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On October 19, 2011, the US Food and Drug Administration (FDA) modified its bottled water quality standard regulations to establish a maximum allowable level of 0.006 mg/L for the chemical di(2-ethylhexyl)phthalate (DEHP). Under this modification to 21 CFR 165.110 , bottled water manufacturers will now be required to monitor their finished products and the source water for DEHP on an annual basis. The new regulation takes effect on April 16, 2012.

Exposure assessment analyses conducted in various studies have concluded that the primary pathway of exposure to the chemical DEHP is through the diet. According to the Environmental Protection Agency (EPA), long-term, chronic exposure to DEHP above the maximum contaminant level (MCL) of 0.006 mg/L may have the potential to cause damage to the liver and testes, reproductive effects, and cancer in humans.

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

Addressing those findings, the FDA has amended its bottled water quality standard regulations by establishing 0.006 mg/L as the maximum allowable level for the DEHP. At least once each year, bottled water manufacturers will be required to monitor their finished bottled water products for DEHP under the current good manufacturing practice (cGMP) regulations for bottled water. Under the new regulation, source water must also be monitored for DEHP as often as necessary but at least once every year unless they meet the criteria for source water monitoring exemptions under the cGMP regulations. The new regulation rule will ensure FDA
standards for the minimum quality of bottled water, as affected by DEHP, are equivalent to those set by the EPA for public drinking water. This rule will be effective on April 16, 2012.

Throughout the SGS global network, we can test bottled water for DEHP by carrying out measurements on a wide range of phthalates as well as by analyzing DEHP at trace levels utilizing GC-MS and LC-MS/MS techniques. If you need more information, please don’t hesitate to contact us. 

Jeremy Li
61 Kai-Fa Road, Nanzih Export Processing Zone, Kaohsiung, Taiwan 81170

t: +886 7 301 2121
f: +886 7 301 2867
Website: www.agriculture-food.sgs.com

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