{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 74 sorted by section_id", "rows": [["10:10:2.0.1.1.14.1.121.1", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 74.1 Purpose.", "NRC", "", "", "[50 FR 7579, Feb. 25, 1985, as amended at 56 FR 55998, Oct. 31, 1991; 67 FR 78144, Dec. 23, 2002]", "(a) This part has been established to contain the requirements for the control and accounting of special nuclear material at fixed sites and for documenting the transfer of special nuclear material. General reporting requirements as well as specific requirements for certain licensees possessing special nuclear material of low strategic significance, special nuclear material of moderate strategic significance, and formula quantities of strategic special nuclear material are included. Requirements for the control and accounting of source material at enrichment facilities are also included.\n\n(b) The general conditions and procedures for the submittal of a license application for the activities covered in this part are detailed in \u00a7 70.22 of this chapter."], ["10:10:2.0.1.1.14.1.121.2", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 74.2 Scope.", "NRC", "", "", "[67 FR 78144, Dec. 23, 2002, as amended at 73 FR 32463, June 9, 2008]", "(a) The general reporting and recordkeeping requirements of subpart B of this part apply to each person licensed under this chapter who possesses special nuclear material in a quantity of one gram or more of contained uranium-235, uranium-233, or plutonium; or who transfers or receives a quantity of special nuclear material of one gram or more of contained uranium-235, uranium-233, or plutonium. The general reporting and recordkeeping requirements of subpart B of this part do not apply to licensees whose MC&A reporting and recordkeeping requirements are covered by \u00a7\u00a7 72.72, 72.76, and 72.78 of this chapter.\n\n(b) In addition, specific control and accounting requirements are included in subparts C, D, and E for certain licensees who:\n\n(1) Possess and use formula quantities of strategic special nuclear material;\n\n(2) Possess and use special nuclear material of moderate strategic significance;\n\n(3) Possess and use special nuclear material of low strategic significance; or\n\n(4) Possess uranium source material and equipment capable of producing enriched uranium.\n\n(c) As provided in part 76 of this chapter, the regulations of this part establish procedures and criteria for material control and accounting for the issuance of a certificate of compliance or the approval of a compliance plan."], ["10:10:2.0.1.1.14.1.121.3", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 74.4 Definitions.", "NRC", "", "", "[50 FR 7579, Feb. 25, 1985, as amended at 52 FR 10039, Mar. 30, 1987; 56 FR 55998, Oct. 31, 1991; 67 FR 78144, Dec. 23, 2002; 73 FR 32463, June 9, 2008; 80 FR 45844, Aug. 3, 2015]", "As used in this part:\n\nAbrupt loss  means a loss occurring in the time interval between consecutive sequential performances of a material control test which is designed to detect anomalies potentially indicative of a loss of strategic special nuclear material from a specific unit of SSNM ( i.e. , a quantity characterized by a unique measurement) introduced into a process.\n\nAccessible location  means a process location at which SSNM could be acquired without leaving evidence of the acquisition,  i.e. , without tools or other equipment to obviously violate the integrity of the containment.\n\nAct  means the Atomic Energy Act of 1954 (68 Stat. 919), including any amendments thereto.\n\nActive inventory  means the sum of additions to inventory, beginning inventory, ending inventory, and removals from inventory, after all common terms have been excluded. Common terms are any material values which appear in the active inventory calculation more than once and come from the same measurement.\n\nAdditions to material in process  means: (1) Receipts that are opened, except for receipts opened only for sampling and subsequently maintained under tamper-safing; (2) opened sealed sources; and (3) material removed from process for nonconformance with chemical or physical specifications that is subsequently reprocessed, measured for contained SSNM, and reintroduced to process.\n\nAlarm Threshold  means a predetermined quantity of SSNM calculated from the specified probability of detection for a given loss and the standard deviation associated with a material control test. An alarm threshold serves to trigger a response action.\n\nBatch  means a portion of source material or special nuclear material handled as a unit for accounting purposes at a key measurement point and for which the composition and quantity are defined by a single set of measurements. The source material or special nuclear material may be in bulk form or contained in a number of separate items.\n\nBeginning inventory (BI)  means the book inventory quantity at the beginning of an inventory period, and is the reconciled physical inventory entered into the books as an adjusted inventory at the completion of the prior inventory period.\n\nBias  means the deviation of the expected value of a random variable from the corresponding correct or assigned value.\n\nCalibration  means the process of determining the numerical relationship between the observed output of a measurement system and the value, based upon reference standards, of the characteristic being measured.\n\nCategory IA material  means SSNM directly useable in the manufacture of a nuclear explosive device, except if:\n\n(1) The dimensions are large enough (at least two meters in one dimension, greater than one meter in each of two dimensions, or greater than 25cm in each of three dimensions) to preclude hiding the item on an individual;\n\n(2) The total weight of an encapsulated item of SSNM is such that it cannot be carried inconspicuously by one person ( i.e.,  at least 50 kilograms gross weight); or\n\n(3) The quantity of SSNM (less than 0.05 formula kilograms) in each container requires protracted diversions to accumulate five formula kilograms.\n\nCategory IB material  means all SSNM material other than Category IA.\n\nCommission  means the Nuclear Regulatory Commission or its duly authorized representatives.\n\nContinuous process  means a unit process in which feed material must be introduced in a systematic manner in order to maintain equilibrium conditions.\n\nControlled access area  means any temporarily or permanently established area which is clearly demarcated, access to which is controlled, and which affords isolation of the material or persons within it.\n\nDOE  means the U.S. Department of Energy or its duly authorized representatives.\n\nEffective kilograms of special nuclear material  means:\n\n(1) For plutonium and uranium-233 their weight in kilograms;\n\n(2) For uranium with an enrichment in the isotope U\n 235  of 0.01 (1 percent) and above, its element weight in kilograms multiplied by the square of its enrichment expressed as a decimal weight fraction; and\n\n(3) For uranium with an enrichment in the isotope U\n 235  below 0.01 (1 percent), its element weight in kilograms multiplied by 0.0001.\n\nElement  means uranium or plutonium.\n\nEstimate  means a specific numerical value arrived at by the application of an estimator.\n\nEstimator  means a function of a sample measurement used to estimate a population parameter.\n\nFissile isotope  means: (1) Uranium U-233, or (2) uranium-235 by enrichment category, (3) plutonium-239, and (4) plutonium-241.\n\nFormula kilogram  means SSNM in any combination in a quantity of 1000 grams computed by the formula, grams = (grams contained U-235) + 2.5 (grams U-233 + grams plutonium).\n\nFormula quantity  means strategic special nuclear material in any combination in a quantity of 5,000 grams or more computed by the formula, grams = (grams contained U\n 235 ) + 2.5 (grams U\n 233  + grams plutonium).\n\nGovernment agency  means any executive department, commission, independent establishment, corporation, wholly or partly owned by the United States of America, which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the Government.\n\nHigh enriched uranium  means uranium enriched to 20 percent or greater in the isotope uranium-235.\n\nInventory difference (ID)  means the arithmetic difference obtained by subtracting the quantity of SNM tabulated from a physical inventory from the book inventory quantity. Book inventory quantity is equivalent to the beginning inventory (BI) plus additions to inventory (A) minus removals from inventory (R), while the physical inventory quantity is the ending inventory (EI) for the material balance period in question (as physically determined). Thus mathematically, ID = (BI + A\u2212R) \u2212EI or ID = BI + A\u2212R\u2212EI\n\nItem  means any discrete quantity or container of special nuclear material or source material, not undergoing processing, having an unique identity and also having an assigned element and isotope quantity.\n\nLicense,  except where otherwise specified, means a license issued pursuant to part 70 of this chapter.\n\nLow enriched uranium  means uranium enriched below 20 percent in the isotope uranium-235.\n\nMaterial  means special nuclear material.\n\nMaterial access area  means any location which contains special nuclear material, within a vault or a building, the roof, walls, and floor of which constitute a physical barrier.\n\nMaterial balance  means the determination of an inventory difference (ID).\n\nMC&A alarm  means a situation in which there is: (1) an out-of-location item or an item whose integrity has been violated, (2) an indication of a flow of SSNM where there should be none, or (3) a difference between a measured or observed amount or property of material and its corresponding predicted or property value that exceeds a threshold established to provide the detection capability required by \u00a7 74.53.\n\nMaterial control test  means a comparison of a pre-established alarm threshold with the results of a process difference or process yield performed on a unit process.\n\nMaterial in process  means any special nuclear material possessed by the licensee except in unopened receipts, sealed sources, measured waste discards, and ultimate product maintained under tamper-safing.\n\nMeasurement  includes sampling and means the determination of mass, volume, quantity, composition or other property of a material where such determinations are used for special nuclear material control and accounting purposes.\n\nMeasurement system  means all of the apparatus, equipment, instruments and procedures used in performing a measurement.\n\nPerson  means:\n\n(1) Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency other than the Commission or the Department of Energy, except that the Department of Energy shall be considered a person within the meaning of the regulations in this part to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission pursuant to section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), any state or any political subdivision of or any political entity within a state, any foreign government or nation or political subdivision of any such government or nation, or other entity; and\n\n(2) Any legal successor, representative, agent, or agency of the foregoing.\n\nPhysical inventory  means determination on a measured basis of the quantity of special nuclear material on hand at a given time. The methods of physical inventory and associated measurements will vary depending on the material to be inventoried and the process involved.\n\nPlant  means a set of processes or operations (on the same site, but not necessarily all in the same building) coordinated into a single manufacturing, R&D, or testing effort. A scrap recovery operation, or an analytical laboratory, serving both onsite and offsite customers (or more than one onsite manufacturing effort) should be treated as a separate plant.\n\nPower of detection  means the probability that the critical value of a statistical test will be exceeded when there is an actual loss of a specific SSNM quantity.\n\nProcess difference  (PD) means the determination of an ID on a unit process level with the additional qualification that difficult to measure components may be modeled.\n\nProcess yield  means the quantity of SSNM actually removed from a unit process compared with the quantity predicted (based on a measured input) to be available for removal. Process yield differs from a process difference in that holdup and sidestreams are not measured or modeled.\n\nProduce  when used in relation to special nuclear material, means: (1) To manufacture, make, produce, or refine special nuclear material; (2) to separate special nuclear material from other substances in which such material may be contained; or (3) to make or to produce new special nuclear material.\n\nRandom error  means the deviation of a random variable from its expected value.\n\nReceipt  means special nuclear material received by a licensee from an off-site source.\n\nReconciliation  means the process of evaluating and comparing licensee reports required under this part to the projected material balances generated by the Nuclear Materials Management and Safeguards System. This process is considered complete when the licensee resolves any differences between the reported and projected balances, including those listed for foreign obligated materials.\n\nReference standard  means a material, device, or instrument whose assigned value is known relative to national standards or nationally accepted measurement systems. This is also commonly referred to as a traceable standard.\n\nRemovals from inventory  means measured quantities of special nuclear material contained in:\n\n(1) Shipments;\n\n(2) Waste materials transferred to an onsite holding account via a DOE/NRC Form 741 transaction;\n\n(3) Measured discards transported offsite; and\n\n(4) Effluents released to the environment.\n\nRemovals of material from process  (or  removals from process ) means measured quantities of special nuclear material contained in:\n\n(1) Effluents released to the environment;\n\n(2) Previously unencapsulated materials that have been encapsulated as sealed sources;\n\n(3) Waste materials that will not be subject to further onsite processing and which are under tamper-safing;\n\n(4) Ultimate product placed under tamper-safing; and\n\n(5) Any materials (not previously designated as removals from process) shipped offsite.\n\nResearch and development  means: (1) Theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes.\n\nScrap  means the various forms of special nuclear material generated during chemical and mechanical processing, other than recycle material and normal process intermediates, which are unsuitable for continued processing, but all or part of which will be converted to useable material by appropriate recovery operations.\n\nSealed source  means any special nuclear material that is physically encased in a capsule, rod, element, etc. that prevents the leakage or escape of the special nuclear material and that prevents removal of the special nuclear material without penetration of the casing.\n\nSource material  means source material as defined in section 11z. of the Act and in the regulations contained in part 40 of this chapter.\n\nSpecial nuclear material  means:\n\n(1) Plutonium, uranium-233, uranium enriched in the isotope U\n 233  or in the isotope U\n 235 , and any other material which the Commission, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or\n\n(2) Any material artificially enriched by any of the foregoing, but does not include source material.\n\nSpecial nuclear material of low strategic significance  means:\n\n(1) Less than an amount of special nuclear material of moderate strategic significance, but more than 15 grams of uranium-235 (contained in uranium enriched to 20 percent or more in the U\n 235  isotope) or 15 grams of uranium-233 or 15 grams of plutonium or the combination of 15 grams when computed by the equation, grams = grams contained U\n 235  + grams plutonium + grams U\n 233 ; or\n\n(2) Less than 10,000 grams but more than 1,000 grams of uranium-235 (contained in uranium enriched to 10 percent or more, but less than 20 percent in the U\n 235  isotope); or\n\n(3) 10,000 grams or more of uranium-235 contained in uranium enriched above natural, but less than 10 percent in the U\n 235  isotope.\n\nSpecial nuclear material of moderate strategic significance  means:\n\n(1) Less than a formula quantity of strategic special nuclear material but more than 1,000 grams of uranium-235 (contained in uranium enriched to 20 percent or more in the U\n 235  isotope) or more than 500 grams of uranium-233 or plutonium or in a combined quantity of more than 1,000 grams when computed by the equation, grams = (grams contained U\n 235 ) + 2 (grams U\n 233  + grams plutonium); or\n\n(2) 10,000 grams or more or uranium-235 (contained in uranium enriched to 10 percent or more but less than 20 percent in the U\n 235  isotope).\n\nStandard Error of the Inventory Difference  (SEID) means the standard deviation of an inventory difference that takes into account all measurement error contributions to the components of the ID.\n\nStandard Error of the Process Difference  means the standard deviation of a process difference value that takes into account both measurement and nonmeasurement contributions to the components of PD.\n\nStrategic special nuclear material  means uranium-235 (contained in uranium enriched to 20 percent or more in the U\n 235  isotope), uranium-233, or plutonium.\n\nTamper-safing  means the use of devices on containers or vaults in a manner and at a time that ensures a clear indication of any violation of the integrity of previously made measurements of special nuclear material within the container or vault.\n\nTraceability  means the ability to relate individual measurement results to national standards or nationally accepted measurement systems through an unbroken chain of comparisons.\n\nUltimate product  means any special nuclear material in the form of a product that would not be further processed at that licensed location.\n\nUnit process  means an identifiable segment or segments of processing activities for which the amounts of input and output SSNM are based on measurements.\n\nUnopened receipts  means receipts not opened by the licensee, including receipts of sealed sources, and receipts opened only for sampling and subsequently maintained under tamper-safing.\n\nVault  means a windowless enclosure with walls, floor, roof and door(s) designed and constructed to delay penetration from forced entry."], ["10:10:2.0.1.1.14.1.121.4", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 74.5 Interpretations.", "NRC", "", "", "[50 FR 7579, Feb. 25, 1985, as amended at 90 FR 55633, Dec. 3, 2025]", "Except as specifically authorized by the Commission in writing, no interpretations of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized as binding on the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the  Federal Register  announcing its determination and revising or removing this section accordingly."], ["10:10:2.0.1.1.14.1.121.5", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 74.6 Communications.", "NRC", "", "", "[50 FR 7579, Feb. 25, 1985, as amended at 53 FR 4112, Feb. 12, 1988; 53 FR 43422, Oct. 27, 1988; 68 FR 58821, Oct. 10, 2003; 74 FR 62685, Dec. 1, 2009; 80 FR 74981, Dec. 1, 2015]", "Any communication or report concerning the regulations in this part and any application filed under these regulations may be submitted to the Commission as follows:\n\n(a) By mail addressed to: ATTN: Document Control Desk, Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.\n\n(b) By hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland.\n\n(c) Where practicable, by electronic submission, for example, via Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at  http://www.nrc.gov/site-help/e-submittals.html;  by e-mail to  MSHD.Resource@nrc.gov;  or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information."], ["10:10:2.0.1.1.14.1.121.6", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 74.7 Specific exemptions.", "NRC", "", "", "", "The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest."], ["10:10:2.0.1.1.14.1.121.7", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 74.8 Information collection requirements: OMB approval.", "NRC", "", "", "[50 FR 7579, Feb. 25, 1985, as amended at 52 FR 10040, Mar. 30, 1987; 52 FR 19305, May 22, 1987; 56 FR 55998, Oct. 31, 1991; 62 FR 52189, Oct. 6, 1997; 67 FR 78144, Dec. 23, 2002; 85 FR 65664, Oct. 16, 2020]", "(a) The Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501  et seq. ). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information if it does not display a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0123.\n\n(b) The approved information collection requirements contained in this part appear in \u00a7\u00a7 74.7, 74.11, 74.13, 74.15, 74.17, 74.19, 74.31, 74.33, 74.41, 74.43, 74.45, 74.51, 74.57, and 74.59.\n\n(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows:\n\n(1) In \u00a7 74.15, DOE/NRC Form-741 is approved under Control No. 3150-0003.\n\n(2) In \u00a7 74.13, DOE/NRC Form-742 is approved under Control No. 3150-0004.\n\n(3) In \u00a7 74.13, DOE/NRC Form-742C is approved under Control No. 3150-0058.\n\n(4) In \u00a7 74.17, NRC Form 327 is approved under Control No. 3150-0139."], ["10:10:2.0.1.1.14.2.121.1", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "B", "Subpart B\u2014General Reporting and Recordkeeping Requirements", "", "\u00a7 74.11 Reports of loss or theft or attempted theft or unauthorized production of special nuclear material.", "NRC", "", "", "[52 FR 21659, June 9, 1987; 52 FR 23257, June 18, 1987, as amended at 56 FR 55998, Oct. 31, 1991, 81 FR 86910, Dec. 2, 2016; 88 FR 15899, Mar. 14, 2023]", "(a) Each licensee who possesses one gram or more of contained uranium-235, uranium-233, or plutonium shall notify the NRC Operations Center within 1 hour of discovery of any loss or theft or other unlawful diversion of special nuclear material which the licensee is licensed to possess, or any incident in which an attempt has been made to commit a theft or unlawful diversion of special nuclear material. The requirement to report within 1 hour of discovery does not pertain to measured quantities of special nuclear material disposed of as discards or inventory difference quantities. Each licensee who operates an uranium enrichment facility shall notify the NRC Operations Center within 1 hour of discovery of any unauthorized production of enriched uranium. For centrifuge enrichment facilities the requirement to report enrichment levels greater than that authorized by license within 1 hour does not apply to each cascade during its start-up process, not to exceed the first 24 hours.\n\n(b) This notification must be made to the NRC Operations Center via the Emergency Notification System if the licensee is party to that system. If the Emergency Notification System is inoperative or unavailable, the licensee shall make the required notification via commercial telephonic service or other dedicated telephonic system or any other method that will ensure that a report is received by the NRC Operations Center within one hour. The exemption of \u00a7 73.22(f)(3) applies to all telephonic reports required by this section.\n\n(c) Notifications required under \u00a7 73.1200 of this chapter need not be duplicated under the requirements of this section."], ["10:10:2.0.1.1.14.2.121.2", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "B", "Subpart B\u2014General Reporting and Recordkeeping Requirements", "", "\u00a7 74.13 Material status reports.", "NRC", "", "", "[67 FR 78144, Dec. 23, 2002, as amended at 73 FR 32463, June 9, 2008; 79 FR 75741, Dec. 19, 2014; 84 FR 65646, Nov. 29, 2019]", "(a) Each licensee, including nuclear reactor licensees as defined in \u00a7\u00a7 50.21 and 50.22 of this chapter, possessing, or who had possessed in the previous reporting period, at any one time and location, special nuclear material in a quantity totaling one gram or more of contained uranium-235, uranium-233, or plutonium shall complete and submit, in computer-readable format Material Balance Reports concerning special nuclear material that the licensee has received, produced, possessed, transferred, consumed, disposed, or lost. This prescribed computer-readable report replaces the DOE/NRC form 742 which has been previously submitted in paper form. The Physical Inventory Listing Report must be submitted with each Material Balance Report. This prescribed computer-readable report replaces the DOE/NRC Form 742C which has been previously submitted in paper form. Reports must be submitted for each Reporting Identification Symbol (RIS) account including all holding accounts. Each licensee shall prepare and submit the reports described in this paragraph as specified in the instructions in NUREG/BR-0007 and NMMSS Report D-24 \u201cPersonal Computer Data Input for NRC Licensees.\u201d Copies of these instructions may be obtained from the U.S. Nuclear Regulatory Commission, Division of Fuel Management, Washington, DC 20555-0001, or by e-mail to  RidsNmssFcss@nrc.gov.  