21 C.F.R. § 176.300   Slimicides.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 176—INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
Subpart B—Substances for Use Only as Components of Paper and Paperboard

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§ 176.300   Slimicides.

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

 ------------------------------------------------------------------------           List of substances                      Limitations------------------------------------------------------------------------Acrolein...............................Alkenyl (C16-C18) dimethylethyl- ammonium bromide.n-Alkyl (C12-C18) dimethyl benzyl ammonium chloride.1,2-Benzisothiazolin-3-one.............  At a level of 0.06 pound per                                          ton of dry weight fiber.Bis(1,4-bromoacetoxy)-2-butene.........5,5-Bis(bromoacetoxymethyl) m-dioxane..2,6-Bis(dimethylaminomethyl) cyclohexanone.1,2-Bis(monobromoacetoxy) ethane [CA     At a maximum level of 0.10 Reg. No. 3785-34-0].                     pound per ton of dry weight                                          fiber.Bis(trichloromethyl)sulfone............4-Bromoacetoxymethyl-m-dioxolane.......2-Bromo-4[prime]-hydroxyacetophenone...2-Bromo-2-nitropropane-1,3-diol (CAS     At a maximum level of 0.6 pound Reg. No. 52-51-7).                       per ton of dry weight fiber.β-Bromo-β-nitrostyrene.......  At a maximum level of 1 pound                                          per ton of dry weight fiber.Chloroethylenebisthiocyanate...........5-Chloro-2 - methyl - 4 - isothiazolin-  At a level of 2.5 pounds per 3-one calcium chloride and 2-methyl-4-   ton of dry weight fiber. isothiazolin-3-one calcium chloride mixture at a ratio of 3 parts to 1 part.Chlorinated levulinic acids............Chloromethyl butanethiolsulfonate......Cupric nitrate.........................n-Dialkyl (C12-C18) benzylmethylammonium chloride.1,2-Dibromo-2,4-dicyanobutane (CAS Reg.  At a maximum level of 0.005% of No. 35691-65-7).                         dry weight fiber.2,2-Dibromo-3-nitrilopropionamide......  At a maximum level of 0.1 lb/                                          ton of dry weight fiber.2,3-Dibromopropionaldehyde.............4,5-dichloro-1, 2-dithiol-3-one (CAS     For use only at levels not to Reg. No. 1192-52-5).                     exceed 10 milligrams per                                          kilogram in the pulp slurry.1,3-Dihalo-5,5-dimethylhydantoin (where  At a maximum level of 1.0 the dihalo (halogen) may be bromine      kilogram (kg) per 1,000 kg of and/or chlorine) that may contain no     dry weight fiber. more than 20 weight percent 1,3-dihalo- 5-ethyl-5-methylhydantoin (where the dihalo (halogen) may be bromine and/or chlorine)..4-(Diiodomethylsulfonyl) toluene (CAS    At a maximum level of 0.2 pound Reg. No. 20018-09-1)..                   per ton (100 grams/1,000                                          kilograms) of dry weight                                          fiber.3,5-Dimethyl 1,3,5,2H- tetrahydrothiadiazine-2-thione.Dipotassium and disodium ethylenebis(dithiocarba-mate).Disodium cyanodithioimidocarbonate.....n-Dodecylguanidine hydrochloride.......  At a maximum level of 0.20                                          pound per ton of dry weight                                          fiber.Glutaraldehyde (CAS Reg. No. 111-30-8).2-(p-hydroxyphenyl) glyoxylohydroximoyl  At a level of 0.02 pound per chloride (CAS Registry No. 34911-46-1).  ton of dry weight fiber.2-Hydroxypropyl methanethiol sulfonate.2-Mercaptobenzothiazole................Methylenebisbutanethiolsulfonate.......Methylenebisthiocyanate................2-Nitrobutyl bromoacetate [CA Reg. No.   At a maximum level of 0.15 32815-96-6].                             pound per ton of dry weight                                          fiber.N-[α-(Nitroethyl)benzyl] ethylenediamine.Potassium 2-mercaptobenzothiazole......Potassium N-hydroxymethyl-N- methyldithiocarba-mate.Potassium N-methyldithiocarbamate......Potassium pentachlorophenate...........Potassium trichlorophenate.............Silver fluoride........................  Limit of addition to process                                          water not to exceed 0.024                                          pound, calculated as silver                                          fluoride, per ton of paper                                          produced.Silver nitrate.........................Sodium dimethyldithiocarbamate.........Sodium 2-mercaptobenzothiazole.........Sodium pentachlorophenate..............Sodium trichlorophenate................1,3,6,8-Tetraazatricyclo[6.2.1.13,6] dodecane.3,3,4,4-Tetrachlorotetrahydrothiophene- 1,1-dioxide.Tetrakis(hydroxymethyl)phosphonium       Maximum use level of 84 mg/kg sulfate (CAS Reg. No. 55566-30-8).       in the pulp slurry. The                                          additive may also be added to                                          water, which when introduced                                          into the pulp slurry, results                                          in a concentration in the pulp                                          slurry not to exceed 84 mg/kg.2-(Thiocyanomethylthio) benzothiazole..Vinylene bisthiocyanate................------------------------------------------------------------------------

(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-tetramethylbutyl)-o-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; 69 FR 24512, May 4, 2004]

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