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CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2019]
[CITE: 21CFR178]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
 
PART 178INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
 

Subpart D--Certain Adjuvants and Production Aids

Sec. 178.3010 Adjuvant substances used in the manufacture of foamed plastics.

The following substances may be safely used as adjuvants in the manufacture of foamed plastics intended for use in contact with food, subject to any prescribed limitations:

List of substances Limitations
AzodicarbonamideFor use as a blowing agent in polyethylene complying with item 2.1 in 177.1520(c) of this chapter at a level not to exceed 5 percent by weight of finished foamed polyethylene.
1,1-Difluoroethane (CAS Reg. No. 75-37-6)For use as a blowing agent in polystyrene.
IsopentaneFor use as a blowing agent in polystyrene.
n-Pentane Do.
1,1,2,2-Tetra-chloroethyleneFor use only as a blowing agent adjuvant in polystyrene at a level not to exceed 0.3 percent by weight of finished foamed polystyrene intended for use in contact with food only of the types identified in 176.170(c) of this chapter, table 1, under Categories I, II, VI, and VIII.
TolueneFor use only as a blowing agent adjuvant in polystyrene at a level not to exceed 0.35 percent by weight of finished foamed polystyrene.

[47 FR 22090, May 21, 1982, as amended at 58 FR 64895, Dec. 10, 1993]

Sec. 178.3120 Animal glue.

Animal glue may be safely used as a component of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) Animal glue consists of the proteinaceous extractives obtained from hides, bones, and other collagen-rich substances of animal origin (excluding diseased or rotted animals), to which may be added other optional adjuvant substances required in its production or added to impart desired properties.

(b) The quantity of any substance employed in the production of animal glue does not exceed the amount reasonably required to accomplish the intended physical or technical effect nor any limitation further provided.

(c) Any substance employed in the production of animal glue and which is the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter conforms with any specification in such regulation.

(d) Optional adjuvant substances employed in the production of animal glue include:

(1) Substances generally recognized as safe in food.

(2) Substances subject to prior sanction or approval for use in animal glue and used in accordance with such sanction or approval.

(3) Substances identified in this paragraph (d)(3) and subject to such limitations as are provided:

List of substances Limitations
Alum (double sulfate of aluminum and ammonium, potassium, or sodium)
4-Chloro-3-methylphenol(p-chlorome-tacresol)For use as preservative only.
Chromium potassium sulfate (chrome alum)For use only in glue used as a colloidal flocculant added to the pulp suspension prior to the sheet-forming operation in the manufacture of paper and paper board.
3,5-Dimethyl-1,3,5,H-tetrahydrothiadia-zine-2-thioneFor use as preservative only.
Disodium cyanodithioimidocarbonate Do.
Defoaming agentsAs provided in 176.210 of this chapter.
Ethanolamine
Ethylenediamine
FormaldehydeFor use as a preservative only.
Potassium N-methyldithiocarbamate Do.
Potassium pentachlorophenate Do.
Rosins and rosin derivativesAs provided in 178.3870.
Sodium chlorate
Sodium dodecylbenzenesulfonate
Sodium 2-mercaptobenzothiazoleFor use as preservative only.
Sodium pentachlorophenate Do.
Sodium o-phenylphenate Do.
Zinc dimethyldithiocarbamate Do.
Zinc 2-mercaptobenzothiazole Do.

(e) The conditions of use are as follows:

(1) The use of animal glue in any substance or article that is the subject of a regulation in this subpart conforms with any specifications or limitations prescribed by such regulation for the finished form of the substance or article.

(2) It is used as an adhesive or component of an adhesive in accordance with the provisions of 175.105 of this chapter.

(3) It is used as a colloidal flocculant added to the pulp suspension prior to the sheet-forming operation in the manufacture of paper and paperboard.

(4) It is used as a protective colloid in resinous and polymeric emulsion coatings.

Sec. 178.3125 Anticorrosive agents.

The substances listed in this section may be used as anticorrosive agents in food-contact materials subject to the provisions of this section:

Substances Limitations
Zinc hydroxy phosphite (CAS Reg. No. 55799-16-1)For use only as a component of resinous and polymeric food-contact coatings intended for repeated use in contact with dry foods.

[50 FR 21835, May 29, 1985]

Sec. 178.3130 Antistatic and/or antifogging agents in food-packaging materials.

The substances listed in paragraph (b) of this section may be safely used as antistatic and/or antifogging agents in food-packaging materials, subject to the provisions of this section:

(a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect.

(b) List of substances:

List of substances Limitations
N-Acyl sarcosines where the acyl group is lauroyl, oleoyl, or derived from the combined fatty acids of coconut oilFor use only:
1. As antistatic and/or antifogging agent at levels not to exceed a total of 0.15 pct by weight of polyolefin film used for packaging meat, fresh fruits, and fresh vegetables. The average thickness of such polyolefin film shall not exceed 0.003 inch.
2. As antistatic and/or antifogging agent at levels not to exceed a total of 0.15 pct by weight of ethylene-vinyl acetate copolymer film complying with 177.1350 of this chapter and used for packaging meat, fresh fruits, fresh vegetables, and dry food of Type VIII described in table 1 of 176.170(c) of this chapter. The average thickness of such ethylene-vinyl acetate copolymer film shall not exceed 0.003 inch when used for packaging meat, fresh fruits, and fresh vegetables.
Alpha-(Carboxymethyl)-omega-(tetradecyloxy)polyoxyethylene)For use only as an antistatic and/or antifogging agent at levels not to exceed 0.2 pct by weight in polyolefin film not exceeding 0.001 inch thickness.
Alkyl mono- and disulfonic acids, sodium salts (produced from n-alkanes in the range of C10-C18 with not less than 50 percent C14-C16)For use only:
1. As antistatic agents at levels not to exceed 0.1 percent by weight of polyolefin films that comply with 177.1520 of this chapter: Provided, that the finished olefin polymers contact foods of Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX described in table 1 of 176.170(c) of this chapter, and under conditions of use E, F, and G described in table 2 of 176.170(c) of this chapter.
2. As antistatic agents at levels not to exceed 3.0 percent by weight of polystyrene or rubber-modified polystyrene complying with 177.1640(c) of this chapter under conditions of use B through H described in table 2 of 176.170(c) of this chapter.
Aluminum Borate ((9Al2O3).2(B2O3), CAS Reg. No. 11121-16-7) produced by reaction between aluminum oxide and/or aluminum hydroxide with boric acid and/or metaboric acid at temperatures in excess of 1000 deg. CFor use only:
1. At levels not to exceed 1 percent by weight of polypropylene films complying with 177.1520(c) of this chapter, item 1.1, of polyethylene films complying with 177.1520(c) of this chapter, items 2.1 and 2.2 and having a density greater than 0.94 gram per cubic centimeter, and of polyolefin copolymer films complying with 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The finished polymers may be used in contact with all food types identified in Table 1 of 176.170(c) of this chapter, under conditions of use A through H as described in Table 2 of 176.170(c) of this chapter. The thickness of the films shall not exceed 0.005 inch.
2. At levels not to exceed 2 percent by weight of polypropylene films complying with 177.1520(c) of this chapter, item 1.1, of polyethylene films complying with 177.1520(c) of this chapter, items 2.1 and 2.2 and having a density greater than 0.94 gram per cubic centimeter, and of polyolefin copolymer films complying with 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The finished polymers may be used in contact with all food types identified in Table 1 of 176.170(c) of this chapter under conditions of use B through H as described in Table 2 of 176.170(c) of this chapter. The thickness of the films shall not exceed 0.005 inch.
N,N-Bis(2-hydroxyethyl)alkyl(C12-C18)amineFor use only as an antistatic agent at levels not to exceed 0.1 pct by weight of polyolefin food-contact films.
N,N-bis(2-hydroxyethyl)alkyl (C13-C15) amine (CAS Reg. No. 70955-14-5)For use only:
1. As an antistatic agent at levels not to exceed 0.2 percent by weight in molded or extruded high-density polyethylene (having a density =0.95 g/cm 3 and polypropylene containers that contact food only of the types identified in 176.170(c) of this chapter, Table 1, under types I, VI-B, VII-B, and VIII, under the conditions of use E through G described in Table 2 of 176.170(c) of this chapter, provided such foods have a pH above 5.0.
2. As an antistatic agent at levels not to exceed 0.1 percent by weight in molded or extruded polypropylene homopolymers and copolymers that contact food only of the types identified in 176.170(c) of this chapter, Table 1, under Types II, III, IV, V, VII-A, and IX, under the conditions of use C through G described in Table 2 of 176.170(c) of this chapter.
N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups (C14-C18) are derived from tallow.For use only:
1. As an antistatic agent at levels not to exceed 0.15 pct by weight in molded or extruded polyethylene containers that contact food only of the types identified in 176.170(c) of this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and VIII, under the conditions of use E through G described in table 2 of 176.170(c) of this chapter provided such foods have a pH above 5.0.
2. As an antistatic agent at levels not to exceed 0.10 mg. per square inch of food-contact surface in vinylidene chloride copolymer coatings complying with 175.320, 177.1200, or 177.1630 of this chapter, provided that such coatings contact food only of the types identified in 176.170(c) of this chapter, table 1, under Types I, IV, VII, VIII, and IX under the conditions of use E through G described in table 2 of 176.170(c) of this chapter. The finished copolymers shall contain at least 70 weight pct of polymer units derived from vinylidene chloride; and shall contain not more than 5 weight pct of total polymer units derived from acrylamide, acrylic acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl methacrylate, and vinyl sulfonic acid.
N,N-Bis(2-hydroxyethyl)dodecanamide produced when diethanolamine is made to react with methyl laurate such that the finished product: Has a minimum melting point of 36 deg. C; has a minimum amide assay of 90 percent; contains no more than 2 percent by weight of free diethanolamine; and contains no more than 0.5 percent by weight of N,N, bis(2-hydroxyethyl)piperazine, as determined by paper chromatography methodFor use only:
1. As an antistatic agent at levels not to exceed 0.5 percent by weight of molded or extruded polyethylene containers intended for contact with honey, chocolate syrup, liquid sweeteners, condiments, flavor extracts and liquid flavor concentrates, grated cheese, light and heavy cream, yogurt, and foods of Type VIII as described in table 1 of 176.170(c) of this chapter.
2. As an antistatic agent at levels not to exceed 0.2 percent by weight in polypropylene films complying with 177.1520 of this chapter, and used in contact with food of Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table 1 of 176.170(c) of this chapter, and under conditions of use B through H described in table 2 of 176.170(c) of this chapter. The average thickness of such polypropylene film shall not exceed 0.001 inches (30 micrometers).
N,N-Bis(2-hydroxyethyl) dodecanamide produced when diethanolamine is made to react with methyl laurate such that the finished product: Has a minimum melting point of 36 deg. C; has a minimum amide assay of 90 percent; contains no more than 2 percent by weight of free diethanolamine; and contains no more than 0.5 percent by weight of N,N'-bis(2-hydroxyethyl) piperazine, as determined by paper chromatography methodFor use only as an antistatic agent at levels not to exceed 0.5 percent by weight of molded or extruded polyethylene containers intended for contact with honey, chocolate syrup, liquid sweeteners, condiments, flavor extracts and liquid flavor concentrates, grated cheese, light and heavy cream, yogurt, and foods of Type VIII as described in table 1 of 176.170(c) of this chapter.
N,N-Bis(2-hydroxyethyl) octadecylamine, Chemical Abstracts Service Registry No. 10213-78-2, N-(2-hydroxyethyl)-N-octadecylglycine (monosodium salt), Chemical Abstracts Service Registry No. 66810-88-6, and N,N-Bis(2-hydroxyethyl)-N-(carboxymethyl) octadecanaminum hydroxide (inner salt), Chemical Abstracts Service Registry No. 24170-14-7, as the major components of a mixture prepared by reacting ethylene oxide with octadecylamine and further reacting this product with sodium monochloroacetate and sodium hydroxide, such that the final product has: A nitrogen content of 3.3-3.8 percent; a melting point of 42deg. -50 deg. C; and a pH of 10.0-11.5 in a 1 percent by weight aqueous solutionFor use only as an antistatic agent at levels not to exceed 0.45 percent by weight in polypropylene films complying with 177.1520 of this chapter, and used for packaging food of Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table 1 of 176.170(c) of this chapter, and under conditions of use B through H described in table 2 of 176.170(c). The average thickness of such polypropylene film shall not exceed 0.002 inch.
[alpha]-n-Dodecanol-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of n-dodecanol with an average of 9.5 moles of ethylene oxide to form a condensate having a hydroxyl content of 2.7 to 2.9 pct and having a cloud point of 80 deg. C to 92 deg. C in 1 pct by weight aqueous solutionFor use only as an antistatic agent at levels not to exceed 0.2 pct by weight in low-density polyethylene film having an average thickness not exceeding 0.005 inch.
Glycerol ester mixtures of ricinoleic acid, containing not more than 50 percent monoricinoleate, 45 pct diricinoleate, 10 pct triricinoleate, and 3.3 pct free glycerineAs an antifogging agent at levels not exceeding 1.5 pct by weight of permitted plasticized vinyl chloride homo-and/or copolymers.
N-Methacryloyloxyethyl-N,N-dimethylammonium-[alpha]-N-methyl carboxylate chloride sodium salt, octadecyl methacrylate, ethyl methacrylate, cyclohexyl methacrylate, N-vinyl-2-pyrrolidone copolymer (CAS Reg. No. 66822-60-4)For use only as an antistatic agent at levels not to exceed 0.2 percent by weight of polyolefin films that contact foods under the conditions of use B through H described in table 2 of 176.170(c) of this chapter. The average thickness of such polyolefin film shall not exceed 0.02 centimeter (0.008 inch).
Octadecanoic acid 2-[2-hydroxyethyl) octadecylamino]ethyl ester (CAS Reg. No. 52497-24-2), (octadecylimino) diethylene distearate (CAS Reg. No. 94945-28-5), and octadecyl bis(hydroxyethyl)amine (CAS Reg. No. 10213-78-2), as the major components of a mixture prepared by reacting ethylene oxide with octadecylamine and further reacting this product with octadecanoic acid, such that the final product has: a maximum acid value of 5 mg KOH/g and total amine value of 86+/-6 mg KOH/g as determined by a method entitled "Total Amine Value," which is incorporated by reference. Copies of the method are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.For use only as an antistatic agent at levels such that the product of film thickness in microns times the weight percent additive does not exceed 16, in polypropylene films complying with 177.1520(c)1.1 of this chapter, and used for packaging food (except for food containing more than 8 percent alcohol) under conditions of use B through H described in table 2 of 176.170(c) of this chapter.

[42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980; 45 FR 85727, Dec. 30, 1980; 46 FR 13688, Feb. 24, 1981; 47 FR 26824, June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457, Aug. 21, 1991; 58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351, Apr. 11, 1995; 62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998; 64 FR 62585, Nov. 17, 1999; 76 FR 59249, Sept. 26, 2011]

Sec. 178.3280 Castor oil, hydrogenated.

Hydrogenated castor oil may be safely used in the manufacture of articles or components of articles intended for use in contact with food subject to the provisions of this section.

(a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect.

(b) The additive is used as follows:

Use Limitations
1. As a lubricant for vinyl chloride polymers used in the manufacture of articles or components of articles authorized for food-contact useFor use only at levels not to exceed 4 pct by weight of vinyl chloride polymers.
2. As a component of cellophaneComplying with 177.1200 of this chapter.
3. As a component of resinous and polymeric coatingsComplying with 175.300 of this chapter.
4. As a component of paper and paperboard in contact with aqueous and fatty foodComplying with 176.170 of this chapter.
5. As a component of closures with sealing gaskets for food containersComplying with 177.1210 of this chapter.
6. As a component of cross-linked polyester resinsComplying with 177.2420 of this chapter.
7. As a component of olefin polymers complying with 177.1520 of this chapterFor use only at levels not to exceed 2 percent by weight of the polymer.

[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990]

Sec. 178.3290 Chromic chloride complexes.

Myristo chromic chloride complex and stearato chromic chloride complex may be safely used as release agents in the closure area of packaging containers intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section:

(a) The quantity used shall not exceed that reasonably required to accomplish the intended technical effect nor exceed 7 micrograms of chromium per square inch of closure area.

(b) The packaging container which has its closure area treated with the release agent shall have a capacity of not less than 120 grams of food per square inch of such treated closure area.

Sec. 178.3295 Clarifying agents for polymers.

Clarifying agents may be safely used in polymers that are articles or components of articles intended for use in contact with food, subject to the provisions of this section:

Substances Limitations
Aluminum, hydroxybis[2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxidato]-(CAS Reg. No. 151841-65-5)For use only as a clarifying agent at levels not to exceed 0.25 percent by weight of polypropylene and polypropylene copolymers complying with 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2. The finished polymers contact food only of types I, II, IV-B, VI-B, VII-B, and VIII as identified in Table 1 of 176.170(c) of this chapter, under conditions of use B through H described in Table 2 of 176.170(c) of this chapter or foods only of types III, IV-A, V, VI-A, VI-C, VII-A, and IX as identified in Table 1 of 176.170(c) of this chapter, under conditions of use C through G described in Table 2 of 176.170(c) of this chapter.
Bis(p-ethylbenzylidene) sorbitol (CAS Reg. No. 79072-96-1)For use only as a clarifying agent at a level not to exceed 0.35 percent by weight of olefin polymers complying with 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.2a, or 3.2b, where the copolymers complying with items 3.1a, 3.2a, or 3.2b contain not less than 85 weight percent of polymer units derived from propylene.
Di(p-tolylidene) sorbitol (CAS Reg. No. 54686-97-4)For use only as a clarifying agent at a level not to exceed 0.32 percent by weight in propylene homopolymer complying with 177.1520(c) of this chapter, item 1.1, and in olefin copolymers complying with 177.1520(c) of this chapter, item 3.1 (containing at least 85 weight percent of polymer units derived from propylene), in contact with all food types under conditions of use C through G described in table 2 of 176.170(c) of this chapter.
Dibenzylidene sorbitol (CAS Reg. No. 32647-67-9) formed by the condensation of two moles of benzaldehyde with one mole of sorbitol, such that the final product has a minimum content of 95 percent dibenzylidene sorbitolFor use only as a clarifying agent for olefin polymers complying with 177.1520(c) 1.1, 3.1, and 3.2 of this chapter under conditions of use C, D, E, F, and G, described in table 2 of 176.170(c) of this chapter at a level not exceeding 0.25 percent by weight of the polymer.
Dimethyldibenzylidene sorbitol (CAS Reg. No. 135861-56-2)For use only as a clarifying agent at a level not to exceed 0.4 percent by weight of olefin polymers complying with 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene. The finished polymers shall be used in contact with food under conditions of use A through H described in table 2 of 176.170(c) of this chapter.
Polyvinylcyclohexane (CAS Reg. No. 25498-06-0)For use only as a clarfiying agent for polypropylene complying with 177.1520(c) of this chapter, item 1.1., and in propylene containing copolymers complying with 177.1520(c) of this chapter, items 3.1 and 3.2, at a level not exceeding 0.1 percent by weight of the polyolefin.
Sodium di(p-tert-butylphenyl)phosphate (CAS Reg. No. 10491-31-3)For use only as a clarifying agent at a level not exceeding 0.35 parts per hundred of the resin in olefin polymers complying with 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from propylene).
Sodium 2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate (CAS Reg. No. 85209-91-2)For use only:
1. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from polypropylene). The finished polymers contact foods only of types I, II, IV-B, VI-B, VII-B, and VIII as identified in table 1 of 176.170(c) of this chapter and limited to conditions of use B through H, described in table 2 of 176.170(c), or foods of all types, limited to conditions of use C through H described in table 2 of 176.170(c).
2. As a clarifying agent at levels not exceeding 0.10 percent by weight of polypropylene complying with 177.1520(c) of this chapter, items 1.1(a) or 1.1(b) and of olefin polymers complying with 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.1(c), 3.2(a), or 3.2(b) (where the copolymers contain not less than 85 weight percent of the polymer units derived from polypropylene.) The finished polymers shall be used in contact with foods only under conditions of use A through H described in Table 2 of 176.170(c) of this chapter.
3. As a clarifying agent at a level not exceeding 0.30 percent by weight of olefin polymers complying with 177.1520(c) of this chapter, item 2.2, where the finished polymer contacts food only of types I, II, IV-B, VI-A, VI-B, and VII-B as identified in Table 1 of 176.170(c) of this chapter, and limited to conditions of use B through H described in Table 2 of 176.170(c) of this chapter, or foods of types III, IV-A, V, VI-C, and VII-A as identified in Table 1 of 176.170(c) of this chapter and limited to conditions of use C through G described in Table 2 of 176.170(c) of this chapter.

[46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 FR 30049, Aug. 10, 1988; 54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan. 11, 1991; 59 FR 13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994; 61 FR 33847, July 1, 1996; 61 FR 51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 56789, Oct. 23, 1998; 63 FR 68392, Dec. 11, 1998; 64 FR 26843, May 18, 1999; 65 FR 16316, Mar. 28, 2000]

Sec. 178.3297 Colorants for polymers.

The substances listed in paragraph (e) of this section may be safely used as colorants in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions and definitions set forth in this section:

(a) The term colorant means a dye, pigment, or other substance that is used to impart color to or to alter the color of a food-contact material, but that does not migrate to food in amounts that will contribute to that food any color apparent to the naked eye. For the purpose of this section, the term "colorant" includes substances such as optical brighteners and fluorescent whiteners, which may not themselves be colored, but whose use is intended to affect the color of a food-contact material.

(b) The colorant must be used in accordance with current good manufacturing practice, including use levels which are not in excess of those reasonably required to accomplish the intended coloring effect.

