EFSA releases preliminary report on occurrence of 3-MCPD in food
By Jenifer Heydinger Galante
The European Food Safety Authority (EFSA) released a preliminary report on September 26, 2013, on the occurrence in Europe of 3-MCPD and 3-MCPD esters in foods. It drew immediate comment from industry groups in Europe and the United States. AOCS also submitted an official response to the report, noting the recent publication of four new validated AOCS methods for the characterization of MCPD-esters, 3-MCPD-esters, and glycidyl-esters (GE) in vegetable oils.
Esters of 3-monochloropropane-1,2-diol (3-MCPD-E) are process contaminants formed during the refining of vegetable oils. (For more information, visit http://tinyurl.com/ProcessContam to access the AOCS online resources on process contaminants.) The presence of 3-MCPD-E in vegetable oils was first reported in 2006. At that point—in the absence of collaboratively studied methods—little was known about the occurrence, toxicokinetics, or toxicity of 3-MCPD-E. Many data gaps were identified then and still remain.
Studies of the unesterified compound—3-MCPD—have linked it with infertility in rats, suppression of immune function, and possible carcinogenicity. The European Union’s (EU) former Scientific Committee on Food established a Tolerable Daily Intake (TDI) of 2 µg/kg body weight for 3-MCPD and, later, legislation in the EU mandated a maximum concentration level of 20 µg/kg of body weight for 3-MCPD in hydrolyzed vegetable proteins and soy sauce. (The TDI is an estimate of the amount of a substance in air, food, or drinking water that can be taken in daily over a lifetime without appreciable health risk.)
The German food safety agency, Bundesinstitut für Risikobewertung (BfR), issued a risk assessment on 3-MCPD-E in 2008. BfR based its risk assessment on toxicological data on free 3-MCPD, under the assumption that 100% of 3-MCPD is released from its esters during digestion. EFSA’s Scientific Panel on Contaminants in the Food Chain (CONTAM) agreed with the BfR estimate, in the absence of toxicokinetic data.
The September 2013 EFSA report is titled “Analysis of occurrence of 3-monochloropropane-1,2-diol (3-MCPD) in food in Europe in the years 2009–2011 and preliminary exposure assessment” and is available online at http://tinyurl.com/EFSA-3MCPD.
EFSA reviewed data from 14 EU member states on the occurrence of 3-MCPD in foods. The review found that although most of the population groups consumed less than half the TDI, toddlers and the elderly could be at risk of consuming more than the recommended maximum amount. Kartika Liotard—a member of the European Parliament (EP) for the Netherlands and a member of the EP’s Committee on the Environment, Public Health and Food Safety—has called for further action on 3-MCPD-E. Specifically, Liotard asked:
- “Will the Commission . . . lay down 3-MCPD content limits for margarine and similar products? If so, when? If not, what was the reasoning behind establishing limit values for soy sauce and not for margarine and similar products?
- “In setting limit values, will the Commission take special account of the eating habits of senior consumers, whose excessive 3-MCPD intake, according to EFSA findings, gives particular cause for concern?
- “The survey also shows that certain types of baby milk powder and follow-on formula contain high 3-MCPD concentrations. However, it gives daily intake figures for only two groups of babies. Does the Commission consider this sufficient to conclude that their intake does not exceed the safety limit? In view of the high 3-MCPD content in baby milk powder and follow-on formula revealed by the survey, will the Commission seek to impose maximum limits in respect of these products?” Liotard’s response to the report received significant press coverage in the Netherlands.
As Inform went to press in late October 2013, the European Commission had not yet responded to her questions or a request by Inform for comment. Inform also asked the US Food and Drug Administration for comment; a spokesperson said, “FDA is aware of the report and is reviewing its findings.”
Industry Response to EFSA FEDIOL
The trade group representing the EU vegetable oil and protein meal industry—responded to the EFSA report on October 3, 2013.
“As acknowledged by EFSA, its report is preliminary,” FEDIOL noted. “Further work is needed to reduce the uncertainty factors detailed by the report and to build a risk assessment upon it. It should also be noted that the data in the EFSA report have been collected between 2009 and 2011, at a time where analytical methods available for vegetable oil and fats were not validated yet.
“The availability of validated methods from 2012 has enabled our sector to explore technologies to reduce the occurrence levels of 3-MCPD-E and their viability,” FEDIOL concluded.
IMACE, the European Margarine Association, said in a written statement: “The food industry, and among them margarine manufacturers, take[s] very seriously all new scientific insights on this class of compounds formed during the refining of vegetable oils and fats and not during the margarine production process. EFSA’s preliminary exposure assessment is a first step toward the risk assessment to be carried out by competent authorities.”
