Water - Frequently Asked Questions

Definitions

What is bottled water?

Bottled water is water sold or distributed to consumers in sealed containers for drinking, culinary, or other purposes involving a likelihood of being ingested by humans.  Bottled water must be bottled only at a licensed water bottling plant.  Bottled water: 1) cannot contain sweeteners, acidifying agents (e.g. citric acid), vitamins, or chemical additives, and 2) with the exception of mineral water, must contain less than 500 parts per million (ppm) of total dissolved solids (TDS).

What is vended water?

Vended water is water for drinking, culinary, or other purposes involving the likelihood of being ingested by humans that is dispensed or supplied from a:

Vended water does not include; water placed in sealed containers by bottlers (see bottled water) or water derived from a public water system that has not undergone additional treatment.

What are the different types of water?

Spring Water:  Water derived from an underground source which flows naturally to the surface of the earth. Spring water must be collected only at the spring or though a borehole tapping the underground source supplying the spring. There must be natural force causing the water to flow to the surface through a natural orifice.  Spring water collected with use of external force must:

Mineral Water: Water which contains more than 250 ppm TDS and originates from a protected underground water source.  No minerals may be allowed to be added to this water.  The label of mineral water must bear a mineral content statement if its TDS is less than 500 ppm or greater than 1,500 ppm.  For example, if a mineral water contains less than 500 ppm of TDS, it must bear a statement “Low Mineral Content” on its label.  If it contains more than 1,500 ppm of TDS, its label must state “High Mineral Content.”  If its TDS is between 500 and 1,500 ppm, however, no statement will be necessary.

Well Water: Water which is extracted through a hole (bored, drilled or otherwise constructed), from a subsurface zone saturated with water that is not under the direct influence of surface water.

Artesian Water:  Water which would meet the definition of well water except it taps a confined aquifer in which the water stands at some height above the top of the aquifer. Another suitable name is "Artesian Well Water".

Purified Water:  Water that is processed by distillation, deionization, reverse osmosis, or other suitable means to reduce its TDS to less than 10 ppm.  The source can be from a spring, well or a public drinking water supply. Other suitable names include: "Demineralized Water", "Distilled Water," “Deionized Water," and "Reverse Osmosis Water," depending on the corresponding treatment process used.

Sparkling Bottled Water:  Bottled water containing natural levels of carbon dioxide.  When the water is treated and carbon dioxide is added to restore displaced levels, the finished product contains the same amount of carbon dioxide as the water that emerged from the source.  Soda water, seltzer water and tonic water are considered soft drinks, not sparkling bottled water.

Sterile Water or Sterilized Water:  Bottled water that meets the requirements of the U. S. Pharmacopeia, 23rd Revision, January 1, 1995 for “Sterility Tests”.  This type of bottled water is not commonly sold in California.

Flavored Water:  Bottled water with natural or added carbonation may be prepared with added flavors, extracts, essences, or fruit juice concentrates derived from a spice or fruit and comprising less than 1 percent by weight of the final product.  The final product must not contain sweeteners or additives other than the flavors, extracts, essences, or fruit juice concentrates and carbon dioxide.

Drinking Water and Potable Water:  They are generic names of bottled water.  Any bottled water, produced by a licensed bottler, may be named as “Drinking Water,” or “Potable Water.”

Are soda water, seltzer water, and tonic water regulated as bottled water?

Under California law bottled water, 1) cannot contain sweeteners, acidifying agents (e.g., citric acid), vitamins, or chemical additives and 2) with the exception of mineral water, must contain less than 500 parts per million (ppm) of total dissolved solids (TDS).  Moreover, products such as: soda water, seltzer water and tonic water are considered soft drinks, not bottled water.

Laws and Regulations

How is bottled and vended water regulated in California?

Manufacturers of bottled water (whether located in-state, out-of-state, or in a foreign country) and providers of vended water must be licensed and regulated by the California Department of Public Health, Food and Drug Branch (FDB) in order to sell or distribute their products in California.  FDB inspects in-state bottlers and vendors for sanitation, manufacturing operation control, equipment and quality control procedures, testing requirements, record keeping, labeling, and advertising.  For bottlers located out-of-state or in foreign countries, FDB relies on the inspection by the pertinent regulatory agency of the state or the country where the plant is located.  However, the bottlers must provide pertinent documents to FDB for review and must apply for a Bottled Water Plant License.

What laws and regulations govern the bottling and vending of water in California?

Health and Safety Code (H&SC)

Sherman Food Drug Cosmetic Law, H&SC Sections 111070 to 111198
California Retail Food Code, H&SC Sections 114145-114245 (vending machines)

Title 21, Code of Federal Regulations (21 CFR)

Beverages (Bottled Water): 21 CFR, Part 165; and
Processing and Bottling of Bottled Drinking Water (Bottled Water GMP's), 21 CFR, Part 129
Good Manufacturing Practices, 21 CFR, Part 110
Food Labeling, 21 CFR, Part 101 and Part 102.33

Are bottled and vended water regulated the same as tap water?

