FDA食品添加劑使用衛(wèi)生標準.rar

FDA食品添加劑使用衛(wèi)生標準.rar,FDA,食品添加劑,使用,衛(wèi)生標準 [Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2006] [CITE: 21CFR176] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED) ? PART 176 INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS ? Subpart A [Reserved] Subpart B--Substances for Use Only as Components of Paper and Paperboard Sec. 176.110 Acrylamide-acrylic acid resins. Acrylamide-acrylic acid resins may be safely used as components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) Acrylamide-acrylic acid resins are produced by the polymerization of acrylamide with partial hydrolysis or by the copolymerization of acrylamide and acrylic acid. (b) The acrylamide-acrylic acid resins contain less than 0.2 percent residual monomer. (c) The resins are used as adjuvants in the manufacture of paper and paperboard in amounts not to exceed that necessary to accomplish the technical effect and not to exceed 2 percent by weight of the paper or paperboard. Sec. 176.120 Alkyl ketene dimers. Alkyl ketene dimers may be safely used as a component of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The alkyl ketene dimers are manufactured by the dehydrohalogenation of the acyl halides derived from the fatty acids of animal or vegetable fats and oils. (b) The alkyl ketene dimers are used as an adjuvant in the manufacture of paper and paperboard under such conditions that the alkyl ketene dimers and their hydrolysis products dialkyl ketones do not exceed 0.4 percent by weight of the paper or paperboard. (c) The alkyl ketene dimers may be used in the form of an aqueous emulsion which may contain sodium lignosulfonate as a dispersant. Sec. 176.130 Anti-offset substances. ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ Carbon tetrachloride...................... Methyl hydrogen polysiloxanes............. Industrial starch_modified................ Complying with 178.3520 of this chapter. Stannous oleate........................... Zinc-2-ethyl hexoate...................... ------------------------------------------------------------------------ ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ Carbon tetrachloride...................... Methyl hydrogen polysiloxanes............. Industrial starch_modified................ Complying with 178.3520 of this chapter. Stannous oleate........................... Zinc-2-ethyl hexoate...................... ------------------------------------------------------------------------ Substances named in paragraphs (b) and (c) of this section may be safely used to prevent the transfer of inks employed in printing and decorating paper and paperboard used for food packaging in accordance with the provisions of this section: (a) The substances are applied to the nonfood contact, printed side of the paper or paperboard in an amount not greater than that required to accomplish the technical effect nor greater than any specific limitations, where such are provided. (b) Anti-offset powders are prepared from substances that are generally recognized as safe in food, substances for which prior sanctions or approvals were granted and which are used in accordance with the specific provisions of such sanction or approval, and substances named in paragraph (c) of this section. (c) The substances permitted are as follows: Sec. 176.150 Chelating agents used in the manufacture of paper and paperboard. ------------------------------------------------------------------------ List of substances Limitations ------------------------------------------------------------------------ Ammonium fructoheptonate.................. Ammonium glucoheptonate................... Disodium ethylenediamine tetraacetate..... Pentasodium salt of diethylenetriamine pentaacetate. Sodium fructoheptonate.................... Sodium glucoheptonate..................... Tetrasodium ethylenediamine tetraacetate.. Trisodium N-hydroxyethyl ethylenediamine triacetate. ------------------------------------------------------------------------ ------------------------------------------------------------------------ List of substances Limitations ------------------------------------------------------------------------ Ammonium fructoheptonate.................. Ammonium glucoheptonate................... Disodium ethylenediamine tetraacetate..... Pentasodium salt of diethylenetriamine pentaacetate. Sodium fructoheptonate.................... Sodium glucoheptonate..................... Tetrasodium ethylenediamine tetraacetate.. Trisodium N-hydroxyethyl ethylenediamine triacetate. ------------------------------------------------------------------------ The substances named in paragraph (a) of this section may be safely used in the manufacture of paper and paperboard, in accordance with the conditions prescribed in paragraphs (b) and (c) of this section: (a) Chelating agents: (b) Any one or any combination of the substances named is used or intended for use as chelating agents. (c) The substances are added in an amount not greater than that required to accomplish