21 C.F.R. Subpart B—Substances for Use Only as Components of Paper and Paperboard
Title 21 - Food and Drugs
Title 21: Food and Drugs
PART 176—INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
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Subpart B—Substances for Use Only as Components of Paper and Paperboard
§ 176.110 Acrylamide-acrylic acid resins.
Acrylamide-acrylic acid resins may be safely used as 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) Acrylamide-acrylic acid resins are produced by the polymerization of acrylamide with partial hydrolysis or by the copolymerization of acrylamide and acrylic acid.
(b) The acrylamide-acrylic acid resins contain less than 0.2 percent residual monomer.
(c) The resins are used as adjuvants in the manufacture of paper and paperboard in amounts not to exceed that necessary to accomplish the technical effect and not to exceed 2 percent by weight of the paper or paperboard.
§ 176.120 Alkyl ketene dimers.
Alkyl ketene dimers 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 alkyl ketene dimers are manufactured by the dehydrohalogenation of the acyl halides derived from the fatty acids of animal or vegetable fats and oils.
(b) The alkyl ketene dimers are used as an adjuvant in the manufacture of paper and paperboard under such conditions that the alkyl ketene dimers and their hydrolysis products dialkyl ketones do not exceed 0.4 percent by weight of the paper or paperboard.
(c) The alkyl ketene dimers may be used in the form of an aqueous emulsion which may contain sodium lignosulfonate as a dispersant.
§ 176.130 Anti-offset substances.
Substances named in paragraphs (b) and (c) of this section may be safely used to prevent the transfer of inks employed in printing and decorating paper and paperboard used for food packaging in accordance with the provisions of this section:
(a) The substances are applied to the nonfood contact, printed side of the paper or paperboard in an amount not greater than that required to accomplish the technical effect nor greater than any specific limitations, where such are provided.
(b) Anti-offset powders are prepared from substances that are generally recognized as safe in food, substances for which prior sanctions or approvals were granted and which are used in accordance with the specific provisions of such sanction or approval, and substances named in paragraph (c) of this section.
(c) The substances permitted are as follows:
------------------------------------------------------------------------ Substances Limitations------------------------------------------------------------------------Carbon tetrachloride......................Methyl hydrogen polysiloxanes.............Industrial starch_modified................ Complying with § 178.3520 of this chapter.Stannous oleate...........................Zinc-2-ethyl hexoate......................------------------------------------------------------------------------
§ 176.150 Chelating agents used in the manufacture of paper and paperboard.
The substances named in paragraph (a) of this section may be safely used in the manufacture of paper and paperboard, in accordance with the conditions prescribed in paragraphs (b) and (c) of this section:
(a) Chelating agents:
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------------------------------------------------------------------------ List of substances Limitations------------------------------------------------------------------------Ammonium fructoheptonate..................Ammonium glucoheptonate...................Disodium ethylenediamine tetraacetate.....Pentasodium salt of diethylenetriamine pentaacetate.Sodium fructoheptonate....................Sodium glucoheptonate.....................Tetrasodium ethylenediamine tetraacetate..Trisodium N-hydroxyethyl ethylenediamine triacetate.------------------------------------------------------------------------
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(b) Any one or any combination of the substances named is used or intended for use as chelating agents.
(c) The substances are added in an amount not greater than that required to accomplish the intended technical effect nor greater than any specific limitation, where such is provided. § 176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine.
The chromium (Cr III) complex of N-ethyl - N -heptadecylfluoro-octane sulfonyl glycine containing up to 20 percent by weight of the chromium (Cr III) complex of heptadecylfluoro-octane sulfonic acid may be safely used as a component of paper for packaging dry food when used in accordance with the following prescribed conditions.
(a) The food additive is used as a component of paper in an amount not to exceed 0.5 percent by weight of the paper.
(b)(1) The food-contact surface of the paper is overcoated with a polymeric or resinous coating at least 1/3-mil in thickness, that meets the provision of §176.170; or
(2) The treated paper forms one or more plies of a paper in a multiwall bag and is separated from the food by at least one ply of packaging films or grease-resistant papers which serves as a functional barrier between the food additive and the food. Such packaging films or grease-resistant papers conform with appropriate food additive regulations.
(c) The labeling of the food additive shall contain adequate directions for its use to insure compliance with the requirements of paragraphs (a) and (b) of this section. § 176.170 Components of paper and paperboard in contact with aqueous and fatty foods.
Substances identified in this section may be safely used as components of the uncoated or coated food-contact surface of paper and paperboard intended for use in producing, manufacturing, packaging, processing, preparing, treating, packing, transporting, or holding aqueous and fatty foods, subject to the provisions of this section. Components of paper and paperboard in contact with dry food of the type identified under Type VIII of table 1 in paragraph (c) of this section are subject to the provisions of §176.180.
(a) Substances identified in paragraph (a) (1) through (5) of this section may be used as components of the food-contact surface of paper and paperboard. Paper and paperboard products shall be exempted from compliance with the extractives limitations prescribed in paragraph (c) of this section: Provided, That the components of the food-contact surface consist entirely of one or more of the substances identified in this paragraph: And provided further, That if the paper or paperboard when extracted under the conditions prescribed in paragraph (c) of this section exceeds the limitations on extractives contained in paragraph (c) of this section, information shall be available from manufacturing records from which it is possible to determine that only substances identified in this paragraph (a) are present in the food-contact surface of such paper or paperboard.
(1) Substances generally recognized as safe in food.
(2) Substances generally recognized as safe for their intended use in paper and paperboard products used in food packaging.
(3) Substances used in accordance with a prior sanction or approval.
(4) Substances that by regulation in parts 170 through 189 of this chapter may be safely used without extractives limitations as components of the uncoated or coated food-contact surface of paper and paperboard in contact with aqueous or fatty food, subject to the provisions of such regulation.
(5) Substances identified in this paragraph, as follows:
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------------------------------------------------------------------------ List of Substances Limitations------------------------------------------------------------------------Acetyl peroxide........................ For use only as polymerization catalyst.Acrylamide-methacrylic acid-maleic For use only as a retention aid anhydride copolymers containing not employed prior to the sheet- more than 0.2 percent of residual forming operation in the acrylamide monomer and having an manufacture of paper and average nitrogen content of 14.9 paperboard in such an amount percent such that a 1 percent by that the finished paper and weight aqueous solution has a minimum paperboard will contain the viscosity of 600 centipoises at 75 additive at a level not in °F, as determined by LVG-series excess of 0.05 percent by Brookfield viscometer (or equivalent) weight of dry fibers in the using a No. 2 spindle at 30 r.p.m. finished paper and paperboard.Acrylamide-β- For use only as a retention aid methacrylyloxyethyltrimethylammonium and flocculant employed prior methyl sulfate copolymer resins to the sheet-forming operation containing not more than 10 molar in the manufacture of paper percent of β- and paperboard. methacrylyloxyethyltrimethylammonium methyl sulfate and containing less than 0.2% of residual acrylamide monomer.Acrylic acid, sodium salt copolymer For use only in paper mill with polyethyleneglycol allyl ether boilers. (CAS Reg. No. 86830-15-1).Acrylic acid copolymer with 2- For use only as a scale acrylamido-2-methylpropane-sulfonic inhibitor prior to the sheet- acid (CAS Reg. No. 40623-75-4) and/or forming operation in the its ammonium/alkali metal mixed salts. manufacture of paper and The copolymer is produced by poly- paperboard and used at a level merization of acrylic acid and 2- not to exceed 1.0 kilogram acrylamido-2-methylpropane-sulfonic (2.2 pounds) of copolymer per acid in a weight ratio of 60/40, such 907 kilograms (1 ton) of dry that a 28 percent by weight aqueous paper and paperboard fibers. solution of the polymer has a viscosity of 75-150 centipoises at 25 °C as determined by LV-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 60 r.p.m.Acrylonitrile polymer, reaction product For use only as a size promoter with ethylenediamine sulfate having a and retention aid at a level nitrogen content of 22.5-25.0 percent not to exceed 0.5 percent by (Kjeldahl dry basis) and containing no weight of the dry paper and more than 0.075 percent monomer as paperboard. ethylenediamine. The finished resin in a 24 percent by weight aqueous solution has a viscosity of 1,000- 2,000 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 4 spindle at 50 r.p.m. (or by other equivalent method).Acrylonitrile polymer with styrene, 1. For use only as a sizing reaction product with ethylenediamine material applied after the acetate, having a nitrogen content of sheet-forming operation in the 7.4-8.3 percent (Kjeldahl dry basis) manufacture of paper and and containing no more than 0.25 paperboard in such amount that percent monomer as ethylenediamine. the paper and paperboard will contain the additive at a level not in excess of 0.25 percent by weight of the dry paper and paperboard. 2. For use only as a sizing material applied prior to the sheet-forming operation in the manufacture of paper and paperboard in such amount that the paper and paperboard will contain the additive at a level not in excess of 1.0 percent by weight of the dry paper and paperboard.1-Alkenyl olefins, containing not less For use only under the than 72 percent of C30 and higher following conditions: olefins. 1. In coatings for paper and paperboard with food of Types I, II, IV-B, and VII-B described in table 1 of paragraph (c) of this section under conditions of use E, F, and G described in table 2 of paragraph (c) of this section. 2. In coatings for paper and paperboard with food of Type VIII described in table I of paragraph (c) of this section under conditions of use A through H described in table 2 of paragraph (c) of this section.(2-Alkenyl) succinic anhydrides For use only as a sizing agent mixture, in which the alkenyl groups employed prior to the sheet- are derived from olefins which contain forming operation in the not less than 95 percent of C15-C21 manufacture of paper and groups. paperboard and limited to use at a level not to exceed 1 percent by weight of the finished dry paper and paperboard fibers.Alkyl(C12-C20)methacrylatemethacrylic For use only as stabilizers acid copolymers (CAS Reg. No. 27401-06- employed prior to the sheet- 5). forming operation in the manufacture of paper and paperboard.tert-Alkyl(C8-C16)mercaptans........... For use only as polymerization- control agent.Aluminum acetate.......................2-Amino-2-methyl-1-propanol (CAS Reg. For use as a dispersant for No. 124-68-5). pigment suspension at a level not to exceed 0.25 percent by weight of pigment. The suspension is used as a component of coatings for paper and paperboard under conditions of use described in paragraph (c) of this section, table 2, conditions of use E through G.Ammonium bis(N-ethyl-2- For use only as an oil and perfluoroalkylsulfonamido ethyl) water repellant at a level not phosphates, containing not more than to exceed 0.17 pound (0.09 15% ammonium mono (N-ethyl-2- pound of fluorine) per 1,000 perfluoroalkylsulfonamido ethyl) square feet of treated paper phosphates, where the alkyl group is or paperboard of a sheet basis more than 95% C8 and the salts have a weight of 100 pounds or less fluorine content of 50.2% to 52.8% as per 3,000 square feet of paper determined on a solids basis. or paperboard, and at a level not to exceed 0.5 pound (0.26 pound of fluorine) per 1,000 square feet of treated paper or paperboard having a sheet basis weight greater than 100 lb. per 3,000 square feet as determined by analysis for total fluorine in the treated paper or paperboard without correction for any fluorine that might be present in the untreated paper or paperboard, when such paper or paperboard is used as follows: 1. In contact, under conditions of use C, D, E, F, G, or H described in table 2 of paragraph (c) of this section, with nonalcoholic food. 2. In contact with bakery products of Type VII, VIII, and IX described in table I of paragraph (c) of this section under good manufacturing practices of commercial and institutional baking.Ammonium persulfate....................Ammonium thiosulfate...................Ammonium zirconium carbonate (CAS Reg. For use only as an No. 32535-84-5) and its tartaric acid insolubilizer for binders used adduct. in coatings for paper and paperboard, and limited to use at a level not to exceed 2.5 percent by weight of coating solids.Ammonium zirconium citrate (CAS Reg. For use as insolubilizers with No. 149564-62-5), ammonium zirconium protein binders in coatings lactate-citrate (CAS Reg. No. 149564- for paper and paperboard, at a 64-7), ammonium zirconium lactate (CAS level not to exceed 1.4 Reg. No. 149564-63-6). percent by weight of coating solids.Anionic polyurethane, produced by For use only as a surface reacting the preliminary adduct formed sizing agent at a level not to from the reaction of glyceryl exceed 0.1 percent by weight monostearate and 2,4- of dry paper and paperboard. toluenediisocyanate with not more than 10 mole percent N-methyldiethanolamine and not less than 90 mole percent dimethylolpropionic acid. The final product is a 15 to 20 percent by weight aqueous solution, having a Brookfield viscosity of 25 to 100 centipoises at 24 °C (75 °F).9,10-Anthraquinone (Chemical Abstracts For use only as a pulping aid Service Registry No. 84-65-1) which in the alkaline pulping of has a purity of not less than 98 lignocellulosic material at percent. levels not to exceed 0.1 percent by weight of the raw lignocellulosic material.Aromatic petroleum hydrocarbon resin, For use only as modifiers in hydrogenated (CAS Reg. No. 88526-47- wax polymer blend coatings for 0), produced by the catalytic paper and paperboard at a polymerization of aromatic substituted level not to exceed 50 weight- olefins from low boiling distillates percent of the coating solids of cracked petroleum stocks with a under conditions of use E, F, boiling point no greater than 220 and G identified in table 2 of °C (428 °F), and the paragraph (c) of this section. subsequent catalytic reduction of the resulting aromatic petroleum hydrocarbon resin. The resin meets the following specifications: softening point 85 °C (185 °F) minimum, as determined by ASTM Method E 28-67 (Reapproved 1982), ``Standard Test Method for Softening Point by Ring-and- Ball Apparatus,'' and aniline point 70 °C (158 °F) minimum, as determined by ASTM Method D 611-82, ``Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydrocarbon Solvents,'' which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741- 6030, or go to: http:// www.archives.gov/federal_register/ code_of_federal_regulations/ ibr_locations.php..Azo-bisisobutyronitrile................ For use only as polymerization catalyst.1,2-Benzisothiazolin-3-one (CAS For use only as a preservative Registry No. 2634-33-5). in paper coating compositions and limited to use at a level not to exceed 0.01 mg/in\2\ (0.0016 mg/cm\2\) of the finished paper and paperboard.Benzoyl peroxide....................... Do.N,N-Bis(2-hydroxyethyl)alkyl (C12- For use only as an adjuvant to C18)amide. control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet forming operation.Bis(methoxymethyl)tetrakis- For use only under the [(octadecyloxy)-methyl]melamine resins following conditions: having a 5.8-6.5 percent nitrogen 1. As a water repellant content (CAS Reg. No. 68412-27-1). employed prior to the sheet- forming operation in the manufacture of paper and paperboard in such amount that the finished paper and paperboard will contain the additive at a level not in excess of 1.6 percent by weight of the finished dry paper and paperboard fibers. 