Code of Federal Regulations

  Title 21, Volume 7, Parts 600 to 799

  Revised as of April 1, 1996

 From the U.S. Government Printing Office via GPO Access

  CITE: 21CFR700

 

  Page 174-175

 

         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 175

 

     (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