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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions
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Last updated July 2026

Listed below are the exemptions that have been issued under 21 CFR 170.39 Threshold of regulation for substances used in food-contact articles. Threshold of Regulation Exemptions are generally applicable and are effective for the food contact substance (FCS) for the listed intended use regardless of manufacturer or supplier. The list includes the name of the company that made the request, the chemical name of the substance, the specific use for which the substance received an exemption from regulation as a food additive, and any appropriate limitations on the substance's use. Questions pertaining to this list should be directed to the Office of Food Additive Safety (premarkt@fda.hhs.gov).

More about food contact substances.

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Records Found: 144 Show All Page 2 of 3
File
(sorted Z-A) 		Requestor Food Contact Substance Use Limitations*
2007-002 REPLACED BY TOR 2010-002 ________ ________
2007-001 Kraska Consultants, Inc.
  1. 1,2-Benzisothiazolin-3-one (BIT); (CAS Reg. No. 2634-33-5),
  2. 1,1,3-tris(5-tert-butyl-4-hydroxy-2-methylphenyl)butane; (CAS Reg. No.1843-03-4), and
  3. naphthalene sulfonic acid-formaldehyde condensate, sodium salt; CAS Reg. No. 9084-06-4).
 As components of an adhesive formulation when used as specified below: Substance A, a biocide preservative will be used according to its FIFRA registration as a product preservative in water based adhesive products. Substances B and C will be used as antioxidants in adhesives and will be used at levels not to exceed 1 percent of the adhesive. The adhesive shall be used at GMP levels (i.e., the minimum amount needed to accomplish the intended technical effect). Also, these substances are limited to use in formulations with modified butadiene /styrene copolymers.
2006-002 Cryovac Sealed Air Corp.
  1. Glycerol monooleate complying with 21 CFR 184.1323, as long as it is used at GMP levels (i.e., the minimum amount necessary to achieve the intended effect);
  2. Polyamide 6/66 complying with 177.1500(b) 4.2 and 177.1395; and,
  3. Polyamide 6/12 complying with 177.1500(b) 13.1 and 177.1395.
 Use as a lidding film to cover a polystyrene foam tray intended to be used in contact with ground beef during electron beam irradiation of the ground beef in a nitrogen atmosphere, at doses of 1.5 to 3.0 kGy. This exemption applies when these components are irradiated, incidental to the irradiation processing of prepackaged food, in a vacuum or in an oxygen-free environment at doses not exceeding 3.0 kGy
2006-001 General Electric Phenol, 4-methyl, reaction products with dicyclopentadiene and isobutylene (CAS Reg. No. 68610-51-5) As an antioxidant/stabilizer to inhibit thermo-oxidative degradation, in methyl methacrylate modified acrylonitrile/butadiene/styrene (ABS) polymers which are the subject of FCN 190 and acrylonitrile/styrene copolymers complying with 21 CFR 177.1040 and 21 CFR 181.32, at a maximum concentration of 1% by weight, and in contact with food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII under conditions of use C through G, as described in Table 2, 21 CFR 176.170(c).
2005-008 Omaha Steaks Co. A multilayer packaging film containing:
  1. The following substances as long as they meet the applicable use level limitations in §178.2010 or §178.3860 or an effective notification:
    1. 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene (CAS Reg. No. 1709-70-2).
    2. Erucamide (CAS Reg. No. 112-84-5)
  2. Zinc oxide as long as it is used at GMP levels (i.e. the minimum amount necessary to achieve the intended technical effect):
  3. An ionomeric resin, complying with §177.1330, as a component of the food contact layer of the laminate.
  4. Polybutylene, complying with §177.1570, as a component of the food contact layer of the laminate.
  5. An urethane adhesive, provided it complies with §175.105, as a component of the adhesive, non-food contact layer of the laminate.