(c) Colorants in this section must conform to the description and specifications indicated. If a polymer described in this section is itself the subject of a regulation promulgated under section 409 of the Federal Food, Drug, and Cosmetic Act, it shall also comply with any specifications and limitations prescribed by that regulation. Extraction testing guidelines to conduct studies for additional uses of colorants under this section are available from the Food and Drug Administration free of charge from the Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, 240-402-1200

(d) Color additives and their lakes listed for direct use in foods, under the provisions of the color additive regulations in parts 73, 74, 81, and 82 of this chapter, may also be used as colorants for food-contact polymers.

(e) List of substances:

Substances Limitations
Aluminum
Aluminum hydrate
Aluminum and potassium silicate (mica)
Aluminum mono-, di-, and tristearate
Aluminum silicate (China clay)
4-<5-<[4-(Aminocarbonyl) phenyl] amino]carbonyl]- 2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxy-2-naphthalene-carboxamide (C.I. Pigment Red 187, CAS Reg. No. 59487-23-9)For use at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact foods only under conditions of use B through H described in table 2 of 176.170(c) of this chapter.
N-[4-(Aminocarbonyl)phenyl]-4-<1-<(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide (C. I. Pigment Yellow 181, CAS Reg. No. 74441-05-7)For use at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through H described in table 2 of 176.170(c) of this chapter.
Anthra(2,1,9-def:(6,5,10-d'e'f)diisoquinoline-1,3,8,10(2H,9H)-tetrone (C.I. Pigment Violet 29; CAS Reg. No. 81-33-4)For use at levels not to exceed 1% by weight of polymers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of 176.170(c) of this chapter.
Barium sulfate
Bentonite
Bentonite, modified with 3-dimethyldioctadecylammonium ion
1,4-Bis[(2,4,6-trimethylphenyl)amino]-9,10-anthracenedione (CAS Reg. No. 116-75-6)For use at levels not to exceed 0.0004 percent by weight of polyethylene phthalate polymers complying with 177.1630 of this chapter.
3,6-Bis(4-chlorophenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione (C.I. Pigment Red 254, CAS Reg. No. 84632-65-5)For use only at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through H, described in table 2 of 176.170(c) of this chapter.
4,4'-Bis(4-anilino-6-diethanolamine-[alpha]-triazin-2-ylamino)-2,2'-stilbene disulfonic acid, disodium saltFor use only in the textile fibers specified in 177.2800 of this chapter.
4,4'-Bis(4-anilino-6-methylethanolamine-[alpha]-triazin-2-ylamino)-2,2'-stilbene disulfonic acid, disodium salt Do.
Burnt umber
Calcium carbonate
Calcium silicate
Calcium sulfate
Carbon black (channel process, prepared by the impingement process from stripped natural gas)
4-Chloro-2-<5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4-yl]azo]-5-methylbenzenesulfonic acid, calcium salt (1:1); (C.I. Pigment Yellow 191, CAS Reg. No. 129423-54-7)For use at levels not to exceed 1.0 percent by weight of the finished polymers. The finished articles are to contact food only under conditions of use B through H as described in table 2 of 176.170(c) of this chapter.
4-Chloro-2-<5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4-yl]azo]-5-methylbenzenesulfonic acid, diammonium salt (1:2): (C.I. Pigment Yellow 191:1, CAS Reg. No. 154946-66-4)For use at levels not to exceed 0.5 percent by weight of polymers. The finished articles are to contact food under conditions of use A through H described in Table 2 of 176.170(c) of this chapter.
Chrome antimony titanium buff rutile (C.I. Pigment Brown 24, CAS Reg. No. 68186-90-3)For use at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of 176.170(c) of this chapter.
Chromium oxide green, Cr2O3 (C.I. Pigment Green 17, C.I. No. 77288)For use only:
1. In polymers used in contact with food at a level not to exceed 5 percent by weight of the polymer, except as specified below.
2. In olefin polymers complying with 177.1520 of this chapter.
3. In repeat-use rubber articles complying with 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber articles.
Cobalt aluminateFor use only:
1. In resinous and polymeric coatings complying with 175.300 of this chapter.
2. Melamine-formaldehyde resins in molded articles complying with 177.1460 of this chapter.
3. Xylene-formaldehyde resins condensed with 4-4'isopropylidenediphenol-epichlorohydrin epoxy resins complying with 175.380 of this chapter.
4. Ethylene-vinyl acetate copolymers complying with 177.1350 of this chapter.
5. Urea-formaldehyde resins in molded articles complying with 177.1900 of this chapter.
6. At levels not to exceed 5 percent by weight of all polymers except those listed under limitations 1 through 5 of this item. The finished articles are to contact food under conditions of use A through H described in table 2 of 176.170(c) of this chapter.
Copper chromite black spinel (C.I. Pigment Black 28, CAS Reg. No. 68186-91-4)For use at levels not to exceed 5 percent by weight of polymers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of 176.170(c) of this chapter.
D&C Red No. 7 and its lakes
Diatomaceous earth
4,4'-Diamino-[1,1'-bianthracene]-9,9',10,10'-tetrone (CAS Reg. No. 4051-63-2)For use at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through H described in table 2 of 176.170(c) of this chapter.
2,9-Dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. Pigment Red 202, CAS Reg. No. 3089-17-6)For use at levels not to exceed 1.0 percent by weight of polymers.
4,5-Dichloro-2-((5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- yl)azo)benzenesulfonic acid, calcium salt(1:1), (C.I. Pigment Yellow 183, CAS Reg. No. 65212-77-3)For use only:
1. At levels not to exceed 1 percent by weight of polypropylene polymers and copolymers complying with 177.1520(c) of this chapter, items 1.1a, 1.1b, 1.2, 1.3, 3.1a, 3.1b, 3.1c, 3.2a, 3.2b, 3.4, or 3.5. The finished articles are to contact food only under conditions of use E through G, as described in Table 2 of 176.170(c) of this chapter.
2. At levels not to exceed 1 percent by weight of high density polyethylene polymers and copolymers complying with 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c, 3.2a, 3.2b, 3.6 (density not less than 0.94 grams per cubic centimeter), or 5. The finished articles are to contact food only under conditions of use E through G, as described in Table 2 of 176.170(c) of this chapter.
5-[(2,3-Dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]-2,4,6(1H, 3H, 5H)-pyrimidinetrione (CAS Reg. No. 72102-84-2)For use at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through H described in table 2 of 176.170(c) of this chapter.
2,9-Dimethylanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone (C.I. Pigment Red 179, CAS Reg. No. 5521-31-3)For use at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of 176.170(c) of this chapter.
3,3'-[(2,5-Dimethyl-1,4-phenylene)bis[imino(1-acetyl-2-oxo-2,1-ethanediyl)azo>bis[4-chloro-N-(5-chloro-2-methylphenyl)-benzamide] (CAS Reg. No. 5280-80-8)For use at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through H described in table 2 of 176.170(c) of this chapter.
3,3'-[(2,5-Dimethyl-1,4-phenylene)bis[imino-carbonyl(2-hydroxy-3,1-naphthalenediyl) azo> bis(4-methylbenzoic acid), bis(2-chloroethyl) ester (CAS Reg. No. 68259-05-2)For use at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through H described in table 2 of 176.170(c) of this chapter.
2,2'-[1,2-Ethanediylbis(oxy-2,1-phenyleneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)]-3-oxo-butanamide (C.I. Pigment Yellow 180, CAS Reg. No. 77804-81-0)For use at levels not to exceed 1.0 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through G described in table 2 of 176.170(c) of this chapter.
2,2'-(1,2-Ethenediyldi-4,1-phenylene) bis(benzoxazole) (CAS Reg. No. 1533-45-5)For use as an optical brightener for all polymers at a level not to exceed 0.025 percent by weight of polymer. The finished polymer shall contact foods only of the types identified in table 1 of 176.170(c) of this chapter, under categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII at temperatures not to exceed 275 deg. F.
High-purity furnace black (CAS Reg. No. 1333-86-4) containing total polynuclear aromatic hydrocarbons not to exceed 0.5 parts per million, and benzo[a]pyrene not to exceed 5.0 parts per billion, as determined by a method entitled "Determination of PAH Content of Carbon Black," dated July 8, 1994, as developed by the Cabot Corp., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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/federalregister/codeoffederalregulations/ibrlocations.htmlFor use at levels not to exceed 2.5 percent by weight of the polymer.
Iron oxides
Kaolin-modified, produced by treating kaolin with a reaction product of isopropyl titanate and oleic acid in which 1 mole of isopropyl titanate is reacted with 1 to 2 moles of oleic acid. The reaction product will not exceed 8 percent of the modified kaolin. The oleic acid used shall meet the requirements specified in 172.860 of this chapterFor use only in olefin polymers complying with 177.1520 of this chapter at levels not to exceed 40 percent by weight of olefin polymer.
Magnesium oxide
Magnesium silicate (talc)
Manganese Violet (manganese ammonium pyrophosphate; CAS Reg. No. 10101-66-3).For use at levels not to exceed 2 percent by weight of polymers. The finished articles are to contact food only under conditions of use A through H as described in table 2 of 176.170(c) of this chapter.
Mixed methylated 4,4'-bis(2-benzoxazolyl)stilbenes with the major portion consisting of 4-(2-benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene (CAS Registry No. 5242-49-9) and lesser portions consisting of 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene (CAS Registry No. 2397-00-4) and 4,4'-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533-45-5)For use as an optical brightener only at levels not to exceed 0.05 percent by weight of rigid and semirigid polyvinyl chloride and not to exceed 0.03 percent by weight in all other polymers. The finished food-contact articles shall be used only under conditions of use D, E, F, and G described in table 2 of 176.170(c) of this chapter.
7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-phenylcoumarin (CAS Reg. No. 3333-62-8) having a melting point of 250 deg. C to 251 deg. C and a nitrogen content of 10.7 to 11.2 percentFor use as an optical brightener only in:
1. Olefin polymers complying with 177.1520 of this chapter only at levels such that the product of concentration of the optical brightener (expressed in parts per million by weight of the olefin polymer) multiplied by the thickness of the olefin polymer (expressed in thousandths of an inch and limited to no more than 0.400 inch) shall not exceed 500; provided that the level of the brightener shall not exceed 20 parts per million by weight of the olefin polymer, and further that the olefin polymers shall comply with specifications for items 1.1, 2.1, 3.1, 3.3, and 4 of 177.1520(c) of this chapter. The polymer may be used under the conditions described in 176.170(c) of this chapter, table 2, under conditions of use E, F, and G.
2. Polyethylene terephthalate specified in 177.2800(d)(5)(i) of this chapter at a level not to exceed 0.035 percent by weight of the finished fibers.
Nickel antimony titanium yellow rutile (C.I. Pigment Yellow 53, CAS Reg. No. 8007-18-9)For use at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use B through H as described in Table 2 of 176.170(c) of this chapter.
1,1'-[(6-Phenyl-1,3,5-triazine-2,4-diyl)diimino]bis-9,10-anthracenedione (CAS Reg. No. 4118-16-5)For use at levels not to exceed 0.25 percent by weight of polyethylene phthalate polymers that comply with 177.1630 of this chapter. The finished articles are to contact food only under conditions of use E, F, and G described in table 2, 176.170(c) of this chapter, except, when such articles are used with food types III, IV-A, and V, described in table 1, 176.170(c) of this chapter, the finished articles are to contact food only under conditions of use D, E, F, and G.
Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147-14-8)
Phthalocyanine green (C.I. pigment green 7, C.I. No. 74260)
C.I. Pigment red 38 (C.I. No. 21120)For use only in rubber articles for repeated use complying with 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber article.
Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900)
Sienna (raw and burnt)
Silica
2,3,4,5-Tetrachloro-6-cyanobenzoic acid, methyl ester reaction products with p-phenyllenediamine and sodium methoxide (CAS reg. No. 106276-80-6)For use only at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditins of use B through H, described in table 2, of 176.170(c) of this chapter.
4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolinyl]-1H-isoindole-1,3(2H)-dione (C. I. Pigment Yellow 138, CAS Reg. No.30125-47-4)For use only at levels not to exceed 1 percent by weight of polymers. The finished articles are to contact food only under conditions of use C through H, as described in table 2 of 176.170(c) of this chapter; provided further that the finished articles shall not be filled at temperatures exceeding 158 deg. F (70 deg. C).
2,2'-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. No. 7128-64-5)For use as an optical brightener:
1. In all polymers at levels not to exceed 0.015 percent by weight of the polymer. The finished articles are to contact food only under conditions of use A through H described in table 2 of 176.170(c) of this chapter.
2. In all polymers at levels not to exceed 0.05 percent by weight of the polymer. The finished articles shall contact foods only of the types identified in table 1 of 176.170(c) of this chapter, under Categories I, II, IV-B, VI-A, VI-B, VI-C, VII-B, and VIII under conditions of use A through H described in table 2 of 176.170(c) of this chapter.
3. In adhesives complying with 175.105 of this chapter and in pressure-sensitive adhesives complying with 175.125 of this chapter.
Titanium dioxide
Titanium dioxide-barium sulfate
Titanium dioxide-magnesium silicate
UltramarinesAs identified in 73.2725 of this chapter.
Zinc carbonateFor use only:
1. In resinous and polymeric coatings complying with 175.300 of this chapter.
2. Melamineformaldehyde resins in molded articles complying with 177.1460 of this chapter.
3. Xylene-formaldehyde resins condensed with 4-4'-isopropylidene diphenol-epichlorohydrin epoxy resins complying with 175.380 of this chapter.
4. Ethylene-vinyl acetate copolymers complying with 177.1350 of this chapter.
5. Urea-formaldehyde resins in molded articles complying with 177.1900 of this chapter.
Zinc chromateFor use only in rubber articles for repeated use complying with 177.2600 of this chapter; total use is not to exceed 10 percent by weight of rubber article.
Zinc oxideFor use only:
1. In resinous and polymeric coatings complying with 175.300 of this chapter.
2. Melamine-formaldehyde resins in molded articles complying with 177.1460 of this chapter.
3. Xylene-formaldehyde resins condensed with 4-4'-isopropylidene-diphenol-epichlorohydrin epoxy resins complying with 175.380 of this chapter.
4. Ethylene-vinyl acetate copolymers complying with 177.1350 of this chapter.
5. Urea-formaldehyde resins in molded articles complying with 177.1900 of this chapter.
Zinc sulfideFor use at levels not to exceed 10 percent by weight.

[48 FR 46775, Oct. 14, 1983]

Editorial Note:

For Federal Register citations affecting 178.3297, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

Sec. 178.3300 Corrosion inhibitors used for steel or tinplate.

Corrosion inhibitors may be safely used for steel or tinplate intended for use in, or to be fabricated as, food containers or food-processing or handling equipment, subject to the provisions of this section.

(a) The corrosion inhibitors are prepared from substances identified in this section and used subject to the limitations prescribed.

(b) The following corrosion inhibitors or adjuvants are used in amounts not to exceed those reasonably required to accomplish the intended physical or technical effect:

(1) Corrosion inhibitors (active ingredients) used in packaging materials for the packaging of steel or tinplate or articles fabricated therefrom:

List of substances Limitations
Dicyclohexylamine and its salts of fatty acids derived from animal or vegetable oil
Dicyclohexylamine nitrite
Morpholine and its salts of fatty acids derived from animal or vegetable oils

(2) Adjuvants employed in the application and use of corrosion inhibitors:

List of substances Limitations
Propylene glycol
Sec. 178.3400 Emulsifiers and/or surface-active agents.

The substances listed in paragraph (c) of this section may be safely used as emulsifiers and/or surface-active agents in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect; and the quantity that may become a component of food as a result of such use shall not be intended to, nor in fact, accomplish any physical or technical effect in the food itself.

(b) The use as an emulsifier and/or surface-active agent in any substance or article that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter conforms with any specifications and limitations prescribed by such regulation for the finished form of the substance or article.

(c) List of substances:

List of substances Limitations
[alpha]-Alkyl-, [alpha]-alkenyl-, and [alpha]-alkylaryl-omega-hydroxypoly(oxyethylene) mixture consisting of 30 weight pct of [alpha]-(2,4,6-triisobutylphenyl)-omega-hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 7 moles and 70 weight pct of a 1:1 weight ratio mixture of [alpha]-(Z)-9-octadecenyl-omega-hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 moles and [alpha]-alkyl(C16-C18)-omega-hydroxypoly(oxyethylene) having an average poly(oxyethylene) content of 18 molesFor use only at levels not to exceed 0.5 pct by weight of coatings complying with 175.320 of this chapter and limited to use as an emulsifier for polyhydric alcohol diesters used as provided in 178.3770(b). The weight of the finished coating shall not exceed 2 milligrams per square inch of food-contact surface.
n-Alkylbenzenesulfonic acid (alkyl group consisting of not less than 95 percent C10 to C16) and its ammonium, calcium, magnesium, potassium, and sodium saltsFor use only as emulsifiers and/or surface active agents as components of nonfood articles complying with 175.300, 175.320, 175.365, 175.380, 176.170, 176.180, 177.1010, 177.1200, 177.1210, 177.1630, 177.2600, and 177.2800 of this chapter and 178.3120.
Alkyl mono- and disulfonic acids, sodium salts (produced from n-alkanes in the range of C10-C18 with not less than 50 percent C14-C16)For use only:
1. As provided in 176.170 of this chapter.
2. At levels not to exceed 2 percent by weight of polyvinyl chloride and/or vinyl chloride copolymers complying with 177.1980 of this chapter.
3. As emulsifiers in vinylidene chloride copolymer or homopolymer coatings at levels not to exceed a total of 2.6 percent by weight of coating solids. The finished polymer contacts food only of the Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX as identified in table 1 of 176.170(c) of this chapter, and limited to conditions of use E, F, and G described in table 2 of 176.170 of this chapter.
4. As emulsifiers and/or surface-active agents at levels not to exceed 3.0 percent by weight of polystyrene or rubber-modified polystyrene complying with 177.1640(c) of this chapter under conditions of use B through H described in table 2 of 176.170(c) of this chapter.
[alpha]-Alkyl-omega-hydroxypoly(oxyethylene) produced by condensation of 1 mole of C11-C15 straight-chain randomly substitued secondary alcohols with an average of 7-20 moles of ethylene oxide
alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not less than 50 percent C14-C16], ammonium, calcium, magnesium, potassium, and sodium saltsFor use only:
1. In acrylonitrile-butadiene copolymers identified in 177.2600(c)(4)(i) of this chapter.
2. At levels not to exceed 1 percent by weight of acrylic coatings complying with 175.300(b)(3)(xx) of this chapter and having a maximum thickness of 0.051 millimeter (0.002 inch). The finished polymers contact food only of the Types V, VIII, and IX as identified in table 1 of 176.170(c) of this chapter.
3. At levels not to exceed 2 percent by weight of vinyl chloride copolymer coatings having a maximum thickness of 0.051 millimeter (0.002 inch) and complying with 175.300(b)(3)(xv) of this chapter. The finished polymers contact food only of the Types V, VIII, and IX as identified in table 1 of 176.170(c) of this chapter.
4. As provided in 175.105 of this chapter.
Alpha-sulfo-omega-(dodecyloxy)poly(oxyethylene) ammonium salt (CAS Reg. No. 32612-48-9)For use only as an emulsifier at levels not to exceed 0.3 percent by weight of styrene-butadiene copolymer coatings for paper and paperboard complying with 176.170 of this chapter.
Ammonium salt of epoxidized oleic acid, produced from epoxidized oleic acid (predominantly dihydroxystearic and acetoxyhydroxystearic acids) meeting the following specifications: Acid number 160-180, saponification number 210-235, iodine number 2-15, and epoxy groups 0-0.4 percentFor use only:
1. As a polymerization emulsifier at levels not to exceed 1.5 pct by weight of vinyl chloride polymers used as components of nonfood articles complying with 175.105, 175.300, 176.170, 176.180, and 177.1210 of this chapter. Such vinyl chloride polymers are limited to polyvinyl chloride and/or vinyl chloride copolymers complying with 177.1980 of this chapter.
2. As a polymerization emulsifier at levels not to exceed 1.5 pct by weight of vinyl chloride-vinyl acetate copolymers used as components of nonfood articles complying with 175.105, 175.300, 176.170, 176.180, and 177.1210 of this chapter.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-9]).For use as a surface active agent as provided in 175.105, 175.125, 176.170, and 176.180 of this chapter.
[alpha]-Di-sec-butylphenyl-omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of di-sec-butylphenol with an average of 4-14 or 30-50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4-14 or 30-50; sec-butyl groups are predominantly (90 percent or more) o-, p-substituents
Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294-49-8)For use only as an emulsifier at levels not to exceed 5 percent by weight of polymers intended for use in coatings.
[alpha]-Dodecyl-omega-hydroxpoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 103-111 and that are produced by the esterification of the condensation product of 1 mole of n-dodecyl alcohol with 4-4.5 moles of ethylene oxide
[alpha]-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of dodecylphenol (dodecyl group is a propylene tetramer isomer) with an average of 4-14 or 30-50 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4-14 or 30-50
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt (CAS Reg. No. 9084-06-4)For use only:
1. At levels not to exceed 10 micrograms/in 2 (0.16 mg/dm 2) in vinylidene chloride copolymer or homopolymer coatings applied to films of propylene polymers complying with 177.1520 of this chapter.
2. At levels not to exceed 14 micrograms/in 2 (0.21 mg/dm 2) in vinylidene chloride copolymer or homopolymer coatings applied to films of polyethylene phthalate polymers complying with 177.1630 of this chapter.
[alpha]-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 49-59 and that are produced by the esterification of a-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) complying with the identity prescribed in 178.3400(c) and having an average poly(oxyethylene) content of 5.5-6.5 moles
[alpha]-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 62-72 and that are produced by the esterification of '-(p-nonylphenyl)omega-hydroxypoly (oxyethylene) complying with the identity prescribed in 178.3400(c) and having an average poly(oxyethylene) content of 9-10 moles
[alpha]-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 98-110 and that are produced by the esterification of [alpha]-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) complying with the identity prescribed in 178.3400(c) and having an average poly(oxyethylene) content of 45-55 moles
[alpha]-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of nonylphenol (nonyl group is a propylene trimer isomer) with an average of 4-14 or 30-50 moles of ethylene oxide: if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4-14 or 30-50
[alpha]-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium or sodium salt: the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content average 4 moles
Polyethyleneglycol alkyl(C10-C12)ether sulfosuccinate, disodium salt (CAS Reg. No. 68954-91-6)For use only at levels not to exceed 5 percent by weight of total monomers used in the emulsion polymerization of polyvinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard.
Poly[(methylene-p-nonylphenoxy) poly(oxypropylene)(4-12 moles) propanol] of minimum molecular weight 3500For use in coatings at levels not to exceed 1 mg per square foot of food-contact surface.
Poly(oxypropylene) (45-48 moles) block polymer with poly(oxyethylene). The finished block polymers meet the following specifications: Average molecular weight 11,000-18,000; hydroxyl number 6.2-10.2; .cloud point above 100 deg. C. for 10 pct solutionFor use only as a surface-active agent at levels not to exceed 0.5 percent by weight of polyolefin film or polyolefin coatings. Such polyolefin film and polyolefin coatings shall have an average thickness not to exceed 0.005 inch and shall be limited to use in contact with foods that have a pH above 5.0 and that contain no more than 8 pct of alcohol.
Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate) meeting the following specifications: Saponification number 40-50, acid number 0-2, hydroxyl number 60-108, oxyethylene content 70-74 pct
Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate) meeting the following specifications: Saponification number 41-52, oxyethylene content 66-70.5 pct
Polysorbate 60 conforming to the identity prescribed in 172.836 of this chapter
Polysorbate 65 conforming to the identity prescribed in 172.838 of this chapter
Polysorbate 80 conforming to the identity prescribed in 172.840 of this chapter
Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meeting the following specifications: Saponification number 80-95, oxyethylene content 46-50 percent
Sodium 1,4-dicylcohexyl sulfosuccinate
Sodium 1,4-dihexyl sulfosuccinate
Sodium 1,4 diisobutyl sulfosuccinate
Sodium dioctyl sulfosuccinate
Sodium 1,4-dipentyl sulfosuccinate
Sodium 1,4-ditridecyl sulfosuccinate
Sodium lauryl sulfate
Sodium monoalkylphenoxybenzenedisulfonate and sodium dialkylphenoxybenzenedisulfonate mixtures containing not less than 70 pct of the monoalkylated product where the alkyl group is C8C16
Sorbitan monolaurate meeting the following specifications. Saponification number 153-170; and hydroxyl number 330-360
Sorbitan monooleate meeting the following specifications: Saponification number 145-160, hydroxyl number 193-210
Sorbitan monopalmitate meeting the following specifications: Saponification No. 140-150; and hydroxyl No. 275-305
Sorbitan monostearate conforming to the identity prescribed in 172.842 of this chapter
Sorbitan trioleate meeting the following specifications: Saponification No. 170-190; and hydroxyl No. 55-70
Sorbitan tristearate meeting the following specifications: Saponification No. 176-188; and hydroxyl No. 66-80
Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether, disodium salt (CAS Reg. No. 39354-45-5)For use only at levels not to exceed 5 percent by weight of total monomers used in the emulsion polymerization of polyvinyl acetate, acrylic, and vinyl/acrylic polymers intended for use as coatings for paper and paperboard.
Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether, disodium salt (alcohol moiety produced by condensation of 1 mole nonylphenol and an average of 9-10 moles of ethylene oxide) (CAS Reg. No. 9040-38-4)For use only at levels not to exceed 5 percent by weight of the total coating monomers used in the emulsion polymerization of polyvinyl acetate and vinyl-acrylate copolymers intended for use as coatings for paper and paperboard.
[alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl] omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-40 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range 4-14 or 30-50
Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinateFor use only as a polymerization emulsifier for resins applied to tea-bag material.
[alpha]-Tridecyl-omega-hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 75-85 and that are produced by the esterification of the condensation product of one mole of "oxo" process tridecyl alcohol with 5.5-6.5 moles of ethylene oxide
[alpha]-Tridecyl-omega-hydroxypoly (oxyethyl-ene) mixture of dihydrogen phosphate and monohydrogen phosphate esters that have an acid number (to pH 5.2) of 58-70 and that are produced by the esterification of the condensation product of one mole of "oxo" process tridecyl alcohol with 9-10 moles of ethylene oxide

