Food & DrinkBottled water everywhere: how to keep it safe

Bottled water everywhere: how to keep it safe


The US Food and Drug Administration (FDA) regulates bottled water products, striving to ensure that they are safe to drink. The FDA protects consumers of bottled water through the federal Food, Drug, and Cosmetic Act (FD&C Act), which holds manufacturers responsible for producing safe, wholesome, and truthfully labeled food products.

There are regulations that specifically focus on bottled water, such as:

  • the “norm of identity”, which defines different types of bottled water
  • the “quality standard”, which establishes the maximum levels of contaminants (including chemical, physical, microbial and radiological) allowed in bottled water
  • “Current Good Manufacturing Practices” (CGMPs), which require bottled water to be safe and produced under sanitary conditions

Types of bottled water

The FDA describes bottled water as water fit for human consumption and sealed in bottles or other containers with no added ingredients, except that it may contain safe and suitable antimicrobial agents. Fluoride may also be added within limits set by the FDA.

The FDA classifies some bottled water products by their origin. These are four of those classifications:

  • Water from an artesian spring. This water is collected from a spring that derives from an aquifer (water-bearing layers of porous rock, sand, and soil) that is under pressure from surrounding layers of rock or clay. When drawn, the pressure in the aquifer, commonly called artesian pressure, pushes the water above the level of the aquifer, sometimes to the surface. Other means can be used to help the water rise to the surface.
  • Mineral water. This water comes from an underground source and contains at least 250 parts per million total dissolved solids. Minerals and trace elements must come from the groundwater source; they cannot have been added later.
  • Mountain spring water. Derived from an underground formation from which it naturally flows to the surface, this water must be collected exclusively at the spring or through a borehole derived from the underground formation that feeds the spring. If some external force is used to collect it through a borehole, the water must be of the same composition and quality as that which naturally flows to the surface.
  • Well water. This is water from a hole drilled in the ground, which derives from an aquifer.

Bottled water can be used as an ingredient in beverages such as diluted juices or bottled flavored waters. However, drinks whose label indicates that they contain “carbonated water”, “sparkling water”, “seltz water”, “tonic water”, “soda” or “club soda” are not included as bottled water, according to the regulation from the FDA. Instead, these drinks are considered soft drinks.

It could be tap water

Some bottled water also comes from municipal sources; in other words, public drinking water or tap water. Municipal water is generally treated before it is bottled. Some examples of water treatments include:

  • Distillation. The water turns to steam, leaving the minerals behind. The steam condenses into the form of water again.
  • Reverse osmosis. The passage of water is forced through membranes to remove minerals.
  • Absolute filtration of 1 micron. The water flows through filters that remove particles larger than one micron (.001 millimeters) in size. These particles include Cryptosporidium, a parasitic pathogen that can cause gastrointestinal illness.
  • Ozonation. Bottlers of all types of water generally use ozone gas, an antimicrobial agent, instead of chlorine to disinfect the water (chlorine can add residual taste and odor to the water).

Bottled water that has been treated by distillation, reverse osmosis, or another appropriate process may meet standards that allow it to be labeled “purified water.”

How to ensure the quality and safety of water

Federal quality standards for bottled water were first adopted in 1973, building on the United States Public Health Service standards for drinking water established in 1962.

The Safe Drinking Water Act of 1974 entrusted regulatory oversight of public drinking water (tap water) service to the United States Environmental Protection Agency (EPA). The FDA later assumed responsibility, under the FD&C Act, for ensuring that quality standards for bottled water are consistent with EPA standards for drinking water.

Every time the EPA sets a standard for a contaminant, the FDA either adopts it or determines that it is not necessary for bottled water.

In some cases, the standards for bottled water and drinking water differ. For example, because lead can leach into water from pipes as it travels from the public water supply to household taps, the EPA has set the limit for lead in drinking water at 15 parts for every billion (ppb). For bottled water, for which lead pipes are not used, the limit is set at 5 ppb.

For the production of bottled water, bottlers must comply with the CGMP regulation that specifically establishes the processing and bottling of drinking water, and enforced by the FDA. Samples of the water must be taken, analyzed, and found to be safe and salubrious. This regulation also requires proper plant and equipment design, accounting, and bottling procedures.

Additionally, bottled water processors are generally required to register with the FDA as a food facility. Domestic and foreign facilities that are required to register as food facilities that must meet the risk-based preventive controls requirements of the FDA’s Food Safety Modernization Act (FSMA), as well as the modernized Current Good Manufacturing Practices (CGMP) of this regulation covering all human food facilities (unless an exemption applies). See the FDA’s Preventive Controls for Human Food webpage for additional details.

In addition, the FDA oversees inspections of bottling plants. The agency inspects bottled water plants under its general food safety program and has states perform some of the inspections on contract (some states also require annual accreditation of bottling companies).

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