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175.250 Paraffin (synthetic).

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.250]

[Page 170]
                        TITLE 21--FOOD AND DRUGS
                          SERVICES (CONTINUED)
--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 
    (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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, 
PA 19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to:
    (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 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]

Additives that reference this regulation:

Source: U.S. Code of Federal Regulations - CFR Title 21, Part 175, Section 250

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