2. The finished paper and paperboard will be used in contact with nonalcoholic foods only. 3. As a water repellant employed after the sheet- forming operation in the manufacture of paper and paperboard in such amount that the finished paper and paperboard will contain the additive at a level not to exceed 1.6 percent by weight of the finished dry paper and paperboard fibers. The finished paper and paperboard will be used only in contact with food of Types I, II, IV- B, VI, VII-B, and VIII described in table 1 of paragraph (c) of this section.2-Bromo-2-nitro-1,3-propanediol (CAS For use only as an Reg. No. 52-51-7). antimicrobial/preservative in fillers, pigment slurries, starch sizing solutions, and latex coatings at levels not to exceed 0.01 percent by weight of those components.Butanedioic acid, sulfo-1,4-di-(C9-C11 For use as a surface active alkyl) ester, ammonium salt (also agent in package coating inks known as butanedioic acid, sulfo-1,4- at levels not to exceed 3 diisodecyl ester, ammonium salt [CAS percent by weight of the Reg. No. 144093-88-9]).. coating ink.tert-Butyl hydroperoxide............... For use only as polymerization catalyst.tert-Butyl peroxide.................... Do.Calcium isostearate.................... For use only with n-decyl alcohol as a stabilizing material for aqueous calcium stearate dispersions intended for use as components of coatings for paper and paperboard.Carrageenan and salts of carrageenan as described in §§ 172.620 and 172.626 of this chapter.Castor oil, hydrogenated...............Castor oil, sulfated, ammonium, potassium, or sodium salt.Cellulose, regenerated.................Chloracetamide......................... For use only as polymerization- control agent.Cobaltous acetate...................... For use only as polymerization catalyst.Cumene hydroperoxide................... Do.Cyanoguanidine......................... For use only: 1. As a modifier for amino resins. 2. As a fluidizing agent in starch and protein coatings for paper and paperboard.n-Decyl alcohol........................ For use only with calcium isostearate as a stabilizing material for aqueous calcium stearate dispersions intended for use as components of coatings for paper and paperboard.Dialdehyde guar gum.................... For use only as a wet-strength agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard and used at a level not to exceed 1% by weight of the finished dry paper and paperboard fibers.Dialdehyde locust bean gum............. Do.Dialkyl(C16-C18)carbamoyl chloride (CAS For use as a sizing agent at a Reg. No. 41319-54-4) manufactured by level not to exceed 0.2 the reaction of secondary amines percent by weight of the dry derived from fatty acids of animal or fiber. vegetable sources with phosgene.Diallyldimethyl ammonium chloride For use only as a retention and/ polymer with acrylamide and potassium or drainage aid employed prior acrylate, produced by copolymerizing to the sheet-forming either (1) diallyldimethyl ammonium operations in the manufacture chloride and acrylamide in a weight of paper and paperboard and ratio of 50/50, with 4.4 percent of limited to use at a level not the acrylamide subsequently hydrolyzed to exceed 0.05 percent by to potassium acrylate or (2) weight of the finished paper polymerized diallyldimethyl ammonium and paperboard. chloride, acrylamide and potassium acrylate (as acrylic acid) in a weight ratio of 50/47.8/2.2, respectively, so that the finished resin in a 1 percent by weight aqueous solution (active polymer) has a viscosity of more than 22 centipoises at 22 °C (72 °F) as determined by LVF series, Brookfield Viscometer using No. 1 spindle at 60 RPM (or by other equivalent method) (CAS Reg. No. 25136- 75-8).Diallyldimethylammonium chloride with For use only as a drainage and/ acrylamide (CAS Reg. No. 26590-05-6). or retention aid employed The copolymer is produced by prior to the sheet-forming copolymerizing diallyldimethylammonium operation in the manufacture chloride with acrylamide in a weight of paper and paperboard and ratio of 50-50 so that the finished limited to use at a level not resin in a 1 percent by weight aqueous to exceed 0.05 percent by solution (active polymer) has a weight of the finished paper viscosity of more than 22 centipoises and paperboard. at 22 °C (71.6 °F), as determined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method).Diallyldiethylammonium chloride polymer with acrylamide, and diallyldimethylammonium chloride, produced by copolymerizing acrylamide, diallyldiethylammonium chloride, and diallyldimethylammonium chloride, respectively, in the following weight ratios and having viscosities determined at 22 °C, by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method), as follows:. 1. Weight ratio: 50-2.5-47.5. The For use only as a retention aid finished resin in a 1 percent by employed prior to the sheet- weight aqueous solution has a forming operation in the minimum viscosity of 22 centipoises. manufacture of paper and paperboard and limited to use at a level not to exceed 0.05 percent by weight of the finished paper and paperboard. 2. Weight ratio: 25-2.5-72.5. The For use only as a drainage and/ finished resin in a 0.20 percent by or retention aid employed weight aqueous solution has a prior to the sheet-forming minimum viscosity of 20 centipoises. operation in the manufacture of paper and paperboard and limited to use at a level not to exceed 0.075 percent by weight of the finished paper and paperboard. 3. Weight ratio: 80-2.5-17.5. The For use only as a drainage and/ finished resin in a 0.30 percent by or retention aid employed weight aqueous solution has a prior to the sheet-forming minimum viscosity of 50 centipoises. operation in the manufacture of paper and paperboard and limited to use at a level not to exceed 0.075 percent by weight of the finished paper and paperboard.Diallyldiethylammonium chloride polymer For use only as a retention aid with acrylamide, potassium acrylate, employed prior to the sheet- and diallyldimethylammonium chloride. forming operation in the The polymer is produced by manufacture of paper and copolymerizing either: (1) acrylamide, paperboard and limited to use diallyldiethylammonium chloride, and at a level not to exceed 0.05 diallyldimethylammonium chloride in a percent by weight of the weight ratio of 50-2.5-47.5, finished paper and paperboard. respectively, with 4.4 percent of the acrylamide subsequently hydrolyzed to potassium acrylate, or (2) acrylamide, potassium acrylate (as acrylic acid), diallyldiethylammonium chloride, and diallyldimethylammonium chloride in a weight ratio of 47.8-2.2-2.5-47.5, so that the finished resin in a 1 percent by weight aqueous solution has a minimum viscosity of 22 centipoises at 22 °C, as determined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method).Diallyldimethylammonium chloride For use only as a dry and wet polymer with acrylamide, reaction strength agent employed prior product with glyoxal, produced by to the sheet-forming operation copolymerizing not less than 90 weight in the manufacture of paper percent of acrylamide and not more and paperboard in such an than 10 weight percent of amount that the finished paper diallyldimethylammonium chloride, and paperboard will contain which is then cross-linked with not the additive at a level not in more than 30 weight percent of excess of 2 percent by weight glyoxal, such that a 10 percent of the dry fibers in the aqueous solution has a minimum finished paper and paperboard. viscosity of 25 centipoises at 25 °C as determined by Brookfield viscometer Model RVF, using a No. 1 spindle at 100 r.p.m.2,2-Dibromo-3-nitrilopropionamide (CAS For use as a preservative at a Reg. No.10222-01-2).. level not to exceed 100 parts per million in coating formulations and in component slurries and emulsions, used in the production of paper and paperboard and coatings for paper and paperboard.2,5-Di-tert-butyl hydroquinone......... For use only as an antioxidant for fatty based coating adjuvants provided it is used at a level not to exceed 0.005% by weight of coating solids.Diethanolamine......................... For use only: 1. As an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet-forming operation. 2.In paper mill boilers.Diethanolamine salts of mono- and bis For use only as an oil and (1H,1H,2H,2H-perfluoroalkyl) water repellant at a level not phosphates where the alkyl group is to exceed 0.17 pound (0.09 even-numbered in the range C8-C18 and pound of fluorine) per 1,000 the salts have a fluorine content of square feet of treated paper 52.4% to 54.4% as determined on a or paperboard, as determined solids basis. by analysis for total fluorine in the treated paper or paperboard without correction for any fluorine which might be present in the untreated paper or paperboard, when such paper or paperboard is used in contact with nonalcoholic foods under the conditions of use described in paragraph (c) of this section, table 2, conditions of use (B) through (H).Diethyl(2-hydroxyethyl) methylammonium For use only as a retention aid methyl sulfate, acrylate, polymer with and drainage aid employed acrylamide, chemical abstract service prior to the sheet-forming registry No. [26796-75-8] having 90-95 operation in the manufacture mole pct. acrylamide, a nitrogen of paper and paperboard at a content of not more than 19.7 pct. level not to exceed 0.15 pct. (Kjeldahl, dry basis), and a residual by weight of finished dry acrylamide monomer content of not more paper and paperboard fibers. than 0.1 pct. The finished polymer in a 1 pct. by weight aqueous solution has a minimum viscosity of 900 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 2 spindle at 12 r.p.m. (or by equivalent method).Diethylenetriamine..................... For use only as a modifier for amino resins.N,N-Diisopropanolamide of tallow fatty For use only as an adjuvant to acids. control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet- forming operation.Dimethylamine-epichlorohydrin copolymer For use only: in which not more than 5 mole-percent 1. As a retention aid employed of dimethylamine may be replaced by an before the sheet-forming equimolar amount of ethylenediamine operation in the manufacture and in which the ratio of total amine of paper and paperboard and to epichlorohydrin does not exceed limited to use at a level not 1:1. The nitrogen content of the to exceed 1 percent by weight copolymer shall be 9.4 to 10.8 weight of the finished paper and percent on a dry basis and a 10 paperboard. percent by weight aqueous solution of 2. At the size press at a level the final product has a minimum not to exceed 0.017 percent by viscosity of 5.0 centipoises at 25 weight of the finished paper °C, as determined by LVT-series and paperboard. Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method).N-[(Dimethylamino)methyl]-acrylamide For use only as a dry-strength polymer with acrylamide and styrene agent employed prior to the having a nitrogen content of not more sheet-forming operation in the than 16.9 percent and a residual manufacture of paper and acrylamide monomer content of not more paperboard and used at a level than 0.2 percent on a dry basis. not to exceed 1 percent by weight of finished dry paper or paperboard fibers.N,N[prime]-Dioleoylethylenediamine.....Diphenylamine.......................... For use only as an antioxidant for fatty based coating adjuvants provided it is used at a level not to exceed 0.005% by weight of coating solids.Dipropylene glycol.....................Disodium salt of 1,4-dihydro-9,10- For use only as a catalyst in dihydroxyanthracene (CAS Reg. No. the alkaline pulping of 73347-80-5). lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials.N,N[prime]-Distearoylethylenediamine...n-Dodecylguanidine acetate............. For use only as an antimicrobial agent in paper and paperboard under the following conditions: 1. For contact only with nonalcoholic food having a pH above 5 and provided it is used at a level not to exceed 0.4 percent by weight of the paper and paperboard.2. For use in the outer ply of multiwall paper bags for contact with dry food of Type VIII described in table I of paragraph (c) of this section and provided it is used at a level of 0.8 percent by weight of the paper.n-Dodecylguanidine hydrochloride....... For use only as an antimicrobial agent in paper and paperboard under the following conditions: 1. For contact only with nonalcoholic food having a pH above 5 and provided it is used at a level not to exceed 0.4 percent by weight of the paper and paperboard. 2. For use in the outer ply of multiwall paper bags for contact with dry food of Type VIII described in table I of paragraph (c) of this section and provided it is used at a level of 0.8 percent by weight of the paper.Fatty acids derived from animal and vegetable fats and oils and salts of such acids, single or mixed, as follows: Aluminum. Ammonium. Calcium. Magnesium. Potassium. Sodium. Zinc.Ferric chloride........................Ferrous ammonium sulfate...............Fish oil, hydrogenated.................Fish oil, hydrogenated, potassium salt.Furcelleran and salts of furcelleran as described in §§ 172.655 and 172.660 of this chapter.Glutaraldehyde (CAS Reg. No. 111-30-8). For use only as an antimicrobial agent in pigment and filler slurries used in the manufacture of paper and paperboard at levels not to exceed 300 parts per million by weight of the slurry solids.Glyceryl lactostearate.................Glyceryl mono-1,2-hydroxystearate......Glyceryl monoricinoleate...............Guar gum modified by treatment with For use only as a retention aid β-diethylamino- ethyl chloride and/or drainage aid employed hydrochloride. prior to the sheet-forming operation in the manufacture of paper and paperboard.Guar gum modified by treatment with not For use only as a retention aid more than 25 weight percent of 2,3- and/or internal size employed epoxypropyltri-methylammonium chloride prior to the sheet-forming such that the finished product has a operation in the manufacture maximum chlorine content of 4.5 of paper and paperboard, and percent, a maximum nitrogen content of limited to use at a level: (1) 3.0 percent, and a minimum viscosity Not to exceed 0.15 percent by in 1-percent-by-weight aqueous weight of the finished dry solution of 1,000 centipoises at 77 paper and paperboard fibers °F, as determined by RV-series intended for use in contact Brookfield viscometer (or equivalent) with all types of foods, using a No. 3 spindle at 20 r.p.m. except (2) not to exceed 0.30 pct. by weight of the finished dried paper and paperboard fibers for use with nonalcoholic and nonfatty food of types identified under Types I, II, IV-B, VI-B, VII- B, and VIII of table I in par. (c) of this section.N, N, N[prime], N[prime], N[Prime], For use only as a water- N[Prime]-Hexakis (methoxymethyl)-1,3,5- repellent applied to the triazine-2,4,6-triamine polymer with surface of paper and stearyl alcohol, α-octadecenyl- paperboard at levels not to omega-hydroxypoly(oxy-1,2-ethanediyl), exceed 1 percent by weight of and alkyl (C20+) alcohols (CAS Reg. the finished dry paperboard No. 130328-24-4). fibers. The finished paper and paperboard will be used in contact with aqueous foods under conditions of use B through G as described in table 2 of paragraph (c) of this section.Hexamethylenetetramine................. For use only as polymerization cross-linking agent for protein, including casein.Hydroquinone and the monomethyl or For use only as an inhibitor monoethyl ethers of hydroquinone. for monomers.Hydroxymethyl-5,5-dimethylhydantoin For use only as a preservative (CAS Reg. No. 27636-82-4), mixture in clay-type fillers at a with 1,3-bis(hydroxymethyl)-5,5- level not to exceed a combined dimethylhydantoin (CAS Reg. No. 6440- total of 1,200 milligrams/ 58-0). kilograms hydroxymethyl-5,5- dimethylhydantoin and 1,3- bis(hydroxymethyl)-5,5- dimethylhydantoin in the filler.Hydroxypropyl guar gum having a minimum For use only as a dry strength viscosity of 5,000 centipoises at 25 and formation aid agent °C., as determined by RV-series employed prior to the sheet- Brookfield viscometer using a No. 4 forming operation in the spindle at 20 r.p.m. (or other manufacture of paper and suitable method) and using a test paperboard and used at a level sample prepared by dissolving 5 grams not to exceed 1.5 percent by of moisture-free hydroxypropyl guar weight of finished dry paper gum in 495 milliliters of a 70 percent or paperboard fibers. by weight aqueous propylene glycol solution.12-Hydroxystearic acid-polyethylene For use only as a surfactant glycol block copolymers (CAS Reg. No. for dispersions of 70142-34-6) produced by the reaction polyacrylamide retention and of polyethylene glycol (minimum drainage aids employed prior molecular weight 200) with 12- to the sheet forming operation hydroxystearic acid. in the manufacture of paper and paperboard.Imidazolium compounds, 2-(C17 and C17- For use only at a level not to unsaturated alkyl)-1-[2-(C18 and C18- exceed 0.5 percent by weight unsaturated amido)ethyl]-4,5-dihydro-1- of the dry paper and methyl, methyl sulfates (CAS Reg. No. paperboard. 72749-55-4)..Isopropyl m- and p-cresols (thymol For use only as an antioxidant derived). for fatty based coating adjuvants provided it is used as a level not to exceed 0.005% by weight of coating solids.Isopropyl peroxydicarbonate............ For use only as polymerization catalyst.Japan wax..............................Lanolin................................Lauryl peroxide........................ For use only as polymerization catalyst.Lauryl sulfate salts: Ammonium. Magnesium. Potassium. Sodium.Lecithin, hydroxylated.................Lignin sulfonate and its calcium, potassium, and sodium salts.Maleic anhydride, polymer with ethyl For use only as a deposit acrylate and vinyl acetate, hydrolyzed control additive prior to the (CAS Reg. No. 113221-69-5) and/or its sheet forming operation to ammonium, potassium, and sodium salts. prevent scale buildup in the manufacture of paper and paperboard in contact with food, at a level not to exceed 0.075 percent (as the acid) by weight of the dry paper and paperboard.Methacrylic acid-acrylic acid copolymer For use only as a boiler water (CAS Reg. No. 25751-21-7). additive at a level not to exceed 50 parts per million in the boiler water.N-methyldiallylamine hydrochloride For use only as a retention polymer with epichlorohydrin having a aid, flocculating agent, and nitrogen content of 4.8 to 5.9 percent wet-strength agent employed in (Kjeldahl dry basis) such that a 20 the manufacture of paper and percent by weight aqueous solution has paperboard prior to the sheet- a minimum viscosity of 30 centipoises forming operation and limited and maximum viscosity of 100 to use at a level not to centipoises at 25 °C, as exceed 1.5 percent by weight determined by LVF Model Brookfield of the dry paper and viscometer using a No. 1 spindle at 60 paperboard. r.p.m. (or equivalent method).Methyl naphthalene sulfonic acid- For use only as an adjuvant to formaldehyde condensate, sodium salt. control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet- forming operation.N-methyl-N-(tall oil acyl) taurine, For use only to control scale sodium salt (CAS Reg. No. 61791-41-1). formation in the manufacture of paper and paperboard prior to the sheetforming operation at a level not to exceed 0.015 percent by weight of the dry paper and paperboard.Mineral oil, white.....................Mono-, di-, tri-(1-methyl-1- For use only as an emulsifier phenylethyl)-phenol, ethoxylated, for rosin based sizing at a sulfated, ammonium salt with an level not to exceed 0.03 average of 12 to 16 moles of ethylene percent by weight of the oxide (CAS Reg. No. 68130-71-2). finished dry paper and paperboard.Monoglyceride citrate..................Monoisopropanolamine (CAS Reg. No. 78- For use as a dispersant for 96-6). titanium dioxide suspensions at a level not to exceed 0.68 percent by weight of titanium dioxide. The finished paper and paperboard will be used in contact with all food types under conditions of use E through G described in table 2 of paragraph (c) of this section.Mustardseed oil, sulfated, ammonium, potassium, or sodium salt.Naphthalene sulfonic acid-formaldehyde For use only as an adjuvant to condensate, sodium salt. control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet- forming operation.Nitrocellulose, 10.9-12.2% nitrogen....Oleic acid, sulfated, ammonium, potassium, or sodium salt.N-Oleoyl-N[prime]- stearoylethylenediamine.Oxystearin.............................Paraformaldehyde....................... For use only as setting agent for protein.Pentanoic acid, 4,4-bis [(gamma-omega- For use only as an oil and perfluoro-C8-20-alkyl)thio] water repellent and used at a derivatives, compounds with level not to exceed 8 pounds diethanolamine (CAS Reg. No. 71608-61- per ton of the finished paper 2). or paperboard when such paper or paperboard is used in contact with nonalcoholic foods under conditions of use E through H described in table 2 of paragraph (c) of this section.Perfluoroalkyl acrylate copolymer (CAS For use only as an oil and Reg. No. 92265-81-1) containing 35 to water repellent at a level not 40 weight percent fluorine, produced to exceed 0.5 percent by by the copolymerization of weight of the finished paper ethanaminium, N,N,N-trimethyl-2-[(2- and paperboard in contact with methyl-1-oxo-2-propenyl)-oxy]-, nonalcoholic foods under chloride; 2-propenoic acid, 2-methyl-, conditions of use C, D, E, F, oxiranylmethyl ester; 2-propenoic G, or H described in table 2 acid, 2-ethoxyethyl ester; and 2- of paragraph (c) of this propenoic acid, 2[[(heptadecafluoro- section. octyl)sulfonyl] methyl amino]ethyl ester.Perfluoroalkyl substituted phosphate For use only as an oil and ester acids, ammonium salts formed by water repellant at a level not the reaction of 2,2-bis[ (γ,v- to exceed 0.44 percent perfluoroC4-20 alkylthio) methyl]-1,3- perfluoroalkyl actives by propanediol, polyphosphoric acid and weight of the finished paper ammonium hydroxide. and paperboard in contact with non-alcoholic foods under condition of use H as described in table 2 of paragraph (c) of this section; and in contact with food of types III, IV-A, V, VII-A, and IX described in table 1 of paragraph (c) of this section under conditions of use C through G as described in table 2 of paragraph (c) of this section.Petrolatum............................. Complying with § 178.3700 of this chapter.Petroleum asphalt, steam and vacuum For use only as a component of refined to meet the following internal sizing of paper and specifications: Softening point paperboard intended for use in 88° C to 93° C, as determined contact only with raw fruits, by ASTM method D36-76, ``Standard Test raw vegetables, and dry food Method for Softening Point of Bitumen of the type identified under (Ring-and-Ball Apparatus);'' Type VIII of table 1 in penetration at 25° C not to exceed paragraph (c) of this section, 0.3 mm, as determined by ASTM method and provided that the asphalt D5-73 (Reapproved 1978), ``Standard is used at a level not to Test Method for Penetration of exceed 5% by weight of the Bituminous Materials,'' which are finished dry paper and incorporated by reference (Copies may paperboard fibers. be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/ federal_register/ code_of_federal_regulations/ ibr_locations.php.); and maximum weight loss not to exceed 3% when distilled to 371° C, nor to exceed an additional 1.1% when further distilled between 371° C and thermal decomposition.Petroleum wax, synthetic............... Complying with § 178.3720 of this chapter.Phenothiazine.......................... For use only as antioxidant in dry rosin size.Phenyl acid phosphate.................. For use only as polymerization catalyst in melamine- formaldehyde modified alkyd coatings and limited to use at a level not to exceed 2% by weight of the coating solids.Phenyl-β-naphthylamine............ For use only as antioxidant in dry rosin size and limited to use at a level not to exceed 0.4% by weight of the dry rosin size.Phosphoric acid esters and polyesters For use as an adjuvant prior to (and their sodium salts) of the sheet forming operation to triethanolamine formed by the reaction control pitch and scale of triethanolamine with polyphosphoric formation in the manufacture acid to produce a mixture of esters of paper and paperboard having an average nitrogen content of intended for use in contact 1.5 percent and an average phosphorus with food only of the types content of 32 percent (as PO4). identified in paragraph (c) of this section, table 1, under Types I, IV, V, VII, VIII, and IX, and used at a level not to exceed 0.075 percent by weight of dry paper or paperboard fibers.Poly[acrylamide-acrylic acid-N- For use only as a drainage aid (dimethyl-aminomethyl)acryl- amide], and retention aid employed produced by reacting 2.40 to 3.12 prior to the sheet-forming parts by weight of polyacrylamide with operation in the manufacture 1.55 parts dimethylamine and 1 part of paper and paperboard for formaldehyde, and containing no more use in contact with fatty than 0.2 percent monomer as acrylamide. foods under conditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G.Poly(2-aminoethyl acrylate nitrate-co-2- For use only as a retention and hydroxypropyl acrylate) produced when drainage aid employed prior to one mole of hydroxypropyl acrylate and the sheet-forming operation in three moles of acrylic acid are the manufacture of paper and reacted with three moles of paperboard at a level not to ethylenimine and three moles of nitric exceed 0.2 percent by weight acid, such that a 35 percent by weight of dry paper or paperboard aqueous solution has a minimum fiber. viscosity of 150 centipoises at 72 °F., as determined by RVF-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 20 r.p.m.Polyacrolein (1 part) -sodium bisulfite For use only as an agent in (0.7 part) adduct, containing excess modifying starches and starch bisulfite (ratio of excess bisulfite gums used in the production of to adduct not to exceed 1.5 to 1). paper and paperboard and limited to use at a level not to exceed 0.09 mg/in\2\ of the finished paper and paperboard.Poly[acrylamide-acrylic acid-N- For use only as a drainage aid, (dimethylaminomethyl) acrylamide] retention aid, or dry-strength (C.A. Registry No. 53800-41-2), agent employed prior to the produced by reacting 9.6-16.4 parts by sheet-forming operation in the weight of polyacrylamide with 1.6 manufacture of paper and parts dimethylamine and 1 part paperboard at a level not to formaldehyde, and containing no more exceed 0.25 percent by weight than 0.2% monomer as acrylamide, such of finished dry paper and that a 20% aqueous solution has a paperboard fibers, when such minimum viscosity of 4,000 cP at 25 paper or paperboard is used in °C., as determined by Brookfield contact with fatty foods under viscometer model RVT, using a No. 5 conditions of use described in spindle at 20 r/min (or equivalent paragraph (c) of this section, method). table 2, conditions of use E, F, and G.Polyamide-epichlorohydrin modified For use only as a retention aid resin produced by reacting adipic acid and flocculant employed prior with diethylene triamine to produce a to the sheet-forming operation basic polyamide which is modified by in the manufacture of paper reaction with formic acid and and paperboard and used at a formaldehyde and further reacted with level not to exceed 0.2 epichlorohydrin in the presence of percent dry resin by weight of ammonium hydroxide to form a water- finished dry paper or soluble cationic resin having a paperboard fibers. nitrogen content of 13-16 percent (Kjeldahl, dry basis) such that a 35 percent by weight aqueous solution has a minimum viscosity of 75 centipoises at 25 °C, as determined by Brookfield viscometer using a No. 1 spindle at 12 r.p.m.Polyamide-epichlorohydrin water-soluble For use only under the thermosetting resins [CAS Reg. No. following conditions: 68583-79-9] prepared by reacting 1. As a retention aid employed adipic acid with diethylenetriamine to prior to the sheet-forming form a basic polyamide and further operation in the manufacture reacting the polyamide with an of paper and paperboard and epichlorohydrin and dimethylamine limited to use at a level not mixture such that the finished resins to exceed 0.12 percent by have a nitrogen content of 17.0 to weight of dry paper or 18.0 percent of a dry basis, and that paperboard. a 30-percent-by-weight aqueous 2. The finished paper or solution has a minimum viscosity of paperboard will be used in 350 centipoises at 20 °C, as contact with food only of the determined by a Brookfield viscometer types identified in paragraph using a No. 3 spindle at 30 r.p.m. (or (c) of this section, table 1, equivalent method). under types I and IV-B and under conditions of use described in paragraph (c) of this section, table 2, conditions of use F and G.Polyamide-epichlorohydrin water-soluble For use only as a wet strength thermosetting resin (CAS Reg. No. agent and/or retention aid 96387-48-3) prepared by reacting N- employed prior to the sheet- methyl-bis(3-aminopropyl) amine with forming operation in the oxalic acid and urea to form a basic manufacture of paper and polyamide and further reacting the paperboard and used at a level polyamide with epichlorohydrin. not to exceed 1.5 percent by weight of dry paper and paperboard fibers.Polyamide-epichlorohydrin water-soluble For use only in the manufacture thermosetting resins prepared by of paper and paperboard under reacting adipic acid, isophthalic conditions such that the acid, itaconic acid or dimethyl resins do not exceed 1.5 glutarate with diethylenetriamine to percent by weight of the paper form a basic polyamide and further or paperboard. reacting the polyamide with one of the following: Epichlorohydrin. Epichlorohydrin and ammonia mixture. Epichlorohydrin and sodium hydrosulfite mixture.Polyamidoamine-ethyleneimine- For use only as a retention aid epichlorohydrin resin prepared by employed prior to the sheet- reacting hexanedioic acid, N-(2- forming operation in the aminoethyl)-1,2-ethanediamine, manufacture of paper and (chloromethyl)oxirane, ethyleneimine paperboard at a level not to (aziridine), and polyethylene glycol, exceed 0.12 percent resin by partly neutralized with sulfuric acid weight of the finished dry (CAS Reg. No. 167678-45-7). paper or paperboard.Polyamidol-epichlorohydrin modified For use only as a wet strength resin produced by reacting glutaric agent employed prior to the acid dimethyl ester with diethylene- sheet-forming operation in the triamine to produce a basic polyamide manufacture of paper and which is modified by reaction with paperboard, and used at a formaldehyde and further reacted with level not to exceed 2.5 epicholorohydrin to form a water percent by weight of dry paper soluble cationic resin having a and paperboard fibers when nitrogen content of 10.9-11.9 percent such paper or paperboard is and a chlorine content of 13.8-14.8 used in contact with food percent, on a dry basis, and a minimum under conditions of use E viscosity, in 12.5 percent by weight through G described in table 2 aqueous solution, of 10 centipoises at of paragraph (c) of this 25 °C, as determined by a section. Brookfield Model LVF viscometer using a No. 1 spindle at 60 r.p.m. (or equivalent method).Polyamine-epichlorohydrin resin For use only as a flocculant, produced by the reaction of drainage aid, formation aid, epichlorohydrin with monomethylamine retention aid, or strength to form a prepolymer and further additive employed prior to the reaction of this prepolymer with sheet-forming operation in the N,N,N[prime],N[prime]- manufacture of paper and tetramethylethylenediamine such that paperboard, and used at a the finished resin having a nitrogen level not to exceed 0.12 content of 11.6 to 14.8 percent and a percent by weight of dry paper chlorine content of 20.8 to 26.4 and paperboard fibers. percent and a minimum viscosity, in 25 percent by weight aqueous solution, of 500 centipoises at 25 °C, as determined by LV-series Brookfield viscometer using a No. 2 spindle at 12 r.p.m. (or by other equivalent method).Polyamine-epichlorohydrin resin For use only as a clarifier in produced by the reaction of N,N- the treatment of influent dimethyl-1,3-propanediamine with water to be used in the epichlorohydrin and further reacted manufacture of paper and with sulfuric acid, Chemical Abstracts paperboard, and used at a Service Registry Number [27029-41-0], level not to exceed 20 parts such that the finished resin has a per million of the influent maximum nitrogen content of 14.4 water. percent (dry basis) and a minimum viscosity in 30 percent by weight aqueous solution (pH 4-6) of 50 centipoises at 25 °C, as determined by Brookfield LVT model viscometer, using a No. 1 spindle at 12 r.p.m. (or equivalent method).Polyamine-epichlorohydrin water-soluble For use only as a wetstrength thermosetting resin produced by agent and/or retention aid reacting epichlorohydrin with: (i) employed prior to the sheet- polyamines comprising at least 95 forming operation in the percent by weight C4 to C6 aliphatic manufacture of paper and diamines and/or their self- paperboard, and used at a condensation products, and/or (ii) level not to exceed 1 percent prepolymers produced by reacting 1,2- by weight of dry paper and dichloroethane with the polyamines in paperboard fibers. (i). The finished resin has a nitrogen content of 5.0 to 9.0 percent, a chlorine content of 18.0 to 35.0 percent on a dry basis, and a minimum viscosity, in a 25 percent by weight aqueous solution, of 50 centipoises at 20 °C (68 °F), as determined by Brookfield HAT model viscometer using a No. 1H spindle at 50 r.p.m. (or equivlent method).Polyamine-epichlorohydrin water-soluble For use only as a wet-strength thermosetting resin produced by agent and/or retention aid reacting epichlorohydrin with: (i) employed prior to the sheet- polyamines comprising at least 95 forming operation in the percent by weight C4 to C6 aliphatic manufacture of paper and diamines and/or their seIf- paperboard, and used at a condensation products and/or (ii) level not to exceed 1 percent hexamethylenediamine, and/or (iii) by weight of dry paper and bis(hexamethylene) triamine and higher paperboard fibers. homologues, and/or (iv) prepolymers produced by reacting 1,2- dichloroethane with the polyamines in (i) and/or (ii) and/or (iii). The finished resin has a nitrogen content of 5.0 to 9.0 percent, a chlorine content of 18.0 to 35.0 percent on a dry basis, and a minimum viscosity, in a 25 percent by weight aqueous solution, of 50 centipoises at 20 °C (68 °F), as determined by Brookfield HAT model viscometer using a No. 1H spindle at 50 r.p.m. (or equivalent method).Polyamine-epichlorohydrin water soluble For use only as a wet-strength thermosetting resin prepared by agent and/or retention aid reacting hexamethylenediamine with 1,2- employed prior to the sheet- dichloroethane to form a prepolymer forming operation in the and further reacting this prepolymer manufacture of paper and with epichlorohydrin. This resin is paperboard, and used at a then reacted with nitrilotris level not to exceed 1 percent (methylene-phosphonic acid), by weight of dry paper and pentasodium salt, such that the paperboard fibers. finished resin has a nitrogen content of 5.0-5.3 percent; a chlorine content of 29.7-31.3 percent; and a phosphorus content of 2.0-2.2 percent, on a dry basis, and a minimum viscosity, in 25 percent by weight aqueous solution, of 50 centipoises at 25 °C., as determined on a Brookfield HAT model viscometer using a No. 1H spindle at 50 r.p.m. (or equivalent method).Polyamine resin produced by the For use only as a retention aid reaction of 1,2-dichloroethane with and/or flocculent employed bis(hexamethylene)triamine and higher prior to the sheet-forming homologues such that the finished operation in the manufacture resin has a nitrogen content of 13.0- of paper and paperboard and 15.0 percent on a dry basis, and a used at a level not to exceed minimum viscosity in 25-percent-by- 0.1 percent by weight of dry weight aqueous solution of 75 paper or paperboard fibers. centipoises at 25 °C., as determined by Brookfield HAT model viscometer using a No. 1 spindle at 50 r.p.m. (or equivalent method).Polyaminoamide-epichlorohydrin modified For use only as a wet-strength resin produced by reacting adipic acid agent and/or retention aid with diethylenetriamine to produce a employed prior to the sheet- polyamide which is modified by forming operation in the reaction with diethylaminopropylamine manufacture of paper and and further reacted with dichloroethyl paperboard, and used at a ether to form a polyamide level not to exceed 0.5 intermediate. This polyamide percent by weight of the intermediate is then reacted with finished dry paper and epichlorohydrin such that the finished paperboard. resins have a nitrogen content of 10.9- 12.4 percent (Kjeldahl, dry basis) and a minimum viscosity in 40 percent-by- weight aqueous solution of 250 centipoises at 22 °C, as determined by a Brookfield Model LVT viscometer using a No. 2 spindle at 30 r.p.m. (or equivalent method).Polybutene, hydrogenated; complying For use only as provided in with the identity prescribed under §§ 175.300, 178.3740 § 178.3740(b) of this chapter. and 178.3860 of this chapter.Poly(diallyldimethylammonium