To FCC 11, First Supplement the Following Index Is for Convenience and Informational Use Only and Shall Not Be Used for Interpretive Purposes
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858 Spec Tech 001/Lab/Pwdr
PRODUCT SPECIFICATIONS & TECHNICAL DATA 858 POWDER CARAMEL COLOR, CLASS IV – E150d CAS No: 8028-89-5 / EINECS: 232-435-9 Description According to Title 21 CFR 73.85, the color additive Caramel is the dark brown liquid or solid material resulting from the carefully controlled heat treatment of food-grade carbohydrates. Certain food-grade acids, alkalis and salts may be employed to assist caramelization. Ingredients list: Caramel Color Labelling: Caramel Color, Caramel Organoleptic properties Appearance: Dark brown powder Odor: Typical Taste: Characteristic bitter, burnt sugar taste Chemical / Physical properties – Specifications (as manufactured) Tinctorial Power: 0.817-0.903 (560 nm, 0.1% solution), Absorbance units pH: 5.0-6.0 (1% w/v solution) Moisture: 4.5% Particle size: 90% through #100 U.S. Standard Sieve Chemical / Physical properties - Indicative values Color Intensity: 0.500-0.561 (610 nm, 0.1 % solution), Absorbance units Dry Matter: 97.4% Microbiological properties Aerobic Plate Count: < 1000 cfu/g Yeast: < 20 cfu/g Mold: < 20 cfu/g E. coli: < 3 MPN/g Salmonella: Negative/375g PAGE SETHNESS PRODUCTS COMPANY Original (mm/dd/yyyy): Revised (mm/dd/yyyy): 1 OF 3 1347 Beaver Channel Parkway, Clinton, IA 52732, USA 01/01/2020 01/01/2020 858 SPEC TECH 001/LAB/PWDR NOTE: Once this document is copied, printed, emailed, downloaded, or modified in any way from what is stated on its’ docsign sheet, it becomes UNCONTROLLED. For the current Controlled Document or assistance contact [email protected] or www.sethness.com or call 888-772-1880. Heavy Metals Arsenic: < 0.1 ppm Lead: < 0.1 ppm Mercury: < 0.01 ppm Cadmium: < 0.1 ppm GMO / Genetically Engineered (GE) status GE: Manufactured from HDCS which is derived from genetically engineered plants. -
Notice of Modification to the List of Permitted Food Enzymesto Enable
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lysophospholipase from Trichoderma reesei RF7206 in the Production of Sugars and Dextrins from Starch Notice of Modification – Lists of Permitted Food Additives Reference Number: NOM/ADM-0172 August 10, 2021 Summary Food additives are regulated in Canada under Marketing Authorizations (MAs) issued by the Minister of Health and the Food and Drug Regulations (Regulations). Approved food additives and their permitted conditions of use are set out in the Lists of Permitted Food Additives that are incorporated by reference in the MAs and published on the Canada.ca website. A petitioner can request that Health Canada approve a new additive or a new condition of use for an already approved food additive by filing a food additive submission with the Department's Food Directorate. Health Canada uses this premarket approval process to determine whether the scientific data support the safety of food additives when used under specified conditions in foods sold in Canada. Health Canada’s Food Directorate received a food additive submission seeking approval for the use of lysophospholipase from Trichoderma reesei RF7206 in starch used in the production of dextrins, dextrose, fructose syrups and solids, glucose (glucose syrup), glucose solids (dried glucose syrup), or maltose. The food enzyme is intended to be used at a level consistent with Good Manufacturing Practice1. Its purpose of use is to improve the efficiency of the starch processing. Lysophospholipase is a type of phospholipase. Phospholipase from other microbial sources is already permitted for use in Canada as a food enzyme in certain foods, but not in the production of sugars and dextrins from starch. -
P250 Spec Tech 001/Lab/Liq
