Food additives permitted for direct addition to food for human consumption

95 Pages·2016·0.61 MB·English

Pt. 172 21 CFR Ch. I (4–1–16 Edition)
shall be furnished in the form specified Subpart D—Special Dietary and Nutritional
in §§171.1 and 171.100 for submitting pe- Additives
titions.
172.310 Aluminum nicotinate.
[42 FR 14491, Mar. 15, 1977, as amended at 42 172.315 Nicotinamide-ascorbic acid complex.
FR 15674, Mar. 22, 1977] 172.320 Amino acids.
172.325 Bakers yeast protein.
172.330 Calcium pantothenate, calcium chlo-
PART 172—FOOD ADDITIVES PER-
ride double salt.
MITTED FOR DIRECT ADDITION TO 172.335 D-Pantothenamide.
FOOD FOR HUMAN CONSUMP- 172.340 Fish protein isolate.
TION 172.345 Folic acid (folacin).
172.350 Fumaric acid and salts of fumaric
acid.
Subpart A—General Provisions 172.365 Kelp.
172.370 Iron-choline citrate complex.
Sec. 172.372 N-Acetyl-L-methionine.
172.5 General provisions for direct food ad- 172.375 Potassium iodide.
ditives. 172.379 Vitamin D2.
172.380 Vitamin D.
3
Subpart B—Food Preservatives 172.381 Vitamin D2bakers yeast.
172.385 Whole fish protein concentrate.
172.105 Anoxomer. 172.395 Xylitol.
172.110 BHA. 172.399 Zinc methionine sulfate.
172.115 BHT.
Subpart E—Anticaking Agents
172.120 Calcium disodium EDTA.
172.130 Dehydroacetic acid. 172.410 Calcium silicate.
172.133 Dimethyl dicarbonate. 172.430 Iron ammonium citrate.
172.135 Disodium EDTA. 172.480 Silicon dioxide.
172.140 Ethoxyquin. 172.490 Yellow prussiate of soda.
172.145 Heptylparaben.
Subpart F—Flavoring Agents and Related
172.150 4-Hydroxymethyl-2,6-di-tert-butyl-
phenol. Substances
172.155 Natamycin (pimaricin). 172.510 Natural flavoring substances and
172.160 Potassium nitrate. natural substances used in conjunction
172.165 Quaternary ammonium chloride with flavors.
combination. 172.515 Synthetic flavoring substances and
172.167 Silver nitrate and hydrogen peroxide adjuvants.
solution. 172.520 Cocoa with dioctyl sodium sulfo-
172.170 Sodium nitrate. succinate for manufacturing.
172.175 Sodium nitrite. 172.530 Disodium guanylate.
172.177 Sodium nitrite used in processing 172.535 Disodium inosinate.
smoked chub. 172.540 DL-Alanine.
172.180 Stannous chloride. 172.560 Modified hop extract.
172.575 Quinine.
172.185 TBHQ.
172.580 Safrole-free extract of sassafras.
172.190 THBP.
172.585 Sugar beet extract flavor base.
172.590 Yeast-malt sprout extract.
Subpart C—Coatings, Films and Related
Substances Subpart G—Gums, Chewing Gum Bases
and Related Substances
172.210 Coatings on fresh citrus fruit.
172.215 Coumarone-indene resin. 172.610 Arabinogalactan.
172.225 Methyl and ethyl esters of fatty 172.615 Chewing gum base.
acids produced from edible fats and oils. 172.620 Carrageenan.
172.230 Microcapsules for flavoring sub- 172.623 Carrageenan with polysorbate 80.
stances. 172.626 Salts of carrageenan.
172.235 Morpholine. 172.655 Furcelleran.
172.250 Petroleum naphtha. 172.660 Salts of furcelleran.
172.255 Polyacrylamide. 172.665 Gellan gum.
172.695 Xanthan gum.
172.260 Oxidized polyethylene.
FR 172.270 Sulfated butyl oleate. Subpart H—Other Specific Usage Additives
with C 172.2r7i5vatSivyenst.h etic paraffin and succinic de- 172.710 Adjuvants for pesticide use dilu-
D
O 172.280 Terpene resin. tions.
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Food and Drug Administration, HHS §172.5
172.712 1,3–Butylene glycol. 172.862 Oleic acid derived from tall oil fatty
172.715 Calcium lignosulfonate. acids.
172.720 Calcium lactobionate. 172.863 Salts of fatty acids.
172.723 Epoxidized soybean oil. 172.864 Synthetic fatty alcohols.
172.725 Gibberellic acid and its potassium 172.866 Synthetic glycerin produced by the
salt. hydrogenolysis of carbohydrates.
172.730 Potassium bromate. 172.867 Olestra.
172.735 Glycerol ester of rosin. 172.868 Ethyl cellulose.
172.736 Glycerides and polyglycides of hy- 172.869 Sucrose oligoesters.
drogenated vegetable oils. 172.870 Hydroxypropyl cellulose.
172.755 Stearyl monoglyceridyl citrate. 172.872 Methyl ethyl cellulose.
172.765 Succistearin (stearoyl propylene gly- 172.874 Hydroxypropyl methylcellulose.
col hydrogen succinate). 172.876 Castor oil.
