Indirect food additives: paper and paperboard components (21 CFR 176.110-176.350)

201 Food and Drug Administration, HHS § 176.110 extractives limitations when tested by the methods provided in § 175.300(e): (1) The coating when extracted with distilled water at 180 °F for 24 hours yields total extractives not to exceed 0.05 milligram per square inch of food contact surface. (2) The coating when extracted with 50 percent (by volume) ethyl alcohol in distilled water at 180 °F for 24 hours yields total extractives not to exceed 0.05 milligram per square inch. § 175.390 Zinc-silicon dioxide matrix coatings. Zinc-silicon dioxide matrix coatings may be safely used as the food-contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, pack aging, transporting, or holding food, subject to the provisions of this sec tion; (a) The coating is applied to a metal surface, cured, and washed with water to remove soluble substances. (b) The coatings are formulated from optional substances which include: (1) Substances generally recognized as safe. (2) Substances for which safe condi tions of use have been prescribed in § 175.300. (3) Substances identified in para graph (c) of this section, subject to the limitations prescribed. (c) The optional substances per mitted are as follows: List of substances Limitations Ethylene glycol ...................... As a solvent removed by water washing. Iron oxide. Lithium hydroxide .................. Removed by water washing. Methyl orange ........................ As an acid-base indicator. Potassium dichromate ........... Removed by water washing. Silica gel. Sodium silicate. Zinc, as particulate metal. (d) The coating in the finished form in which it is to contact food, when ex tracted with the solvent or solvents characterizing the type of food, and under the conditions of its intended use as shown in table 1 and 2 of § 175.300(d) (using 20 percent alcohol as the solvent when the type of food contains approxi mately 20 percent alcohol) shall yield total extractives not to exceed those prescribed in § 175.300(c)(3); lithium ex tractives not to exceed 0.025 milligram per square inch of surface; and chro mium extractives not to exceed 0.05 microgram per square inch of surface. (e) The coatings are used as food-con tact surfaces for bulk reusable con tainers intended for storing, handling, and transporting food. PART 176—INDIRECT FOOD ADDI TIVES: PAPER AND PAPERBOARD COMPONENTS Subpart A [Reserved] Subpart B—Substances for Use Only as Components of Paper and Paperboard Sec. 176.110 Acrylamide-acrylic acid resins. 176.120 Alkyl ketene dimers. 176.130 Anti-offset substances. 176.150 Chelating agents used in the manu facture of paper and paperboard. 176.160 Chromium (Cr III) complex of N ethyl-N-heptadecylfluoro-octane sulfonyl glycine. 176.170 Components of paper and paperboard in contact with aqueous and fatty foods. 176.180 Components of paper and paperboard in contact with dry food. 176.200 Defoaming agents used in coatings. 176.210 Defoaming agents used in the manu facture of paper and paperboard. 176.230 3,5-Dimethyl-1,3,5,2H tetrahydrothiadiazine-2-thione. 176.250 Poly-1,4,7,10,13-pentaaza-15 hydroxyhexadecane. 176.260 Pulp from reclaimed fiber. 176.300 Slimicides. 176.320 Sodium nitrate-urea complex. 176.350 Tamarind seed kernel powder. AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. SOURCE: 42 FR 14554, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 176 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 2005. Subpart A [Reserved] Subpart B—Substances for Use Only as Components of Paper and Paperboard § 176.110 Acrylamide-acrylic acid res ins. Acrylamide-acrylic acid resins may be safely used as components of arti cles intended for use in producing, VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00211 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 202 21 CFR Ch. I (4–1–16 Edition) § 176.120 manufacturing, packing, processing, preparing, treating, packaging, trans porting, or holding food, subject to the provisions of this section. (a) Acrylamide-acrylic acid resins are produced by the polymerization of ac rylamide with partial hydrolysis or by the copolymerization of acrylamide and acrylic acid. (b) The acrylamide-acrylic acid res ins contain less than 0.2 percent resid ual monomer. (c) The resins are used as adjuvants in the manufacture of paper and paper board 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 in tended for use in producing, manufac turing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The alkyl ketene dimers are man ufactured 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 condi tions 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 emul sion 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 pro visions 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 accom plish the technical effect nor greater than any specific limitations, where such are provided. (b) Anti-offset powders are prepared from substances that are generally rec ognized as safe in food, substances for which prior sanctions or approvals were granted and which are used in ac cordance with the specific provisions of such sanction or approval, and sub stances 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 paper board. The substances named in paragraph (a) of this section may be safely used in the manufacture of paper and paper board, in accordance with the condi tions prescribed in paragraphs (b) and (c) of this section: (a) Chelating agents: List of substances Limitations Ammonium fructoheptonate. Ammonium glucoheptonate. Disodium ethylenediamine tetraacetate. Pentasodium salt of diethylenetriamine pentaacetate. Sodium fructoheptonate. Sodium glucoheptonate. Tetrasodium ethylenediamine tetra acetate. Trisodium N-hydroxyethyl ethylene diamine triacetate. (b) Any one or any combination of the substances named is used or in tended 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-oc tane 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00212 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 203 Food and Drug Administration, HHS § 176.170 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 con form 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 pa perboard 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 in tended for use in producing, manufac turing, packaging, processing, pre paring, treating, packing, transporting, or holding aqueous and fatty foods, subject to the provisions of this sec tion. Components of paper and paper board 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 para graph (a) (1) through (5) of this section may be used as components of the food contact surface of paper and paper board. Paper and paperboard products shall be exempted from compliance with the extractives limitations pre scribed in paragraph (c) of this section: Provided, That the components of the food-contact surface consist entirely of one or more of the substances identi fied in this paragraph: And provided fur ther, That if the paper or paperboard when extracted under the conditions prescribed in paragraph (c) of this sec tion exceeds the limitations on extrac tives 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 para graph (a) are present in the food-con tact surface of such paper or paper board. (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 sur face of paper and paperboard in contact with aqueous or fatty food, subject to the provisions of such regulation. (5) Substances identified in this para graph, as follows: List of Substances Limitations Acetyl peroxide ............................................................................ For use only as polymerization catalyst. Acrylamide-methacrylic acid-maleic anhydride copolymers con taining not more than 0.2 percent of residual acrylamide monomer and having an average nitrogen content of 14.9 percent such that a 1 percent by weight aqueous solution has a minimum viscosity of 600 centipoises at 75 °F, as de termined by LVG-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 30 r.p.m. For use only as a retention aid employed prior to the sheet forming operation in the manufacture of paper and paper board in such an amount that the finished paper and paper board will contain the additive at a level not in excess of 0.05 percent by weight of dry fibers in the finished paper and paperboard. Acrylamide-b-methacrylyloxyethyltrimethylammonium methyl sulfate copolymer resins containing not more than 10 molar percent of b-methacrylyloxyethyltrimethylammonium methyl sulfate and containing less than 0.2% of residual acrylamide monomer. For use only as a retention aid and flocculant employed prior to the sheet-forming operation in the manufacture of paper and paperboard. Acrylic acid, sodium salt copolymer with polyethyleneglycol allyl ether (CAS Reg. No. 86830–15–1). For use only in paper mill boilers. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00213 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 204 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of Substances Limitations Acrylic acid copolymer with 2-acrylamido-2-methylpropane-sul fonic acid (CAS Reg. No. 40623–75–4) and/or its ammo nium/alkali metal mixed salts. The copolymer is produced by poly-merization of acrylic acid and 2-acrylamido-2 methylpropane-sulfonic acid in a weight ratio of 60/40, such that a 28 percent by weight aqueous solution of the polymer has a viscosity of 75–150 centipoises at 25 °C as deter mined by LV-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 60 r.p.m. For use only as a scale inhibitor prior to the sheet-forming op eration in the manufacture of paper and paperboard and used at a level not to exceed 1.0 kilogram (2.2 pounds) of copolymer per 907 kilograms (1 ton) of dry paper and paper board fibers. Acrylonitrile polymer, reaction product with ethylenediamine sulfate having a nitrogen content of 22.5–25.0 percent (Kjel dahl dry basis) and containing no more than 0.075 percent monomer as ethylenediamine. The finished resin in a 24 per cent 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). For use only as a size promoter and retention aid at a level not to exceed 0.5 percent by weight of the dry paper and paper board. Acrylonitrile polymer with styrene, reaction product with ethyl enediamine acetate, having a nitrogen content of 7.4–8.3 percent (Kjeldahl dry basis) and containing no more than 0.25 percent monomer as ethylenediamine. 1. For use only as a sizing material applied after the sheet forming operation in the manufacture of paper and paper board in such amount that 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 paper board 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 than 72 percent of C30 and higher olefins. For use only under the following conditions: 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 para graph (c) of this section. (2-Alkenyl) succinic anhydrides mixture, in which the alkenyl groups are derived from olefins which contain not less than 95 percent of C15-C21 groups. For use only as a sizing agent employed prior to the sheet forming operation in the manufacture of paper and paper board 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 acid copolymers (CAS Reg. No. 27401–06–5). For use only as stabilizers employed prior to the sheet-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. No. 124–68–5) .......... For use as a dispersant for pigment suspension at a level not to exceed 0.25 percent by weight of pigment. The suspen sion is used as a component of coatings for paper and pa perboard under conditions of use described in paragraph (c) of this section, table 2, conditions of use E through G. Ammonium bis(N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, containing not more than 15% ammonium mono (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, where the alkyl group is more than 95% C8 and the salts have a fluorine content of 50.2% to 52.8% as determined on a solids basis. For use only as an oil and water repellant at a level not to ex ceed 0.17 pound (0.09 pound of fluorine) per 1,000 square feet of treated paper or paperboard of a sheet basis weight of 100 pounds or less per 3,000 square feet of paper or pa perboard, 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 flu orine 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 de scribed in table 2 of paragraph (c) of this section, with non alcoholic food. 2. In contact with bakery products of Type VII, VIII, and IX de scribed in table I of paragraph (c) of this section under good manufacturing practices of commercial and institutional bak ing. Ammonium persulfate. Ammonium thiosulfate. Ammonium zirconium carbonate (CAS Reg. No. 32535–84–5) and its tartaric acid adduct. For use only as an insolubilizer for binders used in coatings for paper and paperboard, and limited to use at a level not to exceed 2.5 percent by weight of coating solids. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00214 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 205 Food and Drug Administration, HHS § 176.170 List of Substances Limitations Ammonium zirconium citrate (CAS Reg. No. 149564–62–5), ammonium zirconium lactate-citrate (CAS Reg. No. 149564– 64–7), ammonium zirconium lactate (CAS Reg. No. 149564– 63–6). For use as insolubilizers with protein binders in coatings for paper and paperboard, at a level not to exceed 1.4 percent by weight of coating solids. Anionic polyurethane, produced by reacting the preliminary adduct formed from the reaction of glyceryl monostearate and 2,4-toluenediisocyanate with not more than 10 mole per cent N-methyldiethanolamine and not less than 90 mole per cent dimethylolpropionic acid. The final product is a 15 to 20 percent by weight aqueous solution, having a Brookfield vis cosity of 25 to 100 centipoises at 24 °C (75 °F). For use only as a surface sizing agent at a level not to exceed 0.1 percent by weight of dry paper and paperboard. 