amount reasonably required to accomplish the intended effect, which is to prevent or control the formation of foam.

(2) The defoaming agents are used in the preparation and application of coatings for paper and paperboard.

[42 FR 14554, Mar. 15, 1977, as amended at 62 FR 39772, July 24, 1997]

§ 176.210 Defoaming agents used in the manufacture of paper and paperboard.

Defoaming agents may be safely used in the manufacture of paper and paperboard intended for use in packaging, transporting, or holding food in accordance with the following prescribed conditions:

(a) The defoaming agents are prepared from one or more of the substances named in paragraph (d) of this section, subject to any prescribed limitations.

(b) The defoaming agents are used to prevent or control the formation of foam during the manufacture of paper and paperboard prior to and during the sheet-forming process.

(c) The quantity of defoaming agent or agents added during the manufacturing process shall not exceed the amount necessary to accomplish the intended technical effect.

(d) Substances permitted to be used in the formulation of defoaming agents include substances subject to prior sanctions or approval for such use and employed subject to the conditions of such sanctions or approvals, substances generally recognized as safe for use in food, substances generally recognized as safe for use in paper and paperboard, and substances listed in this paragraph, subject to the limitations, if any, prescribed.

(1) Fatty triglycerides, and the fatty acids, alcohols, and dimers derived therefrom:

Beef tallow.

Castor oil.

Coconut oil.

Corn oil.

Cottonseed oil.

Fish oil.

Lard oil.

Linseed oil.

Mustardseed oil.

Palm oil.

Peanut oil.

Rapeseed oil. Ricebran oil. Soybean oil. Sperm oil. Tall oil.

(2) Fatty triglycerides, and marine oils, and the fatty acids and alcohols derived therefrom (paragraph (d)(1) of this section) reacted with one or more of the following, with or without dehydration, to form chemicals of the category indicated in parentheses: Aluminum hydroxide (soaps). Ammonia (amides).

Butanol (esters).

Butoxy-polyoxypropylene, molecular weight
1,000-2,500 (esters).
Butylene glycol (esters).
Calcium hydroxide (soaps).
Diethanolamine (amides).
Diethylene glycol (esters).
Ethylene glycol (esters).
Ethylene oxide (esters and ethers).
Glycerin (mono- and diglycerides).
Hydrogen (hydrogenated compounds).
Hydrogen (amines).
Isobutanol (esters).
Isopropanol (esters).

Magnesium hydroxide (soaps).
Methanol (esters).
Morpholine (soaps).
Oxygen (air-blown oils).
Pentaerythritol (esters).

Polyoxyethylene, molecular weights 200, 300, 400, 600, 700, 1,000, 1,540, 1,580, 1,760, 4,600 (esters).

Polyoxypropylene, molecular weight 2002,000 (esters).

Potassium hydroxide (soaps).
Propanol (esters).

Propylene glycol (esters).

Propylene oxide (esters).
Sodium hydroxide (soaps).
Sorbitol (esters).

Sulfuric acid (sulfated and sulfonated compounds).

Triethanolamine (amides and soaps).

Triisopropanolamine (amides and soaps).
Trimethylolethane (esters).

Zinc hydroxide (soaps).

(3) Miscellaneous:

Alcohols and ketone alcohols mixture (still

bottom product from C12-C18 alcohol manufacturing process).

Amyl alcohol.

Butoxy polyethylene polypropylene glycol molecular weight 900-4,200.

Butoxy-polyoxypropylene molecular weight

1,000-2,500.

Butylated hydroxyanisole.

Butylated hydroxytoluene.

Calcium lignin sulfonate.

Capryl alcohol.

p-Chlorometacresol.

sate, minimum molecular weight 950. Polyoxypropylene-ethylene oxide condensate of ethylene diamine, molecular weight 1,700-3,800.

Polyvinyl pyrrolidone, molecular weight 40,000.

Potassium distearyl phosphate.

Potassium pentachlorophenate.

Potassium trichlorophenate.

Rosins and rosin derivatives identified in § 175.105(c)(5) of this chapter. Silica.

Siloxanes and silicones, dimethyl, methylhydrogen, reaction products with polyethylene-polypropylene glycol monoallyl ether (CAS Reg. No. 71965-38-3).

Sodium alkyl (C9-C15) benzene-sulfonate.
Sodium dioctyl sulfosuccinate.

Sodium distearyl phosphate.

Sodium lauryl sulfate.

Sodium lignin sulfonate.

Sodium 2-mercaptobenzothiazole.

Sodium naphthalenesulfonic acid (3 mols) condensed with formaldehyde (2 mols). Sodium orthophenylphenate.