chloride) For use only: (CAS Reg. No. 26062-79-3) produced by 1. As a pigment dispersant and/ the polymerization of or retention aid prior to the (diallyldimethylammonium chloride) so sheet-forming operation in the that the finished resin has a nitrogen manufacture of paper and content of 8.66±0.4 percent on paperboard, and used at a a dry weight basis and a minimum level not to exceed 10 pounds viscosity in a 40 percent by weight of active polymer per ton of aqueous solution of 1,000 centipoises finished paper and paperboard. at 25 °C (77 °F), determined 2. As a pigment dispersant in by LVF Model Brookfield Viscometer coatings at a level not to using a No. 3 spindle at 30 r.p.m. (or exceed 3.5 pounds of active equivalent method). The level of polymer per ton of finished residual monomer is not to exceed 1 paper and paperboard. percent by weight of the polymer (dry basis).Poly (diallyldimethylammonium chloride) For use only as a flocculant (CAS Reg. No. 26062-79-3) produced by employed prior to the sheet- the polymerization of forming operation in the diallyldimethylammonium chloride so manufacture of paper and that the finished resin has a nitrogen paperboard, and used at a content of 8.66±0.4 percent on level not to exceed 10 mg/L a dry basis and a minimum viscosity in (10 parts per million) of a 15 weight-percent aqueous solution influent water. of 10 centipoises at 25 °C (77 °F), as determined by LVF Model Brookfield viscometer using a No. 1 spindle at 60 r/min (or equivalent method). The level of residual monomer is not to exceed 1 weight-percent of the polymer (dry basis).Poly(1,2-dimethyl-5-vinylpyridinium For use only as an adjuvant methyl sulfate) having a nitrogen employed in the manufacture of content of 5.7 to 7.3 percent and a paper and paperboard prior to sulfur content of 11.7 to 13.3 percent the sheet-forming operation. by weight on a dry basis and having a minimum viscosity in 30-percent-by- weight aqueous solution of 2,000 centipoises at 25 °C., as determined by LV-series Brookfield viscometer (or equivalent) using a No. 4 spindle at 60 r.p.m.Polyester resin produced by reacting For use only as a surface- dimethylolpropionic acid (CAS Registry sizing compound applied after No. 4767-03-7) as a comonomer, at no the sheet-forming operation in more than 30 percent by weight of the manufacture of paper and total polymer solids in reaction with paperboard and limited to use 2,2-dimethyl-1,3-propanediol, phthalic at levels not to exceed 0.1 anhydride and isophthalic acid, such percent by weight of finished that the polyester resin has a dry paper or paperboard. viscosity of 200-600 centipoises at 80 °F as determined by a Brookfield RVT viscometer using a number 3 spindle at 50 rpm (or equivalent method).Polyethylene, oxidized; complying with For use only as component of the identity prescribed in § coatings that contact food 177.1620(a) of this chapter. only of the type identified under Type VII-B of table 1 in paragraph (c) of this section, and limited to use at a level not to exceed 50 percent by weight of the coating solids.Polyethyleneamine mixture produced when For use only as a retention aid 1 mole of ethylene dichloride, 1.05 employed prior to the sheet- moles of ammonia, and 2 moles of forming operation in the sodium hydroxide are made to react so manufacture of paper and that a 10 percent aqueous solution has paperboard. a minimum viscosity of 40 centipoises at 77 °F, as determined by Brookfield viscometer using a No. 1 spindle at 60 r.p.m.Polyethylene glycol (200) dilaurate.... For use only as an adjuvant employed in the manufacture of paper and paperboard prior to the sheet-forming operation.Polyethylene glycol (400) dioleate.....Polyethylene glycol (400) esters of coconut oil fatty acids.Polyethylene glycol (600) esters of tall oil fatty acids.Polyethylene glycol (400) monolaurate..Polyethylene glycol (600) monolaurate..Polyethylene glycol (400) monooleate...Polyethylene glycol (600) monooleate...Polyethylene glycol (400) monostearate.Polyethylene glycol (600) monostearate.Polyethylene glycol (3,000) monostearate.Polyethylenimine, produced by the For use only as an adjuvant polymerization of ethylenimine. employed prior to sheet formation in paper-making systems operated at a pH of 4.5 or higher, and limited to use at a level not to exceed 5% by weight of finished dry paper or paperboard fibers.Poly(isobutene)/maleic anhydride For use only as a surfactant adduct, diethanolamine reaction for dispersions of product. The mole ratio of polyacrylamide retention and poly(isobutene)/maleic anydride adduct drainage aids employed prior to diethanolamine is 1:1. to the sheet formation operation in the manufacture of paper and paperboard.Polymethacrylic acid, sodium salt, For use only as a coating having a viscosity in 30-percent-by- adjuvant for controlling weight aqueous solution of 125-325 viscosity when used at a level centipoises at 25 °C as determined not to exceed 0.3% by weight by LV-series Brookfield viscometer (or of coating solids. equivalent) using a No. 2 spindle at 60 r.p.m.Polymethacrylic acid, sodium salt, For use only as a coating having a viscosity in 40-percent-by- adjuvant for controlling weight aqueous solution of 400-700 viscosity when used at a level centipoises at 25 °C, as not to exceed 0.1% by weight determined by LV-series Brookfield of coating solids. viscometer (or equivalent) using a No. 2 spindle at 30 r.p.m.Poly[(methylimino)(2- For use only as a retention aid hydroxytrimethylene)hydrochloride] employed prior to the sheet- produced by reaction of 1:1 molar forming operation in such an ratio of methylamine and amount that finished paper and epichlorohydrin so that a 31-percent paperboard will contain the aqueous solution at 25° C has a additive at a level not in Stokes viscosity range of 2.5-4.0 as excess of 1 percent by weight determined by ASTM method D1545-76 of the dry paper and (Reapproved; 1981), ``Standard Test paperboard. Method for Viscosity of Transparent Liquids by Bubble Time 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/federal_register/ code_of_federal_regulations/ ibr_locations.php..Poly[oxyethylene (dimethyliminio) For use only to improve dry- ethylene (dimethyliminio) ethylene strength of paper and dichloride] produced by reacting paperboard and as a retention equimolar quantities of N,N,N,N- and drainage aid employed tetramethylethylene-diamine and prior to the sheet-forming dichlorethyl ether to yield a solution operation in the manufacture of the solid polymer in distilled of paper and paperboard and water at 25° C with a reduced limited to use at a level not viscosity of not less than 0.15 to exceed 0.1 percent by deciliter per gram as determined by weight of the finished dry ASTM method D1243-79, ``Standard Test paper and paperboard fibers. Method for -Dilute Solution Viscosity of Vinyl Chloride Polymers,'' which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/ federal_register/ code_of_federal_regulations/ ibr_locations.php.). The following formula is used for determining reduced viscosity:. Reduced viscosity in terms of deciliters per gram=(t-t0)/(t-C), where: t=Solution efflux time to=Water efflux time C=Concentration of solution in terms of grams per deciliterPolypropylene glycol (minimum molecular weight 1,000).Potassium persulfate...................2-Propenoic acid, telomer with sodium 2- For use only as a deposit methyl-2-[(1-oxo-2-propenyl)amino]-1- control additive employed propane sulfonate and sodium prior to the sheet forming phosphinate (CAS Reg. No. 110224-99-2). operation in the manufacture of paper and paperboard and at a level not to exceed 0.15 percent by weight of the dry paper and paperboard.Propylene glycol alginate..............Protein hydrolysate from animal hides or soybean protein condensed with oleic and/or stearic acid.Rapeseed oil, sulfated ammonium, potassium, or sodium salt.Ricebran oil, sulfated ammonium, potassium, or sodium salt.Rosin and rosin derivatives............ As provided in § 178.3870 of this chapter.Siloxanes (silicones), dimethyl, For use only as a component of isopropyl methyl, methyl 1-methyl-C9- polyolefin coatings with 49-alkyl (CAS Reg. No. 144635-08-5). § 177.1520 of this chapter at a level not to exceed 3 percent by weight. The finished coating will be used only for paper and paperboard that contact food of types VI-A and VI-B of table 1 in paragraph (c) of this section, and under conditions of use C, D, and E, as described in table 2 in paragraph (c) of this section, with a maximum hot fill temperature of 200 °F (94 °C).Silver chloride-coated titanium dioxide For use only as a preservative in polymer latex emulsions at a level not to exceed 2.2 parts per million (based on silver ion concentration) in the dry coating.Sodium carboxymethyl guar gum having a For use only as a dry-strength minimum viscosity of 2,700 centipoises and formation-aid agent at 25 °C after 24 hours as employed prior to the sheet- determined by RV-series Brookfield forming operation in the viscometer (or equivalent) using a No. manufacture of paper and 4 spindle at 20 r.p.m. and using a paperboard and used at a level test sample prepared by dissolving 8 not to exceed 1% by weight of grams of sodium carboxymethyl guar gum finished dry paper or in 392 milliliters of 0.2-percent-by- paperboard fibers. weight aqueous sodium o-phenylphenate solution.Sodium dioctyl sulfosuccinate..........Sodium formaldehyde sulfoxylate........ For use only as polymerization catalyst.Sodium hypochlorite....................Sodium N-methyl-N-oleyltaurate......... For use only as an adjuvant to control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet- forming operation.Sodium nitrite......................... For use only: 1. At levels not to exceed 0.2% by weight of lubricants or release agents applied at levels not to exceed 1 lb. per ton of finished paper or paperboard. 2. As an anticorrosion agent at levels not to exceed 0.2% by weight of wax emulsions used as internal sizing in the manufacture of paper and paperboard prior to the sheet- forming operation.Sodium persulfate......................Sodium polyacrylate.................... For use only: 1. As a thickening agent for natural rubber latex coatings, provided it is used at a level not to exceed 2 percent by weight of coating solids. 2. As a pigment dispersant in coatings at a level not to exceed 0.25 percent by weight of pigment.Sodium poly(isopropenylphosphonate) For use only in paper mill (CAS Reg. No. 118632-18-1). boilers.Sodium zinc potassium polyphosphate For use only as a pigment (CAS Reg. No. 65997-17-3). dispersant in coatings at a level not to exceed 1 percent by weight of pigment.Sperm oil, sulfated, ammonium, potassium, or sodium salt.Stannous oleate........................Stearyl-2-lactylic acid and its calcium salt.Styrene-butadiene copolymers produced by copolymerizing styrene-butadiene with one or more of the monomers: acrylamide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, methacrylic acid, and N- methylolacrylamide (CAS Reg. No. 53504- 31-7). The finished copolymers shall contain not more than 10 weight percent of total polymer units derived from acrylic acid, fumaric acid, 2- hydroxyethyl acrylate, itaconic acid, and methacrylic acid, and shall contain not more than 3 weight percent of total polymer units derived from N- methylolacrylamide, and shall contain not more than 2 weight percent of polymer units derived from acrylamide..Styrene-maleic anhydride copolymer, For use only as a surface size amidated, ammonium sodium salt; at a level not to exceed 1 having, in a 25 percent by weight percent by weight of paper or aqueous solution at pH 8.8, a minimum paperboard substrate. viscosity of 600 centipoises at 25 °C as determined by Brookfield model LVT viscometer using a No. 3 spindle at 60 r.p.m. (or equivalent method).Styrene-maleic anhydride copolymer, For use only: sodium salt (minimum molecular weight 1. As a coating thickening 30,000). agent at a level not to exceed 1% by weight of coating solids. 2. As surface size at a level not to exceed 1% by weight of paper or paperboard substrate.Styrene-methacrylic acid copolymer, For use only as a coating potassium salt (minimum molecular thickening agent at a level weight 30,000). not to exceed 1% by weight of coating solids.Synthetic wax polymer prepared by the For use only as a component of catalytic polymerization of alpha petroleum wax and/or synthetic olefins such that the polymer has a petroleum wax complying with maximum iodine number of 18 and a § 178.3710 or § minimum number average molecular 178.3720 of this chapter at weight of 2,400. levels not to exceed 5 percent by weight of the wax: 1. Under conditions of use F and G described in table 2 of paragraph (c) of this section for all foods. 2. Under conditions of use E described in table 2 of paragraph (c) of this section for food Types I, II, IV-B, VI, VII-B and VIII as described in table 1 of paragraph (c) of this section.Tallow.................................Tallow alcohol.........................Tallow alcohol, hydrogenated...........Tallow fatty acid, hydrogenated........Tallow hydrogenated....................Tallow sulfated, ammonium, potassium, or sodium salt.Tetraethylenepentamine................. For use only as a modifier for amino resins.1,4,4a,9a-Tetrahydro-9, 10- For use only as a catalyst in anthracenedione (CAS Reg. No. 56136-14- the alkaline pulping of 2). lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials.N,N,N[prime], N[prime]- For use only as a flocculent, Tetramethylethylenediamine polymer drainage aid or retention aid with bis-(2-chloroethyl) ether, first employed prior to the sheet reacted with not more than 5 percent forming operation in the by weight 1-chloro-2,3-epoxypropane manufacture of paper and and then reacted with not more than 5 paperboard and limited to use percent by weight poly (acrylic acid) at a level not to exceed 0.2 such that a 50 percent by weight percent by weight of the aqueous solution of the product has a finished dry paper and nitrogen content of 4.7-4.9 percent paperboard fibers. and viscosity of 350-700 centipoises at 25 °C as determined by LV series Brookfield viscometer using a No. 2 spindle at 60 r.p.m. (or by other equivalent method).Tetrasodium N- (1,2-dicarboxyethyl) - N For use only as an emulsifier - octadecylsulfo-succinamate. in aqueous dispersions of rosin sizes complying with § 178.3870(a)(4) of this chapter and limited to use prior to the sheet-forming operation in the manufacture of paper and paperboard at a level not to exceed 0.02 pct by weight of finished paper and paperboard.Triethanolamine........................ For use only to adjust pH during the manufacture of amino resins permitted for use as components of paper and paperboard.Triethylene glycol adipic acid For use only as a curl-control monoester produced by reacting agent at a level not to exceed equimolar quantities of triethylene 2% by weight of coated or glycol and adipic acid. uncoated paper and paperboard.Triethylenetetramine................... For use only as a modifier for amino resins.1,3,5-Triethylhexahydro-1,3,5-triazine For use only as an (CAS Registry No. 7779-27-3). antimicrobial agent for coating, binder, pigment, filler, sizing, and similar formulations added prior to the heat drying step in the manufacture of paper and paperboard and limited to use at a level between 0.05 and 0.15 percent by weight of the formulation.Undecafluorocyclohexanemethanol ester For use only as an oil mixture of dihydrogen phosphate, repellent at a level not to compound with 2,2[prime] exceed 0.087 lb (0.046 lb of iminodiethanol (1:1); hydrogen fluorine) per 1,000 ft\2\ of phosphate, compound with 2,2[prime]- treated paper or paperboard, iminodiethanol (1:1); and P,P[prime]- as determined by analysis for dihydrogen pyrophosphate, compound total fluorine in the treated with 2,2[prime]-iminodiethanol (1:2); paper or paperboard without where the ester mixture has a fluorine correction for any fluorine content of 48.3 pct to 53.1 pct as which might be present in the determined on a solids basis. untreated paper or paperboard, when such paper or paperboard is used in contact with food only of the types identified in paragraph (c) of this section, table 1, under Types IVA, V, VIIA, VIII, and IX, and under the conditions of use B through G described in table 2 of paragraph (c) of this section.Viscose rayon fibers...................Wax, petroleum......................... Complying with § 178.3710 of this chapter.Xanthan gum, conforming to the identity For use only at a maximum level and specifications prescribed in of 0.125 percent by weight of § 172.695 of this chapter, except finished paper as a suspension that the residual isopropyl alcohol aid or stabilizer for aqueous shall not exceed 6,000 parts per pigment slurries employed in million. the manufacture of paper and paperboard.Xylene sulfonic acid-formaldehyde For use only as an adjuvant to condensate, sodium salt. control pulp absorbency and pitch content in the manufacture of paper and paperboard prior to the sheet- forming operation.Zeolite Na-A (CAS Reg. No. 68989-22-0). For use as a pigment extender at levels not to exceed 5.4 percent by weight of the finished paper and paperboard.Zinc formaldehyde sulfoxylate.......... For use only as polymerization catalyst.Zinc octoate...........................Zirconium oxide........................ For use only as a component of waterproof coatings where the zirconium oxide is present at a level not to exceed 1 percent by weight of the dry paper or paperboard fiber and where the zirconium oxide is produced by hydrolysis of zirconium acetate.------------------------------------------------------------------------
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(b) Substances identified in paragraphs (b) (1) and (2) of this section may be used as components of the food-contact surface of paper and paperboard, provided that the food-contact surface of the paper or paperboard complies with the extractives limitations prescribed in paragraph (c) of this section.
(1) Substances identified in §175.300(b)(3) of this chapter with the exception of those identified in paragraphs (b)(3) (v), (xv), (xx), (xxvi), (xxxi), and (xxxii) of that section and paragraph (a) of this section.
