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| 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 |
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| 10:10:2.0.1.1.14.1.121.1 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | A | Subpart A—General Provisions | § 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. (b) The general conditions and procedures for the submittal of a license application for the activities covered in this part are detailed in § 70.22 of this chapter. | ||||
| 10:10:2.0.1.1.14.1.121.2 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | A | Subpart A—General Provisions | § 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 §§ 72.72, 72.76, and 72.78 of this chapter. (b) In addition, specific control and accounting requirements are included in subparts C, D, and E for certain licensees who: (1) Possess and use formula quantities of strategic special nuclear material; (2) Possess and use special nuclear material of moderate strategic significance; (3) Possess and use special nuclear material of low strategic significance; or (4) Possess uranium source material and equipment capable of producing enriched uranium. (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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | A | Subpart A—General Provisions | § 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: Abrupt 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. Accessible 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. Act means the Atomic Energy Act of 1954 (68 Stat. 919), including any amendments thereto. Active 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. Additions 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. Alarm 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. Batch 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. Beginning inventory (BI) means the book inventory quantity at the beginning… | ||||
| 10:10:2.0.1.1.14.1.121.4 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | A | Subpart A—General Provisions | § 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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | A | Subpart A—General Provisions | § 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: (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. (b) By hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland. (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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | A | Subpart A—General Provisions | § 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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | A | Subpart A—General Provisions | § 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. (b) The approved information collection requirements contained in this part appear in §§ 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. (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: (1) In § 74.15, DOE/NRC Form-741 is approved under Control No. 3150-0003. (2) In § 74.13, DOE/NRC Form-742 is approved under Control No. 3150-0004. (3) In § 74.13, DOE/NRC Form-742C is approved under Control No. 3150-0058. (4) In § 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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | B | Subpart B—General Reporting and Recordkeeping Requirements | § 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. (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 § 73.22(f)(3) applies to all telephonic reports required by this section. (c) Notifications required under § 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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | B | Subpart B—General Reporting and Recordkeeping Requirements | § 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 §§ 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 “Personal Computer Data Input for NRC Licensees.” 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 § 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 §§ 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 discrep… | ||||
| 10:10:2.0.1.1.14.2.121.3 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | B | Subpart B—General Reporting and Recordkeeping Requirements | § 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, “Personal Computer Data Input for NRC Licensees.” Copies of these instructions NUREG/BR-0006 and NMMSS Report D-24, “Personal Computer Data Input for NRC Licensees” 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. (b) Each licensee who receives 1 gram or more of contained uranium-235, uranium-233, or plutonium from a foreign source shall: (1) Complete in computer-readable format both the supplier's and receiver's portion of the Nuclear Material Transaction Report; (2) Perform independent tests to assure the accurate identification and measurement of the material received, including its weight and enrichment; and (3) Indicate the results of these tests on the receiver's portion of the form. (c) Each licensee who ships special nuclear material in a quantity of one gram or more of contained urani… | ||||
| 10:10:2.0.1.1.14.2.121.4 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | B | Subpart B—General Reporting and Recordkeeping Requirements | § 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 §§ 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 §§ 74.31(c)(5) or 74.33(c)(4). Using an appropriate method listed in § 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. (b) Each licensee subject to the requirements of § 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 § 74.43(c)(7). Using an appropriate method listed in § 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. (c) Each licensee subject to the requirements of § 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 § 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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | B | Subpart B—General Reporting and Recordkeeping Requirements | § 74.19 Recordkeeping | NRC | [67 FR 78145, Dec. 23, 2002] | (a) Licensees subject to the recordkeeping requirements of §§ 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: (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. (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. (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. (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. (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 super… | ||||
| 10:10:2.0.1.1.14.3.121.1 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | C | Subpart C—Special Nuclear Material of Low Strategic Significance | § 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: (1) Confirm the presence of special nuclear material; (2) Resolve indications of missing material; and (3) Aid in the investigation and recovery of missing material. (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. (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: (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; (2) Establish and maintain a measurement system which assures that all quantities in the material accounting records are based on measured values; (3) Follow a measurement control program wh… | ||||
| 10:10:2.0.1.1.14.3.121.2 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | C | Subpart C—Special Nuclear Material of Low Strategic Significance | § 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: (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; (2) Protect against and detect production of uranium enriched to 10 percent or more in the isotope U 235 ; (3) Protect against and detect unauthorized production of uranium of low strategic significance; (4) Resolve indications of missing uranium; (5) Resolve indications of production of uranium enriched to 10 percent or more in the isotope U 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); (6) Resolve indications of unauthorized production of uranium of low strategic significance; (7) Provide information to aid in the investigation of missing uranium; (8) Provide information to aid in the investigation of the production of uranium enriched to 10 percent or more in the isotope U 235 ; and (9) Provide information to aid in the investigation of unauthorized production of uranium of low strategic significance. (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: (1) Submit a fundamental nuclear material control plan describing how the performance objectives of § 74.33(a), the system features and capabilities of § 74.33(c), and the recordkeeping requirements of § 74.33(d) w… | ||||