172.770 Ethylene oxide polymer. 172.878 White mineral oil.
172.775 Methacrylic acid-divinylbenzene co- 172.880 Petrolatum.
polymer. 172.882 Synthetic isoparaffinic petroleum
172.780 Acacia (gum arabic). hydrocarbons.
172.785 Listeria-specific bacteriophage prepa- 172.884 Odorless light petroleum hydro-
ration. carbons.
172.886 Petroleum wax.
Subpart I—Multipurpose Additives 172.888 Synthetic petroleum wax.
172.890 Rice bran wax.
172.800 Acesulfame potassium. 172.892 Food starch-modified.
172.802 Acetone peroxides. 172.894 Modified cottonseed products in-
172.803 Advantame. tended for human consumption.
172.804 Aspartame. 172.896 Dried yeasts.
172.806 Azodicarbonamide. 172.898 Bakers yeast glycan.
172.808 Copolymer condensates of ethylene
oxide and propylene oxide. AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371,
172.809 Curdlan. 379e.
172.810 Dioctyl sodium sulfosuccinate.
SOURCE: 42 FR 14491, Mar. 15, 1977, unless
172.811 Glyceryl tristearate.
otherwise noted.
172.812 Glycine.
172.814 Hydroxylated lecithin. EDITORIAL NOTE: Nomenclature changes to
172.816 Methyl glucoside-coconut oil ester. part 172 appear at 61 FR 14482, Apr. 2, 1996, 66
172.818 Oxystearin. FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27,
172.820 Polyethylene gylcol (mean molec- 2001, 68 FR 15355, Mar. 31, 2003, 70 FR 40880,
ular weight 200–9,500). July 15, 2005, 70 FR 67651, Nov. 8, 2005, and 70
172.822 Sodium lauryl sulfate. FR 72074, Dec. 1, 2005.
172.824 Sodium mono- and dimethyl naph-
thalene sulfonates. Subpart A—General Provisions
172.826 Sodium stearyl fumarate.
172.828 Acetylated monoglycerides.
§172.5 General provisions for direct
172.829 Neotame.
food additives.
172.830 Succinylated monoglycerides.
172.831 Sucralose. (a) Regulations prescribing condi-
172.832 Monoglyceride citrate. tions under which food additive sub-
172.833 Sucrose acetate isobutyrate (SAIB).
stances may be safely used predicate
172.834 Ethoxylated mono- and diglycerides.
usage under conditions of good manu-
172.836 Polysorbate 60.
172.838 Polysorbate 65. facturing practice. For the purposes of
172.840 Polysorbate 80. this part, good manufacturing practice
172.841 Polydextrose. shall be defined to include the fol-
172.842 Sorbitan monostearate. lowing restrictions.
172.844 Calcium stearoyl-2-lactylate. (1) The quantity of the substance
172.846 Sodium stearoyl lactylate.
added to food does not exceed the
172.848 Lactylic esters of fatty acids.
amount reasonably required to accom-
172.850 Lactylated fatty acid esters of glyc-
erol and propylene glycol. plish its intended physical, nutritive,
172.852 Glyceryl-lacto esters of fatty acids. or other technical effect in food.
172.854 Polyglycerol esters of fatty acids. (2) Any substance intended for use in
172.856 Propylene glycol mono- and diesters or on food is of appropriate food grade
of fats and fatty acids. and is prepared and handled as a food
172.858 Propylene glycol alginate.
with CFR 111777222...888566019 FCSouactctoryoa s aebc ufiadtttste. yr ascuibds etisttuetres. from coco- isnc(grbirb)e idTnihge en stea.x fies tceonnced iotifo an sr eogfu luatsieo nf oprr ea-
OD nut oil, palm kernel oil, or both oils. food additive shall not be construed to
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§172.105 21 CFR Ch. I (4–1–16 Edition)
relieve the use of the substance from 202–741–6030, or go to: http://
compliance with any other provision of www.archives.gov/federallregister/
the Act. codeloflfederallregulations/
(c) The existence of any regulation ibrllocations.html.
prescribing safe conditions of use for a (3) Phenol content: Not less than 3.2
nutrient substance does not constitute milliequivalent/gram and not more
a finding that the substance is useful than 3.8 milliequivalent/gram as deter-
or required as a supplement to the diet mined by a method entitled ‘‘Total
of humans. Phenols,’’ 1982, which is incorporated
by reference. Copies are available from
Subpart B—Food Preservatives the Center for Food Safety and Applied
Nutrition (HFS–200), Food and Drug
§172.105 Anoxomer. Administration, 5100 Paint Branch
Anoxomer as identified in this sec- Pkwy., College Park, MD 20740, or at
tion may be safely used in accordance the National Archives and Records Ad-
with the following conditions: ministration (NARA). For information
(a) Anoxomer is 1,4-benzenediol, 2- on the availability of this material at
(1,1-dimethylethyl)-polymer with NARA, call 202–741–6030, or go to: http://
diethenylbenzene, 4-(1,1-dimethyl- www.archives.gov/federallregister/
ethyl)phenol, 4- methoxyphenol, 4,4′-(1- codeloflfederallregulations/
methylethylidene)bis(phenol) and 4- ibrllocations.html.
methylphenol (CAS Reg. No. 60837–57–2) (4) Heavy metals as lead (as Pb), not
prepared by condensation polymeriza- more than 10 parts per million. Arsenic
tion of divinylbenzene (m- and p-) with (as As), not more than 3 parts per mil-
tert-butylhydroquinone, tert-butyl- lion. Mercury (as Hg), not more than 1
phenol, hydroxyanisole, p-cresol and part per million.