PRODUCT SPECIFICATIONS & TECHNICAL DATA P250 LIQUID CARAMEL COLOR, CLASS III – E150c CAS No: 8028-89-5 / EINECS: 232-435-9 Description According to Title 21 CFR 73.85, the color additive Caramel is the dark brown liquid or solid material resulting from the carefully controlled heat treatment of food-grade carbohydrates. Certain food-grade acids, alkalis and salts may be employed to assist caramelization. Ingredients list: Caramel Color Labelling: Caramel Color, Caramel Organoleptic properties Appearance: Dark brown, fluid liquid Odor: Typical Taste: Characteristic bitter, burnt sugar taste Chemical / Physical properties – Specifications (as manufactured) Tinctorial Power: 0.232-0.256 (560 nm, 0.1% solution), Absorbance units pH: 4.1-4.8 (as is) Baume’: 34.7-35.6 @ 60°F (15.5°C) Specific Gravity: 1.315-1.325 @ 60°F (15.5°C) Chemical / Physical properties - Indicative values Color Intensity: 0.128-0.140 (610 nm, 0.1 % solution), Absorbance units Dry Matter: 69.2% Density: 10.95-11.04 (lb/gal @ 60°F (15.5°C)) Microbiological properties Aerobic Plate Count: < 200 cfu/g Yeast: < 10 cfu/g Mold: < 10 cfu/g E. coli: < 3 MPN/g Salmonella: Negative/25g PAGE SETHNESS PRODUCTS COMPANY Original (mm/dd/yyyy): Revised (mm/dd/yyyy): 1 OF 3 1347 Beaver Channel Parkway, Clinton, IA 52732, USA 01/01/2020 01/01/2020 P250 SPEC TECH 001/LAB/LIQ NOTE: Once this document is copied, printed, emailed, downloaded, or modified in any way from what is stated on its’ docsign sheet, it becomes UNCONTROLLED. For the current Controlled Document or assistance contact [email protected] or www.sethness.com or call 888-772-1880. -
INTERNATIONAL TECHNICAL CARAMEL ASSOCIATION Caramel
INTERNATIONAL TECHNICAL CARAMEL ASSOCIATION 1900 K Street, NW Washington, DC 20006 Caramel Colors Safety Status Caramel Colors have been used safely in food products since the 19th century. Caramel Colors are authorized to be used in food products globally. Four different Classes (I, II, III and IV) of Caramel Colors exist based on their means of manufacture and their individual physical properties which are suitable for different applications. Caramel Color is used in a wide range of food products, including but not limited to soft drinks, beer, spirits, bakery products, cereals, sauces, soups, meats and spice blends, etc. Recently, questions were raised about a trace component, 4-methylimidazole (4-MEI) generated during manufacture of certain Caramels Colors (Classes III and IV) as a result of a US National Toxicology Program (NTP) 2007 study finding lung tumors in mice fed very high levels of 4-MEI. In the same study, rats fed high levels of 4-MEI exhibited reductions in 5 tumor types. California’s Office of Environmental Health Hazard Assessment has chosen to list 4-MEI as a Proposition 65 chemical requiring a warning label on all foods/beverages, if the dietary intake of 4-MEI from the food/beverage product exceeds 29 micrograms/kg. No regulatory agency has taken any action concerning the use of Caramel Colors by any national or international regulatory body. The safety of Caramel Colors has been established and reaffirmed numerous times over the last four decades. Regulatory specifications, including specifications for 4-MEI have been established by The Joint Expert Committee for Food Additives (JECFA), The European Food Safety Authority (EFSA), the US Food and Drug Administration (US FDA)/Food Chemical Codex (FCC) and numerous other countries. -
Alkanoyl Lactyl Lactate Salts As Used in Cosmetics
Safety Assessment of Alkanoyl Lactyl Lactate Salts as Used in Cosmetics Status: Final Report Release Date: July 17, 2019 Panel Date: June 6-7, 2019 The 2019 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Executive Director is Bart Heldreth, Ph.D. This report was prepared by Wilbur Johnson, Jr., M.S., Senior Scientific Analyst. © Cosmetic Ingredient Review 1620 L STREET, NW, SUITE 1200 ◊ WASHINGTON, DC 20036-4702 ◊ PH 202.331.0651 ◊ FAX 202.331.0088 ◊ [email protected] ABSTRACT: The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 10 alkanoyl lactyl lactate salts. These ingredients have the surfactant function in cosmetics in common. The Panel reviewed data relevant to the safety of these ingredients, and concluded that these 10 ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating and non-sensitizing, which may be based on a quantitative risk assessment (QRA) or other accepted methodologies. INTRODUCTION The safety of the following 10 alkanoyl lactyl lactate salts as used in cosmetics is reviewed in this Cosmetic Ingredient Review (CIR) safety assessment. Calcium Stearoyl Lactylate Sodium Cupheoyl Lactylate Sodium Behenoyl Lactylate Sodium Isostearoyl -