9,10–Anthraquinone (Chemical Abstracts Service Registry No. 84–65–1) which has a purity of not less than 98 percent. For use only as a pulping aid in the alkaline pulping of lignocellulosic material at levels not to exceed 0.1 percent by weight of the raw lignocellulosic material. Aromatic petroleum hydrocarbon resin, hydrogenated (CAS Reg. No. 88526–47–0), produced by the catalytic polym erization of aromatic substituted olefins from low boiling dis tillates of cracked petroleum stocks with a boiling point no greater than 220 °C (428 °F), and the 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 Meth od for Softening Point by Ring-and-Ball Apparatus,’’ and ani line 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 Hydro carbon Solvents,’’ which are incorporated by reference in ac cordance 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, Phila delphia, PA 19428-2959, or may be examined at the Na tional Archives and Records Administration (NARA). For in formation on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. For use only as modifiers in wax polymer blend coatings for paper and paperboard at a level not to exceed 50 weight percent of the coating solids under conditions of use E, F, and G identified in table 2 of paragraph (c) of this section. Azo-bisisobutyronitrile .................................................................. For use only as polymerization catalyst. 1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ....... For use only as a preservative in paper coating compositions and limited to use at a level not to exceed 0.01 mg/in2 (0.0016 mg/cm2) of the finished paper and paperboard. Benzoyl peroxide ......................................................................... Do. N,N-Bis(2-hydroxyethyl)alkyl (C12-C18)amide .............................. 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. Bis(methoxymethyl)tetrakis-[(octadecyloxy)-methyl]melamine resins having a 5.8–6.5 percent nitrogen content (CAS Reg. No. 68412–27–1). For use only under the following conditions: 1. As a water repellant employed prior to the sheet-forming op eration 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 oper ation 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 Reg. No. 52–51–7) ........ For use only as an 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 alkyl) ester, ammonium salt (also known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt [CAS Reg. No. 144093–88–9]).. For use as a surface active agent in package coating inks at levels not to exceed 3 percent by weight of the 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. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00215 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 206 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of Substances Limitations 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 pa perboard 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 Reg. No. 41319–54– 4) manufactured by the reaction of secondary amines de rived from fatty acids of animal or vegetable sources with phosgene. For use as a sizing agent at a level not to exceed 0.2 percent by weight of the dry fiber. Diallyldimethyl ammonium chloride polymer with acrylamide and potassium acrylate, produced by copolymerizing either (1) diallyldimethyl ammonium chloride and acrylamide in a weight ratio of 50/50, with 4.4 percent of the acrylamide sub sequently hydrolyzed to potassium acrylate or (2) polym erized diallyldimethyl ammonium 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 per cent by weight aqueous solution (active polymer) has a vis cosity of more than 22 centipoises at 22 °C (72 °F) as deter mined by LVF series, Brookfield Viscometer using No. 1 spindle at 60 RPM (or by other equivalent method) (CAS Reg. No. 25136–75–8). For use only as a retention and/or drainage aid employed prior to the sheet-forming operations in the 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 paper board. Diallyldimethylammonium chloride with acrylamide (CAS Reg. No. 26590–05–6). The copolymer is produced by copolym erizing diallyldimethylammonium chloride with acrylamide in a weight ratio of 50–50 so that the finished resin in a 1 per cent by weight aqueous solution (active polymer) has a vis cosity of more than 22 centipoises at 22 °C (71.6 °F), as de termined by LVF-series Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method). For use only as a drainage and/or retention aid employed prior to the sheet-forming operation in the 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 paper board. Diallyldiethylammonium chloride polymer with acrylamide, and diallyldimethylammonium chloride, produced by copolym erizing acrylamide, diallyldiethylammonium chloride, and diallyldimethylammonium chloride, respectively, in the fol lowing weight ratios and having viscosities determined at 22 °C, by LVF-series Brookfield viscometer using a No. 1 spin dle at 60 r.p.m. (or by other equivalent method), as follows:. 1. Weight ratio: 50–2.5–47.5. The finished resin in a 1 per cent by weight aqueous solution has a minimum vis cosity of 22 centipoises. For use only as a retention aid employed prior to the sheet forming operation in the manufacture of paper and paper board and limited to use at a level not to exceed 0.05 per cent by weight of the finished paper and paperboard. 2. Weight ratio: 25–2.5–72.5. The finished resin in a 0.20 percent by weight aqueous solution has a minimum vis cosity of 20 centipoises. For use only as a drainage and/or retention aid employed prior to the sheet-forming 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 paper board. 3. Weight ratio: 80–2.5–17.5. The finished resin in a 0.30 percent by weight aqueous solution has a minimum vis cosity of 50 centipoises. For use only as a drainage and/or retention aid employed prior to the sheet-forming 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 paper board. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00216 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 207 Food and Drug Administration, HHS § 176.170 List of Substances Limitations Diallyldiethylammonium chloride polymer with acrylamide, po tassium acrylate, and diallyldimethylammonium chloride. The polymer is produced by copolymerizing either: (1) acryl amide, diallyldiethylammonium chloride, and diallyldimethylammonium chloride in a weight ratio of 50– 2.5–47.5, respectively, with 4.4 percent of the acrylamide subsequently hydrolyzed to potassium acrylate, or (2) acryl amide, 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 cen tipoises 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). For use only as a retention aid employed prior to the sheet forming operation in the manufacture of paper and paper board and limited to use at a level not to exceed 0.05 per cent by weight of the finished paper and paperboard. Diallyldimethylammonium chloride polymer with acrylamide, re action product with glyoxal, produced by copolymerizing not less than 90 weight percent of acrylamide and not more than 10 weight percent of diallyldimethylammonium chloride, which is then cross-linked with not more than 30 weight per cent of glyoxal, such that a 10 percent aqueous solution has a minimum viscosity of 25 centipoises at 25 °C as deter mined by Brookfield viscometer Model RVF, using a No. 1 spindle at 100 r.p.m. For use only as a dry and wet strength agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard in such an amount that the finished paper and paperboard will contain the additive at a level not in ex cess of 2 percent by weight of the dry fibers in the finished paper and paperboard. 2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No.10222–01–2). For use as a preservative at a level not to exceed 100 parts per million in coating formulations and in component slurries and emulsions, used in the production of paper and paper board and coatings for paper and paperboard. 2,5-Di-tert-butyl hydroquinone ..................................................... For use only as an antioxidant for fatty based coating adju vants 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. Diethyl(2-hydroxyethyl) methylammonium methyl sulfate, acry late, polymer with acrylamide, chemical abstract service reg istry No. [26796–75–8] having 90–95 mole pct. acrylamide, a nitrogen content of not more than 19.7 pct. (Kjeldahl, dry basis), and a residual acrylamide monomer content of not more 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). For use only as a retention aid and drainage aid employed prior to the sheet-forming operation in the manufacture of paper and paperboard at a level not to exceed 0.15 pct. by weight of finished dry paper and paperboard fibers. Diethylenetriamine ....................................................................... For use only as a modifier for amino resins. N,N-Diisopropanolamide of tallow fatty acids ............................. 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. Dimethylamine-epichlorohydrin copolymer in which not more than 5 mole-percent of dimethylamine may be replaced by an equimolar amount of ethylenediamine and in which the ratio of total amine to epichlorohydrin does not exceed 1:1. The nitrogen content of the copolymer shall be 9.4 to 10.8 weight percent on a dry basis and a 10 percent by weight aqueous solution of the final product has a minimum vis cosity of 5.0 centipoises at 25 °C, as determined by LVT-se ries Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or by other equivalent method). For use only: 1. As a retention aid employed before the sheet-forming oper ation in the manufacture of paper and paperboard and lim ited to use at a level not to exceed 1 percent by weight of the finished paper and paperboard. 2. At the size press at a level not to exceed 0.017 percent by weight of the finished paper and paperboard. N-[(Dimethylamino)methyl]-acrylamide polymer with acrylamide and styrene having a nitrogen content of not more than 16.9 percent and a residual acrylamide monomer content of not more than 0.2 percent on a dry basis. For use only as a dry-strength agent employed prior to the sheet-forming operation in the manufacture of paper and pa perboard and used at a level not to exceed 1 percent by weight of finished dry paper or paperboard fibers. N,N′-Dioleoylethylenediamine. Diphenylamine ............................................................................. For use only as an antioxidant for fatty based coating adju vants 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-dihydroxyanthracene (CAS Reg. No. 73347–80–5). For use only as a catalyst in the alkaline pulping of lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials. N,N′-Distearoylethylenediamine. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00217 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 208 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of Substances Limitations n-Dodecylguanidine acetate ........................................................ For use only as an antimicrobial agent in paper and paper board 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 paper board 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 b-diethylamino- ethyl chloride hydrochloride. For use only as a retention aid and/or drainage aid employed prior to the sheet-forming operation in the manufacture of paper and paperboard. Guar gum modified by treatment with not more than 25 weight percent of 2,3-epoxypropyltri-methylammonium chloride such that the finished product has a maximum chlorine content of 4.5 percent, a maximum nitrogen content of 3.0 percent, and a minimum viscosity in 1-percent-by-weight aqueous solution of 1,000 centipoises at 77 °F, as determined by RV-series Brookfield viscometer (or equivalent) using a No. 3 spindle at 20 r.p.m. For use only as a retention aid and/or internal size employed prior to the sheet-forming operation in the manufacture of paper and paperboard, and limited to use at a level: (1) Not to exceed 0.15 percent by weight of the finished dry paper and paperboard fibers intended for use in contact with all types of foods, 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 (methoxymethyl)-1,3,5-triazine-2,4,6 triamine polymer with stearyl alcohol, a-octadecenyl-omega hydroxypoly(oxy-1,2-ethanediyl), and alkyl (C20 + ) alcohols (CAS Reg. No. 130328–24–4). For use only as a water-repellent applied to the surface of paper and paperboard at levels not to exceed 1 percent by weight of the finished dry paperboard 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 monoethyl ethers of hy droquinone. For use only as an inhibitor for monomers. Hydroxymethyl-5,5-dimethylhydantoin (CAS Reg. No. 27636– 82–4), mixture with 1,3-bis(hydroxymethyl)-5,5 dimethylhydantoin (CAS Reg. No. 6440–58–0). For use only as a preservative in clay-type fillers at a level not to exceed a combined total of 1,200 milligrams/kilograms hydroxymethyl-5,5-dimethylhydantoin and 1,3 bis(hydroxymethyl)-5,5-dimethylhydantoin in the filler. Hydroxypropyl guar gum having a minimum viscosity of 5,000 centipoises at 25 °C., as determined by RV-series Brookfield viscometer using a No. 4 spindle at 20 r.p.m. (or other suit able method) and using a test sample prepared by dissolving 5 grams of moisture-free hydroxypropyl guar gum in 495 mil liliters of a 70 percent by weight aqueous propylene glycol solution. For use only as a dry strength and formation aid agent em ployed prior to the sheet-forming operation in the manufac ture of paper and paperboard and used at a level not to ex ceed 1.5 percent by weight of finished dry paper or paper board fibers. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00218 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 209 Food and Drug Administration, HHS § 176.170 List of Substances Limitations 12-Hydroxystearic acid-polyethylene glycol block copolymers (CAS Reg. No. 70142–34–6) produced by the reaction of polyethylene glycol (minimum molecular weight 200) with 12 hydroxystearic acid. For use only as a surfactant for dispersions of polyacrylamide retention and drainage aids employed prior to the sheet forming operation in the manufacture of paper and paper board. Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– [2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1 methyl, methyl sulfates (CAS Reg. No. 72749–55–4).. For use only at a level not to exceed 0.5 percent by weight of the dry paper and paperboard. Isopropyl m- and p-cresols (thymol derived) ............................... For use only as an antioxidant for fatty based coating adju vants 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 acrylate and vinyl acetate, hydrolyzed (CAS Reg. No. 113221–69–5) and/or its ammo nium, potassium, and sodium salts. For use only as a deposit control additive prior to the sheet forming operation to prevent scale buildup in the manufac ture 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 (CAS Reg. No. 25751– 21–7). For use only as a boiler water additive at a level not to exceed 50 parts per million in the boiler water. N-methyldiallylamine hydrochloride polymer with epichlorohydrin having a nitrogen content of 4.8 to 5.9 per cent (Kjeldahl dry basis) such that a 20 percent by weight aqueous solution has a minimum viscosity of 30 centipoises and maximum viscosity of 100 centipoises at 25 °C, as de termined by LVF Model Brookfield viscometer using a No. 1 spindle at 60 r.p.m. (or equivalent method). For use only as a retention aid, flocculating agent, and wet strength agent employed in the manufacture of paper and paperboard prior to the sheet-forming operation and limited to use at a level not to exceed 1.5 percent by weight of the dry paper and paperboard. Methyl naphthalene sulfonic acid-formaldehyde condensate, sodium salt. 