Allowable Levels Established for DEHP in Bottled Water
In April 2012, the Food and Drug Administration (FDA) will begin regulating the level of di(2-ethylhexyl)phthalate (DEHP) in bottled water. Manufacturers will be required to annually monitor their finished bottled water products and source water for DEHP in order to maintain compliance with current good manufacturing practice (cGMP) regulations.
Currently, the Environmental Protection Agency (EPA) monitors public drinking water at a maximum contaminant level (MCL) of 0.006 mg/L for DEHP. The FDA will match this level for bottled water beginning April 16. The decision to regulate DEHP levels was made following the 2010 comment period regarding the 1993 proposal for increased bottled water management.
The FDA is adopting EPA-approved analytical methods for contamination detection. Any bottled water that exceeds the allowable level of DEHP, following analyses using these approved methods, will be labeled misbranded under section 403(h)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act). This misbranding will be fact in all cases that do not present a statement of substandard quality.
Read the full Federal Register notice at http://www.gpo.gov/fdsys/pkg/FR-2011-10-19/pdf/2011-26707.pdf