Each licensee subject to the requirements of \u00a7 74.51 shall compile a report as of March 31 and September 30 of each year and file it within 30 days after the end of the period covered by the report. Licensees subject to the requirements of \u00a7\u00a7 74.19(c), 74.31(c)(5), 74.33(c)(4), or 74.43(c)(6) shall submit a report within 60 calendar days of the beginning of the physical inventory. All other licensees shall submit a report no later than March 31 of each year. The Commission may permit a licensee to submit the reports at other times for good cause. Each licensee required to report material balance, and inventory information, as detailed in this part, shall resolve any discrepancies identified during the report review and reconciliation process within 30 calendar days of notification of a discrepancy identified by NRC.\n\n(b) Any licensee who is required to submit routine Material Status Reports pursuant to \u00a7 75.35 of this chapter (pertaining to implementation of the US/IAEA Safeguards Agreement) shall prepare and submit these reports only as provided in that section (instead of as provided in paragraph (a) of this section)."], ["10:10:2.0.1.1.14.2.121.3", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "B", "Subpart B\u2014General Reporting and Recordkeeping Requirements", "", "\u00a7 74.15 Nuclear material transaction reports.", "NRC", "", "", "[59 FR 35621, July 13, 1994, as amended at 68 FR 58821, Oct. 10, 2003; 73 FR 32464, June 9, 2008; 79 FR 75741, Dec. 19, 2014; 84 FR 65646, Nov. 29, 2019]", "(a) Each licensee who transfers or receives special nuclear material in a quantity of one gram or more of contained uranium-235, uranium-233, or plutonium shall complete in computer-readable format a Nuclear Material Transaction Report. In addition, each licensee who adjusts the inventory in any manner, other than for transfers and receipts, shall submit a Nuclear Material Transaction Report, in computer-readable format, to coincide with the submission of the Material Balance report. This shall be done as specified in the instructions in NUREG/BR-0006 and NMMSS Report D-24, \u201cPersonal Computer Data Input for NRC Licensees.\u201d Copies of these instructions NUREG/BR-0006 and NMMSS Report D-24, \u201cPersonal Computer Data Input for NRC Licensees\u201d may be obtained either by writing the U.S. Nuclear Regulatory Commission, Division of Fuel Management, Washington, DC 20555-0001, or by e-mail to  RidsNmssFcss@nrc.gov.  Each licensee who transfers the material shall submit a Nuclear Material Transaction Report in computer-readable format as specified in the instructions no later than the close of business the next working day. Each licensee who receives the material shall submit a Nuclear Material Transaction Report in computer-readable format in accordance with instructions within ten (10) days after the material is received. This prescribed computer-readable format replaces the DOE/NRC Form 741 which has been previously submitted in paper form.\n\n(b) Each licensee who receives 1 gram or more of contained uranium-235, uranium-233, or plutonium from a foreign source shall:\n\n(1) Complete in computer-readable format both the supplier's and receiver's portion of the Nuclear Material Transaction Report;\n\n(2) Perform independent tests to assure the accurate identification and measurement of the material received, including its weight and enrichment; and\n\n(3) Indicate the results of these tests on the receiver's portion of the form.\n\n(c) Each licensee who ships special nuclear material in a quantity of one gram or more of contained uranium-235, uranium-233, or plutonium to foreign recipient shall complete in computer-readable format the supplier's portion of the Nuclear Material Transaction Report. The licensee shall complete the receiver's portion of the Nuclear Material Transaction Report only if a significant shipper-receiver difference as described in \u00a7\u00a7 74.31, 74.43, or 74.59, as applicable, is identified.\n\n(d) Any licensee who is required to submit inventory change reports pursuant to \u00a7 75.34 of this chapter (pertaining to implementation of the US/International Atomic Energy Agency (IAEA) Safeguards Agreement) shall prepare and submit these reports only as provided in that section (instead of as provided in paragraphs (a) and (b) of this section)."], ["10:10:2.0.1.1.14.2.121.4", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "B", "Subpart B\u2014General Reporting and Recordkeeping Requirements", "", "\u00a7 74.17 Special nuclear material physical inventory summary report.", "NRC", "", "", "[67 FR 78145, Dec. 23, 2002, as amended at 68 FR 58821, Oct. 10, 2003]", "(a) Each licensee subject to the requirements of \u00a7\u00a7 74.31 or 74.33 of this part shall submit a completed Special Nuclear Material Physical Inventory Summary Report on NRC Form 327 not later than 60 calendar days from the start of each physical inventory required by \u00a7\u00a7 74.31(c)(5) or 74.33(c)(4). Using an appropriate method listed in \u00a7 74.6, the licensee shall report the inventory results by plant and total facility to the Director of the NRC's Office of Nuclear Material Safety and Safeguards.\n\n(b) Each licensee subject to the requirements of \u00a7 74.41(a) of this part shall submit a completed Special Nuclear Material Physical Inventory Summary Report on NRC form 327 not later than 60 calendar days from the start of each physical inventory required by \u00a7 74.43(c)(7). Using an appropriate method listed in \u00a7 74.6, the licensee shall report the inventory results by plant and total facility to the Director of the NRC's Office of Nuclear Material Safety and Safeguards.\n\n(c) Each licensee subject to the requirements of \u00a7 74.51 shall submit a completed Special Nuclear Material Physical Inventory Summary Report on NRC form 327 not later than 45 calendar days from the start of each physical inventory required by \u00a7 74.59(f). The licensee shall report the physical inventory results by plant and total facility to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001."], ["10:10:2.0.1.1.14.2.121.5", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "B", "Subpart B\u2014General Reporting and Recordkeeping Requirements", "", "\u00a7 74.19 Recordkeeping", "NRC", "", "", "[67 FR 78145, Dec. 23, 2002]", "(a) Licensees subject to the recordkeeping requirements of \u00a7\u00a7 74.31, 74.33, 74.43, or 74.59 of this part are exempt from the requirements of paragraphs (a)(1) through (4) of this section. Otherwise:\n\n(1) Each licensee shall keep records showing the receipt, inventory (including location and unique identity), acquisition, transfer, and disposal of all special nuclear material in its possession regardless of its origin or method of acquisition.\n\n(2) Each record relating to material control or material accounting that is required by the regulations in this chapter or by license condition must be maintained and retained for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by regulation or license condition, the licensee shall retain the record until the Commission terminates the license that authorizes the activity that is subject to the recordkeeping requirement.\n\n(3) Each record of receipt, acquisition, or physical inventory of special nuclear material that must be maintained pursuant to paragraph (a)(1) of this section must be retained as long as the licensee retains possession of the material and for 3 years following transfer or disposal of the material.\n\n(4) Each record of transfer of special nuclear material to other persons must be retained by the licensee who transferred the material until the Commission terminates the license authorizing the licensee's possession of the material.\n\n(b) Each licensee that is authorized to possess special nuclear material in a quantity exceeding one effective kilogram at any one time shall establish, maintain, and follow written material control and accounting procedures that are sufficient to enable the licensee to account for the special nuclear material in its possession under license. The licensee shall retain these procedures until the Commission terminates the license that authorizes possession of the material and retain any superseded portion of the procedures for 3 years after the portion is superseded.\n\n(c) Other than licensees subject to \u00a7\u00a7 74.31, 74.33, 74.41, or 74.51, each licensee who is authorized to possess special nuclear material, at any one time and site location, in a quantity greater than 350 grams of contained uranium-235, uranium-233, or plutonium, or any combination thereof, shall conduct a physical inventory of all special nuclear material in its possession under license at intervals not to exceed 12 months. The results of these physical inventories need not be reported to the Commission, but the licensee shall retain the records associated with each physical inventory until the Commission terminates the license that authorized the possession of special nuclear material.\n\n(d) Records that must be maintained pursuant to this part may be the original or a reproduced copy or a microform if the reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, or specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records."], ["10:10:2.0.1.1.14.3.121.1", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "C", "Subpart C\u2014Special Nuclear Material of Low Strategic Significance", "", "\u00a7 74.31 Nuclear material control and accounting for special nuclear material of low strategic significance.", "NRC", "", "", "[50 FR 7579, Feb. 25, 1985, as amended at 53 FR 19262, May 27, 1988; 56 FR 55998, Oct. 31, 1991; 67 FR 78145, Dec. 23, 2002]", "(a)  General performance objectives.  Each licensee who is authorized to possess and use more than one effective kilogram of special nuclear material of low strategic significance, excluding sealed sources, at any site or contiguous sites subject to control by the licensee, other than a production or utilization facility licensed pursuant to part 50 or 70 of this chapter, or operations involved in waste disposal, shall implement and maintain a Commission approved material control and accounting system that will achieve the following objectives:\n\n(1) Confirm the presence of special nuclear material;\n\n(2) Resolve indications of missing material; and\n\n(3) Aid in the investigation and recovery of missing material.\n\n(b)  Implementation.  Each applicant for a license, and each licensee that, upon application for modification of its license, would become newly subject to the performance objectives of paragraph (a) of this section, shall submit a fundamental nuclear material control (FNMC) plan describing how the requirements of paragraph (c) of this section will be met. The FNMC plan shall be implemented when a license is issued or modified to authorize the activities being addressed in paragraph (a) of this section, or by the date specified in a license condition.\n\n(c)  System capabilities.  To meet the general performance objectives of paragraph (a) of this section, the material control and accounting system must include the capabilities described in paragraph (c) (1) through (8) of this section. The licensee shall:\n\n(1) Establish, document, and maintain a management structure which assures clear overall responsibility for material control and accounting functions, independence from production responsibilities, separation of key responsibilities, and adequate review and use of critical material control and accounting procedures;\n\n(2) Establish and maintain a measurement system which assures that all quantities in the material accounting records are based on measured values;\n\n(3) Follow a measurement control program which assures that measurement bias is estimated and significant biases are eliminated from inventory difference values of record;\n\n(4) In each inventory period, control total material control and accounting measurement uncertainty so that twice its standard error is less than the greater of 9,000 grams of U-235 or 0.25 percent of the active inventory, and assure that any measurement performed under contract is controlled so that the licensee can satisfy this requirement;\n\n(5) Unless otherwise required to satisfy part 75 of this chapter, perform a physical inventory at least every 12 months and, within 60 days after the start of the inventory, reconcile and adjust the book inventory to the results of the physical inventory, and resolve, or report an inability to resolve, any inventory difference which is rejected by a statistical test which has a 90 percent power of detecting a discrepancy of a quantity of uranium-235 established by NRC on a site-specific basis;\n\n(6) Maintain current knowledge of items when the sum of the time of existence of an item, the time to make a record of the item, and the time necessary to locate the item exceeds 14 days. Store and handle, or subsequently measure, items in a manner so that unauthorized removals of substantial quantities of material from items will be detected. Exempted are items individually containing less than 500 grams of U\n 235  up to a total of 50 kilograms of U\n 235 , solutions with a concentration of less than 5 grams of U\n 235  per liter, and items of waste destined for burial or incineration;\n\n(7) Resolve, on a shipment basis and when required to satisfy part 75 of this chapter, on a batch basis, shipper/receiver differences that exceed both twice the combined measurement standard error for that shipment and 500 grams of U\n 235 ; and\n\n(8) Independently assess the effectiveness of the material control and accounting system at least every 24 months, and document management's action on prior assessment recommendations.\n\n(d)  Recordkeeping.  (1) Each licensee shall establish records that will demonstrate that the requirements of paragraph (c) of this section have been met and maintain these records for at least 3 years, unless a longer retention time is required by part 75 of this chapter.\n\n(2) Records which must be maintained pursuant to this part may be the original or a reproduced copy or a microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures.\n\nThe licensee shall maintain adequate safeguards against tampering with and loss of records."], ["10:10:2.0.1.1.14.3.121.2", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "C", "Subpart C\u2014Special Nuclear Material of Low Strategic Significance", "", "\u00a7 74.33 Nuclear material control and accounting for uranium enrichment facilities authorized to produce special nuclear material of low strategic significance.", "NRC", "", "", "[56 FR 55999, Oct. 31, 1991]", "(a)  General performance objectives.  Each licensee who is authorized by this chapter to possess equipment capable of enriching uranium or operate an enrichment facility, and produce, possess, or use more than one effective kilogram of special nuclear material of low strategic significance at any site or contiguous sites, subject to control by the licensee, shall establish, implement, and maintain a NRC-approved material control and accounting system that will achieve the following objectives:\n\n(1) Maintain accurate, current, and reliable information of and periodically confirm the quantities and locations of source material and special nuclear material in the licensee's possession;\n\n(2) Protect against and detect production of uranium enriched to 10 percent or more in the isotope U\n 235 ;\n\n(3) Protect against and detect unauthorized production of uranium of low strategic significance;\n\n(4) Resolve indications of missing uranium;\n\n(5) Resolve indications of production of uranium enriched to 10 percent or more in the isotope U\n 235  (for centrifuge enrichment facilities this requirement does not apply to each cascade during its start-up process, not to exceed the first 24 hours);\n\n(6) Resolve indications of unauthorized production of uranium of low strategic significance;\n\n(7) Provide information to aid in the investigation of missing uranium;\n\n(8) Provide information to aid in the investigation of the production of uranium enriched to 10 percent or more in the isotope U\n 235 ; and\n\n(9) Provide information to aid in the investigation of unauthorized production of uranium of low strategic significance.\n\n(b)  Implementation dates.  Each applicant for a license who would, upon issuance of a license pursuant to any part of this chapter, be subject to the requirements of paragraph (a) of this section shall:\n\n(1) Submit a fundamental nuclear material control plan describing how the performance objectives of \u00a7 74.33(a), the system features and capabilities of \u00a7 74.33(c), and the recordkeeping requirements of \u00a7 74.33(d) will be met; and\n\n(2) Implement the NRC approved plan submitted pursuant to paragraph (b)(1) of this section prior to:\n\n(i) The cumulative receipt of 5,000 grams of U\n 235  contained in any combination of natural, depleted, or enriched uranium or\n\n(ii) NRC's issuance of a license to test or operate the enrichment facility; whichever occurs first.\n\n(c)  System features and capabilities.  To meet the general performance objectives of paragraph (a) of this section, the Material Control and Accounting (MC&A) system must include the features and capabilities described in paragraphs (c) (1) through (8) of this section. The licensee shall establish, document, and maintain:\n\n(1) A management structure that ensures:\n\n(i) Clear overall responsibility for MC&A functions;\n\n(ii) Independence of MC&A management from production responsibilities;\n\n(iii) Separation of key MC&A responsibilities from each other; and\n\n(iv) Use of approved written MC&A procedures and periodic review of those procedures;\n\n(2) A measurement program that ensures that all quantities of source material and special nuclear material in the accounting records are based on measured values;\n\n(3) A measurement control program that ensures that:\n\n(i) Measurement bias is estimated and minimized through the measurement control program, and any significant biases are eliminated from inventory difference values of record;\n\n(ii) All MC&A measurement systems are controlled so that twice the standard error of the inventory difference, based on all measurement error contributions, is less than the greater of 5,000 grams of U\n 235  or 0.25 percent of the U\n 235  of the active inventory for each total plant material balance; and\n\n(iii) Any measurements performed under contract are controlled so that the licensee can satisfy the requirements of paragraphs (c)(3) (i) and (ii) of this section;\n\n(4) A physical inventory program that provides for:\n\n(i) Performing, unless otherwise required to satisfy part 75 of this chapter, a dynamic (nonshutdown) physical inventory of in-process (e.g., in the enrichment equipment) uranium and U\n 235  at least every 65 days, and performing a static physical inventory of all other uranium and total U\n 235  contained in natural, depleted, and enriched uranium located outside of the enrichment processing equipment at least every 370 calendar days, with static physical inventories being conducted in conjunction with a dynamic physical inventory of in-process uranium and U\n 235  so as to provide a total plant material balance at least every 370 calendar days; and\n\n(ii) Reconciling and adjusting the book inventory to the results of the static physical inventory and resolving, or reporting an inability to resolve, any inventory difference that is rejected by a statistical test which has a 90 percent power of detecting a discrepancy of a quantity of U\n 235 , established by NRC on a site-specific basis, within 60 days after the start of each static physical inventory;\n\n(5) A detection program, independent of production, that provides high assurance of detecting:\n\n(i) Production of uranium enriched to 10 percent or more in the U\n 235  isotope, to the extent that SNM of moderate strategic significance could be produced within any 370 calendar day period;\n\n(ii) Production of uranium enriched to 20 percent or more in the U\n 235  isotope; and\n\n(iii) Unauthorized production of uranium of low strategic significance;\n\n(6) An item control program that ensures that:\n\n(i) Current knowledge is maintained of items with respect to identity, uranium and U\n 235  content, and stored location; and\n\n(ii) Items are stored and handled, or subsequently measured, in a manner so that unauthorized removal of 500 grams or more of U\n 235 , as individual items or as uranium contained in items, will be detected. Exempted from the requirements of paragraph (c)(6) (i) and (ii) of this section are licensed-identified items each containing less than 500 grams U\n 235  up to a cumulative total of 50 kilograms of U\n 235  and items that exist for less than 14 calendar days;\n\n(7) A resolution program that ensures that any shipper-receiver differences are resolved that are statistically significant and exceed 500 grams U\n 235  on:\n\n(i) An individual batch basis; and\n\n(ii) A total shipment basis for all source material and special nuclear material;\n\n(8) An assessment program that:\n\n(i) Independently assesses the effectiveness of the MC&A system at least every 24 months;\n\n(ii) Documents the results of the above assessment;\n\n(iii) Documents management's findings on whether the MC&A system is currently effective; and\n\n(iv) Documents any actions taken on recommendations from prior assessments.\n\n(d)  Recordkeeping.  (1) Each licensee shall establish records that will demonstrate that the performance objectives of paragraph (a) of this section and the system features and capabilities of paragraph (c) of this section have been met and maintain these records in an auditable form, available for inspection, for at least 3 years, unless a longer retention time is required by part 75 of this chapter.\n\n(2) Records that must be maintained pursuant to this part may be the original or a reproduced copy or a microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability for producing, on demand, legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures.\n\n(3) The licensee shall maintain adequate safeguards against tampering with and loss of records."], ["10:10:2.0.1.1.14.4.121.1", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "D", "Subpart D\u2014Special Nuclear Material of Moderate Strategic Significance", "", "\u00a7 74.41 Nuclear material control and accounting for special nuclear material of moderate strategic significance.", "NRC", "", "", "[67 FR 78146, Dec. 23, 2002]", "(a)  General performance objectives.  Each licensee who is authorized to possess special nuclear material (SNM) of moderate strategic significance or SNM in a quantity exceeding one effective kilogram of strategic special nuclear material in irradiated fuel reprocessing operations other than as sealed sources and to use this material at any site other than a nuclear reactor licensed pursuant to part 50 of this chapter; or as reactor irradiated fuels involved in research, development, and evaluation programs in facilities other than irradiated fuel reprocessing plants; or an operation involved with waste disposal, shall establish, implement, and maintain a Commission-approved material control and accounting (MC&A) system that will achieve the following performance objectives:\n\n(1) Maintain accurate, current, and reliable information on, and confirm, the quantities and locations of SNM in the licensee's possession;\n\n(2) Conduct investigations and resolve any anomalies indicating a possible loss of special nuclear material;\n\n(3) Permit rapid determination of whether an actual loss of a significant quantity of SNM has occurred, with significant quantity being either:\n\n(i) More than one formula kilogram of strategic SNM; or\n\n(ii) 10,000 grams or more of uranium-235 contained in uranium enriched up to 20.00 percent.\n\n(4) Generate information to aid in the investigation and recovery of missing SNM in the event of an actual loss.\n\n(b)  Implementation schedule.  Each applicant for a license, and each licensee that, upon application for modification of its license, would become newly subject to the requirements of paragraph (a) of this section shall:\n\n(1) Submit a fundamental nuclear material control (FNMC) plan describing how the performance objectives of \u00a7 74.41(a) will be achieved, and how the system capabilities required by \u00a7 74.41(c) will be met; and\n\n(2) Implement the NRC-approved FNMC plan submitted pursuant to paragraph (b)(1) of this section upon the Commission's issuance or modification of a license or by the date specified in a license condition.\n\n(c)  System capabilities.  To achieve the performance objectives specified in \u00a7 74.41(a), the MC&A system must include the capabilities described in \u00a7\u00a7 74.43 and 74.45, and must incorporate checks and balances that are sufficient to detect falsification of data and reports that could conceal diversion of SNM by:\n\n(1) A single individual, including an employee in any position; or\n\n(2) Collusion between two individuals, one or both of whom have authorized access to SNM."], ["10:10:2.0.1.1.14.4.121.2", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "D", "Subpart D\u2014Special Nuclear Material of Moderate Strategic Significance", "", "\u00a7 74.43 Internal controls, inventory, and records.", "NRC", "", "", "[67 FR 78146, Dec. 23, 2002]", "(a)  General.  Licensees subject to \u00a7 74.41 shall maintain the internal control, inventory, and recordkeeping capabilities required in paragraphs (b), (c), and (d) of this section.\n\n(b) Internal controls.