(d) The provisions of this section are not applicable to emulsifiers and/or surface-active agents listed in 175.105(c)(5) of this chapter and used in food-packaging adhesives complying with 175.105 of this chapter.

[42 FR 14609, Mar. 15, 1977]

Editorial Note:

For Federal Register citations affecting 178.3400, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

Sec. 178.3450 Esters of stearic and palmitic acids.

The ester stearyl palmitate or palmityl stearate or mixtures thereof may be safely used as adjuvants in food-packaging materials when used in accordance with the following prescribed conditions:

(a) They are used or intended for use as plasticizers or lubricants in polystyrene intended for use in contact with food.

(b) They are added to the formulated polymer prior to extrusion.

(c) The quantity used shall not exceed that required to accomplish the intended technical effect.

Sec. 178.3480 Fatty alcohols, synthetic.

Synthetic fatty alcohols may be safely used as components of articles intended for use in contact with food, and in synthesizing food additives and other substances permitted for use as components of articles intended for use in contact with food in accordance with the following prescribed conditions:

(a) The food additive consists of fatty alcohols meeting the specifications and definition prescribed in 172.864 of this chapter, except as provided in paragraph (c) of this section.

(b) It is used or intended for use as follows:

(1) As substitutes for the corresponding naturally derived fatty alcohols permitted for use as components of articles intended for use in contact with food by existing regulations in parts 174, 175, 176, 177, 178 and 179.45 of this chapter: Provided, That the use is in compliance with any prescribed limitations.

(2) As substitutes for the corresponding naturally derived fatty alcohols used as intermediates in the synthesis of food additives and other substances permitted for use as components of food-contact articles.

(c) Synthetic fatty alcohols identified in paragraph (c)(1) of this section may contain not more than 0.8 weight percent of total diols as determined by a method titled "Diols in Monohydroxy Alcohol by Miniature Thin Layer Chromatography (MTLC)," which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

(1) Synthetic fatty alcohols. (i) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl alcohols meeting the specifications and definition prescribed in 172.864 of this chapter, except that they may contain not more than 0.8 weight percent total diols.

(ii) Lauryl, myristyl, cetyl, and stearyl alcohols manufactured by the process described in 172.864(a)(2) of this chapter such that lauryl and myristyl alcohols meet the specifications in 172.864(a)(1)(i) of this chapter, and cetyl and stearyl alcohols meet the specifications in 172.864(a)(1)(ii) of this chapter.

(2) Conditions of use. (i) Synthetic fatty alcohols as substitutes for the corresponding naturally derived fatty alcohols permitted for use in compliance with 178.3910.

(ii) Synthetic lauryl alcohol as a substitute for the naturally derived lauryl alcohol permitted as an intermediate in the synthesis of sodium lauryl sulfate used in compliance with 178.3400.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989]

Sec. 178.3500 Glycerin, synthetic.

Synthetic glycerin may be safely used as a component of articles intended for use in packaging materials for food, subject to the provisions of this section:

(a) It is produced by the hydrogenolysis of carbohydrates, and shall contain not in excess of 0.2 percent by weight of a mixture of butanetriols.

(b) It is used in a quantity not to exceed that amount reasonably required to produce its intended physical or technical effect, and in accordance with any limitations prescribed by applicable regulations in parts 174, 175, 176, 177, 178 and 179 of this chapter. It shall not be intended to, nor in fact accomplish, any direct physical or technical effect in the food itself.

Sec. 178.3505 Glyceryl tri-(12-acetoxystearate).

Glyceryl tri-(12-acetoxystearate) (CAS Reg. No. 139-43-5) may be safely used as a component of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) The additive is applied to the surface of calcium carbonate at a level not to exceed 1 weight-percent of the total mixture.

(b) The calcium carbonate/glyceryl tri-(12-acetoxystearate) mixture is used as an adjuvant in polymers in contact with nonfatty foods at a level not to exceed 20 weight-percent of the polymer.

[50 FR 1503, Jan. 11, 1985]

Sec. 178.3520 Industrial starch-modified.

Industrial starch-modified may be safely used as a component of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) Industrial starch-modified is identified as follows:

(1) A food starch-modified or starch or any combination thereof that has been modified by treatment with one of the reactants hereinafter specified, in an amount reasonably required to achieve the desired functional effect but in no event in excess of any limitation prescribed, with or without subsequent treatment as authorized in 172.892 of this chapter.

List of reactants Limitations
Ammonium persulfate, not to exceed 0.3 pct. or in alkaline starch not to exceed 0.6 pct.
(4-Chlorobutene-2) trimethylammonium chloride, not to exceed 5 pctIndustrial starch modified by this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging.
[beta]-Diethylaminoethyl chloride hydrochloride, not to exceed 4 pct
Dimethylaminoethyl methacrylate, not to exceed 3 pct
Dimethylol ethylene urea, not to exceed 0.375 pctIndustrial starch modified by this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging.
2,3-Epoxypropyltrimethylammonium chloride, not to exceed 5 pct
Ethylene oxide, not to exceed 3 pct of reacted ethylene oxide in finished product
Phosphoric acid, not to exceed 6 pct and urea, not to exceed 20 pctIndustrial starch modified by this treatment shall be used only as internal sizing for paper and paperboard intended for food packaging and as surface sizing and coating for paper and paperboard that contact food only of Types IV-A, V, VII, VIII, and IX described in table 1 of 176.170(c) of this chapter.

(2) A starch irradiated under one of the following conditions to produce free radicals for subsequent graft polymerization with the reactants listed in this paragraph (a)(2):

(i) Radiation from a sealed cobalt 60 source, maximum absorbed dose not to exceed 5.0 megarads.

(ii) An electron beam source at a maximum energy of 7 million electron volts of ionizing radiation, maximum absorbed dose not to exceed 5.0 megarads.

List of reactants Limitations
Acrylamide and [2-(methacryloyloxy) ethyl]trimethylammonium methyl sulfate, such that the finished industrial starch-modified shall contain:For use only as a retention aid and dry strength agent employed before the sheet-forming operation in the manufacture of paper and paperboard intended to contact food, and used at a level not to exceed 0.25 pct by weight of the finished dry paper and paperboard fibers.
1. Not more than 60 weight percent vinyl copolymer (of which not more than 32 weight percent is [2-(methacryloyloxy)ethyl] trimethylammonium methyl sulfate)
2. Not more than 0.20 pct residual acrylamide
3. A minimum nitrogen content of 9.0 pct

(b) The following adjuvants may be used as surface-active agents in the processing of industrial starch-modified:

Polyethylene glycol (400) dilaurate.

Polyethylene glycol (400) monolaurate.

Polyoxyethylene (4) lauryl ether.

(c) To insure safe use of the industrial starch-modified, the label of the food additive container shall bear the name of the additive "industrial starch-modified," and in the instance of an industrial starch-modified which is limited with respect to conditions of use, the label of the food additive container shall contain a statement of such limited use.

[42 FR 14609, Mar. 15, 1977, as amended at 42 FR 49453, Sept. 27, 1977]

Sec. 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic.

Isoparaffinic petroleum hydrocarbons, synthetic, may be safely used in the production of nonfood articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) The isoparaffinic petroleum hydrocarbons, produced by synthesis from petroleum gases consist of a mixture of liquid hydrocarbons meeting the following specifications:

Boiling point 63deg. -260 deg. C, as determined by ASTM method D86-82, "Standard Method for Distillation of Petroleum Products," 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/federalregister/codeoffederalregulations/ibrlocations.html.

Ultraviolet absorbance:

260-319 millimicrons--1.5 maximum.

320-329 millimicrons--0.08 maximum.

330-350 millimicrons--0.05 maximum.

Nonvolatile residue 0.002 gram per 100 milliliters maximum.

Synthetic isoparaffinic petroleum hydrocarbons containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. The ultraviolet absorbance shall be determined by the procedure described for application to mineral oil under "Specifications" on page 66 of the "Journal of the Association of Official Agricultural Chemists," Vol. 45 (February 1962), which is incorporated by reference, disregarding the last sentence of that procedure. For hydrocarbons boiling below 121 deg. C, the nonvolatile residue shall be determined by ASTM method D1353-78, "Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related Products;" for those boiling above 121 deg. C, ASTM procedure D381-80, "Standard Test Method for Existent Gum in Fuels by Jet Evaporation," which are 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/federalregister/codeoffederalregulations/ibrlocations.html.

(b) Isoparaffinic petroleum hydrocarbons may contain antioxidants authorized for use in food in an amount not to exceed that reasonably required to accomplish the intended technical effect.

(c) Isoparaffinic petroleum hydrocarbons are used in the production of nonfood articles. The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect, and the residual remaining in the finished article shall be the minimum amount reasonably attainable.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984]

Sec. 178.3570 Lubricants with incidental food contact.

Lubricants with incidental food contact may be safely used on machinery used for producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section:

(a) The lubricants are prepared from one or more of the following substances:

(1) Substances generally recognized as safe for use in food.

(2) Substances used in accordance with the provisions of a prior sanction or approval.

(3) Substances identified in this paragraph (a)(3).

Substances Limitations
Aluminum stearoyl benzoyl hydroxideFor use only as a thickening agent in mineral oil lubricants at a level not to exceed 10 pct by weight of the mineral oil.
N,N-Bis(2-ethylhexyl)-ar-methyl-1H-benzotriazole-1-methanamine (CAS Reg. No. 94270-86-7)For use as a copper deactivator at a level not to exceed 0.1 percent by weight of the lubricant.
BHA
BHT
[alpha]-Butyl-omega-hydroxypoly(oxyethylene) poly(oxypropylene) produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol; minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9038-95-3Addition to food not to exceed 10 parts per million.
[alpha]-Butyl-omega-hydroxypoly(oxypropylene); minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9003-13-8 Do.
Castor oil Do.
Castor oil, dehydrated Do.
Castor oil, partially dehydrated Do.
Dialkyldimethylammonium aluminum silicate (CAS Reg. No. 68953-58-2), which may contain up to 7 percent by weight 1,6-hexanediol (CAS Reg. No. 629-11-8), where the alkyl groups are derived from hydrogenated tallow fatty acids (C14-C18) and where the aluminum silicate is derived from bentoniteFor use only as a gelling agent in mineral oil lubricants at a level not to exceed 15 percent by weight of the mineral oil.
Dimethylpolysiloxane (viscosity greater than 300 centistokes)Addition to food not to exceed 1 part per million.
Di (n-octyl) phosphite (CAS Reg. No. 1809-14-9)For use only as an extreme pressure-antiwear adjuvant at a level not to exceed 0.5 percent by weight of the lubricant.
Disodium decanedioate (CAS Reg. No. 17265-14-4)For use only:
1. As a corrosion inhibitor or rust preventative in mineral oil-bentonite lubricants at a level not to exceed 2 percent by weight of the grease.
2. As a corrosion inhibitor or rust preventative only in greases at a level not to exceed 2 percent by weight of the grease.
Disodium EDTA (CAS Reg. No. 139-33-3)For use only as a chelating agent and sequestrant at a level not to exceed 0.06 percent by weight of lubricant at final use dilution.
Ethoxylated resin phosphate ester mixture consisting of the following compounds:For use only as a surfactant to improve lubricity in lubricating fluids complying with this section at a level not to exceed 5 percent by weight of the lubricating fluid.
1. Poly(methylene-p-tert-butyl- phenoxy)poly-(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-tert-butylphenol with 2 to 4 moles of formaldehyde and subsequent ethoxylation with 4 to 12 moles of ethylene oxide;
2. Poly(methylene-p-nonylphenoxy) poly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-nonylphenol with 2 to 4 moles of formaldehyde and subsequent ethoxylation with 4 to 12 moles of ethylene oxide; and
3. n-Tridecyl alcohol mixture of dihydrogen phosphate and monohydrogen phosphate esters (40 to 80 percent of the mixture; CAS Reg. No. 56831-62-0)
Fatty acids derived from animal or vegetable sources, and the hydrogenated forms of such fatty acids
2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol (CAS Reg. No. 95-38-5)For use at levels not to exceed 0.5 percent by weight of the lubricant.
Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) (CAS Reg. No. 35074-77-2)For use as an antioxidant at levels not to exceed 0.5 percent by weight of the lubricant.
[alpha]-Hydro-omega-hydroxypoly (oxyethylene) poly(oxypropylene) produced by random condensation of mixtures of ethylene oxide and propylene oxide containing 25 to 75 percent by weight of ethylene oxide; minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9003-11-6Addition to food not to exceed 10 parts per million.
12-Hydroxystearic acid
Isopropyl oleateFor use only as an adjuvant (to improve lubricity) in mineral oil lubricants.
Magnesium ricinoleateFor use only as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil.
Mineral oilAddition to food not to exceed 10 parts per million.
N-Methyl-N-(1-oxo-9- octadecenyl)glycine (CAS Reg. No. 110-25-8)For use as a corrosion inhibitor at levels not to exceed 0.5 percent by weight of the lubricant.
N-phenylbenzenamine, reaction products with 2,4,4-trimethylpentene (CAS Reg. No. 68411-46-1)For use only as an antioxidant at levels not to exceed 0.5 percent by weight of the lubricant.
PetrolatumComplying with 178.3700. Addition to food not to exceed 10 parts per million.
Phenyl-[alpha]-and/or phenyl-[beta]-naphthylamineFor use only, singly or in combination, as antioxidant in mineral oil lubricants at a level not to exceed a total of 1 percent by weight of the mineral oil.
Phosphoric acid, mono- and dihexyl esters, compounds with tetramethylnonylamines and C11-14 alkylaminesFor use only as an adjuvant at levels not to exceed 0.5 percent by weight of the lubricant.
Phosphoric acid, mono- and diisooctyl esters, reacted with tert-alkyl and (C12-C14) primary amines (CAS Reg. No. 68187-67-7)For use only as a corrosion inhibitor or rust preventative inlubricants at a level not to exceed 0.5 percent by weight of the lubricant.
Phosphorothioic acid, O, O, O-triphenyl ester, tert-butyl derivatives (CAS Reg. No. 192268-65-8)For use only as an extreme pressure-antiwear adjuvant at a level not to exceed 0.5 percent by weight of the lubricant.
Polyurea, having a nitrogen content of 9-14 percent based on the dry polyurea weight, produced by reacting tolylene diisocyanate with tall oil fatty acid (C16 and C18) amine and ethylene diamine in a 2:2:1 molar ratioFor use only as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil.
Polybutene (minimum average molecular weight 80,000)Addition to food not to exceed 10 parts per million.
Polybutene, hydrogenated; complying with the identity prescribed under 178.3740 Do.
Polyethylene Do.
Polyisobutylene (average molecular weight 35,000-140,000 (Flory))For use only as a thickening agent in mineral oil lubricants.
Sodium nitriteFor use only as a rust preventive in mineral oil lubricants at a level not to exceed 3 percent by weight of the mineral oil.
Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydro-cinnamate)]methane (CAS Reg. No. 6683-19-8)For use only as an antioxidant in lubricants at a level not to exceed 0.5 percent by weight of the lubricant.
Thiodiethylenebis (3,5-di-tert-butyl-4-hydroxyhydrocinnamate) (CAS Reg. No. 41484-35-9)For use as an antioxidant at levels not to exceed 0.5 percent by weight of the lubricant.
Tri[2(or 4)-C9-10-branched alkylphenyl]phosphorothioate (CAS Reg. No. 126019-82-7)For use only as an extreme pressure-antiwear adjuvant at levels not to exceed 0.5 percent by weight of the lubricant.
Triphenyl phosphorothionate (CAS Reg. No. 597-82-0)For use as an adjuvant in lubricants herein listed at a level not to exceed 0.5 percent by weight of the lubricant.
Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. NO. 31570-04-4)For use only as a stabilizer at levels not to exceed 0.5 percent by weight of the lubricant.
Thiodiethylenebis(3,5-di-tert-butyl-4-hydroxy-hydro- cinnamate) (CAS Reg. No. 41484-35-9)For use as an antioxidant at levels not to exceed 0.5 percent by weight of the lubricant.
Zinc sulfideFor use at levels not to exceed 10 percent by weight of the lubricant.

(b) The lubricants are used on food-processing equipment as a protective antirust film, as a release agent on gaskets or seals of tank closures, and as a lubricant for machine parts and equipment in locations in which there is exposure of the lubricated part to food. The amount used is the minimum required to accomplish the desired technical effect on the equipment, and the addition to food of any constituent identified in this section does not exceed the limitations prescribed.

(c) Any substance employed in the production of the lubricants described in this section that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter conforms with any specification in such regulation.

[42 FR 14609, Mar. 15, 1977]

Editorial Note:

For Federal Register citations affecting 178.3570, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

Sec. 178.3600 Methyl glucoside-coconut oil ester.

Methyl glucoside-coconut oil ester identified in 172.816(a) of this chapter may be safely used as a processing aid (filter aid) in the manufacture of starch, including industrial starch-modified complying with 178.3520, intended for use as a component of articles that contact food.

Sec. 178.3610 [alpha]-Methylstyrene-vinyltoluene resins, hydrogenated.

Hydrogenated [alpha]-methylstyrene-vinyltoluene copolymer resins having a molar ratio of 1 [alpha]-methylstyrene to 3 vinyltoluene may be safely used as components of polyolefin film intended for use in contact with food, subject to the following provisions:

(a) Hydrogenated [alpha]-methylstyrene-vinyltoluene copolymer resins have a drop-softening point of 125deg. to 165 deg. C and a maximum absorptivity of 0.17 liter per gram centimeter at 266 nanometers, as determined by methods titled "Determination of Softening Point (Drop Method)" and "Determination of Unsaturation of Resin 1977," which are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

(b) The polyolefin film is produced from olefin polymers complying with 177.1520 of this chapter, and the average thickness of the film in the form in which it contacts food does not exceed 0.002 inch.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989]

Sec. 178.3620 Mineral oil.

