Infant Formula and 3-MCPDs

IFC Statement on 3-MCPDs and Infant Formula

IFC’s* Position
3-MCPDs, and a related form (i.e., 3-MCPD esters), are substances that may be formed at high temperatures during food processing and home cooking, and are frequently found in foods.  The food industry has been proactively working to minimize free 3-MCPD – suggested to be potentially harmful – as well as 3-MCPD esters, through intensive research.  Although 3-MCPD esters have been found in some foods, no free 3-MCPD has been found in infant formula. 

Thus, no changes in infant feeding practices are recommended; mothers who formula feed should continue to do so.  Parents and health professionals can be assured that the U.S. infant formula industry is committed to providing products that are safe and nutritious for infants and young children.

German Government Study
IFC has reviewed the opinion of the German government’s Federal Institute for Risk Assessment (BfR), which is based on one recent study by a German food control laboratory showing the presence of 3-monochloropropane-1,2-diol esters (bound 3-MCPD) in foods, including infant formulas.  In its opinion, the BfR raises concerns that formulas may contain levels of 3-MCPD esters, which, if hydrolyzed in the body, may release free 3-MCPD’s, thus raising a possible health concern for infants.  However, it is unknown if 3-MCPD esters are hydrolyzed to the free form in humans.  In fact, the BfR has stated that there is a “certain degree of uncertainty” with this recommendation.

Additionally, there is currently no reliable method for detecting and quantifying 3-MCPD esters.  The existing method is new and not yet validated.  The BfR’s concerns were based on the assumptions that 3-MCPD esters would be hydrolyzed to free 3-MCPD in the body, and that if all dietary 3-MCPD esters (100%) were subject to such hydrolysis, the levels of free 3-MCPD would be excessive.  Currently, there is no scientific evidence to support this assumption.  The lack of toxicological data and limited exposure data on 3-MCPD esters preclude a proper risk assessment.  In fact, in their report, it was stated they do not believe that there is “an acute danger.”

Other Regulatory Authorities Opinion
Because 3-MCPD esters are not known to be a health problem, only the free form of 3-MCPD is regulated by the European Union, the Codex Alimentarius and the U.S. Food and Drug Administration with published permitted upper levels.

May 2008

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* The IFC is an association of manufacturers and marketers of formulated nutrition products, e.g., infant formulas and adult nutritionals, whose members are based predominantly in North America.  IFC members are: Abbott Nutrition; Mead Johnson Nutrition; Nestlé Infant Nutrition; and Wyeth Nutrition.