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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2017]
[CITE: 21CFR176.300]



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 176 -- INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

Subpart B--Substances for Use Only as Components of Paper and Paperboard

Sec. 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-oneAt 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 Reg. No. 3785-34-0]At a maximum level of 0.10 pound per ton of dry weight fiber.
Bis(trichloromethyl)sulfone
4-Bromoacetoxymethyl-m-dioxolane
2-Bromo-4'-hydroxyacetophenone
2-bromo-2-nitropropane-1,3-diol (CAS Reg. No. 52-51-7)At a maximum level of 0.6 pound per ton of dry weight fiber.
[beta]-Bromo-[beta]-nitrostyreneAt a maximum level of 1 pound per ton of dry weight fiber.
Chloroethylenebisthiocyanate
5-Chloro-2 - methyl - 4 - isothiazolin-3-one calcium chloride and 2-methyl-4-isothiazolin-3-one calcium chloride mixture at a ratio of 3 parts to 1 partAt a level of 2.5 pounds per ton of dry weight fiber.
Chlorinated levulinic acids
Chloromethyl butanethiolsulfonate
Cupric nitrate
n-Dialkyl (C12-C18) benzylmethylammonium chloride
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691-65-7)At a maximum level of 0.005% of dry weight fiber.
2,2-Dibromo-3-nitrilopropionamideAt a maximum level of 0.1 lb/ton of dry weight fiber.
2,3-Dibromopropionaldehyde
4,5-dichloro-1, 2-dithiol-3-one (CAS Reg. No. 1192-52-5)For use only at levels not to exceed 10 milligrams per kilogram in the pulp slurry.
1,3-Dihalo-5,5-dimethylhydantoin (where the dihalo (halogen) may be bromine and/or chlorine) that may contain no more than 20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin (where the dihalo (halogen) may be bromine and/or chlorine).At a maximum level of 1.0 kilogram (kg) per 1,000 kg of dry weight fiber.
4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018-09-1).At a maximum level of 0.2 pound 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 hydrochlorideAt a maximum level of 0.20 pound per ton of dry weight fiber.
Glutaraldehyde (CAS Reg. No. 111-30-8)
2-(p-hydroxyphenyl) glyoxylohydroximoyl chloride (CAS Registry No. 34911-46-1)At a level of 0.02 pound per ton of dry weight fiber.
2-Hydroxypropyl methanethiol sulfonate
2-Mercaptobenzothiazole
Methylenebisbutanethiolsulfonate
Methylenebisthiocyanate
2-Nitrobutyl bromoacetate [CA Reg. No. 32815-96-6]At a maximum level of 0.15 pound per ton of dry weight fiber.
N-
Potassium 2-mercaptobenzothiazole
Potassium N-hydroxymethyl-N-methyldithiocarba-mate
Potassium N-methyldithiocarbamate
Potassium pentachlorophenate
Potassium trichlorophenate
Silver fluorideLimit 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 sulfate (CAS Reg. No. 55566-30-8)Maximum use level of 84 mg/kg 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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