formulas have been implemented over the 4-year period. The data collected in this occurrence study are suitable for estimating levels of exposure to these compounds for German infants.Abbreviations: 2-MCPD: 2-monochloropropane-1,3-diol; 3-MCPD: 3-monochloropropane-1,2-diol; ARA: arachidonic acid; CE: collision energy; CXP: collision cell exit potential; DHA: docosahexaenoic acid; DP: declustering potential; EP: entrance potential; EPA: eicosapentaenoic acid; EtOAc: ethyl acetate; IPA: isopropanol; LC-MS/MS: liquid chromatography-tandem mass spectrometry; MeOH: methanol; MTBE: methyl tert-butyl ether; SPE: solid-phase extraction.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
D004852 Epoxy Compounds Organic compounds that include a cyclic ether with three ring atoms in their structure. They are commonly used as precursors for POLYMERS such as EPOXY RESINS. Epoxide,Epoxides,Epoxy Compound,Oxiranes,Compound, Epoxy,Compounds, Epoxy
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
D005511 Food Handling Any aspect of the operations in the preparation, processing, transport, storage, packaging, wrapping, exposure for sale, service, or delivery of food. Food Processing,Handling, Food,Processing, Food
D005858 Germany A country in central Europe, bordering the Baltic Sea and the North Sea, between the Netherlands and Poland, south of Denmark. The capital is Berlin.
D006358 Hot Temperature Presence of warmth or heat or a temperature notably higher than an accustomed norm. Heat,Hot Temperatures,Temperature, Hot,Temperatures, Hot
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
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
D041943 Infant Formula Formulations for the nutrition of infants that are substituted for BREAST MILK. Baby Formula,Baby Formulas,Formula, Baby,Formula, Infant,Formulas, Baby,Formulas, Infant,Infant Formulas

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