Information Statement

3-MCPD and glycidyl esters

The Institute of Food Science & Technology has authorised the following Information Statement, dated November 2011, replacing that of June 2011. SUMMARY

3-MCPD (3-monochloropropane-1,2-diol) is the most commonly occurring of a group of contaminants known as chloropropanols. First identified as a contaminant of acidhydrolyzed vegetable proteins and soy sauce it was later found in other food groups. Because it is a potential carcinogen, a maximum daily intake of 2ug/kg body weight (TDI) has been recommended. 3-MCPD and its esters can be formed in heat-processed, fat-containing food from glycerol or acylglycerides in the presence of chloride ions. Much of the 3-MCPD found in foods is present as the fatty acyl esters. Glycidyl Esters are a related process contaminant. It was first thought this compound could be a precursor of 3-MCPD monoesters; however, this is unlikely based on current understandings. Further studies are underway to better understand the food categories where 3 MCPD and its esters are found, mechanisms of formation and toxicological significance. The purpose of this document is to provide an overview on 3MCPD, formation and occurrence in foods, public health significance, legislation, methods of detection, and industry good practices. Further background and information can be found in the references. What is 3-MCPD (3-monochloropropane-1, 2-diol)? 3-MCPD (3-monochoropropane-1, 2-diol) is a contaminant first identified in acid-hydrolyzed vegetable proteins and soy sauce. It is the most commonly occurring of a group of contaminants known as chloropropanols. Chloroesters are also found to be present in certain foods, often at much higher levels than 3MCPD. These compounds structurally relate to 3-MCPD.

Formation OF 3-MCPD 2011 IFST Page 1 of 6

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Institute of Food Science and Technology Information Statement 3-MCPD and glycidyl esters
3-MCPD may be formed as a result of a reaction between a source of chlorine (e.g. chlorinated water or salt) in the food or a food contact material and a lipid source. This reaction is encouraged during the heat processing of foods, including the roasting of cereals and malts used for brewing. It is also known to occur in acid-hydrolysed vegetable protein (HVP) when produced using hydrochloric acid. 3-MCPD has been found to occur at low levels in a number of foods and ingredients. The mechanisms for its formation in some of these are not fully understood. The Foods Standards Agency in the United Kingdom has commissioned a comprehensive research project, aiming to elucidate the factors affecting the production of 3-MCPD in foods. Once formed, the stability of 3-MCPD has been shown to be dependent upon the pH and temperature to which it has been exposed. The higher the pH and the higher the temperature of the heat treatment, the greater will be the rate of degradation of 3-MCPD. During the production of fats and oils, 3-MCPD fatty acid esters may be formed from 3-MCPD when the fats and oils are heated to high temperatures in the presence of chloride ions. The German research institute FEI is currently leading a coordinated project aimed at investigating the mechanism of formation. Once the mechanism of formation is understood mitigation strategies can be put in place in order to minimize levels. Occurrence of 3-MCPD in Foodstuffs 3MCPD has been found in a wide range of food. These foodstuffs include soy sauce, bread, noodles, biscuits; malt based food ingredients, coffee and certain meats, cheeses, salted fish and smoked foods. Main contributors of 3-MCPD to dietary intake were found to be soy sauce and soy-sauce based products, and bread and noodles. The latter two due to high consumption rather than the high levels of 3-MCPD present in these foods. In cereal derived products it is understood that salt, commonly added, is one of the major precursors. The other major precursor is glycerol. Glycerol and chloride react together during the baking stage to form 3MCPD. Other compounds will also form 3 -MCPD on reaction with chloride, various substituted glycerols and phospholipids. The occurrence of 3-MCPD in cheese is generally low, although it can be found in grilled or microwaved cheese. In cooked meats there does not appear to be a clear relationship between the obvious precursors and glycerol. Additionally the impact of the heating process (cooking) is not clear. Low levels have been found in malt derived products used for colouring and flavouring. Formation occurs in the dry kilning of the malted and un malted barley at 170C. In roasted coffee low levels have been found. Levels are non- detectable in the coffee beverages due to dilution. 2011 IFST Page 2 of 6