 The packaging materials are to be used in contact with ground beef during irradiation of the vacuum packed and frozen ground beef at doses not to exceed 3.0 kiloGrays (kGy)
2005-007 Mitec Advanced Technology Polystyrene foam tray with a multi-layer food-contact coating. The coating may contain:
  1. The following substances as long as they meet the applicable use level limitations in §178.2010 or an effective notification:
    1. Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)methane] (CAS Reg. No. 6683-19-8).
    2. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3).
    3. Di-tert-butylphenyl phosphonite condensation product with biphenyl (CAS Reg. No. 119345-01-6).
    4. Tri(mixed mono- and di-nonylphenyl) phosphate (CAS Reg. No. 26523-78-4)
    5. Tris(2,4-di-tert-butyphenyl)phosphite (CAS Reg. No. 31570-04-4)
    6. Cyclic neopentanetetrayl bis(octadecyl phosphite) (CAS Reg. No. 3806-34-6)
  2. The following substances as long as they are used at GMP levels (i.e. the minimum amount necessary to achieve the intended technical effect).
    1. Butylated hydroxytoluene (BHT)
    2. Diatomaceous silica
  3. A blend of a styrene-butadiene thermoplastic elastomer and a styrene-butadiene copolymer, both complying with §177.1640, as components of the non-food contact layers of the laminate.
  4. An ethylene vinyl alcohol copolymer, complying with §177.1360, as a component of the non-food contact layers of the laminate.
 For use in contact with ground beef during electron beam irradiation of the ground beef in a nitrogen atmosphere, at doses not to exceed 3.0 kilograys (kGy).
2005-006 Ciba Specialty Chemical Corp. Sodium perchlorate monohydrate (CAS Reg. No. 7791-07-3) As a conductivity enhancer in the manufacture of antistatic agents for use in polymeric finished articles. The food contact substance may be used at a level not to exceed 1.2 percent by weight of the finished polymer. The finished article may be used in contact with Food Type VIII only.
2005-005 Keller and Heckman on behalf of Dyneon LLC Polytetrafluoroethylene micropowders For repeated use applications in contact with all food types under all conditions of use.
2005-004 Keller and Heckman on behalf of Koch Membrane Systems, Inc A blend of vinyl chloride/vinyl acetate resin, carbon black and isophorone, with maximum use levels of 30%, 20%, and 70%, respectively. As a black ink formulation to mark the outer membrane of a repeat-use food processing module at levels not to exceed 36 mg.
2005-003 Ciba Specialty Chemical Corp. Polyvinylpyrrolidone CAS Reg. No.9003-39-8 As a dispersing agent in colorants for all polymers intended for use as components of food-contact articles, at levels not to exceed 0.03 precent by weight of the polymer, and in contact with all food types.
2005-002 Schiff & Company on behalf of USR Optonix, Inc Zinc sulfide doped with manganese and copper Use of manganese at levels up to 0.5 % by weight; and use of copper at levels up to 1.0% by weight and manganese at levels up to 1% by weight as dopants in zinc sulfide pigments used at levels up to 10% by weight in plastic cups, plates and disposable cutlery destined for food-contact applications.
2005-001 Asahi Glass Fluoropolymers, Ltd Cupric oxide (Cu), copper powder, and aluminum oxide (Al2O3) As thermal stabilizers in the manufacture of ethylene tetrafluoroethylene (ETFE). The maximum use level of the cupric oxide, copper powder, and aluminum oxide (Al2O3) in the copolymer shall not exceed 55 ppm, 300 ppm, and 500 ppm, respectively.
2004-003 HP Polymers, Inc 1H,3H-benzo[1,2-c:4,5-c']difuran-1,3,5,7-tetrone, polymer with 5,5'-carbonylbis[1,3-isobenzofuranedione] and 1,3-diisocyanatomethylbenzene (CAS Reg. No. 134119-41-8) As a filler at a maximum use level of 20% by weight in polytetrafluoroethylene seals, bushings and bearings in food-processing equipment intended for repeated use provided the temperature does not exceed 100E C. In accordance with good manufacturing practice, those food-contact articles containing the subject additive should be thoroughly cleansed prior to their first use in contact with food.
