I (4–1–16 Edition)
200), Food and Drug Administration, nitrite, in the production of cured red
5100 Paint Branch Pkwy., College Park, meat products and cured poultry prod-
MD 20740, or available for inspection at ucts.
the National Archives and Records Ad-
[48 FR 1705, Jan. 14, 1983]
ministration (NARA). For information
on the availability of this material at § 181.34 Sodium nitrite and potassium
NARA, call 202–741–6030, or go to: http:// nitrite.
www.archives.gov/federallregister/
Sodium nitrite and potassium nitrite
codeloflfederallregulations/
are subject to prior sanctions issued by
ibrllocations.html.
the U.S. Department of Agriculture for
(1) In the case of single-use articles
use as color fixatives and preservative
having a volume to surface ratio of 10
agents, with or without sodium or po-
milliliters or more per square inch of
food-contact surface—0.003 milligram/ tassium nitrate, in the curing of red
square inch when extracted to equi- meat and poultry products.
librium at 120 °F with food-simulating [48 FR 1705, Jan. 14, 1983]
solvents appropriate to the intended
conditions of use. PART 182—SUBSTANCES
(2) In the case of single-use articles GENERALLY RECOGNIZED AS SAFE
having a volume to surface ratio of less
than 10 milliliters per square inch of Subpart A—General Provisions
food-contact surface—0.3 part per mil-
lion calculated on the basis of the vol- Sec.
ume of the container when extracted to 182.1 Substances that are generally recog-
equilibrium at 120 °F with food-simu- nized as safe.
lating solvents appropriate to the in- 182.10 Spices and other natural seasonings
and flavorings.
tended conditions of use. 182.20 Essential oils, oleoresins (solvent-
(3) In the case of repeated-use arti- free), and natural extractives (including
cles—0.003 milligram/square inch when distillates).
extracted at a time equivalent to ini- 182.40 Natural extractives (solvent-free)
tial batch usage utilizing food-simu- used in conjunction with spices,
lating solvents and temperatures ap- seasonings, and flavorings.
propriate to the intended conditions of 182.50 Certain other spices, seasonings, es-
use. sential oils, oleoresins, and natural ex-
tracts.
The food-simulating solvents shall in- 182.60 Synthetic flavoring substances and
clude, where applicable, distilled adjuvants.
water, 8 percent or 50 percent ethanol, 182.70 Substances migrating from cotton
3 percent acetic acid, and either n- and cotton fabrics used in dry food pack-
heptane or an appropriate oil or fat. aging.
182.90 Substances migrating to food from
(c) Acrylonitrile monomer may
paper and paperboard products.
present a hazard to health when in- 182.99 Adjuvants for pesticide chemicals.
gested. Accordingly, any food-contact
article containing acrylonitrile copoly- Subpart B—Multiple Purpose GRAS Food
mers or resins that yield acrylonitrile Substances
monomer in excess of that amount pro-
vided for in paragraph (b) of this sec- 182.1045 Glutamic acid.
tion shall be deemed to be adulterated 182.1047 Glutamic acid hydrochloride.
182.1057 Hydrochloric acid.
in violation of section 402 of the Act.
182.1073 Phosphoric acid.
[42 FR 14638, Mar. 15, 1977, as amended at 47 182.1087 Sodium acid pyrophosphate.
FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 182.1125 Aluminum sulfate.
1989] 182.1127 Aluminum ammonium sulfate.
182.1129 Aluminum potassium sulfate.
§ 181.33 Sodium nitrate and potassium 182.1131 Aluminum sodium sulfate.
nitrate. 182.1180 Caffeine.
182.1217 Calcium phosphate.
Sodium nitrate and potassium ni-
182.1235 Caramel.
trate are subject to prior sanctions
jstallworth on DSK7TPTVN1PROD with CFR
182.1320 Glycerin.
issued by the U.S. Department of Agri- 182.1480 Methylcellulose.
culture for use as sources of nitrite, 182.1500 Monoammonium glutamate.
with or without sodium or potassium 182.1516 Monopotassium glutamate.
472
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Food and Drug Administration, HHS § 182.1
182.1711 Silica aerogel. 182.8159 Biotin.
182.1745 Sodium carboxymethylcellulose. 182.8217 Calcium phosphate.
182.1748 Sodium caseinate. 182.8223 Calcium pyrophosphate.
182.1778 Sodium phosphate. 182.8250 Choline bitartrate.
182.1781 Sodium aluminum phosphate. 182.8252 Choline chloride.
182.1810 Sodium tripolyphosphate. 182.8778 Sodium phosphate.
182.8890 Tocopherols.
Subpart C—Anticaking Agents 182.8892 a-Tocopherol acetate.