| 10:10:2.0.1.1.14.4.121.1 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | D | Subpart D—Special Nuclear Material of Moderate Strategic Significance | § 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: (1) Maintain accurate, current, and reliable information on, and confirm, the quantities and locations of SNM in the licensee's possession; (2) Conduct investigations and resolve any anomalies indicating a possible loss of special nuclear material; (3) Permit rapid determination of whether an actual loss of a significant quantity of SNM has occurred, with significant quantity being either: (i) More than one formula kilogram of strategic SNM; or (ii) 10,000 grams or more of uranium-235 contained in uranium enriched up to 20.00 percent. (4) Generate information to aid in the investigation and recovery of missing SNM in the event of an actual loss. (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: (1) Submit a fundamental nuclear material control (FNMC) plan describing how the performance objectives of § 74.41(a) will be achieved, and how the system capabilities required by § 74.41(c) will be met; and (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 dat… | ||||
| 10:10:2.0.1.1.14.4.121.2 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | D | Subpart D—Special Nuclear Material of Moderate Strategic Significance | § 74.43 Internal controls, inventory, and records. | NRC | [67 FR 78146, Dec. 23, 2002] | (a) General. Licensees subject to § 74.41 shall maintain the internal control, inventory, and recordkeeping capabilities required in paragraphs (b), (c), and (d) of this section. (b) Internal controls. (1) A management structure shall be established, documented, and maintained that assures: (i) Clear overall responsibility for material control and accounting (MC&A) functions; (ii) Independence from production and manufacturing responsibilities; and (iii) Separation of key responsibilities. (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. (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. (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. (5) The licensee shall establish, document, and maintain an item control program that: (i) Provides current knowledge of SNM items with respect to identity, element and isotope content, and stored location; and (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. (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 o… | ||||
| 10:10:2.0.1.1.14.4.121.3 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | D | Subpart D—Special Nuclear Material of Moderate Strategic Significance | § 74.45 Measurements and measurement control. | NRC | [67 FR 78146, Dec. 23, 2002] | (a) General. Licensees subject to § 74.41 of this part shall establish and maintain the measurement and measurement control capabilities required by paragraphs (b) and (c) of this section. (b) Measurements. The licensee shall: (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: (i) Sealed sources that have been determined by other means to contain less than 10 grams of uranium-235, uranium-233, or plutonium each; (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; (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 (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. (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: (i) Preparing or acquiring, maintaining, storing, and using reference standards; (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 (iii) Recording, reviewing, and reporting measurem… | ||||
| 10:10:2.0.1.1.14.5.121.1 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | E | Subpart E—Formula Quantities of Strategic Special Nuclear Material | § 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: (1) Prompt investigation of anomalies potentially indicative of SSNM losses; (2) Timely detection of the possible abrupt loss of five or more formula kilograms of SSNM from an individual unit process; (3) Rapid determination of whether an actual loss of five or more formula kilograms occurred; (4) Ongoing confirmation of the presence of SSNM in assigned locations; and (5) Timely generation of information to aid in the recovery of SSNM in the event of an actual loss. (b) System capabilities. To achieve the general performance objectives specified in § 74.51(a), the MC&A system must provide the capabilities described in §§ 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: (1) An individual, including an employee in any position; or (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. (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 is… | ||||
| 10:10:2.0.1.1.14.5.121.2 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | E | Subpart E—Formula Quantities of Strategic Special Nuclear Material | § 74.53 Process monitoring. | NRC | (a) Licensees subject to § 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: (1) SSNM that is subject to the item loss detection requirements of § 74.55; (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; (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 (4) SSNM involved in research and development operations that process less than five formula kilograms during any seven-consecutive-day period. (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: (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; (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 (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. (c) For research and development operations exempt from the requirements of paragraph (b) of this section, the licensee shall: (1) Perform material balance tests on a lot or a batch basis, as ap… | |||||
| 10:10:2.0.1.1.14.5.121.3 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | E | Subpart E—Formula Quantities of Strategic Special Nuclear Material | § 74.55 Item monitoring. | NRC | [52 FR 10040, Mar. 30, 1987, as amended at 80 FR 45844, Aug. 3, 2015] | (a) Licensees subject to § 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: (1) Tamper-safed or placed in a vault or controlled access area that provides protection at least equivalent to tamper-safing; or (2) Sealed such that removal of SSNM would be readily and permanently apparent (e.g., encapsulated). (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: (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); (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; (3) Sixty calendar days for items in a permanently controlled access area outside of an MAA; or (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. (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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | E | Subpart E—Formula Quantities of Strategic Special Nuclear Material | § 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 § 74.51 shall provide the MC&A alarm resolution capabilities described in paragraphs (b) through (f) of this section. (b) Licensees shall resolve the nature and cause of any MC&A alarm within approved time periods. (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: (1) Clerical or computational error is found that clearly was the cause for the alarm; or (2) An assignable cause for the alarm is identified or it is substantiated that no material loss has occurred. (d) If a material loss has occurred, the licensee shall determine the amount of SSNM lost and take corrective action to: (1) Return out-of-place SSNM, if possible, to its appropriate place; (2) Update and correct associated records; and (3) Modify the MC&A system, if appropriate, to prevent similar future occurrences. (e) The licensee shall provide an ability to rapidly assess the validity of alleged thefts. (f) If an abrupt loss detection estimate exceeds five formula kilograms of SSNM: (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. (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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | E | Subpart E—Formula Quantities of Strategic Special Nuclear Material | § 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 § 74.51 shall provide the quality assurance and accounting capabilities described in paragraphs (b) through (h) of this section. (b) Management structure. The licensee shall: (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 (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. (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. (d) Measurements. The licensee shall establish and maintain a system of measurements sufficient to: (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; (2) Enable the estimation of the standard deviation associated with each measured quantity; and (3) Provide the data necessary for performance of the material control tests required by § 74.53(b). (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 … | ||||
