[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: 21CFR175.250]

[Page 160-161]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS--Table of Contents
 
         Subpart C--Substances for Use as Components of Coatings
 
Sec. 175.250  Paraffin (synthetic).

    Synthetic paraffin may be safely used as an impregnant in, coating 
on, or component of coatings on articles used in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food in accordance with the following 
prescribed conditions:
    (a) The additive is synthesized by the Fischer-Tropsch process from 
carbon monoxide and hydrogen, which are catalytically converted to a 
mixture of paraffin hydrocarbons. Lower molecular-weight fractions are 
removed by distillation. The residue is hydrogenated and may be further 
treated by percolation through activated charcoal. This mixture can be 
fractionated into its components by a solvent separation method, using 
synthetic isoparaffinic petroleum hydrocarbons complying with 
Sec. 178.3530 of this chapter.
    (b) Synthetic paraffin shall conform to the following 
specifications:
    (1) Congealing point. There is no specification for the congealing 
point of synthetic paraffin components, except those components that 
have a congealing point below 50  deg.C when used in contact with food 
Types III, IVA, V, VIIA, and IX identified in table 1 of Sec. 176.170(c) 
of this chapter and under conditions of use E, F, and G described in 
table 2 of Sec. 176.170(c) of this chapter shall be limited to a 
concentration not exceeding 15 percent by weight of the finished 
coating. The congealing point shall be determined by ASTM method D938-71 
(Reapproved 1981), ``Standard Test Method for Congealing Point of 
Petroleum Waxes, Including Petrolatum,'' 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) Oil content. The substance has an oil content not exceeding 2.5 
percent as determined by ASTM method D721-56T, ``Tentative Method of 
Test for Oil Content of Petroleum Waxes'' (Revised 1956), which is 
incorporated by reference. See paragraph (b)(1) of this section for 
availability of the incorporation by reference.
    (3) Absorptivity. The substance has an absorptivity at 290 
millimicrons in decahydronaphthalene at 88  deg.C not exceeding 0.01 as 
determined by ASTM method E131-81a, ``Standard Definitions of Terms and 
Symbols Relating to Molecular-Spectroscopy,'' which is

[[Page 161]]

incorporated by reference. See paragraph (b)(1) of this section for 
availability of the incorporation by reference.
    (c) The provisions of this section are not applicable to synthetic 
paraffin used in food-packaging adhesives complying with Sec. 175.105.

[42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19, 1982; 
49 FR 10106, Mar. 19, 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, 
Aug. 3, 1995]