21 C.F.R. § 173.340
Current through September 30, 2024
Defoaming agents may be safely used in processing foods, in accordance with the following conditions:
| Substances | Limitations |
| Dimethylpolysiloxane (substantially free from hydrolyzable chloride and alkoxy groups; no more than 18 percent loss in weight after heating 4 hours at 200 °C; viscosity 300 to 1,050 centistokes at 25 °C; refractive index 1.400-1.404 at 25 °C) | 10 parts per million in food, or at such level in a concentrated food that when prepared as directed on the labels, the food in its ready-for-consumption state will have not more than 10 parts per million except as follows: Zero in milk; 110 parts per million in dry gelatin dessert mixes labeled for use whereby no more than 16 parts per million is present in the ready-to-serve dessert; 250 parts per million in salt labeled for cooking purposes, whereby no more than 10 parts per million is present in the cooked food. |
| Formaldehyde | As a preservative in defoaming agents containing dimethylpolysiloxane, in an amount not exceeding 1.0 percent of the dimethylpolysiloxane content. |
| [ALPHA]-Hydro-omega-hydroxy-poly (oxyethylene)/poly(oxypropylene) (minimum 15 moles)/poly(oxyethylene) block copolymer (CAS Reg. No. 9003-11-6) as defined in § 172.808(a)(3) of this chapter | For use as prescribed in § 172.808(b)(3) of this chapter. |
| Polyacrylic acid, sodium salt | As a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane in an amount reasonably required to accomplish the intended effect. |
| Polyethylene glycol | As defined in § 172.820 of this chapter. |
| Polyoxyethylene 40 monostearate | As defined in U.S.P. XVI. |
| Polysorbate 60 | As defined in § 172.836 of this chapter. |
| Polysorbate 65 | As defined in § 172.838 of this chapter. |
| Propylene glycol alginate | As defined in § 172.858 of this chapter. |
| Silicon dioxide | As defined in § 172.480 of this chapter. |
| Sorbitan monostearate | As defined in § 172.842 of this chapter. |
| White mineral oil: Conforming with § 172.878 of this chapter | As a component of defoaming agents for use in wash water for sliced potatoes at a level not to exceed 0.008 percent of the wash water. |
| Substances | Limitations |
| Aluminum stearate | As defined in § 172.863 of this chapter. |
| Butyl stearate | |
| BHA | As an antioxidant, not to exceed 0.1 percent by weight of defoamer. |
| BHT | Do. |
| Calcium stearate | As defined in § 172.863 of this chapter. |
| Fatty acids | As defined in § 172.860 of this chapter. |
| Formaldehyde | As a preservative. |
| Hydroxylated lecithin | As defined in § 172.814 of this chapter. |
| Isopropyl alcohol | |
| Magnesium stearate | As defined in § 172.863 of this chapter. |
| Mineral oil: Conforming with § 172.878 of this chapter | Not more than 150 p.p.m. in yeast, measured as hydrocarbons. |
| Odorless light petroleum hydrocarbons: Conforming with § 172.884 of this chapter | |
| Petrolatum: Conforming with § 172.880 of this chapter | |
| Petroleum wax: Conforming with § 172.886 of this chapter | |
| Petroleum wax, synthetic | |
| Polyethylene glycol (400)dioleate: Conforming with § 172.820(a)(2) of this chapter and providing the oleic acid used in the production of this substance complies with § 172.860 or § 172.862 of this chapter | As an emulsifier not to exceed 10 percent by weight of defoamer formulation. |
| Synthetic isoparaffinic petroleum hydrocarbons: Conforming with § 172.882 of this chapter | |
| Oleic acid derived from tall oil fatty acids | Complying with § 172.862 of this chapter. |
| Oxystearin | As defined in § 172.818 of this chapter. |
| Polyoxyethylene (600) dioleate | |
| Polyoxyethylene (600) monoricinoleate | |
| Polypropylene glycol | Molecular weight range, 1,200-3,000. |
| Polysorbate 80 | As defined in § 172.840 of this chapter. |
| Potassium stearate | As defined in § 172.863 of this chapter. |
| Propylene glycol mono- and diesters of fats and fatty acids | As defined in § 172.856 of this chapter. |
| Soybean oil fatty acids, hydroxylated | |
| Tallow, hydrogenated, oxidized or sulfated | |
| Tallow alcohol, hydrogenated |
| Substances | Limitations |
| n-Butoxypoly(oxyethylene)- poly(oxypropylene)glycol | Viscosity range, 4,850-5,350 Saybolt Universal Seconds (SUS) at 37.8 °C (100 °F). The viscosity range is deteRmined by the method "Viscosity DeteRmination of n-butoxypoly(oxyethylene)-poly(oxypropylene) glycol" dated April 26, 1995, developed by Union Carbide Corp., P.O. Box 670, Bound Brook, NJ 08805, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the material incorporated by reference are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, and 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: https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. |
| Monoester of alpha-hydro-omega-hydroxy-poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked copolymer derived from low erucic acid rapeseed oil |
21 C.F.R. §173.340