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[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of January 1, 2007] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR176.170] [Page 198-224] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 176 INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS--Table Subpart B Substances for Use Only as Components of Paper and Paperboard Sec. 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 Sec. 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: ------------------------------------------------------------------------ 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 [deg]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-[beta]- 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 [beta]- 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). [[Page 199]] 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 [deg]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 [deg]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. [[Page 200]] 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 [deg]C (75 [deg]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 [deg]C (428 [deg]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 [deg]C (185 [deg]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 [deg]C (158 [deg]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.html.. 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 Sec. Sec. 172.620 and 172.626 of this chapter. [[Page 201]] 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 [deg]C (72 [deg]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 [deg]C (71.6 [deg]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 [deg]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. [[Page 202]] 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 [deg]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 [deg]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-perfluo roalkyl) 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 [deg]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 [deg]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'-Dioleoylethylenediamine........... [[Page 203]] 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'-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 Sec. Sec. 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 [beta]-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 [deg]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', N', N'', N''-Hexakis For use only as a water- (methoxymethyl).1,3,5-triazine-2,4,6- repellent applied to the triamine polymer with stearyl alcohol, surface of paper and [alpha]-octadecenyl-omega- paperboard at levels not to hydroxypoly(oxy.1,2-ethanediyl), and exceed 1 percent by weight of alkyl (C20+) alcohols (CAS Reg. No. the finished dry paperboard 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. [[Page 204]] 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 [deg]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 [deg]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'-stearoylethylenediamine.... Oxystearin............................. Paraformaldehyde....................... For use only as setting agent for protein. [[Page 205]] 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[ to exceed 0.44 percent ([gamma],[omega]-perfluoroC4-20 perfluoroalkyl actives by alkylthio) methyl].1,3-propanediol, weight of the finished paper polyphosphoric acid and ammonium and paperboard in contact with hydroxide. 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 Sec. 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[deg] C to 93[deg] 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[deg] 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.html.); and maximum weight loss not to exceed 3% when distilled to 371[deg] C, nor to exceed an additional 1.1% when further distilled between 371[deg] C and thermal decomposition. Petroleum wax, synthetic............... Complying with Sec. 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-[beta]-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 [deg]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. [[Page 206]] 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 [deg]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 [deg]C, as determined by Brookfield viscom eter 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 [deg]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 [deg]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 prepoly mer and further additive employed prior to the reaction of this prepolymer with sheet-forming operation in the N,N,N',N'-tetramethylethylenediamine manufacture of paper and such that the finished resin having a paperboard, and used at a nitrogen content of 11.6 to 14.8 level not to exceed 0.12 percent and a chlorine content of 20.8 percent by weight of dry paper to 26.4 percent and a minimum and paperboard fibers. viscosity, in 25 percent by weight aqueous solution, of 500 centipoises at 25 [deg]C, as determined by LV- series Brookfield viscometer using a No. 2 spindle at 12 r.p.m. (or by other equivalent method). [[Page 207]] 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 [deg]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 [deg]C (68 [deg]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 [deg]C (68 [deg]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- di chloroethane 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 [deg]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 [deg]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 dichlor paperboard, and used at a oethyl 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 [deg]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 Sec. Sec. 175.300, 178.3740 Sec. 178.3740(b) of this chapter. and 178.3860 of this chapter. [[Page 208]] 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 8.660.4 percent on a dry weight basis level not to exceed 10 pounds and a minimum viscosity in a 40 of active polymer per ton of percent by weight aqueous solution of finished paper and paperboard. 1,000 centipoises at 25 [deg]C (77 2. As a pigment dispersant in [deg]F), determined by LVF Model coatings at a level not to Brookfield Viscometer using a No. 3 exceed 3.5 pounds of active spindle at 30 r.p.m. (or equivalent polymer per ton of finished method). The level of residual monomer paper and paperboard. is not to exceed 1 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 8.660.4 percent on a dry basis and a (10 parts per million) of minimum viscosity in a 15 weight- influent water. percent aqueous solution of 10 centipoises at 25 [deg]C (77 [deg]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 [deg]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 [deg]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 Sec. 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 [deg]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 [deg]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 [deg]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. [[Page 209]] Poly[(methylimino)(2- For use only as a retention aid hydroxytrimethylene)hydrochlo ride] 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[deg] 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.html.. 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[deg] 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.html.). 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 deciliter Polypropylene 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 Sec. 178.3870 of this chapter. Siloxanes (silicones), dimethyl, For use only as a component of isopropyl methyl, methyl 1-methyl-C9- polyolefin coatings with Sec. 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 [deg]F (94 [deg]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 [deg]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. [[Page 210]] 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 [deg]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 po lymerization 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 Sec. 178.3710 or Sec. 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', N'-Tetramethylethylenediamine For use only as a flocculent, polymer with bis-(2-chloroethyl) drainage aid or retention aid ether, first reacted with not more employed prior to the sheet than 5 percent by weight 1-chloro-2,3- forming operation in the epoxypropane and then reacted with not manufacture of paper and more than 5 percent by weight poly paperboard and limited to use (acrylic acid) such that a 50 percent at a level not to exceed 0.2 by weight aqueous solution of the percent by weight of the product has a nitrogen content of 4.7- finished dry paper and 4.9 percent and viscosity of 350-700 paperboard fibers. centipoises at 25 [deg]C as determined by LV series Brookfield viscometer using a No. 2 spindle at 60 r.p.m. (or by other equivalent method). [[Page 211]] Tetrasodium N- (1,2-dicarboxyethyl) - N For use only as an emulsifier - octadecylsulfo-succinamate. in aqueous dispersions of rosin sizes complying with Sec. 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' iminodiethanol exceed 0.087 lb (0.046 lb of (1:1); hydrogen phosphate, compound fluorine) per 1,000 ft\2\ of with 2,2'-iminodiethanol (1:1); and treated paper or paperboard, P,P'-dihydrogen pyrophosphate, as determined by analysis for compound with 2,2'-iminodiethanol total fluorine in the treated (1:2); where the ester mixture has a paper or paperboard without fluorine content of 48.3 pct to 53.1 correction for any fluorine pct as determined on a solids basis. which might be present in the 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 Sec. 178.3710 of this chapter. Xanthan gum, conforming to the identity For use only at a maximum level and specifications prescribed in Sec. of 0.125 percent by weight of 172.695 of this chapter, except that finished paper as a suspension the residual isopropyl alcohol shall aid or stabilizer for aqueous not exceed 6,000 parts per million. pigment slurries employed in 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. ------------------------------------------------------------------------ (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 Sec. 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: ------------------------------------------------------------------------ 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 Sec. 177.1010 of this chapter. [[Page 212]] 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'-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 Sec. 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. [[Page 213]] 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 [deg]C to 155 [deg]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.html.), 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.html.. 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 Sec. 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'-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. [[Page 214]] 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.html.. 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. [alpha]-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1[alpha]- 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.......... [[Page 215]] 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 [deg]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 [deg]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.html.). Specific gravity 0.96-0.99 (20 [deg]C/ 20 [deg]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 [deg]C and that meet the ultraviolet absorbance limits prescribed in Sec. 172.880(b) of this chapter when subjected to the analytical procedure described in Sec. 172.886(b) of this chapter, modified as follows: Treat the product as in the first paragraph under ``Procedure'' in Sec. 172.250(b)(3) of this chapter. Then proceed with Sec. 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 [deg]C-92 [deg]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 Sec. 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 [deg]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. [[Page 216]] 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 [beta]-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