No.  The regulations for tap water are different from those for bottled water mainly because their sources are different.  Source waters for producing public drinking water include lakes, rivers, and wells, while bottled water must be produced only from already approved sources (e.g., public drinking water or a licensed private water source).  The key purpose of treatments for tap water is to make the water safe.  Accordingly, the regulations for tap water are to meet that purpose.  On the other hand, a water bottling plant, a water vending machine, or a retail water facility treats approved water to improve its quality (mainly clarity, flavor, and taste) by treatment with filtration processes (such as activated carbon, reverse osmosis, micro-filtration) and disinfection (such as ozone, ultraviolet light).  Since the source water, purpose, and the types of equipment used for tap water are different from those for bottled water and vended water, comparing the regulations for the two different groups of products is not appropriate.

Does California have different water quality standards for bottled water from those of FDA?

California adopts all federal water quality requirements for bottled water except for trihalomethanes (THMs).  The federal upper limit for THMs is 80 parts per billion (ppb), while California’s upper limit is 10 ppb.

Quality requirements may be found at:

California Health and Safety Code (H&SC) 111080, and 21 CFR Part 165.

Does imported bottled water have to meet the same quality standards as those bottled in-state?

Yes.  Bottled water from other states or foreign countries must meet the same quality and identity standards as those produced in-state.

Bottled Water Reports

What is a bottled water report?

California Health and Safety Code Section 111071(b) requires that, beginning January 1, 2008, all bottlers in California who are licensed to bottle water for sale and distribution in California to prepare a bottled water report.  The bottled water report, shall upon request, be made available to each customer.

Does the bottled water report have to be prepared in non-English languages?

Yes.  The law requires the bottled water report to be in English, Spanish and in the appropriate language for each non-English-speaking group other than Spanish that exceeds 10 percent of the state’s population.  Currently, the reports are required to be prepared in two languages, English and Spanish, because no other non-English-speaking group other than that speaking Spanish exceeds 10 percent of the California population at this time.

What information is required to be included in a bottled water report?

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

• 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.

• Treatment process: A brief description of the treatment process used for producing the bottled water.  These may include: filtration, reverse osmosis, ozonation, or ultra violet treatment.

• Product water Analyses: Not required, but recommended to attach current or immediately previous year test report(s), including: 1) all substances that are required to be analyzed in accordance with Title 21 Code of Federal Regulations, Section 165.110(b); and 2) any unregulated substances if required to be tested by the California Department of Public Health (CDPH).

• Brief and plainly worded definitions for the following terms:

• Statement of quality
  Maximum contaminant level
  Primary Drinking water Standard
  Public health goal

• A statement regarding the water source: The sources of bottled water may 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:

• 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. Pesticides and herbicides that may come from a variety of sources, including, but not limited to, agriculture, urban storm water runoff, and residential uses.

• 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. Microbial organisms that may come from wildlife, agricultural livestock operations, sewage treatment plants, and septic systems.
• Substances with radioactive properties that can be naturally occurring or be the result of oil and gas production and mining activities.”
• A statement regarding contaminants in water:  Drinking 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 (1-888-723-3366).   In order to ensure that bottled water is safe to drink, the United States Food and Drug Administration and the California Department of Public Health prescribe laws and regulations that limit the amount of certain contaminants in water provided by bottled water companies.  Some 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).

• Information regarding product recalls, including water:

• If you would like to know whether a particular bottled water product has been recalled or is being recalled, please visit the FDA’s website.

• If applicable, the following statements must be included in the bottled water report:

• If your bottled water contains nitrate (NO3) levels above 23 parts per million (ppm or mg/L) but below 45 ppm [the maximum contaminant level for nitrate (NO3)]:

• "Nitrate 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 infant'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.

• If your bottled water contains arsenic levels above 5 parts per billion (ppb or ug/L), but below 10 ppb (the maximum contaminant level for (arsenic):

• "Arsenic 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 arsenic'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."

• If applicable, the following information must be disclosed in the bottled water report: 

• Bottlers must fully disclose in the bottled water reports any exemptions or variance that have been granted by the California Department of Public Health’s Food and Drug Branch (FDB) including an explanation of reasons for each exemption or variance and the date of the exemption or variance.

Do licensed water bottlers have to prepare bottled water reports annually?

Yes.  As a condition of licensure, bottlers must update the bottled water  reports every year, and submit copies of the report, in English and Spanish, to the California Department of Public Health’s Food and Drug Branch (FDB) for review at the time the renewal application is submitted.

Labels and Labeling

What are the labeling requirements for bottled water?