4,4′-isopropylidenediphenol. (c) Anoxomer may be safely used as
(b) The polymeric antioxidant meets an antioxidant in food at a level of not
the following specifications: more than 5,000 parts per million based
(1) Polymer, not less than 98.0 per- on fat and oil content of the food.
cent as determined by an ultraviolet
[48 FR 18798, Apr. 26, 1983, as amended at 54
method entitled ‘‘Ultraviolet Assay, FR 24896, June 12, 1989]
‘‘1982, which is incorporated by ref-
erence. Copies are available from the §172.110 BHA.
Center for Food Safety and Applied Nu- The food additive BHA (butylated hy-
trition (HFS–200), Food and Drug Ad- droxyanisole) alone or in combination
ministration, 5100 Paint Branch Pkwy., with other antioxidants permitted in
College Park, MD 20740, or at the Na- food for human consumption in this
tional Archives and Records Adminis- subpart B may be safely used in or on
tration (NARA). For information on specified foods, as follows:
the availability of this material at (a) The BHA meets the following
NARA, call 202–741–6030, or go to: http:// specification:
www.archives.gov/federallregister/
codeloflfederallregulations/ Assay (total BHA), 98.5 percent minimum.
Melting point 48 °C minimum.
ibrllocations.html.
(2) Molecular weight: Total mono- (b) The BHA is used alone or in com-
mers, dimers and trimers below 500 not bination with BHT, as an antioxidant
more than 1 percent as determined by a in foods, as follows:
method entitled ‘‘Low Molecular
Weight Anoxomer Analysis,’’ 1982, Limitations
(total BHA
which is incorporated by reference. Food and BHT)
Copies are available from the Center parts per
million
for Food Safety and Applied Nutrition
(HFS–200), Food and Drug Administra- Dehydrated potato shreds................................... 50
Active dry yeast................................................... 11,000
tion, 5100 Paint Branch Pkwy., College
Beverages and desserts prepared from dry
R Park, MD 20740, or at the National Ar- mixes................................................................ 12
CF chives and Records Administration Dry breakfast cereals .......................................... 50
OD with (aNbAiliRtAy )o. fF tohri sin mfoartmearitaiol na to nN AthReA a, vcaaill-l DDEmrryyu dmlsiciixoeends s gftolaarbz ibeliezdve ferrsrua iftgoer. .s.s. h.a.o.n.r.d.t.e .d.n.e.in.s.g.s.s.e..r..t..s................................................... 112390200
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Food and Drug Administration, HHS §172.120
Limitations the percentage of the additive in the
(total BHA mixture.
Food and BHT)
parts per
million §172.120 Calcium disodium EDTA.
Potato flakes........................................................ 50 The food additive calcium disodium
Potato granules ................................................... 10 EDTA (calcium disodium ethylene-
Sweet potato flakes............................................. 50 diaminetetraacetate) may be safely
1BHA only. used in designated foods for the pur-
poses and in accordance with the condi-
(c) To assure safe use of the additive:
tions prescribed, as follows:
(1) The label of any market package
(a) The additive contains a minimum
of the additive shall bear, in addition
of 99 percent by weight of either the di-
to the other information required by
hydrate C H O N CaNa ·2H O or the
the Act, the name of the additive. 10 12 8 2 2 2
trihydrate C H O N CaNa ·3H O, or
(2) When the additive is marketed in 10 12 8 2 2 2
any mixture of the two.
a suitable carrier, in addition to meet-
(b) It is used or intended for use as
ing the requirement of paragraph (c)(1)
follows:
of this section, the label shall declare
(1) Alone, in the following foods at
the percentage of the additive in the
not to exceed the levels prescribed, cal-
mixture.
culated as the anhydrous compound:
(3) The label or labeling of dry mixes
for beverages and desserts shall bear Limita-
adequate directions for use to provide tion
Food (parts Use
that beverages and desserts prepared per mil-
from the dry mixes contain no more lion)
than 2 parts per million BHA. Cabbage, pickled.......... 220 Promote color, flavor,
and texture retention.
§172.115 BHT. Canned carbonated soft 33 Promote flavor reten-
drinks. tion.
The food additive BHT (butylated hy- Canned white potatoes 110 Promote color retention.
droxytoluene), alone or in combination Clams (cooked canned) 340 Promote color retention.
with other antioxidants permitted in Crabmeat (cooked 275 Retard struvite forma-
canned). tion; promote color
this subpart B may be safely used in or retention.
on specified foods, as follows: Cucumbers pickled....... 220 Promote color, flavor,
(a) The BHT meets the following and texture retention.
