New DEHP water limit will not cost consumers: FDA

23-Oct-2011 - Last updated on 25-Oct-2011 at 12:54 GMT

The US Food and Drug Administration (FDA) insists its new maximum allowable levels for the chemical di(2-ethylhexyl)phthalate (DEHP) in bottled water will not raise costs for consumers.

DEHP is commonly used to make plastics more flexible, and is commonly used in food packaging materials, but can also enter food as an environmental contaminant.

But according to the US Environmental Protection Agency (EPA): “Long-term, chronic exposure to DEHP above the MCL of 0.006 mg/l may have the potential to cause health effects in humans including damage to liver and testes, reproductive effects and cancer.”

Effective from April 2012, the new FDA’s new rule establishes allowable levels for pesticides and other synthetic organic chemicals, including a DEHP level of 0.06 mg/litre.

The FDA rules also require manufacturers to monitor products for DEHP at least once a year under good manufacturing practice (CGMP) regulations.

Monitoring source water

Source water must also be monitored as often as necessary and at least once a year, unless they meet the criteria for source water monitoring exemptions under the CGMP.

The FDA said that its amended rule brought bottled water standards for maximum contaminant levels (MCL) in line with those set by the Environmental Protection Agency (EPA) for public drinking water.

The 0.006 mg/l limit has been adopted by the International Bottled Water Association – representing a large segment of the EU and US industry – in its model code since 1995.

The FDA said in its Federal Register notice announcing the change that it was meeting a requirement under the Food, Drug and Cosmetic Act to amend its regulation in response to the MCL’s changes.

The FDA added: “Although DEHP is not expected to be found in bottled water in levels above the standard, the FDA concludes that this rule is protective of public health.”

It would protect consumers by ensuring that, if the current situation changes, and new sources of water or new manufacturing practices were used, levels of DEHP would remain low.

But one comment addressing the FDA’s previous April 2010 register document on DEHP opposed the standards change, asserting that evidence from 2 studies “put previous concerns to rest” concerning the effects of DEHP consumption in humans.

Adverse health effects

The FDA responded by noting that it was establishing allowable levels for DEHP in water, not changing standards for plastic bottles, while the petitioner did not provide sufficient evidence to challenge the EPA’s finding on adverse health effects above.

“Therefore, the FDA continues to believe that it is appropriate to base its allowable level for DEHP in bottle water upon the MCL established by EPA for public drinking water.”

A second unnamed industry petitioner stated that DEHP did not leach into water in appreciable amounts, and that prohibiting its use would means higher costs to consumers for drinks packaged in plastic bottles.

Again the FDA noted that the rule did not prohibit the use of DEHP in bottles, but simply set allowable levels for its presence in water “for any reason, not just leaching from bottles or caps”.

The administration said the comment did not provide any evidence to quantify its claim that leaching was not appreciable, while it disagreed that the rule change would increase costs for consumers.

“Many US manufacturers already appear to be meeting the allowable level for DEHP in bottled water,” said the FDA.

“Therefore, the FDA does not agree with the comment’s assertion that the rule prohibits the use of DEHP or its assertion that the rule would increase costs for consumers for beverages packaged in plastic bottles.”

The FDA also noted - in its full register decision here - that DEHP is not used in bottled water caps or closures in the US, and is not permitted under European Commission (EC) regulations for plastic caps or plastic lid gaskets used in metal caps.