\n\n(1) A management structure shall be established, documented, and maintained that assures:\n\n(i) Clear overall responsibility for material control and accounting (MC&A) functions;\n\n(ii) Independence from production and manufacturing responsibilities; and\n\n(iii) Separation of key responsibilities.\n\n(2) The overall planning, coordination, and administration of the MC&A functions for special nuclear material (SNM) shall be vested in a single individual at an organizational level sufficient to assure independence of action and objectiveness of decisions.\n\n(3) The licensee shall provide for the adequate review, approval, and use of written MC&A procedures that are identified in the approved FNMC plan as being critical to the effectiveness of the described system.\n\n(4) The licensee shall assure that personnel who work in key positions where mistakes could degrade the effectiveness of the MC&A system are trained to maintain a high level of safeguards awareness and are qualified to perform their duties and/or responsibilities.\n\n(5) The licensee shall establish, document, and maintain an item control program that:\n\n(i) Provides current knowledge of SNM items with respect to identity, element and isotope content, and stored location; and\n\n(ii) Assures that SNM items are stored and handled, or subsequently measured, in a manner such that unauthorized removal of 200 grams or more of plutonium or uranium-233 or 300 grams or more of uranium-235, as one or more whole items and/or as SNM removed from containers, will be detected.\n\n(6) Exempted from the requirements of paragraph (b)(5) of this section are items that exist for less than 14 calendar days and licensee-identified items each containing less than 200 grams of plutonium or uranium-233 or 300 grams or more of uranium-235 up to a cumulative total of one formula kilogram of strategic SNM or 17 kilograms of uranium-235 contained in uranium enriched to 10.00 percent or more but less than 20.00 percent in the uranium-235 isotope.\n\n(7) Conduct and document shipper-receiver comparisons for all SNM receipts, both on an individual batch basis and a total shipment basis, and ensure that any shipper-receiver difference that is statistically significant and exceeds twice the estimated standard deviation of the difference estimator and 200 grams of plutonium or uranium-233 or 300 grams of uranium-235 is investigated and resolved; and\n\n(8) Perform independent assessments of the total MC&A system, at intervals not to exceed 18 months, that assess the performance of the system, review its effectiveness, and document management's action on prior assessment recommendations and identified deficiencies. These assessments must include a review and evaluation of any contractor who performs SNM accountability measurements for the licensee.\n\n(c)  Inventory control and physical inventories.  The licensee shall:\n\n(1) Provide unique identification for each item on inventory and maintain inventory records showing the identity, location, and quantity of SNM for these items;\n\n(2) Document all transfers of SNM between designated internal control areas within the licensee's site;\n\n(3) Maintain and follow procedures for tamper-safing of containers or vaults containing SNM, if tamper-safe seals are to be used for assuring the validity of prior measurements, which include control of access to, and distribution of, unused seals and to records showing the date and time of seal application;\n\n(4) Maintain and follow procedures for confirming the validity of prior measurements associated with unencapsulated and unsealed items on ending inventory;\n\n(5) Maintain and follow physical inventory procedures to assure that:\n\n(i) The quantity of SNM associated with each item on ending inventory is a measured value;\n\n(ii) Each item on ending inventory is listed and identified to assure that all items are listed and no item is listed more than once;\n\n(iii) Cutoff procedures for transfers and processing are established so that all quantities are inventoried and none are inventoried more than once;\n\n(iv) Cutoff procedures for records and reports are established so that only transfers for the inventory and material balance interval are included in the records for the material balance period in question;\n\n(v) Upon completion of the physical inventory, all book and inventory records, for total plant and individual internal control areas, are reconciled with and adjusted to the results of the physical inventory; and\n\n(vi) Measurements will be performed for element and isotope content on all quantities of SNM not previously measured.\n\n(6) Conduct physical inventories according to written instructions for each physical inventory which:\n\n(i) Assign inventory duties and responsibilities;\n\n(ii) Specify the extent to which each internal control area and process is to be shut down, cleaned out, and/or remain static;\n\n(iii) Identify the basis for accepting previously made measurements and their limits of error; and\n\n(iv) Designate measurements to be made for physical inventory purposes and the procedures for making these measurements.\n\n(7) Conduct physical inventories of all possessed SNM for each plant at intervals not to exceed 9 calendar months; and\n\n(8) Within 60 calendar days after the start of each physical inventory required by paragraph (c)(7) of this section:\n\n(i) Calculate, for the material balance period terminated by the physical inventory, the inventory difference (ID) and its associated standard error of inventory difference (SEID) for both element and isotope;\n\n(ii) Reconcile and adjust the book record of quantity of element and isotope content, as appropriate, to the results of the physical inventory; and\n\n(iii) Investigate and report to the Director, Office of Nuclear Material Safety and Safeguards, any occurrence of SEID exceeding 0.125 percent of active inventory, and any occurrence of ID exceeding both three times SEID and 200 grams of plutonium or uranium-233 or 300 grams of uranium-235 contained in high enriched uranium, or 9000 grams of uranium-235 contained in low enriched uranium. The report shall include a statement of the probable reasons for the excessive inventory difference and the corrective actions taken or planned.\n\n(d)  Recordkeeping.  The licensee shall:\n\n(1) Maintain records of the receipt, shipment, disposal, and current inventory associated with all possessed SNM;\n\n(2) Maintain records of the quantities of SNM added to and removed from process;\n\n(3) Maintain records of all shipper-receiver evaluations associated with SNM receipts;\n\n(4) Retain each record pertaining to receipt and disposal of SNM until the Commission terminates the license; and\n\n(5) Establish records that will demonstrate that the performance objectives of \u00a7 74.41(a)(1) through (4), the system capabilities of paragraphs (b) and (c) of this section and \u00a7 74.45(b) and (c) have been met, and maintain these records in an auditable form, available for inspection, for at least 3 years, unless a longer retention time is specified by \u00a7 74.19(b), part 75 of this chapter, or by a specific license condition."], ["10:10:2.0.1.1.14.4.121.3", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "D", "Subpart D\u2014Special Nuclear Material of Moderate Strategic Significance", "", "\u00a7 74.45 Measurements and measurement control.", "NRC", "", "", "[67 FR 78146, Dec. 23, 2002]", "(a)  General.  Licensees subject to \u00a7 74.41 of this part shall establish and maintain the measurement and measurement control capabilities required by paragraphs (b) and (c) of this section.\n\n(b)  Measurements.  The licensee shall:\n\n(1) Establish, maintain, and use a program for the measurement of all SNM received, produced, transferred between internal control areas, on inventory, or shipped, discarded, or otherwise removed from inventory, except for:\n\n(i) Sealed sources that have been determined by other means to contain less than 10 grams of uranium-235, uranium-233, or plutonium each;\n\n(ii) Samples received, transferred between internal control areas, or on inventory that have been determined by other means to contain less than 10 grams of uranium-235, uranium-233, or plutonium each;\n\n(iii) Receipt of sealed sources, of any quantity, previously manufactured and shipped by the licensee and which are returned to the licensee, provided the unique identity and encapsulation integrity have not been compromised, and the booked receipt quantity equals the previously shipped quantity for the involved sealed sources; and\n\n(iv) Heterogeneous scrap that cannot be accurately measured in its as received form, provided this scrap is measured after dissolution within 18 months of receipt. The after dissolution measurement must include measurement of both the resulting solution and any undissolved residues, before any co-mingling with other scrap solutions or residues.\n\n(2) Maintain and follow a program for the development and use of written procedures that includes documented review and approval of these procedures, and any revisions thereof, before use, for:\n\n(i) Preparing or acquiring, maintaining, storing, and using reference standards;\n\n(ii) Calibrating measurement systems, performing bulk mass and volume measurements, conducting nondestructive assay measurements, obtaining samples, and performing laboratory analyses for element concentration and isotope abundance; and\n\n(iii) Recording, reviewing, and reporting measurements.\n\n(c)  Measurement control.  To maintain measurement quality and to estimate measurement uncertainty values, the licensee shall:\n\n(1) Assign responsibility for planning, developing, coordinating, and administering a measurement control program to an individual who has no direct responsibility for performing measurements or for SNM processing or handling, and who holds a position at an organizational level which permits independence of action and has adequate authority to obtain all the information required to monitor and evaluate measurement quality as required by this section.\n\n(2) Ensure that any contractor who performs MC&A measurements services conforms with applicable requirements in paragraphs (c)(5), (6), (7), (10) and (11) of this section. Conformance must include reporting by the contractor of sufficient measurement control data to allow the licensee to calculate bias corrections and measurement limits of error.\n\n(3) Ensure that potential sources of sampling error are identified and that samples are representative by performing process sampling tests using well characterized materials to establish or verify the applicability of utilized procedures for sampling SNM and for maintaining sample integrity during transport and storage. These sampling tests or sample integrity tests, as appropriate, shall be conducted whenever:\n\n(i) A new sampling procedure or technique is used, or new sampling equipment is installed;\n\n(ii) A sampling procedure, technique, or sampling equipment is modified to the extent that a systematic sampling error could be introduced; and\n\n(iii) Sample containers, sample transport methods, or sample storage conditions are changed or modified to the extent that a systematic sampling error could be introduced.\n\n(4) Establish and maintain a measurement control program so that for each inventory period the SEID is less than 0.125 percent of the active inventory, and assure that any MC&A measurements performed under contract are controlled so that the licensee can satisfy this requirement.\n\n(5) Generate current data on the performance of each measurement system used during each material balance period for the establishment of measured values and estimated measurement uncertainties, including estimates of bias, variance components for calibration, sampling, and repeat measurements. The program data must reflect the current process and measurement conditions existing at the time the control measurements are made.\n\n(6) Use standards on an ongoing basis for the calibration and control of all measurement systems used for SNM accountability. Calibrations shall be repeated whenever any significant change occurs in a measurement system or when program data indicate a need for recalibration. Calibrations and control standard measurements shall be based on standards whose assigned values are traceable to certified reference standards or certified standard reference materials. Additionally, control standards shall be representative of the process material or items being measured by the measurement system in question.\n\n(7) Conduct control measurements to provide current data for the determination of random error behavior. On a predetermined schedule, the program shall include, as appropriate:\n\n(i) Replicate analyses of individual samples;\n\n(ii) Analysis of replicate process samples;\n\n(iii) Replicate volume measurements of bulk process batches;\n\n(iv) Replicate weight measurements of process items and bulk batches, or alternatively, the use of data generated from the replicate weighings of control standard weights as derived from the control standard program; and\n\n(v) Replicate NDA measurements of individual process containers (items), or alternatively, the use of data generated from the replicate measurements of NDA control standards as derived from the control standard program.\n\n(8) Use all measurements and measurement controls generated during the current material balance period for the estimation of the SEID.\n\n(9) Evaluate with appropriate statistical methods all measurement system data generated in paragraph (c)(5) of this section to determine significant contributors to the measurement uncertainties associated with inventory differences and shipper-receiver differences, so that if SEID exceeds the limits established in paragraph (c)(4) of this section, the cause of the excessive SEID can be identified for corrective action with respect to controlling the standard error within applicable limits.\n\n(10) Establish and maintain a statistical control system, including control charts and formal statistical procedures, designed to monitor the quality of each measurement device or system. Control chart limits must be established to be equivalent to levels of significance of 0.05 and 0.001.\n\n(11) Promptly investigate and take any appropriate corrective action whenever a control datum exceeds an 0.05 control limit, and whenever a control datum exceeds an 0.001 control limit, the measurement system that generated the datum shall immediately be placed out-of-service with respect to MC&A measurements until the deficiency has been corrected and the system brought into control within the 0.05 control limits."], ["10:10:2.0.1.1.14.5.121.1", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "E", "Subpart E\u2014Formula Quantities of Strategic Special Nuclear Material", "", "\u00a7 74.51 Nuclear material control and accounting for strategic special nuclear material.", "NRC", "", "", "[52 FR 10040, Mar. 30, 1987, as amended at 63 FR 26963, May 15, 1998; 67 FR 78148, Dec. 23, 2002]", "(a)  General performance objectives.  Each licensee who is authorized to possess five or more formula kilograms of strategic special nuclear material (SSNM) and to use such material at any site, other than a nuclear reactor licensed pursuant to part 50 of this chapter, an irradiated fuel reprocessing plant, an operation involved with waste disposal, or an independent spent fuel storage facility licensed pursuant to part 72 of this chapter shall establish, implement, and maintain a Commission-approved material control and accounting (MC&A) system that will achieve the following objectives:\n\n(1) Prompt investigation of anomalies potentially indicative of SSNM losses;\n\n(2) Timely detection of the possible abrupt loss of five or more formula kilograms of SSNM from an individual unit process;\n\n(3) Rapid determination of whether an actual loss of five or more formula kilograms occurred;\n\n(4) Ongoing confirmation of the presence of SSNM in assigned locations; and\n\n(5) Timely generation of information to aid in the recovery of SSNM in the event of an actual loss.\n\n(b)  System capabilities.  To achieve the general performance objectives specified in \u00a7 74.51(a), the MC&A system must provide the capabilities described in \u00a7\u00a7 74.53, 74.55, 74.57 and 74.59 and must incorporate checks and balances that are sufficient to detect falsification of data and reports that could conceal diversion by:\n\n(1) An individual, including an employee in any position; or\n\n(2) Collusion between an individual with MC&A responsibilities and another individual who has responsibility or control within both the physical protection and the MC&A systems.\n\n(c)  Implementation dates.  Each applicant for a license, and each licensee that, upon application for modification of a license, would become newly subject to paragraph (a) of this section, shall submit a fundamental nuclear material control (FNMC) plan describing how the MC&A system shall satisfy the requirement of paragraph (b) of this section. The FNMC plan shall be implemented when a license is issued or modified to authorize the activities being addressed in paragraph (a) of this section, or by the date specified in a license condition.\n\n(d)  Inventories.  Notwithstanding \u00a7 74.59(f)(1), licensees shall perform at least three bimonthly physical inventories after implementation of the NRC approved FNMC Plan and shall continue to perform bimonthly inventories until performance acceptable to the NRC has been demonstrated and the Commission has issued formal approval to perform semiannual inventories. Licensees who have prior experience with process monitoring and/or can demonstrate acceptable performance against all Plan commitments may request authorization to perform semiannual inventories at an earlier date."], ["10:10:2.0.1.1.14.5.121.2", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "E", "Subpart E\u2014Formula Quantities of Strategic Special Nuclear Material", "", "\u00a7 74.53 Process monitoring.", "NRC", "", "", "", "(a) Licensees subject to \u00a7 74.51 shall monitor internal transfers, storage, and processing of SSNM. The process monitoring must achieve the detection capabilities described in paragraph (b) of this section for all SSNM except:\n\n(1) SSNM that is subject to the item loss detection requirements of \u00a7 74.55;\n\n(2) Scrap in the form of small pieces, cuttings, chips, solutions, or in other forms that result from a manufacturing process, held in containers of 30 gallons or larger, with an SSNM content of less than 0.25 grams per liter;\n\n(3) SSNM with an estimated measurement standard deviation greater than five percent that is either input or output material associated with a unit that processes less than five formula kilograms over a consecutive three-month period; and\n\n(4) SSNM involved in research and development operations that process less than five formula kilograms during any seven-consecutive-day period.\n\n(b)  Unit process detection capability.  For each unit process, a licensee shall establish a production quality control program capable of monitoring the status of material in process. The program shall include:\n\n(1) A statistical test that has at least a 95 percent power of detecting an abrupt loss of five formula kilograms within three working days of a loss of Category IA material from any accessible process location and within seven calendar days of a loss of Category IB material from any accessible process location;\n\n(2) A quality control test whereby process differences greater than three times the estimated standard deviation of the process difference estimator and 25 grams of SSNM are investigated; and\n\n(3) A trend analysis for monitoring and evaluating sequences of material control test results from each unit process to determine if they indicate a pattern of losses or gains that are of safeguards significance.\n\n(c) For research and development operations exempt from the requirements of paragraph (b) of this section, the licensee shall:\n\n(1) Perform material balance tests on a lot or a batch basis, as appropriate, or monthly, whichever is sooner, and investigate any difference greater than 200 grams of plutonium or U-233 or 300 grams of U-235 that exceeds three times the estimated standard error of the inventory difference estimator;\n\n(2) Evaluate material balance results generated during an inventory period for indications of measurement biases or unidentified loss streams and investigate, determine the cause(s) of, and institute corrective action for cumulative inventory differences generated during an inventory period that exceed three formula kilograms of SSNM."], ["10:10:2.0.1.1.14.5.121.3", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "E", "Subpart E\u2014Formula Quantities of Strategic Special Nuclear Material", "", "\u00a7 74.55 Item monitoring.", "NRC", "", "", "[52 FR 10040, Mar. 30, 1987, as amended at 80 FR 45844, Aug. 3, 2015]", "(a) Licensees subject to \u00a7 74.51 shall provide the detection capability described in paragraph (b) of this section for laboratory samples containing less than 0.05 formula kilograms of SSNM and any uniquely identified items of SSNM that have been quantitatively measured, the validity of that measurement independently confirmed, and that additionally have been either:\n\n(1) Tamper-safed or placed in a vault or controlled access area that provides protection at least equivalent to tamper-safing; or\n\n(2) Sealed such that removal of SSNM would be readily and permanently apparent (e.g., encapsulated).\n\n(b) The licensee shall verify on a statistical sampling basis, the presence and integrity of SSNM items. The statistical sampling plan must have at least 99 percent power of detecting item losses that total five formula kilograms or more, plant-wide, within:\n\n(1) Thirty calendar days for Category IA items and 60 calendar days for Category IB items contained in a vault or in a permanently controlled access area isolated from the rest of the material access area (MAA);\n\n(2) Three working days for Category IA items and seven calendar days for Category IB items located elsewhere in the MAA, except for reactor components measuring at least one meter in length and weighing in excess of 30 kilograms for which the time interval shall be 30 days;\n\n(3) Sixty calendar days for items in a permanently controlled access area outside of an MAA; or\n\n(4) Sixty calendar days for samples in a vault or permanently controlled access area and 30 calendar days for samples elsewhere in the MAA for samples each containing less than 0.05 formula kilograms of SSNM.\n\n(c) Items containing scrap in the form of small pieces, cuttings, chips, solutions, or in other forms that result from a manufacturing process, held in containers of 30 gallon or larger, with an SSNM concentration of less than 0.25 grams per liter are exempt from the requirements of paragraph (b) of this section."], ["10:10:2.0.1.1.14.5.121.4", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "E", "Subpart E\u2014Formula Quantities of Strategic Special Nuclear Material", "", "\u00a7 74.57 Alarm resolution.", "NRC", "", "", "[52 FR 10040, Mar. 30, 1987, as amended at 54 FR 6877, Feb. 15, 1989; 55 FR 5979, Feb. 21, 1990; 60 FR 24553, May 9, 1995; 67 FR 78148, Dec. 23, 2002]", "(a) Licensees subject to \u00a7 74.51 shall provide the MC&A alarm resolution capabilities described in paragraphs (b) through (f) of this section.\n\n(b) Licensees shall resolve the nature and cause of any MC&A alarm within approved time periods.\n\n(c) Each licensee shall notify the NRC Operations Center by telephone of any MC&A alarm that remains unresolved beyond the time period specified for its resolution in the licensee's fundamental nuclear material control plan. Notification must occur within 24 hours except when a holiday or weekend intervenes in which case the notification must occur on the next scheduled workday. The licensee may consider an alarm to be resolved if:\n\n(1) Clerical or computational error is found that clearly was the cause for the alarm; or\n\n(2) An assignable cause for the alarm is identified or it is substantiated that no material loss has occurred.\n\n(d) If a material loss has occurred, the licensee shall determine the amount of SSNM lost and take corrective action to:\n\n(1) Return out-of-place SSNM, if possible, to its appropriate place;\n\n(2) Update and correct associated records; and\n\n(3) Modify the MC&A system, if appropriate, to prevent similar future occurrences.\n\n(e) The licensee shall provide an ability to rapidly assess the validity of alleged thefts.\n\n(f) If an abrupt loss detection estimate exceeds five formula kilograms of SSNM:\n\n(1) Material processing operations related to the alarm must be suspended until completion of planned alarm resolution activities, unless the suspension of operations will adversely affect the ability to resolve the alarm. Operation of continuous processes may continue for 24 hours from the time of the occurrence of the alarm during which time checks shall be made for mistakes in records or calculations that could have caused the alarm.