(2) Substances identified in this paragraph (b)(2) follow:
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------------------------------------------------------------------------ List of substances Limitations------------------------------------------------------------------------Acrylamide copolymerized with ethyl acrylate and/or stryene and/or methacrylic acid, subsequently reacted with formaldehyde and butyl alcohol.Acrylamide copolymerized with ethylene For use only as coatings or and vinyl chloride in such a manner components of coatings. that the finished copolymers have a minimum weight average molecular weight of 30,000 and contain not more than 3.5 weight percent of total polymer units derived from acrylamide, and in such a manner that the acrylamide portion may or may not be subsequently partially hydrolyzed.2-Acrylamido-2-methyl-propanesulfonic For use only in coatings at a acid, homopolymer, sodium salt (CAS level not to exceed 0.01 mg/ Reg. No. 35641-59-9). in\2\Acrylic and modified acrylic polymers.. Complying with § 177.1010 of this chapter.Acrylic copolymers produced by copolymerizing 2 or more of the acrylate monomers butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acrylate, methyl methacrylate, and n-propyl methacrylate, or produced by copolymerizing one or more of such acrylate monomers together with one or more of the monomers acrylic acid, acrylonitrile, butadiene, 2-ethyl- hexyl acrylate, fumaric acid, glycidyl methacrylate, n-hexyl-methacrylate, itaconic acid, methacrylic acid, styrene, vinyl acetate, vinyl chloride, and vinylidene chloride. The finished copolymers shall contain at least 50 weight percent of polymer units derived from one or more of the monomers butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acrylate, methyl methacrylate, and n- propyl methacrylate; and shall contain not more than 5 weight percent of total polymer units derived from acrylic acid, fumaric acid, glycidyl methacrylate, n-hexyl methacrylate, itaconic acid, and methacrylic acid. The provision limiting the finished acrylic copolymers to not more than 5 units derived from acrylic acid, fumaric acid, glycidyl methacrylate, n- hexyl methacrylate, itaconic acid, and methacrylic acid is not applicable to finished acrylic copolymers used as coating adjuvants at a level not exceeding 2 weight percent of total coating solids.Alkyl mono- and disulfonic acids, For use only: sodium salts (produced from n-alkanes 1. As emulsifiers for in the range of C10-C18 with not less vinylidene chloride copolymer than 50 percent C14-C16).. coatings and limited to use at levels not to exceed 2 percent by weight of the coating solids. 2. As emulsifiers for 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 types identified in paragraph (c) of this section, table 1, under Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX and under conditions of use E, F, and G described in table 2 of paragraph (c) of this section.2-Bromo-4[prime]-hydroxyacetophenone... For use only as a preservative for coating formulations, binders, pigment slurries, and sizing solutions at a level not to exceed 0.006 percent by weight of the coating, solution, slurry or emulsion.Butanedioic acid, sulfo-1,4-di-(C9-C11 For use as a surface active alkyl) ester, ammonium salt (also agent in package coating inks known as butanedioic acid, sulfo-1,4- at levels not to exceed 3 diisodecyl ester, ammonium salt [CAS percent by weight of the Reg. No. 144093-88-9]).. coating ink.Butylbenzyl phthalate.................. Complying with § 178.3740 of this chapter.Butyl oleate, sulfated, ammonium, potassium, or sodium salt.Butyraldehyde..........................Captan (N-trichloromethylmercapto-4- For use only as a mold- and cyclohexene-1, 2-dicarboximide). mildew-proofing agent in coatings intended for use in contact with food only of the types identified in paragraph (c) of this section, table 1, under Type I, II, VI-B, and VIII.Castor Oil, polyoxyethylated (42 moles For use only as an emulsifier ethylene oxide). in nitrocellulose coatings for paper and paperboard intended for use in contact with food only of the types identified in paragraph (c) of this section, table 1, under Types IV A, V, VII A, VIII, and IX; and limited to use at a level not to exceed 8 percent by weight of the coating solids.1-(3-Chloroallyl)-3,5,7-triaza-1- For use only: azoniaadamantane chloride (CAS Reg. 1. As a preservative at a level No. 4080-31-3). of 0.3 weight percent in latexes used as pigment binders in paper and paperboard intended for use in contact with nonacidic, nonalcoholic food and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G. 2. As a preservative at a level not to exceed 0.07 weight percent in latexes and 0.05 weight percent in pigment slurries used as components of coatings for paper and paperboard intended for use in contact with food.5-Chloro-2-methyl-4-isothiazolin-3-one For use only: (CAS Reg. No. 26172-55-4) and 2-methyl- 1. As an antimicrobial agent 4-isothiazolin-3-one (CAS Reg. No. for polymer latex emulsions in 2682-20-4) mixture at a ratio of 3 paper coatings at a level not parts to 1 part, manufactured from to exceed 50 parts per million methyl-3-mercaptopropionate (CAS Reg. (based on isothiazolone active No. 2935-90-2). The mixture may ingredients) in the coating contain magnesium nitrate (CAS Reg. formulation. No. 10377-60-3) at a concentration 2. As an antimicrobial agent equivalent to the isothiazolone active for finished coating ingredients (weight/weight). formulations and for additives used in the manufacture of paper and paperboard including fillers, binders, pigment slurries, and sizing solutions at a level not to exceed 25 parts per million (based on isothiazolone active ingredients) in the coating formulations and additives.Copper 8-quinolinolate................. For use only as preservative for coating formulations.Cyclized rubber produced when natural For use only in coatings for pale crepe rubber dissolved in phenol paper and paperboard intended is catalytically cyclized so that the for use in contact with food finished cyclized rubber has a melting only of the types identified point of 145 °C to 155 °C as in paragraph (c) of this determined by ASTM method E28-67 section, table 1, under Types (Reapproved 1982), ``Standard Test VIII and IX. Method for Softening Point by Ring-and- Ball Apparatus,'' which is incorporated by reference (Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/ federal_register/ code_of_federal_regulations/ ibr_locations.php.), and contains no more than 4000 ppm of residual-free phenol as determined by a gas liquid chromatographic procedure titled ``Determination of Free Phenol in Cyclized Rubber Resin,'' which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS- 200), Food and Drug Administration, 5100 Paint Branch Pkwy., 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/ federal_register/ code_of_federal_regulations/ ibr_locations.php..1,2-Dibromo-2,4-dicyanobutane (CAS Reg. For use only as a preservative No. 35691-65-7). at levels not more than 0.05 weight percent and not less than 0.01 weight percent: in latexes used as pigment binders in coatings; in pigment slurries used in coatings; and/or in coatings themselves. The total level of the preservative in the finished coating shall not exceed 0.04 weight percent of the finished coating solids.Dibutyl phthalate......................Dibutyl sebacate.......................Di(C7,C9-alkyl) adipate................ Complying with § 178.3740 of this chapter.Dicyclohexyl phthalate.................Diethylene glycol dibenzoate (CAS Reg. For use only as a plasticizer No. 120-55-8). for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating solids under conditions described in paragraph (c) of this section, table 2, conditions of use E, F, and G.Diethylene glycol ester of the adduct of terpene and maleic anhydride.Dihydroxy dichlorodiphenyl methane..... For use only as preservative for coating formulations.Dimethylpolysiloxane, 100 centistokes viscosity.Dimethylpolysiloxane-beta-phenylethyl methyl polysiloxane copolymer (2:1), 200 to 400 centistokes viscosity.N,N[prime]-Diphenyl-p-phenylenediamine. For use only as polymerization inhibitor in 2-sulfoethyl methacrylate, sodium salt.Dipropylene glycol dibenzoate (CAS Reg. 1. For use only as a No. 27138-31-4). plasticizer for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating solids under conditions described in paragraph (c) of this section, table 2, condition of use E. 2. For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 10 percent by weight of the coating solids under conditions described in paragraph (c) of this section, table 2, conditions of use F and G.Disodium N-octadecylsulfosuccinamate... For use only as an emulsifier in resin latex coatings and limited to use at a level not to exceed 0.05% by weight of the coating solids.EDTA (ethylenediaminetetraacetic acid) and its sodium and/or calcium salts.Ethanedial, polymer with tetrahydro-4- For use only as an hydroxy-5-methyl-2(1H)pyrimidinone, insolubilizer for starch-based propoxylated (CAS Reg. No. 118299-90- coatings and limited to use at 4). a level not to exceed 5.0 percent by weight of the coating.Ethylene-acrylic acid copolymers produced by the copolymerization of ethylene and acrylic acid and/or their partial ammonium salts. The finished copolymer shall contain no more than 25 weight percent of polymer units derived from acrylic acid and no more than 0.35 weight percent of residual monomeric acrylic acid, and have a melt index not to exceed 350 as determined by ASTM method D1238-82, ``Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,'' which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428- 2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/ federal_register/ code_of_federal_regulations/ ibr_locations.php..Formaldehyde........................... For use only as preservative for coating formulations.Glyoxal................................ For use only as an insolubilizing agent in starch- and protein-based coatings that contact nonalcoholic foods, and limited to use at a level not to exceed 6 percent by weight of the starch or protein fraction of the coating solids.Glyceryl monobutyl ricinoleate.........Hydroxymethyl derivatives (mixture of For use only as a comonomer in mono and poly) of [N-(1, 1-dimethyl-3- polyvinyl acetate latex oxobutyl) acrylamide] produced by coatings and limited to use at reacting 1 mole of the [N-(1,1- a level not to exceed 1 dimethyl-3-oxobutyl) acrylamide] with percent by weight of dry 3 moles of formaldehyde such that the polymer solids. finished product has a maximum nitrogen content of 6.2 percent and a maximum hydroxyl content of 15 percent by weight on a dry basis.Isobutyl oleate, sulfated, ammonium, potassium, or sodium salt.Maleic anhydride adduct of butadiene- styrene copolymer.α-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1α- methylstyrene to 3 vinyltoluene).Modified kaolin clay (CAS Reg. No. 1344- For use only as a component of 00-9) is produced by the reaction of coatings in paper and sodium silicate (CAS Reg. No. 1344-09- paperboard products at a level 8) and kaolinite clay (CAS Reg. No. not to exceed 9 percent by 1332-58-7) under hydrothermal weight of the coating intended conditions. The reaction product has a for use in contact with food molecular weight between 246 and 365 of Types I through IX and consists of 46 to 55 percent described in table 1 of silicon dioxide (Si02), 28 to 42 paragraph (c) of this section percent aluminum oxide (A1203), and 2 under conditions of use C to 7 percent of sodium oxide (Na20). through H described in table 2 The reaction product will not consist of paragraph (c) of this of more than 70 percent modified section. kaolin clay.Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.Oleyl alcohol..........................Oxazolidinylethylmethacrylate (CAS For use only as a binder for Registry No. 46236-15-1) copolymer pigment coatings as a binder with ethyl acrylate and methyl level not to exceed 4.0 methacrylate, and containing not more percent by weight of dry paper than 6 percent by weight of or paperboard. oxazolidinylethylmethacrylate. Maximum nitrogen content shall be 0.5 percent and number average molecular weight of that portion of the copolymer soluble in tetrahydrofuran shall be not less than 50,000.Pentaerythritol tetrastearate..........Petroleum alicyclic hydrocarbon resins, For use only as modifiers in or the hydrogenated product thereof, waxpolymer blend coatings for meeting the following specifications: corrugated paperboard intended Softening point 97 °C minimum, as for use in bulk packaging or determined by ASTM method E28-67 raw fruits, raw vegetables, (Reapproved 1982), ``Standard Test iced meat, iced fish, and iced Method for Softening Point by Ring and poultry; and limited to use at Ball Apparatus;'' aniline point 120 a level not to exceed 30 °C minimum, as determined by ASTM weight-percent of the coating method D611-82, ``Standard Test solids. Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydrocarbon Solvents,'' 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/ federal_register/ code_of_federal_regulations/ ibr_locations.php.). Specific gravity 0.96-0.99 (20 °C/20 °C). Such petroleum hydrocarbon resins are produced by the catalytic polymerization of dienes and olefins from low-boiling distillates of cracked petroleum stocks that contain no material boiling over 200 °C and that meet the ultraviolet absorbance limits prescribed in § 172.880(b) of this chapter when subjected to the analytical procedure described in § 172.886(b) of this chapter, modified as follows: Treat the product as in the first paragraph under ``Procedure'' in § 172.250(b)(3) of this chapter. Then proceed with § 172.886(b) of this chapter, starting with the paragraph commencing with ``Promptly complete transfer of the sample * * *''.Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride and ethylene glycol, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C-92 °C., and a color of K or paler.Polyester resin produced by reacting the acid groups in montan wax with ethylene glycol.Polyethylene, oxidized................. Complying with § 177.1620 of this chapter.Polyethylene reacted with maleic anhydride such that the modified polyethylene has a saponification number not in excess of 6 after Soxhlet extraction for 24 hours with anhydrous ethyl alcohol.Polyoxyethylated (40 moles) tallow Not to exceed 300 p.p.m. in alcohol sulfate, sodium salt. finished coated paper or paperboard.Polyoxypropylene-polyoxyethylene block polymers (minimum molecular weight 6,800).Polyvinyl acetate......................Polyvinyl alcohol (minimum viscosity of 4% aqueous solution at 20 °C. of 4 centipoises).Polyvinyl butyral......................Polyvinyl formal.......................Polyvinylidene chloride................Polyvinyl pyrrolidone..................Polyvinyl stearate.....................Propylene glycol mono- and diesters of fats and fatty acids.Siloxanes and silicones; platinum- For use only as a surface catalyzed reaction product of vinyl- coating. Platinum content not containing dimethyl polysiloxane (CAS to exceed 200 parts per Reg. Nos. 68083-19-2 and 68083-18-1) million. with methyl hydrogen polysiloxane (CAS 1. In coatings for paper and Reg. No. 63148-57-2) or dimethyl paperboard provided the (methyl hydrogen) polysiloxane (CAS coating contacts food only of Reg. No. 68037-59-2). Diallyl maleate the types identified in (CAS Reg No. 999-21-3), dimethyl paragraph (c) of this section, maleate (CAS Reg. No. 624-48-6), 1- table 1, under Types I, II, ethynyl-1-cyclohexanol (CAS Reg. No. VI, and VII-B when used under 78-27-3) and vinyl acetate (CAS Reg. conditions of use E, F, and G No. 108-05-4) may be used as optional described in table 2 of polymerization inhibitors. paragraph (c) of this section. 2. In coatings for paper and paperboard provided the coating contacts food only of the types identified in paragraph (c) of this section, table 1, under Types III, IV, V, VII-A, VIII, and IX when used under conditions of use A through H described in table 2 of paragraph (c) of this section.Siloxanes and silicones; platinum- Platinum content not to exceed catalyzed reaction product of vinyl- 100 parts per million. For use containing dimethylpolysiloxane (CAS only as a release coating for Reg. Nos. 68083-19-2 and 68083-18-1), pressure sensitive adhesives. with methyl hydrogen polysiloxane (CAS Reg. No. 63148-57-2). Dimethyl maleate (CAS Reg. No. 624-48-6), vinyl acetate (CAS Reg. No. 108-05-4), dibutyl maleate (CAS Reg. No. 105-76-0) and diallyl maleate (CAS Reg. No. 999-21- 3) may be used as optional polymerization inhibitors. The polymer may also contain C16-C18 olefins (CAS Reg. No. 68855-60-7) as a control release agent.Sodium decylbenzenesulfonate...........Sodium dihexyl sulfosuccinate..........Sodium n-dodecylpolyethoxy (50 moles) For use only as an emulsifier sulfate-sodium in coatings that contact food isododecylphenoxypolyethoxy (40 moles) only of the types identified sulfate mixtures. in paragraph (c) of this section, table 1, under Types IV-A, V, VII, VIII, and IX; and limited to use at levels not to exceed 0.75 percent by weight of the coating solids.Sodium 2-ethylhexyl sulfate............Sodium oleoyl isopropanolamide sulfosuccinate.Sodium pentachlorophenate.............. For use only as preservative for coating formulations.Sodium o-phenylphenate................. Do.Sodium vinyl sulfonate polymerized.....Sodium xylenesulfonate (CAS Reg. No. For use only in paper and 1300-72-7). paperboard coatings at levels not to exceed 0.01 percent by weight of the finished paper and paperboard.Styrene copolymers produced by For use only as a coating or copolymerizing styrene with maleic component of coatings and anhydride and its methyl and butyl limited to use at a level not (sec- or iso-) esters. Such copolymers to exceed 1% by weight of may contain β-nitrostyrene as a paper or paperboard substrate. polymerization chain terminator.Styrene polymers made by the For use only in contact with polymerization of any combination of foods of Types IV-A, V, and styrene or alpha methyl styrene with VII in table 1 of paragraph acrylic acid, methacrylic acid, 2- (c) of this section, under use ethyl hexyl acrylate, methyl conditions E through G in methacrylate, and butyl acrylate. The table 2 of paragraph (c), and styrene and alpha methyl styrene, with foods of Types VIII and individually, may constitute from 0 to IX without use temperature 80 weight percent of the polymer. The restriction. other monomers, individually, may be from 0 to 40 weight percent of the polymer. The polymer number average molecular weight (Mn) shall be at least 2,000 (as determined by gel permeation chromatography). The acid number of the polymer shall be less than 250. The monomer content shall be less than 0.5 percent.Styrene-acrylic copolymers (CAS Reg. For use only as a component of No. 25950-40-7 produced by coatings and limited to use at polymerizing 77 to 83 parts by weight a level not to exceed 20 of