[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.310]
[Page 138-140]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 173_SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN
CONSUMPTION--Table of Contents
Subpart D_Specific Usage Additives
Sec. 173.310 Boiler water additives.
Boiler water additives may be safely used in the preparation of
steam that will contact food, under the following conditions:
(a) The amount of additive is not in excess of that required for its
functional purpose, and the amount of steam in contact with food does
not exceed that required to produce the intended effect in or on the
food.
(b) The compounds are prepared from substances identified in
paragraphs (c) and (d) of this section, and are subject to the
limitations, if any, prescribed:
(c) List of substances:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Acrylamide-sodium acrylate resin... Contains not more than 0.05 percent
by weight of acrylamide monomer.
Acrylic acid/2-acrylamido-2-methyl Total not to exceed 20 parts per
propane sulfonic acid copolymer million (active) in boiler
having a minimum weight average feedwater.
molecular weight of 9,900 and a
minimum number average molecular
weight of 5,700 as determined by a
method entitled ``Determination of
Weight Average and Number Average
Molecular Weight of 60/40 AA/
AMPS'' (October 23, 1987), which
is incorporated by reference in
accordance with 5 U.S.C. 552(a).
Copies may be obtained from the
Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or
may be examined at the National
Archives and Records
Administration (NARA). For
information on the availability of
this material at NARA, call 202-
741-6030, or go to: http://
www.archives.gov/federal--register/
code--of--federal--regulations/
ibr--locations.html..
Ammonium alginate..................
Cobalt sulfate (as catalyst).......
1-hydroxyethylidene-1,1-
diphosphonic acid (CAS Reg. No.
2809-21-4) and its sodium and
potassium salts.
Lignosulfonic acid.................
Monobutyl ethers of polyethylene- Minimum mol. wt. 1,500.
polypropylene glycol produced by
random condensation of a 1:1
mixture by weight of ethylene
oxide and propylene oxide with
butanol.
Poly(acrylic acid-co- Total not to exceed 1.5 parts per
hypophosphite), sodium salt (CAS million in boiler feed water.
Reg. No. 71050-62-9), produced Copolymer contains not more than
from a 4:1 to a 16:1 mixture by 0.5 percent by weight of acrylic
weight of acrylic acid and sodium acid monomer (dry weight basis).
hypophosphite.
Polyethylene glycol................ As defined in Sec. 172.820 of
this chapter.
Polymaleic acid [CAS Reg. No. 26099- Total not to exceed 1 part per
09-2], and/or its sodium salt. million in boiler feed water
[CAS Reg. No. 30915-61-8 or CAS (calculated as the acid).
Reg. No. 70247-90-4].
Polyoxypropylene glycol............ Minimum mol. wt. 1,000.
Potassium carbonate................
Potassium tripolyphosphate.........
Sodium acetate.....................
Sodium alginate....................
Sodium aluminate...................
Sodium carbonate...................
[[Page 139]]
Sodium carboxymethylcellulose...... Contains not less than 95 percent
sodium carboxymethylcellulose on a
dry-weight basis, with maximum
substitution of 0.9
carboxymethylcellulose groups per
anhydroglucose unit, and with a
minimum viscosity of 15
centipoises for 2 percent by
weight aqueous solution at 25
[deg]C; by the method prescribed
in the ``Food Chemicals Codex,''
4th ed. (1996), pp. 744-745, which
is incorporated by reference in
accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are
available from the National
Academy Press, Box 285, 2101
Constitution Ave. NW., Washington,
DC 20055 (Internet address http://
www.nap.edu), or may be examined
at the Center for Food Safety and
Applied Nutrition's Library, Food
and Drug Administration, 5100
Paint Branch Pkwy., College Park,
MD 20740, or at the National
Archives and Records
Administration (NARA). For
information on the availability of
this material at NARA, call 202-
741-6030, or go to: http://
www.archives.gov/federal--register/
code--of--federal--regulations/
ibr--locations.html.
Sodium glucoheptonate.............. Less than 1 part per million
cyanide in the sodium
glucoheptonate.
Sodium hexametaphosphate...........
Sodium humate......................
Sodium hydroxide...................
Sodium lignosulfonate..............
Sodium metabisulfite...............
Sodium metasilicate................
Sodium nitrate.....................
Sodium phosphate (mono-, di-, tri-)
Sodium polyacrylate................
Sodium polymethacrylate............
Sodium silicate....................
Sodium sulfate.....................
Sodium sulfite (neutral or
alkaline).
Sodium tripolyphosphate............
Sorbitol anhydride esters: a The mixture is used as an
mixture consisting of sorbitan anticorrosive agent in steam
monostearate as defined in Sec. boiler distribution systems, with
172.842 of this chapter; each component not to exceed 15
polysorbate 60 ((polyoxyethylene parts per million in the steam.