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. N-methyl-N-(tall oil acyl) taurine, sodium salt (CAS Reg. No. 61791–41–1). For use only to control scale 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-phenylethyl)-phenol, ethoxylated, sulfated, ammonium salt with an average of 12 to 16 moles of ethylene oxide (CAS Reg. No. 68130–71–2). For use only as an emulsifier for rosin based sizing at a level not to exceed 0.03 percent by weight of the finished dry paper and paperboard. Monoglyceride citrate. Monoisopropanolamine (CAS Reg. No. 78–96–6) ...................... For use as a dispersant for titanium dioxide suspensions at a level not to exceed 0.68 percent by weight of titanium diox ide. The finished paper and paperboard will be used in con tact 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 condensate, sodium salt. 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. 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. Perfluoroalkyl acrylate copolymer (CAS Reg. No. 92265–81–1) containing 35 to 40 weight percent fluorine, produced by the copolymerization of ethanaminium, N,N,N-trimethyl-2-[(2 methyl-1-oxo-2-propenyl)-oxy]-, chloride; 2-propenoic acid, 2 methyl-, oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl ester; and 2-propenoic acid, 2[[(heptadecafluoro octyl)sulfonyl] methyl amino]ethyl ester. For use only as an oil and water repellent at a level not to ex ceed 0.5 percent by weight of the finished paper and paper board in contact with nonalcoholic foods under conditions of use C, D, E, F, G, or H described in table 2 of paragraph (c) of this section. Petrolatum ................................................................................... Complying with § 178.3700 of this chapter. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00219 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 210 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of Substances Limitations Petroleum asphalt, steam and vacuum refined to meet the fol lowing specifications: Softening point 88 °C to 93 °C, as de termined by ASTM method D36–76, ‘‘Standard Test Method for Softening Point of Bitumen (Ring-and-Ball Apparatus);’’ penetration at 25 °C not to exceed 0.3 mm, as determined by ASTM method D5–73 (Reapproved 1978), ‘‘Standard Test Method for Penetration of Bituminous Materials,’’ 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 Ad ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.); 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. For use only as a component of internal sizing of paper and paperboard intended for use in contact only with raw fruits, raw vegetables, and dry food of the type identified under Type VIII of table 1 in paragraph (c) of this section, and pro vided that the asphalt is used at a level not to exceed 5% by weight of the finished dry paper and paperboard fibers. 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-formalde hyde modified alkyd coatings and limited to use at a level not to exceed 2% by weight of the coating solids. Phenyl-b-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 (and their sodium salts) of triethanolamine formed by the reaction of triethanolamine with polyphosphoric acid to produce a mixture of esters hav ing an average nitrogen content of 1.5 percent and an aver age phosphorus content of 32 percent (as PO4). For use as an adjuvant prior to the sheet forming operation to control pitch and scale formation in the manufacture of 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 I, IV, V, VII, VIII, and IX, and used at a level not to exceed 0.075 percent by weight of dry paper or pa perboard fibers. Poly[acrylamide-acrylic acid-N-(dimethyl-aminomethyl)acryl amide], produced by reacting 2.40 to 3.12 parts by weight of polyacrylamide with 1.55 parts dimethylamine and 1 part formaldehyde, and containing no more than 0.2 percent monomer as acrylamide. For use only as a drainage aid and retention aid employed prior to the sheet-forming operation in the manufacture of paper and paperboard for use in contact with fatty 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-hydroxypropyl acrylate) produced when one mole of hydroxypropyl acrylate and three moles of acrylic acid are reacted with three moles of ethylenimine and three moles of nitric acid, such that a 35 percent by weight aqueous solution has a minimum 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. For use only as a retention and drainage aid employed prior to the sheet-forming operation in the manufacture of paper and paperboard at a level not to exceed 0.2 percent by weight of dry paper or paperboard fiber. Polyacrolein (1 part) -sodium bisulfite (0.7 part) adduct, con taining excess bisulfite (ratio of excess bisulfite to adduct not to exceed 1.5 to 1). For use only as an agent in modifying starches and starch gums used in the production of paper and paperboard and limited to use at a level not to exceed 0.09 mg/in2 of the fin ished paper and paperboard. Poly[acrylamide-acrylic acid-N-(dimethylaminomethyl) acryl amide] (C.A. Registry No. 53800–41–2), produced by react ing 9.6–16.4 parts by weight of polyacrylamide with 1.6 parts dimethylamine and 1 part formaldehyde, and containing no more than 0.2% monomer as acrylamide, such that a 20% aqueous solution has a minimum viscosity of 4,000 cP at 25 °C., as determined by Brookfield viscometer model RVT, using a No. 5 spindle at 20 r/min (or equivalent method). For use only as a drainage aid, retention aid, or dry-strength agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard at a level not to ex ceed 0.25 percent by weight of finished dry paper and pa perboard fibers, when such paper or paperboard is used in contact with fatty foods under conditions of use described in paragraph (c) of this section, table 2, conditions of use E, F, and G. Polyamide-epichlorohydrin modified resin produced by reacting adipic acid with diethylene triamine to produce a basic poly amide which is modified by reaction with formic acid and formaldehyde and further reacted with epichlorohydrin in the presence of ammonium hydroxide to form a water-soluble cationic resin having a nitrogen content of 13–16 percent (Kjeldahl, dry basis) such that a 35 percent by weight aque ous 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. For use only as a retention aid and flocculant employed prior to the sheet-forming operation in the manufacture of paper and paperboard and used at a level not to exceed 0.2 per cent dry resin by weight of finished dry paper or paperboard fibers. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00220 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 211 Food and Drug Administration, HHS § 176.170 List of Substances Limitations Polyamide-epichlorohydrin water-soluble thermosetting resins [CAS Reg. No. 68583–79–9] prepared by reacting adipic acid with diethylenetriamine to form a basic polyamide and further reacting the polyamide with an epichlorohydrin and dimethylamine mixture such that the finished resins have a nitrogen content of 17.0 to 18.0 percent of a dry basis, and that a 30-percent-by-weight aqueous solution has a minimum viscosity of 350 centipoises at 20 °C, as determined by a Brookfield viscometer using a No. 3 spindle at 30 r.p.m. (or equivalent method). For use only under the following conditions: 1. As a retention aid employed prior to the sheet-forming oper ation in the manufacture of paper and paperboard and lim ited to use at a level not to exceed 0.12 percent by weight of dry paper or paperboard. 2. The finished paper or paperboard will be used in contact with food only of the types identified in paragraph (c) of this section, table 1, 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 thermosetting resin (CAS Reg. No. 96387–48–3) prepared by reacting N-methyl bis(3-aminopropyl) amine with oxalic acid and urea to form a basic polyamide and further reacting the polyamide with epichlorohydrin. For use only as a wet strength agent and/or retention aid em ployed prior to the sheet-forming operation in the manufac ture of paper and paperboard and used at a level not to ex ceed 1.5 percent by weight of dry paper and paperboard fi bers. Polyamide-epichlorohydrin water-soluble thermosetting resins prepared by reacting adipic acid, isophthalic acid, itaconic acid or dimethyl glutarate with diethylenetriamine to form a basic polyamide and further reacting the polyamide with one of the following: For use only in the manufacture of paper and paperboard under conditions such that the resins do not exceed 1.5 per cent by weight of the paper or paperboard. Epichlorohydrin. Epichlorohydrin and ammonia mixture. Epichlorohydrin and sodium hydrosulfite mixture. Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared by reacting hexanedioic acid, N-(2-aminoethyl)-1,2 ethanediamine, (chloromethyl)oxirane, ethyleneimine (aziridine), and polyethylene glycol, partly neutralized with sulfuric acid (CAS Reg. No. 167678–45–7). For use only as a retention aid employed prior to the sheet forming operation in the manufacture of paper and paper board at a level not to exceed 0.12 percent resin by weight of the finished dry paper or paperboard. Polyamidol-epichlorohydrin modified resin produced by reacting glutaric acid dimethyl ester with diethylene-triamine to produce a basic polyamide which is modified by reaction with formaldehyde and further reacted with epicholorohydrin to form a water soluble cationic resin having a nitrogen con tent of 10.9–11.9 percent and a chlorine content of 13.8– 14.8 percent, on a dry basis, and a minimum viscosity, in 12.5 percent by weight aqueous solution, of 10 centipoises at 25 °C, as determined by a Brookfield Model LVF viscom eter using a No. 1 spindle at 60 r.p.m. (or equivalent meth od). For use only as a wet strength agent employed prior to the sheet-forming operation in the manufacture of paper and pa perboard, and used at a level not to exceed 2.5 percent by weight of dry paper and paperboard fibers when such paper or paperboard is used in contact with food under conditions of use E through G described in table 2 of paragraph (c) of this section. Polyamine-epichlorohydrin resin produced by the reaction of epichlorohydrin with monomethylamine to form a prepolymer and further reaction of this prepolymer with N,N,N′,N′ tetramethylethylenediamine such that the finished resin hav ing a nitrogen content of 11.6 to 14.8 percent and a chlorine content of 20.8 to 26.4 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). For use only as a flocculant, drainage aid, formation aid, reten tion aid, or strength additive employed prior to the sheet forming operation in the manufacture of paper and paper board, and used at a level not to exceed 0.12 percent by weight of dry paper and paperboard fibers. Polyamine-epichlorohydrin resin produced by the reaction of N,N-dimethyl-1,3-propanediamine with epichlorohydrin and further reacted with sulfuric acid, Chemical Abstracts Service Registry Number [27029–41–0], such that the finished resin has a maximum nitrogen content of 14.4 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). For use only as a clarifier in the treatment of influent water to be used in the manufacture of paper and paperboard, and used at a level not to exceed 20 parts per million of the influ ent water. Polyamine-epichlorohydrin water-soluble thermosetting resin produced by reacting epichlorohydrin with: (i) polyamines comprising at least 95 percent by weight C4 to C6 aliphatic diamines and/or their self-condensation products, and/or (ii) prepolymers produced by reacting 1,2-dichloroethane with the polyamines in (i). The finished resin has a nitrogen con tent 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 viscom eter using a No. 1H spindle at 50 r.p.m. (or equivlent meth od). For use only as a wetstrength agent and/or retention aid em ployed prior to the sheet-forming operation in the manufac ture of paper and paperboard, and used at a level not to ex ceed 1 percent by weight of dry paper and paperboard fi bers. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00221 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 212 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of Substances Limitations Polyamine-epichlorohydrin water-soluble thermosetting resin produced by reacting epichlorohydrin with: (i) polyamines comprising at least 95 percent by weight C4 to C6 aliphatic diamines and/or their seIf-condensation products and/or (ii) hexamethylenediamine, and/or (iii) bis(hexamethylene) tri amine and higher homologues, and/or (iv) prepolymers pro duced 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 vis cometer using a No. 1H spindle at 50 r.p.m. (or equivalent method). For use only as a wet-strength agent and/or retention aid em ployed prior to the sheet-forming operation in the manufac ture of paper and paperboard, and used at a level not to ex ceed 1 percent by weight of dry paper and paperboard fi bers. Polyamine-epichlorohydrin water soluble thermosetting resin prepared by reacting hexamethylenediamine with 1,2-di chloroethane to form a prepolymer and further reacting this prepolymer with epichlorohydrin. This resin is then reacted with nitrilotris (methylene-phosphonic acid), pentasodium salt, such that the 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 spin dle at 50 r.p.m. (or equivalent method). For use only as a wet-strength agent and/or retention aid em ployed prior to the sheet-forming operation in the manufac ture of paper and paperboard, and used at a level not to ex ceed 1 percent by weight of dry paper and paperboard fi bers. Polyamine resin produced by the reaction of 1,2-dichloroethane with bis(hexamethylene)triamine and higher homologues such that the finished resin has a nitrogen content of 13.0– 15.0 percent on a dry basis, and a minimum viscosity in 25 percent-by-weight aqueous solution of 75 centipoises at 25 °C., as determined by Brookfield HAT model viscometer using a No. 1 spindle at 50 r.p.m. (or equivalent method). For use only as a retention aid and/or flocculent employed prior to the sheet-forming operation in the manufacture of paper and paperboard and used at a level not to exceed 0.1 percent by weight of dry paper or paperboard fibers. Polyaminoamide-epichlorohydrin modified resin produced by reacting adipic acid with diethylenetriamine to produce a pol yamide which is modified by reaction with diethylaminopropylamine and further reacted with dichlor oethyl ether to form a polyamide intermediate. This poly amide intermediate is then reacted with epichlorohydrin such that the finished 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). For use only as a wet-strength agent and/or retention aid em ployed prior to the sheet-forming operation in the manufac ture of paper and paperboard, and used at a level not to ex ceed 0.5 percent by weight of the finished dry paper and pa perboard. Polybutene, hydrogenated; complying with the identity pre scribed under § 178.3740(b) of this chapter. For use only as provided in §§ 175.300, 178.3740 and 178.3860 of this chapter. Poly(diallyldimethylammonium chloride) (CAS Reg. No. 26062– 79–3) produced by the polymerization of (diallyldimethylammonium chloride) so that the finished resin has a nitrogen content of 8.66±0.4 percent on a dry weight basis and a minimum viscosity in a 40 percent by weight aqueous solution of 1,000 centipoises at 25 °C (77 °F), de termined by LVF Model Brookfield Viscometer using a No. 3 spindle at 30 r.p.m. (or equivalent method). The level of re sidual monomer is not to exceed 1 percent by weight of the polymer (dry basis). For use only: 1. As a pigment dispersant and/or retention aid prior to the sheet-forming operation in the manufacture of paper and pa perboard, and used at a level not to exceed 10 pounds of active polymer per ton of finished paper and paperboard. 