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Rule

Food and Color Additives and Generally Recognized As Safe Substances; Technical Amendments

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendments.

SUMMARY:

The Food and Drug Administration (FDA) is amending its regulations that address food and color additives and generally recognized as safe (GRAS) substances. The purpose of the amendments is to correct minor errors and inadvertent omissions in the Code of Federal Regulations (CFR). The technical amendments made by this final rule are editorial in nature and are intended to provide accuracy and clarity to the agency's regulations.

DATES:

Effective May 4, 2004.

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FOR FURTHER INFORMATION CONTACT:

Ellen M. Waldron, Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3089.

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SUPPLEMENTARY INFORMATION:

FDA is amending its regulations for parts 73, 172, 175, 176, 177, 178, 184, and 186 (21 CFR parts 73, 172, 175, 176, 177, 178, 184, and 186). FDA discovered that minor errors and omissions were inadvertently published in the CFR affecting its regulations that address food and color additives (parts 73, 172, 175, 176, 177, and 178) and GRAS substances (parts 184 and 186). This document makes the needed corrections.

The final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. The changes addressed in this document are as follows:

1. In § 73.1(b)(2), the regulatory section citation for the identification of rosin and rosin derivatives is currently erroneously written as § 172.820 and is corrected to read § 172.615.

2. The listing for “oak moss” in the table in § 172.510(b) is being corrected. The entry under “Limitations” for this listing was amended to “Finished food thujone free1” in the Federal Register of September 6, 1967 (32 FR 12751). Subsequently in the 1972 edition of the Code of Federal Regulations (CFR) the word “free1” was inadvertently dropped from the limitation. This document adds this phrase.

3. The agency is also correcting several Chemical Abstract Service registry numbers (CAS Reg. No.) that are incorrectly listed. The agency is correcting registry numbers found in § 73.3125 Iron oxides; § 175.105 Adhesives; § 176.300 Slimicides; § 177.1632 Poly (phenyleneterephthalamide) resins; § 178.1010 Sanitizing solutions; § 178.2010 Antioxidants and/or stabilizers for polymers; § 178.3400 Emulsifiers and/or surface-active agents; § 178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids; § 178.3910 Surface lubricants used in the manufacture of metallic articles; § 184.1034 Catalase (bovine liver); § 184.1307a Ferrous ascorbate; § 184.1434 Magnesium phosphate; and, § 186.1374 Iron oxides.

4. Finally, the agency is also correcting several typographical errors. Two misspelled terms are being corrected: “Hydroxycitronellol; 3,7-dimethyl-1,7-octanediol” in § 172.515 Synthetic flavoring substances and adjuvants and “Methyl ethers of mono-, di- and tripropylene glycol” in § 176.180 Components of paper and paperboard in contact with dry food. In § 177.1500 Nylon resins an incorrect reference to a paragraph is being corrected as well as a typographical error in the described melting point of “Nylon 46 resins.” Finally, in § 184.1090 Stearic acid the incorrect chemical notation for stearic acid is being corrected.

Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because these amendments are merely correcting nonsubstantive errors.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs,

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PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

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1. The authority citation for

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Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

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2. Section 73.1

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3. Section 73.3125

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PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

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4. The authority citation for

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Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

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5. Section 172.510

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6. Section 172.515

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PART 175—INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS

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7. The authority citation for

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Authority: 21 U.S.C. 321, 342, 348, 379e.

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8. Section 175.105

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PART 176—INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

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9. The authority citation for

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Authority: 21 U.S.C. 321, 342, 346, 348, 379e.

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10. Section 176.180

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11. Section 176.300

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PART 177—INDIRECT FOOD ADDITIVES: POLYMERS

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12. The authority citation for

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Authority: 21 U.S.C. 321, 342, 348, 379e.

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13. Section 177.1500

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14. Section 177.1632

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PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

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15. The authority citation for

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Authority: 21 U.S.C. 321, 342, 348, 379e.

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16. Section 178.1010

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17. Section 178.2010

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18. Section 178.3400

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19. Section 178.3770

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20. Section 178.3910

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PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

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21. The authority citation for

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Authority: 21 U.S.C. 321, 342, 348, 371.

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22. Section 184.1034

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23. Section 184.1090

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24. Section 184.1307a

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25. Section 184.1434

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PART 186—INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

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26. The authority citation for

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Authority: 21 U.S.C. 321, 342, 348, 371.

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27. Section 186.1374

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Dated: March 29, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 04-10026 Filed 5-3-04; 8:45 am]

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