| 10:10:2.0.1.1.14.6.121.1 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | F | Subpart F—Enforcement | § 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. (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. (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. (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. (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… | ||||
| 10:10:2.0.1.1.14.6.121.2 | 10 | Energy | I | 74 | PART 74—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | F | Subpart F—Enforcement | § 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: (a) Special nuclear material; (b) Facilities where special nuclear material is utilized, produced, or stored; and (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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | F | Subpart F—Enforcement | § 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— (1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts. (b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act: (1) For violations of— (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. (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—MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL | F | Subpart F—Enforcement | § 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. (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: §§ 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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | A | Subpart A—Foods | § 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]-α-( 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]-α-( o -sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] ( p -sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[ p -[ethyl ( o -sulfobenzyl) amino] - α - ( o -sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] ( o -sulfobenzyl) ammonium hydroxide inner salt. (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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15.0 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of o -, m -, and p -sulfobenzaldehydes, not more than 1.5 percent. N -Ethyl, N -( m -sulfobenzyl)sulfanilic acid, not more than 0.3 percent. Subsidiary colors, not more than 6.0 percent. Chromium (as Cr), not more than 50 parts per million. Manganese (as Mn), not more than 100 parts per million. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Total color, not less than 85.0 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15.0 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of o -, m -, and… | |||
| 21:21:1.0.1.1.28.1.98.2 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | A | Subpart A—Foods | § 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. (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. (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: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water insoluble matter, not more than 0.4 percent. Isatin-5-sulfonic acid, not more than 0.4 percent. 5-Sulfoanthranilic acid, not more than 0.2 percent. 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. Sodium salt of 2-(1,3-dihydro-3-oxo-2 H -indol-2-ylidene)-2,3-dihydro-3-oxo-1 H -in… | |||
| 21:21:1.0.1.1.28.1.98.3 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | A | Subpart A—Foods | § 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] benzensulfonic 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 to form the dye. The intermediate 2-formyl-5-hydroxybenzenesulfonic acid is prepared by the potassium permanganate oxidation of 2,2′-(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. (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. (b) Specifications. The color additive FD&C Green No. 3 shall conform… | |||
| 21:21:1.0.1.1.28.1.98.4 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | A | Subpart A—Foods | § 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. (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. (b) Specifications. Orange B shall conform to the following specifications: Volatile matter (at 135 °C.), not more than 6.0 percent. Chlorides and sulfates (calculated as the sodium salts), not more than 7.0 percent. Water insoluble matter, not more than 0.2 percent. 1-(4-Sulfophenyl)-3-ethylcarboxy-5-hydroxypyrazolone and 1-(4-sulfophenyl)-3-carboxy-5-hydroxypyrazolone, not more than 0.7 percent. Naphthionic acid, not more than 0.2 percent. Phenylhydrazine- p -sulfonic acid, not more than 0.2 percent. The trisodium salt of 1-(4-sulfophenyl)-3-carboxy-4-(4-sulfonaphthylazo)-5-hydroxypyrazole, not more than 6.0 percent. Other subsidiary dyes, not more than 1.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Total color, not less than 87.0 percent. Volatile matter (at 135 °C.), not more than 6.0 percent. Chlorides and sulfates (calculated as the sodium salts), not more than 7.0 percent. Water insoluble matter, not more than 0.2 percent. 1-(4-Sulfophenyl)-3-ethylcarboxy-5-hydroxypyrazolone and 1-(4-sulfophenyl)-3-carboxy-5-hydroxypyrazolone, not more than 0.7 percent. Naphthionic acid, not more than 0.2 percent. Phenylhydrazine- p -sulfonic acid, not more than 0.2 percent. The trisodium salt of 1-(4-sulfophenyl)-3-carboxy-4-(4-sulfonaphthylazo)-5-hydroxypyrazole, not more than 6.0 percent. Other subsidiary dyes, not more than 1.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Total color, not less than 87.0 percent. (c) Uses and restrictions. Orange B may be safely used for coloring the casin… | ||||
| 21:21:1.0.1.1.28.1.98.5 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | A | Subpart A—Foods | § 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. (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: (i) Suitable diluents used in accordance with § 73.1(a) of this chapter. (ii) Volatile solvents that leave no residue after application to the orange. (iii) Salts of fatty acids meeting the requirements of § 172.863 of this chapter. (iv) Sodium tripolyphosphate, not more than 0.05 percent. (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: Volatile matter (at 100 °C.), not more than 0.5 percent. Water-soluble matter, not more than 0.3 percent. Matter insoluble in carbon tetrachloride, not more than 0.5 percent. Uncombined intermediates, not more than 0.05 percent. Subsidiary dyes, not more than 2.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Total color, not less than 98 percent. Volatile matter (at 100 °C.), not more than 0.5 percent. Water-soluble matter, not more than 0.3 percent. Matter insoluble in carbon tetrachloride, not more than 0.5 percent. Uncombined intermediates, not more than 0.05 percent. Subsidiary dyes, not more than 2.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Total color, not less than 98 percent. (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. (2) Oranges colored with Ci… | ||||
