FDA sets strict DEHP limit for bottled water

How safe is that water bottle you just purchased?  Are you sure the clear, refreshing liquid inside is as pure and chemical free as you expect?  Bottled water is actually regulated quite extensively, but despite that monitoring, new risks continue to be addressed to help reduce any potential threat to long-term consumer health.

Bottled water is federally regulated under the Federal Food, Drug, and Cosmetic Act. Manufacturers of bottled water must follow the FDA’s stringent food safety and labeling  requirements, as well as specific Good Manufacturing Practices to help ensure that the water inside those creatively designed plastic bottles maintains a specific quality level. 

There are also state responsibilities for bottled water.  State health departments efforts are focused on supporting the federal regulations and making sure that they are strictly adhered to. Some of the state responsibilities include:

• Making sure that all water comes from approved sources
• Inspecting and analyzing those approved sources
• Certifying  third-party testing labs to ensure consistent & reliable results
• Random and annual inspections of bottling plants and finished products

Water sources for bottled water sold in the USA can also be outside the U.S. borders, so the bottled water industry also voluntarily follows the International Bottled Water Association Model Code, which requires annual plant and water source inspections.

On the other hand, pubic drinking water (municipal water) is regulated as a product by the Environmental Protection Agency (EPA) through the Safe Drinking Water Act. Public water goes through a water treatment system of coagulation, sedimentation, disinfection and filtration that helps eliminate contaminants and assure the best quality results.

The blitz of popularity that bottled water has enjoyed, also brought with it new environmental and health issues.  One such issue is the release of a chemical known as  DEHP or di(2-ethylhexyl) phthalate. This chemical is on the California Proposition 65 list of chemicals known to cause cancer or birth defects or other reproductive harm. Studies have shown that the main exposure to this chemical is through diet (ingestion). The clear, flexible plastic used to mold the bottles can sometimes contain DEHP, and the potential for this chemical to leach out of the plastic and into the water inside is very real. 

For this reason, effective April 16, 2012, bottled drinking water will have to meet new, stricter FDA water quality standards.  The existing FDA 21 CFR 165.110 was recently amended, establishing a specific allowable DEHP limit of 0.005 mg/litre. Manufacturers of bottled water will now be required to annually monitor both their source water and finished product for appropriate levels of DEHP. By setting a specific DEHP limit, and requiring adherence to Best Practices in Manufacturing, bottled water safety will be equivalent to the EPA’s requirements for public drinking water.

Now - if we can only find a way to reduce the significant assault on the environment that bottled water presents.  The World Wide Fund for Nature suggests that over 1.5 million tons of plastic is used in 89 billion liters of water every year. While the DEHP may be limited in each individual bottle, the accumulative result is large amounts of this chemical leaching out into landfills at amazing rates.

On step forward, but still losing the race.

CPSC Sets Date for Phthalate Testing Requirement

Does your child’s huggable, cuddly soft plastic baby doll contain a hidden hazard? According to many consumer product safety advocates, Congress, and the nation’s top consumer safety authority, the U.S. Consumer Product Safety Commission (CPSC), it may.  For years concerns have been brought up as to the possible health risks associated with prolonged exposure to “phthalates.”

Phthalates are chemicals used during the manufacturing process to add flexibility to some kinds of plastics.  There is some evidence that the most commonly used phthalates may have a long-term use health hazard for children. While there has been much controversy regarding the validity of the risk analysis and the science behind this concern, in 1999 the European Union (EU) placed a temporary ban on DEHP, DBP, BBP, DINP, DIDP and DNOP in children’s products.  In July 2005, the EU made that ban permanent and became the first safety organization to ban phthalates in toys and mouthable toys.  Since that time, many U.S. states have jumped on the bandwagon and banned the use of phthalates in children’s tableware, bottles and mouthable toys.

Three years ago, Congress passed the Consumer Product Safety Act of 2008 (CPSIA) which, among many other restrictions, included a new federal restriction on the use of phthalates.  Using the available research, the limit set by the CPSIA was 0.1 percent.  A product that was found to have more than 0.1% of any one of these six phthalates would be considered to be in violation of the law.

In February 2009, it became unlawful in the United States to manufacture, import or sell certain children’s toys and childcare articles that contain six specific phthalates. CPSIA also mandated that manufacturers have the products tested at a third party testing lab to demonstrate compliance to this new regulation.  Due to the complex testing method, lack of available testing labs, and the time required to re-design manufacturing processes to accommodate for the removal of these phthalates, a stay of enforcement has been in place on the testing requirement portion of the new law.

Last week the CPSC voted unanimously to extend the stay until December 31, 2011.  The vote means that children’s products and childcare articles manufactured on or after that date will be required to have third-party testing documentation showing compliance.  For domestically produced items, the paperwork must be in place prior to placing the product on the market.  For imported items, this testing paperwork must be in place prior to importation of the product into the United States. Manufactures that are found to be in violation of this new federal law could be subject to fines.

To narrow the scope of the testing, CPSC has agreed that only those parts of the product that could potentially contain phthalates (plastics), and only those parts that are accessible to the child are subject to testing.  Manufacturers are encouraged to follow the guidance document published by CPSC in 2009 to determine which materials are subject to this testing.  

Of interest is that the State of California’s Proposition 65 also has a restriction of another phthalate, DnHP, in children’s products that can be mouthed. Many manufacturers are working to eliminate all seven of these phthalates in their soft plastic toys and childcare articles.  

One comment on this restriction:  When manufactures are restricted from using one material, they are often forced to use new materials that could have the same or potentially worse long-term harm.  Since phthalates had been used for decades prior to this concern being raised, it is possible that the substitute chemicals used may one-day undergo the same scrutiny that these seven phthalates have gone through.