[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR700.3]

[Page 135-136]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 700_GENERAL--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 700.3  Definitions.


    As used in this subchapter:
    (a) The term act means the Federal Food, Drug, and Cosmetic Act.
    (b) The term cosmetic product means a finished cosmetic the 
manufacture of which has been completed. Any cosmetic product which is 
also a drug or device or component thereof is also subject to the 
requirements of Chapter V of the act.
    (c) The term flavor means any natural or synthetic substance or 
substances used solely to impart a taste to a cosmetic product.
    (d) The term fragrance means any natural or synthetic substance or 
substances used solely to impart an odor to a cosmetic product.
    (e) The term ingredient means any single chemical entity or mixture 
used as a component in the manufacture of a cosmetic product.
    (f) The term proprietary ingredient means any cosmetic product 
ingredient whose name, composition, or manufacturing process is 
protected from competition by secrecy, patent, or copyright.
    (g) The term chemical description means a concise definition of the 
chemical composition using standard chemical nomenclature so that the 
chemical structure or structures of the components of the ingredient 
would be clear to a practicing chemist. When the composition cannot be 
described chemically, the substance shall be described in terms of its 
source and processing.
    (h) The term cosmetic raw material means any ingredient, including 
an ingredient that is a mixture, which is used in the manufacture of a 
cosmetic product for commercial distribution and is supplied to a 
cosmetic product manufacturer, packer, or distributor by a cosmetic raw 
material manufacturer or supplier.
    (i) The term commercial distribution of a cosmetic product means 
annual gross sales in excess of $1,000 for that product.
    (j) Establishment means a place of business where cosmetic products 
are manufactured or packaged.
    (k) The term manufacture of a cosmetic product means the making of 
any cosmetic product by chemical, physical, biological, or other 
procedures, including manipulation, sampling, testing, or control 
procedures applied to the product.
    (l) The term packaging of a cosmetic product means filling or 
labeling the product container, including changing the immediate 
container or label (but excluding changing other labeling) at any point 
in the distribution of the cosmetic product from the original place of 
manufacture to the person who makes final delivery or sale to the 
ultimate consumer.

[[Page 136]]

    (m) The term all business trading names used by the establishment 
means any name which is used on a cosmetic product label and owned by 
the cosmetic product manufacturer or packer, but is different from the 
principal name under which the cosmetic product manufacturer or packer 
is registered.
    (n) The definitions and interpretations contained in sections 201, 
601, and 602 of the act shall be applicable to such terms when used in 
the regulations in this subchapter.
    (o) System of commercial distribution of a cosmetic product means 
any distribution outside the establishment manufacturing the product, 
whether for sale, to promote future sales (including free samples of the 
product), or to gage consumer acceptance through market testing, in 
excess of $1,000 in cost of goods.
    (p) Filed screening procedure means a procedure that is:
    (1) On file with the Food and Drug Administration and subject to 
public inspection;
    (2) Designed to determine that there is a reasonable basis for 
concluding that an alleged injury did not occur in conjunction with the 
use of the cosmetic product; and
    (3) Which is subject, upon request by the Food and Drug 
Administration, to an audit conducted by the Food and Drug 
Administration at reasonable times and, where an audit is conducted, 
such audit shows that the procedure is consistently being applied and 
that the procedure is not disregarding reportable information.
    (q) Reportable experience means an experience involving any allergic 
reaction, or other bodily injury, alleged to be the result of the use of 
a cosmetic product under the conditions of use prescribed in the 
labeling of the product, under such conditions of use as are customary 
or reasonably foreseeable for the product or under conditions of misuse, 
that has been reported to the manufacturer, packer, or distributor of 
the product by the affected person or any other person having factual 
knowledge of the incident, other than an alleged experience which has 
been determined to be unfounded or spurious when evaluated by a filed 
screening procedure.

[39 FR 10054, Mar.15, 1974, as amended at 46 FR 38073, July 24, 1981]