21 C.F.R. § 178.3570 Lubricants with incidental food contact.
Title 21 - Food and Drugs
Lubricants with incidental food contact may be safely used on machinery used for producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The lubricants are prepared from one or more of the following substances: (1) Substances generally recognized as safe for use in food. (2) Substances used in accordance with the provisions of a prior sanction or approval. (3) Substances identified in this paragraph (a)(3). (b) The lubricants are used on food-processing equipment as a protective antirust film, as a release agent on gaskets or seals of tank closures, and as a lubricant for machine parts and equipment in locations in which there is exposure of the lubricated part to food. The amount used is the minimum required to accomplish the desired technical effect on the equipment, and the addition to food of any constituent identified in this section does not exceed the limitations prescribed. (c) Any substance employed in the production of the lubricants described in this section that is the subject of a regulation in parts 174, 175, 176, 177, 178 and §179.45 of this chapter conforms with any specification in such regulation. [42 FR 14609, Mar. 15, 1977] Editorial Note: For
Title 21: Food and Drugs
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
Subpart D—Certain Adjuvants and Production Aids
§ 178.3570 Lubricants with incidental food contact.
------------------------------------------------------------------------ Substances Limitations------------------------------------------------------------------------Aluminum stearoyl benzoyl hydroxide.... For use only as a thickening agent in mineral oil lubricants at a level not to exceed 10 pct by weight of the mineral oil.N,N-Bis(2-ethylhexyl)-ar-methyl-1H- For use as a copper deactivator benzotriazole-1-methanamine (CAS Reg. at a level not to exceed 0.1 No. 94270-86-7). percent by weight of the lubricant.BHA....................................BHT....................................α-Butyl-omega- Addition to food not to exceed hydroxypoly(oxyethylene) 10 parts per million. poly(oxypropylene) produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol; minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9038-95-3.α-Butyl-omega- Do. hydroxypoly(oxypropylene); minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9003-13- 8.Castor oil............................. Do.Castor oil, dehydrated................. Do.Castor oil, partially dehydrated....... Do.Dialkyldimethylammonium aluminum For use only as a gelling agent silicate (CAS Reg. No. 68953-58-2), in mineral oil lubricants at a which may contain up to 7 percent by level not to exceed 15 percent weight 1,6-hexanediol (CAS Reg. No. by weight of the mineral oil. 629-11-8), where the alkyl groups are derived from hydrogenated tallow fatty acids (C14-C18) and where the aluminum silicate is derived from bentonite.Dimethylpolysiloxane (viscosity greater Addition to food not to exceed than 300 centistokes). 1 part per million.Di (n-octyl) phosphite (CAS Reg. No. For use only as an extreme 1809-14-9). pressure-antiwear adjuvant at a level not to exceed 0.5 percent by weight of the lubricant.Disodium decanedioate (CAS Reg. No. For use only: 17265-14-4). 1. As a corrosion inhibitor or rust preventative in mineral oil-bentonite lubricants at a level not to exceed 2 percent by weight of the grease. 2. As a corrosion inhibitor or rust preventative only in greases at a level not to exceed 2 percent by weight of the grease.Disodium EDTA (CAS Reg. No. 139-33-3).. For use only as a chelating agent and sequestrant at a level not to exceed 0.06 percent by weight of lubricant at final use dilution.Ethoxylated resin phosphate ester For use only as a surfactant to mixture consisting of the following improve lubricity in compounds: lubricating fluids complying with this section at a level not to exceed 5 percent by weight of the lubricating fluid. 1. Poly(methylene-p-tert-butyl- phenoxy)poly-(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-tert-butylphenol with 2 to 4 moles of formaldehyde and subsequent ethoxylation with 4 to 12 moles of ethylene oxide;. 