(20) sorbitan monostearate)) as
defined in Sec. 172.836 of this
chapter; and polysorbate 20
((polyoxyethylene (20) sorbitan
monolaurate)), meeting the
specifications of the Food
Chemicals Codex, 4th ed. (1996),
pp. 306-307, which is incorporated
by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the
National Academy Press, 2101
Constitution Ave. NW., Box 285,
Washington, DC 20055 (Internet
http://www.nap.edu), or may be
examined at the Center for Food
Safety and Applied Nutrition's
Library, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or
at the National Archives and
Records Administration (NARA). For
information on the availability of
this material at NARA, call 202-
741-6030, or go to: http://
www.archives.gov/federal--register/
code--of--federal--regulations/
ibr--locations.html..
Tannin (including quebracho
extract).
Tetrasodium EDTA...................
Tetrasodium pyrophosphate..........
------------------------------------------------------------------------
(d) Substances used alone or in combination with substances in
paragraph (c) of this section:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Cyclohexylamine......................... Not to exceed 10 parts per
million in steam, and
excluding use of such steam
in contact with milk and milk
products.
Diethylaminoethanol..................... Not to exceed 15 parts per
million in steam, and
excluding use of such steam
in contact with milk and milk
products.
Hydrazine............................... Zero in steam.
Morpholine.............................. Not to exceed 10 parts per
million in steam, and
excluding use of such steam
in contact with milk and milk
products.
[[Page 140]]
Octadecylamine.......................... Not to exceed 3 parts per
million in steam, and
excluding use of such steam
in contact with milk and milk
products.
Trisodium nitrilotriacetate............. Not to exceed 5 parts per
million in boiler feedwater;
not to be used where steam
will be in contact with milk
and milk products.
------------------------------------------------------------------------
(e) To assure safe use of the additive, in addition to the other
information required by the Act, the label or labeling shall bear:
(1) The common or chemical name or names of the additive or
additives.
(2) Adequate directions for use to assure compliance with all the
provisions of this section.
[42 FR 14526, Mar. 15, 1977, as amended at 45 FR 73922, Nov. 7, 1980; 45
FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. 15,
1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 53 FR
15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2,
1990; 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, 1999; 64 FR 29227,
June 1, 1999]
Additives that reference this regulation: - 1-HYDROXYETHYLIDENE-1,1-DIPHOSPHONIC ACID
- ACRYLAMIDE-SODIUM ACRYLATE RESIN
- ACRYLIC ACID-2-ACRYLAMIDO-2-METHYL PROPANE SULFONIC ACID COPOLYMER
- ALGINATE, AMMONIUM
- ALGINATE, SODIUM
- ALPHA-BUTYL-OMEGA-HYDROXYPOLY(OXYETHYLENE) POLY(OXYPROPYLENE)
- CARBOXYMETHYL CELLULOSE, SODIUM SALT
- COBALT SULFATE--PROHIBITED
- CYCLOHEXYLAMINE
- DIETHYLAMINOETHANOL
- EDTA, TETRASODIUM
- HYDRAZINE
- LIGNIN SODIUM SULFONATE
- LIGNOSULFONIC ACID
- MORPHOLINE
- OCTADECYLAMINE
- POLY(ACRYLIC ACID-CO-HYPOPHOSPHITE), SODIUM SALT
- POLY(MALEIC ANHYDRIDE), SODIUM SALT
- POLYACRYLIC ACID, SODIUM SALT
- POLYETHYLENE GLYCOL (M W 200-9,500)
- POLYMALEIC ACID
- POLYMALEIC ACID, SODIUM SALT
- POLYPROPYLENE GLYCOL (M W 1,200-3,000)
- POLYSORBATE 20
- POLYSORBATE 60
- POTASSIUM CARBONATE
- POTASSIUM TRIPOLYPHOSPHATE
- QUEBRACHO BARK EXTRACT
- SODIUM ACETATE
- SODIUM ALUMINATE
- SODIUM BISULFITE
- SODIUM CARBONATE
- SODIUM GLUCOHEPTONATE
- SODIUM HEXAMETAPHOSPHATE
- SODIUM HUMATE
- SODIUM HYDROXIDE
- SODIUM METABISULFITE
- SODIUM METAPHOSPHATE
- SODIUM METASILICATE
- SODIUM NITRATE
- SODIUM PHOSPHATE, DIBASIC
- SODIUM PHOSPHATE, MONOBASIC
- SODIUM PHOSPHATE, TRIBASIC
- SODIUM POLYMETHACRYLATE
- SODIUM PYROPHOSPHATE
- SODIUM SILICATE
- SODIUM SULFATE
- SODIUM SULFITE
- SODIUM TRIPOLYPHOSPHATE
- SORBITAN MONOSTEARATE
- TANNIC ACID
- TRISODIUM NITRILOTRIACETATE
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