\n\n(2) Within 24 hours, the licensee shall notify the NRC Operations Center by telephone that an MC&A alarm resolution procedure has been initiated."], ["10:10:2.0.1.1.14.5.121.5", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "E", "Subpart E\u2014Formula Quantities of Strategic Special Nuclear Material", "", "\u00a7 74.59 Quality assurance and accounting requirements.", "NRC", "", "", "[52 FR 10040, Mar. 30, 1987, as amended at 54 FR 6878, Feb. 15, 1989; 55 FR 5979, Feb. 21, 1990; 60 FR 24553, May 9, 1995; 67 FR 78148, Dec. 23, 2002; 68 FR 58822, Oct. 10, 2003]", "(a) Licensees subject to \u00a7 74.51 shall provide the quality assurance and accounting capabilities described in paragraphs (b) through (h) of this section.\n\n(b)  Management structure.  The licensee shall:\n\n(1) Establish and maintain a management structure that includes clear overall responsibility for planning, coordinating, and administering material control and accounting functions, independence of material control and accounting functions from production responsibilities, and separation of functions such that the activities of one individual or organizational unit serve as controls over and checks of the activities of others; and\n\n(2) Provide for the adequate review, approval, and use of those material control and accounting procedures that are identified in the approved FNMC plan as being critical to the effectiveness of the described system.\n\n(c)  Personnel qualification and training.  The licensee shall assure that personnel who work in key positions where mistakes could degrade the effectiveness of the material control and accounting system are trained to maintain a high level of safeguards awareness and are qualified to perform their duties and/or responsibilities.\n\n(d)  Measurements.  The licensee shall establish and maintain a system of measurements sufficient to:\n\n(1) Substantiate the plutonium element and uranium element and isotope content of all SSNM received, produced, transferred between areas of custodial responsibility, on inventory, or shipped, discarded, or otherwise removed from inventory;\n\n(2) Enable the estimation of the standard deviation associated with each measured quantity; and\n\n(3) Provide the data necessary for performance of the material control tests required by \u00a7 74.53(b).\n\n(e)  Measurement control.  The licensee shall assure that the quality of SSNM measurement systems and material processing practices is continually controlled to a level of effectiveness sufficient to satisfy the capabilities required for detection, response, and accounting. To achieve this objective the licensee shall:\n\n(1) Perform engineering analyses and evaluations of the design, installation, preoperational tests, calibration, and operation of all measurement systems to be used for MC&A purposes;\n\n(2) Perform process and engineering tests using well characterized materials to establish or to verify the applicability of existing procedures for mixing and sampling SSNM and maintaining sample integrity during transport and storage. Tests must be repeated at least every three years, at any time there is a process modification that alters the physical or chemical composition of the SSNM, or whenever there is a change in the sampling technique or equipment; and\n\n(3) Generate current data on the performance of measurement processes, including, as appropriate, values for bias corrections, uncertainties on calibration factors, and random error standard deviations. The program must include:\n\n(i) The onging use of standards for calibration and control of all applicable measurement systems. Calibrations must be repeated whenever any change in a measurement system occurs which has the potential to affect a measurement result or when program data, generated by tests performed at a pre-determined frequency, indicate a need for recalibration. Calibrations and tests must be based on standards with traceability to national standards or nationally accepted measurement systems; and\n\n(ii) A system of control measurements to provide current data for the estimation of the standard deviations that are significant contributors to the measurement uncertainties associated with shipper/receiver differences, inventory differences, and process differences.\n\n(4) Utilize the data generated during the current material balance period for the estimation of the standard error of the inventory difference (SEID) and the standard error of the process differences. Calibration and measurement error data collected and used during immediately preceding material balance periods may be combined with current data provided that the measurement systems are in statistical control and the combined data are utilized in characterizing the unknowns.\n\n(5) Evaluate all program data and information to assure that measurement performance is so controlled that the SEID estimator is less than 0.1 percent of active inventory.\n\n(6) Apply bias corrections by an appropriate procedure whereby:\n\n(i) Bias corrections are applied to individual items if for any measurement system the relative bias estimate exceeds twice the standard deviation of its estimator, the absolute bias estimate exceeds 50 grams of SSNM when applied across all affected items, and the absolute bias estimate on an individual item basis exceeds the rounding error of affected items; and\n\n(ii) All biases (regardless of significance) that are not applied as corrections to individual items are applied as a correction to the inventory difference.\n\n(7) Investigate and take corrective action, as appropriate, to identify and reduce associated measurement biases when, for like material types ( i.e. , measured by the same measurement system), the net cumulative shipper/receiver differences accumulated over a six-month period exceed the larger of one formula kilogram or 0.1 percent of the total amount received.\n\n(8) Establish and maintain a statistical control system designed to monitor the quality of each type of program measurement. Control limits must be established to be equivalent to levels of significance of 0.05 and 0.001. Control data exceeding the 0.05 limits must be investigated and corrective action taken in a timely manner. Whenever a single data point exceeds the 0.001 control limit, the measurement system in question must not be used for material control and accounting purposes until it has been brought into control at the 0.05 level.\n\n(f)  Physical inventory.  The licensee shall:\n\n(1) Except as required by part 75 of this Chapter, perform a physical inventory at least every six calendar months and within 45 days after the start of the ending inventory:\n\n(i) Calculate the inventory difference (ID); estimate the standard error of the inventory difference (SEID); and investigate and report any SEID estimate of 0.1 percent or more of active inventory, and any ID that exceeds both three times SEID and 200 grams of plutonium or uranium-233, or 300 grams of uranium-235 contained in high enriched uranium.\n\n(ii) If required to perform an investigation pursuant to paragraph (f)(1)(i) of this section, evaluate the significance of the inventory difference relative to expected performance as determined from an analysis of an appropriate sequence of historical inventory differences;\n\n(iii) Investigate and report, by an appropriate method listed in \u00a7 74.6, to the Director, Office of Nuclear Material Safety and Safeguards, any difference that exceeds three times the standard deviation determined from the sequential analysis;\n\n(iv) Perform a reinventory if directed to do so by the Commission; and\n\n(v) Reconcile and adjust the plant and subsidiary book records to the results of the physical inventory.\n\n(2) Implement policies, practices, and procedures designed to ensure the quality of physical inventories. These must include:\n\n(i) Development of procedures for tamper-safing of containers or vaults containing SSNM not in process that include adequate controls to assure the validity of assigned SSNM values;\n\n(ii) Maintenance of records of the quantities of SSNM added to and removed from process;\n\n(iii) Requirements for signed documentation of all SSNM transfers between areas with different custodial responsibility that reflect all quantities of SSNM transferred;\n\n(iv) Means for control of and accounting for internal transfer documents;\n\n(v) Cutoff procedures for transfers and processing so that all quantities of SSNM are inventoried and none are inventoried more than once;\n\n(vi) Cutoff procedures for records and reports so that all transfers for the inventory and material balance interval and no others are included in the records;\n\n(vii) Inventory procedures for sealed sources and containers or vaults containing SSNM that assure reliable identification and quantification of contained SSNM;\n\n(viii) Inventory procedures for in-process SSNM that provide for measurement of quantities not previously measured for element and isotope, as appropriate, and remeasurement of material previously measured but whose validity has not been assured by tamper-safing or equivalent protection; and\n\n(ix) Written instructions for conducting physical inventories that detail assignments, responsibilities, and preparation for and performance of an inventory.\n\n(g)  Accounting.  The licensee shall establish auditable records sufficient to demonstrate that the requirements of \u00a7\u00a7 74.53, 74.55, 74.57, and 74.59 have been met and retain those records for at least three years unless a longer retention period is required by part 75 of this Chapter.\n\n(h)  Internal control.  The licensee shall:\n\n(1) Establish procedures for shipping and receiving SSNM that provide for:\n\n(i) Accurate identification and measurement of the quantities shipped and received;\n\n(ii) Review and evaluation of shipper/receiver differences on an individual container or lot basis, as appropriate, on a shipment basis, and on a batch basis when required by part 75 of this Chapter;\n\n(iii) Investigation and corrective action when shipper/receiver differences exceed twice the estimated standard deviation of the difference estimator and the larger of 0.5 percent of the amount of SSNM in the container, lot, or shipment, as appropriate, or 50 grams of SSNM; and\n\n(iv) Documentation of shipper/receiver difference evaluations, investigations, and corrective actions.\n\n(2) Establish a scrap control program that assures that:\n\n(i) Internally generated scrap and scrap from other licensees or contractors is segregated until accountability is established; and\n\n(ii) Any scrap measured with a standard deviation greater than five percent of the measured amount is recovered so that the results are segregated by inventory period and recovered within six months of the end of the inventory period in which the scrap was generated except where it can be demonstrated that the scrap measurement uncertainty will not cause noncompliance with \u00a7 74.59(e)(5).\n\n(3) Incorporate checks and balances in the MC&A system sufficient to control the rate of human errors in material control and accounting information.\n\n(4) Perform independent assessments at least every 12 months that assess the performance of the MC&A system, review its effectiveness, and document management's action on prior assessment recommendations. Assessments must include an evaluation of the measurement control program of any outside contractor laboratory performing MC&A measurements for a licensee, unless the contractor is also subject to the requirements of \u00a7 74.59(e).\n\n(5) Assign custodial responsibility in a manner that ensures that such responsibility can be effectively executed for all SSNM possessed under license."], ["10:10:2.0.1.1.14.6.121.1", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "F", "Subpart F\u2014Enforcement", "", "\u00a7 74.81 Inspections.", "NRC", "", "", "[50 FR 7579, Feb. 25, 1985, as amended at 52 FR 31613, Aug. 21, 1987; 54 FR 6878, Feb. 15, 1989; 55 FR 5979, Feb. 21, 1990; 58 FR 29522, May 21, 1993]", "(a) Each licensee shall afford to the Commission at all reasonable times opportunity to inspect special nuclear material and the premises and facilities wherein special nuclear material is used, produced, or stored.\n\n(b) Each licensee shall make available to the Commission for inspection, upon reasonable notice, records kept by the licensee pertaining to its receipt, possession, use, acquisition, import, export, or transfer of special nuclear material.\n\n(c)(1) In the case of fuel cycle facilities where nuclear reactor fuel is fabricated or processed, each licensee shall upon request by the Director, Office of Nuclear Material Safety and Safeguards or the appropriate NRC Regional Administrator, provide rent-free office space for the exclusive use of Commission inspection personnel. Heat, air conditioning, light, electrical outlets, and janitorial services shall be furnished by each licensee. The office shall be convenient to and have full access to the facility, and shall provide the inspector both visual and acoustic privacy.\n\n(2) For a site with a single fuel facility licensed pursuant to part 70 of this chapter, the space provided shall be adequate to accommodate a full-time inspector, a part-time secretary, and transient NRC personnel. It will be generally commensurate with other office facilities at the site. A space of 250 square feet either within the site's office complex or in an office trailer or other on-site space is suggested as a guide. For sites containing multiple fuel facilities, additional space may be requested to accommodate additional full-time inspector(s). The office space that is provided shall be subject to the approval of the Director, Office of Nuclear Material Safety and Safeguards or the appropriate NRC Regional Administrator. All furniture, supplies, and communication equipment will be furnished by the Commission.\n\n(3) The licensee shall afford any NRC resident inspector assigned to their site, or other NRC inspectors identified by the Director of the Office of Nuclear Material Safety and Safeguards as likely to inspect the facility, immediate unfettered access, equivalent to access provided regular plant employees, following proper identification and compliance with applicable access control measures for security, radiological protection, and personal safety.\n\n(d) At a facility using and possessing a formula quantity of strategic special nuclear material in unirradiated form, the licensee may not announce or otherwise communicate to its employees or site contractors the arrival or presence of an NRC safeguards inspector unless specifically requested to do so by the safeguards inspector."], ["10:10:2.0.1.1.14.6.121.2", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "F", "Subpart F\u2014Enforcement", "", "\u00a7 74.82 Tests.", "NRC", "", "", "", "Each licensee shall perform, or permit the Commission to perform, any tests that the Commission deems appropriate or necessary for the administration of the regulations in this part, including tests of:\n\n(a) Special nuclear material;\n\n(b) Facilities where special nuclear material is utilized, produced, or stored; and\n\n(c) Other equipment and devices used in connection with the production, utilization, or storage of special nuclear material."], ["10:10:2.0.1.1.14.6.121.3", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "F", "Subpart F\u2014Enforcement", "", "\u00a7 74.83 Violations.", "NRC", "", "", "[57 FR 55079, Nov. 24, 1992]", "(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of\u2014\n\n(1) The Atomic Energy Act of 1954, as amended;\n\n(2) Title II of the Energy Reorganization Act of 1974, as amended; or\n\n(3) A regulation or order issued pursuant to those Acts.\n\n(b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act:\n\n(1) For violations of\u2014\n\n(i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended;\n\n(ii) Section 206 of the Energy Reorganization Act;\n\n(iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section;\n\n(iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.\n\n(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended."], ["10:10:2.0.1.1.14.6.121.4", 10, "Energy", "I", "", "74", "PART 74\u2014MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL", "F", "Subpart F\u2014Enforcement", "", "\u00a7 74.84 Criminal penalties.", "NRC", "", "", "[57 FR 55079, Nov. 24, 1992]", "(a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 74 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section.\n\n(b) The regulations in part 74 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: \u00a7\u00a7 74.1, 74.2, 74.4, 74.5, 74.6, 74.7, 74.8, 74.83 and 74.84."], ["21:21:1.0.1.1.28.1.98.1", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "A", "Subpart A\u2014Foods", "", "\u00a7 74.101 FD&C Blue No. 1.", "FDA", "", "", "[42 FR 15654, Mar. 22, 1977, as amended at 58 FR 17511, Apr. 5, 1993]", "(a)  Identity.  (1) The color additive FD&C Blue No. 1 is principally the disodium salt of ethyl [4-[ p -[ethyl ( m -sulfobenzyl) amino]-\u03b1-( o -sulfophenyl) benzylidene] - 2,5 -cyclohexadien - 1 - ylidene] ( m -sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl [4-[ p -[ethyl( p -sulfobenzyl) amino]-\u03b1-( o -sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] ( p -sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[ p -[ethyl ( o -sulfobenzyl) amino] - \u03b1 - ( o  -sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] ( o -sulfobenzyl) ammonium hydroxide inner salt.\n\n(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.\n\n(b)  Specifications.  FD&C Blue No. 1 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 15.0 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n Leuco base, not more than 5 percent.\n \n Sum of  o -,  m -, and  p -sulfobenzaldehydes, not more than 1.5 percent.\n \n N -Ethyl, N -( m -sulfobenzyl)sulfanilic acid, not more than 0.3 percent.\n \n Subsidiary colors, not more than 6.0 percent.\n \n Chromium (as Cr), not more than 50 parts per million.\n \n Manganese (as Mn), not more than 100 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Total color, not less than 85.0 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 15.0 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\nLeuco base, not more than 5 percent.\n\nSum of  o -,  m -, and  p -sulfobenzaldehydes, not more than 1.5 percent.\n\nN -Ethyl, N -( m -sulfobenzyl)sulfanilic acid, not more than 0.3 percent.\n\nSubsidiary colors, not more than 6.0 percent.\n\nChromium (as Cr), not more than 50 parts per million.\n\nManganese (as Mn), not more than 100 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nLead (as Pb), not more than 10 parts per million.\n\nTotal color, not less than 85.0 percent.\n\n(c)  Uses and restrictions.  FD&C Blue No. 1 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.1.98.2", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "A", "Subpart A\u2014Foods", "", "\u00a7 74.102 FD&C Blue No. 2.", "FDA", "", "", "[48 FR 5260, Feb. 4, 1983]", "(a)  Identity.  (1) The color additive FD&C Blue No. 2 is principally the disodium salt of 2-(1,3-dihydro-3-oxo-5-sulfo-2 H -indol-2-ylidene)-2,3-dihydro-3-oxo-1 H -indole-5-sulfonic acid (CAS Reg. No. 860-22-0) with smaller amounts of the disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2 H -indol-2-ylidene)-2,3-dihydro-3-oxo-1 H -indole-5-sulfonic acid (CAS Reg. No. 54947-75-0) and the sodium salt of 2-(1,3-dihydro-3-oxo-2 H -indol-2-ylidene)-2,3-dihydro-3-oxo-1 H -indole-5-sulfonic acid (CAS Reg. No. 605-18-5). Additionally, FD&C Blue No. 2 is obtained by heating indigo (or indigo paste) in the presence of sulfuric acid. The color additive is isolated and subjected to purification procedures. The indigo (or indigo paste) used above is manufactured by the fusion of  N -phenylglycine (prepared from aniline and formaldehyde) in a molten mixture of sodamide and sodium and potassium hydroxides under ammonia pressure. The indigo is isolated and subjected to purification procedures prior to sulfonation.\n\n(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Blue No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.\n\n(b)  Specifications.  The color additive FD&C Blue No. 2 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n \n Water insoluble matter, not more than 0.4 percent.\n \n Isatin-5-sulfonic acid, not more than 0.4 percent.\n \n 5-Sulfoanthranilic acid, not more than 0.2 percent.\n \n Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2 H -indol-2-ylidene)-2,3-dihydro-3-oxo-1 H -indole-5-sulfonic acid, not more than 18 percent.\n \n Sodium salt of 2-(1,3-dihydro-3-oxo-2 H -indol-2-ylidene)-2,3-dihydro-3-oxo-1 H -indole-5-sulfonic acid, not more than 2 percent.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 85 percent.\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n\nWater insoluble matter, not more than 0.4 percent.\n\nIsatin-5-sulfonic acid, not more than 0.4 percent.\n\n5-Sulfoanthranilic acid, not more than 0.2 percent.\n\nDisodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2 H -indol-2-ylidene)-2,3-dihydro-3-oxo-1 H -indole-5-sulfonic acid, not more than 18 percent.\n\nSodium salt of 2-(1,3-dihydro-3-oxo-2 H -indol-2-ylidene)-2,3-dihydro-3-oxo-1 H -indole-5-sulfonic acid, not more than 2 percent.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 85 percent.\n\n(c)  Uses and restrictions.  The color additive FD&C Blue No. 2 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with current good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act unless added color is authorized by such standards.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Blue No. 2 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.1.98.3", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "A", "Subpart A\u2014Foods", "", "\u00a7 74.203 FD&C Green No. 3.", "FDA", "", "", "[47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. 17, 1982]", "(a)  Identity.  (1) The color additive FD&C Green No. 3 is principally the inner salt disodium salt of  N -ethyl- N- [4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide (CAS Reg. No. 2353-45-9); with smaller amounts of the isomeric inner salt disodium salt of  N -ethyl- N- [4-[[4-[ethyl[(3-sulfophenyl)methyl] amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-4-sulfobenzenemethanaminium hydroxide; of  N -ethyl- N- [4-[[4-[ethyl[(4-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-4-sulfobenzenemethanaminium hydroxide and of  N -ethyl- N- [4-[[4-[ethyl[(2-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide. Additionally, FD&C Green No. 3 is manufactured by the acid catalyzed condensation of one molecule of 2-formyl-5-hydroxybenzenesulfonic acid with two molecules from a mixture consisting principally of 3-[(ethylphenylamino)methyl]\n\nbenzensulfonic acid, and smaller amounts of 4-[(ethylphenylamino)methyl]\n\nbenzenesulfonic acid and 2-[(ethylphenylamino)methyl]\n\nbenzenesulfonic acid to form the leuco base. The leuco base is then oxidized with lead dioxide and acid or with dichromate and acid to form the dye. The intermediate 2-formyl-5-hydroxybenzenesulfonic acid is prepared by the potassium permanganate oxidation of 2,2\u2032-(1,2-ethenediyl)-bis(5-aminobenzenesulfonic acid) to sodium 5-amino-2-formylbenzenesulfonate. This amine is diazotized and the resulting diazonium salt is hydrolyzed to the desired 2-formyl-5-hydroxybenzenesulfonic acid.\n\n(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Green No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring food.\n\n(b)  Specifications.  The color additive FD&C Green No. 3 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n Leuco base, not more than 5 percent.\n \n Sum of 2-,3-,4-formylbenzenesulfonic acids, sodium salts, not more than 0.5 percent.\n \n Sum of 3- and 4-[[ethyl(4-sulfophenyl)amino]methyl] benzenesulfonic acid, disodium salts, not more than 0.3 percent.\n \n 2-Formyl-5-hydroxybenzenesulfonic acid, sodium salt, not more than 0.5 percent.\n \n Subsidiary colors, not more than 6 percent.\n \n Chromium (as Cr), not more than 50 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 85 percent.\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\nLeuco base, not more than 5 percent.\n\nSum of 2-,3-,4-formylbenzenesulfonic acids, sodium salts, not more than 0.5 percent.\n\nSum of 3- and 4-[[ethyl(4-sulfophenyl)amino]methyl] benzenesulfonic acid, disodium salts, not more than 0.3 percent.\n\n2-Formyl-5-hydroxybenzenesulfonic acid, sodium salt, not more than 0.5 percent.\n\nSubsidiary colors, not more than 6 percent.\n\nChromium (as Cr), not more than 50 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nLead (as Pb), not more than 10 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 85 percent.\n\n(c)  Uses and restrictions.  The color additive FD&C Green No. 3 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with current good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Green No. 3 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.1.98.4", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "A", "Subpart A\u2014Foods", "", "\u00a7 74.250 Orange B.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive Orange B is principally the disodium salt of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4-sulfonaphthylazo)-5-hydro-xypyrazole.\n\n(2) The diluents in color additive mixtures for food use containing Orange B are limited to those listed in part 73 of this chapter as safe and suitable in color additive mixtures for coloring foods.\n\n(b)  Specifications.  Orange B shall conform to the following specifications:\n\nVolatile matter (at 135 \u00b0C.), not more than 6.0 percent.