Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food

Heather Wallace, Alexander Jan, Lars Barregård, Margherita Bignami, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Lutz Edler, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Carlo Stefano Nebbia, Isabelle Oswald, Annette Petersen, Vera Maria Rogiers, Martin Rose, Alain-Claude Roudot, Tanja Schwerdtle, Christiane Vleminckx & 2 others Günter Vollmer, Panel on Contaminants in the Food Chain

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Abstract

EFSA was asked to deliver a scientific opinion on free and esterified 3- and 2-monochloropropane-1,2-diol (MCPD) and glycidyl esters in food. Esters of 3- and 2-MCPD and glycidol are contaminants of processed vegetable oils; free MCPDs are formed in some processed foods. The Panel on Contaminants in the Food Chain (CONTAM Panel) evaluated 7,175 occurrence data. Esters of 3- and 2-MCPD and glycidyl esters were found at the highest levels in palm oil/fat, but most vegetable oil/fats contain substantial quantities. Mean middle bound (MB) dietary exposure values to total 3-MCPD, 2-MCPD and glycidol, respectively, across surveys and age groups in µg/kg body weight (bw) per day were 0.2–1.5, 0.1–0.7 and 0.1–0.9; high exposure (P95) values were 0.3–2.6, 0.2–1.2 and 0.2–2.1. Animal studies show extensive hydrolysis of esterified 3-MCPD and glycidol following oral administration; esterified and free forms were assumed to contribute equally to internal exposures. Nephrotoxicity was consistently observed in rats treated with 3-MCPD. Data on 2-MCPD toxicity were insufficient for dose–response assessments. Chronic treatment with glycidol increased the incidence of tumours in several tissues of rats and mice, likely via a genotoxic mode of action. The Panel selected a BMDL10 value for 3-MCPD of 0.077 mg/kg bw per day for induction of renal tubular hyperplasia in rats and derived a tolerable daily intake (TDI) of 0.8 µg/kg bw per day. The mean exposure to 3-MCPD was above the TDI for ‘Infants’, ‘Toddlers’ and ‘Other children’. For glycidol, the Panel selected a T25 value of 10.2 mg/kg bw per day for neoplastic effects in rats. The margins of exposure (MoEs) were 11,300–102,000 and 4,900–51,000 across surveys and age groups at mean and P95 exposures, respectively. An exposure scenario for infants receiving formula only resulted in MoEs of 5,500 (mean) and 2,100 (P95). MoEs of 25,000 or higher were considered of low health concern.
Original languageEnglish
Article number4426
Pages (from-to)1-159
Number of pages159
JournalEFSA Journal
Volume14
Issue number5
DOIs
Publication statusPublished - May 2016

Fingerprint

glycidol
Esters
Fatty Acids
Food
Health
Body Weight
No-Observed-Adverse-Effect Level
Plant Oils
alpha-Chlorohydrin
Age Groups
Fats
2-monochloropropanediol
Infant Formula
Food Chain
Hyperplasia
Oral Administration
Hydrolysis
Kidney

Keywords

  • MCPD
  • glycidol
  • glycidyl fatty acid esters
  • process contaminant
  • refined oil fat

Cite this

Wallace, H., Jan, A., Barregård, L., Bignami, M., Ceccatelli, S., Cottrill, B., ... Panel on Contaminants in the Food Chain (2016). Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food. EFSA Journal, 14(5), 1-159. [4426]. https://doi.org/10.2903/j.efsa.2016.4426

Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food. / Wallace, Heather; Jan, Alexander; Barregård, Lars; Bignami, Margherita; Ceccatelli, Sandra; Cottrill, Bruce; Dinovi, Michael; Edler, Lutz; Grasl-Kraupp, Bettina ; Hogstrand, Christer ; Hoogenboom, Laurentius (Ron) ; Knutsen, Helle Katrine ; Nebbia, Carlo Stefano ; Oswald, Isabelle ; Petersen, Annette ; Rogiers, Vera Maria; Rose, Martin ; Roudot, Alain-Claude ; Schwerdtle, Tanja ; Vleminckx, Christiane ; Vollmer, Günter ; Panel on Contaminants in the Food Chain .

In: EFSA Journal, Vol. 14, No. 5, 4426, 05.2016, p. 1-159.

