The US Food and Drug Administration (FDA) has completed its decision making process to establish a maximum allowable level of the synthetic organic chemical Di (2-ethylhexyl) phthalate (DEHP) in bottled water. The FDA has determined this rule to be protective of public health. Effective April 16, 2012, bottled water cannot exceed the following limit for DEHP:

About the Requirement
DEHP will now be added to the Chemical Quality section of 21 CFR 165.110. Bottled water manufacturers will be required to monitor finished product and source water (unless an exemption applies) for this chemical contaminant in addition to the many other contaminants currently listed in the Chemical Quality section of 21 CFR 165.110. Bottled water that exceeds this level of DEHP after April 16, 2012 will be deemed misbranded or adulterated as applicable per the regulation.

Background
The proposal to adopt the EPA’s maximum for this contaminant in drinking water occurred in a 1993 Federal Register notice. The comment period for this proposed rule was reopened in April of 2010 to seek a final resolution. The amendment is effective April 16, 2012.

Additional Information

Federal Register Final Rule: http://www.gpo.gov/fdsys/pkg/FR-2011-10-19/html/2011-26707.htm

Bureau Veritas Assistance
If you have any questions, please contact your customer service representative or email: cps.info@us.bureauveritas.com