Final Rules: Food Additives and Color Additives
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Petition(s): CAP 8C0257
Listing of Color Additives Exempt from Certification; Mica-Based Pearlescent Pigments
| Petitioner: | EM Industries, Inc. |
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| Docket number (legacy and/or former docket number(s)): | FDA-1998-C-0080; (1998C-0431); (98C-0431) |
| Subject additive and intended use: | amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in ingested drugs. |
| 21 CFR* affected: | 73.1350; Mica-based pearlescent pigments. |
| Substance(s)*, (CAS Registry® No.): |
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| Federal Register publication history: | Jun 22, 1998; 63 FR 33934; Notice |
| Jun 29, 1999; 64 FR 34816; Notice (Amendment) | |
| Jul 22, 2005; 70 FR 42271; Final Rule; Effective date: Aug 23, 2005 | |
| Jul 20, 2006; 71 FR 41125; Final rule; response to objections; removal of stay; Effective date: Aug 23, 2005 | |
| Mar 8, 2007; 72 FR 10356; Final rule, technical amendment; Section 73.1128 of 21 CFR redesignated as §73.1350; Effective date: Mar 8, 2007 |
*Definitions
- 21 CFR: Title 21 of the Code of Federal Regulations.
- Substance: The name of the substance listed in the CFR.
- CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
- Petitions (see also Questions and Answers About the Petition Process)
- FAP: Food Additive Petition
- CAP: Color Additive Petition
- GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)
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