CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 2]

[CITE: 21CFR129]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION

PART 129 PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

Subpart A - General Provisions

Sec. 129.1 Current good manufacturing practice.

The applicable criteria in parts 110 and 117 of this chapter, as well as the criteria in §§ 129.20, 129.35, 129.37, 129.40, and 129.80 shall apply in determining whether the facilities, methods, practices, and controls used in the processing, bottling, holding, and shipping of bottled drinking water are in conformance with or are operated or administered in conformity with good manufacturing practice to assure that bottled drinking water is safe and that it has been processed, bottled, held, and transported under sanitary conditions.

[80 FR 56167, Sept. 17, 2015]

Sec. 129.3 Definitions.

For the purposes of this part, the following definitions apply:

(a) Approved source when used in reference to a plant's product water or operations water means a source of water and the water therefrom, whether it be from a spring, artesian well, drilled well, municipal water supply, or any other source, that has been inspected and the water sampled, analyzed, and found to be of a safe and sanitary quality according to applicable laws and regulations of State and local government agencies having jurisdiction. The presence in the plant of current certificates or notifications of approval from the government agency or agencies having jurisdiction constitutes approval of the source and the water supply.

(b) Bottled drinking water means all water which is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water.

(c) Lot means a collection of primary containers or unit packages of the same size, type, and style produced under conditions as nearly uniform as possible and designated by a common container code or marking.

(d) Multiservice containers means containers intended for use more than one time.

(e) Nontoxic materials means materials for product water contact surfaces utilized in the transporting, processing, storing, and packaging of bottled drinking water, which are free of substances which may render the water injurious to health or which may adversely affect the flavor, color, odor, or bacteriological quality of the water.

(f) Operations water means water which is delivered under pressure to a plant for container washing, hand washing, plant and equipment cleanup and for other sanitary purposes.

(g) Primary container means the immediate container in which the product water is packaged.

(h) Product water means processed water used by a plant for bottled drinking water.

(i) Shall and should. "Shall" refers to mandatory requirements and "should" refers to recommended or advisory procedures or equipment.

(j) Shipping case means a container in which one or more primary containers of the product are held.

(k) Single-service container means a container intended for one time usage only.

(l) Unit package means a standard commercial package of bottled drinking water, which may consist of one or more containers.

[42 FR 14355, Mar. 6, 1977, as amended at 44 FR 12175, Mar. 6, 1979]

Authority: 21 U.S.C. 342, 348, 350k, 371, 374, 42 U.S.C. 264.
Source: 42 FR 14355, Mar. 15, 1977, unless otherwise noted.