California adopts all federal labeling requirements for bottled water, including:

Food Labeling, 21 CFR, Part 101
Beverages (Bottled Water): 21 CFR, 165.110

California also has additional requirements.  For example, contact information must be stated on the label of bottled water (e.g., telephone number, mailing address, or e-mail address of the bottler or brand owner).  In the case of products in non-returnable bottles, the contact information can be provided on each billing statement.  California has also adopted a definition for “flavored water,” which has not been established in the federal regulations.

In addition, Health and Safety Code, Section 111185 has additional requirements for any bottler, whose corporate name or trademark contains the words "spring", "springs" (or any derivative of "spring"), "well", "artesian well", or "natural".  Bottlers must label each bottle with the source of the water, in typeface at least equal to the size of the typeface of the corporate name or trademark, if the source of the bottled water is different from the source stated in the corporate name or trademark.

Does California have different labeling requirements for bottled water from those of the U.S. FDA?

California adopts all federal labeling requirements for bottled water, but has additional requirements.  For example, contact information be stated on the label of bottled water (e.g., telephone number, mailing address, or e-mail address of the bottler or brand owner).  In the case of products in non-returnable bottles, the contact information can be provided on each billing statement.  California has adopted a definition for “flavored water,” which has not been established in the federal regulations.

If the source of bottled water or vended water is a public drinking water system (or a municipal source), does the source have to be indicated in the label?

When the source for bottled water comes from a public drinking water system, the product label must state that the bottled water is from “a public drinking water” or “from a municipal source.”  However, if the water has been purified to have less than 10 ppm TDS (to meet the legal definition for purified water), it does not have to bear such statement on its label.

Water vending machines and retail water facilities must display, in a position clearly visible to customers, the fact that their source water is obtained from an approved public water supply.

What additional information must water bottlers have to include on the product label, package insert, or an attachment?

California Health and Safety Code Section 111170 (f) requires that , beginning January 1, 2009, each container of bottled water in a beverage container, sold at retail or wholesale in California, include on its label, or on an additional label affixed to the bottle, or on a package insert or attachment, all the following:

What additional information must licensed water bottlers, who distribute bottled water directly to consumers, include in the billing statement?

California Health and Safety Code Section 111170 (g) requires that, beginning January 1, 2009, each bottler who distributes bottled or vended water directly to consumers provide a statement on each billing statement that includes both of the following:

A telephone number and mailing address of the bottler or brand owner.

The means by which a consumer may obtain consumer information relating to water quality, including a bottled water report.

Licenses

What licenses are required to distribute or sell water in California?

State law requires that all water bottlers (regardless of whether located in-state, out-of-state, or in a foreign country), private source operators, bottled water distributors, retail water facility operators, water vending machine operators and water haulers obtain a license to bottle, collect, treat, hold, distribute, haul, vend, or sell water in California.

FDB issues 6 different types of licenses:

Bottled water distributor license is issued to those who deliver water in returnable bottles (e.g., 3- or 5-gallon bottles) from a bottler to a customer’s home or office and do the service of replacing bottled water on a customer’s cooler.  Those who deliver or sell bottled water packaged in single serve bottles (i.e., one time use only-bottles which are found on supermarket shelves; e.g., 16.9 oz size-bottled water) are not required to obtain a bottled water distributor license.

Where can I obtain a license application and procedures for obtaining a license?

All license applications and procedures can be downloaded/obtained at the FDB website. You may also contact the FDB Water Licensing Desk at (916) 650-6500.

Water Testing

How often is bottled and vended water tested?

The law requires bottled and vended water be tested as follows:

California (in-State) water bottlers are required to test product water for: 1) coliform bacteria weekly, and 2) physical, chemical and radiological parameters at least once annually.  Source water, if obtained from other than a public source, must be tested for coliform bacteria weekly.

Out-of-State water bottlers are required to test source water and product water for: 1) coliform bacteria weekly, and 2) physical, chemical, and radiological parameters at least once annually.

Private water source operators are required to test source water for: 1) coliform bacteria weekly, and 2) physical, chemical, and radiological parameters at least once annually.

Retail water facility and Water vending machine operators are required to test their water for coliform bacteria at least once every 6 months.  If purified water is dispensed, dissolved solids must be measured not less frequently than once every 7 days.

Water haulers should test water for coliform bacteria: 1) at the first water load after their hauling tanks have been cleaned and sanitized, and 2) once per 30 days during months when water hauling is performed.

What is the bottled water and source water tested for?

On an annual basis, bottlers and private source water operators must analyze water for:

On a weekly basis, bottlers and private source water operators must test water for coliform bacteria. The full list of substances to be analyzed can be downloaded online

Where can I test the water for compliance with California laws and regulations?