\n \n Chlorides and sulfates (calculated as the sodium salts), not more than 7.0 percent.\n \n Water insoluble matter, not more than 0.2 percent.\n \n 1-(4-Sulfophenyl)-3-ethylcarboxy-5-hydroxypyrazolone and 1-(4-sulfophenyl)-3-carboxy-5-hydroxypyrazolone, not more than 0.7 percent.\n \n Naphthionic acid, not more than 0.2 percent.\n \n Phenylhydrazine- p -sulfonic acid, not more than 0.2 percent.\n \n The trisodium salt of 1-(4-sulfophenyl)-3-carboxy-4-(4-sulfonaphthylazo)-5-hydroxypyrazole, not more than 6.0 percent.\n \n Other subsidiary dyes, not more than 1.0 percent.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 1 part per million.\n \n Total color, not less than 87.0 percent.\n\nVolatile matter (at 135 \u00b0C.), not more than 6.0 percent.\n\nChlorides and sulfates (calculated as the sodium salts), not more than 7.0 percent.\n\nWater insoluble matter, not more than 0.2 percent.\n\n1-(4-Sulfophenyl)-3-ethylcarboxy-5-hydroxypyrazolone and 1-(4-sulfophenyl)-3-carboxy-5-hydroxypyrazolone, not more than 0.7 percent.\n\nNaphthionic acid, not more than 0.2 percent.\n\nPhenylhydrazine- p -sulfonic acid, not more than 0.2 percent.\n\nThe trisodium salt of 1-(4-sulfophenyl)-3-carboxy-4-(4-sulfonaphthylazo)-5-hydroxypyrazole, not more than 6.0 percent.\n\nOther subsidiary dyes, not more than 1.0 percent.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 1 part per million.\n\nTotal color, not less than 87.0 percent.\n\n(c)  Uses and restrictions.  Orange B may be safely used for coloring the casings or surfaces of frankfurters and sausages subject to the restriction that the quantity of the color additive does not exceed 150 parts per million by weight of the finished food.\n\n(d)  Labeling requirements.  The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of Orange B shall be certified in accordance with regulations promulgated under part 80 of this chapter."], ["21:21:1.0.1.1.28.1.98.5", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "A", "Subpart A\u2014Foods", "", "\u00a7 74.302 Citrus Red No. 2.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive Citrus Red No. 2 is principally 1-(2,5-dimethoxyphenylazo)-2-naphthol.\n\n(2) The following diluents may be used in aqueous suspension, in the percentages specified, to facilitate application to oranges in accordance with paragraph (c)(1) of this section:\n\n(i) Suitable diluents used in accordance with \u00a7 73.1(a) of this chapter.\n\n(ii) Volatile solvents that leave no residue after application to the orange.\n\n(iii) Salts of fatty acids meeting the requirements of \u00a7 172.863 of this chapter.\n\n(iv) Sodium tripolyphosphate, not more than 0.05 percent.\n\n(b)  Specifications.  Citrus Red No. 2 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:\n\nVolatile matter (at 100 \u00b0C.), not more than 0.5 percent.\n \n Water-soluble matter, not more than 0.3 percent.\n \n Matter insoluble in carbon tetrachloride, not more than 0.5 percent.\n \n Uncombined intermediates, not more than 0.05 percent.\n \n Subsidiary dyes, not more than 2.0 percent.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 1 part per million.\n \n Total color, not less than 98 percent.\n\nVolatile matter (at 100 \u00b0C.), not more than 0.5 percent.\n\nWater-soluble matter, not more than 0.3 percent.\n\nMatter insoluble in carbon tetrachloride, not more than 0.5 percent.\n\nUncombined intermediates, not more than 0.05 percent.\n\nSubsidiary dyes, not more than 2.0 percent.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 1 part per million.\n\nTotal color, not less than 98 percent.\n\n(c)  Uses and restrictions.  (1) Citrus Red No. 2 shall be used only for coloring the skins of oranges that are not intended or used for processing (or if so used are designated in the trade as  Packinghouse elimination ) and that meet minimum maturity standards established by or under the laws of the States in which the oranges are grown.\n\n(2) Oranges colored with Citrus Red No. 2 shall bear not more than 2.0 parts per million of such color additive, calculated on the basis of the weight of the whole fruit.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter. To meet the requirements of \u00a7 70.25 (b) and (c) of this chapter the label shall bear:\n\n(1) The statement (or its equivalent) \u201cTo be used only for coloring skins of oranges.\u201d\n\n(2) Directions for use to limit the amount of the color additive to not more than 2.0 parts per million, calculated on the basis of the weight of the whole fruit.\n\n(e)  Certification.  All batches of Citrus Red No. 2 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.1.98.6", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "A", "Subpart A\u2014Foods", "", "\u00a7 74.303 FD&C Red No. 3.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive FD&C Red No. 3 is principally the monohydrate of 9 ( o-  carboxyphenyl)-6-hydroxy - 2,4,5,7-tetraiodo-3H-xanthen-3-one, disodium salt, with smaller amounts of lower imdinated fluoresceins.\n\n(2) Color additive mixtures for food use made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.\n\n(b)  Specifications.  FD&C Red No. 3 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:\n\nVolatile matter (at 135 \u00b0C.) and chlorides and sulfates (calculated as the sodium salts), total not more than 13 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n Unhalogenated intermediates, total not more than 0.1 percent.\n \n Sodium iodide, not more than 0.4 percent.\n \n Triiodoresorcinol, not more than 0.2 percent.\n \n 2(2\u2032,4\u2032-Dihydroxy-3\u2032, 5\u2032-diiodobenzoyl) benzoic acid, not more than 0.2 percent.\n \n Monoiodofluoresceins not more than 1.0 percent.\n \n Other lower iodinated fluoresceins, not more than 9.0 percent.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Total color, not less than 87.0 percent.\n\nVolatile matter (at 135 \u00b0C.) and chlorides and sulfates (calculated as the sodium salts), total not more than 13 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\nUnhalogenated intermediates, total not more than 0.1 percent.\n\nSodium iodide, not more than 0.4 percent.\n\nTriiodoresorcinol, not more than 0.2 percent.\n\n2(2\u2032,4\u2032-Dihydroxy-3\u2032, 5\u2032-diiodobenzoyl) benzoic acid, not more than 0.2 percent.\n\nMonoiodofluoresceins not more than 1.0 percent.\n\nOther lower iodinated fluoresceins, not more than 9.0 percent.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nTotal color, not less than 87.0 percent.\n\n(c)  Uses and restrictions.  FD&C Red No. 3 may be safely used for coloring foods generally (including dietary supplements) in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Red No. 3 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.1.98.7", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "A", "Subpart A\u2014Foods", "", "\u00a7 74.340 FD&C Red No. 40.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive FD&C Red No. 40 is principally the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid.\n\n(2) Color additive mixtures for food use (including dietary supplements) made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.\n\n(3) The listing of this color additive includes lakes prepared as described in \u00a7 82.51 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by \u00a7 82.51 of this chapter.\n\n(b)  Specifications.  FD&C Red No. 40 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C.) and chlorides and sulfates (calculated as sodium salts), not more than 14.0 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n Higher sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent.\n \n Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent.\n \n Disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo] -8-(2-methoxy-5-methyl-4-sulfophenoxy)-2-naphthalenesulfonic acid, not more than 1.0 percent.\n \n Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer's salt), not more than 0.3 percent.\n \n 4-Amino-5-methoxy- o-  toluenesulfonic acid, not more than 0.2 percent.\n \n Disodium salt of 6,6\u2032-oxybis (2-naphthalene-sulfonic acid), not more than 1.0 percent.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Total color, not less than 85.0 percent.\n\nSum of volatile matter (at 135 \u00b0C.) and chlorides and sulfates (calculated as sodium salts), not more than 14.0 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\nHigher sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent.\n\nLower sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent.\n\nDisodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo] -8-(2-methoxy-5-methyl-4-sulfophenoxy)-2-naphthalenesulfonic acid, not more than 1.0 percent.\n\nSodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer's salt), not more than 0.3 percent.\n\n4-Amino-5-methoxy- o-  toluenesulfonic acid, not more than 0.2 percent.\n\nDisodium salt of 6,6\u2032-oxybis (2-naphthalene-sulfonic acid), not more than 1.0 percent.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nTotal color, not less than 85.0 percent.\n\n(c)  Uses and restrictions.  FD&C Red No. 40 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.\n\n(d)  Labeling.  The label of the color additive and any lakes or mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Red No. 40 and lakes thereof shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.1.98.8", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "A", "Subpart A\u2014Foods", "", "\u00a7 74.705 FD&C Yellow No. 5.", "FDA", "", "", "[42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979, as amended at 44 FR 37220, June 26, 1979; 51 FR 24519, July 7, 1986]", "(a)  Identity.  (1) The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[4-sulfophenyl-azo]-1 H -pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-amino-benzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt.\n\n(2) Color additive mixtures for food use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.\n\n(b)  Specifications.  FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n 4,4\u2032-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent.\n \n 4-[(4\u2032,5-Disulfo[1,1\u2032-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent.\n \n Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazole-3-carboxylate, disodium salt, not more than 1 percent.\n \n Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent.\n \n 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.\n \n 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent.\n \n Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent.\n \n 4,4\u2032-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent.\n \n 4-Aminoazobenzene, not more than 75 parts per billion.\n \n 4-Aminobiphenyl, not more than 5 parts per billion.\n \n Aniline, not more than 100 parts per billion.\n \n Azobenzene, not more than 40 parts per billion.\n \n Benzidine, not more than 1 part per billion.\n \n 1,3-Diphenyltriazene, not more than 40 parts per billion.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 87 percent.\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\n4,4\u2032-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent.\n\n4-[(4\u2032,5-Disulfo[1,1\u2032-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent.\n\nEthyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazole-3-carboxylate, disodium salt, not more than 1 percent.\n\nSum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent.\n\n4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.\n\n4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent.\n\nEthyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent.\n\n4,4\u2032-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent.\n\n4-Aminoazobenzene, not more than 75 parts per billion.\n\n4-Aminobiphenyl, not more than 5 parts per billion.\n\nAniline, not more than 100 parts per billion.\n\nAzobenzene, not more than 40 parts per billion.\n\nBenzidine, not more than 1 part per billion.\n\n1,3-Diphenyltriazene, not more than 40 parts per billion.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 87 percent.\n\n(c)  Uses and restrictions.  FD&C Yellow No. 5 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.\n\n(d)  Labeling requirements.  (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(2) Foods for human use that contain FD&C Yellow No. 5, including butter, cheese, and ice cream, shall specifically declare the presence of FD&C Yellow No. 5 by listing the color additive as FD&C Yellow No. 5 among the list of ingredients.\n\n(e)  Certification.  All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.1.98.9", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "A", "Subpart A\u2014Foods", "", "\u00a7 74.706 FD&C Yellow No. 6.", "FDA", "", "", "[51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 1988]", "(a)  Identity.  (1) The color additive FD&C Yellow No. 6 is principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid (CAS Reg. No. 2783-94-0). The trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid (CAS Reg. No. 50880-65-4) may be added in small amounts. The color additive is manufactured by diazotizing 4-aminobenzenesulfonic acid using hydrochloric acid and sodium nitrite or sulfuric acid and sodium nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-sulfonic acid. The dye is isolated as the sodium salt and dried. The trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid which may be blended with the principal color is prepared in the same manner except the diazo benzenesulfonic acid is coupled with 3-hydroxy-2,7-naphthalenedisulfonic acid.\n\n(2) Color additive mixtures for food use made with FD&C Yellow No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.\n\n(b)  Specifications.  The color additive FD&C Yellow No. 6 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n \n Water insoluble matter, not more than 0.2 percent.\n \n Sodium salt of 4-aminobenzenesulfonic acid, not more than 0.2 percent.\n \n Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid, not more than 0.3 percent.\n \n Disodium salt of 6,6\u2032-oxybis[2-naphthalenesulfonic acid], not more than 1 percent.\n \n Disodium salt of 4,4\u2032-(1-triazene-1,3-diyl)bis[benzenesulfonic acid], not more than 0.1 percent.\n \n Sum of the sodium salt of 6-hydroxy-5-(phenylazo)-2-naphthalenesulfonic acid and the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]benzenesulfonic acid, not more than 1 percent.\n \n Sum of the trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid and other higher sulfonated subsidiaries, not more than 5 percent.\n \n 4-Aminoazobenzene, not more than 50 parts per billion.\n \n 4-Aminobiphenyl, not more than 15 parts per billion.\n \n Aniline, not more than 250 parts per billion.\n \n Azobenzene, not more than 200 parts per billion.\n \n Benzidine, not more than 1 part per billion.\n \n 1,3-Diphenyltriazene, not more than 40 parts per billion.\n \n 1-(Phenylazo)-2-naphthalenol, not more than 10 parts per million.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 87 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n\nWater insoluble matter, not more than 0.2 percent.\n\nSodium salt of 4-aminobenzenesulfonic acid, not more than 0.2 percent.\n\nSodium salt of 6-hydroxy-2-naphthalenesulfonic acid, not more than 0.3 percent.\n\nDisodium salt of 6,6\u2032-oxybis[2-naphthalenesulfonic acid], not more than 1 percent.\n\nDisodium salt of 4,4\u2032-(1-triazene-1,3-diyl)bis[benzenesulfonic acid], not more than 0.1 percent.\n\nSum of the sodium salt of 6-hydroxy-5-(phenylazo)-2-naphthalenesulfonic acid and the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]benzenesulfonic acid, not more than 1 percent.\n\nSum of the trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid and other higher sulfonated subsidiaries, not more than 5 percent.\n\n4-Aminoazobenzene, not more than 50 parts per billion.\n\n4-Aminobiphenyl, not more than 15 parts per billion.\n\nAniline, not more than 250 parts per billion.\n\nAzobenzene, not more than 200 parts per billion.\n\nBenzidine, not more than 1 part per billion.\n\n1,3-Diphenyltriazene, not more than 40 parts per billion.\n\n1-(Phenylazo)-2-naphthalenol, not more than 10 parts per million.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 87 percent.\n\n(c)  Uses and restrictions.  The color additive FD&C Yellow No. 6 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with current good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.\n\n(d)  Labeling requirements.  (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(2) [Reserved]\n\n(e)  Certification.  All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.1", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1101 FD&C Blue No. 1", "FDA", "", "", "[47 FR 42565, Sept. 28, 1982, as amended at 59 FR 7638, Feb. 16, 1994]", "(a)  Identity.  (1) For ingested drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of \u00a7 74.101(a)(1).\n\n(2) For externally applied drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of \u00a7 74.2101(a).\n\n(3) Color additive mixtures for drug use made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  (1) The color additive FD&C Blue No. 1 for use in coloring drugs generally shall conform in specifications to the requirements of \u00a7 74.101(b).\n\n(2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of \u00a7 82.51 of this chapter.\n\n(c)  Uses and restrictions.  (1) FD&C Blue No. 1 may be safely used for coloring drugs, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.\n\n(2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice, subject to the restrictions on the use of color additives in \u00a7 70.5(b) and (c) of this chapter.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.10", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1255 D&C Orange No. 5.", "FDA", "", "", "[47 FR 44635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984]", "(a)  Identity.  (1) the color additive D&C Orange No. 5 is a mixture consisting principally the sodium salt of 4\u2032,5\u2032-dibromofluorescein (CAS Reg. No. 596-03-2) and 2\u2032,4\u2032,5\u2032-tribromofluorescein (CAS Reg. No. 25709-83-5) and 2\u2032,4\u2032,5\u2032,7\u2032-tetrabromofluorescein (CAS Reg. No. 15086-94-9). D&C Orange No. 5 is manufactured by brominating fluorescein with elemental bromine. The fluorescein is manufactured by the acid condensation of resorcinol and phthalic acid or its anhydride. The fluorescein is isolated and partially purified prior to bromination.\n\n(2) Color additive mixtures for drug use made with D&C Orange No. 5 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  D&C Orange No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice.\n\n4\u2032,5\u2032-dibromofluorescein, not less than 50 percent and not more than 65 percent.\n \n 2\u2032,4\u2032,5\u2032-tribromofluorescein, not less than 30 percent and not more than 40 percent.\n \n 2\u2032,4\u2032,5\u2032,7\u2032-tetrabromofluorescein, not more than 10 percent.\n \n Sum of 2\u2032,4\u2032-dibromofluorescein and 2\u2032,5\u2032-dibromofluorescein, not more than 2 percent.\n \n 4\u2032-Bromofluorescein, not more than 2 percent.\n \n Fluorescein, not more than 1 percent.\n \n Phthalic acid, not more than 1 percent.\n \n 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.\n \n Brominated resorcinol, not more than 0.4 percent.\n \n Sum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 10 percent.\n \n Insoluble matter (alkaline solution), not more than 0.3 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 90 percent.\n\n4\u2032,5\u2032-dibromofluorescein, not less than 50 percent and not more than 65 percent.\n\n2\u2032,4\u2032,5\u2032-tribromofluorescein, not less than 30 percent and not more than 40 percent.\n\n2\u2032,4\u2032,5\u2032,7\u2032-tetrabromofluorescein, not more than 10 percent.\n\nSum of 2\u2032,4\u2032-dibromofluorescein and 2\u2032,5\u2032-dibromofluorescein, not more than 2 percent.\n\n4\u2032-Bromofluorescein, not more than 2 percent.\n\nFluorescein, not more than 1 percent.\n\nPhthalic acid, not more than 1 percent.\n\n2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.\n\nBrominated resorcinol, not more than 0.4 percent.\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 10 percent.\n\nInsoluble matter (alkaline solution), not more than 0.3 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 90 percent.\n\n(c)  Uses and restrictions.  D&C Orange No. 5 may be safely used for coloring mouthwashes and dentifrices that are ingested drugs in amounts consistent with current good manufacturing practice. D&C Orange No. 5 may be safely used in externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Orange No. 5 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.11", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1260 D&C Orange No. 10.", "FDA", "", "", "[46 FR 18953, Mar. 27, 1981]", "(a)  Identity.  (1) The color additive D&C Orange No. 10 is a mixture consisting principally of 4\u2032,5\u2032-diiodofluorescein, 2\u2032,4\u2032,5\u2032-triiodofluorescein, and 2\u2032,4\u2032,5\u2032,7\u2032-tetraiodofluorescein.\n\n(2) Color additive mixtures for drug use made with D&C Orange No. 10 may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Orange No. 10 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 8 percent.\n \n Insoluble matter (alkaline solution), not more than 0.5 percent.\n \n Phthalic acid, not more than 0.5 percent.\n \n 2-[3\u2032,5\u2032-Diiodo-2\u2032,4\u2032-dihydroxybenzoyl] benzoic acid, not more than 0.5 percent.\n \n Fluorescein, not more than 1 percent.\n \n 4\u2032-Iodofluorescein, not more than 3 percent.\n \n 2\u2032,4\u2032-Diiodofluorescein and 2\u2032,5\u2032-diiodofluorescein, not more than 2 percent.\n \n 2\u2032,4\u2032,5\u2032-Triiodofluorescein, not more than 35 percent.\n \n 2\u2032,4\u2032,5\u2032,7\u2032-Tetraiodofluorescein, not more than 10 percent.\n \n 4\u2032,5\u2032-Diiodofluorescein, not less than 60 percent and not more than 95 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 92 percent.\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 8 percent.\n\nInsoluble matter (alkaline solution), not more than 0.5 percent.\n\nPhthalic acid, not more than 0.5 percent.\n\n2-[3\u2032,5\u2032-Diiodo-2\u2032,4\u2032-dihydroxybenzoyl] benzoic acid, not more than 0.5 percent.\n\nFluorescein, not more than 1 percent.\n\n4\u2032-Iodofluorescein, not more than 3 percent.\n\n2\u2032,4\u2032-Diiodofluorescein and 2\u2032,5\u2032-diiodofluorescein, not more than 2 percent.\n\n2\u2032,4\u2032,5\u2032-Triiodofluorescein, not more than 35 percent.\n\n2\u2032,4\u2032,5\u2032,7\u2032-Tetraiodofluorescein, not more than 10 percent.\n\n4\u2032,5\u2032-Diiodofluorescein, not less than 60 percent and not more than 95 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 92 percent.\n\n(c)  Uses and restrictions.  D&C Orange No. 10 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling requirements.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Orange No. 10 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.12", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1261 D&C Orange No. 11.", "FDA", "", "", "[46 FR 18953, Mar. 27, 1981]", "(a)  Identity.  (1) The color additive D&C Orange No. 11 is a mixture consisting principally of the disodium salts of 4\u2032,5\u2032-diiodofluorescein, 2\u2032,4\u2032,5\u2032-triiodofluorescein and 2\u2032,4\u2032,5\u2032,7\u2032-tetraiodofluorescein.\n\n(2) Color additive mixtures for drug use made with D&C Orange No. 11 may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  The color additive D&C Orange No. 11 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 8 percent.\n \n Water-insoluble matter, not more than 0.5 percent.\n \n Phthalic acid, not more than 0.5 percent.\n \n 2-[3\u2032,5\u2032-Diiodo-2\u2032,4\u2032-dihydroxybenzoyl] benzoic acid, sodium salt, not more than 0.5 percent.\n \n Fluorescein, disodium salt, not more than 1 percent.\n \n 4\u2032-Iodofluorescein, disodium salt, not more than 3 percent.\n \n 2\u2032,4\u2032-Diiodofluorescein and 2\u2032,5\u2032-diiodofluorescein, not more than 2 percent.\n \n 2\u2032,4\u2032,5\u2032-Triiodofluorescein, not more than 35 percent.\n \n 2\u2032,4\u2032,5\u2032,7\u2032-Tetraiodofluorescein, disodium salt, not more than 10 percent.\n \n 4\u2032,5\u2032-Diiodofluorescein, disodium salt, not less than 60 percent and not more than 95 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 92 percent.\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 8 percent.\n\nWater-insoluble matter, not more than 0.5 percent.\n\nPhthalic acid, not more than 0.5 percent.\n\n2-[3\u2032,5\u2032-Diiodo-2\u2032,4\u2032-dihydroxybenzoyl] benzoic acid, sodium salt, not more than 0.5 percent.\n\nFluorescein, disodium salt, not more than 1 percent.\n\n4\u2032-Iodofluorescein, disodium salt, not more than 3 percent.\n\n2\u2032,4\u2032-Diiodofluorescein and 2\u2032,5\u2032-diiodofluorescein, not more than 2 percent.\n\n2\u2032,4\u2032,5\u2032-Triiodofluorescein, not more than 35 percent.\n\n2\u2032,4\u2032,5\u2032,7\u2032-Tetraiodofluorescein, disodium salt, not more than 10 percent.\n\n4\u2032,5\u2032-Diiodofluorescein, disodium salt, not less than 60 percent and not more than 95 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 92 percent.\n\n(c)  Uses and restrictions.  D&C Orange No. 11 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling requirements.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Orange No. 11 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.13", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1303 FD&C Red No. 3.", "FDA", "", "", "", "(a)  Identity and specifications.  (1) The color additive FD&C Red No. 3 shall conform in identity and specifications to the requirements of \u00a7 74.303(a)(1) and (b).\n\n(2) Color additive mixtures for ingested drug used made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring ingested drugs.\n\n(b)  Uses and restrictions.  FD&C Red No. 3 may be safely used for coloring ingested drugs in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of FD&C Red No. 3 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.14", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1304 FD&C Red No. 4.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive FD&C Red No. 4 is principally the disodium salt of 3-[(2,4-dimethyl-5-sulfophenyl)azo] -4-hydroxy-1-naphthalenesulfonic acid.\n\n(2) Color additive mixtures for use in externally applied drugs made with FD&C Red No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  FD&C Red No. 4 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C.) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n 5-Amino-2,4-dimethyl-1-benzenesulfonic acid, sodium salt, not more than 0.2 percent.\n \n 4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.2 percent.\n \n Subsidiary colors, not more than 2 percent.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 87 percent.\n\nSum of volatile matter (at 135 \u00b0C.) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\n5-Amino-2,4-dimethyl-1-benzenesulfonic acid, sodium salt, not more than 0.2 percent.\n\n4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.2 percent.\n\nSubsidiary colors, not more than 2 percent.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 87 percent.\n\n(c)  Uses and restrictions.  FD&C Red No. 4 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Red No. 4 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.15", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1306 D&C Red No. 6.", "FDA", "", "", "[47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012]", "(a)  Identity.  (1) The color additive D&C Red No. 6 is principally the disodium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-naphthalenecarboxylic acid (CAS Reg. No. 5858-81-1). To manufacture the additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with hydrochloric acid and sodium nitrite. The diazo compound is coupled in alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid. The resulting dye precipitates as the disodium salt.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  The color additive D&C Red No. 6 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent.\n \n 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.\n \n 2-Amino-5-methylbenzenesulfonic acid, sodium salt, not more than 0.2 percent.\n \n 3-Hydroxy-2-naphthalenecarboxylic acid, sodium salt, not more than 0.4 percent.\n \n 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, sodium salt, not more than 0.5 percent.\n \n p-  Toluidine, not more than 15 parts per million.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 90 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent.\n\n1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.\n\n2-Amino-5-methylbenzenesulfonic acid, sodium salt, not more than 0.2 percent.\n\n3-Hydroxy-2-naphthalenecarboxylic acid, sodium salt, not more than 0.4 percent.\n\n3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, sodium salt, not more than 0.5 percent.\n\np-  Toluidine, not more than 15 parts per million.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 90 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Red No. 6 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 6 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.16", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1307 D&C Red No. 7.", "FDA", "", "", "[47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012]", "(a)  Identity.  (1) The color additive D&C Red No. 7 is principally the calcium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-naphthalenecarboxylic acid (CAS Reg. No. 5281-04-9). To manufacture the additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with hydrochloric acid and sodium nitrite. The diazo compound is coupled in alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid and the resulting dye converted to the calcium salt with calcium chloride.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  The color additive D&C Red No. 7 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent.\n \n 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.\n \n 2-Amino-5-methylbenzenesulfonic acid, calcium salt, not more than 0.2 percent.\n \n 3-Hydroxy-2-naphthalenecarboxylic acid, calcium salt, not more than 0.4 percent.\n \n 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, calcium salt, not more than 0.5 percent.\n \n p -Toluidine, not more than 15 parts per million.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 90 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent.\n\n1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent.\n\n2-Amino-5-methylbenzenesulfonic acid, calcium salt, not more than 0.2 percent.\n\n3-Hydroxy-2-naphthalenecarboxylic acid, calcium salt, not more than 0.4 percent.\n\n3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, calcium salt, not more than 0.5 percent.\n\np -Toluidine, not more than 15 parts per million.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 90 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Red No. 7 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 7 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.17", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1317 D&C Red No. 17.", "FDA", "", "", "[42 FR 15654, Mar. 22, 1977, as amended at 42 FR 27225, May 27, 1977]", "(a)  Identity.  (1) The color additive D&C Red No. 17 is principally 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 17 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Red No. 17 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:\n\nVolatile matter (at 135 \u00b0C), not more than 5 percent.\n \n Matter insoluble in both toluene and water (color additive mixed in toluene and the resultant residue isolated and mixed with water to obtain the matter insoluble in both toluene and water), not more than 0.5 percent.\n \n Chlorides and sulfates (calculated as sodium salts), not more than 3 percent.\n \n Aniline, not more than 0.2 percent.\n \n 4-Aminoazobenzene, not more than 0.1 percent.\n \n 2-Naphthol, not more than 0.2 percent.\n \n 1-(Phenylazo)-2-naphthol, not more than 3 percent.\n \n 1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, not more than 2 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 90 percent.\n\nVolatile matter (at 135 \u00b0C), not more than 5 percent.\n\nMatter insoluble in both toluene and water (color additive mixed in toluene and the resultant residue isolated and mixed with water to obtain the matter insoluble in both toluene and water), not more than 0.5 percent.\n\nChlorides and sulfates (calculated as sodium salts), not more than 3 percent.\n\nAniline, not more than 0.2 percent.\n\n4-Aminoazobenzene, not more than 0.1 percent.\n\n2-Naphthol, not more than 0.2 percent.\n\n1-(Phenylazo)-2-naphthol, not more than 3 percent.\n\n1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, not more than 2 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 90 percent.\n\n(c)  Uses and restrictions.  D&C Red No. 17 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 17 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.18", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1321 D&C Red No. 21.", "FDA", "", "", "[47 FR 53846, Nov. 30, 1982]", "(a)  Identity.  (1) The color additive D&C Red No. 21 is principally 2\u2032,4\u2032,5\u2032,7\u2032-tetrabromofluorescein (CAS Reg. No. 15086-94-9), and may contain smaller amounts of 2\u2032,4\u2032,5\u2032-tribromofluorescein (CAS Reg. No. 25709-83-5) and 2\u2032,4\u2032,7\u2032-tribromofluorescein (CAS Reg. No. 25709-84-6). The color additive is manufactured by brominating fluorescein with elemental bromine. The fluorescein is manufactured by the acid condensation of resorcinol and phthalic acid or its anhydride. The fluorescein is isolated and partially purified prior to bromination.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 21 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  The color additive D&C Red No. 21 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 10 percent.\n \n Insoluble matter (alkaline solution), not more than 0.5 percent.\n \n Phthalic acid, not more than 1 percent.\n \n 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.\n \n 2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromofluorescein, ethyl ester, not more than 1 percent.\n \n Brominated resorcinol, not more than 0.4 percent.\n \n Fluorescein, not more than 0.2 percent.\n \n Sum of mono- and dibromofluoresceins, not more than 2 percent.\n \n Tribromofluoresceins, not more than 11 percent.\n \n 2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromofluorescein, not less than 87 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 90 percent.\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 10 percent.\n\nInsoluble matter (alkaline solution), not more than 0.5 percent.\n\nPhthalic acid, not more than 1 percent.\n\n2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.\n\n2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromofluorescein, ethyl ester, not more than 1 percent.\n\nBrominated resorcinol, not more than 0.4 percent.\n\nFluorescein, not more than 0.2 percent.\n\nSum of mono- and dibromofluoresceins, not more than 2 percent.\n\nTribromofluoresceins, not more than 11 percent.\n\n2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromofluorescein, not less than 87 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 90 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Red No. 21 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 21 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.19", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1322 D&C Red No. 22.", "FDA", "", "", "[47 FR 53846, Nov. 30, 1982]", "(a)  Identity.  (1) The color additive D&C Red No. 22 is principally the disodium salt of 2\u2032,4\u2032,5\u20327\u2032-tetrabromofluorescein (CAS Reg. No. 17372-87-1) and may contain smaller amounts of the disodium salts of 2\u2032,4\u2032,5\u2032-tribromofluorescein and 2\u2032,4\u2032,7\u2032-tribromofluorescein. The color additive is manufactured by alkaline hydrolysis of 2\u2032,4\u2032,5\u2032,7\u2032-tetrabromofluorescein. 2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromofluorescein is manufactured by brominating fluorescein with elemental bromine. The fluorescein is manufactured by the acid condensation of resorcinol and phthalic acid or its anhydride. Fluorescein is isolated and partially purified prior to bromination.\n\n(2) Color additive mixtures for drug use made with Red No. 22 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  The color additive D&C Red No. 22 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as soduim salts), not more than 10 percent.\n \n Water-insoluble matter not more than 0.5 percent.\n \n Disodium salt of phthalic acid, not more than 1 percent.\n \n Sodium salt of 2-(3,5-Dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.5 percent.\n \n 2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromofluorescein, ethyl ester, not more than 1 percent.\n \n Brominated resorcinol, not more than 0.4 percent.\n \n Sum of disodium salts of mono- and dibromofluoresceins, not more than 2 percent.\n \n Sum of disodium salts of tribromofluoresceins, not more than 25 percent.\n \n Disodium salt of 2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromofluorescein, not less than 72 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 90 percent.\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as soduim salts), not more than 10 percent.\n\nWater-insoluble matter not more than 0.5 percent.\n\nDisodium salt of phthalic acid, not more than 1 percent.\n\nSodium salt of 2-(3,5-Dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.5 percent.\n\n2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromofluorescein, ethyl ester, not more than 1 percent.\n\nBrominated resorcinol, not more than 0.4 percent.\n\nSum of disodium salts of mono- and dibromofluoresceins, not more than 2 percent.\n\nSum of disodium salts of tribromofluoresceins, not more than 25 percent.\n\nDisodium salt of 2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromofluorescein, not less than 72 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 90 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Red No. 22 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 22 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.2", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1102 FD&C Blue No. 2.", "FDA", "", "", "[48 FR 5260, Feb. 4, 1983, as amended at 49 FR 10090, Mar. 19, 1984; 64 FR 48290, Sept. 3, 1999]", "(a)  Identity.  (1) The color additive FD&C Blue No. 2 shall conform in identity to the requirements of \u00a7 74.102(a)(1).\n\n(2) Color additive mixtures for use in ingested drugs made with FD&C Blue No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b) The color additive FD&C Blue No. 2 for use in coloring ingested drugs shall conform to the specifications in \u00a7 74.102(b).\n\n(c) The color additive FD&C Blue No. 2 may be safely used for coloring ingested drugs in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Blue No. 2 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.20", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1327 D&C Red No. 27.", "FDA", "", "", "[47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov. 12, 1982]", "(a)  Identity.  (1) The color additive D&C Red No. 27 is principally 2\u2032,4\u2032,5\u2032,7\u2032-tetrabromo-4,5,6,7-tetrachlorofluorescein (CAS Reg. No. 13473-26-2). The color additive is manufactured by brominating 4,5,6,7-tetrachlorofluorescein with elemental bromine. The 4,5,6,7-tetrachlorofluorescein is manufactured by the acid condensation of resorcinol and tetrachlorophthalic acid or its anhydride. The 4,5,6,7-tetrachlorofluorescein is isolated and partially purified prior to bromination.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 27 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  D&C Red No. 27 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 10 percent.\n \n Insoluble matter (alkaline solution), not more than 0.5 percent.\n \n Tetrachlorophthalic acid, not more than 1.2 percent.\n \n Brominated resorcinol, not more than 0.4 percent.\n \n 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.7 percent.\n \n 2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent.\n \n Lower halogenated subsidiary colors, not more than 4 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 90 percent.\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 10 percent.\n\nInsoluble matter (alkaline solution), not more than 0.5 percent.\n\nTetrachlorophthalic acid, not more than 1.2 percent.\n\nBrominated resorcinol, not more than 0.4 percent.\n\n2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.7 percent.\n\n2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent.\n\nLower halogenated subsidiary colors, not more than 4 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 90 percent.\n\n(c)  Uses and restrictions.  D&C Red No. 27 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 27 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.21", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1328 D&C Red No. 28.", "FDA", "", "", "[47 FR 42568, Sept. 28, 1982]", "(a)  Identity.  (1) The color additive D&C Red No. 28 is principally the disodium salt of 2\u2032,4\u2032,5\u2032,7\u2032-tetrabromo-4,5,6,7-tetrachlorofluorescein (CAS Reg. No. 18472-87-2) formed by alkaline hydrolysis of the parent tetrabromotetrachlorofluorescein.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 28 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  D&C Red No. 28 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 15 percent.\n \n Insoluble matter (alkaline solution), not more than 0.5 percent.\n \n Tetrachlorophthalic acid, not more than 1.2 percent.\n \n Brominated resorcinol, not more than 0.4 percent.\n \n 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.7 percent.\n \n 2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent.\n \n Lower halogenated subsidiary colors, not more than 4 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 85 percent.\n\nSum of volatile matter (at 135 \u00b0C) and halides and sulfates (calculated as sodium salts), not more than 15 percent.\n\nInsoluble matter (alkaline solution), not more than 0.5 percent.\n\nTetrachlorophthalic acid, not more than 1.2 percent.\n\nBrominated resorcinol, not more than 0.4 percent.\n\n2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.7 percent.\n\n2\u2032,4\u2032,5\u2032,7\u2032-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent.\n\nLower halogenated subsidiary colors, not more than 4 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 85 percent.\n\n(c)  Uses and restrictions.  D&C Red No. 28 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 28 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.22", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1330 D&C Red No. 30.", "FDA", "", "", "[47 FR 22510, May 25, 1982]", "(a)  Identity.  (1) The color additive D&C Red No. 30 is principally 6-chloro-2-(6-chloro-4-methyl-3-oxobenzo[ b ]thien-2(3 H )-ylidene)-4-methyl-benzo[ b ]thiophen-3(2 H )-one (CAS Reg. No. 2379-74-0).\n\n(2) Color additive mixtures for drug use made with D&C Red No. 30 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  D&C Red No. 30 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:\n\nVolatile matter (at 135 \u00b0C), not more than 5 percent.\n \n Chlorides and sulfates (calculated as sodium salts), not more than 3 percent.\n \n Matter soluble in acetone, not more than 5 percent.\n \n Total color, not less than 90 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n\nVolatile matter (at 135 \u00b0C), not more than 5 percent.\n\nChlorides and sulfates (calculated as sodium salts), not more than 3 percent.\n\nMatter soluble in acetone, not more than 5 percent.\n\nTotal color, not less than 90 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\n(c)  Uses and restrictions.  D&C Red No. 30 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 30 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.23", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1331 D&C Red No. 31.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive D&C Red No. 31 is principally the calcium salt of 3-hydroxy-4-(phenylazo)-2-naphthalenecarboxylic acid.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 31 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Red No. 31 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent.\n \n Aniline, not more than 0.2 percent.\n \n 3-Hydroxy-2-naphthoic acid, calcium salt, not more than 0.4 percent.\n \n Subsidiary colors, not more than 1 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 90 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent.\n\nAniline, not more than 0.2 percent.\n\n3-Hydroxy-2-naphthoic acid, calcium salt, not more than 0.4 percent.\n\nSubsidiary colors, not more than 1 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 90 percent.\n\n(c)  Uses and restrictions.  D&C Red No. 31 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 31 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.24", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1333 D&C Red No. 33.", "FDA", "", "", "[53 FR 33120, Aug. 30, 1988]", "(a)  Identity.  (1) The color additive D&C Red No. 33 is principally the disodium salt of 5-amino-4-hydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid (CAS Reg. No. 3567-66-6). To manufacture the additive, the product obtained from the nitrous acid diazotization of aniline is coupled with 4-hydroxy-5-amino-2,7-naphthalenedisulfonic acid in an alkaline aqueous medium. The color additive is isolated as the sodium salt.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 33 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  D&C Red No. 33 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practices:\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent.\n \n Water-insoluble matter, not more than 0.3 percent.\n \n 4-Amino-5-hydroxy-2,7-naphthalenedisulfonic acid, disodium salt, not more than 0.3 percent.\n \n 4,5-Dihydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium salt, not more than 3.0 percent.\n \n Aniline, not more than 25 parts per million.\n \n 4-Aminoazobenzene, not more than 100 parts per billion.\n \n 1,3-Diphenyltriazene, not more than 125 parts per billion.\n \n 4-Aminobiphenyl, not more than 275 parts per billion.\n \n Azobenzene, not more than 1 part per million.\n \n Benzidine, not more than 20 parts per billion.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 82 percent.\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent.\n\nWater-insoluble matter, not more than 0.3 percent.\n\n4-Amino-5-hydroxy-2,7-naphthalenedisulfonic acid, disodium salt, not more than 0.3 percent.\n\n4,5-Dihydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium salt, not more than 3.0 percent.\n\nAniline, not more than 25 parts per million.\n\n4-Aminoazobenzene, not more than 100 parts per billion.\n\n1,3-Diphenyltriazene, not more than 125 parts per billion.\n\n4-Aminobiphenyl, not more than 275 parts per billion.\n\nAzobenzene, not more than 1 part per million.\n\nBenzidine, not more than 20 parts per billion.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 82 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Red. No 33 may be safely used for coloring ingested drugs, other than mouthwashes and dentifrices, in amounts not to exceed 0.75 milligram per daily dose of the drug. D&C Red No. 33 may be safely used for coloring externally applied drugs, mouthwashes, and dentifrices in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling requirements.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 33 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.25", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1334 D&C Red No. 34.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive D&C Red No. 34 is principally the calcium salt of 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalene-carboxylic acid.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 34 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Red No. 34 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated at sodium salts), not more than 15 percent.\n \n 2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 percent.\n \n 3-Hydroxy-2-naphthoic acid, not more than 0.4 percent.\n \n Subsidiary colors, not more than 4 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color not less than 85 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated at sodium salts), not more than 15 percent.\n\n2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 percent.\n\n3-Hydroxy-2-naphthoic acid, not more than 0.4 percent.\n\nSubsidiary colors, not more than 4 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color not less than 85 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Red No. 34 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 34 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.26", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1336 D&C Red No. 36.", "FDA", "", "", "[53 FR 29031, Aug. 2, 1988; 53 FR 35255, Sept. 12, 1988, as amended at 53 FR 52130, Dec. 27, 1988]", "(a)  Identity.  (1) The color additive D&C Red No. 36 is 1-[(2-chloro-4-nitrophenyl)azo]-2-naphthalenol (CAS Reg. No. 2814-77-9). The color additive is manufactured by diazotization of 2-chloro-4-nitrobenzenamine in acid medium and coupling with 2-naphthalenol in acid medium.\n\n(2) Color additive mixtures for drug use made with D&C Red No. 36 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  D&C Red No. 36 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:\n\nVolatile matter at 135 \u00b0C (275 \u00b0F), not more than 1.5 percent.\n \n Matter insoluble in toluene, not more than 1.5 percent.\n \n 2-Chloro-4-nitrobenzenamine, not more than 0.3 percent.\n \n 2-Naphthalenol, not more than 1 percent.\n \n 2,4-Dinitrobenzenamine, not more than 0.02 percent.\n \n 1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, not more than 0.5 percent.\n \n 4-[(2-Chloro-4-nitrophenyl)azo]-1-naphthalenol, not more than 0.5 percent.\n \n 1-[(4-Nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent.\n \n 1-[(4-Chloro-2-nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 95 percent.\n\nVolatile matter at 135 \u00b0C (275 \u00b0F), not more than 1.5 percent.\n\nMatter insoluble in toluene, not more than 1.5 percent.\n\n2-Chloro-4-nitrobenzenamine, not more than 0.3 percent.\n\n2-Naphthalenol, not more than 1 percent.\n\n2,4-Dinitrobenzenamine, not more than 0.02 percent.\n\n1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, not more than 0.5 percent.\n\n4-[(2-Chloro-4-nitrophenyl)azo]-1-naphthalenol, not more than 0.5 percent.\n\n1-[(4-Nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent.\n\n1-[(4-Chloro-2-nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 95 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Red No. 36 may be safely used for coloring ingested drugs, other than mouthwashes and dentifrices, in amounts not to exceed 1.7 milligrams per daily dose of the drug for drugs that are taken continuously only for less than 1 year. For drugs taken continuously for longer than 1 year, the color additive shall not be used in amounts to exceed 1.0 milligram per daily dose of the drug. D&C Red No. 36 may be safely used for coloring externally applied drugs in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling requirements.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 36 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.27", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1339 D&C Red No. 39.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive D&C Red No. 39 is  o- [ p (\u03b2,\u03b2\u2032-dihydroxy-diethylamino)-phenylazo]-benzoic acid.\n\n(2) Color additive mixtures made with D&C Red No. 39 may contain the following diluents: Water, acetone, isopropyl alcohol, and specially denatured alcohols used in accordance with 26 CFR part 212.\n\n(b)  Specifications.  D&C Red No. 39 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:\n\nVolatile matter (at 100 \u00b0C.), not more than 2.0 percent.\n \n Matter insoluble in acetone, not more than 1.0 percent.\n \n Anthranilic acid, not more than 0.2 percent.\n \n N,N- (\u03b2,\u03b2\u2032-Dihydroxy-diethyl) aniline, not more than 0.2 percent.\n \n Subsidiary colors, not more than 3.0 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Total color, not less than 95.0 percent.\n\nVolatile matter (at 100 \u00b0C.), not more than 2.0 percent.\n\nMatter insoluble in acetone, not more than 1.0 percent.\n\nAnthranilic acid, not more than 0.2 percent.\n\nN,N- (\u03b2,\u03b2\u2032-Dihydroxy-diethyl) aniline, not more than 0.2 percent.\n\nSubsidiary colors, not more than 3.0 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nTotal color, not less than 95.0 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Red No. 39 may be safely used for the coloring of quaternary ammonium type germicidal solutions intended for external application only, and subject to the further restriction that the quantity of the color additive does not exceed 0.1 percent by weight of the finished drug product.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Red No. 39 shall be certified in accordance with regulations promulgated under part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.28", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1340 FD&C Red No. 40.", "FDA", "", "", "[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]", "(a)  Identity and specifications.  (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of \u00a7 74.340(a)(1) and (b).\n\n(2) Color additive mixtures for drug use made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(3) The listing of this color additive includes lakes prepared as described in \u00a7\u00a7 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by \u00a7\u00a7 82.51 or 82.1051 of this chapter.)\n\n(b)  Uses and restrictions.  (1) FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be safely used in coloring drugs, including those intended for use in the area of the eye, subject to the restrictions on the use of color additives in \u00a7 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice.\n\n(2) Other lakes of FD&C Red No. 40 may be safely used in coloring drugs, subject to the restrictions on the use of color additives in \u00a7 70.5 of this chapter, in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive and any lakes or mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of FD&C Red No. 40 and lakes thereof shall be certified in accordance with regulations, in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.29", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1602 D&C Violet No. 2.", "FDA", "", "", "[42 FR 15654, Mar. 22, 1977, as amended at 45 FR 62978, Sept. 23, 1980; 55 FR 18868, May 7, 1990]", "(a)  Identity.  (1) The color additive D&C Violet No. 2 is principally 1-hydroxy -4-[(4-methylphenyl)amino]-9,10-anthracenedione.\n\n(2) Color additive mixtures for use in externally applied drugs made with D&C Violet No. 2 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Violet No. 2 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities can be avoided by good manufacturing practice:\n\nVolatile matter (at 135 \u00b0C.), not more than 2.0 percent.\n \n Matter insoluble in both carbon tetrachloride and water, not more than 0.5 percent.\n \n p-  Toluidine, not more than 0.2 percent.\n \n 1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent.\n \n 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent.\n \n Subsidiary colors, not more than 1.0 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Total color, not less than 96.0 percent.\n\nVolatile matter (at 135 \u00b0C.), not more than 2.0 percent.\n\nMatter insoluble in both carbon tetrachloride and water, not more than 0.5 percent.\n\np-  Toluidine, not more than 0.2 percent.\n\n1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent.\n\n1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent.\n\nSubsidiary colors, not more than 1.0 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nTotal color, not less than 96.0 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Violet No. 2 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.3", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1104 D&C Blue No. 4.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive D&C Blue No. 4 is principally the diammonium salt of ethyl[4-[ p [ethyl( m-  sulfobenzyl)ami-no]-\u03b1-( o-  sulfophenyl)benzylidene]-2,5-cyclo-hexadien-1-ylidene] ( m-  sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the isomeric diammonium salts of ethyl [4-[ p- [ethyl( p-  sulfobenzyl) amino]-\u03b1-( o-  sulfophenyl) benzylidene]-2,5-cyclohexadien - 1-ylidene]( p-  sulfobenzyl) ammonium hydroxide inner salt and ethyl[4-[ p- [ethyl ( o-  sulfobenzyl)amino]-\u03b1-( o-  sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] ( o-  sulfobenzyl) ammonium hydroxide inner salt.\n\n(2) Color additive mixtures for use in externally applied drugs made with D&C Blue No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Blue No. 4 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n Leuco base, not more than 5 percent.\n \n Sum of  o-, m , and  p-  sulfobenzaldehydes, ammonium salt, not more than 1.5 percent.\n \n N-ethyl, N-( m-  sulfobenzyl) sulfanilic acid ammonium salt, not more than 0.3 percent.\n \n Subsidiary colors, not more than 6 percent.\n \n Chromium (as Cr), not more than 50 parts per million.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 85 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\nLeuco base, not more than 5 percent.\n\nSum of  o-, m , and  p-  sulfobenzaldehydes, ammonium salt, not more than 1.5 percent.\n\nN-ethyl, N-( m-  sulfobenzyl) sulfanilic acid ammonium salt, not more than 0.3 percent.\n\nSubsidiary colors, not more than 6 percent.\n\nChromium (as Cr), not more than 50 parts per million.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 85 percent.\n\n(c)  Uses and restrictions.  D&C Blue No. 4 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Blue No. 4 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.30", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1705 FD&C Yellow No. 5.", "FDA", "", "", "[42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979; 50 FR 35782, Sept. 4, 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Nov. 29, 1994]", "(a)  Identity and specifications.  (1) The color additive FD&C Yellow No. 5 shall conform in identity and specifications to the requirements of \u00a7 74.705 (a)(1) and (b).\n\n(2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of \u00a7 82.51 of this chapter.\n\n(3) Color additive mixtures for drug use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Uses and restrictions.  (1) FD&C Yellow No. 5 may be safely used for coloring drugs generally, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.\n\n(2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, when prepared in accordance with \u00a7 82.51 of this chapter.\n\n(c)  Labeling requirements.  (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(2) The label of OTC and prescription drug products intended for human use administered orally, nasally, rectally, or vaginally, or for use in the area of the eye, containing FD&C Yellow No. 5 shall specifically declare the presence of FD&C Yellow No. 5 by listing the color additive using the names FD&C Yellow No. 5 and tartrazine. The label shall bear a statement such as \u201cContains FD&C Yellow No. 5 (tartrazine) as a color additive\u201d or \u201cContains color additives including FD&C Yellow No. 5 (tartrazine).\u201d The labels of certain drug products subject to this labeling requirement that are also cosmetics, such as: antibacterial mouthwashes and fluoride toothpastes, need not comply with this requirement provided they comply with the requirements of \u00a7 701.3 of this chapter.\n\n(3) For prescription drugs for human use containing FD&C Yellow No. 5 that are administered orally, nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by \u00a7 201.100(d) of this chapter shall, in addition to the label statement required under paragraph (c)(2) of this section, bear the warning statement \u201cThis product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.\u201d This warning statement shall appear in the \u201cPrecautions\u201d section of the labeling.\n\n(d)  Certification.  All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.31", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1706 FD&C Yellow No. 6.", "FDA", "", "", "[51 FR 41782, Nov. 19, 1986, as amended at 52 FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 1988]", "(a)  Identity and specifications.  (1) The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of \u00a7 74.706(a)(1) and (b).\n\n(2) Color additive mixtures for drug use made with FD&C Yellow No. 6 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Uses and restrictions.  FD&C Yellow No. 6 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  (1) The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(2) [Reserved]\n\n(d)  Certification.  All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.32", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1707 D&C Yellow No. 7.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive D&C Yellow No. 7 is principally fluorescein.\n\n(2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Yellow No. 7 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:\n\nSum of water and chlorides and sulfates (calculated as sodium salts), not more than 6 percent.\n \n Matter insoluble in alkaline water, not more than 0.5 percent.\n \n Resorcinol, not more than 0.5 percent.\n \n Phthalic acid, not more than 0.5 percent.\n \n 2-2,4-(Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 94 percent.\n\nSum of water and chlorides and sulfates (calculated as sodium salts), not more than 6 percent.\n\nMatter insoluble in alkaline water, not more than 0.5 percent.\n\nResorcinol, not more than 0.5 percent.\n\nPhthalic acid, not more than 0.5 percent.\n\n2-2,4-(Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 94 percent.\n\n(c)  Uses and restrictions.  D&C Yellow No. 7 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.33", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1707a Ext. D&C Yellow No. 7.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive Ext. D&C Yellow No. 7 is principally the disodium salt of 8-hydroxy-5,7-di-nitro-2-naphthalenesulfonic acid.\n\n(2) Color additive mixtures for drug use made with Ext. D&C Yellow No. 7 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  Ext. D&C Yellow No. 7 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n 1-Naphthol, not more than 0.2 percent.\n \n 2,4-Dinitro-1-naphthol, not more than 0.03 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 85 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\n1-Naphthol, not more than 0.2 percent.\n\n2,4-Dinitro-1-naphthol, not more than 0.03 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 85 percent.\n\n(c)  Uses and restrictions.  Ext. D&C Yellow No. 7 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of Ext. D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.34", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1708 D&C Yellow No. 8.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive D&C Yellow No. 8 is principally the disodium salt of fluorescein.\n\n(2) Color additive mixtures for use in externally applied drugs made with D&C Yellow No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Yellow No. 8 shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:\n\nSum of water and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n \n Matter insoluble in alkaline water, not more than 0.3 percent.\n \n Resorcinol, not more than 0.5 percent.\n \n Phthalic acid, not more than 1 percent.\n \n 2-(2,4-Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 85 percent.\n\nSum of water and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n\nMatter insoluble in alkaline water, not more than 0.3 percent.\n\nResorcinol, not more than 0.5 percent.\n\nPhthalic acid, not more than 1 percent.\n\n2-(2,4-Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 85 percent.\n\n(c)  Uses and restrictions.  D&C Yellow No. 8 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Yellow No. 8 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.35", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1710 D&C Yellow No. 10.", "FDA", "", "", "[48 FR 39219, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984]", "(a)  Identity.  (1) The color additive D&C Yellow No. 10 is a mixture of the sodium salts of the mono- and disulfonic acids of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione consisting principally of the sodium salts of 2-(2,3-dihydro-1,3-dioxo-1 H -indene-2-yl)-6-quinolinesulfonic acid and 2-(2,3-dihydro-1,3-dioxo-1 H -indene-2-yl)-8-quinolinesulfonic acid with lesser amounts of the disodium salts of the disulfonic acids of 2-(2-quinolinyl)-1 H -indene-1,3(2 H )-dione (CAS Reg. No. 8004-92-0). D&C Yellow No. 10 is manufactured by condensing quinaldine with phthalic anhydride to give the unsulfonated dye, which is then sulfonated with oleum.\n\n(2) Color additive mixtures made with D&C Yellow No. 10 for drug use may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  The color additive D&C Yellow No. 10 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n \n Matter insoluble in both water and chloroform, not more than 0.2 percent.\n \n Total sulfonated quinaldines, sodium salts, not more than 0.2 percent.\n \n Total sulfonated phthalic acids, sodium salts, not more than 0.2 percent.\n \n 2-(2-Quinolinyl)-1 H -indene-1,3 (2 H )-dione, not more than 4 parts per million.\n \n Sum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione, not less than 75 percent.\n \n Sum of sodium salts of the disulfonates of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione, not more than 15 percent.\n \n 2-(2,3-Dihydro-1,3-dioxo-1 H -indene-2-yl)-6, 8-quinolinedisulfonic acid, disodium salt, not more than 3 percent.\n \n Diethyl ether soluble matter other than that specified, not more than 2 parts per million, using added 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione for calibration.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 85 percent.\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.\n\nMatter insoluble in both water and chloroform, not more than 0.2 percent.\n\nTotal sulfonated quinaldines, sodium salts, not more than 0.2 percent.\n\nTotal sulfonated phthalic acids, sodium salts, not more than 0.2 percent.\n\n2-(2-Quinolinyl)-1 H -indene-1,3 (2 H )-dione, not more than 4 parts per million.\n\nSum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione, not less than 75 percent.\n\nSum of sodium salts of the disulfonates of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione, not more than 15 percent.\n\n2-(2,3-Dihydro-1,3-dioxo-1 H -indene-2-yl)-6, 8-quinolinedisulfonic acid, disodium salt, not more than 3 percent.\n\nDiethyl ether soluble matter other than that specified, not more than 2 parts per million, using added 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione for calibration.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 85 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Yellow No. 10 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.36", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1711 D&C Yellow No. 11.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive D&C Yellow No. 11 is principally 2-(2-quinolyl)-1,3-indandione.\n\n(2) Color additive mixtures, for drug use made with D&C Yellow No. 11 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Yellow No. 11 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:\n\nVolatile matter (at 135 \u00b0C), not more than 1 percent.\n \n Ethyl alcohol-insoluble matter, not more than 0.4 percent.\n \n Phthalic acid, not more than 0.3 percent.\n \n Quinaldine, not more than 0.2 percent.\n \n Subsidiary colors, not more than 5 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 96 percent.\n\nVolatile matter (at 135 \u00b0C), not more than 1 percent.\n\nEthyl alcohol-insoluble matter, not more than 0.4 percent.\n\nPhthalic acid, not more than 0.3 percent.\n\nQuinaldine, not more than 0.2 percent.\n\nSubsidiary colors, not more than 5 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 96 percent.\n\n(c)  Uses and restrictions.  D&C Yellow No. 11 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Yellow No. 11 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.4", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1109 D&C Blue No. 9.", "FDA", "", "", "[42 FR 15654, Mar. 22, 1977, as amended at 49 FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1, 1993]", "(a)  Identity.  The color additive D&C Blue No. 9 is principally 7,16-dichloro-6,15 - dihydro - 5,9,14,18 - anthrazine-tetrone.\n\n(b)  Specifications.  D&C Blue No. 9 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:\n\nVolatile matter (at 135 \u00b0C.), not more than 3 percent.\n \n Matter extractable by alcoholic HCl (0.1 ml of concentrated hydrochloric acid per 50 ml of 95 percent ethyl alcohol), not more than 1 percent.\n \n 2-Amino anthraquinone, not more than 0.2 percent.\n \n Organically combined chlorine in pure dye, 13.0-14.8 percent.\n \n Lead (as Pb), not more than 20 p/m.\n \n Arsenic (as As), not more than 3 p/m.\n \n Total color, not less than 97 percent.\n\nVolatile matter (at 135 \u00b0C.), not more than 3 percent.\n\nMatter extractable by alcoholic HCl (0.1 ml of concentrated hydrochloric acid per 50 ml of 95 percent ethyl alcohol), not more than 1 percent.\n\n2-Amino anthraquinone, not more than 0.2 percent.\n\nOrganically combined chlorine in pure dye, 13.0-14.8 percent.\n\nLead (as Pb), not more than 20 p/m.\n\nArsenic (as As), not more than 3 p/m.\n\nTotal color, not less than 97 percent.\n\n(c)  Uses and restrictions.  D&C Blue No. 9 may be safely used for coloring cotton and silk surgical sutures, including sutures for ophthalmic use, subject to the following restrictions:\n\n(1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).\n\n(2) The quantity of the color additive does not exceed 2.5 percent by weight of the suture.\n\n(3) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissue.\n\n(4) If the suture is a new drug, a new-drug application approved pursuant to section 505 of the act is in effect for it.\n\n(d)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Blue No. 9 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.5", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1203 FD&C Green No. 3.", "FDA", "", "", "[47 FR 52144, Nov. 19, 1982]", "(a)  Identity and specifications.  (1) The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of \u00a7 74.203(a)(1) and (b).\n\n(2) Color additive mixtures for drug use made with FD&C Green No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.\n\n(b)  Uses and restrictions.  The color additive FD&C Green No. 3 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of FD&C Green No. 3 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.6", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1205 D&C Green No. 5.", "FDA", "", "", "[47 FR 24284, June 4, 1982; 47 FR 27551, June 25, 1982, as amended at 59 FR 40805, Aug. 10, 1994]", "(a)  Identity.  (1) The color additive D&C Green No. 5 is principally the disodium salt of 2,2\u2032-[(9,10-dihydro-9,10-dioxo-1,4-anthracenediyl)diimino]bis-[5-methylbenzenesulfonic acid] (CAS Reg. No. 4403-90-1).\n\n(2) Color additive mixtures for use in drugs made with D&C Green No. 5 may contain only those diluents that are suitable and those that are listed in part 73 of this chapter for use in color additive mixtures for coloring drugs.\n\n(b)  Specifications.  (1) D&C Green No. 5 for use in coloring surgical sutures shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent.\n \n Water insoluble matter, not more than 0.2 percent.\n \n 1,4-Dihydroxyanthraquinone, not more than 0.2 percent.\n \n 2-Amino- m -toluenesulfonic acid, not more than 0.2 percent.\n \n Subsidiary colors, not more than 5 percent.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Total color, not less than 80 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent.\n\nWater insoluble matter, not more than 0.2 percent.\n\n1,4-Dihydroxyanthraquinone, not more than 0.2 percent.\n\n2-Amino- m -toluenesulfonic acid, not more than 0.2 percent.\n\nSubsidiary colors, not more than 5 percent.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nTotal color, not less than 80 percent.\n\n(2) D&C Green No. 5 for use in coloring drugs shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n 1,4-Dihydroxyanthraquinone, not more than 0.2 percent.\n \n Sulfonated toluidines, total not more than 0.2 percent.\n \n p -Toluidine, not more than 0.0015 percent.\n \n Sum of monosulfonated D&C Green No. 6 and Ext. D&C Violet No. 2, not more than 3 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 80 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\n1,4-Dihydroxyanthraquinone, not more than 0.2 percent.\n\nSulfonated toluidines, total not more than 0.2 percent.\n\np -Toluidine, not more than 0.0015 percent.\n\nSum of monosulfonated D&C Green No. 6 and Ext. D&C Violet No. 2, not more than 3 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 80 percent.\n\n(c)  Use and restrictions.  (1) D&C Green No. 5 may be safely used to color nylon 66 (the copolymer of adipic acid and hexamethylenediamine) and/or nylon 6[poly-( e -caprolactam)]nonabsorbable surgical sutures for use in general surgery, subject to the following restrictions:\n\n(i) The quantity of color additive does not exceed 0.6 percent by weight of the suture.\n\n(ii) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissue.\n\n(iii) If the suture is a new drug, an approved new drug application, under section 505 of the act, is in effect for it.\n\n(2) D&C Green No. 5 may be safely used for coloring drugs generally, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Green No. 5 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.7", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1206 D&C Green No. 6.", "FDA", "", "", "[42 FR 15654, Mar. 22, 1977, as amended at 47 FR 14146, Apr. 2, 1982; 47 FR 24278, June 4, 1982; 51 FR 9784, Mar. 21, 1986]", "(a)  Identity.  The color additive D&C Green No. 6 is 1,4-bis[(4-methylphenyl)amino]-9,10-anthracenedione (CAS. Reg. No. 128-80-3).\n\n(b)  Specifications.  The color additive D&C Green No. 6 for use in coloring externally applied drugs shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice:\n\nVolatile matter (at 135 \u00b0C), not more than 2.0 percent.\n \n Water-soluble matter, not more than 0.3 percent.\n \n Matter insoluble in carbon tetrachloride, not more than 1.5 percent.\n \n p -Toluidine, not more than 0.1 percent. \n \n 1,4-Dihydroxyanthraquinone, not more than 0.2 percent.\n \n 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than 5.0 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 96.0 percent.\n\nVolatile matter (at 135 \u00b0C), not more than 2.0 percent.\n\nWater-soluble matter, not more than 0.3 percent.\n\nMatter insoluble in carbon tetrachloride, not more than 1.5 percent.\n\np -Toluidine, not more than 0.1 percent.\n\n1,4-Dihydroxyanthraquinone, not more than 0.2 percent.\n\n1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than 5.0 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 96.0 percent.\n\n(c)  Uses and restrictions.  The color additive D&C Green No. 6 may be safely used for coloring externally applied drugs in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Green No. 6 shall be certified in accordance with regulations promulgated under part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.8", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1208 D&C Green No. 8.", "FDA", "", "", "", "(a)  Identity.  (1) The color additive D&C Green No. 8 is principally the trisodium salt of 8-hydroxy-1,3,6-pyrene-trisulfonic acid.\n\n(2) Color additive mixtures for use in externally applied drugs made with D&C Green No. 8 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Green No. 8 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practices:\n\nVolatile matter (at 135 \u00b0C), not more than 15 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n Chlorides and sulfates (calculated as sodium salt), not more than 20 percent.