Distilled alcoholic bev- 25 Promote stability of
specification: Assay (total BHT) 99 per- erages. color, flavor, and/or
cent minimum. product clarity.
(b) The BHT is used alone or in com- Dressings, nonstandard- 75 Preservative.
ized.
bination with BHA, as an antioxidant
Dried lima beans 310 Promote color retention.
in foods, as follows: (cooked canned).
Egg product that is 1200 Preservative.
Limitations hard-cooked and con-
(total BHA sists, in a cylindrical
Food and BHT) shape, of egg white
parts per with an inner core of
million egg yolk.
Fermented malt bev- 25 Antigushing agent.
Dehydrated potato shreds................................... 50 erages.
Dry breakfast cereals .......................................... 50 French dressing............ 75 Preservative.
Emulsion stabilizers for shortenings.................... 200 Legumes (all cooked 365 Promote color retention.
Potato flakes........................................................ 50 canned, other than
Potato granules ................................................... 10 dried lima beans, pink
Sweetpotato flakes .............................................. 50 beans, and red
beans).
(c) To assure safe use of the additive: Mayonnaise .................. 75 Do.
Mushrooms (cooked 200 Promote color retention.
(1) The label of any market package
canned).
of the additive shall bear, in addition Oleomargarine.............. 75 Preservative.
to the other information required by Pecan pie filling ............ 100 Promote color retention.
Pink beans (cooked 165 Promote color retention.
the Act, the name of the additive.
canned).
R (2) When the additive is marketed in Potato salad.................. 100 Preservative.
CF a suitable carrier, in addition to meet- Processed dry pinto 800 Promote color retention.
OD with ionf gt hthise sreecqtuiiorne,m tehnet loafb pela rsahgarlalp dhe (ccl)a(r1e) Rebcdae nabnneesa.dn)s. (cooked 165 Promote color retention.
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§172.130 21 CFR Ch. I (4–1–16 Edition)
Limita- Dehydroacetic acid: Melting point, 109 °C–111
tion °C; assay, minimum 98 percent (dry basis).
Food (parts Use Sodium salt of dehydroacetic acid: Assay,
per mil-
lion) minimum 98 percent (dry basis).
Salad dressing.............. 75 Preservative. (b) It is used or intended for use as a
Sandwich spread.......... 100 Do. preservative for cut or peeled squash,
Sauces.......................... 75 Do. and is so used that no more than 65
Shrimp (cooked 250 Retard struvite forma-
parts per million expressed as dehydro-
canned). tion; promote color
retention. acetic acid remains in or on the pre-
Spice extractives in 60 Promote color and fla- pared squash.
soluble carriers. vor retention.
(c) The label or labeling of any pack-
Spreads, artificially col- 100 Promote color retention.
ored and lemon-fla- age of the additive intended for use in
vored or orange-fla- food shall bear adequate directions for
vored. use to insure compliance with this sec-
1By weight of egg yolk portion. tion.
(2) With disodium EDTA (disodium
ethylenediaminetetraacetate) in the §172.133 Dimethyl dicarbonate.
following foods at not to exceed, in Dimethyl dicarbonate (CAS Reg. No.
combination, the levels prescribed, cal- 4525–33–1) may be safely used in food in
culated as anhydrous C H O N CaNa : accordance with the following pre-
10 12 8 2 2
scribed conditions:
Limita- (a) The additive meets the following
tion
Food (parts Use specifications:
per mil- (1) The additive has a purity of not
lion)
less than 99.8 percent as determined by
Dressings, nonstandardized.... 75 Preservative. the following titration method:
French dressing ...................... 75 Do.
Mayonnaise............................. 75 Do.
Salad dressing ........................ 75 Do. PRINCIPLESOFMETHOD
Sandwich spread..................... 100 Do. Dimethyl dicarbonate (DMDC) is mixed
Sauces .................................... 75 Do. with excess diisobutylamine with which it
reacts quantitatively. The excess amine is
(c) To assure safe use of the additive:
backtitrated with acid.
(1) The label and labeling of the addi-
tive container shall bear, in addition to APPARATUS
the other information required by the
250-milliliter (mL) Beaker
Act, the name of the additive. 100-mL Graduate cylinder
(2) The label or labeling of the addi- 25-mL Pipette
tive container shall bear adequate use 10-mL Burette (automatic, eg., Metrohm bu-
directions to provide a final food prod- rette)
uct that complies with the limitations Stirrer
provided in paragraph (b) of this sec- Device for potentiometric titration
tion. Reference electrode
(d) In the standardized foods listed in Glass electrode
paragraph (b) of this section, the addi- REAGENTS
tives are used only in compliance with
the applicable standards of identity for Acetone, analytical-grade
Solution of 1 N diisobutylamine in chloro-
such foods.
benzene, distilled
[42 FR 14491, Mar. 15, 1977, as amended at 48 1 N Acetic Acid
FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7,
1993; 60 FR 33710, June 29, 1995; 65 FR 48379, PROCEDURE
Aug. 8, 2000] Accurately weigh in about 2 grams of the
sample (W) and dissolve in 100 mL acetone.
