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Regulatory Information Sheet
Regulatory Information Sheet List of Permanently Listed Color Additives Subject to U.S. Certification* Color 21 CFR References CAS Color Common Name Index Medical Number Food Drug Cosmetic Number Devices D&C Black No. 2 Carbon Black 77266 1333-86-4 -- -- 74.2052 -- D&C Black No. 3 Bone Black 77267 8021-99-6 -- -- 74.2053 -- FD&C Blue No. 1 Brilliant Blue FCF 42090 2650-18-2 74.101 74.1101 74.2101 -- FD&C Blue No. 2 Indigotine 73015 860-22-0 74.102 74.1102 -- 74.3102 D&C Blue No. 4 Alphazurine FG 42090 6371-85-3 -- 74.1104 74.2104 -- D&C Blue No. 6 Indigo 73000 482-89-3 -- -- -- 74.3106 D&C Blue No. 9 Indanthrene Blue 69825 130-20-1 -- 74.1109 -- -- D&C Brown No. 1 Resorcin Brown 20170 1320-07-6 -- -- 74.2151 -- FD&C Green No. 3 Fast Green FCF 42053 2353-45-9 74.203 74.1203 74.2203 -- D&C Green No. 5 Alizarin Cyanine Green F 61570 4403-90-1 -- 74.1205 74.2205 -- D&C Green No. 6 Quinizarine Green SS 61565 128-80-3 -- 74.1206 74.2206 74.3206 D&C Green No. 8 Pyranine Concentrated 59040 6358-69-6 -- 74.1208 74.2208 -- Orange B -- 19235 -- 74.250 -- -- -- D&C Orange No. 4 Orange II 15510 633-96-5 -- 74.1254 74.2254 -- D&C Orange No. 5 Dibromofluorescein 45370:1 596-03-2 -- 74.1255 74.2255 -- D&C Orange No. 10 Diiodofluorescein 45425:1 3329-19-9 -- 74.1260 74.2260 -- D&C Orange No. -
Annex 2B Tariff Schedule of the United States See General Notes to Annex 2B for Staging Explanation HTSUS No
Annex 2B Tariff Schedule of the United States See General Notes to Annex 2B for Staging Explanation HTSUS No. Description Base Rate Staging 0101 Live horses, asses, mules and hinnies: 0101.10.00 -Purebred breeding animals Free E 0101.90 -Other: 0101.90.10 --Horses Free E 0101.90.20 --Asses 6.8% B --Mules and hinnies: 0101.90.30 ---Imported for immediate slaughter Free E 0101.90.40 ---Other 4.5% A 0102 Live bovine animals: 0102.10.00 -Purebred breeding animals Free E 0102.90 -Other: 0102.90.20 --Cows imported specially for dairy purposes Free E 0102.90.40 --Other 1 cent/kg A 0103 Live swine: 0103.10.00 -Purebred breeding animals Free E -Other: 0103.91.00 --Weighing less than 50 kg each Free E 0103.92.00 --Weighing 50 kg or more each Free E 0104 Live sheep and goats: 0104.10.00 -Sheep Free E 0104.20.00 -Goats 68 cents/head A 0105 Live poultry of the following kinds: Chickens, ducks, geese, turkeys and guineas: -Weighing not more than 185 g: 0105.11.00 --Chickens 0.9 cents each A 0105.12.00 --Turkeys 0.9 cents each A 0105.19.00 --Other 0.9 cents each A -Other: 0105.92.00 --Chickens, weighing not more than 2,000 g 2 cents/kg A 0105.93.00 --Chickens, weighing more than 2,000 g 2 cents/kg A 0105.99.00 --Other 2 cents/kg A 0106 Other live animals: -Mammals: 0106.11.00 --Primates Free E 0106.12.00 --Whales, dolphins and porpoises (mammals of the order Cetacea); manatees and dugongs (mammals of the order Sirenia) Free E 0106.19 --Other: 2B-Schedule-1 HTSUS No. -
Preparation Range Cotton and Cotton Blend
FORTY YEARS OF WANDERINGS IN TEXTILE CHEMISTRY PROCESS AND MATERIALS RESEARCH DR. FRED L. COOK MSE/GEORGIA TECH OLNEY MEDAL ADDRESS AATCC INTERNATIONAL CONFERENCE WILLIAMSBURG, VA APRIL 21, 2016 COMBINED DESIZE- SCOUR-BLEACH OPPORTUNITIES • Current Continuous Process Requires Three Separate Padding-Steam- Wash Steps/Sections • Process is an Energy, Water, Space, Chemical, etc., “Hog” RESEARCH APPROACH • Create a Chemical Formulation that will Allow a Single Step Path to Fully-Prepared, Cotton-Containing Woven Fabrics, i.e., a Combined Desize-Scour-Bleach Process Cook, F. L., et al., 1982. Evaluating Combined Preparation Processes for Energy And Material Conservation, Textile Chemist and Colorist, 14(1), 10-23. PREPARATION RANGE COTTON AND COTTON BLEND Heat Enzymes NaOH H2O2 Greige Singeing Desizing Scouring Bleaching Fabric Fiber Size Waxes Color Proteins Ends Pectins CONTINUOUS PREPARATION RANGE DSB FORMULATION INITIAL FORMULATION (50/50 COTTON/ POLYESTER FABRICS) 1. NaOH Comparable to Scour Formulation 2. NaSiO2 “ “ “ 3. Chelate “ “ “ 4. H2O2 Huge Excess Compared to Bleaching!! 