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173.310 Boiler water additives.

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[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 173, Section 310


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