Nov 01, 2011

FDA Issues New Rule Requiring Bottled Water Manufacturers to Monitor DEHP Levels

New maximum allowable level for DEHP aligns with IBWA, EPA limits

The Food and Drug Administration (FDA) recently announced a new maximum allowable level for diethylhexyl phthalate (DEHP), a chemical commonly used to make plastics more flexible, in bottled water. The new limit sets the maximum allowable level for DEHP at 0.006 mg/L.

Source water will continue to be monitored according to current good manufacturing practice (cGMP) criteria, but the new rule mandates that finished bottled water products be tested at least once a year starting April 2012.

The International Bottled Water Assn. has already been observing this 0.006 mg/L limit since 1995. The FDA declared that it does not expect to find higher levels with increased monitoring. The limit was formalized as a preventative measure, officials said.

The FDA also explained that the regulations were based on the U.S. Environmental Protection Agency’s limit for DEHP in public drinking water. According to EPA, chronic DEHP exposure above the 0.006 mg/L limit may potentially cause health problems such as liver and testes damage, reproductive effects and cancer.

Water sample testing services are available from companies such as EMSL Analytical Inc., and bottled water manufacturers are recommended to test their products for DEHP and other chemicals controlled by the FDA and EPA.