\n \n The trisodium salt of 1,3,6-pyrenetrisulfonic acid, not more than 6 percent.\n \n The tetrasodium salt of 1,3,6,8-pyrenetetrasulfonic acid, not more than 1 percent.\n \n Pyrene, not more than 0.2 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 65 percent.\n\nVolatile matter (at 135 \u00b0C), not more than 15 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\nChlorides and sulfates (calculated as sodium salt), not more than 20 percent.\n\nThe trisodium salt of 1,3,6-pyrenetrisulfonic acid, not more than 6 percent.\n\nThe tetrasodium salt of 1,3,6,8-pyrenetetrasulfonic acid, not more than 1 percent.\n\nPyrene, not more than 0.2 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 65 percent.\n\n(c)  Uses and restrictions.  D&C Green No. 8 may be safely used in externally applied drugs in amounts not exceeding 0.01 percent by weight of the finished product.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Green No. 8 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.2.98.9", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "B", "Subpart B\u2014Drugs", "", "\u00a7 74.1254 D&C Orange No. 4.", "FDA", "", "", "[42 FR 52396, Sept. 30, 1977, as amended at 43 FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, 1981]", "(a)  Identity.  (1) the color additive D&C Orange No. 4 is principally the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo]benzenesulfonic acid.\n\n(2) Color additive mixtures for use in externally applied drugs made with D&C Orange No. 4 may contain only those diluents that are suitable and that are listed in part 73 of this chapter for use in color additive mixtures for coloring externally applied drugs.\n\n(b)  Specifications.  D&C Orange No. 4 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n 2-Naphthol, not more than 0.4 percent.\n \n Sulfanilic acid, sodium salt, not more than 0.2 percent.\n \n Subsidiary colors, not more than 3 percent.\n \n 4,4\u2032-(Diazoamino)-dibenzenesulfonic acid, not more than 0.1 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 87 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\n2-Naphthol, not more than 0.4 percent.\n\nSulfanilic acid, sodium salt, not more than 0.2 percent.\n\nSubsidiary colors, not more than 3 percent.\n\n4,4\u2032-(Diazoamino)-dibenzenesulfonic acid, not more than 0.1 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 87 percent.\n\n(c)  Uses and restrictions.  D&C Orange No. 4 may be safely used for coloring externally applied drugs in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Orange No. 4 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.1", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2052 D&C Black No. 2.", "FDA", "", "", "[69 FR 44930, July 28, 2004, as amended at 72 FR 10357]", "(a)  Identity.  The color additive D&C Black No. 2 is a high-purity carbon black prepared by the oil furnace process. It is manufactured by the combustion of aromatic petroleum oil feedstock and consists essentially of pure carbon, formed as aggregated fine particles with a surface area range of 200 to 260 meters (m)\n 2 /gram.\n\n(b)  Specifications.  D&C Black No. 2 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:\n\n(1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 200 to 260 m\n 2 /gram.\n\n(2) Weight loss on heating at 950 \u00b0C for 7 minutes (predried for 1 hour at 125 \u00b0C), not more than 2 percent.\n\n(3) Ash content, not more than 0.15 percent.\n\n(4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million).\n\n(5) Lead (total), not more than 10 mg/kg (10 parts per million).\n\n(6) Mercury (total), not more than 1 mg/kg (1 part per million).\n\n(7) Total sulfur, not more than 0.65 percent.\n\n(8) Total PAHs, not more than 0.5 mg/kg (500 parts per billion).\n\n(9) Benzo[ a ]pyrene, not more than 0.005 mg/kg (5 parts per billion).\n\n(10) Dibenz[ a,h ]anthracene, not more than 0.005 mg/kg (5 parts per billion).\n\n(11) Total color (as carbon), not less than 95 percent.\n\n(c)  Uses and restrictions.  D&C Black No. 2 may be safely used for coloring the following cosmetics in amounts consistent with current good manufacturing practice: Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel.\n\n(d)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Black No. 2 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.10", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2254 D&C Orange No. 4.", "FDA", "", "", "[42 FR 52396, Sept. 30, 1977]", "(a)  Identity and specifications.  The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of \u00a7 74.1254 (a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Orange No. 4 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Orange No. 4 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.11", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2255 D&C Orange No. 5.", "FDA", "", "", "[47 FR 49635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984]", "(a)  Identity and specifications.  The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of \u00a7 74.1255 (a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Orange No. 5 may be safely used for coloring mouthwashes and dentifrices that are ingested cosmetics in amounts consistent with current good manufacturing practice. D&C Orange No. 5 may be safely used for coloring lipsticks and other cosmetics intended to be applied to the lips in amounts not exceeding 5.0 percent by weight of the finished cosmetic products. D&C Orange No. 5 may be safely used for coloring externally applied cosmetics in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Orange No. 5 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.12", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2260 D&C Orange No. 10.", "FDA", "", "", "[46 FR 18954, Mar. 27, 1981]", "(a)  Identity and specifications.  The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements of \u00a7 74.1260(a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Orange No. 10 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Orange No. 11 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.13", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2261 D&C Orange No. 11.", "FDA", "", "", "[46 FR 18954, Mar. 27, 1981]", "(a)  Identity and specifications.  The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of \u00a7 74.1261(a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Orange No. 11 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Orange No. 11 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.14", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2304 FD&C Red No. 4.", "FDA", "", "", "", "(a)  Identity and specifications.  The color additive FD&C Red No. 4 shall conform in identity and specifications to the requirements of \u00a7 74.1304(a)(1) and (b).\n\n(b)  Uses and restrictions.  FD&C Red No. 4 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of FD&C Red No. 4 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.15", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2306 D&C Red No. 6.", "FDA", "", "", "[47 FR 57688, Dec. 28, 1982]", "(a)  Identity and specifications.  The color additive D&C Red No. 6 shall conform in identity and specifications to the requirements of \u00a7 74.1306 (a)(1) and (b).\n\n(b)  Uses and restrictions.  The color additive D&C Red No. 6 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 6 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.16", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2307 D&C Red No. 7", "FDA", "", "", "[47 FR 57688, Dec. 28, 1982]", "(a)  Identity and specifications.  The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of \u00a7 74.1307 (a)(1) and (b).\n\n(b)  Uses and restrictions.  The color additive D&C Red No. 7 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 7 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.17", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2317 D&C Red No. 17.", "FDA", "", "", "", "(a)  Identity and specifications.  The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of \u00a7 74.1317(a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Red No. 17 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 17 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.18", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2321 D&C Red No. 21.", "FDA", "", "", "[47 FR 53846, Nov. 30, 1982]", "(a)  Identity and specifications.  The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of \u00a7 74.1321(a)(1) and (b).\n\n(b)  Uses and restrictions.  The color additive D&C Red No. 21 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 21 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.19", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2322 D&C Red No. 22.", "FDA", "", "", "[47 FR 53846, Nov. 30, 1982]", "(a)  Identity and specifications.  The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of \u00a7 74.1322(a)(1) and (b).\n\n(b)  Uses and restrictions.  The color additive D&C Red No. 22 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 22 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.2", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2053 D&C Black No. 3.", "FDA", "", "", "[72 FR 33666, June 19, 2007]", "(a)  Identity.  The color additive D&C Black No. 3 is a washed bone char prepared from calcined cattle bones. The bones are twice heated in excess of 700 \u00b0C for at least 6 hours.\n\n(b)  Specifications.  D&C Black No. 3 shall conform to the following specifications and shall be free from impurities other than those named, to the extent that such other impurities may be avoided by current good manufacturing practices:\n\n(1) Calcium hydroxyapatite (CaO and P 2 O 5 ), not less than 75 percent and not more than 84 percent;\n\n(2) Elemental carbon, not less than 7 percent;\n\n(3) Moisture, not more than 7 percent;\n\n(4) Silica (SiO 2 ), not more than 5 percent;\n\n(5) Arsenic, not more than 3 milligrams (mg)/kilogram (kg) (3 parts per million (ppm));\n\n(6) Lead, not more than 10 mg/kg (10 ppm); and\n\n(7) Total polycyclic aromatic hydrocarbons (PAHs), not more than 5 mg/kg (5 ppm).\n\n(c)  Uses and restrictions.  Cosmetics containing D&C Black No. 3 must comply with \u00a7 700.27 of this chapter with respect to prohibited cattle materials in cosmetic products. D&C Black No. 3 may be safely used for coloring the following cosmetics in amounts consistent with current good manufacturing practice: Eyeliner, eye shadow, mascara, and face powder.\n\n(d)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of D&C Black No. 3 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.20", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2327 D&C Red No. 27.", "FDA", "", "", "[47 FR 42568, Sept. 28, 1982]", "(a)  Identity and specifications.  The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of \u00a7 74.1327 (a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Red No. 27 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 27 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.21", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2328 D&C Red No. 28.", "FDA", "", "", "[47 FR 42568, Sept. 28, 1982]", "(a)  Identity and specifications.  The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of \u00a7 74.1328 (a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Red No. 28 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 28 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.22", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2330 D&C Red No. 30.", "FDA", "", "", "[47 FR 22511, May 25, 1982]", "(a)  Identity and specifications.  The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of \u00a7 74.1330 (a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Red No. 30 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 30 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.23", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2331 D&C Red No. 31.", "FDA", "", "", "", "(a)  Identity and specifications.  The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of \u00a7 74.1331(a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Red No. 31 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 31 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.24", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2333 D&C Red No. 33.", "FDA", "", "", "[53 FR 33120, Aug. 30, 1988]", "(a)  Identity and specifications.  The color additive D&C Red No. 33 shall conform in identity and specifications to the requirements of \u00a7 74.1333(a) (1) and (b).\n\n(b)  Uses and restrictions.  The color additive D&C Red No. 33 may be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 33 may be safely used for coloring mouthwashes (including breath fresheners), dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 33 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.25", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2334 D&C Red No. 34.", "FDA", "", "", "", "(a)  Identity and specifications.  The color additive D&C Red No. 34 shall conform in identity and specifications to the requirements of \u00a7 74.1334(a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Red No. 34 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 34 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.26", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2336 D&C Red No. 36.", "FDA", "", "", "[53 FR 29031, Aug. 2, 1988]", "(a)  Identity and specifications.  The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of \u00a7 74.1336 (a)(1) and (b).\n\n(b)  Uses and restrictions.  The color additive D&C Red No. 36 may be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 36 may be safely used for coloring externally applied cosmetics in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling requirements.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Red No. 36 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.27", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2340 FD&C Red No. 40.", "FDA", "", "", "[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]", "(a)  Identity and specifications.  (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of \u00a7 74.340(a)(1) and (b) of this chapter.\n\n(2) The listing of this color additive includes lakes prepared as described in \u00a7\u00a7 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by \u00a7 82.51 or \u00a7 82.1051 of this chapter.\n\n(b)  Uses and restrictions.  FD&C Red No. 40 may be safely used in coloring cosmetics generally, except that only FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be safely used in coloring cosmetics intended for use in the area of the eye. These uses are subject to the following restrictions:\n\n(1) The color additive may be used in amounts consistent with current good manufacturing practice.\n\n(2) The color additive shall not be exposed to oxidizing or reducing agents that may affect the integrity of the color additives or any other condition that may affect their integrity.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of FD&C Red No. 40 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.28", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2602 D&C Violet No. 2.", "FDA", "", "", "", "(a)  Identity and specifications.  The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of \u00a7 74.1602(a)(1) and (b).\n\n(b)  Uses and restrictions.  The color additive D&C Violet No. 2 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.29", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2602a Ext. D&C Violet No. 2.", "FDA", "", "", "", "(a)  Identity.  The color additive Ext. D&C Violet No. 2 is principally the monosodium salt of 2-[(9,10-dihydro-4-hydroxy -9,10-dioxo-1-anthracenyl) amino]-5-methyl-benzenesulfonic acid.\n\n(b)  Specifications.  Ext. D&C Violet No. 2 shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent.\n \n Water-insoluble matter, not more than 0.4 percent.\n \n 1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent.\n \n 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent.\n \n p-  Toluidine, not more than 0.1 percent.\n \n p-  Toluidine sulfonic acids, sodium salts, not more than 0.2 percent.\n \n Subsidiary colors, not more than 1 percent.\n \n Lead (as Pb), not more than 20 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 80 percent.\n\nSum of volatile matter (at 135 \u00b0C) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent.\n\nWater-insoluble matter, not more than 0.4 percent.\n\n1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent.\n\n1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent.\n\np-  Toluidine, not more than 0.1 percent.\n\np-  Toluidine sulfonic acids, sodium salts, not more than 0.2 percent.\n\nSubsidiary colors, not more than 1 percent.\n\nLead (as Pb), not more than 20 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 80 percent.\n\n(c)  Uses and restrictions.  The color additive Ext. D&C Violet No. 2 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of Ext. D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.3", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2101 FD&C Blue No. 1.", "FDA", "", "", "[47 FR 42565, Sept. 28, 1982, as amended at 58 FR 17511, Apr. 5, 1993; 59 FR 7638, Feb. 16, 1994]", "(a)  Identity.  The color additive FD&C Blue No. 1 is principally the disodium salt of ethyl[4-[ p -[ethyl( m -sulfobenzyl)amino]-\u03b1-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( m -sulfobenzyl)ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl[4-[ p -[ethyl( p -sulfobenzyl)amino]-\u03b1-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( p -sulfobenzyl)ammonium hydroxide inner salt and ethyl[4-[ p -[ethyl( o -sulfobenzyl)amino]-\u03b1-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( o -sulfobenzyl)ammonium hydroxide inner salt. Additionally, FD&C Blue No. 1 is manufactured by the acid catalyzed condensation of one mole of sodium 2-formylbenzenesulfonate with two moles from a mixture consisting principally of 3-[(ethylphenylamino)methyl] benzenesulfonic acid, and smaller amounts of 4-[(ethylphenylamino)methyl] benzenesulfonic acid and 2-[(ethylphenylamino)methyl] benzenesulfonic acid to form the leuco base. The leuco base is then oxidized with lead dioxide and acid, or with dichromate and acid, or with manganese dioxide and acid to form the dye. The intermediate sodium 2-formylbenzenesulfonate is prepared from 2-chlorobenzaldehyde and sodium sulfite.\n\n(b)  Specifications.  (1) The color additive FD&C Blue No. 1 shall conform in specifications to the requirements of \u00a7 74.101(b).\n\n(2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of \u00a7 82.51 of this chapter.\n\n(c)  Uses and restrictions.  (1) FD&C Blue No. 1 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.\n\n(2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.30", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2705 FD&C Yellow No. 5.", "FDA", "", "", "[50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, 1994]", "(a)  Identity.  The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-aminobenzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt.\n\n(b)  Specifications.  (1) FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n \n Water-insoluble matter, not more than 0.2 percent.\n \n 4,4\u2032-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent.\n \n 4-[(4\u2032,5-Disulfo[1,1\u2032-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent.\n \n Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazole-3-carboxylate, disodium salt, not more than 1 percent.\n \n Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent.\n \n 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.\n \n 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent.\n \n Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent.\n \n 4,4\u2032-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent.\n \n 4-Aminoazobenzene, not more than 75 parts per billion.\n \n 4-Aminobiphenyl, not more than 5 parts per billion.\n \n Aniline, not more than 100 parts per billion.\n \n Azobenzene, not more than 40 parts per billion.\n \n Benzidine, not more than 1 part per billion.\n \n 1,3-Diphenyltriazene, not more than 40 parts per billion.\n \n Lead (as Pb), not more than 10 parts per million.\n \n Arsenic (as As), not more than 3 parts per million.\n \n Mercury (as Hg), not more than 1 part per million.\n \n Total color, not less than 87 percent.\n\nSum of volatile matter at 135 \u00b0C (275 \u00b0F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\n\nWater-insoluble matter, not more than 0.2 percent.\n\n4,4\u2032-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent.\n\n4-[(4\u2032,5-Disulfo[1,1\u2032-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent.\n\nEthyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazole-3-carboxylate, disodium salt, not more than 1 percent.\n\nSum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent.\n\n4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.\n\n4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent.\n\nEthyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent.\n\n4,4\u2032-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent.\n\n4-Aminoazobenzene, not more than 75 parts per billion.\n\n4-Aminobiphenyl, not more than 5 parts per billion.\n\nAniline, not more than 100 parts per billion.\n\nAzobenzene, not more than 40 parts per billion.\n\nBenzidine, not more than 1 part per billion.\n\n1,3-Diphenyltriazene, not more than 40 parts per billion.\n\nLead (as Pb), not more than 10 parts per million.\n\nArsenic (as As), not more than 3 parts per million.\n\nMercury (as Hg), not more than 1 part per million.\n\nTotal color, not less than 87 percent.\n\n(2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of \u00a7 82.51 of this chapter.\n\n(c)  Uses and restrictions.  (1) FD&C Yellow No. 5 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.\n\n(2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, subject to the restrictions on use of color additives in \u00a7 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice.\n\n(d)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(e)  Certification.  All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.31", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2706 FD&C Yellow No. 6.", "FDA", "", "", "[51 FR 41782, Nov. 19, 1986]", "(a)  Identity and specifications.  The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of \u00a7 74.706 (a)(1) and (b).\n\n(b)  Uses and restrictions.  FD&C Yellow No. 6 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.32", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2707 D&C Yellow No. 7.", "FDA", "", "", "", "(a)  Identity and specifications.  The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of \u00a7 74.1707(a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Yellow No. 7 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.33", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2707a Ext. D&C Yellow No. 7.", "FDA", "", "", "", "(a)  Identity and specifications.  The color additive Ext. D&C Yellow No. 7 shall conform in identity and specifications to the requirements of \u00a7 74.1707a (a)(1) and (b).\n\n(b)  Uses and restrictions.  Ext. D&C Yellow No. 7 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of Ext. D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.34", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2708 D&C Yellow No. 8.", "FDA", "", "", "", "(a)  Identity and specifications.  The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of \u00a7 74.1708(a)(1) and (b).\n\n(b)  Uses and restrictions.  D&C Yellow No. 8 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Yellow No. 8 shall be certified in accordance with regulations in part 80 of this chapter."], ["21:21:1.0.1.1.28.3.98.35", 21, "Food and Drugs", "I", "A", "74", "PART 74\u2014LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION", "C", "Subpart C\u2014Cosmetics", "", "\u00a7 74.2710 D&C Yellow No. 10.", "FDA", "", "", "[48 FR 39220, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984]", "(a)  Identity and specifications.  The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of \u00a7 74.1710(a)(1) and (b).\n\n(b)  Uses and restrictions.  The color additive D&C Yellow No. 10 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice.\n\n(c)  Labeling.  The label of the color additive shall conform to the requirements of \u00a7 70.25 of this chapter.\n\n(d)  Certification.  All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter."]], "truncated": false, "filtered_table_rows_count": 189, "expanded_columns": [], "expandable_columns": [], "columns": ["section_id", "title_number", "title_name", "chapter", "subchapter", "part_number", "part_name", "subpart", "subpart_name", "section_number", "section_heading", "agency", "authority", "source_citation", "amendment_citations", "full_text"], "primary_keys": ["section_id"], "units": {}, "query": {"sql": "select section_id, title_number, title_name, chapter, subchapter, part_number, part_name, subpart, subpart_name, section_number, section_heading, agency, authority, source_citation, amendment_citations, full_text from cfr_sections where \"part_number\" = :p0 order by section_id limit 101", "params": {"p0": "74"}}, "facet_results": {"title_number": {"name": "title_number", "type": "column", "hideable": false, "toggle_url": 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