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food and drug branch (fdb)

Food Safety Program

ā€‹ā€‹ā€‹Water Bottling Plant-The Bottled Water Report

ā€‹As a condition of licensure each water bottling plant must prepare an annual bottled water report. A ā€œWater Bottling Plantā€ is defined as any facility in which bottled water is produced. ā€œBottled waterā€ is defined as any water that is placed in a sealed container at a water bottling plant. Water bottling plant operators in California are required to make the bottled water report available to each customer, upon request.

The bottled water report must be prepared in both English and Spanish. If any non English speaking group other than Spanish exceeds 10 percent of the stateā€™s population, the report will also need to be prepared in the appropriate language(s).

ā€‹The bottled water report must be updated every year. Water bottling plant operators must submit copies of the bottled water report to the California Department of Public Health, Food and Drug Branch (FDB) at the time the Water-Bottling Plant License is renewed.

Note: When bottled water comes from a municipal source, relevant information from the public water systemā€™s consumer confidence report or water quality report may be incorporated into the annual bottled water report.

Required Information

California Health and Safety Code Section 111071, requires that a bottled water report include at least the following information:

ā€‹1. The source of the bottled water.

Appropriate sources of water are defined in Title 21 Code of Federal Regulations (CFR), Section 129.3(a). Examples of water sources include: 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 the agency with jurisdiction.

2. Brief and plainly worded definitions for the following terms:

  • Statement of quality
  • Maximum contaminant level (MCL)
  • Primary Drinking water Standard
  • Public health goal (PHG)

ā€‹Guidance on these terms may be found at the following links:

3. A brief description of the treatment process used for producing the bottled water. For example for drinking or purified water, the process may include membrane filtration, reverse osmosis, carbon filtration, distillation, deionization, ozonation, or ultraviolet treatment.

4. A reference to the United States Food and Drug Administration (FDA) web site that provides product recall information.

Notices about recalls of FDA-regulated products may be found at the following link:

5. The bottled water companyā€™s address and telephone number that enables customers to obtain further information concerning contaminants and potential health effects.

6. Information on the levels of unregulated substances, if any, for which water bottlers are required to monitor pursuant to state or federal law or regulation. Guidance on this topic may be found at the following website:

  • California Environmental Protection Agency (CalEPA), State Water Resources Control Board (the State Water Board)

Unregulated Contaminantsā€‹

7. Optional ā€“ It is highly recommended to provide current or immediately previous year water quality test results.

Required Statements

Statements regarding contaminants in water:

ā€œDrinking water, including bottled water, may reasonably be expected to contain at least small amounts of some contaminants. The presence of contaminants does not necessarily indicate that water poses a health risk. More information about contaminants and potential health effects can be obtained by calling the United States Food and Drug Administration, Food and Cosmetic Hotline 1-888-SAFEFOOD (1- 888-723-3366).ā€

ā€œIn order to ensure that bottled water is safe to drink, the United States Food and Drug Administration and the State Department of Public Health prescribe regulations that limit the amount of certain contaminants in water provided by bottled water companies.ā€

A statement regarding contaminants in water and vulnerable populations:

ā€œSome persons may be more vulnerable to contaminants in drinking water than the general population. Immuno-compromised persons, including, but not limited to, persons with cancer who are undergoing chemotherapy, persons who have undergone organ transplants, persons with HIV/AIDS or other immune system disorders, some elderly persons, and infants can be particularly at risk from infections. These persons should seek advice about drinking water from their health care providers. The United States Environmental Protection Agency and the Centers for Disease Control and Prevention guidelines on appropriate means to lessen the risk of infection by cryptosporidium and other microbial contaminants are available from the Safe Drinking Water Hotline (1-800-426-4791).ā€

ā€‹A statement regarding the water source:

ā€œThe sources of bottled water include rivers, lakes, streams, ponds, reservoirs, springs, and wells. As water naturally travels over the surface of the land or through the ground, it can pick up naturally occurring substances as well as substances that are present due to animal and human activity.

Substances that may be present in the source water include any of the following:

  1. Inorganic substances, including, but not limited to, salts and metals, that can be naturally occurring or result from farming, urban storm water runoff, industrial or domestic wastewater discharges, or oil and gas production.
  2. Pesticides and herbicides that may come from a variety of sources, including, but not limited to, agriculture, urban storm water runoff, and residential uses.
  3. Organic substances that are byproducts of industrial processes and petroleum production and can also come from gas stations, urban storm water runoff, agricultural application, and septic systems.
  4. Microbial organisms that may come from wildlife, agricultural livestock operations, sewage treatment plants, and septic systems.
  5. Substances with radioactive properties that can be naturally occurring or be the result of oil and gas production and mining activities.ā€

A statement on how to access water quality information:

The label of any bottled water must include a clear and conspicuous statement that informs consumers on how to access water quality information contained in the bottled water report. The statement must provide consumers with a telephone number where the information can be requested and at least one other means of contact for the bottled water company (i.e. mailing address, email, or company website). 

ā€‹If applicable, the following statements must be included ā€‹ā€‹in the bottled water report:

  • If your bottled water contains nitrate levels above 23 ppm but below 45 ppm (the maximum contaminant level for nitrate (NO3))

ā€œNitrate in drinking water at levels above 45 mg/L is a health risk for infants of less than six months of age. These nitrate levels in drinking water can interfere with the capacity of the infantā€™s blood to carry oxygen, resulting in a serious illness. Symptoms include shortness of breath and blueness of the skin. Nitrate levels above 45 mg/L may also affect the ability of the blood to carry oxygen in other individuals, including, but not limited to, pregnant women and those with certain specific enzyme deficiencies. If you are caring for an infant, or you are pregnant, you should ask advice from your health care provider.ā€

  • If your bottled water contains arsenic levels above 5 ppb, but below 10 ppb (the maximum contaminant level for arsenic):

ā€œArsenic levels above 5 ppb and up to 10 ppb are present in your drinking water. While your drinking water meets the current EPA standard for arsenic, it does contain low levels of arsenic. The standard balances the current understanding of arsenicā€™s possible health effects against the costs of removing arsenic from drinking water. The State Department of Public Health continues to research the health effects of low levels of arsenic, which is a mineral known to cause cancer in humans at high concentrations and is linked to other health effects, including, but not limited to, skin damage and circulatory problems.ā€

  • If any exemption or variance has been granted by FDB the bottled water report must include a statement of full disclosure of the exemption or variance and include an explanation of reasons for each exemption or variance and the date of the exemption or variance.ā€‹

Food and Drug Branch

1-800-495-3232

FDBfood@cdph.ca.gov

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