Research output: Contribution to journalArticle

Wallace, H, Jan, A, Barregård, L, Bignami, M, Ceccatelli, S, Cottrill, B, Dinovi, M, Edler, L, Grasl-Kraupp, B, Hogstrand, C, Hoogenboom, LR, Knutsen, HK, Nebbia, CS, Oswald, I, Petersen, A, Rogiers, VM, Rose, M, Roudot, A-C, Schwerdtle, T, Vleminckx, C, Vollmer, G & Panel on Contaminants in the Food Chain 2016, 'Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food', EFSA Journal, vol. 14, no. 5, 4426, pp. 1-159. https://doi.org/10.2903/j.efsa.2016.4426
Wallace, Heather ; Jan, Alexander ; Barregård, Lars ; Bignami, Margherita ; Ceccatelli, Sandra ; Cottrill, Bruce ; Dinovi, Michael ; Edler, Lutz ; Grasl-Kraupp, Bettina ; Hogstrand, Christer ; Hoogenboom, Laurentius (Ron) ; Knutsen, Helle Katrine ; Nebbia, Carlo Stefano ; Oswald, Isabelle ; Petersen, Annette ; Rogiers, Vera Maria ; Rose, Martin ; Roudot, Alain-Claude ; Schwerdtle, Tanja ; Vleminckx, Christiane ; Vollmer, Günter ; Panel on Contaminants in the Food Chain . / Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food. In: EFSA Journal. 2016 ; Vol. 14, No. 5. pp. 1-159.
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abstract = "EFSA was asked to deliver a scientific opinion on free and esterified 3- and 2-monochloropropane-1,2-diol (MCPD) and glycidyl esters in food. Esters of 3- and 2-MCPD and glycidol are contaminants of processed vegetable oils; free MCPDs are formed in some processed foods. The Panel on Contaminants in the Food Chain (CONTAM Panel) evaluated 7,175 occurrence data. Esters of 3- and 2-MCPD and glycidyl esters were found at the highest levels in palm oil/fat, but most vegetable oil/fats contain substantial quantities. Mean middle bound (MB) dietary exposure values to total 3-MCPD, 2-MCPD and glycidol, respectively, across surveys and age groups in µg/kg body weight (bw) per day were 0.2–1.5, 0.1–0.7 and 0.1–0.9; high exposure (P95) values were 0.3–2.6, 0.2–1.2 and 0.2–2.1. Animal studies show extensive hydrolysis of esterified 3-MCPD and glycidol following oral administration; esterified and free forms were assumed to contribute equally to internal exposures. Nephrotoxicity was consistently observed in rats treated with 3-MCPD. Data on 2-MCPD toxicity were insufficient for dose–response assessments. Chronic treatment with glycidol increased the incidence of tumours in several tissues of rats and mice, likely via a genotoxic mode of action. The Panel selected a BMDL10 value for 3-MCPD of 0.077 mg/kg bw per day for induction of renal tubular hyperplasia in rats and derived a tolerable daily intake (TDI) of 0.8 µg/kg bw per day. The mean exposure to 3-MCPD was above the TDI for ‘Infants’, ‘Toddlers’ and ‘Other children’. For glycidol, the Panel selected a T25 value of 10.2 mg/kg bw per day for neoplastic effects in rats. The margins of exposure (MoEs) were 11,300–102,000 and 4,900–51,000 across surveys and age groups at mean and P95 exposures, respectively. An exposure scenario for infants receiving formula only resulted in MoEs of 5,500 (mean) and 2,100 (P95). MoEs of 25,000 or higher were considered of low health concern.",
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T1 - Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food

AU - Wallace, Heather

AU - Jan, Alexander

AU - Barregård, Lars

AU - Bignami, Margherita

AU - Ceccatelli, Sandra

AU - Cottrill, Bruce

AU - Dinovi, Michael

AU - Edler, Lutz

AU - Grasl-Kraupp, Bettina

AU - Hogstrand, Christer

AU - Hoogenboom, Laurentius (Ron)

AU - Knutsen, Helle Katrine

AU - Nebbia, Carlo Stefano

AU - Oswald, Isabelle

AU - Petersen, Annette

AU - Rogiers, Vera Maria

AU - Rose, Martin

AU - Roudot, Alain-Claude

AU - Schwerdtle, Tanja

AU - Vleminckx, Christiane

AU - Vollmer, Günter

AU - Panel on Contaminants in the Food Chain

N1 - The Panel wishes to thank the members of the Working Group on MCPD and glycidyl esters: Mona-Lise Binderup, Colin Crews, Daniel Doerge, Peter Furst, Christer Hogstrand, Alfonso Lampen, Ian Morris and Dieter Schrenk, for the preparatory work on this scientific opinion; and EFSA staff members: Davide Arcella, Marco Binaglia, Barbara Dorr, Natalie Thatcher, Ruth Roldan Torres, Eniko Varga and Francesco Vernazza, for the support provided to this scientific opinion.