2. As a pigment dispersant in coatings at a level not to exceed 3.5 pounds of active polymer per ton of finished paper and paperboard. Poly (diallyldimethylammonium chloride) (CAS Reg. No. 26062–79–3) produced by the polymerization of diallyldimethylammonium chloride so that the finished resin has a nitrogen content of 8.66±0.4 percent on a dry basis and a minimum viscosity in a 15 weight-percent aqueous so lution 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). For use only as a flocculant employed prior to the sheet-form ing operation in the manufacture of paper and paperboard, and used at a level not to exceed 10 mg/L (10 parts per mil lion) of influent water. Poly(1,2-dimethyl-5-vinylpyridinium methyl sulfate) having a ni trogen content of 5.7 to 7.3 percent and a sulfur content of 11.7 to 13.3 percent 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. For use only as an adjuvant employed in the manufacture of paper and paperboard prior to the sheet-forming operation. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00222 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 213 Food and Drug Administration, HHS § 176.170 List of Substances Limitations Polyester resin produced by reacting dimethylolpropionic acid (CAS Registry No. 4767–03–7) as a comonomer, at no more than 30 percent by weight of total polymer solids in reaction with 2,2-dimethyl-1,3-propanediol, phthalic anhydride and isophthalic acid, such that the polyester resin has a viscosity of 200–600 centipoises at 80 °F as determined by a Brook field RVT viscometer using a number 3 spindle at 50 rpm (or equivalent method). For use only as a surface-sizing compound applied after the sheet-forming operation in the manufacture of paper and pa perboard and limited to use at levels not to exceed 0.1 per cent by weight of finished dry paper or paperboard. Polyethylene, oxidized; complying with the identity prescribed in § 177.1620(a) of this chapter. For use only as component of coatings that contact food only of the type identified under Type VII-B of table 1 in para graph (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 1 mole of ethylene dichloride, 1.05 moles of ammonia, and 2 moles of sodium hydroxide are made to react so that a 10 percent aqueous solution has a minimum viscosity of 40 centipoises at 77 °F, as determined by Brookfield viscometer using a No. 1 spin dle at 60 r.p.m. For use only as a retention aid employed prior to the sheet forming operation in the manufacture of paper and paper board. 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 polymerization of ethylenimine. For use only as an adjuvant 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 adduct, diethanolamine reac tion product. The mole ratio of poly(isobutene)/maleic anydride adduct to diethanolamine is 1:1. For use only as a surfactant for dispersions of polyacrylamide retention and drainage aids employed prior to the sheet for mation operation in the manufacture of paper and paper board. Polymethacrylic acid, sodium salt, having a viscosity in 30-per cent-by-weight aqueous solution of 125–325 centipoises at 25 °C as determined by LV-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 60 r.p.m. For use only as a coating adjuvant for controlling viscosity when used at a level not to exceed 0.3% by weight of coat ing solids. Polymethacrylic acid, sodium salt, having a viscosity in 40-per cent-by-weight aqueous solution of 400–700 centipoises at 25 °C, as determined by LV-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 30 r.p.m. For use only as a coating adjuvant for controlling viscosity when used at a level not to exceed 0.1% by weight of coat ing solids. Poly[(methylimino)(2-hydroxytrimethylene)hydrochloride] pro duced by reaction of 1:1 molar ratio of methylamine and epichlorohydrin so that a 31-percent aqueous solution at 25 °C has a Stokes viscosity range of 2.5-4.0 as determined by ASTM method D1545–76 (Reapproved; 1981), ‘‘Standard Test 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 Ma terials, 100 Barr Harbor Dr., West Conshohocken, Philadel phia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For informa tion on the availability of this material at NARA, call 202– 741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.html.. For use only as a retention aid employed prior to the sheet forming operation in such an amount that finished paper and paperboard will contain the additive at a level not in excess of 1 percent by weight of the dry paper and paperboard. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00223 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 214 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of Substances Limitations Poly[oxyethylene (dimethyliminio) ethylene (dimethyliminio) ethylene dichloride] produced by reacting equimolar quan tities of N,N,N,N-tetramethylethylene-diamine and dichlorethyl ether to yield a solution of the solid polymer in distilled water at 25 °C with a reduced viscosity of not less than 0.15 deciliter per gram as determined by ASTM method D1243–79, ‘‘Standard Test Method for -Dilute Solution Vis cosity of Vinyl Chloride Polymers,’’ which is incorporated by reference. Copies may be obtained from the American Soci ety for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be ex amined 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/ federallregister/codeloflfederallregulations/ ibrllocations.html.). The following formula is used for deter mining reduced viscosity:. For use only to improve dry-strength of paper and paperboard and as a retention and drainage aid employed prior to the sheet-forming operation in the manufacture of paper and pa perboard and limited to use at a level not to exceed 0.1 per cent by weight of the finished dry paper and paperboard fi bers. 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 deci liter Polypropylene glycol (minimum molecular weight 1,000). Potassium persulfate. 2-Propenoic acid, telomer with sodium 2-methyl-2-[(1-oxo-2 propenyl)amino]-1-propane sulfonate and sodium phos phinate (CAS Reg. No. 110224–99–2). For use only as a deposit control additive employed prior to the sheet forming 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 con densed 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, isopropyl methyl, methyl 1 methyl-C9-49-alkyl (CAS Reg. No. 144635–08–5). For use only as a component of polyolefin coatings with § 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 minimum viscosity of 2,700 centipoises at 25 °C after 24 hours as determined by RV-series Brookfield viscometer (or equivalent) using a No. 4 spindle at 20 r.p.m. and using a test sample prepared by dissolving 8 grams of sodium carboxymethyl guar gum in 392 milliliters of 0.2-percent-by-weight aqueous sodium o phenylphenate solution. For use only as a dry-strength and formation-aid agent em ployed prior to the sheet-forming operation in the manufac ture of paper and paperboard and used at a level not to ex ceed 1% by weight of finished dry paper or paperboard fi bers. 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 re lease 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 manu facture of paper and paperboard prior to the sheet-forming operation. Sodium persulfate. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00224 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 215 Food and Drug Administration, HHS § 176.170 List of Substances Limitations Sodium polyacrylate .................................................................... For use only: 1. As a thickening agent for natural rubber latex coatings, pro vided 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) (CAS Reg. No. 118632– 18–1). For use only in paper mill boilers. Sodium zinc potassium polyphosphate (CAS Reg. No. 65997– 17–3). For use only as a pigment 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 sty rene-butadiene with one or more of the monomers: acryl amide, 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 con tain 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, amidated, ammonium so dium salt; having, in a 25 percent by weight aqueous solu tion at pH 8.8, a minimum 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). For use only as a surface size at a level not to exceed 1 per cent by weight of paper or paperboard substrate. Styrene-maleic anhydride copolymer, sodium salt (minimum molecular weight 30,000). For use only: 1. As a coating thickening 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, potassium salt (minimum molecular weight 30,000). For use only as a coating thickening agent at a level not to ex ceed 1% by weight of coating solids. Synthetic wax polymer prepared by the catalytic polymerization of alpha olefins such that the polymer has a maximum iodine number of 18 and a minimum number average molecular weight of 2,400. For use only as a component of petroleum wax and/or syn thetic petroleum wax complying with § 178.3710 or § 178.3720 of this chapter at 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-anthracenedione (CAS Reg. No. 56136–14–2). For use only as a catalyst in the alkaline pulping of lignocellulosic materials at levels not to exceed 0.1 percent by weight of the raw lignocellulosic materials. N,N,N′, N′-Tetramethylethylenediamine polymer with bis-(2 chloroethyl) ether, first reacted with not more than 5 percent by weight 1-chloro-2,3-epoxypropane and then reacted with not more than 5 percent by weight poly (acrylic acid) such that a 50 percent by weight aqueous solution of the product has a nitrogen content of 4.7–4.9 percent 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). For use only as a flocculent, drainage aid or retention aid em ployed prior to the sheet forming operation in the manufac ture of paper and paperboard and limited to use at a level not to exceed 0.2 percent by weight of the finished dry paper and paperboard fibers. Tetrasodium N- (1,2-dicarboxyethyl) - N - octadecylsulfo-suc cinamate. For use only as an emulsifier 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 ex ceed 0.02 pct by weight of finished paper and paperboard. Triethanolamine ........................................................................... For use only to adjust pH during the manufacture of amino res ins permitted for use as components of paper and paper board. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00225 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 216 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of Substances Limitations Triethylene glycol adipic acid monoester produced by reacting equimolar quantities of triethylene glycol and adipic acid. For use only as a curl-control agent at a level not to exceed 2% by weight of coated or uncoated paper and paperboard. Triethylenetetramine .................................................................... For use only as a modifier for amino resins. 1,3,5-Triethylhexahydro-1,3,5-triazine (CAS Registry No. 7779– 27–3). For use only as an antimicrobial agent for coating, binder, pig ment, filler, sizing, and similar formulations added prior to the heat drying step in the manufacture of paper and paper board and limited to use at a level between 0.05 and 0.15 percent by weight of the formulation. Undecafluorocyclohexanemethanol ester mixture of dihydrogen phosphate, compound with 2,2′ iminodiethanol (1:1); hydro gen phosphate, compound with 2,2′-iminodiethanol (1:1); and P,P′-dihydrogen pyrophosphate, compound with 2,2′ iminodiethanol (1:2); where the ester mixture has a fluorine content of 48.3 pct to 53.1 pct as determined on a solids basis. For use only as an oil repellent at a level not to exceed 0.087 lb (0.046 lb of fluorine) per 1,000 ft2 of treated paper or pa perboard, as determined by analysis for total fluorine in the treated paper or paperboard without correction for any fluo rine which might be present in the untreated paper or paper board, 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 and specifications pre scribed in § 172.695 of this chapter, except that the residual isopropyl alcohol shall not exceed 6,000 parts per million. For use only at a maximum level of 0.125 percent by weight of finished paper as a suspension aid or stabilizer for aqueous pigment slurries employed in the manufacture of paper and paperboard. Xylene sulfonic acid-formaldehyde condensate, sodium salt ..... 