Perusing the Food Color Palette
[Colors] Vol. 14 No. 12 December 2004 Perusing the Food Color Palette By Sharon Gerdes, Contributing Editor For most foods, color might be the last item on the ingredient legend, but the first consideration in the consumer's mind. Color can create new line extensions and invigorate mature brands. Unexpected bursts of "artificial" colors might boost sales, but label-friendly "natural" colors could prove to have the most-enduring appeal, especially in today's market where natural ingredients seem to increasingly draw a premium. Colorful categories As far back as 1,500 B.C., natural colors started to find their way into our culture, often as dyes for cosmetics and fabrics. Various ancient civilizations used annatto to paint their bodies and color their food. Egyptians, Mayans and Incans are all believed to have used carmine or similar dyes derived from female insects to produce magenta dyes for their clothes and lips. When Columbus attempted to discover a faster route to the East Indies, one of the spices he sought was turmeric, a spice used over the centuries to color food, enhance taste and treat various ailments. Manufacturers still use these pigments today to brighten modern foods. The industrial revolution brought changes. By the early 1900s, almost 80 synthetic dyes were found in food, often with little testing or regard for safety. So in 1907, the U.S. government established the first list of seven colors certified as safe and suitable for use in foods. That list of Food, Drug and Cosmetic (FD&C) colors—outlined in the Food, Drug and Cosmetic Act—has changed over the years, but interestingly, the United States is currently back to seven certified FD&C colors: Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5 and Yellow 6. -
Sethness Products Company
SETHNESS PRODUCTS COMPANY SULFITE IN SETHNESS CARAMEL COLORS Sethness Caramel Colors are 100% Caramel Color. Sethness Caramel Colors do not contain any post manufacturing "sulfiting agents" typically added to food products as oxygen scavengers. These sulfiting agents are used to enhance the stability of the final product. Sulfiting agents used for stabilization are readily determined by both digestive and non- digestive methods. Sethness Caramel Colors do not contain any stabilizing sulfites. The sulfite found in Sethness Caramel Colors comes from one of two sources: 1. When Caramel Color is tested to contain above 50 ppm of sulfite, then sulfite is used as a necessary and allowed process reactant (as defined by 21 CFR 73.85) to assist in the formation of the color bodies generated in the process of manufacturing Caramel Colors. These are Class II (E150b) and Class IV (E150d) Caramel Colors. This sulfite is incorporated into the Caramel Color as a part of the polymer chains. When a Sethness Caramel Color is analyzed for free sulfite using a non-digestive method, the result is nil. 2. When Caramel Color is tested to contain less than 50 ppm of sulfite, then t h e sulfite result is assumed to be from residual levels in the carbohydrate source. Also, the test for sulfite is such that it will not give a result that is conclusively free of sulfites. Therefore, we have set our sulfite limits to be within the limit of detection and accuracy of the test and possible residual sulfites from the carbohydrate source. These are Class I (E150a) and Class III (E150c) Caramel Colors. -
Dietary Supplements Compendium Volume 1