§172.130 Dehydroacetic acid. Add accurately 25 mL of the 1 N diisobutyl-
The food additive dehydroacetic acid amine solution by pipette and allow to stand
and/or its sodium salt may be safely for 5 minutes. Subsequently, titrate the re-
action mixture potentiometrically with 1 N
used in accordance with the following
with CFR pr(eas)c rTibheed fcooondd iatdiodnitsi:v e meets the fol- sshtuyimdrrrpiontcigho.ln o,F ricocar ra rcdyie dto e(ucrtom ntishnueimn agpn taitolhynes= iasb lmwainLtk)h owuchoti nlae-
OD lowing specifications: sample (consumption=b mL).
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Food and Drug Administration, HHS §172.135
CALCULATION cent, in an amount not to exceed 250
parts per million.
(b−a)×13.4 (c) To ensure the safe use of the food
=% DMDC additive, the label of the package con-
W taining the additive shall bear, in addi-
NOTE: For adding the diisobutylamine so- tion to other information required by
lution, always use the same pipette and wait the Federal Food, Drug, and Cosmetic
for a further three drops to fall when the Act:
flow has stopped. (1) The name of the additive ‘‘di-
(2) The additive contains not more methyl dicarbonate.’’
than 2,000 ppm (0.2 percent) dimethyl (2) The intended use of the additive.
carbonate as determined by a method (3) Adequate directions for use to en-
entitled ‘‘Gas Chromatography Method sure compliance with this section.
for Dimethyl Carbonate Impurity in
[53 FR 41329, Oct. 21, 1988, as amended at 58
Dimethyl Dicarbonate,’’ which is incor-
FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994;
porated by reference in accordance 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29,
with 5 U.S.C. 552(a). Copies are avail- 1996; 66 FR 13653, Mar. 7, 2001]
able from the Center for Food Safety
and Applied Nutrition (HFS–200), 5100 §172.135 Disodium EDTA.
Paint Branch Pkwy., College Park, MD The food additive disodium EDTA
20740, or at the National Archives and (disodium ethylenediaminetetraace-
Records Administration (NARA). For tate) may be safely used in designated
information on the availability of this foods for the purposes and in accord-
material at NARA, call 202–741–6030, or ance with the following prescribed con-
go to: http://www.archives.gov/ ditions:
federallregister/ (a) The additive contains a minimum
codeloflfederallregulations/ of 99 percent disodium ethylenedia-
ibrllocations.html. minetetraacetate dihydrate
(b) The additive is used or intended (C H O N Na ·2H O).
10 14 8 2 2 2
for use as a microbial control agent in (b) It is used or intended for use as
the following beverages under normal follows:
circumstances of bottling, canning, or (1) Alone, in the following foods at
other forms of final packaging, where not to exceed the levels prescribed, cal-
the viable microbial load has been re- culated as anhydrous calcium disodium
duced to 500 microorganisms per milli- EDTA:
liter or less by current good manufac-
turing practices such as heat treat- Limita-
tion
ment, filtration, or other technologies Food (parts Use
per mil-
prior to the use of dimethyl dicar- lion)
bonate:
(1) In wine, dealcoholized wine, and Aqueous multivitamin prep- 150 With iron salts as a
arations. stabilizer for vita-
low alcohol wine in an amount not to min B12in liquid
exceed 200 parts per million. multivitamin prep-
(2) In ready-to-drink teas in an arations.
Canned black-eyed peas .... 145 Promote color re-
amount not to exceed 250 parts per mil- tention.
lion. Canned kidney beans ......... 165 Preservative.
(3) In carbonated or noncarbonated, Canned strawberry pie filling 500 Promote color re-
tention.
nonjuice-containing (less than or equal Cooked sausage ................. 36 As a cure accel-
to 1 percent juice), flavored or erator with so-
unflavored beverages containing added dium ascorbate
or ascorbic acid.
electrolytes (5–20 milliequivalents/liter
Dressings, nonstandardized 75 Preservative.
sodium ion (Na + ) and 3–7 milli- French dressing .................. 75 Do.
equivalents/liter potassium ion (K + )) Frozen white potatoes in- 100 Promote color re-
cluding cut potatoes. tention.
in an amount not to exceed 250 parts
Gefilte fish balls or patties in 150 Inhibit discoloration.
R per million. packing medium.
CF (4) In carbonated, dilute beverages Legumes (all cooked 165 Promote color re-
OD with cwointhta jiuniicneg c jounitceen, tf rnuoitt tfol aevxocre,e do r5 0b optehr-, Maceyayonenndne padei,s aeost)h...e..r. .t.h..a..n.. ..b..la..c..k..-. . 75 Prteesnetriovant.i ve.
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§172.140 21 CFR Ch. I (4–1–16 Edition)
Limita- §172.140 Ethoxyquin.
tion
Food (parts Use (a) Ethoxyquin (1,2-dihydro-6-ethoxy-
per mil-
lion) 2,2,4-trimethylquinoline) may be safely
used as an antioxidant for preservation
Ready-to-eat cereal prod- 2315 Promote color re- of color in the production of chili pow-
ucts containing dried ba- tention.
nanas. der, paprika, and ground chili at levels
Salad dressing .................... 75 Preservative. not in excess of 100 parts per million.
