(2) Extractives limitations. Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters. 4,4-Diisocyanato-3,3-dimethylbiphenyl (bi-tolylene diisocyanate). This is facilitated by a special gas cover consisting of an inverted flat Pyrex crystallizing dish of an appropriate size (190 millimeters 100 millimeters) to fit a 1-liter beaker. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The test shall be run on a sample approximately the size of a 18-inch cube in at least 25 milliliters of 4.2 normal hydrochloric acid. (ii) Direct reading viscoelastometric method titled Direct Reading Viscoelastrometric Method for Determining Glass Transition Points of Styrene Block Polymers (which is incorporated by reference; copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). Add n-hexane (1 liter) to the extraction vessel and clamp the assembly into a water bath set at 49.5 C 0.5 C. The spectrophotometer is adjusted for 0 and 100 percent transmittance at 700 m. (v) Duplicate permanganate test determinations shall be run on samples of distilled water and 8 and 50 percent alcohol solvents that have been exposed to the temperature-time conditions of the extraction test without the plastic sample. Weigh 1 to 2 grams of sample to the nearest 0.001 gram and place in a 125-milliliter Pyrex reagent bottle containing a 1-inch long tetrafluoroethylene-resin-coated stirring bar. Surfactant such as polysorbate 80 enhance the rate of oxidation of a scorbic acid at low concentrations but protect above its critical micelle concentration ( CMC) presumably by entrapping the drug in the spherical micelle offer a site for surface adsorption of catalytic ion. The ethylene-acrylic acid copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for use in contact with food subject to the provisions of this section. The absorbance in the 8 and 50 percent alcohol must not be less than 0.85 nor more than 1.15. (3) The copolymer, when extracted with n-hexane at reflux temperature for 2 hours, yields total extractives not to exceed 0.05 percent. Sodium oleyl sulfate-sodium cetyl sulfate mixture. (a) Identity. 24969-25-3) or the reaction product of trioxane (cyclic trimer of formaldehyde) and a maximum of 5 percent by weight of butanediol formal (CAS Reg. (c) Optional adjuvant substances. 15, 1977, as amended at 47 FR 11842, Mar. Acrylic copolymers (CAS Reg. The vinylidene chloride-methyl acrylate copolymers identified in and complying with this section, when used as components of the food contact surface of any article that is subject to a regulation in parts 174 through 178 and 179.45 of this chapter, shall comply with any specifications and limitations prescribed by such regulation for the article in the finished form in which it is to contact food. (e) Conditions of use. PLO improves the topical administration of drug mainly because of desired drug partitioning, biphasic drug solubility, and the modification of skin barrier system by organogel components. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). 2022
(Note: In testing the finished food-contact article, use a separate test sample for each required extracting solvent.). [64 FR 28098, May 25, 1999, as amended at 65 FR 16817, Mar. The last few milliliters should be evaporated in an oven maintained at a temperature of 221 F (105 C). (b) Optional adjuvant substances. 24936-41-2) polymer produced by the polymerization of p-methylstyrene. Cellophane may be safely used for packaging food in accordance with the following prescribed conditions: (a) Cellophane consists of a base sheet made from regenerated cellulose to which have been added certain optional substances of a grade of purity suitable for use in food packaging as constituents of the base sheet or as coatings applied to impart desired technological properties. The vinyl chloride-ethylene copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for contact with food, under conditions of use D, E, F, or G described in table 2 of 176.170 (c) of this chapter, subject to the provisions of this section. With broad resin solubility, it is suitable for use in coil coatings. The gelatin so used shall be technical grade or better. The finished copolyester-graft-acrylate copolymer shall meet the following specifications: (i) Weight average molecular weight 15,000-35,000. s = Total surface of the plastic sample in square inches. Eastman PM Solvent, a medium-boiling glycol ether, is an active solvent for cellulose acetate butyrate, nitrocellulose, epoxy, phenolic, acrylic, and alkyd resins. (ii) Total extractives do not exceed 0.03 weight-percent when extracted with water at 150 F for 2 hours. The cover is equipped with a thermometer and an efficient reflux condenser. Anti oxidant