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Institute of Food Science and Technology Information Statement 3-MCPD and glycidyl esters
Mechanisms of formation in smoked foods are not clearly understood and thought to be linked to the smoking process. Fatty acid esters of 3-MCPD have been found in high levels in refined edible oils and fats and derived foods, including milk powder for infants by the German control authorities. The processes which were considered to be possible factors in 3-MCPD formation included: naturally occurring levels in the raw materials storage of raw materials use of chlorinated water for washing purposes Commercial production processing treatments including baking, evaporation, fermentation, malting, pasteurisation, roasting, smoking, sprays drying, sterilisation and UHT. migration from food contact materials storage of prepared products Domestic preparation including baking, boiling, frying, grilling and toasting. Public health significance. The Scientific Committee on Food established a tolerable daily intake (TDI) of 2 g/kg body weight (b.w.) in 2001 based on a carcinogenicity study in rats with a LOAEL of 1.1 mg /kg b.w. for kidney hyperplasia and by applying an uncertainty factor of 500. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established a provisional maximum tolerable daily intake (PMTDI) of 2 g/kg b.w. in 2001. In 2006 the JECFA noted that no new pivotal studies had become available, and retained the PMTDI for 3-MCPD. The JECAF noted that 3MCPD esters had been reported in foods, but there were insufficient data to evaluate their intake or toxicological significance. Significant amounts of 3-MCPD fatty acid esters have now been detected by food control authorities in numerous edible fats and fat-containing foods, for instance in infant formula and follow-up formula. The Federal Institute for Risk Assessment (BfR) has assessed the health implications of the detected levels and recommended that concerted action be taken to lower the concentrations of 3-MCPD esters in infant formula and follow-up formula. Toxicological studies on glycidol fatty acid esters are currently not available. It is likewise not known whether and to what extent glycidol fatty acid esters are converted to glycidol during digestion. Glycidol has mutagenic and carcinogenic properties and was classified by IARC as "probably carcinogenic to humans" . Pending the availability of corresponding study results, a risk assessment must, therefore, assume provisionally the worst case in hypothetic terms, i.e. a full transformation into glycidol. Alternatively, it would be necessary to carry out long-term toxicological studies with the corresponding fatty acid esters. For 3-MCPD fatty acid esters there is a similar problem. 3-MCPD causes renal tumours in rats. The way the tumours develop is not clarified in a satisfactory manner. 3-MCPD does not exhibit any mutagenic properties in vivo unlike in the in vitro studies. A paper by Nestle suggests that only 15% of the 3-MCPD may be released from the ester form by pancreatic lipase activity. 2011 IFST Page 3 of 6
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Institute of Food Science and Technology Information Statement 3-MCPD and glycidyl esters
Legislation European Commission Regulation (EC) No1881/2006 prescribes maximum levels of 3-MCPD of 0.02 mg/kg (20g/kg) for hydrolysed vegetable protein and soy sauce. In the case of the soy sauce, the limit is based on a product containing 40% dry matter (corresponding to a maximum level of 0.05mg/kg (50g/kg) in the dry matter). Detection A method using derivatization of the analytes and GCMS (the Weisshaar method) was primarily used for the analysis of 3-MCPD, but subsequently the method was found to produce false results. While developing further and better methods for the analysis of 3-MCPD esters, glycidyl esters (glycidol is a monoglyceride with an epoxide bridge in position 1 and 3 of the glycerine molecule) also were found in various refined oils. Additionally, it was shown that in the Weisshaar method, glycidol was converted to 3-MCPD and partially caused the misleading results. Several methods for the analysis of both ester types have now been developed, including direct methods that need nearly no sample preparation, as well as various modifications of the Weisshaar method. Still, the analytical situation is unclear as there are differences between the levels found with direct and indirect measurement methods. European Food Safety Agency and the Codex Committee on Contamination in Foods indicate there are insufficient data to proceed with an analysis of 3-MCPD esters due to current method accuracy. AOCS (American Oil Chemists Society) established an Expert Panel on Process Contaminants in December 2009. The panel is initially focusing on two process contaminants - 3monochloropropane-1,2-diol (3-MCPD) esters and glycidyl (glycidol) esters. Industry good practices. In cases where the mechanism of formation is understood, such as cereals, measures can be taken to reduce the levels of precursors. However for many food groups the mechanism of formation is not clearly understood. Any reduction measures need to ensure a comprehensive HACCP review taking into account impact to chemical, microbiological and physical hazards for the target consumer group. In addition quality parameters and consumer acceptance need to be reviewed.

References 1. http://ec.europa.eu/food/food/chemicalsafety/contaminants/mcpd_en.htm Legislation EC 1881/2006 Sampling and analysis EC 333/2007 Scientific opinions ILSI 3 MCPD esters workshop presentations SCOOP report chloropropanols in food 2011 IFST Page 4 of 6

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Institute of Food Science and Technology Information Statement 3-MCPD and glycidyl esters
2. http://www.aocs.org/tech/Background%20and%20references20090423.pdf Further analytical information 3-MCPD and glycidyl Esters analytics and mitigation Expert panel updates Papers from May 2011 meeting 3. Direct Determination of MCPD Fatty Acid Esters and Glycidyl Fatty Acid Esters in Vegetable Oils by LC-TOFMS by ADM as published in JAOCS. http://www.springerlink.com/3MCPDesters/ADM 4. http://www.bfr.bund.de/cm/279/frequently_asked_questions_about_3_monochloropropane_ 1_2_diol.pdf Focus on risk assessment of 3 MCPD esters Risk assessment of 3MCPD esters in food. 5. http://europe.ilsi.org/events/past/Workshop3MCPDesters.htm International workshop on 3 MCPD esters 6. http://www.food.gov.uk/search?p=Q&mainresults=mt_mainresults_yes&ts=v2&w=3+mcpd& submit.x=10&submit.y=3 FSA Background information Occurrence in foods Incidents COT report Research study 7. Strategies for the reduction of 3-MCPD esters and related compounds in vegetable oils 1,* 2 2 1 Bertrand Matthus , Frank Pudel , Peer Fehling , Klaus Vosmann , Anne 1 Freudenstein FSA 8. FEI research program Fatty acid esters of chloropropanols and related compounds in food: Toxicological aspects Benoit Schilter , Gabriele Scholz, Walburga Seefelder Nestle paper can be found in : Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008 Apr;25(4):391-400. Esters of 3-chloro-1,2-propanediol (3-MCPD) in vegetable oils: significance in the formation of 3-MCPD. Seefelder W, Varga N, Studer A, Williamson G, Scanlan FP, Stadler RH. 10. Further paper on in vivo absorption of 3 MCPD esters: Buhrke, T., Weihaar, R., and Lampen, A., Absorption and Metabolism of the Food Contaminant 3-Chloro-1,2-propanediol (3-MCPD) and its Fatty Acid Esters by Human Intestinal Caco-2 Cells, Archives of Toxicology: 1-8 (2011). Web 11 May 2011.

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Institute of Food Science and Technology Information Statement 3-MCPD and glycidyl esters
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