New Bottling Standards

New FDA Bottled Water Standards In Effect May 13, 2008.

The final regulation, published in November sets standard definitions for different types of bottled waters. This includes artesian, ground, mineral, purified, sparkling, spring, sterile, and well water.

The regulation requires mineral water to meet the bottled water quality standards. It must come from a protected underground source and contain at least 250 parts per million in total dissolved solids.

The new Bottled Water Standards also requires that water bottled from municipal water supplies must be clearly labeled as such. Unless it is processed sufficiently to be labeled as "distilled" or "purified" water.

Bottled Water, like all other foods regulated by FDA, must be processed, packaged, shipped, and stored in a safe and sanitary manner. It must be truthfully and accurately labeled. Bottled water products must also meet specific FDA quality standards for contaminants.

Bottled water is regulated as a food under the Federal Food, Drug, and Cosmetic Act (FFDCA) by the FDA. New and specific FDA regulations now cover Current Good Manufacturing Practices (CGMP's) for bottled water production.

Recent regulatory activity on bottled water includes adoption of New Bottling Standards with allowable levels of certain disinfectants and disinfection byproducts in the quality standard for bottled water.

Also required is a publication of a feasibility study on the appropriate methods for providing consumers with information on the contents of bottled water.

New Bottling Standards Identity

The FDA standard definition for different types of boiled water are:

Artesian Water: Water from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer.

Mineral Water: Water containing not less than 250 ppm total dissolved solids that originates from a geologically and physically protected underground water source. Mineral water is characterized by constant levels and relative proportions of minerals and trace elements at the source. No minerals may be added to mineral water.

Municipal Water Supplies: The regulation also requires that water bottled from municipal water supplies must be clearly labeled as such, unless it is processed sufficiently to be labeled as "distilled" or "purified" water.

Purified Water: Water that is produced by distillation, deionization, reverse osmosis or other suitable processes and that meets the definition of "purified water" in the U.S.

As appropriate, also may be called "demineralized water," "deionized water," "distilled water," and "reverse osmosis water."

Sparkling Bottled Water: Water that, after treatment and possible replacement of carbon dioxide, contains the same amount of carbon dioxide that it had at emergence from the source.

Spring Water: Water derived from an underground formation from which water flows naturally to the surface of the earth at an identified location.

Spring water may be collected at the spring or through a bore hole tapping the underground formation feeding the spring, but there are additional requirements for use of a bore hole.

New Bottling Standards

Section 165.110(b) also lists methods that the FDA will use to determine whether bottled water samples comply with the quality standard. Bottlers are not required to use these methods in their own facilities; alternate methods are acceptable.

Whatever method they use, bottlers are responsible for ensuring that their bottled water can pass the tests used by FDA in its own laboratories, should testing be performed by the FDA.

The Standard of Quality also includes allowable levels for more than 70 different Chemical Water Contaminants

State And Local New Bottling Standards

In addition to the FDA, state and local governments also regulate bottled water. The FDA relies on state and local government agencies to approve water sources for safety and sanitary quality, as specified in part 129.3 of the bottled water regulations.

Also, some states have regulations that differ from FDA's in content or coverage. For example, Texas requires water haulers transporting water in a tank truck or trailer to maintain a minimum chlorine residual of 0.5 mg/L in the water, whereas FDA does not have any specific regulations requiring chlorination of water.

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