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

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 BMDL 10 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. Amendment: A few editorial amendments were carried out that do not materially affect the contents of the outcome of this scientific output: on pages 5 and 91 'chorine' has been replaced with 'chlorine'; on page 52 the word 'it' has been replaced by 'its' in the first paragraph after Figure 7; on page 54 in the Repeated dose section the reference to MCPD has been replaced with 3-MCPD; on page 54 the 429.5 mg/kg bw day dose has been replaced with 29.5 mg/kg bw day; on page 55 in the first paragraph of the Hematology section the reference 'mg/kg per day' has been replaced with 'mg/kg bw per day; on page 55 the year for the reference Marchesini et al. has been changed from 1989 to 1986; on page 59, in the first paragraph of the Developmental toxicity section the word 'days' has been cancelled; on page 65 the reference 'Onami et al., 2014a,b' has been replaced with 'Onami et al., 2014b'; on page 85 first paragraph, reference to the lowest T25 of 10 has been replaced to 10.2. To avoid confusion, the older version has been removed from the EFSA Journal, but is available on request, as is a version sho...

Re‐evaluation of mono‐ and di‐glycerides of fatty acids (E 471) as food additives

“…According to EFSA Panel on Contaminants in Food Chain (CONTAM), refined vegetable oil, which can be used for manufacturing of mono-and di-glycerides of fatty acids (E 471), is the only identified source of glycidyl esters of fatty acids (EFSA CONTAM Panel, 2016). Glycidyl esters of fatty acids are hydrolysed in the gastrointestinal tract to produce free glycidol, which is classified as probably carcinogenic to humans 2A (IARC, 2000;BfR, 2009) and as a carcinogenic and genotoxic compound by the EFSA CONTAM Panel (EFSA CONTAM Panel, 2016). The Panel noted that there is no limit for glycidyl esters in the specifications for mono-and di-glycerides of fatty acids (E 471).…”

“…Maximum limits for erucic acid have been established in EU according to Commission Regulation (EU) No 696/2014 10 in edible oils and fats as well as in food containing fats and oils. A tolerable daily intake (TDI) of 7 mg/kg bw per day for erucic acid has been established by the EFSA CONTAM Panel based on a no observed adverse effect level (NOAEL) of 700 mg/kg bw per day for myocardial lipidosis observed in a 7-day feeding study in young (5-7 weeks) rats and in a 2-week feeding study in newborn piglets (EFSA CONTAM Panel, 2016). The Panel noted that there are no limits for erucic acid in the current EU specifications for mono-and di-glycerides of fatty acids (E 471).…”

Twitter communication of agri‐food chain actors on palm oil environmental, socio‐economic, and health sustainability

“…Finally, palm oil benefits relate to the lack of trans fat acids (FAO/WHO, 2016;Micha & Mozaffarian, 2008;Mukherjee & Mitra, 2009;Ong & Goh, 2002;Scrimshaw, 2000;Wahid et al, 2005). Studies investigating health risks from palm oil consumption refer to the process of oxidation for palm oil transformation (refined oil) that generate toxicants that are potentially harmful for the bodies and the content of saturated fats as favouring cardiovascular diseases (Disdier et al, 2013;Ebong, Owu, & Isong, 1999;EFSA CONTAM Panel, 2016…”

“…However, since the 1990s, palm oil production has been accused for adversely affecting sustainability issues relating to environmental issues (e.g., forest and wild life preservation, land use, and pesticide use) and socio-economic global challenges (e.g., smallholders, land rights, exports, and price/accessibility; Omont, 2005; Tan, Lee, Mohamed, & Bhatia, 2009;Venter, Meijaard, & Wilson, 2008). Palm oil use as food ingredient has been also questioned for potential health risks associated to an excessive consumption (EFSA CONTAM Panel, 2016). Over the years, concerns on palm oil sustainability has generated significant debates and consumers' protest campaign at global level, with particular intensity in European countries starting from 2000 (Disdier, Marette, & Millet, 2013;European Parliament, 2017aEuropean Union, 2013).…”

Outcome of a public consultation on the draft update of the guidance on the use of the benchmark dose approach in risk assessment

“…In this context, we would like to highlight an important discrepancy using the recent example of the opinion on the presence of 3-MCPD and its esters in foods(EFSA CONTAM Panel, 2016), where the 2009 guidance was applied, Lines 30-37 -The SC considers that previous assessments using the NOAEL approach or the 2009 guidance do not need reconsideration, 'because, on average, the two approaches give comparable results'.…”