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REGULATION

The bottled water industry 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 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.

Water Availability and Classification



The FDA classifies bottled water according to its origin.
  • Artesian well water. Water from a well that taps an aquifer--layers of porous rock, sand and earth that contain water--which is under pressure from surrounding upper layers of rock or clay. When tapped, the pressure in the aquifer, commonly called artesian pressure, pushes the water above the level of the aquifer, sometimes to the surface. Other means may be used to help bring the water to the surface.

    According to the EPA, water from artesian aquifers often is more pure because the confining layers of rock and clay impede the movement of contamination. However, despite the claims of some bottlers, there is no guarantee that artesian waters are any cleaner than ground water from an unconfined aquifer, the EPA says.
     
  • Mineral water. Water from an underground source that contains at least 250 parts per million total dissolved solids. Minerals and trace elements must come from the source of the underground water. They cannot be added later.
     
  • Spring water. Derived from an underground formation from which water flows naturally to the earth's surface. Spring water must be collected only at the spring or through a borehole tapping the underground formation feeding the spring. If some external force is used to collect the water through a borehole, the water must have the same composition and quality as the water that naturally flows to the surface.
     
  • Well water. Water from a hole bored or drilled into the ground, which taps into an aquifer.
Bottled water may be used as an ingredient in beverages, such as diluted juices or flavored bottled waters. However, beverages labeled as containing "sparkling water," "seltzer water," "soda water," "tonic water," or "club soda" are not included as bottled water under the FDA's regulations, because these beverages have historically been considered soft drinks.

Some bottled water also comes from municipal sources--in other words--the tap. Municipal water is usually treated before it is bottled.

Examples of water treatments include:
  • Distillation. In this process, water is turned into a vapor. Since minerals are too heavy to vaporize, they are left behind, and the vapors are condensed into water again.
     
  • Reverse osmosis. Water is forced through membranes to remove minerals in the water.
     
  • Absolute 1 micron filtration. Water flows through filters that remove particles larger than one micron in size, such as Cryptosporidium, a parasitic protozoan.
     
  • Ozonation. Bottlers of all types of waters typically use ozone gas, an antimicrobial agent, to disinfect the water instead of chlorine, since chlorine can leave residual taste and odor to the water.
Bottled water that has been treated by distillation, reverse osmosis, or other suitable process and that meets the definition of "purified water" in the U.S. Pharmacopoeia can be labeled as "purified water."

 

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