In the United States, the Institute for Shortening and Edible Oils (ISEO; Washington, DC) affirmed that its “members view food safety as their utmost concern; therefore, ISEO will continue to monitor scientific developments and to assist academic researchers, industry partners, and government agencies when possible to expand our knowledge of 3-MCPD esters. In the meantime, caution should be exercised in translating the EFSA occurrence findings to intakes in the United States and other areas around the globe. Consumption patterns and food formulations, including the types and amounts of fats in oils, may differ markedly from region to region.”
The vegetable oil industry has also worked to develop mitigation strategies. The key unit operation in the refining process for the mitigation of 3-MCPD-E is bleaching, according to Wim De Greyt, R&D manager at Desmet Ballestra Group (Zaventem, Belgium), which supplies engineering services as well as plants and equipment for all fats and oils-related industries.
3-MCPD-E are not formed during the bleaching process, De Greyt explained in an email, but precursors such as acid and chlorine are brought into the oil during bleaching if HCl-activated bleaching earth is used. “We therefore recommend the use of non-HCl-activated or neutral bleaching earth,” he said.
AOCS’ Response and Method Validation
AOCS submitted a formal response to the EFSA report on October 4, 2013. In it, Technical Director and Chief Science Officer Richard Cantrill details the Society’s efforts, from forming an Expert Panel on Process Contaminants in 2009 to publishing four validated methods for the analysis of 3-MCPD-E and GE in 2012 and 2013.
“The AOCS Expert Panel has monitored the development of indirect methods,” Cantrill noted in the response, “and in 2012 it established protocols for the three most robust indirect methods. This decision was based on two needs: first, laboratories involved in food analysis needed a method that was cost effective and simple; and, second, they needed a comparison of popular methods to determine their precision and accuracy in a side-by-side comparison.”
AOCS conducted a collaborative study with 20 participants from eight countries that validated three indirect methods for characterizing 3-MCPD-E, 2-MCPD-E, and GE in oils and fats. These methods were published in September 2013.
“AOCS has worked together with the global edible oil industry to validate methods so that occurrence and exposure data can be as robust as possible,” said Cantrill. “Although primarily focused on direct analysis of contaminants, the Expert Panel decided to benchmark the three most commonly referenced indirect methods using a set of carefully manufactured authentic reference standards. Our experts were encouraged to find that the three methods not only performed equally well but also gave results close to the known content of the manufactured reference materials. AOCS is proud to have provided this valuable analytical contribution.”
In related news, Cantrill recently announced that he took part in informal discussions about the EFSA report during the October 2013 Euro Fed Lipid meeting. Those discussions led to the decision for the AOCS Expert Panel on Process Contaminants to put out a call for extraction methods for fat-containing food matrices. AOCS will then conduct a collaborative study of those extraction methods, comparing the products of extractions using the recently validated AOCS methods for the characterization of MCPD- and glycidyl-esters in oils and fats. For more information, or to submit a method, contact Cantrill by email (firstname.lastname@example.org) or phone (+1 217-693-4830).
AOCS Methods for Characterization of 3-MCPD-E and GE
Three new validated indirect methods are available on the AOCS website. This is in addition to the direct method for the characterization of GE published in 2012.
- AOCS Official Method Cd 29a-13 —2- and 3-MCPD Fatty Acid Esters and Glycidol Fatty Acid Esters in Edible Oils and Fats by Acid Transesterification.
- AOCS Official Method Cd 29b-13 —Determination of Bound Monochloropropanediol- (MCPD-) and Bound 2,3-epoxy-1-propanol (glycidol-) by Gas Chromatography/Mass Spectrometry (GC/MS).
- AOCS Official Method Cd 29c-13 —Fatty-acid-bound 3-chloropropane-1,2,diol (3-MCPD) and 2,3-epoxi-propane-1-ol (glycidol), Determination in Oils and Fats by GC/MS (Differential Measurement).
- AOCS Official Method Cd 28-10 —Glycidyl Fatty Acid Esters in Edible Oils.
- In early 2014, AOCS Press will publish the text Processing Contaminants in Edible Oils: MCPD and Glycidyl Esters. Edited by Shaun MacMahon of the US Food and Drug Administration, the book covers mitigation and removal strategies as well as analytical techniques and toxicology. Visit www.aocs.org/newbooks for the latest on this new addition to AOCS’ resources on process contaminants.