2004-002 Huntsman Corp. C16 - C18 fatty alcohol reacted with approximately 16 moles of ethylene oxide (natural fatty alcohol) and diethylene glycol monobutyl ether As a production aid in the manufacture of latex rubber gloves for food contact use complying with 21 FR 177.2600.
2004-001 Interplastic Corp. 2,4-pentanedione (CAS Reg. No. 123-54-6) and N,N-dimethylacetoacetamide (CAS Reg. No. 2044-64-6) For use at maximum levels of 0.05 percent and 0.08 percent by weight, respectively, to assist the curing of thermosetting styrenated polyester resins complying with 21 CFR 177.2420 and intended for repeat use as articles or as components of articles used in contact with food, the finished resins must meet the extractive limitations in 21 CFR 177.2420(c) and must be thoroughly cleansed prior to their use with food as specified in 21 CFR 177.2420(d).
2003-001 Keller and Heckman A mixture of parafinic oil (CAS Reg. No. 64742-65-0) and sulfonated paraffinic oil (CAS Reg. No. 64742-20-7) As components of a grease lubricant with incidental food contact as specified in 21 CFR 178.3570 and at a maximum total use level of 13.2 percent by weight.
2000-003 Keller and Heckman on behalf of BASF Corporation An ethoxylated and propoxylated tallow fatty alcohol (CAS Reg. No. 68002-96-0) As a defoaming agent in the manufacture of uncoated paper and paperboard at levels not exceeding 0.1% by weight of dry pulp.
2000-002 HP Polymer, Inc. 1H,3H-benzo(1,2-c:4,5-c')difuran-1,3,5,7-tetrone, polymer with 5,5'-carbonylbis(1,3-isobenzofuranedione) and 1,3-diisocyanatomethylbenzene As a filler at a maximum use level of 20% by weight in polytetrafluoroethylene seals, bushings and bearings in food-processing equipment intended for repeated use provided the temperature does not exceed 120°F. In accordance with good manufacturing practice, those food-contact articles containing the subject additive should be thoroughly cleansed prior to their first use in contact with food.
2000-001 Keller and Heckman on behalf of KoSa Polyethylene terephthalate/isophthalate copolymers containing 94 weight percent of the polymer units derived from ethylene terephthalate. As a component of repeat use food-contact articles in contact with aqueous, acidic and low-alcohol foods (alcohol content not exceeding 15 %) at temperatures not exceeding 49°C.
1999-022 Keller and Heckman on behalf of Mitsui Chemicals Inc. A copolymer consisting of linear low density polyethylene complying with 21 CFR 177.1520(c), item 3.2, which has been subsequently grafted with 0.8% or less by weight of maleic anhydride. The intended use would involve the blending of the subject additive at levels up to 15 weight percent with other polyolefins complying with 21 CFR 177.1520 to form a polymeric film with a maximum thickness of 1 mil. The blended polymeric film would function either as the adhesive non food-contact inner-layer or as the heat seal food-contact layer in multilayered packaging that will be approximately 4 mils thick and used to hold processed meat during and after cooking.
1999-021 Environ on behalf of ICI Polyurethanes Three polymeric diphenyl-methane diisocyanate (PMDI) formulations consisting mainly of PMDI (CAS Reg. No. 9016-87-9) and 4,4'-methylenediphenyl diisocyanate (MDI)(CAS Reg. No. 101-68-8). The three PMDI formulations would contain up to 53% PMDI and 52% MDI. For use as strengthening agents at levels up to 1% by weight in paper and paperboard (coated and uncoated) in contact with aqueous food at temperatures that do not exceed 120°F.