| 21:21:1.0.1.1.28.1.98.6 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | A | Subpart A—Foods | § 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. (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. (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: Volatile matter (at 135 °C.) and chlorides and sulfates (calculated as the sodium salts), total not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. Unhalogenated intermediates, total not more than 0.1 percent. Sodium iodide, not more than 0.4 percent. Triiodoresorcinol, not more than 0.2 percent. 2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic acid, not more than 0.2 percent. Monoiodofluoresceins not more than 1.0 percent. Other lower iodinated fluoresceins, not more than 9.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 87.0 percent. Volatile matter (at 135 °C.) and chlorides and sulfates (calculated as the sodium salts), total not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. Unhalogenated intermediates, total not more than 0.1 percent. Sodium iodide, not more than 0.4 percent. Triiodoresorcinol, not more than 0.2 percent. 2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic acid, not more than 0.2 percent. Monoiodofluoresceins not more than 1.0 percent. Other lower iodinated fluoresceins, not more than 9.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 87.0 percent. (c) … | ||||
| 21:21:1.0.1.1.28.1.98.7 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | A | Subpart A—Foods | § 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. (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. (3) The listing of this color additive includes lakes prepared as described in § 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 § 82.51 of this chapter. (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: Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as sodium salts), not more than 14.0 percent. Water-insoluble matter, not more than 0.2 percent. Higher sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent. Lower sulfonated subsidiary colors (as sodium salts), not more than 1.0 percent. 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. Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer's salt), not more than 0.3 percent. 4-Amino-5-methoxy- o- toluenesulfonic acid, not more than 0.2 percent. Disodium salt of 6,6′-oxybis (2-naphthalene-sulfonic acid), not more than 1.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 85.0 percent. Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as sodium salts), not more than 14.0 percent. Water-insoluble matter, not more than 0.2 percent. Higher su… | ||||
| 21:21:1.0.1.1.28.1.98.8 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | A | Subpart A—Foods | § 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. (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. (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: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4′-[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. 4-[(4′,5-Disulfo[1,1′-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. 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. 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. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic… | |||
| 21:21:1.0.1.1.28.1.98.9 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | A | Subpart A—Foods | § 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. (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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water insoluble matter, not more than 0.2 percent. Sodium salt of 4-aminobenzenesulfonic acid, not more than 0.2 percent. Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid, not more than 0.3 percent. Disodium salt of 6,6′-oxybis[2-naphthalenesulfonic acid], not more than 1 percent. Disodium salt of 4,4′-(1-triazene-1,3-diyl)bis[benzenesulfonic acid], not more than 0.1 percent. 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 percen… | |||
| 21:21:1.0.1.1.28.2.98.1 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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 § 74.101(a)(1). (2) For externally applied drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of § 74.2101(a). (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. (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 § 74.101(b). (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (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. (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 § 70.5(b) and (c) of this chapter. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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′,5′-dibromofluorescein (CAS Reg. No. 596-03-2) and 2′,4′,5′-tribromofluorescein (CAS Reg. No. 25709-83-5) and 2′,4′,5′,7′-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. (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. (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. 4′,5′-dibromofluorescein, not less than 50 percent and not more than 65 percent. 2′,4′,5′-tribromofluorescein, not less than 30 percent and not more than 40 percent. 2′,4′,5′,7′-tetrabromofluorescein, not more than 10 percent. Sum of 2′,4′-dibromofluorescein and 2′,5′-dibromofluorescein, not more than 2 percent. 4′-Bromofluorescein, not more than 2 percent. Fluorescein, not more than 1 percent. Phthalic acid, not more than 1 percent. 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Brominated resorcinol, not more than 0.4 percent. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.3 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. 4′,5′-dibromofluorescein, not less than 50 percent and not more than 65… | |||
| 21:21:1.0.1.1.28.2.98.11 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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′,5′-diiodofluorescein, 2′,4′,5′-triiodofluorescein, and 2′,4′,5′,7′-tetraiodofluorescein. (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. (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: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 8 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic acid, not more than 0.5 percent. Fluorescein, not more than 1 percent. 4′-Iodofluorescein, not more than 3 percent. 2′,4′-Diiodofluorescein and 2′,5′-diiodofluorescein, not more than 2 percent. 2′,4′,5′-Triiodofluorescein, not more than 35 percent. 2′,4′,5′,7′-Tetraiodofluorescein, not more than 10 percent. 4′,5′-Diiodofluorescein, not less than 60 percent and not more than 95 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 92 percent. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 8 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic acid, not more than 0.5 percent. Fluorescein, not more than 1 percent. 4′-Iodofluorescein, not more than 3 percent. 2′,4′-Diiodofluorescein and 2′,5′-diiodofluorescein, not more than 2 percent. 2′,4′,5′-Triiodofluorescein, not more than 35… | |||
| 21:21:1.0.1.1.28.2.98.12 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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′,5′-diiodofluorescein, 2′,4′,5′-triiodofluorescein and 2′,4′,5′,7′-tetraiodofluorescein. (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. (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: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 8 percent. Water-insoluble matter, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic acid, sodium salt, not more than 0.5 percent. Fluorescein, disodium salt, not more than 1 percent. 4′-Iodofluorescein, disodium salt, not more than 3 percent. 2′,4′-Diiodofluorescein and 2′,5′-diiodofluorescein, not more than 2 percent. 2′,4′,5′-Triiodofluorescein, not more than 35 percent. 2′,4′,5′,7′-Tetraiodofluorescein, disodium salt, not more than 10 percent. 4′,5′-Diiodofluorescein, disodium salt, not less than 60 percent and not more than 95 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 92 percent. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 8 percent. Water-insoluble matter, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic acid, sodium salt, not more than 0.5 percent. Fluorescein, disodium salt, not more than 1 percent. 4′-Iodofluorescein, disodium salt, not more than 3 percent. 2′… | |||
| 21:21:1.0.1.1.28.2.98.13 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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 § 74.303(a)(1) and (b). (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. (b) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring ingested drugs in amounts consistent with good manufacturing practice. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 5-Amino-2,4-dimethyl-1-benzenesulfonic acid, sodium salt, not more than 0.2 percent. 4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.2 percent. Subsidiary colors, not more than 2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 5-Amino-2,4-dimethyl-1-benzenesulfonic acid, sodium salt, not more than 0.2 percent. 4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.2 percent. Subsidiary colors, not more than 2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (c) Uses and restrictions. FD&C Red No. 4 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared ther… | ||||
