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''.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...................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 C;
by the ``Viscosity of Cellulose
Gum'' method prescribed in the
Food Chemicals Codex, pp. 1128-
1129.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 milligrams per kilogram in the
(20) sorbitan monostearate)) as steam.
defined in Sec. 172.836 of this
chapter; and polysorbate 20
((polyoxyethylene (20) sorbitan
monolaurate)), meeting the
specifications of the Food
Chemicals Codex, pp. 825-827..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.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.
(f) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/cfr/ibr-locations.html.
(1) FDA Main Library, 10903 New Hampshire Ave., Silver Spring, MD 20993:
(i) ``Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS'' (October 23, 1987).
(ii) [Reserved]
(2) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org):
(i) Food Chemicals Codex, 7th ed. (2010), pp. 1128-1129.
(ii) Food Chemicals Codex, 7th ed. (2010), pp. 825-827. [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; 78 FR 71466, Nov. 29, 2013]