Water Regulations
The bottled water industry in the United States, is regulated on three levels: federal, state and trade association. U.S. Food and Drug Administration (FDA) regulations, coupled with state and industry standards, offer consumers assurance that the bottled water they purchase is stringently regulated, tested and of the highest quality.The International Bottled Water Association (IBWA) has been a long-standing proponent of additional federal regulations for bottled water and is active at all levels of the local, state and federal government assisting in the development of such regulations.
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.
- Standards of Identity (Labeling Regulations): FDA's labeling rules for bottled water (see 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 FDA's extensive regulatory requirements, the bottled water industry is subject to state regulatory requirements as well.
Inspections: A significant responsibility of the states is inspecting, sampling, analyzing and approving sources of water. Under the federal GMPs, only approved sources of water can 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.
IBWA STANDARDS:
- Third-party Inspections: As a condition of membership, 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, a strict set of standards called the Model Code. The Model Code establishes tougher requirements than federal and state authorities.
EUROPEAN UNION:
All European imports must meet the federal and state standards as applicable.They must also meet strict standards set by the European Union. 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, mineral bottled water must have at least 250 ppm in TDS. Also includes certain types of flavored bottled water. 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: Defined as 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 it 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 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.