Sandwich spread................. 100 Do. (b) In order to provide for the safe
Sauces ................................ 75 Do.
use of the additive in feed prepared in
1Based on total weight of finished product including packing accordance with §§573.380 and 573.400 of
medium.
2In dried banana component of cereal product. this chapter, tolerances are established
for residues of ethoxyquin in or on edi-
(2) With calcium disodium EDTA
ble products of animals as follows:
(calcium disodium ethylenediamine-
tetraacetate; calcium disodium 5 parts per million in or on the uncooked fat
(ethylenedinitrilo) tetraacetate), in the of meat from animals except poultry.
following foods at not to exceed, in 3 parts per million in or on the uncooked
combination, the levels prescribed, cal- liver and fat of poultry.
culated as anhydrous C H O N CaNa : 0.5 part per million in or on the uncooked
10 12 8 2 2
muscle meat of animals.
Limita- 0.5 part per million in poultry eggs.
tion
Food (parts Use Zero in milk.
per mil-
lion) §172.145 Heptylparaben.
Dressings, nonstandardized 75 Preservative. (a) The food additive heptylparaben
French dressing .................. 75 Do. is the chemical n-heptyl p-hydroxy-
Mayonnaise......................... 75 Do.
benzoate.
Salad dressing .................... 75 Do.
Sandwich spread................. 100 Do. (b) It may be safely used to inhibit
Sauces ................................ 75 Do. microbiological spoilage in accordance
with the following prescribed condi-
(3) Alone, as a sequestrant in the
tions:
nonnutritive sweeteners that are listed
(1) In fermented malt beverages in
in §180.37 of this chapter and that, in
amounts not to exceed 12 parts per mil-
addition, are designed for aqueous solu-
lion.
tion: Provided, That the amount of the
additive, calculated as anhydrous cal- (2) In noncarbonated soft drinks and
cium disodium EDTA, does not exceed fruit-based beverages in amounts not
0.1 percent by weight of the dry non- to exceed 20 parts per million, when
nutritive sweetener. standards of identity established under
(c) To assure the safe use of the addi- section 401 of the Act (21 U.S.C. 341) do
tive: not preclude such use.
(1) The label and labeling of the addi-
§172.150 4-Hydroxymethyl-2,6-di-tert-
tive container shall bear, in addition to
butylphenol.
the other information required by the
act, the name of the additive. The food additive 4-hydroxymethyl-
(2) The label or labeling of the addi- 2,6-di-tert-butylphenol may be safely
tive container shall bear adequate use used in food in accordance with the fol-
directions to provide a final food prod- lowing prescribed conditions:
uct that complies with the limitations (a) The additive has a solidification
provided in paragraph (b) of this sec- point of 140 °C–141 °C.
tion. (b) The additive is used as an anti-
(d) In the standardized foods listed in oxidant alone or in combination with
paragraphs (b) (1) and (2) of this section other permitted antioxidants.
the additives are used only in compli- (c) The total amount of all anti-
ance with the applicable standards of
oxidants added to such food shall not
CFR identity for such foods. exceed 0.02 percent of the oil or fat con-
with [42 FR 14491, Mar. 15, 1977, as amended at 65 tent of the food, including the essential
OD FR 48379, Aug. 8, 2000] (volatile) oil content of the food.
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Food and Drug Administration, HHS §172.167
§172.155 Natamycin (pimaricin). §172.165 Quaternary ammonium chlo-
ride combination.
(a) Natamycin (CAS Reg. No. 7681–93–
8), also known as pimaricin, is a pol- The food additive, quaternary ammo-
yene macrolide antimycotic substance nium chloride combination, may be
possessing an empirical formula of safely used in food in accordance with
C H NO and a molecular weight of the following conditions:
33 47 13
665.7. (a) The additive contains the fol-
(b) The additive shall conform to the lowing compounds: n-dodecyl dimethyl
following specifications: benzyl ammonium chloride (CAS Reg.
No. 139–07–1); n-dodecyl dimethyl ethyl-
Purity: 97 percent ±2 percent on an anhy-
benzyl ammonium chloride (CAS Reg.
drous basis.
Arsenic: Not more than 1 part per million. No. 27479–28–3); n-hexadecyl dimethyl
Heavy metals (as Pb): Not more than 20 parts benzyl ammonium chloride (CAS Reg.
per million. No. 122–18–9); n-octadecyl dimethyl
benzyl ammonium chloride (CAS Reg.
