Annexure-VII

1.      "Mineral Water" means water containing not less than 250 parts per million (ppm) total dissolved solids (TDS), coming from a source tapped at one or more boreholes 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.

2.      "Bottled Water" means 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 the limitations established in 21 CFR Section 165.110 (b)(4)(ii). Firms may manufacture non-standardized bottled water products with ingredients such as minerals for flavor. The common or usual name of the resultant product must reflect these additions. Bottled water may be used as an ingredient in beverages (e.g., diluted juices, flavored bottled waters). It does not include those food ingredients that are declared in ingredient labeling as “water”, “carbonated water,” “disinfected water," "filtered water," "seltzer water," "soda water," "sparkling water," and "tonic water." The processing and bottling of bottled water shall comply with applicable regulations in 21 CFR Part 129.

3.      "Sparkling Bottled Water" means bottled water that, after treatment and possible replacement of carbon dioxide, contains the same amount of carbon dioxide that it had at the emergence from the source. Manufacturers may add carbonation to previously noncarbonated bottled water products and label such water appropriately (e.g., sparkling spring water).

4.      "Natural Water" means bottled spring, mineral, artesian, or well water which is derived from an underground formation or water from surface water that only requires minimal processing, is not derived from a municipal system or public water supply, and is unmodified except for limited treatment (e.g., filtration, Ozonation or equivalent disinfection process).

5.      "Purified Water" means bottled water produced by distillation, deionization, reverse osmosis, or other suitable process and that meets the definition of purified water.

6.      "Artesian Water" means bottled 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 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.

7.      "Demineralized Water" means bottled water which is produced by distillation, deionization, reverse, or other suitable process and that meets the definition of purified water in the United States Pharmacopoeia, 23rd revision, January1, 1995, attached as Appendix B.

8.      "Deionized Water" means water that has been produced by a process of deionization and that meets the definition of "purified water" in the United States Pharmacopoeia, 23d Revision, January 1, 1995, attached as Appendix B and specified by FDA in 21 CFR Section 165.110 (a)(2)(iv).

9.      "Distilled Water" means water which has been produced by a process of distillation and meets the definition of "purified water" in the United States Pharmacopoeia, 23d Revision, January 1, 1995, attached as Appendix B and specified by FDA in 21 CFR Section 165.110 (a)(2)(iv).

10.  "Drinking Water" means 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 ant microbial agents. Fluoride may be optionally added within the limitations established in 21 CFR Section 165.110(b)(4)(ii). Firms may manufacture non-standardized drinking water products with ingredients such as minerals for flavor. The common or usual name of the resultant product must reflect these additions. Drinking water may be used as an ingredient in beverages (e.g., diluted juices, flavored bottled waters). It does not include those food ingredients that are declared in ingredient labeling a "water," "carbonated water," "disinfected water," "filtered water," "seltzer water," "soda water," "sparkling water," and "tonic water." The processing and bottling of drinking water shall comply with applicable regulations in 21 CFR Part 129.

11.  "Approved Source" when used in reference to a bottled water plant's product water or water used in the plant's operations, means the source of the water whether it be from a spring, artesian well, drilled well, public or community water system, or any other source that has been inspected and the water sampled, analyzed, and found of a safe and sanitary quality with or without treatment. Approval shall be obtained and maintained in accordance with rule 3 (c) and rule 4 (a) through (e). The bottler shall maintain in the plant a current certification or notification of approval from the applicable state agency which shall constitute approval of the source and which shall be available for inspection by the applicable state agency, and a copy of which shall be made available to consumers upon request.