5. Surfactant Comparable to Scour Formulation INITIAL RESULTS • All properties consistent with plant standards except whiteness (achieved ~ 70 on the whiteness scale, needed ~77 MAGIC CHEMICAL • Tetrapotassiumperoxydiphosphate, KPP (FMC Corp.) • Required only ~1% w/w concentration in pad to give desired whiteness DYEING/PRINTING OF NOMEX® ALTERNATE DYEING PROCESS • STX System from Rhone-Poulenc (France) • Based on 90% Perchloroethylene (PERC)/10% Methanol • Ionic Dyes Soluble in the Mixture, but not in PERC • Process is Based on the Differential Boiling Points between Methanol (~ 65C) and PERC (~121C) • R-P Developed the System for Acid Dyeing of Nylon (Commercialized in a Beam Dyeing Platform on Tufted Carpet in Belgium) 1. -
401 Part 73—Listing of Color Ad- Ditives Exempt from Certifi- Cation
Food and Drug Administration, HHS Pt. 73 the act, has notified the sponsor or in- 73.352 Paracoccus pigment. vestigator that the proposed disposi- 73.355 Phaffia yeast. tion for food is authorized. Any person 73.450 Riboflavin. 73.500 Saffron. who contests a refusal to grant such 73.530 Spirulina extract. authorization shall have an oppor- 73.575 Titanium dioxide. tunity for a regulatory hearing before 73.585 Tomato lycopene extract; tomato ly- the Food and Drug Administration pur- copene concentrate. suant to part 16 of this chapter. 73.600 Turmeric. (b) The person who introduced such 73.615 Turmeric oleoresin. shipment or who delivers the color ad- ditive or a food, drug, or cosmetic con- Subpart B—Drugs taining such an additive into interstate 73.1001 Diluents in color additive mixtures commerce shall maintain adequate for drug use exempt from certification. records showing the name and post-of- 73.1010 Alumina (dried aluminum hydrox- fice address of the expert to whom the ide). color additive is shipped, date, quan- 73.1015 Chromium-cobalt-aluminum oxide. tity, and batch or code mark of each 73.1025 Ferric ammonium citrate. 73.1030 Annatto extract. shipment and delivery for a period of 2 73.1070 Calcium carbonate. years after such shipment and delivery. 73.1075 Canthaxanthin. Upon the request of a properly author- 73.1085 Caramel. ized employee of the Department, at 73.1095 b-Carotene. reasonable times, he shall make such 73.1100 Cochineal extract; carmine. records available for inspection and 73.1125 Potassium sodium copper copying. chlorophyllin (chlorophyllin-copper com- plex). -
Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted Or Referenced in Inds and Ndas
MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 5021.2 POLICY AND PROCEDURES OFFICE OF PHARMACEUTICAL QUALITY Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAs Table of Contents PURPOSE ..............................................................................1 BACKGROUND ...................................................................2 POLICY .................................................................................4 RESPONSIBILITIES ...........................................................5 PROCEDURES .....................................................................7 EFFECTIVE DATE ..............................................................9 CHANGE CONTROL TABLE ............................................9 Attachment 1: Listing of Color Additives Subject to Certification (21 CFR Part 74, Subpart B, Drugs) .............10 Attachment 2: Listing of Color Additives Exempt From Certification (Subpart B, Drugs) ........................................12 PURPOSE This MAPP describes the policies, procedures, and responsibilities in the Office of Pharmaceutical Quality (OPQ), in collaboration with the Office of New Drugs (OND), for assessing a color additive1 or a flavor present as an excipient in an oral drug product submitted as part of an investigational new drug application (IND), new drug application (NDA), NDA supplement, or an amendment to one of these submissions, or referenced in a Type IV drug master file (DMF).2,3 Specifically, -