Mineral oil may be safely used as a component of nonfood articles intended for use in contact with food, subject to the provisions of this section:

(a) White mineral oil meeting the specifications prescribed in 172.878 of this chapter may be used as a component of nonfood articles provided such use complies with any applicable limitations in parts 170 through 189 of this chapter. The use of white mineral oil in or on food itself, including the use of white mineral oil as a protective coating or release agent for food, is subject to the provisions of 172.878 of this chapter.

(b) Technical white mineral oil identified in paragraph (b)(1) of this section may be used as provided in paragraph (b)(2) of this section.

(1) Technical white mineral oil consists of specially refined distillates of virgin petroleum or of specially refined distillates that are produced synthetically from petroleum gases. Technical white mineral oil meets the following specifications:

(i) Saybolt color 20 minimum as determined by ASTM method D156-82, "Standard Test Method for Saybolt Color of Petroleum Products (Saybolt Chromometer Method)," 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/federalregister/codeoffederalregulations/ibrlocations.html.

(ii) Ultraviolet absorbance limits as follows:

Wavelength (m[micro]) Maximum absorbance per centimeter optical pathlength
280 to 2894.0
290 to 2993.3
300 to 3292.3
330 to 3500.8

Technical white mineral oil containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. The ultraviolet absorbance shall be determined by the procedure described for application to mineral oil under "Specification" on page 66 of the "Journal of the Association of Official Agricultural Chemists," Volume 45 (February 1962) (which is incorporated by reference; copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html. ), disregarding the last two sentences of that procedure and substituting therefor the following: Determine the absorbance of the mineral oil extract in a 10-millimeter cell in the range from 260-350 m[micro], inclusive, compared to the solvent control. If the absorbance so measured exceeds 2.0 at any point in range 280-350 m[micro], inclusive, dilute the extract and the solvent control, respectively, to twice their volume with dimethyl sulfoxide and remeasure the absorbance. Multiply the remeasured absorbance values by 2 to determine the absorbance of the mineral oil extract per centimeter optical pathlength.

(2) Technical white mineral oil may be used wherever mineral oil is permitted for use as a component of nonfood articles complying with 175.105, 176.200, 176.210, 177.2260, 177.2600, and 177.2800 of this chapter and 178.3570 and 178.3910.

(3) Technical white mineral oil may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the Act, in an amount not greater than that required to produce its intended effect.

(c) Mineral oil identified in paragraph (c)(1) of this section may be used as provided in paragraph (c)(2) of this section.

(1) The mineral oil consists of virgin petroleum distillates refined to meet the following specifications:

(i) Initial boiling point of 450 deg. F minimum.

(ii) Color 5.5 maximum as determined by ASTM method D1500-82, "Standard Test Method for ASTM Color of Petroleum Products (ASTM Color Scale)," which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b)(1)(i) of this section.

(iii) Ultraviolet absorbance limits as follows as determined by the analytical method described in paragraph (c)(3) of this section:

Wavelength (m[micro]) Maximum absorbance per centimeter optical pathlength
280 to 2890.7
290 to 2990.6
300 to 3590.4
360 to 400.09

(2) The mineral oil may be used wherever mineral oil is permitted for use as a component of nonfood articles complying with 175.105 and 176.210 of this chapter and 178.3910 (for use only in rolling of metallic foil and sheet stock), 176.200, 177.2260, 177.2600, and 177.2800 of this chapter.

(3) The analytical method for determining ultraviolet absorbance limit is as follows:

general instructions

Because of the sensitivity of the test, the possibility of errors arising from contamination is great. It is of the greatest importance that all glassware be scrupulously cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of oil samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light.

apparatus

Separatory funnels. 250-milliliter, 500-milliliter, 1,000-milliliter, and preferably 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks.

Reservoir. 500-milliliter capacity, equipped with a 24/40 standard taper male fitting at the bottom and a suitable ball-joint at the top for connecting to the nitrogen supply. The male fitting should be equipped with glass hooks.

Chromatographic tube. 180 millimeters in length, inside diameter to be 15.7 millimeters +/-0.1 millimeter, equipped with a coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female 24/40 standard tapered fitting at the opposite end. (Overall length of the column with the female joint is 235 millimeters.) The female fitting should be equipped with glass hooks.

Disc. Tetrafluoroethylene polymer 2-inch diameter disk approximately 3/16-inch thick with a hole bored in the center to closely fit the stem of the chromatographic tube.

Suction flask. 250-milliliter or 500-milliliter filter flask.

Condenser. 24/40 joints, fitted with a drying tube, length optional.

Evaporation flask (optional). 250-milliliter or 500-milliliter capacity all-glass flask equipped with standard taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of contained liquid to be evaporated.

Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5,000 centimeter +/-0.005 centimeter; also for checking spectrophotometer performance only, optical path length in the range 1,000 centimeter +/-0.005 centimeter. With distilled water in the cells, determine any absorbance differences.

Spectrophotometer. Spectral range 250 millimicrons--400 millimicrons with spectral slit width of 2 millimicrons or less; under instrument operating conditions for these absorbance measurements, the spectrophotometer shall also meet the following performance requirements:

Absorbance repeatability, +/-0.01 at 0.4 absorbance.

Absorbance accuracy 1 +/-0.05 at 0.4 absorbance.

Wavelength accuracy, +/-1.0 millimicron.

Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

reagents and materials

Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this specification. The isooctane, benzene, acetone, and methyl alcohol designated in the list following this paragraph shall pass the following test:

To the specified quantity of solvent in a 250-milliliter Erlenmeyer flask, add 1 milliliter of purified n- hexadecane and evaporate on the steam bath under a stream of nitrogen (a loose aluminum foil jacket around the flask will speed evaporation). Discontinue evaporation when not over 1 milliliter of residue remains. (To the residue from benzene add a 10-milliliter portion of purified isooctane, reevaporate, and repeat once to insure complete removal of benzene.)

Alternatively, the evaporation time can be reduced by using the optional evaporation flask. In this case the solvent and n- hexadecane are placed in the flask on the steam bath, the tube assembly is inserted, and a stream of nitrogen is fed through the inlet tube while the outlet tube is connected to a solvent trap and vacuum line in such a way as to prevent any flow-back of condensate into the flask.

Dissolve the 1 milliliter of hexadecane residue in isooctane and make to 25 milliliters volume. Determine the absorbance in the 5-centimeter path length cells compared to isooctane as reference. The absorbance of the solution of the solvent residue (except for methyl alcohol) shall not exceed 0.01 per centimeter path length between 280 and 400 m[micro]. For methyl alcohol this absorbance value shall be 0.00.

Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test described in the preceding paragraph. Purify, if necessary, by passage through a column of activated silica gel (Grade 12, Davison Chemical Company, Baltimore, Maryland, or equivalent) about 90 centimeters in length and 5 centimeters to 8 centimeters in diameter.

Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. Purify, if necessary, by distillation or otherwise.

Acetone, A.C.S. reagent grade. Use 200 milliliters for the test. Purify, if necessary, by distillation.

Eluting mixtures:

1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene into a 250-milliliter glass-stoppered volumetric flask and adjust to volume with isooctane, with mixing.

2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene into a 250-milliliter glass-stoppered volumetric flask and adjust to volume with isooctane, with mixing.

3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380 milliliters of acetone and 200 milliliters of benzene, and mix.

n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n- hexadecane to 25 milliliters with isooctane and determine the absorbance in a 5-centimeter cell compared to isooctane as reference point between 280 m[micro]-400 m[micro]. The absorbance per centimeter path length shall not exceed 0.00 in this range. Purify, if necessary, by percolation through activated silica gel or by distillation.

Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl alcohol. Purify, if necessary, by distillation.

Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach Corporation, Camas, Washington, or equivalent). Absorbance (1-centimeter cell, distilled water reference, sample completely saturated with nitrogen).

Wavelength Absorbance (maximum)
261.51.00
270.20
275.09
280.06
300.015

There shall be no irregularities in the absorbance curve within these wavelengths.

Phosphoric acid. 85 percent A.C.S. reagent grade.

Sodium borohydride. 98 percent.

Magnesium oxide (Sea Sorb 43, Food Machinery Company, Westvaco Division, distributed by chemical supply firms, or equivalent). Place 100 grams of the magnesium oxide in a large beaker, add 700 milliliters of distilled water to make a thin slurry, and heat on a steam bath for 30 minutes with intermittent stirring. Stir well initially to insure that all the adsorbent is completely wetted. Using a Buchner funnel and a filter paper (Schleicher & Schuell No. 597, or equivalent) of suitable diameter, filter with suction. Continue suction until water no longer drips from the funnel. Transfer the adsorbent to a glass trough lined with aluminum foil (free from rolling oil). Break up the magnesia with a clean spatula and spread out the adsorbent on the aluminum foil in a layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours at 160 deg. C +/-1 deg. C. Pulverize the magnesia with mortar and pestle. Sieve the pulverized adsorbent between 60-180 mesh. Use the magnesia retained on the 180-mesh sieve.

Celite 545. Johns Mansville Company, diatomaceous earth, or equivalent.

Magnesium oxide-Celite 545 mixture (2 + 1) by weight. Place the magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions, respectively, by weight in a glass-stoppered flask large enough for adequate mixing. Shake vigorously for 10 minutes. Transfer the mixture to a glass trough lined with aluminum foil (free from rolling oil) and spread it out on a layer about 1 centimeter to 2 centimeters thick. Reheat the mixture at 160 deg. C +/-1 deg. C for 2 hours, and store in a tightly closed flask.

Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in granular form. For each bottle of sodium sulfate reagent used, establish as follows the necessary sodium sulfate prewash to provide such filters required in the method: Place approximately 35 grams of anhydrous sodium sulfate in a 30-milliliter course, fritted-glass funnel or in a 65-millimeter filter funnel with glass wool plug; wash with successive 15-milliliter portions of the indicated solvent until a 15-milliliter portion of the wash shows 0.00 absorbance per centimeter path length between 280 m[micro] and 400 m[micro] when tested as prescribed under "Organic solvents." Usually three portions of wash solvent are sufficient.

Before proceeding with analysis of a sample, determine the absorbance in a 5-centimeter path cell between 250 millimicrons and 400 millimicrons for the reagent blank by carrying out the procedure, without an oil sample, recording the spectra after the extraction stage and after the complete procedure as prescribed. The absorbance per centimeter pathlength following the extraction stage should not exceed 0.02 in the wavelength range from 280 m[micro] to 400 m[micro]; the absorbance per centimeter pathlength following the complete procedure should not exceed 0.02 in the wavelength range from 280 m[micro] to 400 m[micro]. If in either spectrum the characteristic benzene peaks in the 250 m[micro]-260 m[micro] region are present, remove the benzene by the procedure under "Organic solvents" and record absorbance again.

Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory funnel and add 75 milliliters of phosphoric acid. Mix the contents of the funnel and allow to stand for 10 minutes. (The reaction between the sulfoxide and the acid is exothermic. Release pressure after mixing, then keep funnel stoppered.) Add 150 milliliters of isooctane and shake to pre-equilibrate the solvents. Draw off the individual layers and store in glass-stoppered flasks.

Weigh a 20-gram sample of the oil and transfer to a 500-milliliter separatory funnel containing 100 milliliters of pre-equilibrated sulfoxide-phosphoric acid mixture. Complete the transfer of the sample with small portions of preequilibrated isooctane to give a total volume of the oil and solvent of 75 milliliters. Shake the funnel vigorously for 2 minutes. Set up three 250-milliliter separatory funnels with each containing 30 milliliters of pre-equilibrated isooctane. After separation of liquid phases, carefully draw off lower layer into the first 250-milliliter separatory funnel and wash in tandem with the 30-milliliter portions of isooctane contained in the 250-milliliter separatory funnels. Shaking time for each wash is 1 minute. Repeat the extraction operation with two additional portions of the sulfoxide-acid mixture and wash each extractive in tandem through the same three portions of isooctane.

Collect the successive extractives (300 milliliters total) in a separatory funnel (preferably 2-liter) containing 480 milliliters of distilled water; mix, and allow to cool for a few minutes after the last extractive has been added. Add 80 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the extraction with 80 milliliters of isooctane. Draw off and discard the aqueous layer. Wash each of the 80-milliliter extractives three times with 100-milliliter portions of distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate prewashed with isooctane (see Sodium sulfate under "Reagents and Materials" for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the first separatory funnel with the second 80-milliliter isooctane extractive and pass through the sodium sulfate. Then wash the second and first separatory funnels successively with a 20-milliliter portion of isooctane and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n -hexadecane and evaporate the isooctane on the steam bath under nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane, reevaporate to 1 milliliter of hexadecane, and repeat this operation once.

Quantitatively transfer the residue with isooctane to a 200-milliliter volumetric flask, make to volume, and mix. Determine the absorbance of the solution in the 1-centimeter pathlength cells compared to isooctane as reference between 280 m[micro]-400 m[micro] (take care to lose none of the solution in filling the sample cell). Correct the absorbance values for any absorbance derived from reagents as determined by carrying out the procedure without an oil sample. If the corrected absorbance does not exceed the limits prescribed in this paragraph, the oil meets the ultraviolet absorbance specifications. If the corrected absorbance per centimeter pathlength exceeds the limits prescribed in this paragraph, proceed as follows: Quantitatively transfer the isooctane solution to a 125-milliliter flask equipped with 24/40 joint, and evaporate the isooctane on the steam bath under a stream of nitrogen to a volume of 1 milliliter of hexadecane. Add 10 milliliters of methyl alcohol and approximately 0.3 gram of sodium borohydride. (Minimize exposure of the borohydride to the atmosphere. A measuring dipper may be used.) Immediately fit a water-cooled condenser equipped with a 24/40 joint and with a drying tube into the flask, mix until the borohydride is dissolved, and allow to stand for 30 minutes at room temperature, with intermittent swirling. At the end of this period, disconnect the flask and evaporate the methyl alcohol on the steam bath under nitrogen until the sodium borohydride begins to come out of the solution. Then add 10 milliliters of isooctane and evaporate to a volume of about 2-3 milliliters. Again, add 10 milliliters of isooctane and concentrate to a volume of approximately 5 milliliters. Swirl the flask repeatedly to assure adequate washing of the sodium borohydride residues.

Fit the tetrafluoroethylene polymer disc on the upper part of the stem of the chromatographic tube, then place the tube with the disc on the suction flask and apply the vacuum (approximately 135 millimeters Hg pressure). Weigh out 14 grams of the 2:1 magnesium oxide-Celite 545 mixture and pour the adsorbent mixture into the chromatographic tube in approximately 3-centimeter layers. After the addition of each layer, level off the top of the adsorbent with a flat glass rod or metal plunger by pressing down firmly until the adsorbent is well packed. Loosen the topmost few millimeters of each adsorbent layer with the end of a metal rod before the addition of the next layer. Continue packing in this manner until all the 14 grams of the adsorbent is added to the tube. Level off the top of the adsorbent by pressing down firmly with a flat glass rod or metal plunger to make the depth of the adsorbent bed approximately 12.5 centimeters in depth. Turn off the vacuum and remove the suction flask. Fit the 500-milliliter reservoir onto the top of the chromatographic column and prewet the column by passing 100 milliliters of isooctane through the column. Adjust the nitrogen pressure so that the rate of descent of the isooctane coming off the column is between 2-3 milliliters per minute. Discontinue pressure just before the last of the isooctane reaches the level of the adsorbent. (Caution: Do not allow the liquid level to recede below the adsorbent level at any time.) Remove the reservoir and decant the 5-milliliter isooctane concentrate solution onto the column and with slight pressure again allow the liquid level to recede to barely above the adsorbent level. Rapidly complete the transfer similarly with two 5-milliliter portions of isooctane, swirling the flask repeatedly each time to assure adequate washing of the residue. Just before the final 5-milliliter wash reaches the top of the adsorbent, add 100 milliliters of isooctane to the reservoir and continue the percolation at the 2-3 milliliters per minute rate. Just before the last of the isooctane reaches the adsorbent level, add 100 milliliters of 10 percent benzene in isooctane to the reservoir and continue the percolation at the aforementioned rate. Just before the solvent mixture reaches adsorbent level, add 25 milliliters of 20 percent benzene in isooctane to the reservoir and continue the percolation at 2-3 milliliters per minute until all this solvent mixture has been removed from the column. Discard all the elution solvents collected up to this point. Add 300 milliliters of the acetone-benzene-water mixture to the reservoir and percolate through the column to eluate the polynuclear compounds. Collect the eluate in a clean 1-liter separatory funnel. Allow the column to drain until most of the solvent mixture is removed. Wash the eluate three times with 300-milliliter portions of distilled water, shaking well for each wash. (The addition of small amounts of sodium chloride facilitates separation.) Discard the aqueous layer after each wash. After the final separation, filter the residual benzene through anhydrous sodium sulfate pre-washed with benzene (see Sodium sulfate under "Reagents and Materials" for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the separatory funnel with two additional 20-milliliter portions of benzene which are also filtered through the sodium sulfate. Add 1 milliliter of n -hexadecane and completely remove the benzene by evaporation under nitrogen, using the special procedure to eliminate benzene as previously described under "Organic solvents." Quantitatively transfer the residue with isooctane to a 200-milliliter volumetric flask and adjust to volume. Determine the absorbance of the solution in the 1-centimeter pathlength cells compared to isooctane as reference between 250 m[micro]-400 m[micro]. Correct for any absorbance derived from the reagents as determined by carrying out the procedure without an oil sample. If either spectrum shows the characteristic benzene peaks in the 250 m[micro]-260 m[micro] region, evaporate the solution to remove benzene by the procedure under "Organic solvents." Dissolve the residue, transfer quantitatively, and adjust to volume in isooctane in a 200-milliliter volumetric flask. Record the absorbance again. If the corrected absorbance does not exceed the limits proposed in this paragraph, the oil meets the proposed ultraviolet absorbance specifications.

(d) Mineral oil identified in paragraph (d)(1) of this section may be used as provided in paragraph (d)(2) of this section.

(1) The mineral oil consists of virgin petroleum distillates refined to meet the following specifications:

(i) Distillation endpoint at 760 millimeters pressure not to exceed 371 deg. C, with a maximum residue not to exceed 2 percent, as determined by ASTM method D86-82, "Standard Method for Distillation of Petroleum Products," which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b)(1)(i) of this section.

(ii) Ultraviolet absorbance limits as follows as determined by the method described in paragraph (d)(3) of this section.

Wavelength (m[micro]) Maximum absorb-ance per centimeter optical pathlength
280 to 2992.3
300 to 3191.2
320 to 359.8
360 to 400.3

(iii) Pyrene content not to exceed a maximum of 25 parts per million as determined by the method described in paragraph (d)(3) of this section.

(2) The mineral oil may be used only in the processing of jute fiber employed in the production of textile bags intended for use in contact with the following types of food: Dry grains and dry seeds (for example, beans, peas, rice, and lentils); whole root crop vegetables of the types identified in 40 CFR 180.34(f); unshelled and shelled nuts (including peanuts); and dry animal feed. The finished processed jute fiber shall contain no more than 6 percent by weight of residual mineral oil.

(3) The analytical method for determining ultraviolet absorbance limits and pyrene content is as follows:

I. Apparatus. A. Assorted beakers, separatory funnels fitted with tetrafluoroethylene polymer stopcocks, and graduated cylinders.

B. Volumetric flasks, 200-milliliter.

C. A chromatographic column made from nominal 1.3 centimeters outside diameter * 75 centimeters glass tubing tapered at one end and joined to a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The opposite end is flanged and joined to a female 24/40 standard taper fitting. This provides for accommodating the 500-milliliter reservoir described in item I.E below.

D. A chromatographic column made from nominal 1.7 centimeters outside diameter * 115 centimeters glass tubing tapered at one end and joined to a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The opposite end is flanged and joined to a 2.5 centimeters outside diameter * 9.0 centimeters glass tube having a female 24/40 standard taper fitting. This provides for accommodating the 500-milliliter reservoir described in item I. E below.

E. A 500-milliliter reservoir having a 24/40 standard taper male fitting at bottom and a suitable ball joint at the top for connecting to the nitrogen supply. The female fitting of the chromatographic columns described in items I. C and D above and the male fitting of the reservoir described in this item E should both be equipped with glass hooks.

(Note: Rubber stoppers are not to be used. Stopcock grease is not to be used on ground-glass joints in this method.)

F. A spectrophotometer equipped to automatically record absorbance of liquid samples in 1-centimeter pathlength cells in the spectral region of 280-400 m[micro] with a spectral slit width of 2 m[micro] or less. At an absorbance level of about 0.4, absorbance measurements shall be repeatable within +/-0.01 and accurate within +/-0.05. Wavelength measurements shall be repeatable with +/-0.2 m[micro] and accurate within +/-1.0 m[micro]. Instrument operating conditions are selected to realize this performance under dynamic (automatic) recording operations. Accuracy of absorbance measurements are determined at 290, 345, and 400 m[micro], using potassium chromate as the reference standard. (National Bureau of Standards Circular 484, Spectrophotometry, U.S. Department of Commerce, 1949.)

G. Two fused quartz cells having pathlengths of 1.00+/-0.005 centimeter or better.

II. Purity of reagents and materials. Reagent-grade chemicals shall be used in all tests. It is further specified that each chemical shall be tested for purity in accordance with the instruction given under "Reagents and Materials" in III below. In addition, a blank run by the procedure shall be made on each purified lot of reagents and materials. Unless otherwise indicated, references to water shall be understood to mean distilled water.

III. Reagents and materials-- A. Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this section III. The isooctane, benzene, cyclohexane, nitromethane, and n -hexadecane designated shall pass the following test: To the specified quantity of solvent in a 150-milliliter beaker, add 1 milliliter of purified n -hexadecane and evaporate on the steam bath under a stream of nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains (to the residue from benzene and nitromethane add a 10-milliliter portion of purified isooctane, re-evaporate, and repeat once to insure complete removal of solvent). Dissolve the 1 milliliter of n -hexadecane residue in isooctane and make to 10-milliliter volume. Determine the absorbance in 1.0-centimeter pathlength cells compared to water as reference. The absorbance of the solution of solvent residue shall not exceed 0.05 between 280 and 400 m[micro].