styrene with 13 to 17 parts of percent by weight of the methyl methacrylate, 3 to 4 parts of coating solids. butyl methacrylate, 0.5 to 2.5 parts of methacrylic acid, and 0.1 to 0.3 part of butyl acrylate such that the finished copolymers have a minimum number average molecular weight greater than 100,000 and a level of residual styrene monomer in the polymer not to exceed 0.1 percent by weight.Styrene-butadiene copolymers produced by copolymerizing styrene-butadiene with one or more of the monomer: acrylamide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and methacrylic acid. The finished copolymers shall contain not more than 10 weight percent of total polymer units derived from acrylic acid, fumaric acid, 2- hydroxyethyl acrylate, itaconic acid and methacrylic acid, and shall contain not more than 2 weight percent of polymer units derived from acrylamide.Styrene-butadiene copolymers with 2- hydroxyethyl acrylate and acrylic acid containing not more than 15 weight percent acrylic acid and no more than 20 weight percent of a combination of 2-hydroxyethyl acrylate and acrylic acid.Styrene-butadiene-vinylidene chloride For use only as coatings or copolymers containing not more than 40 components of coatings. weight percent of vinylidene chloride in the finished copolymers. The finished copolymers may contain not more than 10 weight percent of total polymer units derived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and/or methacrylic acid.Styrene-dimethylstyrene-α- For use only in coatings for methylstyrene copolymers produced by paper and paperboard intended polymerizing equimolar ratios of the for use in contact with three comonomers such that the nonfatty food and limited to finished copolymers have a minimum use at a level not to exceed average molecular weight of 835 as 50% by weight of the coating determined by ASTM method D2503-82, solids. ``Standard Test Method for Molecular Weight (Relative Molecular Mass) of Hydrocarbons by Thermoelectric Measurement of Vapor Pressure,'' which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741- 6030, or go to: http:// www.archives.gov/federal_register/ code_of_federal_regulations/ ibr_locations.php..Styrene-isobutylene copolymers (weight For use only in coatings for average molecular weight not less than paper and paperboard intended 6,300). for use in contact under conditions of use D G described in table 2 of paragraph (c) of this section, with food of Types I, II, IV- B, VI-B, VII-B, and VIII described in table 1 of paragraph (c) of this section; and limited to use at a level not to exceed 40 percent by weight of the coating solids.Styrene-maleic anhydride copolymers.... For use only as a coating or component of coatings and limited for use at a level not to exceed 2 percent by weight of paper or paperboard substrate.Styrene-methacrylic acid copolymers containing no more than 5 weight percent of polymer units derived from methacrylic acid.Styrene-vinylidene chloride copolymers For use only as coatings or containing not more than 40 weight components of coatings. percent of vinylidene chloride in the finished copolymers. The finished copolymers may contain not more than 5 weight percent of total polymer units derived from acrylic acid, fumaric acid, itaconic acid, and/or methacrylic acid.2-Sulfoethyl methacrylate, sodium salt For use only in copolymer [Chemical Abstracts Service No. 1804- coatings under conditions of 87-1]. use E, F, and G described in paragraph (c) of this section, table 2, and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating.α[p-(1,1,3,3-Tetramethylbutyl) For use only as a surface- phenyl]-omega-hydroxypoly active agent at levels not to (oxyethylene) hydrogen sulfate, sodium exceed 3 percent by weight of salt mixture with α-[p-(1,1,3,3- vinyl acetate polymer with tetramethylbutyl)-phenyl]-omega- ethylene and N-(hydroxymethyl) hydroxypoly (oxyethylene) with both acrylamide intended for use in substances having a poly(oxyethylene) coatings for paper and content averaging 3 moles. paperboard intended for use in contact with foods: 1. Of the types identified in paragraph (c) of this section, table 1, under Types I, II, III, IV, VI-B, and VII, and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G. 2. Of the types identified in paragraph (c) of this section, table 1, under Types V, VIII and IX and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use C, D, E, F, and G.Tetrasodium N-(1,2-dicarboxyethyl)-N- For use only as an emulsifier octadecylsulfo-succinamate. in resin latex coatings, and limited to use at a level not to exceed 0.05% by weight of the coating solids.Toluenesulfonamide-formaldehyde resins.Vinyl acetate copolymers produced by copolymerizing vinyl acetate with one or more of the monomers acrylamide, acrylic acid, acrylonitrile, bicyclo- [2.2.1]hept-2-ene-6-methylacrylate, butyl acrylate, crotonic acid, decyl acrylate, diallyl fumarate, diallyl maleate, diallyl phthalate, dibutyl fumarate, dibutyl itaconate, dibutylmaleate, di(2-ethylhexyl) maleate, divinyl benzene, ethyl acrylate, 2-ethyl-hexyl acrylate, fumaric acid, itaconic acid, maleic acid, methacrylic acid, methyl acrylate, methyl methacrylate, mono(2- ethylhexyl) maleate, monoethyl maleate, styrene, vinyl butyrate, vinyl crotonate, vinyl hexoate, vinylidene chloride, vinyl pelargonate, vinyl propionate, vinyl pyrrolidone, vinyl stearate, and vinyl sulfonic acid. The finished copolymers shall contain at least 50 weight percent of polymer units derived from vinyl acetate and shall contain no more than 5 weight percent of total polymer units derived from acrylamide, acrylic acid, crotonic acid, decyl acrylate, dibutyl itaconate, di(2- ethylhexyl) maleate, fumaric acid, itaconic acid, maleic acid, methacrylic acid, mono(2-ethylhexyl) maleate, monoethyl maleate, vinyl butyrate, vinyl hexoate, vinyl pelargonate, vinyl propionate, vinyl stearate, and vinyl sulfonic acid.Vinyl acetate polymer with ethylene and For use only in coatings for N-(hydroxymethyl) acrylamide paper and paperboard intended containing not more than 6 weight for use in contact with foods: percent of total polymer units derived 1. Of the types identified in from N-(hydroxymethyl) acrylamide. paragraph (c) of this section, table 1, under Types I, II, III, IV, VI B, and VII and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G. 2. Of the types identified in paragraph (c) of this section, table 1, under Types V, VIII, and IX and under the conditions of use described in paragraph (c) of this section, table 2, conditions of use C, D, E, F, and G.Vinyl chloride copolymers produced by copolymerizing vinyl chloride with one or more of the monomers acrylonitrile; fumaric acid and its methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, or octyl esters; maleic acid and its methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, or octyl esters; maleic anhydride; 5-norbornene-2, 3- dicarboxylic acid, mono-n-butyl ester; vinyl acetate-and vinylidene chloride. The finished copolymers shall contain at least 50 weight percent of polymer units derived from vinyl chloride: shall contain no more than 5 weight percent of total polymer units derived from fumaric and/or maleic acid and/or their methyl, ethyl, propyl, butyl, amyl, heptyl, or octyl monoesters or from maleic anhydride or from mono-n- butyl ester of 5-norbornene-2, 3- dicarboxylic acid (however, in any case the finished copolymers shall contain no more than 4 weight percent of total polymer units derived from mono-n-butyl ester of 5-norbornene-2,3- dicarboxylic acid).Vinyl chloride-vinyl acetate hydroxyl- modified copolymers.Vinyl chloride-vinyl acetate hydroxyl- modified copolymers reacted with trimellitic anhydride.Vinylidene chloride copolymers produced by copolymerizing vinylidene chloride with one or more of the monomers acrylamide acrylic acid, acrylonitrile, butyl acrylate, butyl methacrylate ethyl acrylate, ethyl methacrylate, fumaric acid, itaconic acid, methacrylic acid, methyl acrylate, methyl methacrylate, octadecyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride and vinyl sulfonic acid. The finished copolymers shall contain at least 50 weight percent of polymer units derived from vinylidene chloride; and shall contain no more than 5 weight percent of total polymer units derived from acrylamide, acrylic acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl methacrylate, and vinyl sulfonic acid.Colorants:............................. Aluminum............................. For use as a colorant only. Aluminum hydrate..................... Do. Aluminum and potassium silicate Do. (mica). Aluminum mono-, di-, and tristearate. Do. Aluminum silicate (China clay)....... Do. Barium sulfate....................... Do. Bentonite............................ Do. Bentonite, modified with Do. dimethyldioctadecylammonium ion. Burnt umber.......................... Do. Calcium carbonate.................... Do. Calcium silicate..................... Do. Calcium sulfate...................... Do. Carbon black (channel process)....... Do. Cobalt aluminate..................... Do. Diatomaceous earth................... Do. Iron oxides.......................... Do. Magnesium oxide...................... Do. Magnesium silicate (talc)............ Do. Phthalocyanine blue (C.I. pigment Do. blue 15, 15:1, 15:2, 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147-14- 8). Raw sienna........................... Do. Silica............................... Do. Tartrazine lake (certified FD&C Do. Yellow No. 5 only). Titanium dioxide..................... Do. Titanium dioxide-barium sulfate...... Do. Titanium dioxide-magnesium........... Do. silicate............................ Zinc carbonate....................... Do. Zinc oxide........................... Do.------------------------------------------------------------------------
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(c) The food-contact surface of the paper and paperboard in the finished form in which it is to contact food, when extracted with the solvent or solvents characterizing the type of food, and under conditions of time and temperature characterizing the conditions of its intended use as determined from tables 1 and 2 of this paragraph, shall yield net chloroform-soluble extractives (corrected for wax, petrolatum, mineral oil and zinc extractives as zinc oleate) not to exceed 0.5 milligram per square inch of food-contact surface as determined by the methods described in paragraph (d) of this section.
Table 1—Types of Raw and Processed Foods
I. Nonacid, aqueous products; may contain salt or sugar or both (pH above 5.0).
II. Acid, aqueous products; may contain salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat; may contain salt, and including water-in-oil emulsions of low- or high-fat content.
IV. Dairy products and modifications:
A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oil.
VI. Beverages:
A. Containing up to 8 percent of alcohol.
B. Nonalcoholic.
C. Containing more than 8 percent alcohol.
VII. Bakery products other than those included under Types VIII or IX of this table:
A. Moist bakery products with surface containing free fat or oil.
B. Moist bakery products with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil (no end test required).
IX. Dry solids with the surface containing free fat or oil.
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Table 2_Test Procedures with Time Temperature Conditions for Determining Amount of Extractives From the Food- Contact Surface of Uncoated or Coated Paper and Paperboard, Using Solvents Simulating Types of Foods and Beverages---------------------------------------------------------------------------------------------------------------- Food-simulating solvents ------------------------------------------------------------------ Water Heptane \1\ 8 percent 50 percent Condition of use Types of food ---------------------------------- alcohol alcohol (see table 1) -------------------------------- Time and Time and Time and Time and temperature temperature temperature temperature----------------------------------------------------------------------------------------------------------------A. High temperature heat- I, IV-B, VII-B. 250 °F, 2 ............... ............... .............. sterilized (e.g., over 212 hr. °F). III, IV-A, VII- ......do....... 150 °F, 2 ............... .............. A. hr.B. Boiling water sterilized. II, VII-B...... 212 °F, 30 min. III, VII-A..... ......do....... 120 °F, 30 ............... .............. min.C. Hot filled or pasteurized II, IV-B, VII-B Fill boiling, ............... ............... .............. above 150 °F. cool to 100 °F. III, IV-A, VII- ......do....... 120 °F, 15 ............... .............. A. min. V, IX.......... ............... ......do....... ............... ..............D. Hot filled or pasteurized II, IV-B, VI-B, ............... ............... ............... .............. below 150 °F. VII-B.......... 150 °F, 2 ............... ............... .............. hr. III, IV-A, VII- ......do....... 100 °F, 30 ............... .............. A. min. V, IX.......... ............... ......do....... ............... .............. VI-A........... ............... ............... 150 °F, 2 .............. hr. VI-C........... ............... ............... ............... 150 °F, 2 hr.E. Room temperature filled I, II, IV-B, VI- 120 °F, 24 ............... ............... .............. and stored (no thermal B, VII-B. hr. treatment in the container). III, IV-A, VII- ......do....... 70 °F, 30 ............... .............. A. min. V, IX.......... ............... ......do....... ............... .............. VI-A........... ............... ............... 120 °F, 24 .............. hr. VI-C........... ............... ............... ............... 120 °F, 24 hr.F. Refrigerated storage (no III, IV-A, VII- 70 °F, 48 70 °F, 30 ............... .............. thermal treatment in the A. hr. min. container). I, II, IV-B, VI- ......do....... ............... ............... .............. B, VII-B. VI-A........... ............... ............... 70 °F, 48 .............. hr. VI-C........... ............... ............... ............... 70 °F, 48 hr.G. Frozen storage (no I, II, IV-B, 70 °F, 24 ............... ............... .............. thermal treatment in the VII-B. hr. container). III, VII-A..... ......do....... 70 °F, 30 ............... .............. min.H. Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container at time of use: 1. Aqueous or oil-in-water I, II, IV-B, 212 °F, 30 ............... ............... .............. emulsion of high- or low- VII-B. min. fat. 2. Aqueous, high- or low- III, IV-A, VII- ......do....... 120 °F, 30 ............... .............. free oil or fat. A, IX. min.----------------------------------------------------------------------------------------------------------------\1\ Heptane extractability results must be divided by a factor of five in arriving at the extractability for a food product having water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required in the case of wax-polymer blend coatings for corrugated paperboard containers intended for use in bulk packaging of iced meat, iced fish, and iced poultry.
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(d) Analytical methods—(1) Selection of extractability conditions. First ascertain the type of food product (table 1, paragraph (c) of this section) that is being packed commercially in the paper or paperboard and the normal conditions of thermal treatment used in packaging the type of food involved. Using table 2, paragraph (c) of this section, select the food-simulating solvent or solvents and the time-temperature exaggerations of the paper or paperboard use conditions. Having selected the appropriate food-simulating solvent or solvents and the time-temperature exaggeration over normal use, follow the applicable extraction procedure.
(2) Reagents—(i) Water. All water used in extraction procedures should be freshly demineralized (deionized) distilled water.
(ii) n-Heptane. Reagent grade, freshly redistilled before use, using only material boiling at 208 °F.
(iii) Alcohol. 8 or 50 percent (by volume), prepared from undenatured 95 percent ethyl alcohol diluted with demineralized (deionized) distilled water.
(iv) Chloroform. Reagent grade, freshly redistilled before use, or a grade having an established consistently low blank.
(3) Selection of test method. Paper or paperboard ready for use in packaging shall be tested by use of the extraction cell described in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 21.010–21.015, under “Exposing Flexible Barrier Materials for Extraction,” 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/federal_register/code_of_federal_regulations/ibr_locations.php.); also described in ASTM method F34–76 (Reapproved 1980), “Standard Test Method for Liquid Extraction of Flexible Barrier Materials,” which is incorporated by reference (copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php.), except that formed paper and paperboard products may be tested in the container by adapting the in-container methods described in §175.300(e) of this chapter. Formed paper and paperboard products such as containers and lids, that cannot be tested satisfactorily by any of the above methods may be tested in specially designed extraction equipment, usually consisting of clamping devices that fit the closure or container so that the food-contact surface can be tested, or, if flat samples can be cut from the formed paper or paperboard products without destroying the integrity of the food-contact surface, they may be tested by adapting the following “sandwich” method:
(i) Apparatus. (a) Thermostated (±1.0 °F) water bath, variable between 70 °F and 120 °F water bath cover capable of holding at least one 800-milliliter beaker partially submersed in bath.
(b) Analytical balance sensitive to 0.1 milligram with an approximate capacity of 100 grams.
(c) Tongs.
(d) Hood and hot-plate facilities.
(e) Forced draft oven.
For each extraction, the following additional apparatus is necessary:
(f) One No. 2 paper clip.
(g) One 800-milliliter beaker with watch-glass cover.
(h) One 250-milliliter beaker.
(i) Five 21/2-inch-square aluminum screens (standard aluminum window screening is acceptable).
(j) One wire capable of supporting sample stack.
(ii) Procedure. (a) For each extraction, accurately cut eight 21/2-inch-square samples from the formed paper or paperboard product to be tested.
(b) Carefully stack the eight 21/2-inch-square samples and the five 21/2-inch-square aluminum screens in sandwich form such that the food-contact side of each sample is always next to an aluminum screen, as follows: Screen, sample, sample, screen, sample, sample, screen, etc. Clip the sandwich together carefully with a No. 2 paper clip, leaving just enough space at the top to slip a wire through.
(c) Place an 800-milliliter beaker containing 100-milliliters of the appropriate food-simulating solvent into the constant temperature bath, cover with a watch glass and condition at the desired temperature.
