Regulations
Bottled water facilities in Kentucky are classified as a public community water system. Therefore, the bottled water facility must comply with public drinking water regulations as specified in Title 401, Chapter 8 of the Kentucky Administrative Regulations (KAR). Unlike public water systems, however, bottled water facilities are not required to issue the Consumer Confidence Report.
(Water bottled outside the state is not covered by this administrative regulation, regardless of its source.)
New bottled water facilities must submit to the Drinking Water Branch the following information:
- Engineering plans and specifications.
- Analysis by a certified laboratory of source water, referred to as raw water, for all parameters regulated under 401 KAR Chapter 8. The source water may be a spring, well, stream, river or lake.
Existing bottled water facilities wishing to change the raw water source or make changes to the facility must submit the following information:
- Engineering plans and specifications that show revisions to the existing facility.
- Analysis by a certified laboratory of new raw water source for all parameters regulated under 401 KAR Chapter 8.
Kentucky Revised Statute (KRS) 224.10-110 directs the cabinet to enforce the administrative regulations adopted by the secretary for the regulation and control of the purification of water for public and semipublic use. In 2004, an amendment revised 401 KAR 8:700 to clarify the monitoring for contaminants in bottled water systems and to create conformity with bottled water rules of the U.S. Food and Drug Administration (FDA).
FDA Requirements
The FDA regulates the labeling of bottled water and requires some testing. All bottled water products must comply with the FDA's quality standards in Section 103.35(d)(2) of Title 21 of the Code of Federal Regulations.
In Kentucky, the Cabinet for Health and Family Services, Environmental Health and Community Safety, has jurisdiction regarding FDA requirements. For information on their requirements for bottled water, call 502-564-7181 or 502-564-7398.
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, which was previously exempt, must also meet these bottled water standards.
Definitions for bottled water established by the 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, Jan. 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 of sterility tests as defined in the United States Pharmacopeia, 23d Revision, Jan. 1, 1995.
Well water: Water from a hole bored, drilled or otherwise constructed in the ground that taps the water of an aquifer.
Labeling
Water bottled from municipal water supplies must be clearly labeled as "from a community water system" or, alternatively, "from a municipal source" unless it has been processed sufficiently to be labeled as "distilled" or "purified" water.
The FDA regulaton also requires accurate labeling of bottled water marketed for infants. For bottled water to be labeled "sterile," it must have been processed to meet FDA sterility requirements. 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.
For more information on FDA requirements, contact the Kentucky Cabinet for Health and Family Services at 502-564-7181 or 502-564-7398.
