§165.110. Bottled water. — Inbound Citations

(2) The ingredient is used to treat the following foods at levels not to exceed current good manufacturing practice: for use in washing and lye peeling of fruits, vegetables, and nuts when used in accordance with § 173.315 of this chapter; for use as a denuding agent in tripe; for use as a hog scald agent in removing hair; and for use as a corrosion preventative in canned and bottled water when used in accordance with § 165.110 of this chapter.

(2) The public water system must receive a certification from the bottled water company that the bottled water supplied has been taken from an “approved source” as defined in 21 CFR 129.3(a); the bottled water company has conducted monitoring in accordance with 21 CFR 129.80(g) (1) through (3); and the bottled water does not exceed any MCLs or quality limits as set out in 21 CFR 165.110, part 110, and part 129. The public water system shall provide the certification to the State the first quarter after it supplies bottled water and annually thereafter. At the State's option a public water system may satisfy the requirements of this subsection if an approved monitoring program is already in place in another State.

(ii) Test and sample methods shall be those recognized and approved by the government agency or agencies having jurisdiction over the approval of the water source, and shall be consistent with the minimum requirements set forth in § 165.110(b) of this chapter.

(g) A quality standard for bottled drinking water is established in § 165.110(b) of this chapter. To assure that the plant's production of bottled drinking water complies with the applicable standards, laws, and regulations of the government agency or agencies having jurisdiction, the plant will analyze product samples as follows:

(1) For bacteriological purposes, take and analyze at least once a week for total coliform a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production. The representative sample shall consist of primary containers of product or unit packages of product. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are E. coli.

(2) For chemical, physical, and radiological purposes, take and analyze at least annually a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production. The representative sample(s) consists of primary containers of product of unit packages of product.

(3) The plant shall maintain records of date of sampling, type of product sampled, production code, and results of the analysis.

(g) Bottled water must meet the quality standards for bottled water in § 165.110(b)(2) through (b)(5) of this chapter, including the limits specified for total silver and nitrate, unless the water bears a label statement of substandard quality, as provided for under § 165.110(c) of this chapter.

(g) Bottled water must meet the quality standards for bottled water in § 165.110(b)(2) through (b)(5) of this chapter, including the limits specified for total silver and nitrate, unless the water bears a label statement of substandard quality, as provided for under § 165.110(c) of this chapter.

(g) Bottled water must meet the quality standards for bottled water in § 165.110(b)(2) through (b)(5) of this chapter, including the limits specified for total silver and nitrate, unless the water bears a label statement of substandard quality, as provided for under § 165.110(c) of this chapter.

(1) 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 the limitations established in § 165.110(b)(4)(ii). 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 part 129 of this chapter.

(1) The amount of silver in the treated bottled water is determined using the method for silver designated in 21 CFR 165.110(b)(4)(iii)(G)(2)(i).

(iii) Firms that do not use a public water system as the source of their water and whose source water has not been treated with a chlorine-based disinfectant or ozone do not have to test their source water for the residual disinfectants and DBP's listed in § 165.110(b)(4)(iii)(H) of this chapter. Firms that do not use a public water system as the source of their water but whose source water has been treated with a chlorine-based disinfectant or ozone must test their source water for the residual disinfectants and the DBP's listed in § 165.110(b)(4)(iii)(H) that are likely to result from such treatment.

(g) Bottled water must meet the quality standards for bottled water in § 165.110(b)(2) through (b)(5) of this chapter, including the limits specified for total silver and nitrate, unless the water bears a label statement of substandard quality, as provided for under § 165.110(c) of this chapter.

(g) Bottled water must meet the quality standards for bottled water in § 165.110(b)(2) through (b)(5) of this chapter, including the limits specified for total silver and nitrate, unless the water bears a label statement of substandard quality, as provided for under § 165.110(c) of this chapter.

The Commissioner of Food and Drugs has concluded that it is in the interest of the public health to limit the addition of fluorine compounds to foods (a) to that resulting from the fluoridation of public water supplies, (b) to that resulting from the fluoridation of bottled water within the limitation established in § 165.110(d) of this chapter, and (c) to that authorized by regulations (40 CFR part 180) under section 408 of the Act.