The required testing must be performed: 1) at a laboratory certified for the particular analysis by the California Department of Public Health’s Environmental Laboratory Accreditation Program (ELAP).  A list of certified laboratories near you can be downloaded at the ELAP website or obtained by contacting ELAP at (510) 620-3155, or 2) at a laboratory certified by the primary enforcement authority in those states (or foreign countries) which have been granted primacy by the U.S. Environmental Protection Agency, or laboratories certified (accredited) by a third-party organization acceptable to a primacy state.  Other non-required tests (e.g., internal quality control testing), however, may be performed in-house.

Water Vending Machines and Retail Water Facilities

May an operator of a Water Vending Machine or a Retail Water Facility (or retail water store) bottle water?

No.  Water vending machine (WVM) operators or retail water facility (RWF) operators are not allowed to bottle water because WVMs and RWFs are not water bottling plants.  A WVM is a water-connected vending machine designed to dispense drinking, purified, or other water products.  This machine must be designed to reduce or remove turbidity, off-tastes, and odors and provide disinfection treatment.  Processes for removal or reduction of dissolved solids must be used.  A RWF is any commercial establishment where vended water is sold and placed in the containers of a customer, who come to the establishment to obtain water.

May an operator of a Water Vending Machine or a Retail Water Facility deliver his or her water to a customer’s home or office?

No.  The law does not allow operators of WVMs or RWFs to deliver water to their customers’ homes or offices.  WVMs and RWFs have been classified by law, as a device or a commercial establishment, to which customers bring their containers to obtain vended water.

What information must licensed retail water facility operators display in their facilities (or stores)?

California Health and Safety Code Section 111170 (c), requires that, beginning January 1, 2009, each retail water facility display in a position clearly visible to customers the following information, both in English and Spanish:

May a Retail Water Facility operator clean and/or sanitize customers’ containers?

RWF operators should not clean and/or sanitize their customers’ containers on their premises.

It is the customer’s responsibility to bring clean containers to a RWF to obtain vended water.

Must licensed water vending machine operators provide information regarding their water vending machines in electronic format?

Yes.  California Health and Safety Code Section 111130 (c) requires that, beginning January 1, 2008, an applicant for renewal of a water vending machine operator license provide to FDB, in electronic format, the serial number of each machine and the street address, city, Zip code, and county where the machine is located.  A model form can be obtained online.

What are the requirements for cleaning and sanitizing water vending machines?

California Health and Safety Code Section 111115 (a) and 111170(b), requires that, beginning January 1, 2009:
Water vending machines be cleaned, serviced, and sanitized in accordance with the manufacturer’s specifications at least once every 30 days.

The maintenance records (for cleaning, servicing, sanitizing) be kept for every visit made by either the operator or the maintenance personnel.  These records must show the date and time of the visit, any tests performed, any maintenance performed, and the signature or electronic signature of the operator or maintenance personnel. The records must be kept by the owner of the water-vending machine for a minimum of two years and shall be made available to FDB upon request.

In addition, a sign or label indicating the date on which the water vending machine was last sanitized and serviced (both in English and Spanish) must be displayed in a position clearly visible to customers.

Must licensed water vending machine operators keep a record of consumer complaints?

Yes.  California Health and Safety Code Section 111115 (a), requires that a record of any consumer complaints be kept on file with the owner of the water-vending machine for a minimum of two years, and must be made available to FDB upon request.

Must licensed water vending machine operators affix a decal to indicate that a license fee has been paid?

Yes.  California Health and Safety Code Section 111130 (d), states that it is the duty of water vending operator or owner to affix a valid decal in a prominent place to each water vending machine in service.  The decal will indicate that a license fee has been paid for the current year.

What information must licensed water vending machine operators display on their water vending machines?

California Health and Safety Code Section 111170 (c), requires that, beginning January 1, 2009, each vending machine display in a position clearly visible to customers the following information, both in English and Spanish:

General Concerns

Who has the responsibility for maintaining a bottled water cooler?

A bottled water cooler is an independent device that can be used to dispense water from removable 3- to 5-gallon plastic bottles usually positioned on top of the unit.  Bottle water coolers can be cold units that can dispense only cold water, or hot and cold units that can dispense both hot and cold water.   Like a refrigerator in your house, the owner has the responsibility to clean and keep the cooler in sanitary condition.  If the owner has rented or leased the cooler from a bottler (or a bottled water distributor), it may the responsibility of the bottler (or the bottled water distributor) to maintain or periodically replace the cooler, depending on the terms of the contract.

Who should I contact if I receive illness complaints associated with my bottled or vended water?

If a consumer becomes ill after eating any food including bottled and vended water, they should be directed to contact their  physician immediately.  If the medical examination indicates that the illness may have been due to the food or drink consumed, the consumer or your company should call the local county or city health department listed in the white pages of the telephone directory.  In addition to the local health department, you may wish to report the illness to the “FDB Consumer Complaint Hotline” at 1-800-495-3232.