The finished polyarylsulfone resin when extracted for 2 hours with the following solvents at the specified temperatures yields total extractives in each extracting solvent not to exceed 0.008 milligram per square centimeter of food-contact surface: distilled water at 121 C (250 F), 50 percent (by volume) ethyl alcohol in distilled water at 71.1 C (160 F), 3 percent acetic acid in distilled water at 100 C (212 F), and n-heptane at 65.6 C (150 F). 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). Chloroform-soluble extractives shall not exceed 0.08 milligram/centimeter2 (0.5 milligram/inch2) of food-contact surface of the modified polyethylene terephthalate article when exposed to the following solvents at temperatures and times indicated: (a) Distilled water at 49 C (120 F) for 24 hours; (b) n-Heptane at 49 C (120 F) for 24 hours; (c) 8 percent ethyl alcohol at 49 C (120 F) for 24 hours. Methyl acetate is a VOC-exempt, non-HAP, non-ODS, readily biodegradable solvent that can be used in blends to develop environmentally friendly cleaners. The absorbance of the 50 percent alcohol when measured versus distilled water in the reference cell shall not exceed 0.05 at any point in the wavelength region of 245 to 310 m. 8, 1983; 48 FR 17347, Apr. Chlorinated polyethylene identified in this section may be safely used as articles or components of articles that contact food, except for articles used for packing or holding food during cooking, subject to the provisions of this section. III. For use only as polymerization reaction control agent. 177.2410 Phenolic resins in molded articles. 177.1640 Polystyrene and rubber-modified polystyrene. Kirkland Signature Heavy Duty Laundry Detergent, #119903; Kirkland Signature Ultra Clean Premium Laundry Detergent Pacs Refreshing Scent, #1054838 (3) Preparation of solvents. Polybutadiene resin (molecular weight range 2,000-10,200; bromine number range 210-320). There is no attempt to include every possible procedure, but to provide the most useful selection. (i) Principle. switch to drafting.ecfr.gov. (3) Residual maleic anhydride monomer content. Turn on heating jacket with transformer set at a predetermined voltage to bring the temperature of the contents to 50 C within 20-25 minutes. Macrogol 1540,3000,4000 :- waxy solids, Preservatives
591-22-0), not more than 12 percent; and other dimethylpyridines, not more than 6 percent, For use only as an adjuvant substance in the production of propylene homopolymers complying with items 1.1, 1.2, and 1.3, and propylene copolymers complying with items 3.1, and 3.2 of, Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. (ii) Not to exceed 0.02 milligram per square inch of food contact surface when extracted for 2 hours at 150 F with n-heptane. 177.1390 Laminate structures for use at temperatures of 250 F and above. Triethylene glycol diacetate, prepared from triethylene glycol containing not more than 0.1 percent of diethylene glycol 2,2,4-Trimethyl-1,3 pentanediol diisobutyrate For use only in cellophane coatings and limited to use at a level not to exceed 10 percent by weight of the coating solids except when used as provided in 178.3740 of this chapter (6) Determination of amount of extractives -. It is anhydrous non- washable and do not absorb water. [42 FR 54533, Oct. 7, 1977, as amended at 42 FR 61594, Dec. 6, 1977]. Pipette 25 milliliters of the appropriate solvent into a clean, 125-milliliter Erlenmeyer flask that has been rinsed several times with aliquots of the same solvent. ), using No. (3) Maximum bromine value. The polyester elastomers identified in paragraph (a) of this section may be safely used as the food-contact surface of articles intended for use in contact with bulk quantities of dry food of the type identified in 176.170(c) of this chapter, table 1, under Type VIII, in accordance with the following prescribed conditions: (a) For the purpose of this section, polyester elastomers are those produced by the ester exchange reaction when one or more of the following phthalates - dimethyl terephthalate, and dimethyl isophthalate - is made to react with alpha-hydroomega-hydroxypoly (oxytetramethylene) and/or 1,4-butanediol such that the finished elastomer has a number average molecular weight between 20,000 and 30,000. Has very good synergy with Plurafac SLF 180, specially when used as a rinse aid in a low temperature dishwashing machines. (3) Substances regulated in 178.2010(b) of this chapter for use in polycarbonate resins complying with 177.1580: Provided, That the substances are used in accordance with any limitation on concentration, conditions of use, and food types specified in 178.2010(b) of this chapter. (b) The finished food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of its intended use as determined from tables 1 and 2 of 176.170(c) of this chapter, yields net acidified chloroform-soluble extractives not to exceed 0.5 milligram per square inch of food-contact surface when tested by the methods described in 177.1330(c), except that net acidified chloroform-soluble extractives from paper and paperboard complying with 176.170 of this chapter may be corrected for wax, petrolatum, and mineral oil as provided in 176.170(d)(5)(iii)(b) of this chapter. The copolyester is polymerized terephthalic acid (55 mol%), adipic acid (40 mol%), and fumaric acid (5 mol%) with ethylene glycol (40 mol%) and 1,4-butanediol (60 mol%). 