2015 Dietary Supplements Compendium DSC Volume 1 General Notices and Requirements USP–NF General Chapters USP–NF Dietary Supplement Monographs USP–NF Excipient Monographs FCC General Provisions FCC Monographs FCC Identity Standards FCC Appendices Reagents, Indicators, and Solutions Reference Tables DSC217M_DSCVol1_Title_2015-01_V3.indd 1 2/2/15 12:18 PM 2 Notice and Warning Concerning U.S. Patent or Trademark Rights The inclusion in the USP Dietary Supplements Compendium of a monograph on any dietary supplement in respect to which patent or trademark rights may exist shall not be deemed, and is not intended as, a grant of, or authority to exercise, any right or privilege protected by such patent or trademark. All such rights and privileges are vested in the patent or trademark owner, and no other person may exercise the same without express permission, authority, or license secured from such patent or trademark owner. Concerning Use of the USP Dietary Supplements Compendium Attention is called to the fact that USP Dietary Supplements Compendium text is fully copyrighted. Authors and others wishing to use portions of the text should request permission to do so from the Legal Department of the United States Pharmacopeial Convention. Copyright © 2015 The United States Pharmacopeial Convention ISBN: 978-1-936424-41-2 12601 Twinbrook Parkway, Rockville, MD 20852 All rights reserved. DSC Contents iii Contents USP Dietary Supplements Compendium Volume 1 Volume 2 Members . v. Preface . v Mission and Preface . 1 Dietary Supplements Admission Evaluations . 1. General Notices and Requirements . 9 USP Dietary Supplement Verification Program . .205 USP–NF General Chapters . 25 Dietary Supplements Regulatory USP–NF Dietary Supplement Monographs . -
Fcc-9-Second-Supplement-Index.Pdf
Index to FCC 9, Second Supplement The following Index is for convenience and informational use only and shall not be used for interpretive purposes. In addition to effective articles, this Index may also include items recently omitted from the FCC in the indicated Book or Supplement. The monographs and general tests and assay listed in this Index may reference other general test and assay specifications. The articles listed in this Index are not intended to be autonomous standards and should only be interpreted in the context of the entire FCC publication. For the most current version of the FCC please see the FCC Online. Second Supplement, FCC 9 Index / Allura Red AC / I-1 Index Titles of monographs are shown in the boldface type. A 2-Acetylpyrrole, 21 Alcohol, Absolute, 1486 2-Acetyl Thiazole, 18 Alcohol, Aldehyde-Free, 1487 Abbreviations, 7, 1813, 1899 Acetyl Valeryl, 563 Alcohol C-6, 579 Absolute Alcohol (Reagent), 6, 1812, Acetyl Value, 1425 Alcohol C-8, 867 1898 Achilleic Acid, 25 Alcohol C-9, 856 Acacia, 557 Acid (Reagent), 6, 1812, 1898 Alcohol C-10, 355 ªAccuracyº, Defined, 1503 Acid-Hydrolyzed Milk Protein, 22 Alcohol C-11, 1247 Acesulfame K, 9, 1901 Acid-Hydrolyzed Proteins, 22 Alcohol C-12, 675 Acesulfame Potassium, 9, 1901 Acid Calcium Phosphate, 213 Alcohol C-16, 1924 Acetal, 10 Acid Hydrolysates of Proteins, 22 Alcohol Content of Ethyl Oxyhydrate Acetaldehyde, 11 Acidic Sodium Aluminum Phosphate, Flavor Chemicals (Other than Acetaldehyde Diethyl Acetal, 10 1071 Essential Oils), 1462 Acetaldehyde Test Paper, 1498 Acidified -
Caramel Color Prepared by Ammonium-Sulfite Process
20 Abstracts of the Articles Printed in NIPPON NOGEIKAGAKY KAISHI ea were examined. Forty compounds were detected Caramel color prepared by ammonium-sulfite process Dm the oil of each Mentha gentilis L., and the com contains some imidazoles including toxic 4-methyl- osition of pulegone (1) and 8-hydroxy-3-p-menthene(2) imidazole. The imidazoles are combined both with each oil collected in the different seasons was shown acidic low-molecular-weight substances and high- follows: 1(82.5% and 86.2%) and 2(1.8% and molecular-weight coloring matters. On ultrafiltration 6%) in August, whereas 1(64.0% and 68.6%) and of the caramel color solution, the imidazoles bound (19.2% and 11.7%) in October and 1(48.5% and •¬ with low-molecular-weight