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 free
1
” 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 “free
1
” 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.
List of Subjects
21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
21 CFR Part 172
Food additives, Reporting and recordkeeping requirements.
21 CFR Part 175
Adhesives, Food additives, Food packaging.
21 CFR Parts 176, 177, and 178
Food additives, Food packaging.
21 CFR 184
Food additives.
21 CFR 186
Food additives, Food packaging.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 73, 172, 175, 176, 177, 178, 184, and 186 are amended as follows:
PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
1. The authority citation for 21 CFR part 73 continues to read as follows:
Authority:
21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
2. Section 73.1
Diluents in color additive mixtures for food use exempt from certification
is amended in paragraph (b)(2) by removing “Rosin and rosin derivatives (as identified in § 172.820 of this chapter).” and by adding in its place “Rosin and rosin derivatives (as identified in § 172.615 of this chapter).”.
3. Section 73.3125
Iron oxides
is amended in paragraph (a) by removing “(CAS Reg. No. 977053–38–5)” and by adding in its place “(CAS Reg. No. 1332–37–2)”.
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
4. The authority citation for 21 CFR part 172 continues to read as follows:
Authority:
21 U.S.C. 321, 341, 342, 348, 371, 379e.
5. Section 172.510
Natural flavoring substances and natural substances used in conjunction with flavors
is amended in the table in paragraph (b) in the entry for “Oak moss” under the heading “Limitations” by adding “free
1
” after “thujone”.
6. Section 172.515
Synthetic flavoring substances and adjuvants
is amended in paragraph (b) by removing “Hydroxycitronellal; 3,7–dimethyl–1,7–octanediol” and adding in its place “Hydroxycitronellol; 3,7–dimethyl–1,7–octanediol”.
PART 175—INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
7. The authority citation for 21 CFR part 175 continues to read as follows:
Authority:
21 U.S.C. 321, 342, 348, 379e.
8. Section 175.105
Adhesives
is amended in the table in paragraph (c)(5) in the entry for “Isodecyl benzoate” under the heading “Substances” by removing “(CAS Reg. No. 131298–44–77)” and adding in its place “(CAS Reg. No. 131298–44–7)”.
PART 176—INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
9. The authority citation for 21 CFR part 176 continues to read as follows:
Authority:
21 U.S.C. 321, 342, 346, 348, 379e.
10. Section 176.180
Components of paper and paperboard in contact with dry food
is amended in the table in paragraph (b)(2) by removing the entry for “Methyl esters of mono-, di- and tripropylene glycol” and adding in its place “Methyl ethers of mono-, di- and tripropylene glycol”.
11. Section 176.300
Slimicides
is amended in the table in paragraph (c) in the entry for “4-(Diiodomethylsulfonyl) toluene” under the heading “List of substances” by removing “(CAS Reg. No. 20018–09–01)” and adding in its place “(CAS Reg. No. 20018–09–1)”.
PART 177—INDIRECT FOOD ADDITIVES: POLYMERS
12. The authority citation for 21 CFR part 177 continues to read as follows:
Authority:
21 U.S.C. 321, 342, 348, 379e.
13. Section 177.1500
Nylon resins
is amended in paragraph (a) by removing “methods described in paragraph (c)” and adding in its place “methods described in paragraph (d)”, and in the table in paragraph (b) in entry 15 for “Nylon 46 resins” under the heading “Melting point (degrees Fahrenheit)” by removing “551–09592” and adding in its place “551–592”.
14. Section 177.1632
Poly (phenyleneterephthalamide) resins
is amended in the table in paragraph (b)(2) in the entry for “Poly(oxyethylene) mono(nonylphenyl)ether” under the heading “List of substances” by removing “(CAS Reg. No. 9019–45–9)” and adding in its place “(CAS Reg. No. 9016–45–9)”.
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
15. The authority citation for 21 CFR part 178 continues to read as follows:
Authority:
21 U.S.C. 321, 342, 348, 379e.
16. Section 178.1010
Sanitizing solutions
is amended in paragraph (b)(36) by removing “1,2–octanedisulfonic acid (CAS Reg. No. 1934210)” and adding in its place “1,2–octanedisulfonic acid (CAS Reg. No. 113669–58–2)”.
17. Section 178.2010
Antioxidants and/or stabilizers for polymers
is amended in the table in paragraph (b) in the entry for “2–Hydroxy–4–isooctoxy- benzophenone” under the heading “Substances” by removing “CA Registry No. 330:59–05–1” and adding in its place “CAS Registry No. 33059–05–1”.
18. Section 178.3400
Emulsifiers and/or surface-active agents
is amended in the table in paragraph (c) in the entry for “
Alpha
-sulfo-
omega
-(dodecyloxy)poly(oxyethylene) ammonium salt” under the heading “List of substances” by removing “(CAS Reg. No. 30174–67–5)” and adding in its place “(CAS Reg. No. 32612–48–9)”.
19. Section 178.3770
Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids
is amended in paragraph (c)(1) by removing “(CAS Reg. No. 9005–98–2)” and adding in its place “(CAS Reg. No. 9004–98–2)”.
20. Section 178.3910
Surface lubricants used in the manufacture of metallic articles
is amended in the table in paragraph (a)(2) in the entry for “Sodium petroleum sulfonate” under the heading “Listing of substances” by removing “(CAS Reg. No. 68608–24–4)” and adding in its place “(CAS Reg. No. 68608–26–4)”.
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
21. The authority citation for 21 CFR part 184 continues to read as follows:
Authority:
21 U.S.C. 321, 342, 348, 371.
22. Section 184.1034
Catalase (bovine liver)
is amended in paragraph (a) by removing “(CAS Reg. No. 9001–05–2)” and adding in its place “(CAS Reg. No. 81457–95–6)”.
23. Section 184.1090
Stearic acid
is amended in paragraph (a) by removing “C
16
H
36
O
2
” and adding in its place “C
18
H
36
O
2
”.
24. Section 184.1307a
Ferrous ascorbate
is amended in paragraph (a) by removing “(CAS Reg. No. 14536–17–5)” and adding in its place “(CAS Reg. No. 24808–52–4)”.
25. Section 184.1434
Magnesium phosphate
is amended in paragraph (a) by removing “CAS Reg. No. 7727–0987–091” and adding in its place “CAS Reg. No. 7757–87–1”.
PART 186—INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
26. The authority citation for 21 CFR part 186 continues to read as follows:
Authority:
21 U.S.C. 321, 342, 348, 371.
27. Section 186.1374
Iron oxides
is amended in paragraph (a) by removing “CAS Reg. No. 97705–33–85” and adding in its place“CAS Reg. No. 1332–37–2”.
Dated: March 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.