1. Isooctane (2,2,4-trimethylpentane ). Use 240 milliliters for the above test. Purify, if necessary, by passage through a column of activated silica gel.

2. Benzene. Use 200 milliliters for the above test. Purify, if necessary, by distillation or otherwise.

3. Cyclohexane. Use 70 milliliters for the above test. Purify, if necessary, by distillation, silica gel percolation, or otherwise.

4. Nitromethane. Use 125 milliliters for the above test. Purify, if necessary, by distillation or otherwise.

5. n-Hexadecane. Determine the absorbance on this solvent directly. Purify, if necessary, by silica gel percolation or otherwise.

B. Other materials-- 1. Pyrene standard reference. Pyrene, reagent grade, melting point range 150-152 deg. C. (Organic Chemical 3627, Eastman Kodak Co., Rochester, N.Y., or equivalent). The standard reference absorbance is the absorbance at 334 millimicrons of a standard reference solution of pyrene containing a concentration of 1.0 milligram per liter in purified isooctane measured against isooctane of the same spectral purity in 1.0-centimeter cells. (This absorbance will be approximately 0.28.)

2. Chrysene solution. Prepare a solution at a concentration of 5.0 milligrams per liter by dissolving 5.0 milligrams of chrysene in purified isooctane in a 1-liter volumetric flask. Adjust to volume with isooctane.

3. Nitrogen gas. Water pumped or equivalent purity, cylinder with regulator, and valve control flow at 5 p.s.i.

4. Silica gel. 100-200 mesh (Davison Chemical, Baltimore, Md., Grade 923, or equivalent), purified and activated by the following procedure: Place about 1 kilogram of silica gel in a large column and wash with contaminant-free benzene until a 200-milliliter sample of the benzene coming off the column will pass the ultraviolet absorption test for benzene. This test is performed as stipulated under "Organic solvents" in A under III above. When the silica gel has been sufficiently cleaned, activate the gel before use by placing the 1-kilogram batch in a shallow container in a layer no greater than 1 inch in depth and heating in an oven (Caution! Explosion Hazard) at 130 deg. C. for 16 hours, and store in a vacuum desiccator. Reheating about once a week is necessary if the silica gel is repeatedly removed from the desiccator.

5. Aluminum oxide (Aluminum Co. of America, Grade F-20, or equivalent grade ). 80-200 mesh, purified and activated by the following procedure: Place about 1 kilogram of aluminum oxide in a large column and wash with contaminant-free benzene until a 200-milliliter sample of the benzene coming off the column will pass the ultraviolet absorption test for benzene. This test is performed as stipulated under "Organic solvents" in A under III above. (Caution! Remove Benzene From Adsorbent Under Vacuum To Minimize Explosion Hazard in Subsequent Heating!) When the aluminum oxide has been sufficiently cleaned and freed of solvent, activate it before use by placing the 1-kilogram batch in a shallow container in a layer no greater than 1 inch in depth. Heat in an oven at 130 deg. C for 16 hours. Upon removal from heat, store at atmospheric pressure over 80 percent (by weight) sulfuric acid in a desiccator for at least 36 hours before use. This gives aluminum oxide with between 6 to 9.5 percent volatiles. This is determined by heating a weighed sample of the prepared aluminum oxide at 2,000 deg. F for 2 hours and then quickly reweighing. To insure the proper adsorptive properties of the aluminum oxide, perform the following test:

a. Weigh 50 grams +/-1 gram of the activated aluminum oxide and pack into the chromatographic column (1.3 centimeters * 75 centimeters) described under "Apparatus" in C under I above. Use glass wool at the column exit to prevent the aluminum oxide from passing through the column.

b. Place a 250-milliliter graduated cylinder under the column to measure the amount of eluate coming from the column.

c. Prewet the aluminum oxide by passing 40 milliliters of isooctane through the column. Adjust the nitrogen pressure so that the rate of descent of the isooctane coming off the column is between 1.5 to 2.5 milliliters per minute.

d. Just prior to the last of the isooctane reaching the top of the aluminum oxide bed, add 10 milliliters of the isooctane solution containing 5.0 milligrams of chrysene per liter.

e. Continue percolation until the isooctane is just above the aluminum oxide. Then add 200 milliliters of a mixture of benzene and isooctane (33 1/3 percent benzene and 66 2/3 percent isooctane by volume) to the reservoir and continue percolation.

f. Continue percolation, collecting the eluates (40 milliliters of the prewet solution, 10 milliliters of the sample solution, and 200 milliliters of the gradient solution) in the 250-milliliter graduated cylinder until the level of the gradient solution is just above the aluminum oxide. Add 200 milliliters of the eluting solution of benzene and isooctane (90 percent benzene and 10 percent isooctane by volume) to the column and continue collecting until a total of 250 milliliters of solution has been obtained. This may be discarded. Now begin to collect the final eluate.

g. Place a 100-milliliter graduated cylinder under the column and continue the percolation until a 100-milliliter eluate has been obtained.

h. Measure the amount of chrysene in this 100-milliliter fraction by ultraviolet analysis. If the aluminum oxide is satisfactory, more than 80 percent of the original amount of chrysene should be found in this fraction. (Note: If the amount of chrysene recovered is less than 80 percent, the original batch of aluminum oxide should be sieved between 100-160 mesh. Activation and testing of this sieved batch should indicate a satisfactory aluminum oxide for use.)

IV. Sampling. Precautions must be taken to insure that an uncontaminated sample of the mineral oil is obtained since ultraviolet absorption is very sensitive to small amounts of extraneous material contaminating the sample through careless handling.

V. Procedure. A. Blank. Before proceeding with the analysis of a sample, determine the absorbance of the solvent residues by carrying out the procedure without a sample.

B. Sample. 1. Weigh out 20.0 grams +/-0.1 gram of the mineral oil into a beaker and transfer to a 250-milliliter separatory funnel fitted with a tetrafluoroethylene polymer stopcock, using enough cyclohexane (25 milliliters) to give a final total volume of 50 milliliters (mineral oil plus cyclohexane).

2. Add 25 milliliters of nitromethane saturated with cyclohexane and shake by hand vigorously for 3 minutes. Recover the lower nitromethane layer in a 150-milliliter beaker containing 1 milliliter of n -hexadecane and evaporate on the steam bath under nitrogen. Repeat the extraction four more times, recovering each extract in the 150-milliliter beaker. Exercise care not to fill the beaker to such a capacity that solvent losses may occur. Evaporate the combined nitromethane extracts to 1 milliliter of n -hexadecane residue containing the nitromethane-soluble mineral oil extractives. (Note: Complete removal of the nitromethane is essential. This can be assured by two successive additions of 5 milliliters of isooctane and reevaporation.)

3. Remove the beaker from the steam bath and allow to cool.

4. Weigh 50 grams +/-1 gram of activated aluminum oxide and pack into the chromatographic column (1.3 centimeters * 75 centimeters) described under "Apparatus" in C under I above. (Note: A small plug of glass wool is placed at the column exit to prevent the aluminum oxide from passing through the column. After adding aluminum oxide, tap the column lightly to remove air voids. All percolations using aluminum oxide are performed under nitrogen pressure. The 500-milliliter reservoir described under "Apparatus" in E under I above is to be used to hold the elution solvents.)

5. Prewet the column by adding 40 milliliters of isooctane to the column. Adjust nitrogen pressure so that rate of descent of the isooctane coming off the column is 2.0 to 3.0 milliliters per minute. Be careful to maintain the level of solvent in the reservoir to prevent air from entering the aluminum oxide bed. New or additional solvent is added just before the last portion of the previous solvent enters the bed. To minimize possible photo-oxidation effects, the following procedures (steps 6 through 18) shall be carried out in subdued light.

6. Before the last of the isooctane reaches the top of the aluminum oxide bed, release the nitrogen pressure and turn off the stopcock on the column. Transfer the n -hexadecane residue from the 150-milliliter beaker from procedure step 3 above onto the column, using several washes of isooctane (total volume of washes should be no greater than 10-15 milliliters).

7. Open the stopcock and continue percolation until the isooctane is about 1 centimeter above the top of the aluminum oxide bed. Add 200 milliliters of isooctane to the reservoir, and continue the percolation at the specified rate.

8. Just before the isooctane surface reaches the top of the aluminum oxide bed, add 200 milliliters of a mixture of benzene and isooctane (33 1/3 percent benzene and 66 2/3 percent isooctane by volume) to the reservoir, and continue the percolation.

9. Just before the surface of this mixture reaches the top of the aluminum oxide bed, release the nitrogen pressure, turn off the stopcock, and discard all the elution solvents collected up to this point.

10. Add to the reservoir 300 milliliters of a mixture of benzene and isooctane (90 percent benzene and 10 percent isooctane by volume), place a 25-milliliter graduated cylinder under the column, continue the percolation until 20 milliliters of eluate has been collected, and then discard the eluate.

11. At this point, place a clean 250-milliliter Erlenmeyer flask under the column. Continue the percolation and collect all the remaining eluate.

(Note: Allow the column to drain completely. An increase in the nitrogen pressure may be necessary as the last of the solvent comes off the column.)

12. Place 1 milliliter of n -hexadecane into a 150-milliliter beaker. Place this onto a steam bath under a nitrogen stream and transfer in small portions the eluate from step 11 above. Wash out the Erlenmeyer flask with small amounts of benzene and transfer to the evaporation beaker. Evaporate until only 1 milliliter of hexadecane residue remains. (Note: Complete removal of the benzene is essential. This can be assured by two successive additions of 5 milliliters of isooctane and reevaporation.)

13. Remove the beaker from the steam bath and cool.

14. Place a sample of 113.5 grams activated 100- 200-mesh silica gel in a 500-milliliter glass-stoppered Erlenmeyer flask. Add to the silica gel 46.2 grams (41 milliliters) of nitromethane. Stopper and shake the flask vigorously until no lumps of silica gel are observed and then shake occasionally during a period of 1 hour. The resultant nitromethane-treated silica gel is 29 weight-percent nitro-methane and 71 weight-percent silica gel.

15. Place a small plug of glass wool in the tapered end of the 1.7 centimeters outside diameter * 115 centimeters column, described under "Apparatus" in D of I above, adjacent to the stopcock to prevent silica gel from passing through the stopcock. Pack the nitromethane-treated silica gel into the column, tapping lightly. The resultant silica gel bed should be about 95 centimeters in depth. Place into a flask 170 milliliters of isooctane saturated with nitromethane.

16. Place a 100-milliliter graduated cylinder under the column and transfer the residue from the beaker in procedure step 13 above with several washes of the 170 milliliters of isooctane, saturated with nitromethane, onto the top of the column. (Total volume of washes should be no greater than 10 to 15 milliliters.) Permit isooctane solution to enter the silica gel bed until the liquid level is at the top bed level. Place the remaining amount of the 170 milliliters of isooctane, saturated with nitromethane, in the reservoir above the bed for percolation through the silica gel. Apply nitrogen pressure to the top of the column, adjusting the pressure so that the isooctane is collected at the rate of 2.5 to 3.5 milliliters per minute, and percolate isooctane through the bed until a quantity of 75.0 milliliters of eluate is collected. Discard the 75 milliliters of eluate. Turn off the stopcock and add 250 milliliters of benzene to the reservoir above the bed. Use a 400-milliliter beaker to collect the remaining eluate.

17. Open the stopcock, renew the pressure, and percolate the remaining isooctane and benzene through the column eluting the remaining aromatics. Transfer the eluate in small portions from the 400 milliliter beaker to a 150-milliliter beaker containing 1 milliliter of n -hexadecane and evaporate on the steam bath under nitrogen. Rinse the 400-milliliter beaker well with small portions of isooctane to obtain a complete transfer.

(Note: Complete removal of the nitromethane and benzene is essential. This can be assured by successive additions of 5 milliliters of isooctane and reevaporation.)

18. Transfer the residue with several washes of isooctane into a 200-milliliter volumetric flask. Add isooctane to mark.

19. Record the spectrum of the sample solution in a 1-centimeter cell compared to isooctane from 270 to 400 m[micro]. After making necessary corrections in the spectrum for cell differences and for the blank absorbance, record the maximum absorbance in each of the wavelength intervals (m[micro]), 280-299, 300-319, 320-359, 360-400.

a. If the spectrum then shows no discernible peak corresponding to the absorbance maximum of the pyrene reference standard solution at 334 m[micro], the maximum absorbances in the respective wavelength intervals recorded shall not exceed those prescribed in paragraph (d)(1)(ii) of this section.

b. If such a peak is evident in the spectrum of the sample solution, and the spectrum as a whole is not incompatible with that of a pyrene contaminant yielding such a peak of the observed absorbance, calculate the concentration of pyrene that would yield this peak (334 m) by the base-line technique described in ASTM method E169-63 (Reapproved 1981), "Standard Recommended Practices for General Techniques of Ultraviolet Quantitative Analysis," which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b)(1)(i) of this section. Correct each of the maximum absorbances in the respective specified wavelength intervals by subtracting the absorbance due to pyrene, determined as follows:

where:

Cp = Calculated concentration of pyrene in sample solution;

Sp = Concentration of pyrene reference standard solution in same units of concentration;

Sa = Absorbance of pyrene reference standard solution at wavelength of maximum absorbance of sample solution in the respective specified wavelength intervals.

Also calculate the pyrene content of the oil sample in parts per million as follows:

where:

C = Calculated concentration of pyrene in milligrams per liter of sample solution.

c. The pyrene content so determined shall not exceed 25 p.p.m. The maximum absorbances corrected for pyrene content as described in this step 19 for each of the specified wavelength intervals shall not exceed the limits prescribed in paragraph (d)(1)(ii) of this section.

d. If the spectrum as a whole of the sample solution is in any respect clearly incompatible with the presence of pyrene as the source of the peak at 334 m[micro], then the maximum absorbances in the respective wavelength intervals without correction for any assumed pyrene content shall not exceed the limits prescribed in paragraph (d)(1)(ii) of this section.

1As determined by procedure using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrophotometry, U.S. Department of Commerce (1949). The accuracy is to be determined by comparison with the standard values at 290, 345, and 400 millimicrons. Circular 484 is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989]

Sec. 178.3650 Odorless light petroleum hydrocarbons.

Odorless light petroleum hydrocarbons may be safely used, as a component of nonfood articles intended for use in contact with food, in accordance with the following prescribed conditions:

(a) The additive is a mixture of liquid hydrocarbons derived from petroleum or synthesized from petroleum gases. The additive is chiefly paraffinic, isoparaffinic, or naphthenic in nature.

(b) The additive meets the following specifications:

(1) Odor is faint and not kerosenic.

(2) Initial boiling point is 300 deg. F minimum.

(3) Final boiling point is 650 deg. F maximum.

(4) Ultraviolet absorbance limits determined by method specified in 178.3620(b)(1)(ii), as follows:

Wavelength (M[micro]) Maximum absorbance per centimeter optical pathlength
280 to 2894.0
290 to 2993.3
300 to 3292.3
330 to 360.8

(c) The additive is used as follows:

Use Limitations
As a plasticizer and absorber oil in the manufacture of polyolefin articles authorized for food contact useIn an amount not to exceed that required to produce intended effect, consistent with good manufacturing practice.
As a lubricant of fibers of textiles authorized for food contact useAt a use level not to exceed 0.15 percent by weight of finished fibers.
As a component of adhesivesComplying with 175.105 of this chapter.
As a defoamer in the manufacture of paper and paperboardComplying with 176.210 of this chapter.
As a defoamer in coatingsComplying with 176.200 of this chapter.
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 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 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, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(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 (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

(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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

(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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(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 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; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]

Sec. 178.3700 Petrolatum.

Petrolatum may be safety used as a component of nonfood articles in contact with food, in accordance with the following conditions:

(a) Petrolatum complies with the specifications set forth in the United States Pharmacopeia XX (1980) for white petrolatum or in the National Formulary XV (1980) for yellow petrolatum.

(b) Petrolatum meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in 172.886(b) of this chapter:

Ultraviolet absorbance per centimeter pathlength:

Millimicrons Maximum
280 to 2890.25
290 to 299.20
300 to 359.14
360 to 400.04

(c) It is used or intended for use as a protective coating of the surfaces of metal or wood tanks used in fermentation process, in an amount not in excess of that required to produce its intended effect.

(d) Petrolatum as defined by this section may be used for the functions described and within the limitations prescribed by specific regulations in parts 175, 176, 177, and 178 of this chapter which prescribe uses of petrolatum. For the purpose of cross-reference, such specific regulations include: 175.105, 175.125, 175.300, 176.170, 176.200, 176.210, 177.2600, 177.2800, and 178.3570 of this chapter.

(e) Petrolatum may contain any antioxidant permitted in food by regulations issued pursuant to section 409 of the act, in an amount not greater than that required to produce its intended effect.

[42 FR 14609, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, 1990]

Sec. 178.3710 Petroleum wax.

Petroleum wax may be safely used as a component of nonfood articles in contact with food, in accordance with the following conditions:

(a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in nature, derived from petroleum, and refined to meet the specifications prescribed in this section.

(b) The petroleum wax meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in 172.886(b) of this chapter.

Ultraviolet absorbance per centimeter pathlength:

Millimicrons Maximum
280 to 2890.15
290 to 299.12
300 to 359.08
360 to 400.02

(c) Petroleum wax may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the act, in an amount not greater than that required to produce its intended effect.

(d) Petroleum wax may contain a total of not more than 1 weight percent of residues of the following polymers when such residues result from use of the polymers as processing aids (filter aids) in the production of the petroleum wax: Homopolymers and/or copolymers derived from one or more of the mixed n -alkyl (C12, C14, C16, and C18) methacrylate esters where the C12 and C14 alkyl groups are derived from coconut oil and the C16 and C18 groups are derived from tallow.

(e) Petroleum wax may contain 2-hydroxy-4-n -octoxybenzophenone as a stabilizer at a level not to exceed 0.01 weight percent of the petroleum wax.

(f) Petroleum wax may contain poly(alkylacrylate) (CAS Reg. No. 27029-57-8), as described in 172.886(c)(2) of this chapter, as a processing aid in the manufacture of petroleum wax.

[42 FR 14609, Mar. 15, 1977, as amended at 51 FR 19545, May 30, 1986]

Sec. 178.3720 Petroleum wax, synthetic.

Synthetic petroleum wax may be safely used in applications and under the same conditions where naturally derived petroleum wax is permitted in subchapter B of this chapter as a component of articles intended to contact food, provided that the synthetic petroleum wax meets the definition and specifications prescribed in 172.888 of this chapter.

Sec. 178.3725 Pigment dispersants.

Subject to the provisions of this regulation, the substances listed in this section may be safely used as pigment dispersants in food-contact materials.

Substances Limitations
Dimethylolpropionic acid (CAS Reg. No. 4767-03-7)For use only at levels not to exceed 0.45 percent by weight of the pigment. The pigmented articles may contact all foods under conditions of use A through H as described in Table 2 of 176.170(c) of this chapter.
Phosphorylated tall oil fatty acids (CAS Reg. No. 68604-99-9), prepared by the reaction of dimethyl hydrogen phosphite with tall oil fatty acidsFor use only at levels not to exceed 1.0 percent by weight of the pigment. The pigmented polymeric films may contact all food under conditions of use D, E, F, and G described in table 2 of 176.170(c) of this chapter.
Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, compd. with 1,1',1[Prime]-nitrilotris [2-propanol] (1:1) (CAS Reg. No. 221281-21-6)For use only at levels not to exceed 0.45 percent by weight of the pigment. The pigmented articles may contact all food under conditions of use A through H as described in Table 2 of 176.170(c) of this chapter.
Siloxanes and silicones; cetylmethyl, dimethyl, methyl 11-methoxy-11-oxoundecyl (CAS Reg. No. 155419-59-3)For use only at levels not to exceed 0.5 percent by weight of the pigment. The pigmented polymers may contact all foods under conditions of use C, D, E, F, and G described in Table 2 of 176.170(c) of this chapter.
Trimethylolethane (CAS Reg. No. 77-85-0)For use only at levels not to exceed 0.45 percent by weight of inorganic pigment. The pigmented articles may contact all food under conditions of use A through H described in Table 2 of 176.170(c) of this chapter.

[61 FR 43157, Aug. 21, 1996, as amended at 63 FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, 1999; 64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000]

Sec. 178.3730 Piperonyl butoxide and pyrethrins as components of bags.

Piperonyl butoxide in combination with pyrethrins may be safely used for insect control on bags that are intended for use in contact with dried feed in compliance with 561.310 and 561.340 of this chapter, or that are intended for use in contact with dried food in compliance with 193.60 and 193.390 of this chapter.

Sec. 178.3740 Plasticizers in polymeric substances.

Subject to the provisions of this regulation, the substances listed in paragraph (b) of this section may be safely used as plasticizers in polymeric substances used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food.

(a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect.