| 21:21:1.0.1.1.28.2.98.15 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. 2-Amino-5-methylbenzenesulfonic acid, sodium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, sodium salt, not more than 0.4 percent. 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, sodium salt, not more than 0.5 percent. p- Toluidine, not more than 15 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. 2-Amino-5-methylbenzenesulfonic acid, sodium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, sodium salt, not more than 0.4 percent. 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalene… | |||
| 21:21:1.0.1.1.28.2.98.16 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. 2-Amino-5-methylbenzenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, calcium salt, not more than 0.4 percent. 3-Hydroxy-4-[(4-methylphenyl)azo]-2-naphthalenecarboxylic acid, calcium salt, not more than 0.5 percent. p -Toluidine, not more than 15 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. 2-Amino-5-methylbenzenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, calcium salt, not more than 0.4 percent. 3-Hydroxy-4-[(4-methylp… | |||
| 21:21:1.0.1.1.28.2.98.17 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Volatile matter (at 135 °C), not more than 5 percent. 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. Chlorides and sulfates (calculated as sodium salts), not more than 3 percent. Aniline, not more than 0.2 percent. 4-Aminoazobenzene, not more than 0.1 percent. 2-Naphthol, not more than 0.2 percent. 1-(Phenylazo)-2-naphthol, not more than 3 percent. 1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, not more than 2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. Volatile matter (at 135 °C), not more than 5 percent. 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. Chlorides and sulfates (calculated as sodium salts), not more than 3 percent. Aniline, not more than 0.2 percent. 4-Aminoazobenzene, not more than 0.1 percent. 2-Naphthol, not more than 0.2 percent. 1-(Phenylazo)-2-naphthol, not more than 3 percent. 1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, not more than 2 percent. Lead (as Pb), not more than 20 parts… | |||
| 21:21:1.0.1.1.28.2.98.18 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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′,4′,5′,7′-tetrabromofluorescein (CAS Reg. No. 15086-94-9), and may contain smaller amounts of 2′,4′,5′-tribromofluorescein (CAS Reg. No. 25709-83-5) and 2′,4′,7′-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. (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. (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: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Phthalic acid, not more than 1 percent. 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, not more than 1 percent. Brominated resorcinol, not more than 0.4 percent. Fluorescein, not more than 0.2 percent. Sum of mono- and dibromofluoresceins, not more than 2 percent. Tribromofluoresceins, not more than 11 percent. 2′,4′,5′,7′-Tetrabromofluorescein, not less than 87 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not… | |||
| 21:21:1.0.1.1.28.2.98.19 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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′,4′,5′7′-tetrabromofluorescein (CAS Reg. No. 17372-87-1) and may contain smaller amounts of the disodium salts of 2′,4′,5′-tribromofluorescein and 2′,4′,7′-tribromofluorescein. The color additive is manufactured by alkaline hydrolysis of 2′,4′,5′,7′-tetrabromofluorescein. 2′,4′,5′,7′-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. (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. (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: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as soduim salts), not more than 10 percent. Water-insoluble matter not more than 0.5 percent. Disodium salt of phthalic acid, not more than 1 percent. Sodium salt of 2-(3,5-Dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.5 percent. 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, not more than 1 percent. Brominated resorcinol, not more than 0.4 percent. Sum of disodium salts of mono- and dibromofluoresceins, not more than 2 percent. Sum of disodium salts of tribromofluoresceins, not more than 25 percent. Disodium salt of 2′,4′,5′,7′-Tetrabromofluorescein, not less than 72 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. Sum of volatile matter (at 135 °C… | |||
| 21:21:1.0.1.1.28.2.98.2 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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 § 74.102(a)(1). (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. (b) The color additive FD&C Blue No. 2 for use in coloring ingested drugs shall conform to the specifications in § 74.102(b). (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. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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′,4′,5′,7′-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. (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. (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: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Tetrachlorophthalic acid, not more than 1.2 percent. Brominated resorcinol, not more than 0.4 percent. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl) benzoic acid, not more than 0.7 percent. 2′,4′,5′,7′-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent. Lower halogenated subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 10 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Tetrachlorophthalic acid, not more than 1.2 percent. Brominated resorcinol, not more than 0.4 percent. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl) … | |||
| 21:21:1.0.1.1.28.2.98.21 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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′,4′,5′,7′-tetrabromo-4,5,6,7-tetrachlorofluorescein (CAS Reg. No. 18472-87-2) formed by alkaline hydrolysis of the parent tetrabromotetrachlorofluorescein. (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. (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: Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 15 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Tetrachlorophthalic acid, not more than 1.2 percent. Brominated resorcinol, not more than 0.4 percent. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.7 percent. 2′,4′,5′,7′-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent. Lower halogenated subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. Sum of volatile matter (at 135 °C) and halides and sulfates (calculated as sodium salts), not more than 15 percent. Insoluble matter (alkaline solution), not more than 0.5 percent. Tetrachlorophthalic acid, not more than 1.2 percent. Brominated resorcinol, not more than 0.4 percent. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-dihydroxybenzoyl)benzoic acid, not more than 0.7 percent. 2′,4′,5′,7′-Tetrabromo-4,5,6,7-tetrachlorofluorescein, ethyl ester, not more than 2 percent. Lower halogenated subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts pe… | |||
