Cosmetic Industry Specific Definitions

All Business Trading Names Used By the Establishment

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.  (From 21 CFR 700.3)

Chemical Description 

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.  (From 21 CFR 700.3)

Commercial Distribution of a Cosmetic Product 

Annual gross sales in excess of $1,000 for that product.  (From 21 CFR 700.3)

Cosmetic Product 

The 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. (From 21 CFR 700.3)

Cosmetic Raw Material 

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.  (From 21 CFR 700.3)

EIR

Establishment Inspection Report

Establishment 

means a place of business where cosmetic products are manufactured or packaged.  (From 21 CFR 700.3)

Flavor 

Any natural or synthetic substance or substances used solely to impart a taste to a cosmetic product. (From 21 CFR 700.3)

Filed Screening Procedure 

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.  (From 21 CFR 700.3)

Fragrance

 Any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product. (From 21 CFR 700.3)

Ingredient 

Any single chemical entity or mixture used as a component in the manufacture of a cosmetic product. (From 21 CFR 700.3)

Label

 Any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity. (21 CFR 1.3)

Labeling

Includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (From 21 CFR 1.3)

Manufacture of a Cosmetic Product 

The making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.  (From 21 CFR 700.3)

Packaging of a Cosmetic Product 

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.  (From 21 CFR 700.3)

Proprietary Ingredient 

Any cosmetic product ingredient whose name, composition, or manufacturing process is protected from competition by secrecy, patent, or copyright. (From 21 CFR 700.3)

Reportable experience 

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.  (From 21 CFR 700.3)

System of Commercial Distribution of a Cosmetic Product 

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.  (From 21 CFR 700.3)