the intended technical effect nor greater than any specific limitation, where such is provided. Sec. 176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine. The chromium (Cr III) complex of N-ethyl - N -heptadecylfluoro-octane sulfonyl glycine containing up to 20 percent by weight of the chromium (Cr III) complex of heptadecylfluoro-octane sulfonic acid may be safely used as a component of paper for packaging dry food when used in accordance with the following prescribed conditions. (a) The food additive is used as a component of paper in an amount not to exceed 0.5 percent by weight of the paper. (b)(1) The food-contact surface of the paper is overcoated with a polymeric or resinous coating at least 1/3-mil in thickness, that meets the provision of 176.170; or (2) The treated paper forms one or more plies of a paper in a multiwall bag and is separated from the food by at least one ply of packaging films or grease-resistant papers which serves as a functional barrier between the food additive and the food. Such packaging films or grease-resistant papers conform with appropriate food additive regulations. (c) The labeling of the food additive shall contain adequate directions for its use to insure compliance with the requirements of paragraphs (a) and (b) of this section. Sec. 176.170 Components of paper and paperboard in contact with aqueous and fatty foods. Substances identified in this section may be safely used as components of the uncoated or coated food-contact surface of paper and paperboard intended for use in producing, manufacturing, packaging, processing, preparing, treating, packing, transporting, or holding aqueous and fatty foods, subject to the provisions of this section. Components of paper and paperboard in contact with dry food of the type identified under Type VIII of table 1 in paragraph (c) of this section are subject to the provisions of 176.180. (a) Substances identified in paragraph (a) (1) through (5) of this section may be used as components of the food-contact surface of paper and paperboard. Paper and paperboard products shall be exempted from compliance with the extractives limitations prescribed in paragraph (c) of this section: Provided, That the components of the food-contact surface consist entirely of one or more of the substances identified in this paragraph: And provided further, That if the paper or paperboard when extracted under the conditions prescribed in paragraph (c) of this section exceeds the limitations on extractives contained in paragraph (c) of this section, information shall be available from manufacturing records from which it is possible to determine that only substances identified in this paragraph (a) are present in the food-contact surface of such paper or paperboard. (1) Substances generally recognized as safe in food. (2) Substances generally recognized as safe for their intended use in paper and paperboard products used in food packaging. (3) Substances used in accordance with a prior sanction or approval. (4) Substances that by regulation in parts 170 through 189 of this chapter may be safely used without extractives limitations as components of the uncoated or coated food-contact surface of paper and paperboard in contact with aqueous or fatty food, subject to the provisions of such regulation. (5) Substances identified in this paragraph, as follows: ------------------------------------------------------------------------ List of Substances Limitations ------------------------------------------------------------------------ Acetyl peroxide........................ For use only as polymerization catalyst. Acrylamide-methacrylic acid-maleic For use only as a retention aid anhydride copolymers containing not employed prior to the sheet- more than 0.2 percent of residual forming operation in the acrylamide monomer and having an manufacture of paper and average nitrogen content of 14.9 paperboard in such an amount percent such that a 1 percent by that the finished paper and weight aqueous solution has a minimum paperboard will contain the viscosity of 600 centipoises at 75 additive at a level not in deg. F, as determined by LVG-series excess of 0.05 percent by Brookfield viscometer (or equivalent) weight of dry fibers in the using a No. 2 spindle at 30 r.p.m. finished paper and paperboard. Acrylamide-[beta]- For use only as a retention aid methacrylyloxyethyltrimethylammonium and flocculant employed prior methyl sulfate copolymer resins to the sheet-forming operation containing not more than 10 molar in the manufacture of paper percent of [beta]- and paperboard. methacrylyloxyethyltrimethylammonium methyl sulfate and containing less than 0.2% of residual acrylamide monomer. Acrylic acid, sodium salt copolymer For use only in paper mill with polyethyleneglycol allyl ether boilers. (CAS Reg. No. 86830-15-1). Acrylic acid copolymer with 2- For use only as a scale acrylamido-2-methylpropane-sulfonic inhibitor prior to the sheet- acid (CAS Reg. No. 40623-75-4) and/or forming operation in the its