1999-020 Keller and Heckman on behalf of Ferro Corporation Solvent Yellow 72 (CAS Reg. No. 4645-07-2) and Disperse Orange 47 (CAS Reg. No. 5718-26-3) Solvent Yellow 72 and Disperse Orange 47 as colorants at levels up to 0.39% and 0.30% by weight, respectively, in foamed polystyrene articles used in contact with all types of food, including meat, fish and poultry, under the following conditions: (1) Conditions of Use F and G; (Table 2, 21 CFR 176.170) and (2) Condition of Use E for storage times of one hour or less.
1999-019 Keller and Heckman C.I. Solvent Blue 36 (CAS Reg. No. 14233-37-5) As a colorant at levels up to 0.011 % by weight in foamed polystyrene articles used in contact with all types of food under refrigerated temperatures and below (Conditions of Use F and G; Table 2, 21 CFR 176.170).
1999-018 Keller and Heckman on behalf of ReedSpectrum Solvent Red 26 (CAS Reg. No. 4477-79-6) As a colorant at levels up to 0.2 % by weight in foamed polystyrene articles used in contact with all types of food, including meat and poultry, under refrigerated temperatures and below (Conditions of Use F and G; Table 2, 21 CFR 176.170).
1999-017 Technogenia Inc. An alloy consisting of tungsten carbide (68% by weight) and a matrix of nickel (11.2% or less by weight), chromium (11% or less by wt.), iron (3.6% or less by wt. ) boron(2% or less by wt.), silicon (3.5% or less by wt.) and trace amounts of carbon (0.6% or less by wt.) and cobalt (0.1% or less) For use in the manufacture of food -processing equipment.
1999-016 Schiff and Company Copper and copper cobalt Copper and copper cobalt, at levels up to 0.1% by weight, as dopants in zinc sulfide pigments used at levels up to 10% by weight in plastic cups, plates and disposable cutlery destined for food-contact applications.
1999-015 Elementis Performance Polymers 2-Ethyl-1,3-hexanediol (CAS Reg. No. 94-96-2) As the diol component of polyurethane adhesives used in the construction of reverse osmosis membranes for filtering water and aqueous-based liquid food provided the reverse osmosis membrane meets all applicable limitations in 21 CFR 177.2550 and the maximum temperature of use does not exceed 140°F.
1999-014 Tecknor Color Company Solvent Red 24 (CAS Reg. No. 85-83-6), Solvent Yellow 72 (CAS Reg. No. 4645-07-2) and Solvent Orange 60 (CAS Reg. No. 6925-69-5) Solvent Red 24, Solvent Yellow 72 and Solvent Orange 60 as colorants at levels up to 0.15%, 0.045% and 0.025% by weight, respectively, in foamed polystyrene articles used in contact with all types of food, including meat and poultry, under refrigerated temperatures and below (Conditions of Use F and G; Table 2, 21 CFR 176.170).
1999-013 CanTox Incorporated on behalf of Rohm Enzyme Finland Xylanases (hemicellulase enzyme preparations) manufactured by fermentation of genetically modified strains of Trichoderma Reesei As pre-bleaching agents for wood pulp used in the manufacture of food-contact paper provided the use level does not exceed 100 Birchwood Xylanase Units (BXU)/g pulp or 100 Thermo Xylanase Units (TXU)/g pulp. ( 1 BXU or 1 TXU = 1 nanokatal)
1999-012 Interplastic Corporation; Silmar Resins Division Potassium 2-ethylhexanoate (CAS Reg. No. 3164-85-0) and dodecyltrimethyl ammonium chloride (CAS Reg. No. 112-00-5) Potassium 2-ethylhexanoate and dodecyltrimethyl ammonium chloride, at maximum use levels of 0.075% and 0.03% by weight, respectively, in the manufacture of thermosetting styrenated polyester resins complying with 21 CFR 177.2420 and intended for use as articles or components of articles for repeated use in contact with food , provided the finished resins meet the extractive limitations in 21 CFR 177.2420(c) and the finished articles are thoroughly cleansed prior to their first use in contact with food in accordance with 21 CFR 177.2420(d).
