Dear oceanmark-ga;
Thank you for allowing me an opportunity to answer your interesting
question. Let's first talk briefly about legal requirements and
federal definitions before we get to the state's position:
?The FDA has established specific regulations for bottled water in
Title 21 of the Code of Federal Regulations (21 CFR), including
standard of identity regulations (21 CFR § 165.110[a]) that define
different types of bottled water, such as spring water and mineral
water, and standard of quality regulations (21 CFR §165.110[b]) that
establish allowable levels for contaminants (chemical, physical,
microbial and radiological) in bottled water. FDA also has established
Current Good Manufacturing Practice (CGMP) regulations for the
processing and bottling of bottled drinking water (21 CFR part 129).
Labeling regulations (21 CFR part 101) and CGMP regulations (21 CFR
part 110) for foods in general also apply to bottled water. It is
worth noting that bottled water is one of the few foods for which FDA
has developed specific CGMP regulations or such a detailed standard of
quality.?
U. S. FOOD AND DRUG ADMINISTRATION
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
http://www.cfsan.fda.gov/~dms/botwatr.html
The FDA classifies some bottled water according to its origin:
ARTESIAN WATER: Water from a well tapping a confined aquifer in which
the water level stands at some height above the top of the aquifer.
MINERAL WATER: Water containing not less than 250 ppm total dissolved
solids that originates from a geologically and physically protected
underground water source. Mineral water is characterized by constant
levels and relative proportions of minerals and trace elements at the
source. No minerals may be added to mineral water.
PURIFIED WATER: Water that is produced by distillation, deionization,
reverse osmosis or other suitable processes and that meets the
definition of "purified water" in the U.S. Pharmacopeia, 23d Revision,
Jan. 1, 1995. As appropriate, also may be called "demineralized
water," "deionized water," "distilled water," and "reverse osmosis
water."
SPARKLING BOTTLED WATER: Water that, after treatment and possible
replacement of carbon dioxide, contains the same amount of carbon
dioxide that it had at the time of its emergence from the source, is
classified as ?sparkling bottled water? by the FDA.
SPRING WATER: Springs water is water derived from an underground
formation from which water flows naturally to the surface of the earth
at an identified location. Spring water may be collected at the spring
or through a borehole tapping the underground formation feeding the
spring, but there are additional requirements for use of a borehole.
Some bottled water also comes from municipal sources--in other
words--the tap. Municipal water is usually treated before it is
bottled.
Code of Federal Regulations
Title 21, Volume 2
U.S. Government Printing Office
CITE: 21CFR165.110]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=165.110
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Now, since the Food and Drug Administration is a Federal agency and
FEDERAL LAW SUPERSEDES STATE LAW, the laws pertaining to bottle water
in California (and indeed all other states) must at least meet the
minimum standards set forth in Federal law. That is to say that
California may impose stricter or additional requirements when it
comes to bottle water regulations and classifications, but the state
laws must also, on their face, adhere to the ENTIRETY of the Federal
mandate, which it does, as evidenced by this document by I.H. (Mel)
Suffet, Ph.D. Professor, Environmental Science and Engineering Program
and Department of Environmental Health Sciences, in which he explains
the State of California?s position on the issue of classification:
BOTTLED WATER
http://www.ioe.ucla.edu/publications/report01/BottledWater.htm
Clearly you can see that the State of California meets the minimum
Federal standards in its classification of bottle waters but goes
further in that it takes the liberty to add ?Still Water?,
?De-mineralized Water? and ?Natural Water? to its list. ?Natural
water? is defined by California as ?water taken directly from nature
that is unmodified by mineral additions or deletions.? Normally, this
would apply to natural water with the exception of the desalinization
process required to make it potable. Other treatment would also be
required per the State of California in order to distribute the
product to the public. Treatment to control any microbiological or
chemical hazards of the raw water, and to provide consumers with
clear, taste-and-odor free, colorless product is mandatory. Treatment
includes a minimum of filtration and disinfections by ozone or UV
light. This type of treatment then would exempt ?deep ocean? water
designed for marketing as drinking water from being classified as
?natural water? since the treatment itself would place the product in
the category of ?purified water? instead (see FDA classification
above which California also recognizes).
In addition, it should be noted the concept of ?deep ocean water?
being marketed as bottled drinking water is relatively unchartered
territory in terms of product precedent. As seen by this graphic, the
depths of the ocean as one of the normal sources for bottled water
isn?t even discussed. The marketing of such a product would
undoubtedly require a ruling from State of California, Department of
Health Services, Food and Drug Branch (Cal DHS-FDB) if not the opinion
of the Federal Food and Drug Administration.
FIGURE 3: GROUND WATER SUPPLIES FOR DRINKING WATER
http://www.ioe.ucla.edu/publications/report01/Bottled/Fig3P401.gif
As for the requirements for marketing the product, you would first be
required to reveal its source water and treatment system to the state
of California. Each company producing bottled water is free to process
the water as it sees fit, subject to oversight of the State of
California, Department of Health Services, Food and Drug Branch (Cal
DHS-FDB). The bottled water vendors pay a licensing fee to distribute
their water in California. The application to sell bottled water in
California asks for a list of all product brand names of bottled water
produced at the same bottled water plant. The finished product must
meet the specification shown in this graphic:
Sidebar 3: A Summary of Differences in Rules for Tap and Bottled Water
Sold in Other States and California (Bottled Water Regulations: FDA,
Title 21 and Cal DHS-FDB Health and Safety Code #111080)
http://www.ioe.ucla.edu/publications/report01/BottledWater.htm
(About half-way down the page in a blue table entitled SIDEBAR 3)
You must seek approval from the State of California to market the
product by filling out this application and submitting the application
and your $448.85 processing fee:
BOTTLED WATER DISTRIBUTOR APPLICATION
http://www.dhs.cahwnet.gov/publications/forms/pdf/dhs8590.pdf
I hope you find that my research exceeds your expectations. If you
have any questions about my research please post a clarification
request prior to rating the answer. Otherwise I welcome your rating
and your final comments and I look forward to working with you again
in the near future. Thank you for bringing your question to us.
Best regards;
Tutuzdad-ga
INFORMATION SOURCES
NATIONAL RESOURCES DEFENSE COUNCIL
?Bottled Water: Pure Drink or Pure Hype??
http://www.nrdc.org/water/drinking/nbw.asp
U. S. FOOD AND DRUG ADMINISTRATION
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
http://www.cfsan.fda.gov/~dms/botwatr.html
FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=165.110
BOTTLED WATER
http://www.ioe.ucla.edu/publications/report01/BottledWater.htm
BOTTLED WATER DISTRIBUTOR APPLICATION
http://www.dhs.cahwnet.gov/publications/forms/pdf/dhs8590.pdf
SEARCH STRATEGY
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SEARCH TERMS USED:
BOTTLED WATER, CALIFORNIA, FDA RULES, FDA REGULATIONS, BOTTLED WATER
REQUIREMENTS, BOTTLED WATER LAW |
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