(d) After conditioning, carefully lower the sample sandwich with tongs into the beaker.
(e) At the end of the extraction period, using the tongs, carefully lift out the sample sandwich and hang it over the beaker with the wire.
(f) After draining, pour the food-simulating solvent solution into a tared 250-milliliter beaker. Rinse the 800-milliliter beaker three times, using a total of not more than 50 milliliters of the required solvent.
(g) Determine total nonvolatile extractives in accordance with paragraph (d)(5) of this section.
(4) Selection of samples. Quadruplicate samples should be tested, using for each replicate sample the number of cups, containers, or preformed or converted products nearest to an area of 100 square inches.
(5) Determination of amount of extractives—(i) Total residues. At the end of the exposure period, remove the test container or test cell from the oven and combine the solvent for each replicate in a clean Pyrex (or equivalent) flask or beaker being sure to rinse the test container or cell with a small quantity of clean solvent. Evaporate the food-simulating solvents to about 100 milliliters in the flask or beaker, and transfer to a clean, tared evaporating dish (platinum or Pyrex), washing the flask three times with small portions of solvent used in the extraction procedure, and evaporate to a few milliliters on a nonsparking, low-temperature hotplate. The last few milliliters should be evaporated in an oven maintained at a temperature of approximately 221 °F. Cool the evaporating dish in a desiccator for 30 minutes and weigh the residue to the nearest 0.1 milligram, (e). Calculate the extractives in milligrams per square inch of the container or sheeted paper or paperboard surface.
(a) Water and 8- and 50-percent alcohol. Milligrams extractives per square inch=(e)/(s).
(b) Heptane. Milligrams extractives per square inch=(e)/(s)(F)
where:
e=Milligrams extractives per sample tested.
s=Surface area tested, in square inches.
F=Five, the ratio of the amount of extractives removed by heptane under exaggerated time-temperature test conditions compared to the amount extracted by a fat or oil under exaggerated conditions of thermal sterilization and use.
e′=Chloroform-soluble extractives residue.
ee′=Corrected chloroform-soluble extractives residue.
e′ or ee′ is substituted for e in the above equations when necessary.
If when calculated by the equations in paragraph (d)(5)(i) (a) and (b) of this section, the extractives in milligrams per square inch exceeds the limitations prescribed in paragraph (c) of this section, proceed to paragraph (d)(5)(ii) of this section (method for determining the amount of chloroform-soluble extractives residues).
(ii) Chloroform-soluble extractives residue. Add 50 milliliters of chloroform (freshly distilled reagent grade or a grade having an established consistently low blank) to the dried and weighed residue, (e), in the evaporating dish obtained in paragraph (d)(5)(i) of this section. Warm carefully, and filter through Whatman No. 41 filter paper (or equivalent) in a Pyrex (or equivalent) funnel, collecting the filtrate in a clean, tared evaporating dish (platinum or Pyrex). Repeat the chloroform extraction, washing the filter paper with this second portion of chloroform. Add this filtrate to the original filtrate and evaporate the total down to a few milliliters on a low-temperature hotplate. The last few milliliters should be evaporated in an oven maintained at approximately 221 °F. Cool the evaporating dish in a desiccator for 30 minutes and weigh to the nearest 0.1 milligram to get the chloroform-soluble extractives residue (′). This ′ is substituted for e in the equations in paragraph (d)(5)(i) (a) and (b) of this section. If the chloroform-soluble extractives in milligrams per square inch still exceeds the limitation prescribed in paragraph (c) of this section, proceed to paragraph (d)(5)(iii) of this section (method for determining corrected chloroform-soluble extractives residue).
(iii) Corrected chloroform-soluble extractives residue—(a) Correction for zinc extractives. Ash the residue in the evaporating dish by heating gently over a Meker-type burner to destroy organic matter and hold at red heat for about 1 minute. Cool in the air for 3 minutes, and place the evaporating dish in the desiccator for 30 minutes and weigh to the nearest 0.1 milligram. Analyze this ash for zinc by standard Association of Official Agricultural Chemists methods or equivalent. Calculate the zinc in the ash as zinc oleate, and subtract from the weight of chloroform-soluble extractives residue (′) to obtain the zinc-corrected chloroform-soluble extractives residue (e′). This e′ is substituted for e in the equations in paragraph (d)(5)(i) (a) and (b) of this section.
(b) Correction for wax, petrolatum, and mineral oil—(1) Apparatus. Standard 10 millimeter inside diameter × 60 centimeter chromatographic column (or standard 50-milliliter buret with an inside diameter of 10–11 millimeters) with a stopcock of glass, perfluorocarbon resin, or equivalent material. The column (or buret) may be optionally equipped with an integral coarse, fritted glass disc and the top of the column (or buret) may be optionally fitted with a 100-millimeter solvent reservoir.
(2) Preparation of column. Place a snug pledget of fine glass wool in the bottom of the column (or buret) if the column (or buret) is not equipped with integral coarse, fritted glass disc. Overlay the glass wool pledget (or fritted glass disc) with a 15–20 millimeter deep layer of fine sand. Measure in a graduated cylinder 15 milliliters of chromatographic grade aluminum oxide (80–200 mesh) that has been tightly settled by tapping the cylinder. Transfer the aluminum oxide to the chromatographic tube, tapping the tube during and after the transfer so as to tightly settle the aluminum oxide. Overlay the layer of aluminum oxide with a 1.0–1.5 centimeter deep layer of anhydrous sodium sulfate and on top of this place an 8–10 millimeter thick plug of fine glass wool. Next carefully add about 25 milliliters of heptane to the column with stopcock open, and allow the heptane to pass through the column until the top level of the liquid just passes into the top glass wool plug in the column, and close stopcock.
(3) Chromatographing of sample extract—(i) For chloroform residues weighing 0.5 gram or less. To the dried and weighed chloroform-soluble extract residue in the evaporating dish, obtained in paragraph (d)(5)(ii) of this section, add 20 milliliters of heptane and stir. If necessary, heat carefully to dissolve the residue. Additional heptane not to exceed a total volume of 50 milliliters may be used if necessary to complete dissolving. Cool to room temperature. (If solution becomes cloudy, use the procedure in paragraph (d)(5)(iii)(b)(3)(ii) of this section to obtain an aliquot of heptane solution calculated to contain 0.1–0.5 gram of chloroform-soluble extract residue.) Transfer the clear liquid solution to the column (or buret). Rinse the dish with 10 millimeters of additional heptane and add to column. Allow the liquid to pass through the column into a clean, tared evaporating dish (platinum or Pyrex) at a dropwise rate of about 2 milliliters per minute until the liquid surface reaches the top glass wool plug; then close the stopcock temporarily. Rinse the Pyrex flask which contained the filtrate with an additional 10–15 milliliters of heptane and add to the column. Wash (elute) the column with more heptane collecting about 100 milliliters of total eluate including that already collected in the evaporating dish. Evaporate the combined eluate in the evaporating dish to dryness on a steam bath. Dry the residue for 15 minutes in an oven maintained at a temperature of approximately 221 °F. Cool the evaporating dish in a desiccator for 30 minutes and weigh the residue to the nearest 0.1 milligram. Subtract the weight of the residue from the weight of chloroform-soluble extractives residue (′) to obtain the wax-, petrolatum-, and mineral oil-corrected chloroform-soluble extractives residue (e′). This e′ is substituted for e in the equations in paragraph (d)(5)(i) (a) and (b) of this section.
(ii) For chloroform residues weighing more than 0.5 gram. Redissolve the dried and weighed chloroform-soluble extract residue as described in paragraph (d)(5)(iii)(b)(3)(i) of this section using proportionately larger quantities of heptane. Transfer the heptane solution to an appropriate-sized volumetric flask (i.e., a 250-milliliter flask for about 2.5 grams of residue) and adjust to volume with additional heptane. Pipette out an aliquot (about 50 milliliters) calculated to contain 0.1–0.5 gram of the chloroform-soluble extract residue and analyze chromatographically as described in paragraph (d)(5)(iii)(b)(3)(i) of this section. In this case the weight of the dried residue from the heptane eluate must be multiplied by the dilution factor to obtain the weight of wax, petrolatum, and mineral oil residue to be subtracted from the weight of chloroform-soluble extractives residue (′) to obtain the wax-, petrolatum-, and mineral oil-corrected chloroform-soluble extractives residue (e′). This e′ is substituted for e in the equations in paragraph (d)(5)(i) (a) and (b) of this section. (Note: In the case of chloroform-soluble extracts which contain high melting waxes (melting point greater than 170 °F), it may be necessary to dilute the heptane solution further so that a 50-milliliter aliquot will contain only 0.1–0.2 gram of the chloroform-soluble extract residue.)
(e) Acrylonitrile copolymers identified in this section shall comply with the provisions of §180.22 of this chapter, except where the copolymers are restricted to use in contact with food only of the type identified in paragraph (c), table 1 under Category VIII.
[42 FR 14554, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting §176.170, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 176.180 Components of paper and paperboard in contact with dry food.
The substances listed in this section may be safely used as components of the uncoated or coated food-contact surface of paper and paperboard intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding dry food of the type identified in §176.170(c), table 1, under Type VIII, subject to the provisions of this section.
(a) The substances are used in amounts not to exceed that required to accomplish their intended physical or technical effect, and are so used as to accomplish no effect in food other than that ordinarily accomplished by packaging.
(b) The substances permitted to be used include the following:
(1) Substances that by §176.170 and other applicable regulations in parts 170 through 189 of this chapter may be safely used as components of the uncoated or coated food-contact surface of paper and paperboard, subject to the provisions of such regulation.
(2) Substances identified in the following list:
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------------------------------------------------------------------------ List of substances Limitations------------------------------------------------------------------------Acrylamide polymer with sodium 2- For use at a level not to acrylamido-2-methylpropane-sulfonate exceed 0.015 weight percent of (CAS Reg. No. 38193-60-1). dry fiber.(2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived from olefins which contain not less than 78 percent C30 and higher groups (CAS Reg. No. 70983-55-0)..4-[2-[2-(2-Alkoxy(C12-C15) ethoxy) For use as a polymerization ethoxy]ethyl]disodium sulfosuccinate. emulsifier and latex emulsion stabilizer at levels not to exceed 5 percent by weight of total emulsion solids.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)..Aluminum and calcium salts of FD & Colorant. C dyes on a substrate of alumina.Ammonium nitrate.......................Amylose................................Barium metaborate...................... For use as preservative in coatings and sizings.1,2-Benzisothiazolin-3-one (CAS For use only as a preservative Registry No. 2634-33-5). in paper coating compositions and limited to use at a level not to exceed 0.02 mg/in\2\ (0.0031 mg/cm\2\) of finished paper and paperboard.N,N[prime]-Bis(hydroxyethyl)lauramide..Bis(trichloromethyl) sulfone C.A. For use only as a preservative Registry No. 3064-70-8. in coatings.Borax.................................. For use as preservative in coatings.Boric acid............................. Do.Butanedioic acid, sulfo-1,4-di-(C9-C11 For use as a surface active alkyl) ester, ammonium salt (also agent in package coating inks known as butanedioic acid, sulfo-1,4- at levels not to exceed 3 diisodecyl ester, ammonium salt [CAS percent by weight of the Reg. No. 144093-88-9]).. coating ink.sec-Butyl alcohol......................Butyl benzyl phthalate.................Candelilla wax.........................Carbon tetrachloride...................Castor oil, polyoxyethylated (42 moles ethylene oxide)..Cationic soy protein hydrolyzed For use only as a coating (hydrolyzed soy protein isolate adhesive, pigment structuring modified by treatment with 3-chloro-2- agent, and fiber retention hydroxypropyl-trimethylammonium aid. chloride).Cationic soy protein (soy protein For use only as a coating isolate modified by treatment with 3- adhesive, pigment structuring chloro-2-hydroxypropyltrimethyl- agent, and fiber retention ammonium chloride). aid.Chloral hydrate........................ Polymerization reaction-control agent.N-Cyclohexyl-p-toluene sulfonamide.....2,5-Di-tert-butyl hydroquinone.........Diethanolamine.........................Diethylene glycol dibenzoate (CAS Reg. For use only as a plasticizer No. 120-55-8). in polymeric substances.Diethylene glycol monobutyl ether......Diethylene glycol monoethyl ether......Diethylenetriamine.....................N,N-Diisopropanolamide of tallow fatty acids..N-[(dimethylamino)methyl]acrylamide polymer with acrylamide and styrene..N,N-Dioleoylethylenediamine, N,N- dilinoeoyl-ethylenediamine, and N- oleoyl-N-linoleoyl-ethylenediamine mixture produced when tall oil fatty acids are made to react with ethylenediamine such that the finished mixture has a melting point of 212°-228 °F, as determined by ASTM method D127-60, and an acid value of 10 maximum. ASTM Method D127-60 ``Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax'' (Revised 1960) is incorporated by reference. Copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, 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/federal_register/ code_of_federal_regulations/ ibr_locations.php..Diphenylamine..........................Dipropylene glycol dibenzoate (CAS Reg. For use only as plasticizer in No. 27138-31-4). polymeric substances.Disodium N-octadecylsulfosuccinamate...tert-Dodecyl thioether of polyethylene glycol..Erucamide (erucylamide)................Ethanedial, polymer with tetrahydro-4- hydroxy-5-methyl-2(1H)pyrimidinone, propoxylated..Ethylene oxide......................... Fumigant in sizing.Ethylene oxide adduct of mono-(2- ethylhexyl) o-phosphate..Fatty acid (C12-C18) diethanolamide....Fish oil fatty acids, hydrogenated, potassium salt..Formaldehyde...........................Glyceryl monocaprate...................Glyceryl tribenzoate (CAS Reg. No. 614- For use only as a plasticizer 33-5). in polymeric coatings.Glyoxal................................Glyoxal-urea-formaldehyde condensate For use as an insolubilizer for (CAS Reg. No. 27013-01-0) formed by starch in coatings. reaction in the molar ratio of approximately 47:33:15, respectively. The reaction product has a number average molecular weight of 278±14 as determined by a suitable method.Glyoxal-urea polymer (CAS Reg. No. For use as an insolubilizer for 53037-34-6). starch.Hexamethylenetetramine................. Polymerization crosslinking agent for protein, including casein. As neutralizing agent with myristochromic chloride complex and stearato-chromic chloride complex.Hexylene glycol (2-methyl-2,4- pentanediol)..Hydroabietyl alcohol...................5-Hydroxymethoxymethyl-1-aza-3,7- For use only as an dioxabicyclo[3.3.0] octane, 5- antibacterial preservative. hydroxymethyl-1-aza-3,7- dioxabicyclo[3.3.0]octane, and 5- hydroxypoly-[methyleneoxy]methyl-1-aza- 3,7-dioxabicyclo[3.3.0] octane mixture.Imidazolium compounds, 2-(C17 and C17- For use only at levels not to unsaturated alkyl)-1-[2-(C18 and C18- exceed 0.5 percent by weight unsaturated amido)ethyl]-4,5-dihydro-1- of the dry paper and methyl, methyl sulfates (CAS Reg. No. paperboard. 72749-55-4)..Isopropanolamine hydrochloride.........Isopropyl m- and p-cresol (thymol derived)..Itaconic acid..........................Maleic anhydride-diisobutylene copolymer, ammonium or sodium salt..Melamine-formaldehyde modified with: Basic polymer. Alcohols (ethyl, butyl, isobutyl, propyl, or isopropyl). Diethylenetriamine. Imino-bis-butylamine. Imino-bis-ethyleneimine. Imino-bis-propylamine. Polyamines made by reacting ethylenediamine or trimethylenediamine with dichloroethane or dichloropropane. Sulfanilic acid. Tetraethylenepentamine. Triethylenetetramine.Methyl alcohol.........................Methyl ethers of mono-, di-, and tripropylene glycol..Methyl napthalene sulfonic acid- formaldehyde condensate, sodium salt..Methylated poly(N-1,2-dihydroxyethylene- For use only only as an in 1,3-imidazolidin-2-one). solubilizer for starch.Modified polyacrylamide resulting from For use only as a dry strength an epichlorohydrin addition to a and pigment retention aid condensate of formaldehyde- agent employed prior to the dicyandiamide-diethylene triamine and sheetforming operation in the which product is then reacted with manufacture of paper and polyacrylamide and urea to produce a paperboard and used at a level resin having a nitrogen content of 5.6 not to exceed 1 percent by to 6.3 percent and having a minimum weight of dry fibers. viscosity in 56 percent-by-weight aqueous solution of 200 centipoises at 25 °C, as determined by LVT-series Brookfield viscometer using a No. 4 spindle at 60 r.p.m. (or equivalent method).Mono- and di(2-alkenyl)succinyl esters For use only as an emulsifier. of polyethylene glycol containing not less than 90 percent of the diester product and in which the alkenyl groups are derived from olefins that contain not less than 95 percent of C15-C21 groups.Monoglyceride citrate..................Myristo chromic chloride complex.......Napthalene sulfonic acid-formaldehyde condensate, sodium salt..Nickel.................................