1999-011 Lewis and Harrison (1) A mixture composed of bromochloro-5, 5-dimethyl-hydantoin (CAS Reg. No. 32718-18-6), dichloro-5,5-dimethylhydantoin (CAS Reg. No. 118-52-5) and dichloro-5-ethyl-5-methylhydantoin (CAS Reg. No. 89415-87-2). (2) A mixture composed of dichloro-5,5-dimethyl-hydantoin and dichloro-5-ethyl-5-methylhydantoin As slimicides in the manufacture of food-contact paper and paperboard at a maximum use level of 150 ppm expressed on a dry pulp weight basis.
1999-010 National Starch and Chemical Company Manganese(2+), bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-N1,N4,N7), tri-μ-oxodi-, bis[hexafluorophosphate(1-)] (CAS Reg. No. 116633-52-4) As a catalyst in the treatment of starch intended for use in the manufacture of paper and paperboard for food-contact applications at a maximum use level of 0.05 µg/in2 in the finished paper.
1999-009 Schunk Graphite Technology Molybdenum disulfide and phenol-formaldehyde resins complying with 21 CFR 177.2410 For use in the manufacture of carbon-graphite seals for food-processing equipment. The phenol-formaldehyde resins complying with 21 CFR 177.2410, which are used to impregnate the carbon graphite material, must be post-cured if the seals are intended to contact acid foods (pH < 5.0). (The use of phenol-formaldehyde resins, as components of carbon-graphite seals for food processing equipment, in contact with nonacid foods (pH > 5.0) would be covered by 21 CFR 177.2410.)
1999-008 Frederick Brewing Co. Diabase rocks (Blue Stone) For use in the manufacture of beer.
1999-007 Zeneca Biocides 2-Methyl-4,5-trimethylene-4-isothiazolin-3-one As a preservative at levels not exceeding 0.015% by weight in water-based adhesives complying with 21 CFR 175.105 for use at temperatures not exceeding 120°F.
1999-006 Keller and Heckman on behalf of Great Lakes Chemical Corporation Bromochloro-5,5-dimethylhydantoin
(equimolar mixture of 1-bromo-3-chloro-5,5-dimethylhydantoin, CAS Reg. No. 16079-88-2; 3-bromo-1-chloro-5,5-dimethylhydantoin, CAS Reg. No. 126-06-7; 1,3-dibromo-5,5-dimethylhydantoin, CAS Reg. No. 77-48-5; and 1,3-dichloro-5,5-dimethylhydantoin, CAS Reg. No. 118-52-5) 		As a slimicide in the manufacture of food-contact paper and paperboard at a maximum use level of 150 ppm on a dry pulp weight basis. As a slimicide in the manufacture of food-contact paper and paperboard at a maximum use level of 150 ppm by weight expressed on a dry solids basis (i.e., pulp, fillers and other materials found in the finished paper) provided the dimethylhydantoin hydrolysis product of the additive is not substantive to the pulp, fillers or any other additive remaining with the finished paper.
1999-005 S.I. Graham and Associates 3-Iodo-2-propynyl butyl carbamate As a biological growth control agent at a maximum use level of 1% by weight in pressure sensitive adhesive formulations complying with 21 CFR 175.125.
1999-004 Lewis and Harrison Consultants Tetrakis(hydroxymethyl)phosphonium sulfate (CAS Reg. No. 55566-30-8) At a maximum concentration of 500 ppm as a preservative for alkyl ketene dimer (AKD) emulsions applied to food-contact paper at the dry end of the paper machine.
1999-003 Keller and Heckman on behalf of FMC Corporation 1-Hydroxyethylidene-1,1-diphosphonic acid At levels not excceding 14 ppm (expressed on a dry pulp basis) as a stabilizer in antimicrobial agent formulations used in the manufacture of food-contact paper.
