Issue Date: April 5, 2010
FDA Revisits Phthalate In Bottled Water
FDA is proposing to set a maximum allowable level of 6 ppb for di(2-ethylhexyl) phthalate (DEHP) in bottled water. The agency first proposed such a standard in 1993, but the rule was put on hold in 1996. Because it has been so long since the rule was first proposed, FDA is reopening the proposal for public comment. DEHP is a suspected endocrine disrupter and probable human carcinogen. The Federal Food, Drug & Cosmetic Act requires bottled water rules to be at least as stringent as EPA’s tap water rules. EPA’s limit for DEHP in tap water is 6 ppb. The International Bottled Water Association, a trade group representing much of the U.S. bottled water industry, has adopted the 6-ppb standard for DEHP in its guidance to industry, suggesting that U.S. manufacturers already meet this level. Previously, some bottled water was shown to have levels of DEHP higher than the proposed standard after storage for long periods; DEHP leached from caps and closures.
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