Update of the risk assessment on 3‐monochloropropane diol and its fatty acid esters

Helle Katrine Knutsen, Jan Alexander, Lars Barregård, Margherita Bignami, Beat Brüschweiler, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Lutz Edler, Bettina Grasl-Kraupp, Laurentius (Ron) Hoogenboom, Carlo Stefano Nebbia, Isabelle P. Oswald, Annette Petersen, Martin Rose, Alain-Claude Roudot, Tanja Schwerdtle, Christiane Vleminckx, Günter Vollmer, Heather Wallace & 8 others Alfonso Lampen, Ian Morris, Aldert Piersma, Dieter Schrenk, Marco Binaglia, Sara Levorato, Christer Hogstrand, EFSA Panel on Contaminants in the Food Chain (CONTAM)

Research output: Contribution to journalArticle

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Abstract

The CONTAM Panel updated the assessment of the risks for human health related to the presence of 3‐monochloropropane diol (3‐MCPD) and its fatty acid esters in food published in 2016 in view of the scientific divergence identified in the establishment of the tolerable daily intake (TDI) in the Joint FAO/WHO Expert Committee on Food Additives and Contaminants (FAO/WHO) report published in 2017. In this update, dose–response analysis was performed following the recent EFSA Scientific Committee guidance on the use of benchmark dose (BMD) approach in risk assessment, and a review of available data on developmental and reproduction toxicity was included. The outcome of this review indicates that in rats short‐term exposure to 3‐MCPD above 1 mg/kg body weight (bw) per day can induce reduced sperm motility associated with reduced male fecundity. Decreased sperm count and histopathological changes in the testis and epididymis were observed following longer treatment periods at higher doses. Regarding increased incidence kidney tubular hyperplasia, BMD analysis using model averaging resulted in a BMDL10 of 0.20 mg/kg bw per day in male rats, which was selected as the new Reference Point (RP) for renal effects. For the effects on male fertility, decreased sperm motility was selected as the most sensitive relevant endpoint and a BMDL05 of 0.44 mg/kg bw per day was calculated. The RP for renal effects was considered to derive an updated group TDI of 2 μg/kg bw per day for 3‐MCPD and its fatty acid esters and was considered protective also for effects on male fertility. The established TDI of 2 μg/kg bw per day is not exceeded in the adult population. A slight exceedance of the TDI was observed in the high consumers of the younger age groups and in particular for the scenarios on infants receiving formula only.
Original languageEnglish
Article numbere05083
Number of pages48
JournalEFSA Journal
Volume16
Issue number1
Early online date10 Jan 2018
DOIs
Publication statusPublished - Jan 2018

Fingerprint

No-Observed-Adverse-Effect Level
Esters
Fatty Acids
Body Weight
Fertility
Benchmarking
Sperm Motility
Kidney
Food Additives
Infant Formula
Sperm Count
Epididymis
Hyperplasia
Reproduction
Testis
Age Groups
Joints
Food
Incidence
Health

Keywords

  • 3-MCPD
  • fatty acid esters
  • process contaminant
  • refined vegetable oils
  • benchmark dose
  • risk assessment

Cite this

Knutsen, H. K., Alexander, J., Barregård, L., Bignami, M., Brüschweiler, B., Ceccatelli, S., ... EFSA Panel on Contaminants in the Food Chain (CONTAM) (2018). Update of the risk assessment on 3‐monochloropropane diol and its fatty acid esters. EFSA Journal, 16(1), [e05083]. https://doi.org/10.2903/j.efsa.2018.5083

Update of the risk assessment on 3‐monochloropropane diol and its fatty acid esters. / Knutsen, Helle Katrine ; Alexander, Jan; Barregård, Lars; Bignami, Margherita; Brüschweiler, Beat ; Ceccatelli, Sandra; Cottrill, Bruce; Dinovi, Michael; Edler, Lutz; Grasl-Kraupp, Bettina ; Hoogenboom, Laurentius (Ron) ; Nebbia, Carlo Stefano ; Oswald, Isabelle P.; Petersen, Annette ; Rose, Martin ; Roudot, Alain-Claude ; Schwerdtle, Tanja ; Vleminckx, Christiane ; Vollmer, Günter ; Wallace, Heather; Lampen, Alfonso; Morris, Ian; Piersma, Aldert; Schrenk, Dieter; Binaglia, Marco ; Levorato, Sara; Hogstrand, Christer ; EFSA Panel on Contaminants in the Food Chain (CONTAM).

In: EFSA Journal, Vol. 16, No. 1, e05083, 01.2018.

