New Bottled Water Regulations From FDA

On May 13, 1996 new bottled water regulations from FDA will take effect. These new regulations are aimed at alleviating consumer confusion about the many different types of bottled water on the market by providing standard definitions for the terms "artesian water," "ground water," "mineral water," "purified water," "sparkling bottled water," "spring water," "sterile water," "well water", and others. They also bring mineral water under existing quality standards for bottled water.

Bottled water, like all other foods regulated by FDA, must be processed, packaged, shipped and stored in a safe and sanitary manner and be truthfully and accurately labeled. Bottled water products must also meet specific FDA quality standards for contaminants. Mineral water will for the first time have to meet these bottled water standards. Mineral water had previously been exempt from standards that applied to other bottled water.

The following definitions have been established by FDA:

Bottled water: Water that is intended for human consumption and that is sealed in bottles or other containers with no added ingredients except that it may contain safe and suitable antimicrobial agents. Artesian water or Artesian well water: Water from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer.

Ground water: Water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure.

Mineral water: Water containing not less than 250 parts per million total dissolved solids, originating from an underground water source. No minerals may be added to this water.

Purified water: Water that has been produced by distillation, deionization, reverse osmosis, or other processes and that meets the definition in the United States Pharmacopeia, 23d Revision, January 1, 1995.

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.

Sterile water or Sterilized water: Water that meets the requirements under "Sterility Tests" in the United States Pharmacopeia, 23d Revision, January 1, 1995.

Well water: Water from a hole bored, drilled, or otherwise constructed in the ground which taps the water of an aquifer.

Besides defining these terms, the regulation addresses various other labeling concerns. For example, water bottled from municipal water supplies must be clearly labeled as "from a community water system" or, alternatively, "from a municipal source", unless it is processed sufficiently to be labeled as "distilled" or "purified" water.

The regulation also requires accurate labeling of bottled water marketed for infants. If a product is labeled "sterile" it must be processed to meet FDA's requirements for commercial sterility (see definition above). Otherwise, the labeling must indicate that it is not sterile and should be used in preparation of infant formula only as directed by a physician or according to infant formula preparation instructions.

Source: Federal Register, November 13, 1995

Rob Brannan, M.S.
Coordinator, FACS Rapid Response Center

3/96 File: FOOD SAFETY/Laws and Regulations

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