(b) List of substances:

Substances Limitations
Butylbenzyl phthalateFor use only:
1. As provided in 175.105 and 176.180 of this chapter.
2. In polymeric substances used in food-contact articles complying with 175.300, 175.320, or 176.170 of this chapter: Provided, That the butyl benzyl phthalate contains not more than 1 percent by weight of dibenzyl phthalate.
3. In polymeric substances used in other permitted food-contact articles: Provided, That the butyl benzyl phthalate contains not more than 1 percent by weight of dibenzyl phthalate; and Provided further, That the finished food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of its intended use as determined from tables 1 and 2 of 175.300(d) of this chapter, shall yield net chloroform-soluble extractives not to exceed 0.5 mg. per square inch, as determined by the methods prescribed in 175.300(e) of this chapter.
1,3-Butylene glycoladipic acid polyester (1,700-2,200 molecular weight) terminated with a 16 percent by weight mixture of myristic, palmitic, and stearic acidsFor use at levels not exceeding 33 percent by weight of polyvinyl chloride homopolymers used in contact with food (except foods that contain more than 8 percent of alcohol) at temperatures not to exceed room temperature. The average thickness of such homopolymers in the form in which they contact food shall not exceed 0.004 inch.
Di(C7, C9-alkyl) adipate, in which the C7, C9-alkyl groups are derived from linear alpha olefins by the oxo processFor use only under the conditions listed below, and excluding use as a component of resinous and polymeric coatings described in 175.300 of this chapter.
1. At levels not to exceed 24 percent by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch.
2. At levels not to exceed 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch.
3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymer in the form in which they contact food shall not exceed 0.002 inch.
4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of 176.170(c) of this chapter with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch.
Di-n-alkyl adipate made from C6 C8-C10 (predominately C8 and C10) or C8-C10 synthetic fatty alcohols complying with 172.864 of this chapterFor use only:
1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch.
2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch.
3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch.
4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of 176.170(c) of this chapter, with fatty foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in which they contact food shall not exceed 0.002 inch.
Dicyclohexyl phthalateFor use only:
1. As provided in 175.105, 176.170, 176.180, and 177.1200 of this chapter.
2. Alone or in combination with other phthalates, in plastic film or sheet prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride copolymers complying with 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid.
Di(2-ethylhexyl) adipate
Diisononyl adipateFor use only:
1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch.
2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact under conditions of use F and G described in table 2 of 176.170(c) of this chapter with fatty, nonalcoholic foods having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch.
3. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic foods. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch.
4. At levels not exceeding 35 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of 176.170(c) of this chapter with fatty, nonalcoholic foods having a fat and oil content not exceeding a total of 40 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.002 inch.
Diisononyl phthalateFor use only at levels not exceeding 43 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with food only of the types identified in 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, and VIII, at temperatures not exceeding room temperature. The average thickness of such polymers in the form in which they contact food shall not exceed 0.005 inch.
Di(2-ethylhexyl) azelateFor use only:
1. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact with nonfatty, nonalcoholic food. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch.
2. At levels not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F and G described in table 2 of 176.170(c) of this chapter, with fatty, nonalcoholic food having a fat and oil content not exceeding a total of 30 percent by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch.
Di-n-hexylazelateFor use only:
1. In polymeric substances used in contact with nonfatty food.
2. In polymeric substances used in contact with fatty food and limited to use at levels not exceeding 15 pct by weight of such polymeric substance except as provided under limitation 3.
3. At levels greater than 15 but not exceeding 24 pct by weight of permitted vinyl chloride homo- and/or copolymers used in contact, under conditions of use F or G described in table 2 of 176.170(c) of this chapter, with fatty food having a fat and oil content not exceeding a total of 30 pct by weight. The average thickness of such polymers in the form in which they contact food shall not exceed 0.003 inch.
Dihexyl phthalateFor use only:
1. As provided in 175.105 of this chapter.
2. In articles that contact food only of the types identified in 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-B, and VIII.
Diphenyl phthalateFor use only:
1. As provided in 175.105 of this chapter.
2. Alone or in combination with other phthalates, in plastic film or sheet prepared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride copolymers complying with 177.1980 of this chapter. Such plastic film or sheet shall be used in contact with food at temperatures not to exceed room temperature and shall contain no more than 10 pct by weight of total phthalates, calculated as phthalic acid.
Epoxidized butyl esters of linseed oil fatty acidsIodine number, maximum 5; oxirane oxygen, minimum 7.8 pct.
Epoxidized linseed oilIodine number, maximum 5; oxirane oxygen, minimum 9-pct.
Mineral oil, white
Polybutene, hydrogenated (minimum viscosity at 99 deg. F, 39 Saybolt Universal seconds, as determined by ASTM methods D445-82 ("Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (and the Calculation of Dynamic Viscosity)") and D2161-82 ("Standard Method for Conversion of Kinematic Viscosity to Saybolt Universal Viscosity or to Saybolt Furol Viscosity"), and bromine number of 3 or less, as determined by ASTM method D1492-78 ("Standard Test Method for Bromine Index of Aromatic Hydrocarbons by Coulometric Titration"), which are 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/federalregister/codeoffederalregulations/ibrlocations.html.For use only:
1. In polymeric substances used in contact with non-fatty food.
2. In polyethylene complying with 177.1520 of this chapter and used in contact with fatty food, provided that the hydrogenated polybutene is added in an amount not to exceed 0.5 pct by weight of the polyethylene, and further provided that such plasticized polyethylene shall not be used as a component of articles intended for packing or holding food during cooking.
3. In polystyrene complying with 177.1640 of this chapter and used in contact with fatty food, provided that the hydrogenated polybutene is added in an amount not to exceed 5 pct by weight of the polystyrene, and further provided that such plasticized polystyrene shall not be used as a component of articles intended for packing or holding food during cooking.
Polyisobutylene (mol weight 300-5,000)For use in polyethylene complying with 177.1520 of this chapter, provided that the polyisobutylene is added in an amount not exceeding 0.5 pct by weight of the polyethylene, and further provided that such plasticized polyethylene shall not be used as a component of articles intended for packing or holding food during cooking.
Polyisobutylene complying with 177.1420 of this chapter
Polypropylene glycol (CAS registry No. 25322-69-4) (minimum mean molecular weight 1,200)For use only in polystyrene plastics, identified in 177.1640(a)(1), in an amount not to exceed 6 pct by weight of the finished food-contact article.
Propylene glycol azelate (average mol. weight 3,000)For use only at levels not exceeding 41 pct by weight of permitted polyvinyl chloride coatings. Such coatings shall be used only as bulk food contact surfaces of articles intended for repeated use, complying with 177.2600 of this chapter.
Triethylene glycolDiethylene glycol content not to exceed 0.1 pct.
2,2,4-Trimethyl-1,3-pentanediol diisobutyrateFor use only in cellulosic plastics in an amount not to exceed 15 pct by weight of the finished food-contact article, provided that the finished plastic article contacts food only of the types identified in 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, VII-B, and VIII.

(c) The use of the plasticizers in any polymeric substance or article subject to any regulation in parts 174, 175, 176, 177, 178 and 179 of this chapter must comply with any specifications and limitations prescribed by such regulation for the finished form of the substance or article.

[42 FR 14609, Mar. 15, 1977, as amended at 42 FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986]

Sec. 178.3750 Polyethylene glycol (mean molecular weight 200-9,500).

Polyethylene glycol identified in this section may be safely used as a component of articles intended for use in contact with food, in accordance with the following prescribed conditions:

(a) The additive is an addition polymer of ethylene oxide and water with a mean molecular weight of 200 to 9,500.

(b) It contains no more than 0.2 percent total by weight of ethylene and diethylene glycols if its mean molecular weight is 350 or higher and no more than 0.5 percent total by weight of ethylene and diethylene glycols if its mean molecular weight is below 350, when tested by the analytical methods prescribed in 172.820(b) of this chapter.

(c) The provisions of paragraph (b) of this section are not applicable to polyethylene glycols used in food-packaging adhesives complying with 175.105 of this chapter.

Sec. 178.3760 Polyethylene glycol (400) monolaurate.

Polyethylene glycol (400) monolaurate containing not more than 0.1 percent by weight of ethylene and/or diethylene glycol may be used at a level not to exceed 0.3 percent by weight of twine as a finish on twine to be used for tying meat provided the twine fibers are produced from nylon resins complying with 177.1500 of this chapter.

Sec. 178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids.

Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids identified in this section may be safely used as components of articles intended for use in contact with food in accordance with the following prescribed conditions:

(a) The polyhydric alcohol esters identified in this paragraph may be used as lubricants in the fabrication of vinyl chloride plastic food-contact articles prepared from polyvinyl chloride and/or from vinyl chloride copolymers complying with 177.1980 of this chapter. Such esters meet the following specifications and are produced by partial esterification of oxidatively refined (Gersthofen process) montan wax acids by either ethylene glycol or 1,3-butanediol with or without neutralization of unreacted carboxylic groups with calcium hydroxide:

(1) Dropping point 76deg. -105 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, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(2) Acid value 10-20, as determined by ASTM method D1386-78 ("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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html. ) using as solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1 ratio.

(3) Saponification value 100-160, as determined by ASTM method D1387-78 ("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 (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html. ) using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl alcohol in preparation of potassium hydroxide solution.

(4) Ultraviolet absorbance limits as follows, as determined by the analytical method described in this subparagraph:

Ultraviolet absorbance per centimeter pathlength.

Millimicrons Maximum
280 to 2890.07
290 to 299.06
300 to 359.04
360 to 400.01

Analytical Method

general instructions

Because of the sensitivity of the test, the possibility of errors arising from contamination is great. It is of the greatest importance that all glassware be scrupulously cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of wax samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light.

apparatus

Separatory funnels. 250-milliliter, 500-milliliter, 1,000-milliliter, and preferably 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks.

Reservoir. 1,000-milliliter capacity, equipped with a 24/40 standard taper male fitting at the bottom and a suitable balljoint at the top.

Chromatographic tube. 1,200 millimeters in length, inside diameter to be 16.5 millimeters +/-0.5 millimeter, equipped with a coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female 24/40 standard tapered fitting at the opposite end. (Overall length of the column with the female joint is 1,255 millimeters.) The female fitting should be equipped with glass hooks.

Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately 3/16-inch thick with a hole bored in the center to closely fit the stem of the chromatographic tube.

Heating jackets. Conical, for 500-milliliter and 1,000-milliliter separatory funnels. (Used with variable transformer heat control.)

Suction flask. 250-milliliter or 500-milliliter filter flask.

Condenser. 24/40 joints, fitted with a drying tube, length optional.

Evaporation flasks (optional ). A 250-milliliter or 500-milliliter capacity and a 1-liter capacity all-glass flask equipped with standard taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of contained liquid to be evaporated.

Vacuum distillation assembly. All glass (for purification of dimethyl sulfoxide) 2-liter distillation flask with heating mantle; Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters in length and distilling head with separable cold finger condenser. Use of tetrafluoroethylene polymer sleeves on the glass joints will prevent freezing. Do not use grease on stopcocks or joints.

Oil bath. Capable of heating to 90 deg. C.

Spectrophotometric cells. Fused quartz cells, optical pathlength in the range 1.000 centimeter +/-0.005 centimeter. With distilled water in the cells, determine any absorbance differences.

Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons with spectral slit width of 0.2 millimicron or less; under instrument operating conditions for these absorbance measurements. The spectrophotometer shall also meet the following performance requirements:

Absorbance repeatability, +/-0.01 at 0.4 absorbance.

Absorbance accuracy, 1 +/-0.05 at 0.4 absorbance.

Wavelength repeatability, +/-0.2 millimicron.

Wavelength accuracy, +/-1.0 millimicron.

Recording time, 50 seconds.

Time constant, 0.6 second.

Sensitivity, 30.

Ordinate scale, 90-100 percent transmission through scale.

Abscissa scale, 8X.

Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

reagents and materials

Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this specification. The isooctane and benzene designated in the list following this paragraph shall pass the following test:

To be specified quantity of solvent in a 250-milliliter Erlenmeyer flask, add 1 milliliter of purified n -hexadecane and evaporate on the steam bath under a stream of nitrogen (a loose aluminum foil jacket around the flask will speed evaporation). Discontinue evaporation when not over 1 milliliter of residue remains. (To the residue from benzene add a 10-milliliter portion of purified isooctane, reevaporate, and repeat once to insure complete removal of benzene.)

Alternatively, the evaporation time can be reduced by using the optional evaporation flask. In this case the solvent and n -hexadecane are placed in the flask on the steam bath, the tube assembly is inserted, and a stream of nitrogen is fed through the inlet tube while the outlet tube is connected to a solvent trap and vacuum line in such a way as to prevent any flow-back of condensate into the flask.

Dissolve the 1 milliliter of hexadecane residue in isooctane and make up to 25 milliliters volume. Determine the absorbance in the 1-centimeter pathlength cells compared to isooctane as reference. The absorbance of the solution of the solvent residue (except for methyl alcohol) shall not exceed 0.01 per centimeter pathlength between 280 m[micro] and 400 m[micro].

Isooctane (2,2,4-trimethylpentane ). Use 180 milliliters for the test described in the preceding paragraph. Purify, if necessary, by passage through a column of activated silica gel (Grade 12, Davison Chemical Co., Baltimore, Md., or equivalent) about 90 centimeters in length and 5 centimeters to 8 centimeters in diameter.

Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. Purify, if necessary, by distillation or otherwise.

n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n -hexadecane to 25 milliliters with isooctane and determine the absorbance in a 1-centimeter cell compared to isooctane as reference point between 280 m[micro]-400 m[micro]. The absorbance per centimeter pathlength shall not exceed 0.00 in this range. If necessary, purify by filtering through a column containing 100 grams of aluminum oxide (use same grade as described below) in the lower half and 100 grams of activated silica gel in the upper half keeping the column at 150 deg. C., for a period of 15 hours or overnight. The first 100 milliliters of eluate are used. Purification can also be accomplished by distillation.

Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18deg. minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240 milliliters of distilled water in a 500-milliliter separatory funnel, mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second 500-milliliter separatory funnel and repeat the extraction with 40 milliliters of isooctane. Draw off and discard the aqueous layer. Wash each of the 40-milliliter extractives three times with 50-milliliter portions of distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate prewashed with isooctane (see Sodium sulfate under "Reagents and materials" for preparation of filter), into a 250-milliliter Erlenmeyer flask, or optionally into the evaporating flask. Wash the first separatory funnel with the second 40-milliliter isooctane extractive, and pass through the sodium sulfate into the flask. Then wash the second and first separatory funnels successively with a 10-milliliter portion of isooctane, and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n -hexadecane and evaporate the isooctane on the steam bath under nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane and reevaporate to 1 milliliter of hexadecane. Again, add 10 milliliters of isooctane to the residue and evaporate to 1 milliliter of hexadecane to insure complete removal of all volatile materials. Dissolve the 1 milliliter of hexadecane in isooctane and make to 25-milliliter volume. Determine the absorbance in 1-centimeter pathlength cells compared to isooctane as reference. The absorbance of the solution should not exceed 0.02 per centimeter pathlength in the 280 m[micro]-400 m[micro] range. (Note: Difficulty in meeting this absorbance specification may be due to organic impurities in the distilled water. Repetition of the test omitting the dimethyl sulfoxide will disclose their presence. If necessary to meet the specification, purify the water by redistillation, passage through an ion-exchange resin, or otherwise.)

Purify, if necessary, by the following procedure: To 1,500 milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask, add 6.0 milliliters of phosphoric acid and 50 grams of Norit A (decolorizing carbon, alkaline) or equivalent. Stopper the flask, and with the use of a magnetic stirrer (tetrafluoroethylene polymer coated bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide through four thicknesses of fluted paper (18.5 centimeters, Schleicher & Schuell, No. 597, or equivalent). If the initial filtrate contains carbon fines, refilter through the same filter until a clear filtrate is obtained. Protect the sulfoxide from air and moisture during this operation by covering the solvent in the funnel and collection flask with a layer of isooctane. Transfer the filtrate to a 2-liter separatory funnel and draw off the dimethyl sulfoxide into the 2-liter distillation flask of the vacuum distillation assembly and distill at approximately 3-millimeter Hg pressure or less. Discard the first 200-milliliter fraction of the distillate and replace the distillate collection flask with a clean one. Continue the distillation until approximately 1 liter of the sulfoxide has been collected.

At completion of the distillation, the reagent should be stored in glass-stoppered bottles since it is very hygroscopic and will react with some metal containers in the presence of air.

Phosphoric acid. 85 percent A.C.S. reagent grade.

Aluminum oxide (80-200 mesh Woelm neutral activity grade 1 [Brockmann ], Alupharm Chemicals, New Orleans, La., or equivalent ). Pipette 1 milliliter of distilled water into a dry 250-milliliter Erlenmeyer flask equipped with a ground-glass stopper. Stopper the flask and rotate it in such a manner as to completely wet out the inside surfaces. When this has been done add 180 grams of the aluminum oxide and shake until no lumps or wet spots remain. Allow to stand at room temperature for a period of 2 hours. At the end of this time the water should be evenly distributed throughout the aluminum oxide powder, and it should have the same free flowing properties as the original material (flow velocity with water 0.2 milliliter per minute). At this point the aluminum oxide has an activity of 1 as expressed in Brockmann degrees, and the amount of added water is 0.5 percent by volume. This product is used in toto and as is, without further screening.

Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in granular form. For each bottle of sodium sulfate reagent used, establish as follows the necessary sodium sulfate prewash to provide such filters required in the method: Place approximately 35 grams of anhydrous sodium sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-millimeter filter funnel with glass wool plug; wash with successive 15-milliliter portions of the indicated solvent until a 15-milliliter portion of the wash shows 0.00 absorbance per centimeter pathlength between 280 m[micro] and 400 m[micro] when tested as prescribed under "Organic solvents." Usually three portions of wash solvent are sufficient.

procedure

Before proceeding with analysis of a sample, determine the absorbance in a 1-centimeter path cell between 250 m[micro] and 400 m[micro] for the reagent blank by carrying out the procedure, without a wax sample, at room temperature, recording the spectrum after the complete procedure as prescribed. The absorbance per centimeter pathlength following the complete procedure should not exceed 0.04 in the wavelength range from 280 m[micro] to 299 m[micro], inclusive, nor 0.02 in the wavelength range from 300 m[micro] to 400 m[micro]. If in either spectrum the characteristic benzene peaks in the 250 m[micro]-260 m[micro] region are present, remove the benzene by the procedure under "Organic solvents" and record absorbance again. Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory funnel and add 75 milliliters of phosphoric acid. Mix the contents of the funnel and allow to stand for 10 minutes. (The reaction between the sulfoxide and the acid is exothermic. Release pressure after mixing, then keep funnel stoppered.) Add 150 milliliters of isooctane and shake to preequilibrate the solvents. Draw off the individual layers and store in glass-stoppered flasks.

In a 1-liter separatory funnel place a representative 25-gram sample of wax, add 50 milliliters of isooctane, heat gently, stir until the wax is in solution; add 100 milliliters of preequilibrated sulfoxide-phosphoric acid mixture and shake, making sure it remains in solution. If the wax comes out of solution during these operations, let the stoppered funnel remain in the jacket until the wax redissolves. (Remove stopper from the funnel at intervals to release pressure.) When the wax is in solution, remove the funnel from the jacket and shake it vigorously for 2 minutes. Set up three 250-milliliter separatory funnels with each containing 30 milliliters of preequilibrated isooctane. After separation of the liquid phases, allow to cool until the main portion of the wax-isooctane solution begins to show a precipitate. Gently swirl the funnel when precipitation first occurs on the inside surface of the funnel to accelerate this process. Carefully draw off the lower layer, filter it slowly through a thin layer of glass wool fitted loosely in a filter funnel into the first 250-milliliter separatory funnel, and wash in tandem with the 30-milliliter portions of isooctane contained in the 250-milliliter separatory funnels. Shaking time for each wash is 1 minute. Repeat the extraction operation with two additional portions of the sulfoxide-acid mixture, replacing the funnel in the jacket after each extraction to keep the wax in solution and washing each extractive in tandem through the same three portions of isooctane.

Collect the successive extractives (300 milliliters total) in a separatory funnel (preferably 2-liter), containing 480 milliliters of distilled water, mix, and allow to cool for a few minutes after the last extractive has been added. Add 80 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the extraction with 80 milliliters of isooctane. Draw off and discard the aqueous layer. Wash each of the 80-milliliter extractives three times with 100-milliliter portions of distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate prewashed with isooctane (see Sodium sulfate under "Reagents and Materials" for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the first separatory funnel with the second 80-milliliter isooctane extractive and pass through the sodium sulfate. Then wash the second and first separatory funnels successively with a 20-milliliter portion of isooctane and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n -hexadecane and evaporate the isooctane using an aspirator vacuum under nitrogen and in an oil bath temperature of approximately 90 deg. C. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane, reevaporate to 1 milliliter of hexadecane, and repeat this operation once.

Reserve the residue for column chromatography on the aluminum oxide. Fit the tetrafluoroethylene polymer disc on the upper part of the stem of the chromatographic tube, then place the tube with the disc on the suction flask and apply the vacuum (approximately 135 millimeters Hg pressure). Weigh out 180 grams of the aluminum oxide and pour the adsorbent mixture into the chromatographic tube in approximately 30-centimeter layers. After the addition of each layer, level off the top of the adsorbent with a flat glass rod or metal plunger by pressing down firmly until the adsorbent is well packed. Loosen the topmost few millimeters of each adsorbent layer with the end of a metal rod before the addition of the next layer. Continue packing in this manner until all the 180 grams of the adsorbent is added to the tube. Level off the top of the adsorbent by pressing down firmly with a flat glass rod or metal plunger to make the depth of the adsorbent bed approximately 80 centimeters in depth. Turn off the vacuum and remove the suction flask. Dissolve the hexadecane residue in 10 milliliters of warm benzene and decant the solution onto the column and allow the liquid level to recede to barely above the adsorbent level. Rapidly complete the transfer similarly with two 10-milliliter portions of benzene swirling the flask repeatedly each time to assure adequate washing of the residue. Fix the 1,000-milliliter reservoir onto the top of the chromatographic column. Just before the final 10-milliliter wash reaches the top of the adsorbent, add 670 milliliters of benzene to the reservoir and continue the percolation at the 2-3 milliliter per minute rate until a total of 670 milliliters of benzene has been utilized. Collect the eluate in a clean 1-liter Erlenmeyer flask (or optionally into a 1-liter evaporation flask). Allow the column to drain until most of the solvent mixture is removed. Add 1 milliliter of n -hexadecane and completely remove the benzene by evaporation under nitrogen, using the special procedure to eliminate benzene as previously described under "Organic Solvents." Quantitatively transfer the residue with isooctane to a 25-milliliter volumetric flask and adjust to volume. Determine the absorbance of the solution in the 1-centimeter pathlength cells compared to isooctane as reference between 250 m[micro]-400 m[micro]. Correct for any absorbance derived from the reagents as determined by carrying out the procedure without a wax sample. If either spectrum shows the characteristic benzene peaks in the 250 m[micro]-260 m[micro] region, evaporate the solution to remove benzene by the procedure under "Organic Solvents." Dissolve the residue, transfer quantitatively, and adjust to volume in isooctane in a 25-milliliter volumetric flask. Record the absorbance again. If the corrected absorbance does not exceed the limits prescribed in paragraph (a) of this section, the wax meets the ultraviolet absorbance specifications.