substances can permeate .6 %) and 2(26.1% and 24.0%) in November, respec through the membrane but ones bound with high- •¬ ely. molecular-weight coloring matters are retained in the On the basis of the seasonal variation of these com concentrate. ments in the oil of each plant, 2 seems to be derived The latter bound imidazoles were completely released om 1 via cis-pulegol in the biosynthetic pathway. from the coloring matters when sulfuric acid or sodium hydroxide was added to 10% diafiltered caramel color solution until its concentration reached 0.1 N. The Release of Bound Imidazoles in Caramel Color lowest concentration of sulfuric acid required for the (Ultrafiltration of Caramel Color Part IV) complete release of the bound imidazoles was 0.55 N (p. 273•`275) and 0.025 N for 10% original and diafiltered caramel Shiro KisHIHARA, Satoshi Funs and Masahiko color solution, respectively. -
21 CFR Ch. I (4–1–13 Edition) § 184.1857
§ 184.1857 21 CFR Ch. I (4–1–13 Edition) this section do not exist or have been (c) In accordance with § 184.1(b)(1), waived. the ingredient is used in food with no limitation other than current good [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, manufacturing practice. 1989, as amended at 73 FR 8608, Feb. 14, 2008] (d) Prior sanctions for this ingredient § 184.1857 Corn sugar. different from the uses established in this section do not exist or have been (a) Corn sugar (C6H12O6, CAS Reg. No. waived. 50–99–7), commonly called D-glucose or dextrose, is the chemical a-D- [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, glucopyranose. It occurs as the anhy- 1989, as amended at 73 FR 8608, Feb. 14, 2008] drous or the monohydrate form and is § 184.1865 Corn syrup. produced by the complete hydrolysis of corn starch with safe and suitable acids (a) Corn syrup, commonly called or enzymes, followed by refinement and ‘‘glucose sirup’’ or ‘‘glucose syrup,’’ is crystallization from the resulting hy- obtained by partial hydrolysis of corn drolysate. starch with safe and suitable acids or (b) The ingredient meets the speci- enzymes. It may also occur in the de- fications of the Food Chemicals Codex, hydrated form (dried glucose sirup). 3d Ed. (1981), pp. 97–98 under the head- Depending on the degree of hydrolysis, ing ‘‘Dextrose,’’ which is incorporated corn syrup may contain, in addition to by reference in accordance with 5 glucose, maltose and higher U.S.C. -
Food and Drug Administration, HHS § 184.1415
Food and Drug Administration, HHS § 184.1415 Street, NW., suite 700, Washington, DC basis as determined by the method in 20408. the Food Chemicals Codex, 3d Ed. (2) Ash. Not more than 9.5 percent for (1981), p. 466, which is incorporated by licorice, 2.5 percent for ammoniated reference. glycyrrhizin, and 0.5 percent for (4) Heavy metals (as Pb). Not more monoammonium glycyrrhizinate on an than 40 parts per million as determined anhydrous basis as determined by the by method II in the Food Chemicals method in the Food Chemicals Codex, Codex, 3d Ed. (1981), p. 512, which is in- 3d Ed. (1981), p. 466, which is incor- corporated by reference. porated by reference. Copies are avail- (5) Arsenic (As). Not more than 3 parts able from the National Academy Press, per million as determined by the meth- 2101 Constitution Ave. NW., Wash- od in the Food Chemicals Codex. 3d Ed. ington, DC 20418, or available for in- (1981), p. 464, which is incorporated by spection at the Office of the Federal reference. Register, 800 North Capitol Street, (c) In accordance with § 184.1(b)(2), NW., suite 700, Washington, DC 20408. these ingredients are used in food only (3) Acid unsoluble ash. Not more than within the following specific limita- 2.5 percent for licorice on an anhydrous tions: Maximum level in food (percent Category of food glycyrrhizin con- Functional use tent of food) (as served) Baked foods, §170.3(n)(1) of this chapter ................. 0.05 Flavor enhancer, §170.3(o)(11) of this chapter; fla- voring agent, §170.3(o)(12) of this chapter.