42 Whatman filter paper, and the filtrate is collected in a graduated cylinder. 1,2-Dihydro-2,2,4-trimethyl-6-phenylquinoline. PEGs are used as humectant in cream. The vinylidene chloride/methyl acrylate/methyl methacrylate basic polymers and/or finished food-contact articles meet the following specifications and limitations: (i) The basic vinylidene chloride/methyl acrylate/methyl methacrylate polymers contain not more than 2 weight percent of polymer units derived from methyl acrylate monomer and not more than 6 weight percent of polymer units derived from methyl methacrylate monomer. Transfer the filtrate to flat glass dishes that are warmed on a hot plate and evaporate the solvent with the aid of a stream of filtered air. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). If you would like to comment on the current content, please use the 'Content Feedback' button below for instructions on contacting the issuing agency. Styrene-divinylbenzene resins, cross-linked. The resin discs when extracted with distilled water at 121 C (250 F) for 2 hours yield total nonvolatile extractives of not more than 12.3 micrograms per square centimeter. Oxalic acid, for use only as a polymerization catalyst aid. The total exposed surface should be 5 square inches 0.5-square inch. (b) Urethane cross-linking agent, comprising not more than twelve percent by weight of the cured adhesive, and formulated from trimethylol propane (CAS Reg. No. (4) Olefin basic copolymers manufactured by the catalytic polymerization of ethylene and octene-1 shall contain not less than 50 weight-percent of polymer units derived from ethylene. (i) The food contact surface meets the specifications in paragraph (f)(1) of this section and. Therefore it is very suitable for formulating gels as well as for stabilizing emulsions. 107-15-3). Flashpoint: 59F (15C), ASTM Closed Cup % VOC: Complies with Federal and State regulations for VOC content. The total amount of filtrate (without washing) is measured and called A milliliters. In the search of alternative resources to make commodity chemicals and transportation fuels for a low carbon future, lignocellulosic biomass with over 180-billion-ton annual production rate has been identified as a promising feedstock. 115-83-3). Lastly, the growth in organic farming, and the establishment of the Organic Farming Centre for Wales, funded by the National Assembly for Wales and based in the University of Wales, Institute of Rural Studies, Aberystwyth, has engendered a fresh interest in analytical methods more suitable for sustainable agriculture, and a chapter is included on this area of analysis. (vii) Polyester-polyurethane resin-acid dianhydride adhesives for use at temperatures not to exceed 121 C (250 F), in contact only with food Types I, II, VIA, VIB, VIIB, and VIII as described in Table I of 176.170 of this chapter, and formulated from the following mixture: (1) Polyesterpolyurethanediol resins prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 175.300(b)(3)(vii) of this chapter and 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. (i) Duplicate determinations of residual solids shall be run on samples of each solvent that have been exposed to the temperature-time conditions of the extraction test without the plastic sample. Butadiene-styrene-methacrylic acid copolymer. (ii) A minimum weight-average molecular weight of 27,000, as determined by gel permeation chromatography using polystyrene standards. Calculation: (ii) Olefin copolymers described in paragraph (a)(3)(i) of this section and polyethylene. For the purpose of this section, ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer consists of the basic copolymer produced by the catalytic polycondensation of isophthalic acid and terephthalic acid with ethylene glycol and 1,3-bis(2-hydroxyethoxy)benzene such that the finished resin contains between 42 and 48 mole-percent of isophthalic moieties, between 2 and 8 mole-percent of terephthalic moieties, and not more than 10 mole-percent of 1,3-bis(2-hydroxyethoxy)benzene moieties. The polyphenylene sulfone resins (CAS Reg. 10, shall yield total extractives as follows: (i) Not to exceed 0.20 percent by weight of the copolymer when extracted for 6 hours with distilled water at reflux temperature. (i) Gas chromatograph. Hydroxyethyl cellulose film, water-insoluble. BHT is odorless, odorless with good thermal stability. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Pluronic P123 is a symmetric triblock copolymer comprising poly(ethylene oxide) (PEO) and poly(propylene oxide) (PPO) in an alternating linear fashion, PEO-PPO-PEO. (g) Acrylonitrile copolymers identified in this section shall comply with the provisions of 180.22 of this chapter. (2) Residual acrylonitrile monomer content of the finished copolymer articles is not more than 11 parts per million as determined by a gas chromatographic method titled Determination of Residual Acrylonitrile and Styrene Monomers-Gas Chromatographic Internal Standard Method, which is incorporated by reference. If the crossed nicol apparatus is not available, use the lowest temperature at which the sample becomes transparent or the sharp edges or corners of the sample become rounded as the melting point. To link to the Machine-Readable Files, please click on the URL provided for EIN 36-2709818: https://www.anthem.com/machine-readable-file/search, Designed byWindy City Web Designs|Strategies, Anthem creates and publishes the Machine-Readable Files on behalf of EMCO Chemical Distributors. Copolymer of 1,4-cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate may be safely used as an article or component of articles used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The copolymer is a basic polyester produced by the catalytic condensation of dimethyl terephthalate and dimethyl isophthalate with 1,4-cyclohexanedimethanol, to which may have been added certain optional substances required in its production or added to impart desired physical and technical properties. The average difference in the absorbances in the region of 544 to 552 m shall be used as a blank correction for the determination of permanganate oxidizable extractives according to paragraph (c)(7)(iv) of this section. 19, 1982; 54 FR 24897, June 12, 1989]. (3) Nylon 66/610 resins are manufactured by the condensation of equal-weight mixtures of nylon 66 salts and nylon 610 salts. High-purity dry nitrogen containing less than 10 parts per million of oxygen. Not to exceed 0.01 percent by weight of the base polymer. Polyvinyl alcohol with melamine formaldehyde. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (c) Cyclohexanone when used as a solvent in the production of the filters shall not exceed 0.35 percent by weight of the microporous polymeric filters. The high solvent activity, slow evaporation rate, low density and surface tension, and high boiling point of Eastman MIAK (Methyl Isoamyl Ketone), make it ideal in formulating low-viscosity, high solids coatings with reduced VOC. (9) Nylon 12 resins are manufactured by the condensation of omega-laurolactam. developer resources. Potassium sorbate E202 solubility. The basic polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymers. The vinyl chloride-hexene-1 copolymers identified in paragraph (a) of this section or as components of articles intended for use in contact with food, under conditions of use D, E, F, or G described in table 2 of 176.170(c) of this chapter, subject to the provisions of this section. For information on the availability of this material at NARA, call 202-741-6030, or go to: The finished copolymer shall contain not more than 800 ppm 2-mercaptoethanol acrylonitrile adduct as determined by a method titled Analysis of Cycopac Resin for Residual -(2-Hydroxyethylmercapto) propionitrile, which is incorporated by reference. For the purposes of this section vinylidene chloride/methyl acrylate copolymers consist of basic copolymers produced by the copolymerization of vinylidene chloride and methyl acrylate such that the copolymers contain not more than 15 weight-percent of polymer units derived from methyl acrylate. Using tweezers and noting the number of film pieces, transfer 2.5 grams (accurately weighed to 0.1 milligram) of polymer to the extraction vessel. For use only in copolymer coatings on polyethylene phthalate film under conditions of use E, F, and G described in table 2 of 175.300(d) of this chapter, and limited to use at a level not to exceed 2.0 percent by weight of the dry copolymer coating. Minimum 10 pct solution viscosity at 25 C (77 F) is 10cP. Transfer the weighing dish with its residue to a vacuum desiccator, and allow it to remain overnight (at least 12 hours), after which the net weight of the dry residue is determined to the nearest 0.0001 gram. 177.1020 Acrylonitrile/butadiene/styrene co-polymer. (f) Polyethylene phthalate plastics conforming with the specifications prescribed in paragraph (f)(1) of this section are used as provided in paragraph (f)(2) of this section: (i) The food contact surface, when exposed to distilled water at 250 F for 2 hours, yields chloroform-soluble extractives not to exceed 0.5 mg/in2 of food contact surface exposed to the solvent; and. Poly(vinylidene fluoride) homopolymer (CAS Reg. At least 50 weight-percent of the polymer content of the acrylic and modified acrylic materials used as finished articles or as components of articles shall consist of polymer units derived from one or more of the acrylic or methacrylic monomers listed in paragraph (a)(1) of this section. The food contact surface when exposed to 95 percent ethanol at 120 F for 24 hours should not yield chloroform-soluble extractives in excess of 0.05 mg/in2. Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Allow the n-hexane to preheat for 1 hour to bring the temperature to 49.5 C0.5 C. The following extractive limitations are determined by an infrared spectrophotometric method titled, Infrared Spectrophotometric Determination of Polymer Extracted from Borex 210 Resin Pellets, which is incorporated by reference. Polyarylsulfone resins are copolymers containing not more than 25 percent of oxy-p-phenylene-oxy-p-phenylenesulfonyl-p-phenylene polymer units and not less than 75 percent of oxy-p-phenylenesulfonyl-p-phenylene-oxy-p-phenylenesulfonyl-p-phenylene polymer units. (b) Optional adjuvant substances. 