(b) The polyhydric alcohol esters identified in this paragraph may be used as release agents in resinous and polymeric coatings for polyolefin films complying with 175.320 of this chapter. Such esters meet the following specifications and are produced by partial esterification of oxidatively refined (Gersthofen process) montan wax acids with equimolar proportions of ethylene glycol and 1,3-butanediol:

(1) Dropping point 77deg. -82 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. The availability of this incorporation by reference is given in paragraph (a)(1) of this section.

(2) Acid value 25-35, as determined by ASTM method D1386-78 ("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), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html. ) using as solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 1:2 ratio.

(3) Saponification value 135-150, as determined by ASTM method D1387-78 ("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 (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html. ) using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl alcohol in preparation of potassium hydroxide solution.

(4) Ultraviolet absorbance limits specified in paragraph (a)(4) of this section, as determined by the analytical method described therein.

(c) The polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids, identified in paragraph (a) or (b) of this section, may also be used as a component of an aqueous dispersion of vinylidene chloride copolymers, subject to the conditions described in paragraphs (c) (1) and (2) of this section.

(1) The aqueous dispersion of the additive contains not more that 18 percent polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids, not more than 2 percent poly(oxyethylene) (minimum 20 moles of ethylene oxide) oleyl ether (CAS Reg. No. 9004-98-2), and not more than 1 percent poly(oxyethylene) (minimum 3 moles ethylene oxide) cetyl alcohols (CAS Reg. No. 9004-95-9).

(2) The aqueous dispersion described in paragraph (c)(1) of this section is used as an additive to aqueous dispersions of vinylidene chloride copolymers, regulated in 175.300, 175.320, 175.360, 176.170, 176,180, and 177.1630 of this chapter, at levels not to exceed 1.5 percent (solids basis) in the finished coating.

(d) The polyhydric alcohol esters identified in this paragraph may be used as lubricants in the fabrication of vinyl chloride plastic food contact articles prepared from vinyl chloride polymers. Such esters meet the following specifications and are produced by partial esterification of oxidatively refined (Gersthofen process) montan wax acids with glycerol followed by neutralization:

(1) Dropping point 79 to 85 deg. C, as determined by the American Society for Testing and Materials (ASTM), Method D-566-76 (Reapproved 1982), "Standard Test Method for Dropping Point of Lubricating Grease," which is incorporated by reference in accordance with 5 U.S.C. 552(a). The availability of this incorporation by reference is given in paragraph (a)(1) of this section.

(2) Acid value 20-30, as determined by ASTM Method D-1386-78 "Standard Test Method for Acid Number (Empirical) of Synthetic and Natural Waxes" (Revised 1978) (which is incorporated by reference in accordance with 5 U.S.C. 552(a); the availability of this incorporation by reference is given in paragraph (a)(2) of this section), using as a solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1 ratio.

(3) Saponification value 130-160, as determined by ASTM Method D-1387-78 "Standard Test Method for Saponification Number (Empirical) of Synthetic and Natural Waxes" (Revised 1978), (which is incorporated by reference in accordance with 5 U.S.C. 552(a); the availability of this incorporation by reference is given in paragraph (a)(3) of this section), using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl alcohol in the preparation of potassium hydroxide solution.

(4) Ultraviolet absorbance limits specified in paragraph (a)(4) of this section, as determined by the analytical method described therein.

1As determined by procedure using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrometry, U.S. Department of Commerce (1949). The accuracy is to be determined by comparison with the standard values at 290, 345, and 400 millimicrons. Circular 484 is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19, 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898, June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR 17512, Apr. 5, 1993; 69 FR 24512, May 4, 2004]

Sec. 178.3780 Polyhydric alcohol esters of long chain monobasic acids.

Polyhydric alcohol esters of long chain monobasic acids identified in this section may be safely used as lubricants in the fabrication of polyvinyl chloride and/or polyvinyl chloride copolymer articles complying with 177.1980 of this chapter that contact food of Types I, II, IV-B, VI-B, VII-B, and VIII identified in table 1 in 176.170(c) of this chapter under conditions of use E, F, and G described in table 2 in 176.170(c) of this chapter, subject to the provisions of this section.

(a) Identity. For the purpose of this section, polyhydric alcohol esters of long chain monobasic acids consist of polyhydric alcohol esters having number average molecular weights in the range of 1,050 to 1,700. The esters are produced by the reaction of either ethylene glycol or glycerol with long chain monobasic acids containing from 9 to 49 carbon atoms obtained by the ozonization of long chain alpha -olefins, the unreacted carboxylic acids in the formation of the glycerol esters being neutralized with calcium hydroxide to produce a composition having up to 2 percent by weight calcium. The alpha -olefins, obtained from the polymerization of ethylene, have 20 to 50 carbon atoms and contain a minimum of 75 percent by weight straight chain alpha -olefins and not more than 25 percent vinylidene compounds.

(b) Specifications. The polyhydric alcohol esters have the following specifications:

(1) Melting point of 60-80 deg. C for the ethylene glycol ester and 90-105 deg. C for the glycerol ester as determined by the Fisher Johns method as described in "Semimicro Qualitative Organic Analysis--The Systematic Identification of Organic Compounds," by Cheronis and Entrikin, 2d Ed., Interscience Publishers, NY, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

(2) Acid value 15-25 for each ester as determined by the A.O.C.S. method Trla-64T "Titer Test," which is incorporated by reference. Copies are available from American Association of Oil Chemists, 36 East Wacker Drive, Chicago, IL 60601, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html. The method is modified to use as the acid solvent a 1:1 volume mixture of anhydrous isopropyl alcohol and toluene. The solution is titrated with 0.1N methanolic sodium hydroxide.

(3) Saponification value 120-160 for the ethylene glycol ester and 90-130 for the glycerol ester as determined the A.O.C.S. method Trla-64T "Saponification Value," which is incorporated by reference. Copies are available from American Association of Oil Chemists, 36 East Wacker Drive, Chicago, IL 60601, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

(4) Ultraviolet absorbance as specified in 178.3770(a)(4) of this chapter when tested by the analytical method described therein.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 61 FR 14481, Apr. 2, 1996]

Sec. 178.3790 Polymer modifiers in semirigid and rigid vinyl chloride plastics.

The polymers identified in paragraph (a) of this section may be safely admixed, alone or in mixture with other permitted polymers, as modifiers in semirigid and rigid vinyl chloride plastic food-contact articles prepared from vinyl chloride homopolymers and/or from vinyl chloride copolymers complying with 177.1950, 177.1970, and/or 177.1980 of this chapter, in accordance with the following prescribed conditions:

(a) For the purpose of this section, the polymer modifiers are identified as follows:

(1) Acrylic polymers identified in this subparagraph provided that such polymers contain at least 50 weight-percent of polymer units derived from one or more of the monomers listed in paragraph (a)(1)(i) of this section.

(i) Homopolymers and copolymers of the following monomers:

n -Butyl acrylate.

n -Butyl methacrylate.

Ethyl acrylate.

Methyl methacrylate.

(ii) Copolymers produced by copolymerizing one or more of the monomers listed in paragraph (a)(1)(i) of this section with one or more of the following monomers:

Acrylonitrile.

Butadiene.

a -Methylstyrene.

Styrene.

Vinylidene chloride.

(iii) Polymers identified in paragraphs (a)(1) (i) and (ii) of this section containing no more than 5 weight-percent of total polymer units derived by copolymerization with one or more of the following monomers:

Acrylic acid.

1,3-Butylene glycol dimethacrylate.

Divinylbenzene.

Methacrylic acid.

(iv) Mixtures of polymers identified in paragraph (a)(1) (i), (ii), and (iii) of this section; provided that no chemical reactions, other than addition reactions, occur when they are mixed.

(2) Polymers identified in paragraph (a)(1) of this section combined during their polymerization with butadiene-styrene copolymers; provided that no chemical reactions, other than addition reactions, occur when they are combined. Such combined polymers may contain 50 weight-percent or more of total polymer units derived from the butadiene-styrene copolymers.

(b) The polymer content of the finished plastic food-contact article consists of:

(1) Not less than 80 weight-percent of polymer units derived from the vinyl chloride polymers identified in the introduction to this section and not more than 5 weight-percent of polymer units derived from polymers identified in paragraph (a)(1) of this section and may optionally contain up to 15 weight-percent of polymer units derived from butadiene-styrene copolymers; or

(2) Not less than 50 weight-percent of polymer units derived from the vinyl chloride polymers identified in the introduction to this section, not more than 50 weight-percent of polymer units derived from homopolymers and/or copolymers of ethyl acrylate and methyl methacrylate, and not more than 30 weight-percent of polymer units derived from copolymers of methyl methacrylate, a -methylstyrene and acrylonitrile and may optionally contain up to 15 weight-percent of polymer units derived from butadiene-styrene copolymers.

(c) No chemical reactions, other than addition reactions, occur among the vinyl chloride polymers and the modifying polymers present in the polymer mixture used in the manufacture of the finished plastic food-contact article.

(d) The finished plastic food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of its intended use as determined from tables 1 and 2 of 176.170(c) of this chapter, yields extractives not to exceed the limits prescribed in 177.1010 (b) (1), (2), (3), and (4) of this chapter when tested by the methods prescribed in 177.1010 (c) of this chapter.

(e) Acrylonitrile copolymers identified in this section shall comply with the provisions of 180.22 of this chapter.

Sec. 178.3800 Preservatives for wood.

Preservatives may be safely used on wooden articles that are used or intended for use in packaging, transporting, or holding raw agricultural products subject to the provisions of this section:

(a) The preservatives are prepared from substances identified in paragraph (b) of this section and applied in amounts not to exceed those necessary to accomplish the technical effect of protecting the wood from decay, mildew, and water absorption.

(b) The substances permitted are as follows:

List of substances Limitations
Copper-8-quinolinolate
Mineral spirits
Paraffin waxUsed singly or in combination so as to constitute not less than 50% of the solids.
Petroleum hydrocarbon resin, produced by the homo- and copolymerization of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene type from distillates of cracked petroleum stocks Do.
Pentachlorophenol and its sodium saltNot to exceed 50 p.p.m. in the treated wood, calculated as pentachlorophenol.
Rosins and rosin derivativesAs provided in 178.3870.
Zinc salt of sulfonated petroleum
Sec. 178.3850 Reinforced wax.

Reinforced wax may be safely used as an article or component of articles intended for use in producing, manufacturing, packing, processing, transporting, or holding food subject to the provisions of this section.

(a) Reinforced wax consists of petroleum wax to which have been added certain optional substances required in its production, or added to impart desired physical or technical properties.

(b) The quantity of any optional adjuvant substance employed in the production of or added to reinforced wax does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation provided in this section.

(c) Any substance employed in the production of reinforced wax, including any optional substance, that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter, conforms with any specification in such regulation.

(d) The substances and optional adjuvant substances employed in the production of or added to reinforced wax include:

(1) Substances generally recognized as safe in food.

(2) Substances subject to prior sanction for use in reinforced wax and used in accordance with such sanction or approval.

(3) Substances identified in this subparagraph and subject to any limitations provided therein:

List of substances Limitations
Copolymer of isobutylene modified with isoprene
Petroleum wax, Type I and Type II
Polyethylene
Rosins and rosin derivatives as provided in 178.3870
Synthetic wax polymer as described in 176.170(a)(5) of this chapterNot to exceed 5 percent by weight of the petroleum wax.

(e) Reinforced wax conforming with the specifications in this paragraph is used as provided in paragraph (e)(2) of this section.

(1) The chloroform-soluble portion of the water extract obtained by exposing reinforced wax to demineralized water at 70 deg. F for 48 hours shall not exceed 0.5 milligram per square inch of food-contact surface.

(2) It is used as a packaging material or component of packaging materials for cheese and cheese products.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 1288, Jan. 12, 1982]

Sec. 178.3860 Release agents.

Substances listed in paragraph (b) of this section may be safely used as release agents in petroleum wax complying with 178.3710 and in polymeric resins that contact food, subject to the provisions of this section.

(a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect or any limitations prescribed in this section.

(b) Release agents:

List of substances Limitations
Erucamide (erucylamide)
Formaldehyde, polymer with 1-naphthalenol (CAS Reg. No. 25359-91-5)For use only as an antiscaling or release agent, applied on the internal parts of reactors employed in the production of polyvinyl chloride and acrylic copolymers, provided that the residual levels of the additive in the ploymer do not exceed 4 parts per million.
N,N'-DioleoylethylenediamineFor use only in polyvinyl chloride films in amounts such that the concentration of the substance in these films in the form in which the films contact food shall not exceed 0.055 milligram of the substance per square inch of film.
Oleyl palmitamide
Polybutene, hydrogenated; complying with the identity prescribed under 178.3740(b)For use only subject to the limitations prescribed for hydrogenated polybutene under 178.3740(b).
Poly(vinyl acetate/vinyl N-octadecylcarbamate) (CAS Reg. No. 70892-21-6) produced by the reaction between stoichiometrically equivalent amounts of octadecyl isocyanate and vinyl alcohol/vinyl acetate copolymer; minimum average molecular weight is 500,000For use only in application to the backing of pressuresensitive adhesive tapes at levels not to exceed 0.2 milligram per square centimeter (1.29 milligrams per square inch) of backing.
Rice bran waxFor use only in plastics intended for contact with dry foods identified as Type VIII in table 1 of 176.170(c) of this chapter, at levels not in excess of 1.0 percent by weight of the polymer.
Saturated fatty acid amides manufactured from fatty acids derived from animal, marine, or vegetable fats and oils
Stearyl erucamide

[42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 FR 51902, Oct. 23, 1981; 61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 15, 1996]

Sec. 178.3870 Rosins and rosin derivatives.

The rosins and rosin derivatives identified in paragraph (a) of this section may safely be used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) The rosins and rosin derivatives are identified as follows:

(1) Rosins:

(i) Gum rosin, refined to color grade of K or paler.

(ii) Wood rosin, refined to color grade of K or paler.

(iii) Tall oil rosin, refined to color grade of K or paler.

(iv) Dark tall oil rosin, a fraction resulting from the refining of tall oil rosin produced by multicolumnar distillation of crude tall oil to effect removal of fatty acids and pitch components and having a saponification number of from 110-135 and 32 percent-44 percent rosin acids.

(v) Dark wood rosin, all or part of the residue after the volatile terpene oils are distilled from the oleoresin extracted from pine wood.

(2) Modified rosins manufactured from rosins identified in paragraph (a)(1) of this section:

(i) Partially hydrogenated rosin, catalytically hydrogenated to a maximum refractive index of 1.5012 at 100 deg. C, and a color of WG or paler.

(ii) Fully hydrogenated rosin, catalytically hydrogenated to a maximum dehydroabietic acid content of 2 percent, a minimum drop-softening point of 79 deg. C, and a color of X or paler.

(iii) Partially dimerized rosin, dimerized by sulfuric acid catalyst to a drop-softening point of 95deg. -105 deg. C and a color of WG or paler.

(iv) Fully dimerized rosin, dimerized by sulfuric acid catalyst, and from which sufficient nondimerized rosin has been removed by distillation to achieve a minimum drop-softening point of 143 deg. C, and a color of H or paler.

(v) Disproportionated rosin, catalytically disproportionated to a minimum dehydroabietic acid content of 35 percent, a maximum abietic acid content of 1 percent, a maximum content of substituted phenanthrenes (as retene) of 0.25 percent, and a color of WG or paler.

(3) Rosin esters manufactured from rosins and modified rosins identified in paragraphs (a)(1) and (2) of this section:

(i) Glycerol ester of wood rosin purified by steam stripping to have an acid number of 3 to 9, a drop-softening point of 88deg. -96 deg. C, and a color of N or paler.

(ii) Glycerol ester of partially hydrogenated wood rosin, having an acid number of 3 to 10, a drop-softening point of 79deg. -88 deg. C, and a color of N or paler.

(iii) Glycerol ester of partially dimerized rosin, having an acid number of 3 to 8, a drop-softening point of 109deg. -119 deg. C, and a color of M or paler.

(iv) Glycerol ester of fully dimerized rosin, having an acid number of 5 to 16, a drop-softening point of 165deg. -175 deg. C, and a color of H or paler.

(v) Glycerol ester of maleic anhydride-modified wood rosin, having an acid number of 30 to 40, a drop-softening point of 138deg. -146 deg. C, a color of M or paler, and a saponification number less than 280.

(vi) Methyl ester of rosin, partially hydrogenated, purified by steam stripping to have an acid number of 4 to 8, a refractive index of 1.5170 to 1.5205 at 20 deg. C, and a viscosity of 23 to 66 poises at 25 deg. C.

(vii) Pentaerythritol ester of wood rosin, having an acid number of 6 to 16, a drop-softening point of 109deg. -116 deg. C, and a color of M or paler.

(viii) Pentaerythritol ester of partially hydrogenated wood rosin, having an acid number of 7 to 18, a drop-softening point of 102deg. -110 deg. C, and a color of K or paler.

(ix) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 8 to 16, a drop-softening point of 154deg. -162 deg. C, a color of M or paler, and having a saponification number less than 280.

(x) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 9 to 16, a drop-softening point of 130deg. -140 deg. C, a color of N or paler, and having a saponification number less than 280.

(xi) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 134 to 145, a drop-softening point of 127deg. -137 deg. C, a color of M or paler, and having a saponification number less than 280.

(xii) Pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 30 to 40, a drop-softening point of 131deg. -137 deg. C, a color of N or paler, and having a saponification number less than 280.

(xiii) Pentaerythritol ester of maleic anhydride-modified wood rosin, further modified by reaction with 4,4'-isopropyl-idenediphenol-formaldehyde condensate, having an acid number of 10 to 22, a drop-softening point of 162deg. -172 deg. C, a color of K or paler, a saponification number less than 280, and a maximum ultraviolet absorbance of 0.14 at 296 m[micro] (using a 1-centimeter cell and 200 milligrams of the rosin ester per liter of solvent consisting of ethyl alcohol made alkaline by addition of 0.1 percent of potassium hydroxide).

(xiv) Mixed methyl and pentaerythritol ester of maleic anhydride-modified wood rosin, having an acid number of 73 to 83, a drop-softening point of 113deg. -123 deg. C, a color of M or paler, and a saponification number less than 280.

(xv) Triethylene glycol ester of partially hydrogenated wood rosin, having an acid number of 2 to 10, a color of K or paler, and a viscosity of 350 to 425 seconds Saybolt at 100 deg. C.

(xvi) Glycerol ester of maleic anhydride-modified wood rosin, having an acid number of 17 to 23, a drop-softening point of 136deg. -140 deg. C, a color of M or paler, and a saponification number less than 280. For use only in cellophane complying with 177.1200 of this chapter.

(xvii) Citric acid-modified glycerol ester of rosin, having an acid number less than 20, a drop-softening point of 105deg. -115 deg. C, and a color of K or paler. For use only as a blending agent in coatings for cellophane complying with 177.1200 of this chapter.

(xviii) Glycerol ester of tall oil rosin, purified by steam stripping to have an acid number of 5-12, a softening point of 80deg. -88 deg. C, and a color of N or paler.

(xix) Glycerol ester of maleic anhydride-modified tall oil rosin, having an acid number of 30 to 40, a drop-softening point of 141deg. -146 deg. C, a color of N or paler, and a saponification number less than 280.

(xx) Glycerol ester of disproportionated tall oil rosin, having an acid number of 5 to 10, a drop-softening point of 84deg. -93 deg. C, a color of WG or paler, and a saponification number less than 180.

(4) Rosin salts and sizes--Ammonium, calcium, potassium, sodium, or zinc salts of rosin manufactured by the partial or complete saponification of any one of the rosins or modified rosins identified in paragraph (a)(1) and (2) of this section, or blends thereof, and with or without modification by reaction with one or more of the following:

(i) Formaldehyde.

(ii) Fumaric acid.

(iii) Maleic anhydride.

(iv) Saligenin.

(b) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect.

(c) The use in any substance or article that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter shall conform with any specifications and limitations prescribed by such regulation for the finished form of the substance or article.

(d) The provisions of this section are not applicable to rosins and rosin derivatives identified in 175.300(b)(3)(v) of this chapter and used in resinous and polymeric coatings complying with 175.300 of this chapter.

(e) The provisions of this section are not applicable to rosins and rosin derivatives identified in 175.105(c)(5) of this chapter and used in defoaming agents complying with 176.210 of this chapter, food-packaging adhesives complying with 175.105 of this chapter, and rubber articles complying with 177.2600 of this chapter.

(f) The analytical methods for determining whether rosins and rosin derivatives conform to the specifications prescribed in paragraph (a) of this section are as follows:

(1) Color: Color shall be as determined by ASTM method D509-70 (Reapproved 1981), "Standard Methods of Sampling and Grading Rosin," 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/federalregister/codeoffederalregulations/ibrlocations.html.

(2) Refractive index: Refractive index shall be as determined by ASTM method D1747-62 (Reapproved 1978), "Standard Test Method for Refractive Index of Viscous Materials," which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (f)(1) of this section.

(3) Acid number: Acid number shall be as determined by ASTM method D465-82, "Standard Test Methods for Acid Number of Rosin," which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (f)(1) of this section.

(4) Viscosity: Viscosity in poises shall be as determined by ASTM method D1824-66 (Reapproved 1980), "Standard Test Method for Apparent Viscosity of Plastisols and Organosols at Low Shear Rates by Brookfield Viscometer," and in Saybolt seconds by ASTM method D88-81, "Standard Test Method for Saybolt Viscosity," which are incorporated by reference. The availability of this incorporation by reference is given in paragraph (f)(1) of this section.

