Standard: HHS - 21 CFR PART 129


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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.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 129
Publish Date: 2017-04-01
Page Count: 6
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 129 Change Type: COMPLETE REVISION Update Date: 2014-04-01 Status: ACTV
21 CFR PART 129 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV
21 CFR PART 129 Change Type: COMPLETE REVISION Update Date: 2016-04-01 Status: ACTV

Standards That Reference This Standard

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