2. Poly(methylene-p-nonylphenoxy) poly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters (0 to 40 percent of the mixture). The resin is formed by condensation of 1 mole of p-nonylphenol with 2 to 4 moles of formaldehyde and subsequent ethoxylation with 4 to 12 moles of ethylene oxide; and. 3. n-Tridecyl alcohol mixture of dihydrogen phosphate and monohydrogen phosphate esters (40 to 80 percent of the mixture; CAS Reg. No. 56831-62-0).Fatty acids derived from animal or vegetable sources, and the hydrogenated forms of such fatty acids.2-(8-Heptadecenyl)-4,5-dihydro-1H- For use at levels not to exceed imidazole-1-ethanol (CAS Reg. No. 95- 0.5 percent by weight of the 38-5). lubricant.Hexamethylenebis(3,5-di-tert-butyl-4- For use as an antioxidant at hydroxyhydrocinnamate) (CAS Reg. No. levels not to exceed 0.5 35074-77-2). percent by weight of the lubricant.α-Hydro-omega-hydroxypoly Addition to food not to exceed (oxyethylene) poly(oxypropylene) 10 parts per million. produced by random condensation of mixtures of ethylene oxide and propylene oxide containing 25 to 75 percent by weight of ethylene oxide; minimum molecular weight 1,500; Chemical Abstracts Service Registry No. 9003-11-6.12-Hydroxystearic acid.................Isopropyl oleate....................... For use only as an adjuvant (to improve lubricity) in mineral oil lubricants.Magnesium ricinoleate.................. For use only as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil.Mineral oil............................ Addition to food not to exceed 10 parts per million.N-Methyl-N-(1-oxo-9- For use as a corrosion octadecenyl)glycine (CAS Reg. No. 110- inhibitor at levels not to 25-8). exceed 0.5 percent by weight of the lubricant.N-phenylbenzenamine, reaction products For use only as an antioxidant with 2,4,4-trimethylpentene (CAS Reg. at levels not to exceed 0.5 No. 68411-46-1). percent by weight of the lubricant.Petrolatum............................. Complying with § 178.3700. Addition to food not to exceed 10 parts per million.Phenyl-α-and/or phenyl-β- For use only, singly or in naphthylamine. combination, as antioxidant in mineral oil lubricants at a level not to exceed a total of 1 percent by weight of the mineral oil.Phosphoric acid, mono- and dihexyl For use only as an adjuvant at esters, compounds with levels not to exceed 0.5 tetramethylnonylamines and C11-14 percent by weight of the alkylamines. lubricant.Phosphoric acid, mono- and diisooctyl For use only as a corrosion esters, reacted with tert-alkyl and inhibitor or rust preventative (C12-C14) primary amines (CAS Reg. No. inlubricants at a level not to 68187-67-7). exceed 0.5 percent by weight of the lubricant.Phosphorothioic acid, O, O, O-triphenyl For use only as an extreme ester, tert-butyl derivatives (CAS pressure-antiwear adjuvant at Reg. No. 192268-65-8). a level not to exceed 0.5 percent by weight of the lubricant.Polyurea, having a nitrogen content of For use only as an adjuvant in 9-14 percent based on the dry polyurea mineral oil lubricants at a weight, produced by reacting tolylene level not to exceed 10 percent diisocyanate with tall oil fatty acid by weight of the mineral oil. (C16 and C18) amine and ethylene diamine in a 2:2:1 molar ratio.Polybutene (minimum average molecular Addition to food not to exceed weight 80,000). 10 parts per million.Polybutene, hydrogenated; complying Do. with the identity prescribed under § 178.3740.Polyethylene........................... Do.Polyisobutylene (average molecular For use only as a thickening weight 35,000-140,000 (Flory)). agent in mineral oil lubricants.Sodium nitrite......................... For use only as a rust preventive in mineral oil lubricants at a level not to exceed 3 percent by weight of the mineral oil.Tetrakis[methylene(3,5-di-tert-butyl-4- For use only as an antioxidant hydroxyhydro-cinnamate)]methane (CAS in lubricants at a level not Reg. No. 6683-19-8). to exceed 0.5 percent by weight of the lubricant.Thiodiethylenebis (3,5-di-tert-butyl-4- For use as an antioxidant at hydroxyhydrocinnamate) (CAS Reg. No. levels not to exceed 0.5 41484-35-9). percent by weight of the lubricant.Tri[2(or 4)-C9-10-branched For use only as an extreme alkylphenyl]phosphorothioate (CAS Reg. pressure-antiwear adjuvant at No. 126019-82-7). levels not to exceed 0.5 percent by weight of the lubricant.Triphenyl phosphorothionate (CAS Reg. For use as an adjuvant in No. 597-82-0). lubricants herein listed at a level not to exceed 0.5 percent by weight of the lubricant.Tris(2,4-di-tert-butylphenyl)phosphite For use only as a stabilizer at (CAS Reg. NO. 31570-04-4). levels not to exceed 0.5 percent by weight of the lubricant.Thiodiethylenebis(3,5-di-tert-butyl-4- For use as an antioxidant at hydroxy-hydro- cinnamate) (CAS Reg. levels not to exceed 0.5 No. 41484-35-9). percent by weight of the lubricant.Zinc sulfide........................... For use at levels not to exceed 10 percent by weight of the lubricant.------------------------------------------------------------------------
