FDA Seeks Comments on Proposed Rule Regarding Bottled Water Standards

The Food and Drug Administration (FDA) has reopened the comment period for a proposed rule published August 4, 1993, that would amend the quality standard for bottled water. FDA is seeking further comment on finalizing the allowable level for the chemical di(2 ethylhexyl)phthalate (DEHP) in the bottled water quality standard.

In a final rule published March 26, 1996, FDA deferred final action on DEHP’s proposed allowable level of 0.006 milligrams/liter (mg/L) in response to a comment which “maintained that finalizing the proposed allowable level for DEHP would result in a limit on the level of this chemical in bottled water that conflicts with this chemical’s permitted use under the existing food additive regulation for closures with sealing gaskets, and that taking such action would effectively ban the use of this plasticizer.” The comment further stated that “gaskets containing DEHP are permitted for use in packaging food and bottled water under relevant European national regulations.”

FDA stated in the 1996 final rule that it “was not aware of the potential conflict between the proposed allowable level for DEHP and the existing prior sanction” at the time it published the proposal. The agency is now considering finalizing DEHP’s allowable level of 0.006 mg/L. Comments are due by June 1, 2010. See Federal Register, April 1, 2010.