List of Spectra /Compound Names
IS NIR Spectra Complete collection (6049 spectra) This collection includes all NIR spectra collected within this project. Those are organic and inorganic chemicals, pharmaceutical excipients, drugs, polymers, additives, coatings, dyes, pigments, toxic substances, hazardous substances like explosives, agrochemicals and other types of materials. This collection should be chosen by customers with broad range of analytical applications. The near infrared spectral library „IS NIR Spectra“ is a unique collection of 6049 NIR (near infrared) digital spectra. The spectra have been collected in range 4200-10000 cm-1 (=2.4 – 1 micrometers). „IS NIR Spectra“ is the biggest and newest NIR library available on the market. This spectral library has been designed for users who use their NIR spectrometer not only for quantitative and chemometric analysis, but also want to identify unknown samples or just want to use the library as reference spectra database. ra t IS means “Intergrating Sphere” and at the same time “Identify Samplec”. e Technical parameters: p The „IS NIR Spectra“ were collected using the FT-NIR Spectrometer equipped with Integrating Sphere Accessory. Resolution: standard 4cm-1 IR Customized resolution: upon special request the speNctra can be delivered in customized resolution to reach better correspondence with spectr a collected by customer NIR instrument Spectral range in wavenumbers units: 4200-1000I0S cm-1 Spectral range in wavelength units: 2.4 – 1 micr ometers Only one spectrum/compound covering the mentioned spectral range Typical text information about the sample inmcludes (when available): Compound name including synonyms o CAS number .c Chemical formula a Molecular weight tr Additional information about thec sample like manufacturer and comments. -
United States Patent Office Patented Mar
3,124,411 United States Patent Office Patented Mar. 10, 1964 2 The amount of sodium hydroxide required in the re 3,124,411 ducing bath varies with the class of vat dye used and can METHOD FOR DYENG TEXTELEMATERALS be determined from the booklets published by the dye WITH WAT DYES manufacturer. Each dye works best at a certain sodi Gilbert S. Pansoa and Carol E. Weill, Livingston, N.J., um hydroxide level. Sufficient sodium hydroxide in ex assignors to Metal Hydrides Incorporated, Beverly, cess of the amount required to convert the dye to its Mass., a corporation of Massachusetts alkali leuco form must be present to stabilize the bath. No Drawing. Fied July 17, 1961, Ser. No. 124,373 In some instances in commercial operation it is desira 6 Claims. (C. 8-34) ble to dry the impregnated fabric before immersion in This invention relates to dyeing textile materials with 0. the reducing bath. Cloth impregnated with vat dye and vat dyes. sodium bisulfite in accordance with the invention can be Textile materials, such as cotton fabrics, usually are dried at 110 C. for 1 to 2 hours and then immersed dyed by padding a vat dye on to the fabric, squeezing in the reducing bath and obtain the desired shade. This out the excess, and then passing the dye impregnated indicates the great stability of the mixture of bisulfite fabric through an aqueous bath containing sodium hy and vat dye. droxide, sodium hydrosulfite and sodium chloride. The Reduction of the dye to the sodium leuco and ex reducing liquor reduces the dye and converts it to the haustion of the dye in to the fabric is dependent upon the water soluble sodium leuco form, the presence of the salt temperature of the bath and the time of contact. -
PART 73—LISTING of COLOR AD- Plex)
