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

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 BMDL 10 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 BMDL 05 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 lg/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 lg/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.

Updated Food Composition Database for Cereal-Based Gluten Free Products in Spain: Is Reformulation Moving on?

“…In fact, recent research on palm fat and oil has brought up intriguing health issues, due to the presence of toxic contaminants generated in the processing of palm oil and other vegetable oils. This has promoted an update on the tolerable daily intakes (TDI) for toxic contaminants (2-and 3-monochloropropanediols and glycidyl esters [28,29]), but has also posed some misunderstandings in mass communication [28]. Consumers have been aware of these issues through the media, demanding and purchasing only palm oil free biscuits, especially for children.…”

Re‐evaluation of acetic acid, lactic acid, citric acid, tartaric acid, mono‐ and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono‐ and diglycerides of fatty acids (E 472a‐f) as food additives

“…Esters of 3‐monochloropropane‐1,2‐diol (3‐MCPD) were found at the highest levels in palm oil/fat (EFSA CONTAM Panel, 2016a), which can be used as a raw material for E 472a‐f. It has been confirmed that the toxicity of 3‐MCPD fatty acid esters should be considered equivalent (on a molar basis) to that of the parent compound (3‐MCPD) (EFSA CONTAM Panel, 2016a, ). The Panel noted that there is no limit for 3‐MCPD/3‐MCPD esters in the specifications for E 472a‐f.…”

The Evaluation of Childhood Foods and Infant Formula Exposure to Furan, Chloropropanols and Acrylamide Contamination by Food Processing

“…However, current evidence suggests that these compounds can be considered within low risk group for human health for the reason that the level of the presence of these compounds in foodstuffs is low [43]. EFSA determined the tolerable daily intake (TDI) for 3-MCPD as 0.8 μg/kg bw per day, whereas JECFA suggested the provisional maximum tolerable daily intake (PMTDI) of 4 μg/kg bw/day [44,45]. Recent studies revealed that chloropropanols was found in several foodstuffs at different levels particularly in soy sauces, meat and meat products, fish and sea foods, cereals, snacks, bread, biscuits, crisps, chips, baby foods and infant formulas as well [46,47].…”