Boiler water additives may be safely used in the preparation of steam that will contact food, under the following conditions:

1. (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.
2. (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:

3. (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 propane sulfonic acid copolymer having a minimum weight average 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”	Total not to exceed 20 parts per million (active) in boiler feedwater.
   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-polypropylene glycol produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol	Minimum mol. wt. 1,500.
   Poly(acrylic acid-co-hypophosphite), sodium salt (CAS Reg. No. 71050-62-9), produced from a 4:1 to a 16:1 mixture by weight of acrylic acid and sodium hypophosphite	Total not to exceed 1.5 parts per million in boiler feed water. Copolymer contains not more than 0.5 percent by weight of acrylic acid monomer (dry weight basis).
   Polyethylene glycol	As defined in § 172.820 of this chapter.
   Polymaleic acid [CAS Reg. No. 26099-09-2], and/or its sodium salt. [CAS Reg. No. 30915-61-8 or CAS Reg. No. 70247-90-4]	Total not to exceed 1 part per million in boiler feed water (calculated as the acid).
   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 mixture consisting of sorbitan monostearate as defined in § 172.842 of this chapter; polysorbate 60 ((polyoxyethylene (20) sorbitan monostearate)) as defined in § 172.836 of this chapter; and polysorbate 20 ((polyoxyethylene (20) sorbitan monolaurate)), meeting the specifications of the Food Chemicals Codex, pp. 825-827.	The mixture is used as an anticorrosive agent in steam boiler distribution systems, with each component not to exceed 15 milligrams per kilogram in the steam.
   Tannin (including quebracho extract)
   Tetrasodium EDTA
   Tetrasodium pyrophosphate

4. (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.

5. (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. (1) The common or chemical name or names of the additive or additives.
   2. (2) Adequate directions for use to assure compliance with all the provisions of this section.

6. (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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. (1) Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday:

      1. (i) “Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS” (October 23, 1987).
      2. (ii) [Reserved]

   2. (2) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org):

      1. (i) Food Chemicals Codex, 7th ed.
      2. (2010) , pp. 1128-1129.
      3. (ii) Food Chemicals Codex, 7th ed.
      4. (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; 88 FR 17723, Mar. 24, 2023]