1999-002 Keller and Heckman on behalf of Solvay Interox Inc. 1-Hydroxyethylidene-1,1-diphosphonic acid (HEPA) and dipicolinic acid HEPA and dipicolinic acid at levels not excceding 7000 ppm and 300 ppm, respectively, (7.0 ppm and 0.3 ppm when expressed on a dry pulp basis) as stabilizers in antimicrobial agent formulations used in the manufacture of food-contact paper.
1999-001 Lewis and Harrison Consultants on behalf of Albright and Wilson Americas, Inc. Methylene bis(thiocyanate) and xanthan gum As components of an adhesive preservative. The adhesive will be used in packaging materials for dry foods only and the use level of the methylene bis thiocyanate and xanthan gum will not exceed 0.01% and 0.0004% by weight of the adhesive.
1998-026 Industrial Wear Reduction Systems Triisodecyl tridecyl trimellitic ester (CAS Reg. No. 70225-05-7) and trimethylol propane-trioleate ester of isostearic acid As components of lubricants applied to the wheels of overhead trolley-type conveyors found in meat and poultry plants, provided the level of use and frequency of application is limited to good manufacturing practice (i.e., the minimum level needed to accomplish the intended technical effect).
1998-025 John Crane, Inc. Neodymium fluoride, toluhydroquinone, 1-methoxy-2-propanol, and dicyclopentadiene As components of impregnated carbon-graphite composites intended for use in the manufacture of mechanical and shaft seals used in food processing equipment.
1998-024 Technology Sciences Group, Inc. on behalf of Wacker Silicones/Wacker Chemie GmbH. Hexamethyl disilazane-treated silica (CAS Reg. No. 68909-20-6) and hexamethyl - disilazane/divinyl tetramethyl-disilazane - treated silica (CAS Reg. No. 68988-89-6) As components of antifoam formulations used in the manufacture of the following food-contact articles (i.e., paper, adhesives, and polymer coatings destined for use on paper and metal substrates) provided the maximum use level does not exceed 0.005% by weight.
1998-023 Keller and Heckman on behalf of ReedSpectrum Pigment Red 202 (CAS Reg. No. 3089-17-6) As a colorant at levels up to 0.15 % by weight in polyethylene terephthlate articles, including dual-ovenable trays, used in contact with all types of food at baking temperatures and below.
1998-022 Keller and Heckman on behalf of ReedSpectrum Pigment Red 247 (CAS Reg. No. 43035-18-3) As a colorant at levels up to 1.3 % by weight in polyethylene terephthlate articles, including dual-ovenable trays, used in contact with all types of food at baking temperatures and below.
1998-021 Center For Regulatory Services Polyglycerol esters of fatty acids regulated in 21 CFR 172.854. As antifogging agents in polyolefin films complying with 21 CFR 177.1520 at a maximum use level of 0.152 mg/in2.
1998-020 Keller and Heckman on behalf of Hydranautics. Polyvinyl alcohol (PVA) crossed-linked with 1,3,5-benzenetricarbonyl trichloride and piperazine At a maximum use level of 16% by weight as a component of the barrier layer of reverse osmosis membranes complying with 21 CFR 177.2550.
1998-019 Paper Chemicals Inc. Oxirane, methyl-, polymer with oxirane, ether with (1,2-ethanediyldinitrilo)tetrakis(propanol) (CAS Reg. No. 11111-34-5) For use as a defoamer or as a component of a defoamer during the manufacture of food-contact paper products, provided its use level at the washing stage of the pulp does not exceed 0.5 lb/ton of pulp.
1998-018 S.I. Graham and Associates on behalf of FTI Inc. N,N'-ethylene-bis-12-hydroxystearamide (CAS Reg. No. 123-26-2) At a maximum use level of 0.35% by weight in lubricants intended for incidental food contact (21 CFR 178.3570).

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*For references to food types and conditions of use, see Food Types & Conditions of Use for Food Contact Substances

File
(sorted Z-A) 		Requestor Food Contact Substance Use Limitations*
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