(5) Softening point: Softening point shall be as determined by ASTM method E28-67, "Standard Test Method for Softening Point by Ring and Ball Apparatus" (Reapproved 1977), which is incorporated by reference. Copies are available from American Society for Testing and Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

(6) Analytical methods for determining drop-softening point, saponification number, and any other specifications not listed under paragraphs (f)(1) through (5) of this section, titled: (i) "Determination of Abeitic Acid and Dehydroabietic Acid in Rosins"; (ii) "Determination of Softening Point of Solid Resins"; (iii) "Determination of Saponification Number of Rosin Esters," and (iv) "Determination of Phenolic Modification of Rosin Derivatives," which are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19, 1984; 54 FR 24899, June 12, 1989]

Sec. 178.3900 Sodium pentachlorophenate.

Sodium pentachlorophenate may be safely used as a preservative for ammonium alginate employed as a processing aid in the manufacture of polyvinyl chloride emulsion polymers intended for use as articles or components of articles that contact food at temperatures not to exceed room temperature. The quantity of sodium pentachlorophenate used shall not exceed 0.5 percent by weight of ammonium alginate solids.

Sec. 178.3910 Surface lubricants used in the manufacture of metallic articles.

The substances listed in this section may be safely used in surface lubricants employed in the manufacture of metallic articles that contact food, subject to the provisions of this section.

(a) The following substances may be used in surface lubricants used in the rolling of metallic foil or sheet stock provided that total residual lubricant remaining on the metallic article in the form in which it contacts food does not exceed 0.015 milligram per square inch of metallic food-contact surface:

(1) Substances identified in paragraphs (b)(1) and (2) of this section.

(2) Substances identified in this paragraph.

List of substances Limitations
[alpha]-Butyl-[Omega]--hydroxypoly (oxyethylene)-poly (oxypropylene) (CAS Reg. No. 9038-95-3) produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol and having a minimum molecular weight of 1,000
[alpha]-Butyl-[Omega]-hydroxypoly(oxypropylene) (CAS Reg. No. 9003-13-8) having a minimum molecular weight of 1000
[alpha]-Lauroyl-[Omega]-hydroxpoly(oxyethylene) (CAS Reg. No. 9004-81-3) having a minimum molecular weight of 200
Acetate esters derived from synthetic straight chain alcohols (complying with 172.864 of this chapter) that have even numbers of carbon atoms in the range C8-C18
alpha-Alkyl-omega-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of C12-C15 straight chain primary alcohols with an average of 3 moles of ethylene oxide (CAS Reg. No. 68002-97-1)
Benzotriazole (CAS Reg. No. 95-14-7)
Bis(hydrogenated tallow alkyl)amine (CAS Reg. No. 61789-79-5)Not to be used in combination with sodium nitrite.
Bis(hydrogenated tallow alkyl)aminoethanol (CAS Reg. No. 116438-56-3)
N,N-Bis(2-hydroxyethyl)butylamine (CAS Reg. No. 102-79-4)
Tert-Butyl alcohol
Di(2-ethylhexyl)phthalate
Diethyl phthalate
Diethylene glycol monobutylether (CAS Reg. No. 112-34-5)
Dimers, trimers, and/or their partial methyl esters; such dimers and trimers are of unsaturated C18 fatty acids derived from animal and vegetable fats and oils and/or tall oil, and such partial methyl esters meet the following specifications: Saponification value 180-200, acid value 70-130, and maximum iodine value 120For use only at a level not to exceed 10 percent by weight of finished lubricant formulation.
Di-n-octyl sebacate
Ethylenediaminetetraacetic acid, sodium salts
Isopropyl alcohol
Isopropyl laurate (CAS Reg. No. 10233-13-3)For use at a level not to exceed 10 percent by weight of the finished lubricant formulation.
Isopropyl oleate
Isotridecyl alcohol, ethoxylated (CAS Reg. No. 9043-30-5)
Methyl esters of coconut oil fatty acids
Methyl esters of fatty acids (C16-C18) derived from animal and vegetable fats and oils
Polybutene, hydrogenated: complying with the identity prescribed under 178.3740(b)
Polyethylene glycol (400) monostearate
Polyisobutylene (minimum molecular weight 300)
Polyoxyethylated (5 moles) tallow amine (CAS Reg. No. 61791-26-2)
Polyvinyl alcohol
Sodium nitriteFor use only as a rust inhibitor in lubricant formulations provided the total residual sodium nitrite on the metallic article in the form in which it contacts food does not exceed 0.007 milligram per square inch of metallic food-contact surface.
Sodium petroleum sulfonate, MW 440-450 (CAS Reg. No. 68608-26-4) derived from naphthenic oil having a Saybolt viscosity range of 500-600 Saybolt Universal Seconds (SUS at 37-8 deg. C (100 deg. F) as determined by ASTM method D88-81, "Standard Test Method for Saybolt Viscosity," which is incorporated by reference. Copies are available from the American Society for Testing Materials, 1961 Race St., Philadelphia, PA 19103, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html.
Synthetic alcohol mixture of straight-and branched-chain alcohols that have even numbers of carbon atoms in the range C4C18 and that are prepared from ethylene, aluminum, and hydrogen such that the finished synthetic alcohol mixture contains not less than 75 pct of straight-chain primary alcohols and contains not less than 85 pct total C10 and C12 alcohols
Synthetic primary alcohol mixture of straight- and branched-chain alcohols that contain at least 99 pct primary alcohols consisting of the following: not less than 70 pct normal alcohols; not less than 96.5 pct C12-C15 alcohols; and not more than 2.5 pct alpha, omega C13-C16 diols. The alcohols are prepared from linear olefins from a purified kerosene fraction, carbon monoxide and hydrogen using a modified oxo process, such that the finished primary alcohol mixture meets the following specifications: Molecular weight, 207+/-4; hydroxyl number, 266-276For use at a level not to exceed 8 pct by weight of the finished lubricant formulation.
Synthetic primary alcohol mixture of straight- and branched-chain alcohols that contain at least 99 pct primary alcohols consisting of the following: not less than 70 percent normal alcohols; not less than 93 pct C12-C13 alcohols; not more than 5 pct C14-C15 alcohols; and not more than 2.5 pct alpha, omega, C13-C16 diols. The alcohols are prepared from linear olefins from a purified kerosene fraction, carbon monoxide and hydrogen using a modified oxo process, such that the finished primary alcohol mixture meets the following specifications:For use only at a level not to exceed 8 pct by weight of the finished lubricant formulation.
Molecular weight 194+/-5; hydroxyl number, 283-296
Tallow, sulfonated
Triethanolamine

(3) Mineral oil conforming to the identity prescribed in 178.3620(c).

(4) Light petroleum hydrocarbons identified in paragraph (a)(4) (i) of this section: Provided, That the total residual lubricant on the metallic article in the form in which it contacts food meets the ultraviolet absorbance limits prescribed in paragraph (a) (4) (ii) of this section as determined by the analytical method described in paragraph (a) (4) (iii) of this section.

(i) Light petroleum hydrocarbons are derived by distillation from virgin petroleum stocks or are synthesized from petroleum gases. They are chiefly paraffinic, isoparaffinic, napthenic, or aromatic in nature, and meet the following specifications:

(a ) Initial boiling point is 24 deg. C minimum and final boiling point is 288 deg. C maximum, as determined by ASTM method D86-82, "Standard Method for Distillation of Petroleum Products," 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/federalregister/codeoffederalregulations/ibrlocations.html.

(b ) Nonvolatile residue is 0.005 gram per 100 milliliters, maximum, as determined by ASTM method D381-80, "Standard Test Method for Existent Gum in Fuels by Jet Evaporation," when the final boiling point is 121 deg. C or above and by ASTM method D1353-78, "Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related Products," when the final boiling point is below 121 deg. C. These ASTM methods are incorporated by reference. The availability of these incorporations by reference is given in paragraph (a)(4)(i)(a ) of this section.

(c ) Saybolt color 20 minimum as determined by ASTM method D156-82, "Standard Test Method for Saybolt Color of Petroleum Products (Saybolt Chromometer Method)," which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a)(4)(i)(a ) of this section.

(d ) Aromatic component content shall not exceed 32 percent.

(e ) Conforms with ultraviolet absorbance limits prescribed in 178.3620(c) as determined by the analytical method described therein.

(ii) Ultraviolet absorbance limits on residual lubricants are as follows:

Wavelength (m[micro]) Maximum absorbance per 5 centimeters optical pathlength
280-2890.7
290-299.6
300-359.4
360-400.09

(iii) The analytical method for determining ultraviolet absorbance limits on residual lubricants is as follows:

general instructions

Because of the sensitivity of the test, the possibility of errors arising from contamination is great. It is of the greatest importance that all glassware be scrupulously cleaned to remove all organic matter such as oil, grease, detergent, residues, etc. Examine all glassware including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of oil samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light.

apparatus

Separatory funnels. 250-milliliter, 500-milliliter, 1,000-milliliter, and preferably 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks.

Evaporation flask (optional ). 250-milliliter or 500-milliliter capacity all-glass flask equipped with standard-taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of contained liquid to be evaporated.

Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5,000 centimeters +/-0.005 centimeter; also for checking spectrophotometer performance only, optical path length in the range 1.000 centimeter +/-0.005 centimeter. With distilled water in the cells, determine any absorbance differences.

Spectrophotometer. Special range 250 millicrons-400 millimicrons with spectral slit width of 2 millimicrons or less; under instrument operating conditions for these absorbance measurements, the spectrophotometer shall also meet the following performance requirements:

Absorbance repeatability, +/-0.01 at 0.4 absorbance.

Absorbance accuracy, 1 +/-0.05 at 0.4 absorbance.

Wavelength repeatability, +/-0.2 millimicron.

Wavelength accuracy, +/-1.0 millimicron.

Soxhlet apparatus. 60-millimeter diameter body tubes fitted with condenser and 500-milliliter round-bottom boiling flask. A supply of paper thimbles to fit is required.

Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

reagents and materials

Organic solvents. All solvents used throughout the procedure shall meet the specifications and tests described in this specification. The isooctane (2,2,4-trimethylpentane) shall pass the following test:

Place 180 milliliters of solvent in a 250-milliliter Erlenmeyer flask, add 1 milliliter of purified n -hexadecane and evaporate on the steam bath under a stream of nitrogen (a loose aluminum foil jacket around the flask will speed evaporation). Discontinue evaporation when not over 1 milliliter of residue remains.

Alternatively, the evaporation time can be reduced by using the optional evaporation flask. In this case the solvent and n -hexadecane are placed in the flask on the steam bath, the tube assembly is inserted, and a stream of nitrogen is fed through the inlet tube while the outlet tube is connected to a solvent trap and vacuum line in such a way as to prevent any flow-back of condensate into the flask.

Dissolve the 1 milliliter of hexadecane residue in isooctane and make to 25 milliliters volume. Determine the absorbance in the 5-centimeter path length cells compared to isooctane as reference. The absorbance of the solution of the solvent residue shall not exceed 0.01 per centimeter path length between 280 and 400 m[micro]. Purify, if necessary, by passage through a column of activated silica gel (Grade 12, Davison Chemical Co., Baltimore, Maryland, or equivalent) about 90 centimeters in length and 5 centimeters to 8 centimeters in diameter.

n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of n -hexadecane to 25 milliliters with isooctane and determine the absorbance in a 5-centimeter cell compared to isooctane as reference point between 280 m[micro]-400 m[micro]. The absorbance per centimeter path length shall not exceed 0.00 in this range. Purify, if necessary, by percolation through activated silica gel or by distillation.

Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach Corp., Camas, Washington, or equivalent). Absorbance (1-centimeter cell, distilled water reference, sample completely saturated with nitrogen).

Wavelength Absorbance (maximum)
261.51.00
270.20
275.09
280.06
300.015

There shall be no irregularities in the absorbance curve within these wavelengths.

Phosphoric acid. 85 percent A.C.S. reagent grade.

Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in granular form. For each bottle of sodium sulfate reagent used, establish as follows the necessary sodium sulfate prewash to provide such filters required in the method: Place approximately 35 grams of anhydrous sodium sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-milliliter filter funnel with glass wool plug; wash with successive 15-milliliter portions of the indicated solvent until a 15-milliliter portion of the wash shows 0.00 absorbance per centimeter path length between 280 m[micro] and 400 m[micro] when tested as prescribed under "Organic solvents." Usually three portions of wash solvent are sufficient.

Before proceeding with analysis of a sample, determine the absorbance in a 5-centimeter path cell between 250 millimicrons and 400 millimicrons for the reagent blank by carrying out the procedure, without a metal sample. The absorbance per centimeter path length should not exceed 0.02 in the wavelength range from 280 m[micro] to 400 m[micro].

Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory funnel and add 75 milliliters of phosphoric acid. Mix the contents of the funnel and allow to stand for 10 minutes. (The reaction between the sulfoxide and the acid is exothermic. Release pressure after mixing, then keep funnel stoppered.) Add 150 milliliters of isooctane and shake to pre-equilibrate the solvents. Draw off the individual layers and store in glass-stoppered flasks.

procedure

Sample. Select metal foil or sheet stock for the test which has not been previously contaminated by careless handling or exposure to atmospheric dust and fumes. A commercial coil in the form supplied for spindle mounting in a packaging line or wrapping machine is most suitable. Strip off the outside turn of metal and discard. Carefully avoid contamination or damage from handling the metal (wear gloves). Remove a 16-18-foot length from the coil and place it on a flat surface protected by a length of new kraft paper. Cut four 15-foot strips from the sample, each 3 inches wide (avoid tearing the edges of the strips). Using a piece of suitable glass rod, roll the strips of metal into loose coils and insert each into a Soxhlet thimble. Each turn of coil should be visibly separated from the adjacent turn.

Extraction. Fill each of the four Soxhlet tubes with purified isooctane (see under heading "Reagents and Materials," above) until siphon action occurs and then refill the tube body. Supply heat to the boiling flask and allow extraction to continue for at least 8 hours or until repeated weighings of the dried and cooled coil show no further weight loss.

Combine the isooctane extracts from the four Soxhlet units in a suitable beaker, rinsing each tube and flask into the beaker with fresh purified solvent. Evaporate the solvent under an atmosphere of inert gas (nitrogen) to residual volume of 50-60 milliliters and transfer this solution to a 500-milliliter separatory funnel containing 100 milliliters of pre-equilibrated sulfoxide-phosphoric acid mixture. Complete the transfer of the sample with small portions of pre-equilibrated isooctane to give a total volume of the residue and solvent of 75 milliliters. Shake the funnel vigorously for 2 minutes. Set up three 250-milliliter separatory funnels with each containing 30 milliliters of pre-equilibrated isooctane. After separation of liquid phases, carefully draw off lower layer into the first 250-milliliter separatory funnel and wash in tandem with the 30-milliliter portion of isooctane contained in the 250-milliliter separatory funnels. Shaking time for each wash is 1 minute. Repeat the extraction operation with two additional portions of the sulfoxide-acid mixture and wash each extractive in tandem through the same three portions of isooctane.

Collect the successive extractives (300 milliliters total) in a separatory funnel (preferably 2-liter) containing 480 milliliters of distilled water; mix, and allow to cool for a few minutes after the last extractive has been added. Add 80 milliliters of isooctane to the solution and extract by shaking the funnel vigorously for 2 minutes. Draw off the lower aqueous layer into a second separatory funnel (preferably 2-liter) and repeat the extraction with 80 milliliter of isooctane. Draw off and discard the aqueous layer. Wash each of the 80 milliliter extractives three times with 100-milliliter portions distilled water. Shaking time for each wash is 1 minute. Discard the aqueous layers. Filter the first extractive through anhydrous sodium sulfate pre-washed with isooctane (see sodium sulfate under "Reagents and Materials" for preparation of filter) into a 250-milliliter Erlenmeyer flask (or optionally into the evaporation flask). Wash the first separatory funnel with the second 80-milliliter isooctane extractive and pass through the sodium sulfate. Then wash the second and first separatory funnels successively with a 20-milliliter portion of isooctane and pass the solvent through the sodium sulfate into the flask. Add 1 milliliter of n -hexadecane and evaporate the isooctane on the steam bath under nitrogen. Discontinue evaporation when not over 1 milliliter of residue remains. To the residue, add a 10-milliliter portion of isooctane, reevaporate to 1 milliliter of hexadecane, and repeat this operation once.

Quantitatively transfer the residue with isooctane to a 25-milliliter volumetric flask, make to volume, and mix. Determine the absorbance of the solution in 5-centimeter pathlength cells compared to isooctane as reference between 280m[micro]-400m[micro] (take care to lose none of the solution in filling the sample cell). Correct the absorbance values for any absorbance derived from reagents as determined by carrying out the procedure without a metal sample. If the corrected absorbance does not exceed the limits prescribed in this paragraph, the residue meets the ultraviolet absorbance specifications.

(b) The following substances may be used in surface lubricants used to facilitate the drawing, stamping, or forming of metallic articles from rolled foil or sheet stock by further processing provided that the total residual lubricant remaining on the metallic article in the form in which it contacts food does not exceed 0.2 milligram per square inch of food-contact surface:

(1) Antioxidants used in compliance with regulations in parts 170 through 189 of this chapter.

(2) Substances identified in this subparagraph.

List of substances Limitations
Acetyl tributyl citrate
Acetyl triethyl citrate
Butyl stearate
Castor oil
Dibutyl sebacate
Di(2-ethylhexyl) azelate
Di(2-ethylhexyl) sebacate
Diisodecyl phthalate
DimethylpolysiloxaneConforming to the identity prescribed in 181.28 of this chapter.
Dipropylene glycol
Epoxidized soybean oilConforming to the identity prescribed in 181.27 of this chapter.
Fatty acids derived from animal and vegetable fats and oils, and salts of such acids, single or mixed, as follows:
Aluminum
Magnesium
Potassium
Sodium
Zinc
Fatty alcohols, straight-chain with even number carbon atoms (C10 or greater)
Isobutyl stearate
Lanolin
Linoleic acid amide
Mineral oilConforming to the identity prescribed in 178.3620 (a) or (b).
Mono-, di-, and tristearyl citrate
Oleic acid amide
Palmitic acid amide
PetrolatumConforming to the identity prescribed in 178.3700.
Phosphoric acid, mono- and dihexyl esters, compounds with tetramethylnonylamines and C11-14-alkylamines (CAS Reg. No. 80939-62-4)For use only at levels not to exceed 0.5 percent by weight of the finished surface lubricant formulation.
Polyethylene glycol (molecular weight 300 or greater)Mono- and diethylene glycol content not to exceed a total of 0.2 pct.
Stannous stearate
Stearic acid amide
Stearyl stearate
Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] methane (CAS Registry No. 6683-19-8)For use at a level not to exceed 0.5 percent by weight of the finished surface lubricant formulation.
Triethylene glycolDiethylene glycol content not to exceed 0.1 pct.
Wax, petroleumComplying with 178.3710.

(c) The substances identified in paragraph (a)(2) of this section may be used in surface lubricants used to facilitate the drawing, stamping, and forming of metallic articles from rolled foil and sheet stock provided that total residual lubricant remaining on the metallic article in the form in which it contacts food does not exceed 0.015 milligram per square inch of food-contact surface.

(d) Subject to any prescribed limitations, the quantity of surface lubricant used in the manufacture of metallic articles shall not exceed the least amount reasonably required to accomplish the intended technical effect and shall not be intended to nor, in fact, accomplish any technical effect in the food itself.

(e) The use of the surface lubricants in the manufacture of any article that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter must comply with any specifications prescribed by such regulation for the finished form of the article.

(f) Any substance that is listed in this section and the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter shall comply with any applicable specifications prescribed by such regulation.

1As determined by procedure using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrometry, U.S. Department of Commerce (1949), which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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/federalregister/codeoffederalregulations/ibrlocations.html. The accuracy is to be determined by comparison with the standard values at 210, 345, and 400 millimicrons.

[42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984; 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR 55456, Oct. 28, 1991; 57 FR 23953, June 5, 1992; 58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30, 1999; 69 FR 24512, May 4, 2004]

Sec. 178.3930 Terpene resins.

The terpene resins identified in paragraph (a) of this section may be safely used as components of polypropylene film intended for use in contact with food, and the terpene resins identified in paragraph (b) of this section may be safely used as components of polyolefin film intended for use in contact with food;

(a) Terpene resins consisting of the hydrogenated polymers of terpene hydrocarbons obtainable from sulfate turpentine and meeting the following specifications: Drop-softening point of 118deg. -138 deg. C; iodine value less than 20.

(b) Terpene resins consisting of polymers of beta-pinene and meeting the following specifications: Acid value less than 1; saponification number less than 1; color less than 4 on the Gardner scale as measured in 50 percent mineral spirits solution.

Sec. 178.3940 Tetraethylene glycol di-(2-ethylhexoate).

Tetraethylene glycol di-(2-ethylhexoate) containing not more than 22 parts per million ethylene and/or diethylene glycols may be used at a level not to exceed 0.7 percent by weight of twine as a finish on twine to be used for tying meat provided the twine fibers are produced from nylon resins complying with 177.1500 of this chapter.

Sec. 178.3950 Tetrahydrofuran.

Tetrahydrofuran may be safely used in the fabrication of articles intended for packaging, transporting, or storing foods, subject to the provisions of this section.

(a) It is used as a solvent in the casting of film from a solution of polymeric resins of vinyl chloride, vinyl acetate, or vinylidene chloride that have been polymerized singly or copolymerized with one another in any combination, or it may be used as a solvent in the casting of film prepared from vinyl chloride copolymers complying with 177.1980 of this chapter.

(b) The residual amount of tetrahydrofuran in the film does not exceed 1.5 percent by weight of film.

Authority: 21 U.S.C. 321, 342, 348, 379e.
Source: 42 FR 14609, Mar. 15, 1977, unless otherwise noted.

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