| 21:21:1.0.1.1.28.2.98.22 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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). (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. (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: Volatile matter (at 135 °C), not more than 5 percent. Chlorides and sulfates (calculated as sodium salts), not more than 3 percent. Matter soluble in acetone, not more than 5 percent. Total color, not less than 90 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Volatile matter (at 135 °C), not more than 5 percent. Chlorides and sulfates (calculated as sodium salts), not more than 3 percent. Matter soluble in acetone, not more than 5 percent. Total color, not less than 90 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (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. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. Aniline, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, calcium salt, not more than 0.4 percent. Subsidiary colors, not more than 1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 10 percent. Aniline, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, calcium salt, not more than 0.4 percent. Subsidiary colors, not more than 1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 90 percent. (c) Uses and restrictions. D&C Red No. 31 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent. Water-insoluble matter, not more than 0.3 percent. 4-Amino-5-hydroxy-2,7-naphthalenedisulfonic acid, disodium salt, not more than 0.3 percent. 4,5-Dihydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium salt, not more than 3.0 percent. Aniline, not more than 25 parts per million. 4-Aminoazobenzene, not more than 100 parts per billion. 1,3-Diphenyltriazene, not more than 125 parts per billion. 4-Aminobiphenyl, not more than 275 parts per billion. Azobenzene, not more than 1 part per million. Benzidine, not more than 20 parts per billion. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 82 percent. Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent. Water-insoluble matter, not more than 0.3 percent. 4-Amino-5-hydroxy-2,7-naphthalenedisulfonic acid, disodium salt, not more than… | |||
| 21:21:1.0.1.1.28.2.98.25 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated at sodium salts), not more than 15 percent. 2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, not more than 0.4 percent. Subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color not less than 85 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated at sodium salts), not more than 15 percent. 2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, not more than 0.4 percent. Subsidiary colors, not more than 4 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color not less than 85 percent. (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. (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 § 70.25 of this chapter. (e) Certification. All batches of… | ||||
| 21:21:1.0.1.1.28.2.98.26 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Volatile matter at 135 °C (275 °F), not more than 1.5 percent. Matter insoluble in toluene, not more than 1.5 percent. 2-Chloro-4-nitrobenzenamine, not more than 0.3 percent. 2-Naphthalenol, not more than 1 percent. 2,4-Dinitrobenzenamine, not more than 0.02 percent. 1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, not more than 0.5 percent. 4-[(2-Chloro-4-nitrophenyl)azo]-1-naphthalenol, not more than 0.5 percent. 1-[(4-Nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent. 1-[(4-Chloro-2-nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 95 percent. Volatile matter at 135 °C (275 °F), not more than 1.5 percent. Matter insoluble in toluene, not more than 1.5 percent. 2-Chloro-4-nitrobenzenamine, not more than 0.3 percent. 2-Naphthalenol, not more than 1 percent. 2,4-Dinitrobenzenamine, not more than 0.02 percent. 1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol, not more than 0.5 percent. 4-[(2-Chloro-4-nitrophenyl)azo]-1-naphthalenol, not more than 0.5 percent. 1-[(4-Nitrophenyl)azo]-2-naphthalenol, not more than 0.3 percent. 1-[(4-Chloro-2-nitrophenyl)azo]-2-naphthal… | |||
| 21:21:1.0.1.1.28.2.98.27 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 74.1339 D&C Red No. 39. | FDA | (a) Identity. (1) The color additive D&C Red No. 39 is o- [ p (β,β′-dihydroxy-diethylamino)-phenylazo]-benzoic acid. (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. (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: Volatile matter (at 100 °C.), not more than 2.0 percent. Matter insoluble in acetone, not more than 1.0 percent. Anthranilic acid, not more than 0.2 percent. N,N- (β,β′-Dihydroxy-diethyl) aniline, not more than 0.2 percent. Subsidiary colors, not more than 3.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 95.0 percent. Volatile matter (at 100 °C.), not more than 2.0 percent. Matter insoluble in acetone, not more than 1.0 percent. Anthranilic acid, not more than 0.2 percent. N,N- (β,β′-Dihydroxy-diethyl) aniline, not more than 0.2 percent. Subsidiary colors, not more than 3.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 95.0 percent. (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. (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 § 70.25 of this chapter. (e) Certification. All batches of D&C Red No. 39 shall be certified in accordance with regulations promul… | ||||
| 21:21:1.0.1.1.28.2.98.28 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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 § 74.340(a)(1) and (b). (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. (3) The listing of this color additive includes lakes prepared as described in §§ 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 §§ 82.51 or 82.1051 of this chapter.) (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 § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice. (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 § 70.5 of this chapter, in amounts consistent with current good manufacturing practice. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Volatile matter (at 135 °C.), not more than 2.0 percent. Matter insoluble in both carbon tetrachloride and water, not more than 0.5 percent. p- Toluidine, not more than 0.2 percent. 1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent. 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent. Subsidiary colors, not more than 1.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 96.0 percent. Volatile matter (at 135 °C.), not more than 2.0 percent. Matter insoluble in both carbon tetrachloride and water, not more than 0.5 percent. p- Toluidine, not more than 0.2 percent. 1-Hydroxy-9,10-anthracenedione, not more than 0.5 percent. 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.5 percent. Subsidiary colors, not more than 1.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 96.0 percent. (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. (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 § 70.25 of this chapter. (e) Certificati… | |||
| 21:21:1.0.1.1.28.2.98.3 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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]-α-( 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]-α-( o- sulfophenyl) benzylidene]-2,5-cyclohexadien - 1-ylidene]( p- sulfobenzyl) ammonium hydroxide inner salt and ethyl[4-[ p- [ethyl ( o- sulfobenzyl)amino]-α-( o- sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] ( o- sulfobenzyl) ammonium hydroxide inner salt. (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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of o-, m , and p- sulfobenzaldehydes, ammonium salt, not more than 1.5 percent. N-ethyl, N-( m- sulfobenzyl) sulfanilic acid ammonium salt, not more than 0.3 percent. Subsidiary colors, not more than 6 percent. Chromium (as Cr), not more than 50 parts per million. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Leuco base, not more than 5 percent. Sum of o-, m , and p- s… | ||||
| 21:21:1.0.1.1.28.2.98.30 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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 § 74.705 (a)(1) and (b). (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (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. (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. (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 § 82.51 of this chapter. (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 § 70.25 of this chapter. (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 “Contains FD&C Yellow No. 5 (tartrazine) as a color additive” or “Contains color additives including FD&C Yellow No. 5 (tartrazine).” 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 § 701.3 of this chapter. (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 … | |||
