Assyro AI

Title 21 CFR reference

Explore the full hierarchy of this title across chapters, subchapters, and parts.

Select a part from the tree to begin

Browse chapters and parts on the left to load sections

United States • Title 21 CFR • Part 165

Part 165PART 165—BEVERAGES

This part of the CFR outlines definitions and standards for beverages, with a specific focus on bottled water. It details requirements for the identity, nomenclature, labeling, and quality (microbiological, physical, and chemical) of bottled water.

What this part covers

  • Defines 'lot', 'sample', and 'analytical unit' for quality assessment.
  • Establishes the identity and nomenclature for bottled water, including various types like artesian, ground, mineral, purified, spring, sterile, and well water.
  • Specifies labeling requirements, including statements for low/high mineral content, source from community water systems, and warnings for infant use.
  • Sets standards of quality for bottled water, covering microbiological (total coliform, E. coli), physical (turbidity, color, odor), and chemical (THM, HAA5, fluoride, inorganic substances, VOCs, SOCs) parameters.
  • Incorporates by reference various standard methods for water analysis from the United States Pharmacopeia and the American Public Health Association.

Sections in Part 165

§ 165.110

Bottled water.

IdentityDescription.(a) —(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. Nomenclature.(2) The name of the food is “bottled water,” “drinking water,” or alternatively one or more of the following terms as appropriate: (i) The name of water from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer is “artesian water” or “artesian well water.” Artesian water may be collected with the assistance of external force to enhance the…

§ 165.3

Definitions.

lot(a) A is: (1) For purposes of determining quality factors related to manufacture, processing, or packing, a collection of primary containers or units of the same size, type, and style produced under conditions as nearly uniform as possible and usually designated by a common container code or marking, or in the absence of any common container code or marking, a day's production. (2) For purposes of determining quality factors related to distribution and storage, a collection of primary containers or units transported, stored, or held under conditions as nearly uniform as possible. sample(b) A consists of 10 subsamples (consumer units), one taken from each of 10 different randomly chosen shipping cases to be representative of a given lot, unless otherwise specified in a specific standard in this part. analytical unit(c) An is the portion(s) of food taken from a subsample of a sample for the purpose of analysis.

Regulatory Context

This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.

United StatesCFR

Related Terms

Operational Use Cases

Related Actions