β-Nitrostyrene.................... Basic polymer.Octadecanoic acid, reaction products For use prior to sheet forming with 2-[(2-aminoethyl)amino]ethanol at levels not to exceed 12 and urea (CAS Reg. No. 68412-14-6), pounds per ton of paper. and the acetate salts thereof (CAS Reg. No. 68784-21-4), which may be emulsified with ethoxylated tallow alkyl amines (CAS Reg. No. 61791-26-2).α-cis-9-Octadecenyl-omega- hydroxypoly (oxyethylene); the octadecenyl group is derived from oleyl alcohol and the poly(oxyethylene) content averages not less than 20 moles..α-(p-Nonylphenyl)-omega- hydroxypoly (oxyethylene) sulfate, ammonium salt; the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content averages 9 or 30 moles..Oleic acid reacted with N-alkyl-(C16- C18) trimethylenediamine..Oxidized soy isolate having 50 to 70 For use as a binder adhesive percent of its cystine residues component of coatings. oxidized to cysteic acid.Petroleum alicyclic hydrocarbon resins, For use as modifiers at levels or the hydrogenated product thereof, up to 30 weight-percent of the complying with the identity prescribed solids content of wax-polymer in § 176.170(b)(2). blend coatings.Petroleum hydrocarbon resins (produced by the catalytic polymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked petroleum stocks)..Petroleum hydrocarbons, light and odorless..o-Phthalic acid modified hydrolyzed soy protein isolate..Pine oil...............................Poly(2-aminoethyl acrylate nitrate-co-2- hydroxypropyl acrylate) complying with the identity described in § 176.170(a)..Polyamide-epichloro hydrin modified resins resulting from the reaction of the initial caprolactam-itaconic acid product with diethylenetriamine and then condensing this prepolymer with epichlorohydrin to form a cationic resin having a nitrogen content of 11- 15 percent and chlorine level of 20-23 percent on a dry basis..Polyamide-ethyleneimine-epichlorohydrin resin is prepared by reacting equimolar amounts of adipic acid and three amines (21 mole percent of 1,2- ethanediamine, 51 mole percent of N-(2- aminoethyl)-1,3-propanediamine, and 28 mole percent of N, N[prime]-1,2- ethanediylbis(1,3-propanediamine)) to form a basic polyamidoamine which is modified by reaction with ethyleneimine (5.5:1.0 ethyleneimine:polyamidoamine). The modified polyamidoamine is reacted with a crosslinking agent made by condensing approximately 34 ethylene glycol units with (chloromethyl)oxirane, followed by pH adjustment with formic acid or sulfuric acid to provide a finished product as a formate (CAS Reg. No. 114133-44-7) or a sulfate (CAS Reg. No. 167678-43-5), having a weight- average molecular weight of 1,300,000 and a number-average molecular weight of 16,000..Polyamide-ethyleneimine-epichlorohydrin resin (CAS Reg. No. 115340-77-7), prepared by reacting equimolar amounts of adipic acid and N-(2-aminoethyl)- 1,2-ethanediamine to form a basic polyamidoamine which is modified by reaction with ethyleneimine, and further reacted with formic acid and (chloromethyl)oxirane-α-hydro- omega-hydroxypoly(oxy-1,2-ethanediyl)..Polybutene, hydrogenated; complying with the identity prescribed under § 178.3740(b) of this chapter..Poly [2-(diethylamino) ethyl methacrylate] phosphate..Polyethylene glycol (200) dilaurate....Polyethylene glycol monoisotridecyl For use only as a surfactant at ether sulfate, sodium salt (CAS Reg. levels not to exceed 3 percent No. 150413-26-6). in latex formulations used in pigment binders for paper and paperboard.Polymers: Homopolymers and copolymers Basic polymer. of the following monomers: Acrylamide. Acrylic acid and its methyl, ethyl, butyl, propyl, or octyl esters. Acrylonitrile. Butadiene. Crotonic acid. Cyclol acrylate. Decyl acrylate. Diallyl fumarate. Diallyl maleate. Diallyl phthalate. Dibutyl fumarate. Dibutyl itaconate. Dibutyl maleate. Di(2-ethylhexyl) maleate. Dioctyl fumarate. Dioctyl maleate. Divinylbenzene. Ethylene. 2-Ethylhexyl acrylate. Fumaric acid. Glycidyl methacrylate. 2-Hydroxyethyl acrylate. N-(Hydroxymethyl) acrylamide. Isobutyl acrylate. Isobutylene. Isoprene. Itaconic acid. Maleic anhydride and its methyl or butyl esters. Methacrylic acid and its methyl, ethyl, butyl, or propyl esters. Methylstyrene. Mono(2-ethylhexyl) maleate. Monoethyl maleate. 5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester. Styrene. Vinyl acetate. Vinyl butyrate. Vinyl chloride. Vinyl crotonate. Vinyl hexoate. Vinylidene chloride. Vinyl pelargonate. Vinyl propionate. Vinyl pyrrolidone. Vinyl stearate. Vinyl sulfonic acid.Polymer prepared from urea, ethanedial, For use only as a starch and formaldehyde, and propionaldehyde (CAS protein reactant in paper and Reg. No. 106569-82-8). paperboard coatings.Polyoxyethylene (minimum 12 moles) ester of tall oil (30%-40% rosin acids)..Polyoxypropylene-polyoxyethylene glycol (minimum molecular weight 1,900)..Polyvinyl alcohol......................Potassium titanate fibers produced by calcining titanium dioxide, potassium chloride, and potassium carbonate, such that the finished crystalline fibers have a nominal diameter of 0.20- 0.25 micron, a length-to-diameter ratio of approximately 25:1 or greater, and consist principally of K2Ti4O9 and K2Ti 6O13..Sodium diisobutylphenoxy diethoxyethyl sulfonate..Sodium diisobutylphenoxy monoethoxy ethylsulfonate..Sodium n-dodecylpolyethoxy (50 moles) sulfate..Sodium isododecylphenoxypolyethoxy (40 moles) sulfate..Sodium N-methyl-N-oleyl taurate........Sodium methyl siliconate...............Sodium nitrite.........................Sodium polyacrylate....................Sodium bis-tridecylsulfosuccinate......Sodium xylene sulfonate................Stearato chromic chloride complex......Styrene-allyl alcohol copolymers.......Styrene-methacrylic acid copolymer, potassium salt..Tetraethylenepentamine................. Polymerization cross-linking agent.α-[p-(1,1,3,3- Tetramethylbutyl)phenyl]-omega hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and their sodium, potassium, and ammonium salts having a poly(oxyethylene) content averaging 6- 9 or 40 moles..α-[p-(1,1,3,3- Tetramethylbutyl)phenyl or p- nonylphenyl]-omega-hydroxypoly (oxyethylene) where nonyl group is a propylene trimer isomer..Tetrasodium N-(1,2-dicarboxyethyl)-N- octadecyl sulfosuccinamate..Toluene................................Triethanolamine........................Triethylenetetramine................... Polymerization cross-linking agent.Triethylenetetramine monoacetate, partially stearoylated..Urea-formaldehyde chemically modified with: Alcohol (methyl, ethyl, butyl, isobutyl, propyl, or isopropyl). Aminomethylsulfonic acid. Diaminobutane. Diaminopropane. Diethylenetriamine. N,N[prime]-Dioleoylethylenediamine. Diphenylamine. N,N[prime]-Distearoylethylenediamine. Ethylenediamine. Guanidine. Imino-bis-butylamine. Imino-bis-ethylamine. Imino-bis-propylamine. N-Oleoyl-N[prime]- stearoylethylenediamine. Polyamines made by reacting ethylenediamine or triethylenediamine with dichloroethane or dichloropropane. Tetraethylenepentamine. Triethylenetetramine.Xylene.................................Xylene sulfonic acid-formaldehyde condensate, sodium salt..Zinc stearate..........................------------------------------------------------------------------------
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[42 FR 14554, Mar. 15, 1977]
Editorial Note: For additional Federal Register citations affecting §176.180, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
§ 176.200 Defoaming agents used in coatings.
The defoaming agents described in this section may be safely used as 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 defoaming agents are prepared as mixtures of substances described in paragraph (d) of this section.
(b) The quantity of any substance employed in the formulation of defoaming agents does not exceed the amount reasonably required to accomplish the intended physical or technical effect in the defoaming agents or any limitation further provided.
(c) Any substance employed in the production of defoaming agents 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) Substances employed in the formulation of defoaming agents include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in defoaming agents 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:
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------------------------------------------------------------------------ List of substances Limitations------------------------------------------------------------------------n-Butyl alcohol........................tert-Butyl alcohol.....................Butyl stearate.........................Castor oil, sulfated, ammonium, potassium, or sodium salt.Cetyl alcohol..........................Cyclohexane............................Cyclohexanol...........................Diethylene glycol monolaurate..........Diethylene glycol monostearate.........Dimers and trimers of unsaturated C18 For use only at levels not to fatty acids derived from: exceed 0.1% by weight of total coating solids. Animal and vegetable fats and oils. Tall oil.Dimethylpolysiloxane...................α-(Dinonylphenyl)-v-hydroxy- For use only in defoaming poly(oxy-1,2-ethanediyl), containing 7 agents for the production of to 24 moles of ethylene oxide per mole styrene-butadiene coatings at of dinonylphenol (CAS Reg. No. 9014-93- a level not to exceed 0.05 1). percent by weight of the finished coating.Dipropylene glycol.....................Ethyl alcohol..........................Fats and oils derived from animal, marine, or vegetable sources: Fatty acids derived from animal, marine, or vegetable fats and oils, and salts of such acids, single or mixed, as follows: Aluminum....................... Ammonium....................... Calcium........................ Magnesium...................... Potassium...................... Sodium......................... Zinc...........................Formaldehyde........................... For use as preservative of defoamer only.Glyceryl mono-12-hydroxystearate.......Glyceryl monostearate..................Hexane.................................Hexylene glycol (2-methyl-2,4- pentanediol).Isobutyl alcohol.......................Isopropyl alcohol......................Kerosene...............................Lecithin hydroxylated..................Methyl alcohol.........................Methylcellulose........................Methyl esters of fatty acids derived from animal, marine, or vegetable fats and oils.Methyl oleate..........................Methyl palmitate.......................Mineral oil............................Mustardseed oil, sulfated, ammonium, potassium, or sodium salt.Myristyl alcohol.......................Naphtha................................β-Naphthol........................ For use as preservative of defoamer only.Nonylphenol............................Odorless light petroleum hydrocarbons.. As defined in § 178.3650 of this chapter.Oleic acid, sulfated, ammonium, potassium, or sodium salt.Parachlorometacresol................... For use as preservative of defoamer only.Peanut oil, sulfated, ammonium, potassium, or sodium salt.Petrolatum.............................Pine oil...............................Polyacrylic acid, sodium salt.......... As a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane.Polyethylene...........................Polyethylene, oxidized.................Polyethylene glycol (200) dilaurate....Polyethylene glycol (400) dioleate.....Polyethylene glycol (600) dioleate.....Polyethylene glycol (400) esters of coconut oil fatty acids.Polyethylene glycol (400) monooleate...Polyethylene glycol (600) monooleate...Polyethylene glycol (600) monoricinoleate.Polyethylene glycol (400) monostearate.Polyoxybutylene-polyoxypropylene- polyoxyethylene glycol (min. mol. wt. 3,700).Polyoxyethylated (min. 3 mols) cetyl alcohol.Polyoxyethylated (min. 5 mols) oleyl alcohol.Polyoxyethylated (min. 1.5 mols) tridecyl alcohol.Polyoxyethylene (min. 15 mols) ester of rosin.Polyoxyethylene (min. 8 mols) monooleate.Polyoxyethylene (40) stearate..........Polyoxypropylated (min. 20 mols) butyl alcohol.Polyoxypropylene glycol (min. mol. wt. 200).Polyoxypropylene (min. 20 mols) oleate butyl ether.Polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 1,900).Polyoxypropylene (min. 40 mols) stearate butyl ether.Potassium pentachlorophenate........... For use as preservative of defoamer only.Potassium trichlorophenate............. Do.Propylene glycol monoester of soybean oil fatty acids.Propylene glycol monoester of tallow fatty acids.Ricebran oil, sulfated, ammonium, potassium, or sodium salt.Rosins and rosin derivatives........... As provided in § 178.3870 of this chapter.Silica.................................Sodium 2-mercaptobenzothiazole......... For use as preservative of defoamer only.Sodium pentachlorophenate.............. Do.Sodium trichlorophenate................ Do.Sperm oil, sulfated, ammonium, potassium, or sodium salt.Stearyl alcohol........................Tall oil fatty acids...................Tallow fatty acids, hydrogenated or sulfated.Tallow, sulfated, ammonium, potassium, or sodium salt.Triethanolamine........................Triisopropanolamine....................Waxes, petroleum.......................------------------------------------------------------------------------
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(e) The defoaming agents are used as follows:
(1) The quantity of defoaming agent or agents used shall not exceed the 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 200–2,000 (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.
Cyclohexanol.
Diacetyltartaric acid ester of tallow mono-glyceride.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7), for use as a preservative at a level not to exceed 0.05 weight-percent of the defoaming agent.
Diethanolamine.
Diethylene triamine.
Di-(2-ethylhexyl) phthalate.
2,6-Dimethyl heptanol-4 (nonyl alcohol).
Dimethylpolysiloxane.
Di-tert-butyl hydroquinone.
Dodecylbenzene sulfonic acids.
Ethanol.
2-Ethylhexanol.
Ethylenediamine tetraacetic acid tetrasodium salt.
Formaldehyde.
Heavy oxo-fraction (a still-bottom product of iso-octyl alcohol manufacture, of approximate composition: Octyl alcohol 5 percent nonyl alcohol 10 percent, decyl and higher alcohols 35 percent, esters 45 percent, and soaps 5 percent).
2-Heptadecenyl-4-methyl-4-hydroxymethyl-2-oxazoline.
Hexylene glycol (2-methyl-2-4-pentanediol).
12-Hydroxystearic acid.
Isobutanol.
Isopropanol.
Isopropylamine salt of dodecylbenzene sulfonic acid.
Kerosine.
Lanolin.
Methanol.
Methyl 12-hydroxystearate.
Methyl taurine-oleic acid condensate, molecular weight 486.
a,a′-[Methylenebis[4-(1,1,3,3-tetramethylbu-tyl)-o-phenylene]]bis[omega-hydroxypoly (oxyethylene)] having 6–7.5 moles of ethylene oxide per hydroxyl group.
Mineral oil.
Mono-, di-, and triisopropanolamine.
Mono- and diisopropanolamine stearate.
Monobutyl ether of ethylene glycol.
Monoethanolamine.
Morpholine.
Myristyl alcohol.
Naphtha.
β-Naphthol.
Nonylphenol.
Odorless light petroleum hydrocarbons.
Oleyl alcohol.
Petrolatum.
o-Phenylphenol.
Pine oil.
Polybutene, hydrogenated; complying with the identity prescribed under §178.3740(b) of this chapter.
Polyethylene.
Polyethylene, oxidized (air-blown).
Polymer derived from N-vinyl pyrrolidone and copolymers derived from the mixed alkyl (C12-C15, C16, C18, C20, and C22) methacrylate esters, butyl methacrylate (CAS Reg. No. 97–88–1), isobutyl methacrylate (CAS Reg. No. 97–86–9) and methyl methacrylate (CAS Reg. No. 80–62–6); the combined polymer contains no more than 5 weight percent of polymer units derived from N-vinyl pyrrolidone and is present at a level not to exceed 7 parts per million by weight of the finished dry paper and paperboard fibers.
Polyoxyethylene (4 mols) decyl phosphate.
Polyoxyethylene (4 mols) di(2-ethyl hexanoate).
Polyoxyethylene (15 mols) ester of rosin.
Polyoxyethylene (3–15 mols) tridecyl alcohol.
Polyoxypropylene, molecular weight 200–2,000.
Polyoxypropylene-polyoxethylene condensate, 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 sulfonate, molecular weight 440–450.
Sodium trichlorophenate.
Stearyl alcohol.
α-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, p-nonylphenyl-, or p-dodecylphenyl]-omega-hydroxypoly(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-1,3,5,2H-tetrahydrothiadiazine-2-thione.
3,5-Dimethyl-1,3,5,2H-tetrahydrothi-adiazine-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-hydrox-yhexadecane 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. § 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:
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------------------------------------------------------------------------ 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................------------------------------------------------------------------------
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(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] § 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 intended 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.
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