Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 3 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)
/ PART 173 - SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
/ Subpart D - Specific Usage Additives / § 173.340 Defoaming agents.
§ 173.340 Defoaming agents.
Defoaming agents may be safely used in processing foods, in accordance with the following conditions:
(a) They consist of one or more of the following:
(1) Substances generally recognized by qualified experts as safe in food or covered by prior sanctions for the use prescribed by this section.
(2) Substances listed in this paragraph (a)(2) of this section, subject to any limitations imposed:
| 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. |
| α-Hydro- | 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. |
(3) Substances listed in this paragraph (a)(3), provided they are components of defoaming agents limited to use in processing beet sugar and yeast, and subject to any limitations imposed:
| 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 |
(4) The substances listed in this paragraph (a)(4), provided they are components of defoaming agents limited to use in processing beet sugar only, and subject to the limitations imposed:
| Substances | Limitations |
|---|---|
| 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 | |
| Monoester of alpha-hydro-omega-hydroxy-poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked copolymer derived from low erucic acid rapeseed oil |
(b) They are added in an amount not in excess of that reasonably required to inhibit foaming.