Pt. 73 21 CFR Ch. I (4–1–18 Edition) states prominently, ‘‘Caution—Con- 73.165 Ferrous lactate. tains new color additive—For inves- 73.169 Grape color extract. tigational use only.’’ No animals used 73.170 Grape skin extract (enocianina). 73.185 Haematococcus algae meal. in such investigations, or their prod- 73.200 Synthetic iron oxide. ucts, such as milk or eggs, shall be 73.250 Fruit juice. used for food purposes, unless the spon- 73.260 Vegetable juice. sor or the investigator has submitted 73.275 Dried algae meal. to the Commissioner data dem- 73.295 Tagetes (Aztec marigold) meal and onstrating that such use will be con- extract. sistent with the public health, and the 73.300 Carrot oil. Commissioner, proceeding as he would 73.315 Corn endosperm oil. 73.340 Paprika. in a matter involving section 409(i) of 73.345 Paprika oleoresin. the act, has notified the sponsor or in- 73.350 Mica-based pearlescent pigments. vestigator that the proposed disposi- 73.352 Paracoccus pigment. tion for food is authorized. Any person 73.355 Phaffia yeast. who contests a refusal to grant such 73.450 Riboflavin. authorization shall have an oppor- 73.500 Saffron. tunity for a regulatory hearing before 73.530 Spirulina extract. the Food and Drug Administration pur- 73.575 Titanium dioxide. 73.585 Tomato lycopene extract; tomato ly- suant to part 16 of this chapter. copene concentrate. (b) The person who introduced such 73.600 Turmeric. shipment or who delivers the color ad- 73.615 Turmeric oleoresin. ditive or a food, drug, or cosmetic con- taining such an additive into interstate Subpart B—Drugs commerce shall maintain adequate 73.1001 Diluents in color additive mixtures records showing the name and post-of- for drug use exempt from certification. -
Analysis of Artificial Colorants in Various Food Samples Using Monolithic Silica Columns and LC-MS by Stephan Altmaier, Merck Millipore, Frankfurter Str
31 Analysis of Artificial Colorants in Various Food Samples using Monolithic Silica Columns and LC-MS by Stephan Altmaier, Merck Millipore, Frankfurter Str. 250, 64293 Darmstadt, Germany This work describes a simple and sensitive high performance liquid chromatography method with UV or mass spectrometry detection for the analysis of artificial colorants from dye classes such as azo or chinophthalone in various food samples. After a short sample preparation procedure all samples were separated on C18 reversed phase monolithic silica columns via a gradient elution profile and directly transferred to UV or MS for the analysis of the main components. This setup enabled the identification of dyes in real life samples such as beverages or sweets within very short analysis times and with a minimised sample preparation step. In the nineteenth century chemicals such as azo compounds (see Tables 1 and 2 and by an organism very easily. mercury sulphide, lead oxide, copper salts or Figure 1). They are utilised as a single Most of the current artificial colorants can now fuchsine were utilised to artificially colour colouring ingredient or as a mixture with be replaced by natural dyes very easily. food such as cheese, confectionary, pickles other colorants in a wide variety of foods and Nevertheless, for economic reasons they are [1] or wine [2]. In the end of that century the beverages. All listed dyes are nontoxic and still used to improve the attractiveness of discovery of many synthetic organic food water soluble and can therefore be excreted sweets or soft drinks towards children or of colorants allowed for more brilliant colours than traditional natural dyes. -
List of Colorants in Cosmetic Products
List of Colorants in Cosmetic Products This rule has been translated into English according to the original Chinese version. If there is any inconsistency or ambiguity between these two versions, the Chinese version shall prevail. Explanation of Colorants Classification: Class 1: Colorants allowed in all cosmetic products Class 2: Colorants allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes Class 3: Colorants allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes Class 4: Colorants allowed exclusively in cosmetic products intended to come into contact only briefly with the skin Colour Index Number/ Scope of Number Alias Name Restriction Ingredient Name Application 1 CI 10006 Pigment Green 8 4 Acid Green 1 3 Using in hair dye 2 CI 10020 Ext. D&C Green No. 1 products is forbidden. Naphthol Green B Acid Yellow 1 2 3 CI 10316 Ext. D&C Yellow No. 7 Naphthol Yellow S Pigment Yellow 1 3 4 CI 11680 Ext. D&C Yellow No. 5 Hansa Yellow G 5 CI 11710 Pigment Yellow 3 3 Pigment Orange 1 4 6 CI 11725 Hansa Yellow 3R Food Orange 3 1 Using in hair dye 7 CI 11920 products is forbidden. Solvent Red 3 3 Using in hair dye 8 CI 12010 products is forbidden. Pigment Red 4 1 1. Limited content: D&C Red No. 36 3% 9 CI 12085 Permanent Red 2. Using in hair dye products is forbidden. 