| 21:21:1.0.1.1.28.2.98.31 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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 § 74.706(a)(1) and (b). (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. (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. (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 § 70.25 of this chapter. (2) [Reserved] (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 74.1707 D&C Yellow No. 7. | FDA | (a) Identity. (1) The color additive D&C Yellow No. 7 is principally fluorescein. (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. (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: Sum of water and chlorides and sulfates (calculated as sodium salts), not more than 6 percent. Matter insoluble in alkaline water, not more than 0.5 percent. Resorcinol, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-2,4-(Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 94 percent. Sum of water and chlorides and sulfates (calculated as sodium salts), not more than 6 percent. Matter insoluble in alkaline water, not more than 0.5 percent. Resorcinol, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent. 2-2,4-(Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 94 percent. (c) Uses and restrictions. D&C Yellow No. 7 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (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 § 70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 7 shall be certified in accordance with regulation… | ||||
| 21:21:1.0.1.1.28.2.98.33 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. 1-Naphthol, not more than 0.2 percent. 2,4-Dinitro-1-naphthol, not more than 0.03 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. 1-Naphthol, not more than 0.2 percent. 2,4-Dinitro-1-naphthol, not more than 0.03 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (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. (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 § 70.25 of this chapter. (e) Certification. All batches of Ext. D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of t… | ||||
| 21:21:1.0.1.1.28.2.98.34 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Sum of water and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Matter insoluble in alkaline water, not more than 0.3 percent. Resorcinol, not more than 0.5 percent. Phthalic acid, not more than 1 percent. 2-(2,4-Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. Sum of water and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Matter insoluble in alkaline water, not more than 0.3 percent. Resorcinol, not more than 0.5 percent. Phthalic acid, not more than 1 percent. 2-(2,4-Dihydroxybenzoyl) benzoic acid, not more than 0.5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 85 percent. (c) Uses and restrictions. D&C Yellow No. 8 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. Matter insoluble in both water and chloroform, not more than 0.2 percent. Total sulfonated quinaldines, sodium salts, not more than 0.2 percent. Total sulfonated phthalic acids, sodium salts, not more than 0.2 percent. 2-(2-Quinolinyl)-1 H -indene-1,3 (2 H )-dione, not more than 4 parts per million. Sum of sodium salts of the monosulfonates of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione, not less than 75 percent. Sum of sodium salts of the disulfonates of 2-(2-quinolinyl)-1 H -indene-1,3 (2 H )-dione, not more than 15 percent. 2-(2,3-Dihydro-1,3-dioxo-1 H -indene-2-yl)-6, 8-quinolinedisulfonic acid, disodium salt, not more than 3 percent. Diethyl ether soluble matter other than that specified, not more than 2 parts per million, using added 2-(2-qui… | |||
| 21:21:1.0.1.1.28.2.98.36 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Volatile matter (at 135 °C), not more than 1 percent. Ethyl alcohol-insoluble matter, not more than 0.4 percent. Phthalic acid, not more than 0.3 percent. Quinaldine, not more than 0.2 percent. Subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 96 percent. Volatile matter (at 135 °C), not more than 1 percent. Ethyl alcohol-insoluble matter, not more than 0.4 percent. Phthalic acid, not more than 0.3 percent. Quinaldine, not more than 0.2 percent. Subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 96 percent. (c) Uses and restrictions. D&C Yellow No. 11 may be safely used in externally applied drugs in amounts consistent with good manufacturing practice. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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: Volatile matter (at 135 °C.), not more than 3 percent. 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. 2-Amino anthraquinone, not more than 0.2 percent. Organically combined chlorine in pure dye, 13.0-14.8 percent. Lead (as Pb), not more than 20 p/m. Arsenic (as As), not more than 3 p/m. Total color, not less than 97 percent. Volatile matter (at 135 °C.), not more than 3 percent. 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. 2-Amino anthraquinone, not more than 0.2 percent. Organically combined chlorine in pure dye, 13.0-14.8 percent. Lead (as Pb), not more than 20 p/m. Arsenic (as As), not more than 3 p/m. Total color, not less than 97 percent. (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: (1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980). (2) The quantity of the color additive does not exceed 2.5 percent by weight of the suture. (3) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissue. (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. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Blue No. 9 sha… | |||
| 21:21:1.0.1.1.28.2.98.5 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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 § 74.203(a)(1) and (b). (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. (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. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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′-[(9,10-dihydro-9,10-dioxo-1,4-anthracenediyl)diimino]bis-[5-methylbenzenesulfonic acid] (CAS Reg. No. 4403-90-1). (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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent. Water insoluble matter, not more than 0.2 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 2-Amino- m -toluenesulfonic acid, not more than 0.2 percent. Subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 80 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent. Water insoluble matter, not more than 0.2 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 2-Amino- m -toluenesulfonic acid, not more than 0.2 percent. Subsidiary colors, not more than 5 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Total color, not less than 80 percent. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 20 percent. … | |||
| 21:21:1.0.1.1.28.2.98.7 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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). (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: Volatile matter (at 135 °C), not more than 2.0 percent. Water-soluble matter, not more than 0.3 percent. Matter insoluble in carbon tetrachloride, not more than 1.5 percent. p -Toluidine, not more than 0.1 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than 5.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 96.0 percent. Volatile matter (at 135 °C), not more than 2.0 percent. Water-soluble matter, not more than 0.3 percent. Matter insoluble in carbon tetrachloride, not more than 1.5 percent. p -Toluidine, not more than 0.1 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than 5.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 96.0 percent. (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. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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: Volatile matter (at 135 °C), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Chlorides and sulfates (calculated as sodium salt), not more than 20 percent. The trisodium salt of 1,3,6-pyrenetrisulfonic acid, not more than 6 percent. The tetrasodium salt of 1,3,6,8-pyrenetetrasulfonic acid, not more than 1 percent. Pyrene, not more than 0.2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 65 percent. Volatile matter (at 135 °C), not more than 15 percent. Water-insoluble matter, not more than 0.2 percent. Chlorides and sulfates (calculated as sodium salt), not more than 20 percent. The trisodium salt of 1,3,6-pyrenetrisulfonic acid, not more than 6 percent. The tetrasodium salt of 1,3,6,8-pyrenetetrasulfonic acid, not more than 1 percent. Pyrene, not more than 0.2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 65 percent. (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. (d) Labeling. The label of the color additive and any mixtures prepared therefr… | ||||
