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food and drug branch (FDB)

Food Safety Program

ā€‹Water Bottling Plant Inspection Procedures and Operating Requirements

ā€‹ā€‹California Health and Safety Code (H&SC) Section 111120 requires operators of water bottling plants in California to obtain a Water Bottling Plant License issued by the California Department of Public Health, Food and Drug Branch (FDB). H&SC Sections 111120 and 111125 require out-of-state or foreign bottlers to obtain a Water Bottling Plant license issued by FDB to sell or distribute bottled water products in California. The Water Bottling Plant license must be renewed annually.

FDB will perform a pre-licensing inspection of in-state water bottling plants to ensure readiness to operate. Once licensed, FDB will conduct periodic on-site inspections to assess compliance with applicable State and Federal laws and regulations. The inspection will include a review of your water quality test results, bottled water report, equipment maintenance and sanitation records; and an inspection of your bottling operations, and labeling.

Water Quality Test Results

ā€‹ā€‹FDB will review your source water and product (bottled) water quality test results during on-site inspections. All testing must be conducted by a certified laboratory.

  • Source water quality test results
    • Source water quality test results must be maintained at the water bottling plant and available for review by FDB upon request.
  • Product (bottled) water quality test results
    • Pursuant to H&SC Sections 111080 and 111155, you are required to test your bottled water to establish conformance with quality standards.

ā€‹You are required to perform analyses at the frequency listed below:

ā€‹Type of Analysisā€‹
ā€‹Frequency of Testing
ā€‹Physical
ā€‹Annuallyā€‹
ā€‹Chemical
ā€‹Annually
ā€‹ā€‹Volatile Organic Chemicals
ā€‹Annually
ā€‹Non-Volatile Synthetic Organic Chemicals
ā€‹Annually
ā€‹Residual Disinfectants and DBPs
ā€‹Annually
ā€‹Radioactivity
ā€‹Bottled Water-Every Year
ā€‹Bacteriological
ā€‹ā€‹Bottled Water-Weekly


ā€‹All testing must be conducted by a laboratory certified by the California ā€‹Environmental Laboratory Accreditation Program (ELAP) or the United States Environmental Protection Agency (USEPA). For a list of ELAP- certified drinking water laboratories, please visit the agency website.

  • If more than one type of product is bottled at the facility, separate sets of analyses must be submitted and/or maintained for each type of product.
  • The laboratory results report must clearly identify your firm name, address, and FDB Water Bottling Plant license number.
  • Additional details regarding the required analyses, allowable analyses limits, and frequency of testing are listed on the water guidance document.
  • Pursuant to H&SC Section 111155, FDB may require you to test for other contaminants if FDB suspects the substances may be present in the water.

Bacteriological quality

  • You must test all product waters for total coliforms at least once every week.
  • If E. coli is present, the bottled water will be deemed adulterated. Notify the FDB Water program desk at 1-800-495-3232, investigate the cause of the problem; take corrective actions and resample/retest the water.

ā€‹ā€‹Bottling Operation Inspection

The following documents may be requested and reviewed:

  • Schematic - site (facility) diagram
  • Schematic - water treatment diagram
  • Schematic - bottling process diagram
  • Equipment specifications
  • Recall plan

On-site inspection will include an inspection of the following:

  • Bottling room and plant construction and design
  • Source and product water quality test results and records
  • Effectiveness of your sanitary operations, and monitoring records
  • Equipment condition, and maintenance records
  • Production and process controls
  • Labeling and advertising

The Bottled Water Report:

As a condition of licensure, each bottled water plant must prepare a bottled water report every year and must, upon request, make that report available to each customer. Currently the report must be prepared in English and Spanish. The report must be submitted to FDB for review during the license renewal process and must be maintained at the water bottling plant and available for review by FDB upon request. More information regarding The Bottled Water Report requirements may be found online at the Food and Drug Branch website. ā€‹

Food and Drug Branch

1-800-495-3232

FDBfood@cdph.ca.gov

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