PY - 2016/5

Y1 - 2016/5

N2 - EFSA was asked to deliver a scientific opinion on free and esterified 3- and 2-monochloropropane-1,2-diol (MCPD) and glycidyl esters in food. Esters of 3- and 2-MCPD and glycidol are contaminants of processed vegetable oils; free MCPDs are formed in some processed foods. The Panel on Contaminants in the Food Chain (CONTAM Panel) evaluated 7,175 occurrence data. Esters of 3- and 2-MCPD and glycidyl esters were found at the highest levels in palm oil/fat, but most vegetable oil/fats contain substantial quantities. Mean middle bound (MB) dietary exposure values to total 3-MCPD, 2-MCPD and glycidol, respectively, across surveys and age groups in µg/kg body weight (bw) per day were 0.2–1.5, 0.1–0.7 and 0.1–0.9; high exposure (P95) values were 0.3–2.6, 0.2–1.2 and 0.2–2.1. Animal studies show extensive hydrolysis of esterified 3-MCPD and glycidol following oral administration; esterified and free forms were assumed to contribute equally to internal exposures. Nephrotoxicity was consistently observed in rats treated with 3-MCPD. Data on 2-MCPD toxicity were insufficient for dose–response assessments. Chronic treatment with glycidol increased the incidence of tumours in several tissues of rats and mice, likely via a genotoxic mode of action. The Panel selected a BMDL10 value for 3-MCPD of 0.077 mg/kg bw per day for induction of renal tubular hyperplasia in rats and derived a tolerable daily intake (TDI) of 0.8 µg/kg bw per day. The mean exposure to 3-MCPD was above the TDI for ‘Infants’, ‘Toddlers’ and ‘Other children’. For glycidol, the Panel selected a T25 value of 10.2 mg/kg bw per day for neoplastic effects in rats. The margins of exposure (MoEs) were 11,300–102,000 and 4,900–51,000 across surveys and age groups at mean and P95 exposures, respectively. An exposure scenario for infants receiving formula only resulted in MoEs of 5,500 (mean) and 2,100 (P95). MoEs of 25,000 or higher were considered of low health concern.

AB - EFSA was asked to deliver a scientific opinion on free and esterified 3- and 2-monochloropropane-1,2-diol (MCPD) and glycidyl esters in food. Esters of 3- and 2-MCPD and glycidol are contaminants of processed vegetable oils; free MCPDs are formed in some processed foods. The Panel on Contaminants in the Food Chain (CONTAM Panel) evaluated 7,175 occurrence data. Esters of 3- and 2-MCPD and glycidyl esters were found at the highest levels in palm oil/fat, but most vegetable oil/fats contain substantial quantities. Mean middle bound (MB) dietary exposure values to total 3-MCPD, 2-MCPD and glycidol, respectively, across surveys and age groups in µg/kg body weight (bw) per day were 0.2–1.5, 0.1–0.7 and 0.1–0.9; high exposure (P95) values were 0.3–2.6, 0.2–1.2 and 0.2–2.1. Animal studies show extensive hydrolysis of esterified 3-MCPD and glycidol following oral administration; esterified and free forms were assumed to contribute equally to internal exposures. Nephrotoxicity was consistently observed in rats treated with 3-MCPD. Data on 2-MCPD toxicity were insufficient for dose–response assessments. Chronic treatment with glycidol increased the incidence of tumours in several tissues of rats and mice, likely via a genotoxic mode of action. The Panel selected a BMDL10 value for 3-MCPD of 0.077 mg/kg bw per day for induction of renal tubular hyperplasia in rats and derived a tolerable daily intake (TDI) of 0.8 µg/kg bw per day. The mean exposure to 3-MCPD was above the TDI for ‘Infants’, ‘Toddlers’ and ‘Other children’. For glycidol, the Panel selected a T25 value of 10.2 mg/kg bw per day for neoplastic effects in rats. The margins of exposure (MoEs) were 11,300–102,000 and 4,900–51,000 across surveys and age groups at mean and P95 exposures, respectively. An exposure scenario for infants receiving formula only resulted in MoEs of 5,500 (mean) and 2,100 (P95). MoEs of 25,000 or higher were considered of low health concern.

KW - MCPD

KW - glycidol

KW - glycidyl fatty acid esters

KW - process contaminant

KW - refined oil fat

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DO - 10.2903/j.efsa.2016.4426

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JO - EFSA Journal

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SN - 1831-4732

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