Stepan Technology Addresses Suspected Carcinogens in Infant Formula

09 May 2016 –- European Food Safety Authority (EFSA) have exposed that infant formulas and certain other products consumed by toddlers and children contain levels of Glycidyl and MCPD esters (which are suspected carcinogens) that exceed acceptable levels, in some cases up to ten times. Ingredient supplier Stepan Lipid Nutrition notes that since 2011 they have utilized their patented process to manufacture Neobee Medium Chain Triglycerides with extremely low levels of Glycidyl and MCPD esters.

EFSA assessed the risks for public health of the substances: glycidyl fatty acid esters (GE), 3-monochloropropanediol (3-MCPD), and 2-monochloropropanediol (2-MCPD) and their fatty acid esters. The substances form during food processing, in particular, when refining vegetable oils at high temperatures (approx. 200°C).

The highest levels of GE, as well as 3-MCPD and 2-MCPD (including esters) were found in palm oils and palm fats, followed by other oils and fats. For consumers aged three and above, margarines and ‘pastries and cakes’ were the main sources of exposure to all substances.

EFSA’s expert Panel on Contaminants in the Food Chain (CONTAM) considered information on the toxicity of glycidol (the parent compound of GE) for its risk assessment of GE, assuming a complete conversion of the esters into glycidol following ingestion.

Dr Helle Knutsen, Chair of the CONTAM Panel, said: “There is sufficient evidence that glycidol is genotoxic and carcinogenic, therefore the CONTAM Panel did not set a safe level for GE.”

When assessing genotoxic and carcinogenic substances that are unintentionally present in the food chain, EFSA calculates a ‘margin of exposure’ for consumers. In general, the higher the margin of exposure is, the lower the level of concern for consumers.

The Panel concluded that GE is a potential health concern for all younger age groups with average exposures, and for consumers with high exposure in all age groups.

“The exposure to GE of babies consuming solely infant formula is a particular concern as this is up to ten times what would be considered of low concern for public health,” said Dr Knutsen.

“We have set a tolerable daily intake (TDI) of 0.8 micrograms per kilogram of body weight per day (µg/kg bw/day) for 3-MCPD and its fatty acid esters based on evidence linking this substance to organ damage in animal tests,” explained Dr Knutsen. She added that, “the toxicological information is too limited, however, to set a safe level for 2-MCPD.”

Estimated average and high exposures to 3-MCPD from both forms for young age groups including adolescents (up to 18 years of age) exceed the TDI and are a potential concern for health.

Palm oil is a major contributor to 3-MCPD and 2-MCPD exposure for most individuals. Levels of 3-MCPD and its fatty acid esters in vegetable oils were largely unchanged over the last five years.

Stepan Lipid Nutrition began addressing this issue in 2009 and their work led to a process patent issued in the US in 2015. Since 2011 they have utilized their patented process to manufacture Neobee Medium Chain Triglycerides with extremely low levels of Glycidyl and MCPD esters. “We continue to work towards offering the industry the highest quality, safest and most cost effective MCTs available,” said Robert Peacock in an open statement to Stepan Lipid Nutrition customers.

Jenifer Galante, Ph.D. Sr. Research Manager for Stepan Lipid Nutrition told FoodIngredientsFirst: "GE and MCPD levels are regulated in the US under California's Prop 65 Enforcement Act. In our experience other regions of the world commonly follow EFSAs lead on regulatory guidance."

"When Stepan began addressing the issue in 2009 the analytical methodology was still evolving. Today there are accepted methods in place and customers are incorporating limits into their specifications," claims Galante.

"This is an issue for all food products containing fats and oils that originated over concerns of high levels of MCPD found in soy sauce," she adds. "Our ongoing research into this area continues to demonstrate the usefulness of this processing across a wide variety of edible oils at production scale."

Neobee MCT were the original Medium Chain Triglycerides, introduced to the market in the 1950s. Today Stepan manufactures Neobee MCTs in their FSSC-22000 certified plant in Maywood, NJ.

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