[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR175.250]
[Page 171]
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
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, 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: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
(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]
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