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. Zeolite Na-A (CAS Reg. No. 68989–22–0) ................................. For use as a pigment extender at levels not to exceed 5.4 per cent 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 para graphs (b) (1) and (2) of this section may be used as components of the food contact surface of paper and paper board, provided that the food-contact surface of the paper or paperboard com plies with the extractives limitations prescribed in paragraph (c) of this sec tion. (1) Substances identified in § 175.300(b)(3) of this chapter with the exception of those identified in para graphs (b)(3) (v), (xv), (xx), (xxvi), (xxxi), and (xxxii) of that section and paragraph (a) of this section. (2) Substances identified in this para graph (b)(2) follow: List of substances Limitations Acrylamide copolymerized with ethyl acrylate and/or stryene and/or methacrylic acid, subsequently reacted with formalde hyde and butyl alcohol. Acrylamide copolymerized with ethylene and vinyl chloride in such a manner 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. For use only as coatings or components of coatings. 2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, so dium salt (CAS Reg. No. 35641–59–9). For use only in coatings at a level not to exceed 0.01 mg/in2 Acrylic and modified acrylic polymers ......................................... Complying with § 177.1010 of this chapter. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00226 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 217 Food and Drug Administration, HHS § 176.170 List of substances Limitations 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 fin ished 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 acry late, 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 meth acrylate, 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 co polymers used as coating adjuvants at a level not exceeding 2 weight percent of total coating solids. Alkyl mono- and disulfonic acids, sodium salts (produced from n-alkanes in the range of C10-C18 with not less than 50 per cent C14-C16).. For use only: 1. As emulsifiers for vinylidene chloride copolymer 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 poly mer 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, bind ers, pigment slurries, and sizing solutions at a level not to exceed 0.006 percent by weight of the coating, solution, slur ry or emulsion. Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt [CAS Reg. No. 144093–88–9]).. For use as a surface active agent in package coating inks at levels not to exceed 3 percent by weight of the coating ink. Butylbenzyl phthalate .................................................................. Complying with § 178.3740 of this chapter. Butyl oleate, sulfated, ammonium, potassium, or sodium salt. Butyraldehyde. Captan (N-trichloromethylmercapto-4-cyclohexene-1, 2 dicarboximide). For use only as a mold- and mildew-proofing agent in coatings intended for use in contact with food only of the types identi fied in paragraph (c) of this section, table 1, under Type I, II, VI-B, and VIII. Castor Oil, polyoxyethylated (42 moles ethylene oxide) ............. For use only as an emulsifier 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- azoniaadamantane chloride (CAS Reg. No. 4080–31–3). For use only: 1. As a preservative at a level 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 para graph (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 pa perboard intended for use in contact with food. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00227 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 218 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of substances Limitations 5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172– 55–4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682–20–4) mixture at a ratio of 3 parts to 1 part, manufac tured from methyl-3-mercaptopropionate (CAS Reg. No. 2935–90–2). The mixture may contain magnesium nitrate (CAS Reg. No. 10377–60–3) at a concentration equivalent to the isothiazolone active ingredients (weight/weight). For use only: 1. As an antimicrobial agent for polymer latex emulsions in paper coatings at a level not to exceed 50 parts per mil lion (based on isothiazolone active ingredients) in the coating formulation. 2. As an antimicrobial agent for finished coating 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 mil lion (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 pale crepe rubber dis solved in phenol is catalytically cyclized so that the finished cyclized rubber has a melting point of 145 °C to 155 °C as determined by ASTM method E28–67 (Reapproved 1982), ‘‘Standard Test 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/federallregister/ codeloflfederallregulations/ibrllocations.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/ federallregister/codeloflfederallregulations/ ibrllocations.html.. For use only in coatings for paper and paperboard intended for use in contact with food only of the types identified in para graph (c) of this section, table 1, under Types VIII and IX. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. For use only as a preservative 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. No. 120–55–8) ........... For use only as a 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, conditions of use E, F, and G. Diethylene glycol ester of the adduct of terpene and maleic an hydride. Dihydroxy dichlorodiphenyl methane .......................................... For use only as preservative for coating formulations. Dimethylpolysiloxane, 100 centistokes viscosity. Dimethylpolysiloxane-beta-phenylethyl methyl polysiloxane co polymer (2:1), 200 to 400 centistokes viscosity. N,N′-Diphenyl-p-phenylenediamine ............................................. For use only as polymerization inhibitor in 2-sulfoethyl meth acrylate, sodium salt. Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... 1. For use only as a plasticizer for polyvinyl acetate coatings at a level not to exceed 5 percent by weight of the coating sol ids under conditions described in paragraph (c) of this sec tion, 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 coat ing solids. EDTA (ethylenediaminetetraacetic acid) and its sodium and/or calcium salts. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00228 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 219 Food and Drug Administration, HHS § 176.170 List of substances Limitations Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl 2(1H)pyrimidinone, propoxylated (CAS Reg. No. 118299-90 4). For use only as an insolubilizer for starch-based coatings and limited to use at a level not to exceed 5.0 percent by weight of the coating. Ethylene-acrylic acid copolymers produced by the copolym erization of ethylene and acrylic acid and/or their partial am monium 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 Ma terials, 100 Barr Harbor Dr., West Conshohocken, Philadel phia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For informa tion on the availability of this material at NARA, call 202– 741–6030, or go to: http://www.archives.gov/ federallregister/codeloflfederallregulations/ ibrllocations.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 mono and poly) of [N-(1, 1-dimethyl-3-oxobutyl) acrylamide] produced by reacting 1 mole of the [N-(1,1-dimethyl-3-oxobutyl) acrylamide] with 3 moles of formaldehyde such that the 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. For use only as a comonomer in polyvinyl acetate latex coat ings and limited to use at a level not to exceed 1 percent by weight of dry polymer solids. Isobutyl oleate, sulfated, ammonium, potassium, or sodium salt. Maleic anhydride adduct of butadiene-styrene copolymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a methylstyrene to 3 vinyltoluene). Modified kaolin clay (CAS Reg. No. 1344–00–9) is produced by the reaction of sodium silicate (CAS Reg. No. 1344–09– 8) and kaolinite clay (CAS Reg. No. 1332–58–7) under hy drothermal conditions. The reaction product has a molecular weight between 246 and 365 and consists of 46 to 55 per cent silicon dioxide (Si02), 28 to 42 percent aluminum oxide (A1203), and 2 to 7 percent of sodium oxide (Na20). The re action product will not consist of more than 70 percent modi fied kaolin clay. For use only as a component of coatings in paper and paper board products at a level not to exceed 9 percent by weight of the coating intended for use in contact with food of Types I through IX described in table 1 of paragraph (c) of this sec tion under conditions of use C through H described in table 2 of paragraph (c) of this section. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt. Oleyl alcohol. Oxazolidinylethylmethacrylate (CAS Registry No. 46236–15–1) copolymer with ethyl acrylate and methyl methacrylate, and containing not more than 6 percent by weight of 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. For use only as a binder for pigment coatings as a binder level not to exceed 4.0 percent by weight of dry paper or paper board. Pentaerythritol tetrastearate. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00229 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 220 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of substances Limitations Petroleum alicyclic hydrocarbon resins, or the hydrogenated product thereof, meeting the following specifications: Soft ening point 97 °C minimum, as determined by ASTM method E28–67 (Reapproved 1982), ‘‘Standard Test Method for Soft ening Point by Ring and Ball Apparatus;’’ aniline point 120 °C minimum, as determined by ASTM method D611–82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydrocarbon Solvents,’’ which are incorporated by reference (Copies may be ob tained 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/federallregister/ codeloflfederallregulations/ibrllocations.html.). Specific gravity 0.96–0.99 (20 °C/20 °C). Such petroleum hydro carbon resins are produced by the catalytic polymerization of dienes and olefins from low-boiling distillates of cracked pe troleum 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 * * *’’. For use only as modifiers in waxpolymer blend coatings for corrugated paperboard intended for use in bulk packaging or raw fruits, raw vegetables, iced meat, iced fish, and iced poultry; and limited to use at a level not to exceed 30 weight-percent of the coating solids. Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride and ethylene gly col, 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 modi fied polyethylene has a saponification number not in excess of 6 after Soxhlet extraction for 24 hours with anhydrous ethyl alcohol. Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt Not to exceed 300 p.p.m. in finished coated paper or paper board. 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-catalyzed reaction product of vinyl-containing dimethyl polysiloxane (CAS Reg. Nos. 68083–19–2 and 68083–18–1) with methyl hydrogen polysiloxane (CAS Reg. No. 63148–57–2) or dimethyl (meth yl hydrogen) polysiloxane (CAS Reg. No. 68037–59–2). Diallyl maleate (CAS Reg No. 999–21–3), dimethyl maleate (CAS Reg. No. 624–48–6), 1-ethynyl-1-cyclohexanol (CAS Reg. No. 78–27–3) and vinyl acetate (CAS Reg. No. 108– 05–4) may be used as optional polymerization inhibitors. For use only as a surface coating. Platinum content not to ex ceed 200 parts per million. 1. 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 I, II, VI, and VII-B when used 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 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 de scribed in table 2 of paragraph (c) of this section. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00230 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 221 Food and Drug Administration, HHS § 176.170 List of substances Limitations Siloxanes and silicones; platinum-catalyzed reaction product of vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. 68083–19–2 and 68083–18–1), 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. Platinum content not to exceed 100 parts per million. For use only as a release coating for pressure sensitive adhesives. Sodium decylbenzenesulfonate. Sodium dihexyl sulfosuccinate. Sodium n-dodecylpolyethoxy (50 moles) sulfate-sodium isododecylphenoxypolyethoxy (40 moles) sulfate mixtures. For use only as an emulsifier in coatings that contact food only of the types identified 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. 1300–72–7) ................. For use only in paper and paperboard coatings at levels not to exceed 0.01 percent by weight of the finished paper and pa perboard. Styrene copolymers produced by copolymerizing styrene with maleic anhydride and its methyl and butyl (sec- or iso-) esters. Such copolymers may contain b-nitrostyrene as a po lymerization chain terminator. For use only as a coating or component of coatings and limited to use at a level not to exceed 1% by weight of paper or pa perboard substrate. Styrene polymers made by the polymerization of any combina tion of styrene or alpha methyl styrene with acrylic acid, methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, and butyl acrylate. The styrene and alpha methyl styrene, in dividually, may constitute from 0 to 80 weight percent of the polymer. The other monomers, individually, may be from 0 to 40 weight percent of the polymer. The polymer number aver age molecular weight (Mn) shall be at least 2,000 (as deter mined 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. For use only in contact with foods of Types IV-A, V, and VII in table 1 of paragraph (c) of this section, under use conditions E through G in table 2 of paragraph (c), and with foods of Types VIII and IX without use temperature restriction. Styrene-acrylic copolymers (CAS Reg. No. 25950–40–7 pro duced by polymerizing 77 to 83 parts by weight of styrene with 13 to 17 parts of methyl methacrylate, 3 to 4 parts of 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 copoly mers have a minimum number average molecular weight greater than 100,000 and a level of residual styrene mon omer in the polymer not to exceed 0.1 percent by weight. For use only as a component of coatings and limited to use at a level not to exceed 20 percent by weight of the coating solids. Styrene-butadiene copolymers produced by copolymerizing sty rene-butadiene with one or more of the monomer: acryl amide, 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 poly mer units derived from acrylic acid, fumaric acid, 2-hydroxy ethyl acrylate, itaconic acid and methacrylic acid, and shall contain not more than 2 weight percent of polymer units de rived 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 com bination of 2-hydroxyethyl acrylate and acrylic acid. Styrene-butadiene-vinylidene chloride copolymers containing not more than 40 weight percent of vinylidene chloride in the finished copolymers. The finished copolymers may contain not more than 10 weight percent of total polymer units de rived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid, and/or methacrylic acid. For use only as coatings or components of coatings. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00231 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 222 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of substances Limitations Styrene-dimethylstyrene-a-methylstyrene copolymers produced by polymerizing equimolar ratios of the three comonomers such that the finished copolymers have a minimum average molecular weight of 835 as determined by ASTM method D2503–82, ‘‘Standard Test Method for Molecular Weight (Relative Molecular Mass) of Hydrocarbons by Thermo electric Measurement of Vapor Pressure,’’ which is incor porated 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 Adminis tration (NARA). For information on the availability of this ma terial at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.. For use only in coatings for paper and paperboard intended for use in contact with nonfatty food and limited to use at a level not to exceed 50% by weight of the coating solids. Styrene-isobutylene copolymers (weight average molecular weight not less than 6,300). For use only in coatings for paper and paperboard intended 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 para graph (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 containing not more than 40 weight 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. For use only as coatings or components of coatings. 2-Sulfoethyl methacrylate, sodium salt [Chemical Abstracts Service No. 1804–87–1]. For use only in copolymer coatings under conditions of 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. a[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly (oxy ethylene) hydrogen sulfate, sodium salt mixture with a-[p (1,1,3,3-tetramethylbutyl)-phenyl]-omega-hydroxypoly (oxy ethylene) with both substances having a poly(oxyethylene) content averaging 3 moles. For use only as a surface-active agent at levels not to exceed 3 percent by weight of vinyl acetate polymer with ethylene and N-(hydroxymethyl) acrylamide intended for use in coat ings for paper and 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 con ditions 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, condi tions of use C, D, E, F, and G. Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecylsulfo-succina mate. For use only as an emulsifier in resin latex coatings, and lim ited to use at a level not to exceed 0.05% by weight of the coating solids. Toluenesulfonamide-formaldehyde resins. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00232 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 223 Food and Drug Administration, HHS § 176.170 List of substances Limitations Vinyl acetate copolymers produced by copolymerizing vinyl ac etate 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 propio nate, vinyl pyrrolidone, vinyl stearate, and vinyl sulfonic acid. The finished copolymers shall contain at least 50 weight per cent 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 ac rylate, 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 N-(hydroxymethyl) ac rylamide containing not more than 6 weight percent of total polymer units derived from N-(hydroxymethyl) acrylamide. For use only in coatings for paper and 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 con ditions 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, condi tions of use C, D, E, F, and G. Vinyl chloride copolymers produced by copolymerizing vinyl chloride with one or more of the monomers acrylonitrile; fu maric 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 an hydride; 5-norbornene-2, 3-dicarboxylic acid, mono-n-butyl ester; vinyl acetate-and vinylidene chloride. The finished co polymers 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 re acted with trimellitic anhydride. Vinylidene chloride copolymers produced by copolymerizing vi nylidene chloride with one or more of the monomers acryl amide acrylic acid, acrylonitrile, butyl acrylate, butyl meth acrylate ethyl acrylate, ethyl methacrylate, fumaric acid, itaconic acid, methacrylic acid, methyl acrylate, methyl meth acrylate, octadecyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride and vinyl sulfonic acid. The fin ished 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 sul fonic acid. Colorants:. Aluminum .............................................................................. For use as a colorant only. Aluminum hydrate ................................................................ Do. Aluminum and potassium silicate (mica) ............................. Do. Aluminum mono-, di-, and tristearate ................................... Do. Aluminum silicate (China clay) ............................................. Do. Barium sulfate ...................................................................... Do. Bentonite .............................................................................. Do. Bentonite, modified with dimethyldioctadecylammonium ion Do. Burnt umber .......................................................................... Do. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00233 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 224 21 CFR Ch. I (4–1–16 Edition) § 176.170 List of substances Limitations 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 blue 15, 15:1, 15:2, 15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147–14– 8). Do. Raw sienna ........................................................................... Do. Silica ..................................................................................... Do. Tartrazine lake (certified FD&C Yellow No. 5 only) ............. Do. Titanium dioxide ................................................................... Do. Titanium dioxide-barium sulfate ........................................... Do. Titanium dioxide-magnesium ............................................... Do. silicate. Zinc carbonate ...................................................................... Do. Zinc oxide ............................................................................. Do. (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 sol vents characterizing the type of food, and under conditions of time and tem perature characterizing the conditions of its intended use as determined from tables 1 and 2 of this paragraph, shall yield net chloroform-soluble extrac tives (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 con taining 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 in cluded under Types VIII or IX of this table: A. Moist bakery products with surface con taining free fat or oil. B. Moist bakery products with surface con taining 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. TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES Condition of use Types of food (see table 1) Food-simulating solvents Water Heptane 1 8 percent al-cohol 50 percent al cohol Time and temperature Time and temperature Time and temperature Time and tem perature A. High temperature heat-sterilized (e.g., over 212 °F). I, IV-B, VII-B ...... 250 °F, 2 hr ..................... ..................... ........................ III, IV-A, VII-A .... ......do .......... 150 °F, 2 hr ..................... ........................ B. Boiling water sterilized .............................. II, VII-B ............... 212 °F, 30 min. III, VII-A .............. ......do .......... 120 °F, 30 min. ..................... ........................ VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00234 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 225 Food and Drug Administration, HHS § 176.170 TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Continued Condition of use Types of food (see table 1) Food-simulating solvents Water Heptane 1 8 percent al-cohol 50 percent al cohol Time and temperature Time and temperature Time and temperature Time and tem perature C. Hot filled or pasteurized above 150 °F .... II, IV-B, VII-B ..... Fill boiling, cool to 100 °F. ..................... ..................... ........................ III, IV-A, VII-A .... ......do .......... 120 °F, 15 min. ..................... ........................ V, IX ................... ..................... ......do .......... ..................... ........................ D. Hot filled or pasteurized below 150 °F ..... II, IV-B, VI-B, ..... ..................... ..................... ..................... ........................ VII-B ................... 150 °F, 2 hr ..................... ..................... ........................ III, IV-A, VII-A .... ......do .......... 100 °F, 30 min. ..................... ........................ V, IX ................... ..................... ......do .......... ..................... ........................ VI-A .................... ..................... ..................... 150 °F, 2 hr ........................ VI-C .................... ..................... ..................... ..................... 150 °F, 2 hr. E. Room temperature filled and stored (no thermal treatment in the container). I, II, IV-B, VI-B, VII-B. 120 °F, 24 hr ..................... ..................... ........................ III, IV-A, VII-A .... ......do .......... 70 °F, 30 min. ..................... ........................ V, IX ................... ..................... ......do .......... ..................... ........................ VI-A .................... ..................... ..................... 120 °F, 24 hr ........................ VI-C .................... ..................... ..................... ..................... 120 °F, 24 hr. F. Refrigerated storage (no thermal treat ment in the container). III, IV-A, VII-A .... 70 °F, 48 hr 70 °F, 30 min. ..................... ........................ I, II, IV-B, VI-B, VII-B. ......do .......... ..................... ..................... ........................ VI-A .................... ..................... ..................... 70 °F, 48 hr ........................ VI-C .................... ..................... ..................... ..................... 70 °F, 48 hr. G. Frozen storage (no thermal treatment in the container). I, II, IV-B, VII-B .. 70 °F, 24 hr ..................... ..................... ........................ 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 emulsion of high- or low-fat. I, II, IV-B, VII-B .. 212 °F, 30 min. ..................... ..................... ........................ 2. Aqueous, high- or low-free oil or fat .. III, IV-A, VII-A, IX ......do .......... 120 °F, 30 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. (d) Analytical methods—(1) Selection of extractability conditions. First ascertain the type of food product (table 1, para graph (c) of this section) that is being packed commercially in the paper or paperboard and the normal conditions of thermal treatment used in pack aging the type of food involved. Using table 2, paragraph (c) of this section, select the food-simulating solvent or solvents and the time-temperature ex aggerations of the paper or paperboard use conditions. Having selected the ap propriate food-simulating solvent or solvents and the time-temperature ex aggeration over normal use, follow the applicable extraction procedure. (2) Reagents—(i) Water. All water used in extraction procedures should be freshly demineralized (deionized) dis tilled water. (ii) n-Heptane. Reagent grade, freshly redistilled before use, using only mate rial boiling at 208 °F. (iii) Alcohol. 8 or 50 percent (by vol ume), prepared from undenatured 95 percent ethyl alcohol diluted with demineralized (deionized) distilled water. (iv) Chloroform. Reagent grade, fresh ly redistilled before use, or a grade VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00235 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 226 21 CFR Ch. I (4–1–16 Edition) § 176.170 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 Extrac tion,’’ which is incorporated by ref erence (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 Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.); also described in ASTM method F34–76 (Reapproved 1980), ‘‘Standard Test Method for Liq uid Extraction of Flexible Barrier Ma terials,’’ which is incorporated by ref erence (copies may be obtained from the American Society for Testing Ma terials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428 2959, or may be examined at the Na tional Archives and Records Adminis tration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.), 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 spe cially 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 integ rity of the food-contact surface, they may be tested by adapting the fol lowing ‘‘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 beak er partially submersed in bath. (b) Analytical balance sensitive to 0.1 milligram with an approximate capac ity of 100 grams. (c) Tongs. (d) Hood and hot-plate facilities. (e) Forced draft oven. For each extraction, the following ad ditional 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 extrac tion, 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 alu minum screen, as follows: Screen, sam ple, sample, screen, sample, sample, screen, etc. Clip the sandwich together carefully with a No. 2 paper clip, leav ing just enough space at the top to slip a wire through. (c) Place an 800-milliliter beaker con taining 100-milliliters of the appro priate food-simulating solvent into the constant temperature bath, cover with a watch glass and condition at the de sired temperature. (d) After conditioning, carefully lower the sample sandwich with tongs into the beaker. (e) At the end of the extraction pe riod, using the tongs, carefully lift out the sample sandwich and hang it over the beaker with the wire. (f) After draining, pour the food-sim ulating solvent solution into a tared 250-milliliter beaker. Rinse the 800-mil liliter beaker three times, using a total of not more than 50 milliliters of the required solvent. (g) Determine total nonvolatile ex tractives 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00236 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 227 Food and Drug Administration, HHS § 176.170 cups, containers, or preformed or con verted products nearest to an area of 100 square inches. (5) Determination of amount of extrac tives—(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 rep licate 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 extrac tives removed by heptane under exagger ated 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 extrac tives residue. e′ or ee′ is substituted for e