Research output: Contribution to journalArticle

Knutsen, HK, Alexander, J, Barregård, L, Bignami, M, Brüschweiler, B, Ceccatelli, S, Cottrill, B, Dinovi, M, Edler, L, Grasl-Kraupp, B, Hoogenboom, LR, Nebbia, CS, Oswald, IP, Petersen, A, Rose, M, Roudot, A-C, Schwerdtle, T, Vleminckx, C, Vollmer, G, Wallace, H, Lampen, A, Morris, I, Piersma, A, Schrenk, D, Binaglia, M, Levorato, S, Hogstrand, C & EFSA Panel on Contaminants in the Food Chain (CONTAM) 2018, 'Update of the risk assessment on 3‐monochloropropane diol and its fatty acid esters', EFSA Journal, vol. 16, no. 1, e05083. https://doi.org/10.2903/j.efsa.2018.5083
Knutsen HK, Alexander J, Barregård L, Bignami M, Brüschweiler B, Ceccatelli S et al. Update of the risk assessment on 3‐monochloropropane diol and its fatty acid esters. EFSA Journal. 2018 Jan;16(1). e05083. https://doi.org/10.2903/j.efsa.2018.5083
Knutsen, Helle Katrine ; Alexander, Jan ; Barregård, Lars ; Bignami, Margherita ; Brüschweiler, Beat ; Ceccatelli, Sandra ; Cottrill, Bruce ; Dinovi, Michael ; Edler, Lutz ; Grasl-Kraupp, Bettina ; Hoogenboom, Laurentius (Ron) ; Nebbia, Carlo Stefano ; Oswald, Isabelle P. ; Petersen, Annette ; Rose, Martin ; Roudot, Alain-Claude ; Schwerdtle, Tanja ; Vleminckx, Christiane ; Vollmer, Günter ; Wallace, Heather ; Lampen, Alfonso ; Morris, Ian ; Piersma, Aldert ; Schrenk, Dieter ; Binaglia, Marco ; Levorato, Sara ; Hogstrand, Christer ; EFSA Panel on Contaminants in the Food Chain (CONTAM). / Update of the risk assessment on 3‐monochloropropane diol and its fatty acid esters. In: EFSA Journal. 2018 ; Vol. 16, No. 1.
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AU - Alexander, Jan

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AU - Brüschweiler, Beat

AU - Ceccatelli, Sandra

AU - Cottrill, Bruce

AU - Dinovi, Michael

AU - Edler, Lutz

AU - Grasl-Kraupp, Bettina

AU - Hoogenboom, Laurentius (Ron)

AU - Nebbia, Carlo Stefano

AU - Oswald, Isabelle P.

AU - Petersen, Annette

AU - Rose, Martin

AU - Roudot, Alain-Claude

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AU - Vleminckx, Christiane

AU - Vollmer, Günter

AU - Wallace, Heather

AU - Lampen, Alfonso

AU - Morris, Ian

AU - Piersma, Aldert

AU - Schrenk, Dieter

AU - Binaglia, Marco

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AU - Hogstrand, Christer

AU - EFSA Panel on Contaminants in the Food Chain (CONTAM)

N1 - The Panel wishes to thank the following for the support provided to this scientific output: the experts of the EFSA Standing Working Group on Benchmark Dose: Marc Aerts, Diane Benford, Lutz Edler, Wim Mennes, Josef Rudolf Schlatter and Wout Slob. Adopted: 21 November 2017 This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4426/full

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N2 - The CONTAM Panel updated the assessment of the risks for human health related to the presence of 3‐monochloropropane diol (3‐MCPD) and its fatty acid esters in food published in 2016 in view of the scientific divergence identified in the establishment of the tolerable daily intake (TDI) in the Joint FAO/WHO Expert Committee on Food Additives and Contaminants (FAO/WHO) report published in 2017. In this update, dose–response analysis was performed following the recent EFSA Scientific Committee guidance on the use of benchmark dose (BMD) approach in risk assessment, and a review of available data on developmental and reproduction toxicity was included. The outcome of this review indicates that in rats short‐term exposure to 3‐MCPD above 1 mg/kg body weight (bw) per day can induce reduced sperm motility associated with reduced male fecundity. Decreased sperm count and histopathological changes in the testis and epididymis were observed following longer treatment periods at higher doses. Regarding increased incidence kidney tubular hyperplasia, BMD analysis using model averaging resulted in a BMDL10 of 0.20 mg/kg bw per day in male rats, which was selected as the new Reference Point (RP) for renal effects. For the effects on male fertility, decreased sperm motility was selected as the most sensitive relevant endpoint and a BMDL05 of 0.44 mg/kg bw per day was calculated. The RP for renal effects was considered to derive an updated group TDI of 2 μg/kg bw per day for 3‐MCPD and its fatty acid esters and was considered protective also for effects on male fertility. The established TDI of 2 μg/kg bw per day is not exceeded in the adult population. A slight exceedance of the TDI was observed in the high consumers of the younger age groups and in particular for the scenarios on infants receiving formula only.

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KW - fatty acid esters

KW - process contaminant

KW - refined vegetable oils

KW - benchmark dose

KW - risk assessment

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