Bottled Water [Food and Drug Administration (FDA)] | AIChE

Bottled Water [Food and Drug Administration (FDA)]

As defined by the FDA [Department of Health and Human Services, Federal Register, Part III, 21 CFR Part 165, Subpart B–Requirements for Specific Standardized Beverages, effective May 13, 1996] bottled water is water that is intended for human consumption and that is sealed in bottles or other containers with no added ingredients except that it may optionally contain safe and suitable antimicrobial agents. Fluoride may be optionally added within certain specified limitations. Bottled water may be named bottled water, drinking water, or alternatively one of the following terms may be used as appropriate:

  1. 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 tope of the aquifer.
  2. Ground Water – Water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure; ground water must not be under the direct influence of surface water.
  3. Mineral Water – Water containing not less than 250 parts per million (ppm) total dissolved solids (TDS), coming from a source tapped at one or more bore holes or springs, originating from a geologically and physically protected underground water source; mineral water shall be distinguished from other types of water by its constant level and relative proportions of minerals and trace elements at the point of emergence from the source; no minerals may be added to this water. Mineral water containing less than 500 ppm TDS must be labeled “low mineral content”. Conversely, if the water has more than 1,500 ppm TDS, it must be labeled “high mineral content”.
  4. Purified Water – Water that has been produced by distillation, deionization, reverse osmosis, or other suitable processes and that meets the definition of “purified water” in the United States Pharmacopeia. May also be called demineralized water, purified drinking water, or alternatively, based on the process used, deionized (drinking) water, distilled (drinking) water, reverse osmosis (drinking) water, etc.
  5. Sparkling Bottled Water – Water that, after treatment and possible replacement of carbon dioxide, contains the same amount of carbon dioxide from the source that it had at emergence from the source.
  6. Spring Water – Water derived from an underground formation from which water flows naturally to the surface of the earth; shall be collected only at the spring or through a bore hole tapping the underground formation feeding the spring.
  7. Sterile or Sterilized Water – Water that meets the requirements under “Sterility Tests” in the United States Pharmacopeia.
  8. Well Water – Water from a hole bored, drilled, or otherwise constructed in the ground which taps the water of an aquifer. Other label statements for bottled water include “low mineral content” for TDS levels below 500 ppm, “high mineral content” for TDS levels above 1,500 ppm, or when the water comes from a community water system, it must be labeled “from a community water system,” or, alternatively, “from a municipal source.”

Go to Process Safety Glossary

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