Sodium pentachlorophenate.
Sodium petroleum

weight 440-450.

sulfonate, molecular

Sodium trichlorophenate. Stearyl alcohol. a-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, pnonylphenyl-, or p-dodecylphenyl]-omegahydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-alkylphenol (alkyl group is 1,1,3,3-tetramethylbutyl, a propylene trimer isomer, or a propylene tetramer isomer) with an average of 1.5-15 moles of ethylene oxide. Tetrahydrofurfuryl alcohol. Tributoxyethyl phosphate. Tributyl phosphate. Tridecyl alcohol.

Triethanolamine.

Triethylene glycol di(2-ethyl hexanoate). Tri-(2-ethylhexyl) phosphate.

Tristearyl phosphate.

Wax, petroleum, Type I and Type II.
Wax, petroleum (oxidized).

Wax (montan).

[42 FR 14554, Mar. 15, 1977, as amended at 47 FR 17986, Apr. 27, 1982; 47 FR 46495, Oct. 19, 1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897, June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR 14246, Apr. 1, 1996]

§ 176.230 3,5-Dimethyl-1,3,5,2Htetrahydrothiadiazine-2-thione. 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione may safely be used as a preservative in the manufacture and coating of paper and paperboard intended for use in contact with food in accordance with the following prescribed conditions:

(a) It is used as follows:

(1) In the manufacture of paper and paperboard as a preservative for substances added to the pulp suspension prior to the sheet-forming operation provided that the preservative is volatilized by heat in the drying and finishing of the paper and paperboard.

(2) As a preservative for coatings for paper and paperboard, Provided, That the preservative is volatilized by heat in the drying and finishing of the coated paper or paperboard.

(b) The quantity used 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 physical or technical effect in the food itself.

(c) The use of a preservative in any substance or article subject to any regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter must comply with any specifications and limitations prescribed by such regulation for the substance or article.

$176.250 Poly-1,4,7,10,13-pentaaza-15

hydroxyhexadecane.

Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane may be safely used as a retention aid employed prior to the sheet-forming operation in the manufacture of paper and paperboard intended for use in contact with food in an amount not to exceed that necessary to accomplish the intended physical or technical effect and not to exceed 6 pounds per ton of finished paper or paperboard.

§ 176.260 Pulp from reclaimed fiber.

(a) Pulp from reclaimed fiber may be safely used as a component of articles used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of paragraph (b) of this section.

(b) Pulp from reclaimed fiber is prepared from the paper and paperboard products described in paragraphs (b) (1) and (2) of this section, by repulping with water to recover the fiber with the least possible amount of nonfibrous substances.

(1) Industrial waste from the manufacture of paper and paperboard products excluding that which bears or contains any poisonous or deleterious substance which is retained in the recovered pulp and that migrates to the food, except as provided in regulations promulgated under sections 406 and 409 of the Federal Food, Drug, and Cosmetic Act.

(2) Salvage from used paper and paperboard excluding that which (i) bears or contains any poisonous or deleterious substance which is retained in the recovered pulp and that migrates to the food, except as provided in regulations promulgated under sections 406 and 409 of the act or (ii) has been used for shipping or handling any such substance.

(a) Slimicides may be safely used in the manufacture of paper and paperboard that contact food, in accordance with the following prescribed conditions:

(1) Slimicides are used as antimicrobial agents to control slime in the manufacture of paper and paperboard.

(2) Subject to any prescribed limitations, slimicides are prepared from one or more of the slime-control substances named in paragraph (c) of this section to which may be added optional adjuvant substances as provided for under paragraph (d) of this section.

(3) Slimicides are added to the process water used in the production of paper or paperboard, and the quantity added shall not exceed the amount necessary to accomplish the intended technical effect.

(b) To insure safe usage, the label or labeling of slimicides shall bear adequate directions for use.

(c) Slime-control substances permitted for use in the preparation of

List of substances

slimicides include substances subject to prior sanction or approval for such use and the following:

Limitations

Acrolein.

Alkenyl (C16-C18) dimethylethyl-ammonium bromide
n-Alkyl (C12 C18) dimethyl benzyl ammonium chloride.
1,2-Benzisothiazolin-3-one
Bis(1,4-bromoacetoxy)-2-butene

5,5-Bis(bromoacetoxymethyl) m-dioxane .
2,6-Bis(dimethylaminomethyl) cyclohexanone.

1,2-Bis(monobromoacetoxy) ethane [CA Reg. No. 3785-34-0] Bis(trichloromethyl)sulfone.

4-Bromoacetoxymethyl-m-dioxolane . 2-Bromo-4'-hydroxyacetophenone.

