(A) The name of the food is bottled water or alternatively one or more of the following terms as appropriate:
(1) Artesian water or artesian well water is the name of the water from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer. Artesian water or artesian well water may be collected with the assistance of external force to enhance the natural underground pressure. On request, plants shall demonstrate to appropriate regulatory officials that the water level stands at some height above the top of the aquifer.
(2) Ground water is the name of the 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 as defined in 40 C.F.R. Part 141.2(1975).
(3) Mineral water is the name of the water containing not less than two hundred fifty ppm total dissolved solids. Mineral water must come 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, due account being taken of the cycles of natural fluctuations. No minerals may be added to this water.
(4) Purified water is the name of the water from an approved source, 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, 23rd revision, January 1, 1995. Purified water may be called "deionized water" if the water has been processed by deionization, "distilled water" if it is produced by distillation, "reverse osmosis water" if the water has been processed by reverse osmosis, and " drinking water" with the blank being filled in with one of the defined terms describing the water in this paragraph (e.g., "purified drinking water" or "deionized drinking water").
(5) Sparkling bottled water is the name of the 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 is the name of the water derived from an underground formation from which water flows naturally to the surface of the earth. Spring water shall be collected only at the spring or through a bore hole tapping the underground formation feeding the spring. There shall be a natural force causing the water to flow to the surface through a natural orifice. The location of the spring shall be identified. Spring water collected with the use of an external force shall be from the same underground stratum as the spring, as shown by a measurable hydraulic connection using a hydrogeologically valid method between the bore hole and the natural spring, and shall have all the physical properties, before treatment, and be of the same composition and quality, as the water that flows naturally to the surface of the earth. If spring water is collected with the use of an external force, water must continue to flow naturally to the surface of the earth through the spring's natural orifice. Plants shall demonstrate using a hydrogeologically valid method, that an appropriate hydraulic connection exists between the natural orifice of the spring and the bore hole.
(7) Sterile water is the name of the water that meets sterility tests in the United States pharmacopeia, 23rd revision, January 1, 1995, which can be found at www.usp.org. Alternatively the water may be called sterilized water.
(8) Well water is the name of the water from a hole bored, drilled, or otherwise constructed in the ground which taps the water of an aquifer.
In addition to labeling standards set forth in paragraph (A) of this rule and rule 901:3-1-11 of the Administrative Code, the following standards shall also apply:
(1) If the TDS content of mineral water is below five hundred ppm, or if it is greater than one thousand five hundred ppm, the statement "low mineral content'' or the statement "high mineral content'', respectively, shall appear on the principal display panel following the statement of identity in type size at least one-half the size of the statement of identity but in no case of less than one-sixteenth of an inch. If the TDS of mineral water is between five hundred and one thousand five hundred ppm, no additional statement need appear.
(2) When bottled water comes from a community water system, as defined in 40 C.F.R. Part 141.2(1975), except when it has been treated to meet the definition of purified water in paragraph (A)(4) of this rule, or sterile water in paragraph (A)(7) of this rule, and is labeled as such, the label shall state "from a community water system'' or, alternatively, "from a municipal source'' as appropriate, on the principal display panel or panels. This statement shall immediately and conspicuously precede or follow the name of the food without intervening written, printed, or graphic matter, other than statements required by paragraph (B)(3) of this rule, in type size at least one-half the size of the statement of identity but in no case of less than one-sixteenth of an inch.
(3) When the label or labeling of a bottled water product states or implies that the bottled water is for use in feeding infants, and the product is not commercially sterile under paragraph (B)(4) of rule 901:3-3-01 of the Administrative Code, the product's label shall bear conspicuously and on the principal display panel the statement "Not sterile. Use as directed by physician or by labeling directions for use of infant formula.''
(4) For the purposes of this rule, the standard of quality for bottled water, including water for use as an ingredient in beverages shall be specified in 21 C.F.R., Part 165.110(2011). When the microbiological, physical, chemical, or radiological quality of bottled water is below that prescribed in 21 C.F.R. Part 165.110(2011), the label shall bear the statement of substandard quality as applicable:
(a) "Contains Excessive Bacteria."
(b) "Excessively Turbid", "Abnormal Color," or "Abnormal Odor".
(c) "Contains Excessive ________ ," with the blank filled in with the name of the chemical for which a maximum contaminant level is exceeded. Except that "Contains Excessive Chemical Substances" may be used if the bottled water is not mineral water.
(d) "Excessively Radioactive."