182.2122 Aluminum calcium silicate. 182.8985 Zinc chloride.
182.2227 Calcium silicate. 182.8988 Zinc gluconate.
182.2437 Magnesium silicate. 182.8991 Zinc oxide.
182.2727 Sodium aluminosilicate. 182.8994 Zinc stearate.
182.2729 Sodium calcium aluminosilicate, 182.8997 Zinc sulfate.
hydrated. AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
182.2906 Tricalcium silicate.
SOURCE: 42 FR 14640, Mar. 15, 1977, unless
Subpart D—Chemical Preservatives otherwise noted.
473
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§ 182.10 21 CFR Ch. I (4–1–16 Edition)
grade or lot of the substance is of suit- ‘‘affirmed as GRAS’’ under part 184 or
able purity for use in food and would 186 of this chapter; ‘‘food additive regu-
generally be regarded as safe for the lation’’ under parts 170 through 180 of
purpose intended, by experts qualified this chapter; ‘‘interim food additive
to evaluate its safety. regulation’’ under part 180 of this chap-
(c) The inclusion of substances in the ter; or ‘‘prohibited from use in food’’
list of nutrients does not constitute a under part 189 of this chapter.
finding on the part of the Department
that the substance is useful as a sup- [42 FR 14640, Mar. 15, 1977, as amended at 53
plement to the diet for humans. FR 44875, Nov. 7, 1988]
(d) Substances that are generally rec-
ognized as safe for their intended use § 182.10 Spices and other natural
seasonings and flavorings.
within the meaning of section 409 of
the act are listed in this part. When Spices and other natural seasonings
the status of a substance has been re- and flavorings that are generally rec-
evaluated, it will be deleted from this ognized as safe for their intended use,
part, and will be issued as a new regu- within the meaning of section 409 of
lation under the appropriate part, e.g., the Act, are as follows:
Common name Botanical name of plant source
474
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Food and Drug Administration, HHS § 182.20
[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979;
50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]
§ 182.20 Essential oils, oleoresins (sol- ing distillates) that are generally rec-
vent-free), and natural extractives ognized as safe for their intended use,
(including distillates). within the meaning of section 409 of
Essential oils, oleoresins (solvent- the Act, are as follows:
free), and natural extractives (includ-
Common name Botanical name of plant source
475
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§ 182.20 21 CFR Ch. I (4–1–16 Edition)
476
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Food and Drug Administration, HHS § 182.20
[42 FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 47 FR 29953, July 9, 1982;
jstallworth on DSK7TPTVN1PROD with CFR
477
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§ 182.40 21 CFR Ch. I (4–1–16 Edition)
[42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26, 1982]
478
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Food and Drug Administration, HHS § 182.1087
Sodium silicate. Finding Aids section of the printed volume
Sodium tripolyphosphate. and at www.fdsys.gov.
Soybean oil (hydrogenated).
Talc. § 182.99 Adjuvants for pesticide chemi-
Tallow (hydrogenated). cals.
Tallow flakes.
Tapioca starch. Adjuvants, identified and used in ac-
Tetrasodium pyrophosphate. cordance with 40 CFR 180.910 and 40
Wheat starch. CFR 180.920, which are added to pes-
Zinc chloride. ticide use dilutions by a grower or ap-
[42 FR 14640, Mar. 15, 1977, as amended at 43 plicator prior to application to the raw
FR 11698, Mar. 21, 1978; 44 FR 28323, May 15, agricultural commodity, are exempt
1979; 45 FR 6085, Jan. 25, 1980; 47 FR 27807, from the requirement of tolerances
27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; under section 409 of the Federal Food,
48 FR 51616, Nov. 10, 1983; 48 FR 51909, Nov. 15, Drug, and Cosmetic Act (21 U.S.C. 348).
1983; 48 FR 52441, 52443, 52445, 52446, Nov. 18,
1983; 51 FR 16830, May 7, 1986; 51 FR 27171, [76 FR 59249, Sept. 26, 2011]
July 30, 1986; 60 FR 62208, Dec. 5, 1995]
479
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§ 182.1125 21 CFR Ch. I (4–1–16 Edition)
(b) Conditions of use. This substance used in accordance with good manufac-
is generally recognized as safe when turing practice.
used in accordance with good manufac-
turing practice. § 182.1320 Glycerin.
