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US EPA National Drinking Water Regulations and Standards

Current Drinking Water Regulations and Standards

The bottled water industry in the United States is somewhat regulated; on three levels: federal, state and trade association. U.S. Food and Drug Administration (FDA) regulations, along with state and industry standards, offer consumers some assurance that the bottled water they purchase is regulated, supposed to be tested and of specified quality. The reality is often different from the regulations. See this page for a description of the contaminants that are most commonly found in drinking water (both bottled and tap waters). And if you are looking for Training materials to obtain your own Drinking Water operator's license to get a job in the industry, download these training materials.

FEDERAL REGULATIONS

Bottled water is regulated as a food product by the FDA. Bottled water companies must adhere to the FDA's Quality Standards, Standards of Identity (Labeling Regulations) and Good Manufacturing Practices.

Quality Standards:

All bottled water products must comply with the FDA's Quality Standards in Section 165.110(b) of Title 21 of the Code of Federal Regulations (CFR). These standards, along with the FDA's Good Manufacturing Practices, ensure the safety of all bottled water products from production to packaging to consumption. Here are the National Primary and Secondary Drinking Water Regulations

Standards of Identity:

FDA's labeling rules for bottled water (see more on this below) establish standards of identity and standardized definitions for terms found on bottled water labels such as "artesian," "distilled," "drinking," "mineral," "purified," "sparkling" and "spring." Seltzer, soda water and tonic water are considered soft drinks; therefore, they are excluded from these regulations.

Good Manufacturing Practices:

Bottled water is subject to both general food Good Manufacturing Practices (GMPs) and GMPs specific to bottled water processing and bottling. General food GMPs govern such areas as plant and ground maintenance, sanitary maintenance of buildings and fixtures and sanitary facilities, including water supply, plumbing and sewage disposal. Bottled water GMPs provide detailed regulations governing plant construction and design, sanitary facilities and operations, equipment design and construction, production and process controls specific to the production and processing of bottled drinking water, and record keeping.

STATE STANDARDS

In addition to the FDA's extensive regulatory requirements, the bottled water industry is subject to state regulatory requirements as well.

Inspections:

Significant responsibilities of the states are inspecting, sampling, analyzing and approving sources of water. Under the federal GMPs, only approved sources of water may be used to supply a bottling plant.

Laboratory Certification:

Another area in which some states have important responsibilities that complement federal regulation is the certification of testing laboratories. As with any food establishment, the states perform unannounced plant inspections, and some states perform annual inspections.

International Bottled Water Associations Standards (purely voluntary)

Keep in mind, these are voluntary, and can not be independently verified.

Third-party Inspections:

As a condition of membership in the IBWA, bottlers must submit to an annual, unannounced plant inspection administered by an independent, internationally recognized third-party inspection organization. This inspection audits quality and testing records; reviews all areas of plant operation from source through finished product; and checks compliance with FDA Quality Standards, Good Manufacturing Practices and any state regulations.

IBWA Model Code:

IBWA has established a quality assurance program comprising a strict set of standards called the Model Code. The Model Code establishes tougher requirements than federal and state authorities.

INTERNATIONAL STANDARDS

The intergovernmental body for the development of internationally recognized standards for food is the Codex Alimentarius Commission (CAC). The World Health Organization (WHO), one of the co-sponsors of the CAC, has advocated use of the Guidelines for Drinking-water Quality as the basis for derivation of standards for all bottled waters.

The CAC has developed the "Codex Standard for Natural Mineral Waters" and an associated code of practice. The Codex Standard describes the product and its labeling, compositional and quality factors, including limits for certain chemicals, hygiene, packaging and labeling. The "Codex Code of Practice for Collecting, Processing and Marketing of Natural Mineral Waters" provides guidance to the industry on a range of good manufacturing practices and other matters. While CAC standards and recommendations are not strictly mandatory, its Codex health and safety requirements are recognized by the World Trade Organization as representing the international consensus for consumer protection. Any deviation from Codex recommendations may require a scientifically-based justification.

This Commission is currently developing a draft of a Codex Standard for Bottled/Packaged Waters to cover drinking-water other than natural mineral waters. Under the existing Codex Standard and Code of Practice, natural mineral waters must conform to strict requirements concerning, for example, their direct collection and bottling without further treatment from a natural source, such as a spring or well. In comparison, the draft Codex Standard for Bottled/Packaged Waters has been proposed to include waters from other sources, in addition to springs and wells, and treatment to improve their safety and quality. The distinctions between these standards are especially relevant in regions where natural mineral waters have a long cultural history. Within the CAC, the Codex Committee for Natural Mineral Waters, which is hosted by Switzerland, is responsible for the development of draft Codex Standards and Codes of Practice in consultation with other relevant Codex Committees, notably the Codex Committees on Food Additives and Contaminants and Food Hygiene. Parties interested in participating in this work of Codex should contact the National Codex Contact Point in their country.

It should be noted that neither the CAC nor WHO offer certification of any bottled or mineral water products. In this regard, WHO does not permit its name or emblem to be used in connection with any commercial purposes. While many countries have national standards for bottled waters and some have national certification schemes, no universally accepted international certification scheme now exists. Persons seeking information on bottled water certification should approach the national authorities in the country concerned. In addition, international bottler members of IBWA that sell products in the U.S. must submit a certificate of inspection to IBWA.

LABELING REGULATIONS

According to the Food & Drug Administration (FDA) bottled water, like all other foods regulated by FDA, must be processed, packaged, shipped and stored in a safe and sanitary manner, and truthfully and accurately labeled. Bottled water products must also meet specific FDA quality standards for contaminants. These are set in response to requirements that the USEPA has established for tap water. The FDA implements standard definitions for various terms used on the labels of bottled water. They may include the terms "mineral," "spring," "artesian," "well," "distilled," and "purified," which are frequently used on labels, but prior to 1993 had no standardized meanings.

"We want to ensure that bottled water is labeled truthfully," said former FDA Commissioner David A. Kessler. "If the label says it's mineral water, it should be mineral water. If it's from a municipal water source, the water should be so labeled."

Mineral Water

Previously exempt from definition, bottled mineral water must have at least 250 parts per million (ppm) in total dissolved solids (TDS). Certain types of flavored bottled water fit into this category as well. Sources must be "tapped at one or more bore holes or springs, originating from a geologically and physically protected underground water source." If the TDS content of mineral water is below 500 ppm, or it is greater than 1,500 ppm, the statement "low mineral content" or "high mineral content," respectively, must appear on the principal display panel. If the TDS of mineral water is between 500 and 1,500 ppm, no additional statements are needed.

Spring Water

This is water obtained from an underground formation from which water flows naturally to the surface or would flow if it were not collected from the underground via the borehole. To be identified as spring water on the label, the water has to be collected at the spring or through a borehole next to the point where the spring emerges. Excluded from this are products labeled as "carbonated water," "seltzer water," "soda water," and "tonic water," all of which are considered soft drinks.

Municipal Source

Water bottled from municipal water supplies must be clearly labeled as such. The requirement is dropped if municipal water was used but was processed and treated so that it could be labeled as "distilled" or "purified" water.

Infant Brands

Accurate labeling of bottled waters is required for products marketed for infants. If a product is labeled "sterile," it must be processed to meet the FDA's requirement for commercial sterility. Otherwise, the labeling must indicate it's not sterile and should be used in preparation of infant formula only as directed by a physician or according to infant formula preparation instructions.