ammonium/alkali metal mixed salts. manufacture of paper and The copolymer is produced by poly- paperboard and used at a level merization of acrylic acid and 2- not to exceed 1.0 kilogram acrylamido-2-methylpropane-sulfonic (2.2 pounds) of copolymer per acid in a weight ratio of 60/40, such 907 kilograms (1 ton) of dry that a 28 percent by weight aqueous paper and paperboard fibers. solution of the polymer has a viscosity of 75-150 centipoises at 25 deg. C as determined by LV-series Brookfield viscometer (or equivalent) using a No. 2 spindle at 60 r.p.m. Acrylonitrile polymer, reaction product For use only as a size promoter with ethylenediamine sulfate having a and retention aid at a level nitrogen content of 22.5-25.0 percent not to exceed 0.5 percent by (Kjeldahl dry basis) and containing no weight of the dry paper and more than 0.075 percent monomer as paperboard. ethylenediamine. The finished resin in a 24 percent by weight aqueous solution has a viscosity of 1,000- 2,000 centipoises at 25 deg. C as determined by LVT-series Brookfield viscometer using a No. 4 spindle at 50 r.p.m. (or by other equivalent method). Acrylonitrile polymer with styrene, 1. For use only as a sizing reaction product with ethylenediamine material applied after the acetate, having a nitrogen content of sheet-forming operation in the 7.4-8.3 percent (Kjeldahl dry basis) manufacture of paper and and containing no more than 0.25 paperboard in such amount that percent monomer as ethylenediamine. the paper and paperboard will contain the additive at a level not in excess of 0.25 percent by weight of the dry paper and paperboard. 2. For use only as a sizing material applied prior to the sheet-forming operation in the manufacture of paper and paperboard in such amount that the paper and paperboard will contain the additive at a level not in excess of 1.0 percent by weight of the dry paper and paperboard. 1-Alkenyl olefins, containing not less For use only under the than 72 percent of C30 and higher following conditions: olefins. 1. In coatings for paper and paperboard with food of Types I, II, IV-B, and VII-B described in table 1 of paragraph (c) of this section under conditions of use E, F, and G described in table 2 of paragraph (c) of this section. 2. In coatings for paper and paperboard with food of Type VIII described in table I of paragraph (c) of this section under conditions of use A through H described in table 2 of paragraph (c) of this section. (2-Alkenyl) succinic anhydrides For use only as a sizing agent mixture, in which the alkenyl groups employed prior to the sheet- are derived from olefins which contain forming operation in the not less than 95 percent of C15-C21 manufacture of paper and groups. paperboard and limited to use at a level not to exceed 1 percent by weight of the finished dry paper and paperboard fibers. Alkyl(C12-C20)methacrylatemethacrylic For use only as stabilizers acid copolymers (CAS Reg. No. 27401-06- employed prior to the sheet- 5). forming operation in the manufacture of paper and paperboard. tert-Alkyl(C8-C16)mercaptans........... For use only as polymerization- control agent. Aluminum acetate....................... 2-Amino-2-methyl-1-propanol (CAS Reg. For use as a dispersant for No. 124-68-5). pigment suspension at a level not to exceed 0.25 percent by weight of pigment. The suspension is used as a component of coatings for paper and paperboard under conditions of use described in paragraph (c) of this section, table 2, conditions of use E through G. Ammonium bis(N-ethyl-2- For use only as an oil and perfluoroalkylsulfonamido ethyl) water repellant at a level not phosphates, containing not more than to exceed 0.17 pound (0.09 15% ammonium mono (N-ethyl-2- pound of fluorine) per 1,000 perfluoroalkylsulfonamido ethyl) square feet of treated paper phosphates, where the alkyl group is or paperboard of a sheet basis more than 95% C8 and the salts have a weight of 100 pounds or less fluorine content of 50.2% to 52.8% as per 3,000 square feet of paper determined on a solids basis. or paperboard, and at a level not to exceed 0.5 pound (0.26 pound of fluorine) per 1,000 square feet of treated paper or paperboard having a sheet basis weight greater than 100 lb. per 3,000 square feet as determined by analysis for total fluorine in the treated paper or paperboard without correction for any fluorine that might be present in the untreated paper or paperboard, when such paper or paperboard is used as follows: 1. In contact, under conditions of use C, D, E, F, G, or H described in table 2 of paragraph (c) of this section, with nonalcoholic food. 2. In contact with bakery products of Type VII, VIII, and IX described in table I of paragraph (c) of this section under good manufacturing practices of commercial and institutional baking. Ammonium persulfate.................... Ammonium thiosulfate................... Ammonium zirconium carbonate (CAS Reg. For use only as an No. 32535-84-5) and its tartaric acid insolubilizer for binders used adduct. in coatings for paper and