[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3690]

[Page 411-412]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents
 
            Subpart D--Certain Adjuvants and Production Aids
 
Sec. 178.3690  Pentaerythritol adipate-stearate.

    Pentaerythritol adipate-stearate identified in paragraph (a) of this 
section may be safely used as a lubricant in the fabrication of rigid 
and semi-rigid polyvinyl chloride and/or vinyl chloride-propylene 
copolymers complying with Sec. 177.1980 of this chapter used as articles 
or components of articles that contact food, excluding food with alcohol 
content greater than 8 percent under conditions of use of E, F, and G 
described in table 2 in Sec. 175.300(d) of this chapter, subject to the 
provisions of this section.
    (a) Identity. For the purpose of this section, pentaerythritol 
adipate-stearate is an ester of pentaerythritol with adipic acid and 
stearic acid and its associated fatty acids (chiefly palmitic), with 
adipic acid comprising 14 percent and stearic acid and its associated 
acids (chiefly palmitic) comprising 71 percent of the organic moieties.
    (b) Specifications. Pentaerythritol adipate-stearate has the 
following specifications:
    (1) Melting point (dropping) of 55-58  deg.C as determined by ASTM 
method D566-76 (Reapproved 1982), ``Standard Test Method for Dropping 
Point of Lubricating Grease,'' which is incorporated by reference. 
Copies may be obtained from the American Society for Testing Materials, 
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (2) Acid value not to exceed 15 as determined by ASTM method D1386-
78, ``Standard Test Method for Saponification Number (Empirical) of 
Synthetic and Natural Waxes'' (Revised 1978), which is incorporated by 
reference. Copies are available from American Society for Testing and 
Materials

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(ASTM), 1916 Race Street, Philadelphia, PA 19103, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (3) Saponification number of 270-280 as determined by ASTM method 
D1387-78, ``Standard Test Method for Acid Number (Empirical) of 
Synthetic and Natural Waxes'' (Revised 1978), which is incorporated by 
reference. Copies are available from American Society for Testing and 
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (4) Iodine number not to exceed 2 as determined by Iodine Absorption 
Number, Hanus Method, of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' sections 28.018-28.019, 
13th Ed. (1980), which is incorporated by reference. Copies may be 
obtained from the Association of Official Analytical Chemists 
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877-2504, or may be examined at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC 20408.
    (c) The total amount of ester (calculated as free pentaerythritol) 
shall not exceed 0.4 percent by weight of the polyvinyl chloride and/or 
the vinyl chloride-propylene copolymers complying with Sec. 177.1980.

[45 FR 1018, Jan. 4, 1980, as amended at 47 FR 11848, Mar. 19, 1982; 49 
FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 57 FR 18082, Apr. 
29, 1992]