in the above equa tions 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 sec tion, proceed to paragraph (d)(5)(ii) of this section (method for determining the amount of chloroform-soluble ex tractives residues). (ii) Chloroform-soluble extractives res idue. Add 50 milliliters of chloroform (freshly distilled reagent grade or a grade having an established consist ently 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 equiva lent) funnel, collecting the filtrate in a clean, tared evaporating dish (platinum or Pyrex). Repeat the chloroform ex traction, 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 mil liliters on a low-temperature hotplate. The last few milliliters should be evap orated in an oven maintained at ap proximately 221 °F. Cool the evaporating dish in a desiccator for 30 minutes and weigh to the nearest 0.1 milligram to get the chloroform-solu ble extractives residue (′). This ′ is sub stituted for e in the equations in para graph (d)(5)(i) (a) and (b) of this sec tion. If the chloroform-soluble extrac tives 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 res idue). (iii) Corrected chloroform-soluble ex tractives 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. Cal culate the zinc in the ash as zinc ole ate, and subtract from the weight of chloroform-soluble extractives residue (′) to obtain the zinc-corrected chloro form-soluble extractives residue (e′). This e′ is substituted for e in the equa tions 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 centi meter chromatographic column (or VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00237 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 228 21 CFR Ch. I (4–1–16 Edition) § 176.170 standard 50-milliliter buret with an in side 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 option ally fitted with a 100-millimeter sol vent 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. Over lay the glass wool pledget (or fritted glass disc) with a 15–20 millimeter deep layer of fine sand. Measure in a grad uated cylinder 15 milliliters of chromatographic grade aluminum oxide (80–200 mesh) that has been tight ly 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 col umn 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 ex tract—(i) For chloroform residues weigh ing 0.5 gram or less. To the dried and weighed chloroform-soluble extract residue in the evaporating dish, ob tained 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 ob tain an aliquot of heptane solution cal culated to contain 0.1–0.5 gram of chlo roform-soluble extract residue.) Trans fer the clear liquid solution to the col umn (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 milli liters of heptane and add to the col umn. Wash (elute) the column with more heptane collecting about 100 mil liliters 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 min utes in an oven maintained at a tem perature 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 res idue (′) 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 para graph (d)(5)(iii)(b)(3)(i) of this section using proportionately larger quantities of heptane. Transfer the heptane solu tion 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. Pi pette out an aliquot (about 50 milli liters) 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 sec tion. In this case the weight of the dried residue from the heptane eluate must be multiplied by the dilution fac tor to obtain the weight of wax, petro latum, and mineral oil residue to be subtracted from the weight of chloro form-soluble extractives residue (′) to obtain the wax-, petrolatum-, and min eral oil-corrected chloroform-soluble extractives residue (e′). This e′ is sub stituted for e in the equations in para graph (d)(5)(i) (a) and (b) of this sec tion. (Note: In the case of chloroform VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00238 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 229 Food and Drug Administration, HHS § 176.180 soluble extracts which contain high melting waxes (melting point greater than 170 °F), it may be necessary to di lute 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 identi fied in this section shall comply with the provisions of § 180.22 of this chap ter, 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 ci tations affecting § 176.170, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 176.180 Components of paper and pa perboard 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 in tended for use in producing, manufac turing, 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 sec tion. (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 pack aging. (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 sur face of paper and paperboard, subject to the provisions of such regulation. (2) Substances identified in the fol lowing list: List of substances Limitations Acrylamide polymer with sodium 2-acrylamido-2 methylpropane-sulfonate (CAS Reg. No. 38193–60–1). For use at a level not to exceed 0.015 weight percent of 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) ethoxy]ethyl]disodium sulfo succinate. For use as a polymerization emulsifier and latex emulsion sta bilizer 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 per cent C14-C16).. Aluminum and calcium salts of FD & C dyes on a substrate of alumina. Colorant. Ammonium nitrate.. Amylose.. Barium metaborate ...................................................................... For use as preservative in coatings and sizings. 1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ....... For use only as a preservative in paper coating compositions and limited to use at a level not to exceed 0.02 mg/in2 (0.0031 mg/cm2) of finished paper and paperboard. N,N′-Bis(hydroxyethyl)lauramide. Bis(trichloromethyl) sulfone C.A. Registry No. 3064–70–8 ......... For use only as a preservative in coatings. Borax ........................................................................................... For use as preservative in coatings. Boric acid ..................................................................................... Do. Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt [CAS Reg. No. 144093–88–9]).. For use as a surface active agent in package coating inks at levels not to exceed 3 percent by weight of the coating ink. sec-Butyl alcohol.. Butyl benzyl phthalate.. Candelilla wax.. Carbon tetrachloride.. Castor oil, polyoxyethylated (42 moles ethylene oxide).. Cationic soy protein hydrolyzed (hydrolyzed soy protein isolate modified by treatment with 3-chloro-2-hydroxypropyl trimethylammonium chloride). For use only as a coating adhesive, pigment structuring agent, and fiber retention aid. Cationic soy protein (soy protein isolate modified by treatment with 3-chloro-2-hydroxypropyltrimethyl-ammonium chloride). For use only as a coating adhesive, pigment structuring agent, and fiber retention aid. Chloral hydrate ............................................................................ Polymerization reaction-control agent. N-Cyclohexyl-p-toluene sulfonamide.. 2,5-Di-tert-butyl hydroquinone. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00239 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 230 21 CFR Ch. I (4–1–16 Edition) § 176.180 List of substances Limitations Diethanolamine.. Diethylene glycol dibenzoate (CAS Reg. No. 120–55–8) ........... For use only as a plasticizer 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 ethylene diamine 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/federallregister/ codeloflfederallregulations/ibrllocations.html.. Diphenylamine.. Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... For use only as plasticizer in 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. 614–33–5) ......................... For use only as a plasticizer in polymeric coatings. Glyoxal.. Glyoxal-urea-formaldehyde condensate (CAS Reg. No. 27013– 01–0) formed by 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. For use as an insolubilizer for starch in coatings. Glyoxal-urea polymer (CAS Reg. No. 53037–34–6) ................... For use as an insolubilizer for 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-dioxabicyclo[3.3.0] octane, 5-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. For use only as an antibacterial preservative. Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– [2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1 methyl, methyl sulfates (CAS Reg. No. 72749–55–4).. For use only at levels not to exceed 0.5 percent by weight of the dry paper and paperboard. Isopropanolamine hydrochloride.. Isopropyl m- and p-cresol (thymol derived).. Itaconic acid.. Maleic anhydride-diisobutylene copolymer, ammonium or so dium 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.. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00240 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 231 Food and Drug Administration, HHS § 176.180 List of substances Limitations Methyl naphthalene sulfonic acid-formaldehyde condensate, sodium salt.. Methylated poly(N-1,2-dihydroxyethylene-1,3-imidazolidin-2 one). For use only only as an in solubilizer for starch. Modified polyacrylamide resulting from an epichlorohydrin addi tion to a condensate of formaldehyde-dicyandiamide diethylene triamine and which product is then reacted with polyacrylamide and urea to produce a resin having a nitro gen content of 5.6 to 6.3 percent and having a minimum vis cosity in 56 percent-by-weight aqueous solution of 200 centi poises at 25 °C, as determined by LVT-series Brookfield vis cometer using a No. 4 spindle at 60 r.p.m. (or equivalent method). For use only as a dry strength and pigment retention aid agent employed prior to the sheetforming operation in the manu facture of paper and paperboard and used at a level not to exceed 1 percent by weight of dry fibers. Mono- and di(2-alkenyl)succinyl esters 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. For use only as an emulsifier. Monoglyceride citrate.. Myristo chromic chloride complex.. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.. Nickel.. b-Nitrostyrene .............................................................................. Basic polymer. Octadecanoic acid, reaction products with 2-[(2 aminoethyl)amino]ethanol and urea (CAS Reg. No. 68412– 14–6), 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). For use prior to sheet forming at levels not to exceed 12 pounds per ton of paper. a-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.. a-(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 percent of its cystine resi dues oxidized to cysteic acid. For use as a binder adhesive component of coatings. Petroleum alicyclic hydrocarbon resins, or the hydrogenated product thereof, complying with the identity prescribed in § 176.170(b)(2). For use as modifiers at levels up to 30 weight-percent of the solids content of wax-polymer blend coatings. Petroleum hydrocarbon resins (produced by the catalytic po lymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked pe troleum 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′-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 mo lecular weight of 1,300,000 and a number-average molecular weight of 16,000.. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00241 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 232 21 CFR Ch. I (4–1–16 Edition) § 176.180 List of substances Limitations 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-a-hydro-omega-hydroxypoly(oxy-1,2 ethanediyl).. Polybutene, hydrogenated; complying with the identity pre scribed under § 178.3740(b) of this chapter.. Poly [2-(diethylamino) ethyl methacrylate] phosphate.. Polyethylene glycol (200) dilaurate.. Polyethylene glycol monoisotridecyl ether sulfate, sodium salt (CAS Reg. No. 150413–26–6). For use only as a surfactant at levels not to exceed 3 percent in latex formulations used in pigment binders for paper and paperboard. Polymers: Homopolymers and copolymers of the following monomers: Basic polymer. 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, formaldehyde, and propionaldehyde (CAS Reg. No. 106569–82–8). For use only as a starch and protein reactant in paper and pa perboard 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 diox ide, 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.. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00242 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 233 Food and Drug Administration, HHS § 176.200 List of substances Limitations 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. a-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-omega hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and their sodium, po tassium, and ammonium salts having a poly(oxyethylene) content averaging 6–9 or 40 moles.. a-[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′-Dioleoylethylenediamine. Diphenylamine. N,N′-Distearoylethylenediamine. Ethylenediamine. Guanidine. Imino-bis-butylamine. Imino-bis-ethylamine. Imino-bis-propylamine. N-Oleoyl-N′-stearoylethylenediamine. Polyamines made by reacting ethylenediamine or triethylenediamine with dichloroethane or dichloropropane. Tetraethylenepentamine. Triethylenetetramine. Xylene.. Xylene sulfonic acid-formaldehyde condensate, sodium salt.. Zinc stearate.. [42 FR 14554, Mar. 15, 1977] EDITORIAL NOTE: For 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 at www.fdsys.gov. § 176.200 Defoaming agents used in coatings. The defoaming agents described in this section may be safely used as com ponents of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, pack aging, transporting, or holding food, subject to the provisions of this sec tion. (a) The defoaming agents are pre pared as mixtures of substances de scribed in paragraph (d) of this section. (b) The quantity of any substance employed in the formulation of de foaming agents does not exceed the amount reasonably required to accom plish the intended physical or technical effect in the defoaming agents or any limitation further provided. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00243 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 234 21 CFR Ch. I (4–1–16 Edition) § 176.200 (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 speci fication in such regulation. (d) Substances employed in the for mulation of defoaming agents include: (1) Substances generally recognized as safe in food. (2) Substances subject to prior sanc tion or approval for use in defoaming agents and used in accordance with such sanction or approval. (3) Substances identified in this para graph (d)(3) and subject to such limita tions as are provided: 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 fatty acids derived from: For use only at levels not to exceed 0.1% by weight of total coating solids. Animal and vegetable fats and oils. Tall oil. Dimethylpolysiloxane. a-(Dinonylphenyl)-w-hydroxy-poly(oxy-1,2-ethanediyl), con taining 7 to 24 moles of ethylene oxide per mole of dinonylphenol (CAS Reg. No. 9014–93–1). For use only in defoaming agents for the production of styrene butadiene coatings at a level not to exceed 0.05 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. b-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. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00244 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 235 Food and Drug Administration, HHS § 176.210 List of substances Limitations 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. (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 accom plish 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 paper board. Defoaming agents may be safely used in the manufacture of paper and paper board intended for use in packaging, transporting, or holding food in accord ance with the following prescribed con ditions: (a) The defoaming agents are pre pared from one or more of the sub stances named in paragraph (d) of this section, subject to any prescribed limi tations. (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 manufac turing 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, VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00245 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 236 21 CFR Ch. I (4–1–16 Edition) § 176.210 and substances listed in this para graph, 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 dehy dration, to form chemicals of the cat egory 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 com pounds). 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 manu facturing 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 tetra sodium salt. Formaldehyde. Heavy oxo-fraction (a still-bottom product of iso-octyl alcohol manufacture, of approxi mate 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 sul fonic acid. Kerosine. Lanolin. Methanol. Methyl 12-hydroxystearate. Methyl taurine-oleic acid condensate, molec ular weight 486. a,a′-[Methylenebis[4-(1,1,3,3-tetramethylbu tyl)-o-phenylene]]bis[omega-hydroxypoly (oxyethylene)] having 6–7.5 moles of ethyl ene oxide per hydroxyl group. Mineral oil. Mono-, di-, and triisopropanolamine. Mono- and diisopropanolamine stearate. Monobutyl ether of ethylene glycol. Monoethanolamine. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00246 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 237 Food and Drug Administration, HHS § 176.230 Morpholine. Myristyl alcohol. Naphtha. b-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) meth acrylate esters, butyl methacrylate (CAS Reg. No. 97–88–1), isobutyl methacrylate (CAS Reg. No. 97–86–9) and methyl meth acrylate (CAS Reg. No. 80–62–6); the com bined 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 paper board fibers. Polyoxyethylene (4 mols) decyl phosphate. Polyoxyethylene (4 mols) di(2-ethyl hexano ate). Polyoxyethylene (15 mols) ester of rosin. Polyoxyethylene (3–15 mols) tridecyl alcohol. Polyoxypropylene, molecular weight 200– 2,000. Polyoxypropylene-polyoxethylene conden sate, minimum molecular weight 950. Polyoxypropylene-ethylene oxide condensate of ethylene diamine, molecular weight 1,700–3,800. Polyvinyl pyrrolidone, molecular weight 40,000. Potassium distearyl phosphate. Potassium pentachlorophenate. Potassium trichlorophenate. Rosins and rosin derivatives identified in § 175.105(c)(5) of this chapter. Silica. Siloxanes and silicones, dimethyl, methylhy drogen, reaction products with poly ethylene-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. a-[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 in tended for use in contact with food in accordance with the following pre scribed conditions: (a) It is used as follows: (1) In the manufacture of paper and paperboard as a preservative for sub stances added to the pulp suspension prior to the sheet-forming operation provided that the preservative is vola tilized by heat in the drying and fin ishing 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 coat ed paper or paperboard. (b) The quantity used shall not ex ceed the least amount reasonably re quired to accomplish the intended technical effect and shall not be in tended 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 reg ulation 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. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00247 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 238 21 CFR Ch. I (4–1–16 Edition) § 176.250 § 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 manu facture of paper and paperboard in tended for use in contact with food in an amount not to exceed that nec essary 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, treat ing, packaging, transporting, or hold ing food, subject to the provisions of paragraph (b) of this section. (b) Pulp from reclaimed fiber is pre pared 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 manu facture of paper and paperboard prod ucts excluding that which bears or con tains any poisonous or deleterious sub stance which is retained in the recov ered pulp and that migrates to the food, except as provided in regulations promulgated under sections 406 and 409 of the Federal Food, Drug, and Cos metic Act. (2) Salvage from used paper and pa perboard excluding that which (i) bears or contains any poisonous or delete rious substance which is retained in the recovered pulp and that migrates to the food, except as provided in regu lations promulgated under sections 406 and 409 of the act or (ii) has been used for shipping or handling any such sub stance. § 176.300 Slimicides. (a) Slimicides may be safely used in the manufacture of paper and paper board that contact food, in accordance with the following prescribed condi tions: (1) Slimicides are used as anti microbial agents to control slime in the manufacture of paper and paper board. (2) Subject to any prescribed limita tions, 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 adju vant substances as provided for under paragraph (d) of this section. (3) Slimicides are added to the proc ess water used in the production of paper or paperboard, and the quantity added shall not exceed the amount nec essary to accomplish the intended technical effect. (b) To insure safe usage, the label or labeling of slimicides shall bear ade quate directions for use. (c) Slime-control substances per mitted for use in the preparation of slimicides include substances subject to prior sanction or approval for such use and the following: List of substances Limitations Acrolein. Alkenyl (C16-C18) dimethylethyl-ammonium bromide. n-Alkyl (C12-C18) dimethyl benzyl ammonium chloride. 1,2-Benzisothiazolin-3-one .......................................................... At a level of 0.06 pound per ton of dry weight fiber. Bis(1,4-bromoacetoxy)-2-butene. 5,5-Bis(bromoacetoxymethyl) m-dioxane. 2,6-Bis(dimethylaminomethyl) cyclohexanone. 1,2-Bis(monobromoacetoxy) ethane [CA Reg. No. 3785–34–0] At a maximum level of 0.10 pound per ton of dry weight fiber. Bis(trichloromethyl)sulfone. 4-Bromoacetoxymethyl-m-dioxolane. 2-Bromo-4′-hydroxyacetophenone. 2-Bromo-2-nitropropane-1,3-diol (CAS Reg. No. 52–51–7) ........ At a maximum level of 0.6 pound per ton of dry weight fiber. b-Bromo-b-nitrostyrene ................................................................ At a maximum level of 1 pound per ton of dry weight fiber. Chloroethylenebisthiocyanate. 5-Chloro-2 - methyl - 4 - isothiazolin-3-one calcium chloride and 2-methyl-4-isothiazolin-3-one calcium chloride mixture at a ratio of 3 parts to 1 part. At a level of 2.5 pounds per ton of dry weight fiber. Chlorinated levulinic acids. Chloromethyl butanethiolsulfonate. Cupric nitrate. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00248 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 239 Food and Drug Administration, HHS § 176.300 List of substances Limitations n-Dialkyl (C12-C18) benzylmethylammonium chloride. 1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. At a maximum level of 0.005% of dry weight fiber. 2,2-Dibromo-3-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 Reg. No. 1192–52–5) ........ For use only at levels not to exceed 10 milligrams per kilogram in the pulp slurry. 1,3-Dihalo-5,5-dimethylhydantoin (where the dihalo (halogen) may be bromine and/or chlorine) that may contain no more than 20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin (where the dihalo (halogen) may be bromine and/or chlo rine).. At a maximum level of 1.0 kilogram (kg) per 1,000 kg of dry weight fiber. 4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018–09–1). At a maximum level of 0.2 pound per ton (100 grams/1,000 kilograms) of dry weight fiber. 3,5-Dimethyl 1,3,5,2H-tetrahydrothiadiazine-2-thione. Dipotassium and disodium ethylenebis(dithiocarba-mate). Disodium cyanodithioimidocarbonate. n-Dodecylguanidine 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 chloride (CAS Reg istry No. 34911–46–1). At a level of 0.02 pound per ton of dry weight fiber. 2-Hydroxypropyl methanethiol sulfonate. 2-Mercaptobenzothiazole. Methylenebisbutanethiolsulfonate. Methylenebisthiocyanate. 2-Nitrobutyl bromoacetate [CA Reg. No. 32815–96–6] .............. At a maximum level of 0.15 pound per ton of dry weight fiber. N-[a-(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 sulfate (CAS Reg. No. 55566–30–8). Maximum use level of 84 mg/kg in the pulp slurry. The additive may also be added to water, which when introduced into the pulp slurry, results in a concentration in the pulp slurry not to exceed 84 mg/kg. 2-(Thiocyanomethylthio) benzothiazole. Vinylene bisthiocyanate. (d) Adjuvant substances permitted to be used in the preparation of slimicides include substances generally recog nized as safe for use in food, substances generally recognized as safe for use in paper and paperboard, substances per mitted to be used in paper and paper board by other regulations in this chapter, and the following: Acetone. Butlylene oxide. Dibutyl phthalate. Didecyl phthalate. N,N-Dimethylformamide. Dodecyl phthalate. Ethanolamine. Ethylene glycol. Ethylenediamine. N-methyl-2-pyrrolidone (CAS Reg. No. 872– 50–4). a,a′-[Methylenebis[4-(1,1,3,3-tetramethyl butyl)-o-phenylene]] bis[omega-hydroxypoly (oxyethylene)] having 6–7.5 moles of ethyl ene oxide per hydroxyl group. Monomethyl ethers of mono-, di-, and tri propylene glycol. Nonylphenol reaction product with 9 to 12 molecules of ethylene oxide. Octylphenol reaction product with 25 mol ecules 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] VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00249 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 240 21 CFR Ch. I (4–1–16 Edition) § 176.320 § 176.320 Sodium nitrate-urea complex. Sodium nitrate-urea complex may be safely used as a component of articles intended for use in producing, manu facturing, packing, processing, pre paring, treating, packaging, trans porting, 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 con forming 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 plas ticizer in glassine and greaseproof paper. (ii) The amount used does not exceed that required to accomplish its in tended technical effect or exceed 15 percent by weight of the finished paper. (2) Conditions of use. The glassine and greaseproof papers are used for pack aging dry food or as the food-contact surface for dry food. § 176.350 Tamarind seed kernel pow der. Tamarind seed kernel powder may be safely used as a component of articles intended for use in producing, manu facturing, packing, processing, pre paring, treating, packaging, trans porting, or holding food, subject to the provisions of this section. (a) Tamarind seed kernel powder is the ground kernel of tamarind seed (Tamarindus indica L.) after removal of the seed coat. (b) It is used in the manufacture of paper and paperboard. PART 177—INDIRECT FOOD ADDITIVES: POLYMERS Subpart A [Reserved] Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces Sec. 177.1010 Acrylic and modified acrylic plas tics, semirigid and rigid. 177.1020 Acrylonitrile/butadiene/styrene co polymer. 177.1030 Acrylonitrile/butadiene/styrene/ methyl methacrylate copolymer. 177.1040 Acrylonitrile/styrene copolymer. 177.1050 Acrylonitrile/styrene copolymer modified with butadiene/styrene elas tomer. 177.1060 n-Alkylglutarimide/acrylic copoly mers. 177.1200 Cellophane. 177.1210 Closures with sealing gaskets for food containers. 177.1211 Cross-linked polyacrylate copoly mers. 177.1240 1,4-Cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer. 177.1310 Ethylene-acrylic acid copolymers. 177.1312 Ethylene-carbon monoxide copoly mers. 177.1315 Ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers. 177.1320 Ethylene-ethyl acrylate copoly mers. 177.1330 Ionomeric resins. 177.1340 Ethylene-methyl acrylate copoly mer resins. 177.1345 Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer. 177.1350 Ethylene-vinyl acetate copolymers. 177.1360 Ethylene-vinyl acetate-vinyl alco hol copolymers. 177.1380 Fluorocarbon resins. 177.1390 Laminate structures for use at tem peratures of 250 °F and above. 177.1395 Laminate structures for use at tem peratures between 120 °F and 250 °F. 177.1400 Hydroxyethyl cellulose film, water insoluble. 177.1420 Isobutylene polymers. 177.1430 Isobutylene-butene copolymers. 177.1440 4,4′-Isopropylidenediphenol epichlorohydrin resins minimum molec ular weight 10,000. 177.1460 Melamine-formaldehyde resins in molded articles. 177.1480 Nitrile rubber modified acrylo nitrile-methyl acrylate copolymers. 177.1500 Nylon resins. 177.1520 Olefin polymers. 177.1550 Perfluorocarbon resins. 177.1555 Polyarylate resins. 177.1556 Polyaryletherketone resins. 177.1560 Polyarylsulfone resins. 177.1570 Poly-1-butene resins and butene/ ethylene copolymers. 177.1580 Polycarbonate resins. 177.1585 Polyestercarbonate resins. 177.1590 Polyester elastomers. 177.1595 Polyetherimide resin. 177.1600 Polyethylene resins, carboxyl modi fied. 177.1610 Polyethylene, chlorinated. 177.1615 Polyethylene, fluorinated. 177.1620 Polyethylene, oxidized. 177.1630 Polyethylene phthalate polymers. 177.1632 Poly(phenyleneterephthalamide) resins. 177.1635 Poly(p-methylstyrene) and rubber modified poly(p-methylstyrene). VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00250 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R