| 21:21:1.0.1.1.28.2.98.9 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | B | Subpart B—Drugs | § 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. (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. (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. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 2-Naphthol, not more than 0.4 percent. Sulfanilic acid, sodium salt, not more than 0.2 percent. Subsidiary colors, not more than 3 percent. 4,4′-(Diazoamino)-dibenzenesulfonic acid, not more than 0.1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 2-Naphthol, not more than 0.4 percent. Sulfanilic acid, sodium salt, not more than 0.2 percent. Subsidiary colors, not more than 3 percent. 4,4′-(Diazoamino)-dibenzenesulfonic acid, not more than 0.1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (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. (d) Labeling. The label of the color additive and any mixtures prepared th… | |||
| 21:21:1.0.1.1.28.3.98.1 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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) 2 /gram. (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: (1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 200 to 260 m 2 /gram. (2) Weight loss on heating at 950 °C for 7 minutes (predried for 1 hour at 125 °C), not more than 2 percent. (3) Ash content, not more than 0.15 percent. (4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million). (5) Lead (total), not more than 10 mg/kg (10 parts per million). (6) Mercury (total), not more than 1 mg/kg (1 part per million). (7) Total sulfur, not more than 0.65 percent. (8) Total PAHs, not more than 0.5 mg/kg (500 parts per billion). (9) Benzo[ a ]pyrene, not more than 0.005 mg/kg (5 parts per billion). (10) Dibenz[ a,h ]anthracene, not more than 0.005 mg/kg (5 parts per billion). (11) Total color (as carbon), not less than 95 percent. (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. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1254 (a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1255 (a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1260(a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1261(a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1304(a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1306 (a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1307 (a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1317(a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1321(a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1322(a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 °C for at least 6 hours. (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: (1) Calcium hydroxyapatite (CaO and P 2 O 5 ), not less than 75 percent and not more than 84 percent; (2) Elemental carbon, not less than 7 percent; (3) Moisture, not more than 7 percent; (4) Silica (SiO 2 ), not more than 5 percent; (5) Arsenic, not more than 3 milligrams (mg)/kilogram (kg) (3 parts per million (ppm)); (6) Lead, not more than 10 mg/kg (10 ppm); and (7) Total polycyclic aromatic hydrocarbons (PAHs), not more than 5 mg/kg (5 ppm). (c) Uses and restrictions. Cosmetics containing D&C Black No. 3 must comply with § 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. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1327 (a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1328 (a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1330 (a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1331(a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1333(a) (1) and (b). (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. (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 § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1334(a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1336 (a)(1) and (b). (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. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.340(a)(1) and (b) of this chapter. (2) The listing of this color additive includes lakes prepared as described in §§ 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 § 82.51 or § 82.1051 of this chapter. (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: (1) The color additive may be used in amounts consistent with current good manufacturing practice. (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1602(a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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. (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: Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent. Water-insoluble matter, not more than 0.4 percent. 1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent. 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent. p- Toluidine, not more than 0.1 percent. p- Toluidine sulfonic acids, sodium salts, not more than 0.2 percent. Subsidiary colors, not more than 1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 80 percent. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 18 percent. Water-insoluble matter, not more than 0.4 percent. 1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent. 1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent. p- Toluidine, not more than 0.1 percent. p- Toluidine sulfonic acids, sodium salts, not more than 0.2 percent. Subsidiary colors, not more than 1 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 80 percent. (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. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (… | ||||
| 21:21:1.0.1.1.28.3.98.3 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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]-α-( 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]-α-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( p -sulfobenzyl)ammonium hydroxide inner salt and ethyl[4-[ p -[ethyl( o -sulfobenzyl)amino]-α-( 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. (b) Specifications. (1) The color additive FD&C Blue No. 1 shall conform in specifications to the requirements of § 74.101(b). (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (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. (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. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No… | |||
| 21:21:1.0.1.1.28.3.98.30 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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. (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: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4′-[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. 4-[(4′,5-Disulfo[1,1′-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. 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. 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. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent. 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], d… | |||
| 21:21:1.0.1.1.28.3.98.31 | 21 | Food and Drugs | I | A | 74 | PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.706 (a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1707(a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1707a (a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1708(a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (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—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION | C | Subpart C—Cosmetics | § 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 § 74.1710(a)(1) and (b). (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. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter. |
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