(a) Product. Glycerin.
§ 182.1125 Aluminum sulfate.
(b) Conditions of use. This substance
(a) Product. Aluminum sulfate. is generally recognized as safe when
(b) Conditions of use. This substance used in accordance with good manufac-
is generally recognized as safe when turing practice.
used in accordance with good manufac-
turing practice. § 182.1480 Methylcellulose.
§ 182.1127 Aluminum ammonium sul- (a) Product. U.S.P. methylcellulose,
fate. except that the methoxy content shall
not be less than 27.5 percent and not
(a) Product. Aluminum ammonium
more than 31.5 percent on a dry-weight
sulfate.
basis.
(b) Conditions of use. This substance
(b) Conditions of use. This substance
is generally recognized as safe when
is generally recognized as safe when
used in accordance with good manufac-
used in accordance with good manufac-
turing practice.
turing practice.
§ 182.1129 Aluminum potassium sul-
fate. § 182.1500 Monoammonium glutamate.
(a) Product. Aluminum potassium sul- (a) Product. Monoammonium glu-
fate. tamate.
(b) Conditions of use. This substance (b) Conditions of use. This substance
is generally recognized as safe when is generally recognized as safe when
used in accordance with good manufac- used in accordance with good manufac-
turing practice. turing practice.
480
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Food and Drug Administration, HHS § 182.3041
anhydroglucose unit, and with a min- exceeding 2 percent in table salt and 5
imum viscosity of 25 centipoises for 2 percent in baking powder in accordance
percent by weight aqueous solution at with good manufacturing practice.
25 °C.
(b) Conditions of use. This substance § 182.2437 Magnesium silicate.
is generally recognized as safe when (a) Product. Magnesium silicate.
used in accordance with good manufac- (b) Tolerance. 2 percent.
turing practice. (c) Limitations, restrictions, or expla-
nation. This substance is generally rec-
§ 182.1748 Sodium caseinate.
ognized as safe when used in table salt
(a) Product. Sodium caseinate. in accordance with good manufacturing
(b) Conditions of use. This substance practice.
is generally recognized as safe when
used in accordance with good manufac- § 182.2727 Sodium aluminosilicate.
turing practice. (a) Product. Sodium aluminosilicate
§ 182.1778 Sodium phosphate. (sodium silicoaluminate).
(b) Tolerance. This substance is gen-
(a) Product. Sodium phosphate erally recognized as safe for use at a
(mono-, di-, and tribasic). level not exceeding 2 percent in accord-
(b) Conditions of use. This substance ance with good manufacturing prac-
is generally recognized as safe when tice.
used in accordance with good manufac-
turing practice. § 182.2729 Sodium calcium
aluminosilicate, hydrated.
§ 182.1781 Sodium aluminum phos-
phate. (a) Product. Hydrated sodium calcium
aluminosilicate (sodium calcium
(a) Product. Sodium aluminum phos-
silicoaluminate).
phate.
(b) Tolerance. This substance is gen-
(b) Conditions of use. This substance
erally recognized as safe for use at a
is generally recognized as safe when
level not exceeding 2 percent in accord-
used in accordance with good manufac-
ance with good manufacturing prac-
turing practice.
tice.
§ 182.1810 Sodium tripolyphosphate.
§ 182.2906 Tricalcium silicate.
(a) Product. Sodium
tripolyphosphate. (a) Product. Tricalcium silicate.
(b) Conditions of use. This substance (b) Tolerance. 2 percent.
is generally recognized as safe when (c) Limitations, restrictions, or expla-
used in accordance with good manufac- nation. This substance is generally rec-
turing practice. ognized as safe when used in table salt
in accordance with good manufacturing
practice.
Subpart C—Anticaking Agents
§ 182.2122 Aluminum calcium silicate. Subpart D—Chemical
(a) Product. Aluminum calcium sili- Preservatives
cate.
§ 182.3013 Ascorbic acid.
(b) Tolerance. 2 percent.
(c) Limitations, restrictions, or expla- (a) Product. Ascorbic acid.
nation. This substance is generally rec- (b) Conditions of use. This substance
ognized as safe when used in table salt is generally recognized as safe when
in accordance with good manufacturing used in accordance with good manufac-
practice. turing practice.
481
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§ 182.3089 21 CFR Ch. I (4–1–16 Edition)
482
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Food and Drug Administration, HHS § 182.6197
483
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§ 182.6203 21 CFR Ch. I (4–1–16 Edition)
484
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Food and Drug Administration, HHS Pt. 184
485
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