2-Bromo-2-nitropropane-1,3-diol (CAS Reg. No. 52-51-7) B-Bromo-B-nitrostyrene

Chloroethylenebisthiocyanate.

At a level of 0.06 pound per ton of dry weight fiber.

At a maximum level of 0.10 pound per ton of dry weight fiber.

At a maximum level of 0.6 pound per ton of dry weight fiber. At a maximum level of 1 pound per ton of dry weight fiber. At a level of 2.5 pounds per ton of dry weight fiber.

At a maximum level of 0.005% of dry weight fiber. At a maximum level of 0.1 lb/ton of dry weight fiber.

For use only at levels not to exceed 10 milligrams per kilogram in the pulp slurry.

At a maximum level of 1.0 kilogram (kg) per 1,000 kg of dry weight fiber.

(d) Adjuvant substances permitted to be used in the preparation of slimicides include substances generally recognized as safe for use in food, substances generally recognized as safe for use in paper and paperboard, substances permitted to be used in paper and paperboard by other regulations in this chapter, and the following:

Acetone.

Butlylene oxide.

Dibutyl phthalate.

Didecyl phthalate.
N,N-Dimethylformamide.
Dodecyl phthalate.
Ethanolamine.
Ethylene glycol.
Ethylenediamine.

N-methyl-2-pyrrolidone (CAS Reg. No. 872

50-4).

a,a'-[Methylenebis[4-(1,1,3,3-tetramethyl

butyl)-0-phenylene]] bis[omega-hydroxypoly (oxyethylene)] having 6-7.5 moles of ethylene oxide per hydroxyl group. Monomethyl ethers of mono-, di-, and tripropylene glycol.

Nonylphenol reaction product with 9 to 12 molecules of ethylene oxide.

Octylphenol reaction product with 25 molecules of propylene oxide and 40 molecules of ethylene oxide.

[42 FR 14554, Mar. 15, 1977, as amended at 42 FR 41854, Aug. 19, 1977; 44 FR 75627, Dec. 21, 1979; 46 FR 36129, July 14, 1981; 49 FR 5748, Feb. 15, 1984; 51 FR 19059, May 27, 1986; 51 FR 43734, Dec. 4, 1986; 54 FR 18103, Apr. 27, 1989; 55 FR 31825, Aug. 6, 1990; 64 FR 46130, Aug. 24, 1999; 64 FR 69900, Dec. 15, 1999; 65 FR 40497, June 30, 2000; 65 FR 70790, Nov. 28, 2000]

§ 176.320 Sodium nitrate-urea complex.

Sodium nitrate-urea complex 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) Sodium nitrate-urea complex is a clathrate of approximately two parts urea and one part sodium nitrate.

(b) Sodium nitrate-urea complex conforming to the limitations prescribed in paragraph (b)(1) of this section is used as provided in paragraph (b)(2) of this section.

(1) Limitations. (i) It is used as a plasticizer in glassine and greaseproof paper.

(ii) The amount used does not exceed that required to accomplish its in

tended technical effect or exceed 15 percent by weight of the finished paper. (2) Conditions of use. The glassine and greaseproof papers are used for packaging dry food or as the food-contact surface for dry food.

§ 176.350 Tamarind seed kernel powder.

Tamarind seed kernel powder 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) Tamarind seed kernel powder is the ground kernel of tamarind seed (Tamarindus indica L.) after removal of the seed coat.

(b) It is used in the manufacture of paper and paperboard.

PART 177-INDIRECT FOOD

ADDITIVES: POLYMERS

Subpart A [Reserved]

Subpart B-Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces

Sec.

177.1010 Acrylic and modified acrylic plastics, semirigid and rigid.

177.1020 Acrylonitrile/butadiene/styrene copolymer.

177.1030 Acrylonitrile/butadiene/styrene/ methyl methacrylate copolymer. 177.1040 Acrylonitrile/styrene copolymer. 177.1050 Acrylonitrile/styrene copolymer modified with butadiene/styrene elastomer.

177.1060 n-Alkylglutarimide/acrylic copoly

mers.

177.1200 Cellophane.

177.1210 Closures with sealing gaskets for food containers.

177.1211 Cross-linked polyacrylate copoly

mers.

177.1240 1,4-Cyclohexylene

dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer. 177.1310 Ethylene-acrylic acid copolymers. 177.1312 Ethylene-carbon monoxide copoly

mers.

177.1315 Ethylene-1,4-cyclohexylene

dimethylene terephthalate copolymers. copoly

177.1320 Ethylene-ethyl acrylate

mers.

177.1330 Ionomeric resins.

177.1340 Ethylene-methyl acrylate copolymer resins.