(c) The additive may be applied on
No. 122–19–0); n-tetradecyl dimethyl
cheese, as an antimycotic, in amounts
benzyl ammonium chloride (CAS Reg.
not to exceed 20 milligrams per kilo-
No. 139–08–2); n-tetradecyl dimethyl
gram (20 parts per million) in the fin-
ethylbenzyl ammonium chloride (CAS
ished product as determined by Inter-
Reg. No. 27479–29–4).
national Dairy Federation (IDF) Stand-
ard 140A:1992, ‘‘Cheese and Cheese (b) The additive meets the following
Rind-Determination of Natamycin Con- specifications: pH (5 percent active so-
tent-Method by Molecular Absorption lution) 7.0–8.0; total amines, maximum
Spectrometry and by High-Perform- 1 percent as combined free amines and
ance Liquid Chromatography,’’ which amine hydrochlorides.
is incorporated by reference. The Di- (c) The additive is used as an anti-
rector of the Office of the Federal Reg- microbial agent, as defined in
ister approves this incorporation by §170.3(o)(2) of this chapter, in raw sugar
reference in accordance with 5 U.S.C. cane juice. It is added prior to clari-
552(a) and 1 CFR part 51. Copies are fication when further processing of the
available from the Division of Product sugar cane juice must be delayed.
Policy (HFS–206), Center for Food Safe- (d) The additive is applied to the
ty and Applied Nutrition, Food and sugar juice in the following quantities,
Drug Administration, 5100 Paint based on the weight of the raw cane:
Branch Pkwy., College Park, MD 20740,
or may be examined at the Food and Component Pmaritlsli opne r
Drug Administration’s Main Library,
10903 New Hampshire Ave., Bldg. 2, n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0
Third Floor, Silver Spring, MD 20993, n-Dodecyl dimethyl ethylbenzyl ammonium
chloride........................................................... 3.4–13.5
301–796–2039, or at the National Ar- n-Hexadecyl dimethyl benzyl ammonium chlo-
chives and Records Administration ride ................................................................. 1.5–6.0
(NARA). For information on the avail- n-Octadecyl dimethyl benzyl ammonium chlo-
ability of this material at NARA, call ride ................................................................. 0.25–1.0
n-Tetradecyl dimethyl benzyl ammonium chlo-
202–741–6030, or go to: http:// ride ................................................................. 3.0–12.0
www.archives.gov/federallregister/ n-Tetradecyl dimethyl ethylbenzyl ammonium
codeloflfederallregulations/ chloride........................................................... 1.6–6.5
ibrllocations.html.
[50 FR 3890, Jan. 29, 1985]
[47 FR 26823, June 22, 1982, as amended at 50
FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1,
§172.167 Silver nitrate and hydrogen
1998; 66 FR 13847, Mar. 8, 2001; 81 FR 5591, Feb.
peroxide solution.
3, 2016]
An aqueous solution containing a
§172.160 Potassium nitrate. mixture of silver nitrate and hydrogen
The food additive potassium nitrate peroxide may be safely used in accord-
R may be safely used as a curing agent in ance with the following prescribed con-
CF the processing of cod roe, in an amount ditions:
with not to exceed 200 parts per million of (a) The additive is used as an anti-
OD the finished roe. microbial agent in bottled water.
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§172.170 21 CFR Ch. I (4–1–16 Edition)
(b) Hydrogen peroxide meets the tration (NARA). For information on
specifications of the Food Chemicals the availability of this material at
Codex, 7th ed. (2010), pp. 496–497, which NARA, call 202–741–6030 or go to: http://
is incorporated by reference. The Di- www.archives.gov/federallregister/
rector of the Office of the Federal Reg- codeloflfederallregulations/
ister approves this incorporation by ibrllocations.html.
reference in accordance with 5 U.S.C. (e) Substances generally recognized
552(a) and 1 CFR part 51. You may ob- as safe in or on food may be used to
tain copies from the United States stabilize the additive to ensure that
Pharmacopeial Convention, 12601 the additive will perform its intended
Twinbrook Pkwy., Rockville, MD 20852 technical effect.
(Internet address http://www.usp.org). (f) The additive may not be added to
Copies may be examined at the Food bottled water that has been filtered or
and Drug Administration’s Main Li- is intended to be filtered through a sil-
brary, 10903 New Hampshire Ave., Bldg. ver-containing water filter.
2, Third Floor, Silver Spring, MD 20993, (g) Bottled water must meet the
301–796–2039, or at the National Ar- quality standards for bottled water in
chives and Records Administration §165.110(b)(2) through (b)(5) of this
(NARA). For information on the avail- chapter, including the limits specified
ability of this material at NARA, call for total silver and nitrate, unless the
202–741–6030 or go to: http:// water bears a label statement of sub-
www.archives.gov/federal-register/cfr/ibr- standard quality, as provided for under
locations.html. §165.110(c) of this chapter.
(c) The amount of silver added will
not exceed 17 micrograms per kilogram [74 FR 11478, Mar. 18, 2009, as amended at 78
in the treated bottled water, and the FR 71461, Nov. 29, 2013; 81 FR 5591, Feb. 3,
2016]
amount of hydrogen peroxide will not
exceed 23 milligrams per kilogram in
§172.170 Sodium nitrate.
the treated bottled water. Analyses for
silver and hydrogen peroxide shall be The food additive sodium nitrate
conducted on samples of treated bot- may be safely used in or on specified
tled water at the site of bottling, using foods in accordance with the following
samples of the water intended for prescribed conditions:
treatment for the blank determination. (a) It is used or intended for use as
(d)(1) The amount of silver in the follows:
treated bottled water is determined (1) As a preservative and color fixa-
using the method for silver designated tive, with or without sodium nitrite, in
in 21 CFR 165.110(b)(4)(iii)(G)(2)(i). smoked, cured sablefish, smoked, cured
(2) The amount of hydrogen peroxide salmon, and smoked, cured shad, so
in the treated bottled water is deter- that the level of sodium nitrate does
mined using a Hydrogen Peroxide Test not exceed 500 parts per million and the
Kit from the HACH Co., or equivalent. level of sodium nitrite does not exceed
The manual from the Hydrogen Per- 200 parts per million in the finished
oxide Test Kit, Model HYP–1, Catalog product.