1 Colour Index Number/ Scope of Number Alias Name Restriction Ingredient Name Application Pigment Red 3 4 10 CI 12120 D&C Red No. -
Regulatory Information Sheet
Regulatory Information Sheet Color Additives Exempt from Certification Permitted for Use in the U.S.* 21 CFR References Color Index Color CAS Number Medical Number Food Drug Cosmetic Devices Algae Meal (Dried) -- -- 73.275 -- -- -- Algae Meal (Haematococcus) -- -- 73.185 -- -- -- Alumina (Dried Aluminum Hydroxide) 77002 1332-73-6 -- 73.1010 -- -- Aluminum Powder 77000 7429-90-5 -- 73.1645 73.2645 -- Annatto Extract 75120 8015-67-6 73.30 73.1030 73.2030 -- Astaxanthin -- -- 73.35 -- -- -- Astaxanthin Dimethyldisuccinate -- -- 73.37 -- -- -- Beta-Apo-8’-Carotenal 40820 1107-26-2 73.90 -- -- -- Beta Carotene 40800 7235-40-7 73.95 73.1095 73.2095 -- Beet Powder (Dehydrated Beets) -- 57917-55-2 73.40 -- -- -- Bismuth Citrate -- -- -- -- 73.2110 -- 7440-50-8 Bronze Powder 77440 -- 73.1646 73.2646 -- 7740-66-6 Calcium Carbonate 77220 471-34-1 -- 73.1070 -- -- Canthaxanthin 40850 514-78-3 73.75 73.1075 -- -- Caramel -- 8028-89-5 73.85 73.1085 73.2085 -- Carbazole Violet 51319 6358-30-1 -- -- -- 73.3107 Carmine 75470 1390-65-4 73.100 73.1100 73.2087 -- Carrot Oil -- 8015-88-1 73.300 -- -- -- Chlorophyll Copper Complex 75810 -- -- 73.1125 73.2125 73.3110 Chromium-Cobalt-Aluminum Oxide 77343 68187-11-1 -- 73.1015 -- 73.3110a Chromium Hydroxide Green 77289 12182-82-0 -- 73.1326 73.2326 -- Chromium Oxide Greens 77288 1308-38-9 -- 73.1327 73.2327 73.3111 C.I. Vat Orange 1 59105 -- -- -- -- 73.3112 Cochineal Extract 75470 1260-17-9 73.100 73.1100 -- -- Corn Endosperm Oil -- -- 73.315 -- -- -- Copper Powder 77400 7440-50-6 -- 73.1647 73.2647 -- 1,4-Bis[(2-hydroxyethyl)amino]-9,10- -
Technological Applications of Natural Colorants in Food Systems: a Review
foods Review Technological Applications of Natural Colorants in Food Systems: A Review Ivan Luzardo-Ocampo 1 , Aurea K. Ramírez-Jiménez 2 , Jimena Yañez 2 , Luis Mojica 3 and Diego A. Luna-Vital 2,* 1 Instituto de Neurobiología, Universidad Nacional Autónoma de México (UNAM), Santiago de Querétaro, QRO 76230, Mexico; [email protected] 2 Tecnologico de Monterrey, School of Engineering and Science, Avenida Eugenio Garza Sada 2501 Sur, Monterrey, N. L. 64849, Mexico; [email protected] (A.K.R.-J.); [email protected] (J.Y.) 3 Tecnología Alimentaria, Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ), A. C., Camino Arenero #1227 Col. El Bajío, Zapopan, JAL 45019, Mexico; [email protected] * Correspondence: [email protected] Abstract: Natural colorants have emerged as an alternative to their synthetic counterparts due to an existing health concern of these later. Moreover, natural-food colorants are a renewable option providing health benefits and interesting technological and sensory attributes to the food systems containing them. Several sources of natural colorants have been explored aiming to deliver the required wide color range demanded by consumers. This review aimed to compare and discuss the technological applications of the main natural-food colorants into food system in the last six years, giving additional information about their extraction process. Although natural colorants are promising choices to replace synthetic ones, optimization of processing conditions, research on new sources, and new formulations to ensure stability are required to equate their properties to their Citation: Luzardo-Ocampo, I.; synthetic counterparts. Ramírez-Jiménez, A.K.; Yañez, J.; Mojica, L.; Luna-Vital, D.A.