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FDA Defines Maximum Level of DEHP for Bottled Water

On October 19, 2011, the US Food and Drug Administration (FDA) modified its regulations for bottled water quality standards to establish a maximum allowed level of 0.006 mg/L for the chemical di(2-ethylhexyl)phthalate (DEHP), bringing it into line with existing regulations for tap water. The modification to regulation 21 CFR 165.110, will require bottled water manufacturers to monitor their finished products, and the source water, for DEHP content on an annual basis. The new regulation takes effect on April 16, 2012.


Taiwan, China -- (SBWIRE) -- 01/02/2012 -- Various studies have concluded through exposure assessment analyses that the primary pathway for public exposure to the chemical DEHP is food and drinks. Phthlalates are used in the manufacture of plastics and trace amounts can transfer from contact with a plastic container. The Environmental Protection Agency (EPA) states that the long-term and chronic exposure to DEHP above the maximum contaminant level (MCL) of 0.006 mg/L has the potential to cause damage to the liver and testes, produce reproductive effects and give rise to cancer in humans.

Contaminant (CAS Reg. No.): Di(2-ethylhexyl)phthalate (117-81-7)
Maximum contaminant level (MCL) in milligrams per liter (ppm): 0.006

In response to these findings, the FDA ( has amended its regulations for bottled water quality standards by establishing 0.006 mg/L as the maximum allowable concentration of DEHP. At least once a year from April 2012, bottled water manufacturers will be required to monitor their finished bottled water products for DEHP content under the current good manufacturing practice (cGMP) regulations for bottled water. Unless it is exempted, source water must also be monitored for DEHP as often as necessary under the new regulations, but at least once every year. The new rules will ensure the FDA’s minimum quality standards for bottled water, with regards to DEHP content, are equivalent to those set by the EPA for public drinking water. The rule will be effective throughout the USA from April 16, 2012.

About SGS Food Safety Services
SGS Food Safety Services ( can test bottled water for DEHP at many of the laboratories in the worldwide SGS network, by carrying out analyses for a wide range of phthalates as well as determining trace levels of DEHP utilizing gas and liquid chromatography mass spectroscopy techniques.

Please don’t hesitate to contact SGS’ experts should you need more information.


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