1,3,5-Triethyl-hexahydro-s-triazine (triethyltrimethylenetriamine). (3) In accordance with good manufacturing practice, finished articles containing polyoxymethylene homopolymer shall be thoroughly cleansed prior to first use in contact with food. 6 and that will be held on a U.S. Standard Sieve No. (e) Conditions of use. (i) Polypropylene consists of basic polymers manufactured by the catalytic polymerization of propylene. (3) Substances that are the subject of regulations in parts 174, 175, 176, 177, 178 and 179.45 of this chapter and used in accordance with the conditions prescribed. [42 FR 14572, Mar. Low-Temperature Storage Chilling and Freezing 6. For the purposes of this section, poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene) are basic polymers, manufactured as described in this paragraph, meeting the specifications prescribed in paragraph (c) of this section. Close the test tube with a ground-glass stopper and expose to the specified temperature for the specified time. Remove the excess solvent by briefly blowing the basket with a stream of nitrogen or dry air. 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins. (1) Specifications. Nylon resins PA 6-3-T for repeated-use (excluding bottles) in contact with food of type VIA and VIB described in table 1 of, Aromatic petroleum hydrocarbon resin, hydrogenated (CAS Reg. Oleaginous bases :- It is consists of oil and fat. 15, 1977, as amended at 49 FR 10111, Mar. No. II. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). Fluorocarbon resins may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, fluorocarbon resins consist of basic resins produced as follows: (1) Chlorotrifluoroethylene resins produced by the homopolymerization of chlorotrifluoroethylene. (g) In accordance with good manufacturing practice finished rubber articles intended for repeated use in contact with food shall be thoroughly cleansed prior to their first use in contact with food. 9011-17-0) having a fluorine content of 65 to 71 percent and a Mooney viscosity of at least 28, as determined by a method entitled Mooney Viscosity, which is incorporated by reference in accordance with, For use only as an extrusion aid in the production of extruded olefin polymers at levels not to exceed 0.2 percent by weight of the polymer. (iii) Recorder. (ii) Nylon MXD-6 resins (CAS Reg. Addition of a chelating agent to a product will be useful when traces of heavy metal catalyst the oxidation. (iii) Antioxidants and antiozonants (total not to exceed 5 percent by weight of rubber product). The film when extracted with n-heptane at 38 C (100 F) for 30 minutes yields total extractives not to exceed 0.0078 milligram per square centimeter (0.05 milligram per square inch) of food-contact surface, after correcting the total extractives by dividing by a factor of five. (2) Minimum inherent viscosity: 0.13 deciliters per gram. (b) The basic polysulfone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. Oleic acid, dibutylamine salt (dibutylammonium oleate). The optional adjuvant substances required in the production of the basic olefin polymers or finished food-contact articles may include substances permitted for such use by applicable regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food and food packaging, substances used in accordance with a prior sanction or approval, and the following: (d) The analytical methods for determining whether olefin polymers conform to the specifications prescribed in this section are as follows, and are applicable to the basic polymer in film form not exceeding 4 mils in thickness. Enhanced content is provided to the user to provide additional context. For Federal Register citations affecting 177.2600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. information or personal data. (a) For the purpose of this section, isobutylene-butene copolymers consist of basic copolymers produced by the copolymerization of isobutylene with mixtures of n-butenes such that the finished basic copolymers contain not less than 45 weight percent of polymer units derived from isobutylene and meet the specifications prescribed in paragraph (b) of this section when tested by the methods described in paragraph (c) of this section. (2) Residual styrene monomer content. The basic poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. (g) Polymeric resins that comply with an applicable regulation in this chapter which permits food type and time/temperature conditions to which the container will be exposed, including sterilization processing. Filter the contents of the flask rapidly through No. You can download the paper by clicking the button above. (e) Resin-bonded filters conforming with the specifications of paragraph (e)(1) of this section are used as provided in paragraph (e)(2) of this section: (1) Total extractives.
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