applicability within a growing global consumer marketplace.
The dictionary continues to be designed to provide consumers
with a repository where straightforward and reliable information and references on cosmetic ingredients are readily
The FDA regulations on cosmetic labeling ( 21 CFR Part 701)
include prescribed guidelines on how to define ingredients in a
cosmetic product. Since the 2nd Edition was published in 1977,
the INCI dictionary has been considered the primary source
for names used in declaration of cosmetic ingredients for back
labeling. In the absence of an assigned name in the INCI dictionary, the FDA has clearly established guidelines to allow names
assigned from other acceptable sources (21CFR701.3(c)). Theoretically speaking, if there is no name assigned in the INCI dictionary, one could use a standard chemical nomenclature that
is recognized by consumers. This is not common practice, since
the process for getting an assigned name is relatively easy, and
the FDA could frown on the use of a name that is not from one
of the recognized sources outlined in the regulations.
There has been a general misunderstanding of what an
INCI assigned nomenclature is and what it does and does not
represent. The assignment of an INCI name and inclusion of
an ingredient in the INCI dictionary is not an endorsement of
safety or regulatory acceptance, or substantiated function for
use as a cosmetic ingredient in the United States or any other
country. The dictionary’s only purpose is to provide a recogniz-
ably defined name for cosmetic ingredients, thus establishing
a common language for communicating the identity of ingredi-
ents on a global basis. Therefore, it is the responsibility of the
user of those ingredients to do due diligence to insure safety
and regulatory acceptability before incorporating any ingredi-
ent into a consumer personal care product. It is also the respon-
sibility of the cosmetic company to make sure that the product
has the correct assigned nomenclature and is representative
of the definition of that ingredient. Consequently, it behooves
cosmetic companies to require ingredient suppliers to supply
letters assuring that the ingredient and tradename as supplied
is in fact representative of the INCI assigned name. Further, the
committee is not responsible for establishing the ingredient’s
functional use. Information about functional use is provided by
the submitter and is not substantiated by the committee.
INCI names are assigned on the basis of the chemical com-
position of an ingredient, and the INC can only work from the
information provided by the manufacturer; so, prescribed
acceptable information needs to be clearly indicated on the
INCI application. See Fig. 1 for a flow chart on the process used
to assign a monograph from a Tradename (TN ) application.
Note that the committee assigns names that are representative
of the chemical description of the raw material. Additionally,
the committee will ensure that disclaimers are included in the
definition of an ingredient purported to have a function that
implies over-the-counter (OTC) drug status in the United States
and specific regulatory status in other countries (such as the
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