Number 22917–00, 1991, is incorporated (2) As a preservative and color fixa-
by reference. The Director of the Fed- tive, with or without sodium nitrite, in
eral Register approves this incorpora- meat-curing preparations for the home
tion by reference in accordance with 5 curing of meat and meat products (in-
U.S.C. 552(a) and 1 CFR part 51. You cluding poultry and wild game), with
may obtain copies of the test kit man- directions for use which limit the
ual from the HACH Co., P.O. Box 389, amount of sodium nitrate to not more
Loveland CO, 80359 (1–800–227–4224), than 500 parts per million in the fin-
Model HYP–1, Catalog Number 22917–00. ished meat product and the amount of
Copies may be examined at the Food sodium nitrite to not more than 200
and Drug Administration’s Main Li- parts per million in the finished meat
R brary, 10903 New Hampshire Ave., Bldg. product.
CF 2, Third Floor, Silver Spring, MD 20993, (b) To assure safe use of the additive,
with 301–796–2039, 301–436–2163, or at the Na- in addition to the other information re-
OD tional Archives and Records Adminis- quired by the Act:
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Food and Drug Administration, HHS §172.177
(1) The label of the additive or of a (ii) A statement of the concentration
mixture containing the additive shall of the additive in any mixture.
bear: (2) If in a retail package intended for
(i) The name of the additive. household use, the label and labeling of
(ii) A statement of the concentration the additive, or of a mixture con-
of the additive in any mixture. taining the additive, shall bear ade-
(2) If in a retail package intended for quate directions for use to provide a
household use, the label and labeling of final food product which complies with
the additive, or of a mixture con- the limitations prescribed in paragraph
taining the additive, shall bear ade- (a) of this section.
quate directions for use to provide a (3) If in a retail package intended for
final food product that complies with household use, the label of the addi-
the limitations prescribed in paragraph tive, or of a mixture containing the ad-
(a) of this section. ditive, shall bear the statement ‘‘Keep
(3) If in a retail package intended for out of the reach of children’’.
household use, the label of the additive
or of a mixture containing the addi- §172.177 Sodium nitrite used in proc-
tive, shall bear the statement ‘‘Keep essing smoked chub.
out of the reach of children’’. The food additive sodium nitrite may
be safely used in combination with salt
§172.175 Sodium nitrite. (NaCl) to aid in inhibiting the out-
The food additive sodium nitrite may growth and toxin formation from Clos-
be safely used in or on specified foods tridium botulinum type E in the com-
in accordance with the following pre- mercial processing of smoked chub in
scribed conditions: accordance with the following pre-
(a) It is used or intended for use as scribed conditions:
follows: (a) All fish in smoking establish-
(1) As a color fixative in smoked ments shall be clean and wholesome
cured tunafish products so that the and shall be expeditiously processed,
level of sodium nitrite does not exceed packed, and stored under adequate san-
10 parts per million (0.001 percent) in itary conditions in accordance with
the finished product. good manufacturing practice.
(2) As a preservative and color fixa- (b) The brining procedure is con-
tive, with or without sodium nitrate, trolled in such a manner that the
in smoked, cured sablefish, smoked, water phase portion of the edible por-
cured salmon, and smoked, cured shad tion of the finished smoked product has
so that the level of sodium nitrite does a salt (NaCl) content of not less than
not exceed 200 parts per million and the 3.5 percent, as measured in the loin
level of sodium nitrate does not exceed muscle, and the sodium nitrite content
500 parts per million in the finished of the edible portion of the finished
product. smoked product is not less than 100
(3) As a preservative and color fixa- parts per million and not greater than
tive, with sodium nitrate, in meat-cur- 200 parts per million, as measured in
ing preparations for the home curing of the loin muscle.
meat and meat products (including (c) Smoked chub shall be heated by a
poultry and wild game), with directions controlled heat process which provides
for use which limit the amount of so- a monitoring system positioned in as
dium nitrite to not more than 200 parts many strategic locations in the smoke-
per million in the finished meat prod- house as necessary to assure a contin-
uct, and the amount of sodium nitrate uous temperature throughout each fish
to not more than 500 parts per million of at least 160 °F for a minimum of 30
in the finished meat product. minutes.
(b) To assure safe use of the additive, (d) The finished product shall be
in addition to the other information re- cooled to a temperature of 50 °F or
quired by the Act: below within 3 hours after smoking and
R (1) The label of the additive or of a further cooled to a temperature of 38 °F
CF mixture containing the additive shall or below within 12 hours after smoking.
with bear: A temperature of 38 °F or below shall
OD (i) The name of the additive. be maintained during all subsequent
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