Food
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Threshold of Regulation Exemptions
October 2000; Updated April 2012
Listed below are the exemptions that have been issued under 21 CFR 170.39 Threshold of regulation for substances used in food-contact articles. 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).
| File | Company | Chemicals | Use Limitations |
|---|---|---|---|
| 96-001 | Hogan and Hartson on behalf of Gycor International Limited. | Tetrasodium ethylenediamine tetraacetate (tetrasodium EDTA) (Chemical Abstract Service Registry Number 64-02-8) | As a chelator in place of disodium EDTA in a sanitizing solution codified in § 178.1010(b)(44) and (c)(38) (Final rule: 60 FR 18739) provided its "at use" concentration in the sanitizer does not exceed 1400 ppm and the use of the sanitizer is restricted to clean-in-place food-processing equipment and utensils including its use on dairy-processing equipment. Exemption does not include the use in public eating establishments. |
| 96-002 | Morgan, Lewis and Bockius on behalf of Chesapeake Paper Products, Inc. | C.I. solvent blue 129 (CAS Reg. No. 68155-92-0), C.I. solvent yellow 143 (CAS Reg. No. 68239-62-3), 1-propanol, and silanol (CAS Reg.No. 70131-67-8) | As components of ink formulations used to mark pulp bale wrappers that will subsequently be repulped and used in the manufacture of food-contact paper provided the maximum use levels in the ink formulations do not exceed 3% by weight in the case of the C.I. solvent blue 129 and 1-propanol components and 1% by weight for the C.I. solvent yellow 143 and silanol components. |
| 96-003 | Selective Services, Ltd. | Di(2-ethylhexyl)sebacate (CAS Reg. No. 122-62-3) | As a component of oil-based lubricants at levels up to 5% by weight. The exemption would be limited to use in lubricants with only incidental contact with food in accordance with 21 CFR 178.3570. |
| 96-004 | Zeneca Biocides | Poly(hexamethylenebiguanide) hydrochloride (CAS Reg. No. 32289-58-0) | As an antimicrobial agent at levels up to 1000 ppm (0.1% by weight) in water-based latex adhesives complying with 21 CFR 175.105 for use at temperatures that do not exceed 120o F. |
| 96-005 | S.C. Johnson and Son, Inc. | Acrylic polymers consisting of methacrylic acid, methyl methacrylate, and 2-ethylhexyl acrylate in which the methacrylic acid is present at levels not exceeding 9% by weight and the 2-ethylhexyl acrylate and methyl methacrylate are present at no less than 50% by weight of the finished polymer in accordance with 21 CFR 177.1010 | As a moisture barrier coating of paper in contact with aqueous or fatty food at temperatures at or below 120oF provided the finished paper meets the applicable extractives limitations of 21 CFR 176.170. |
| 96-006 | Ciba - Geigy Corp. | Bis(2,4-di-tert-butyl - 6-methyl phenyl)ethyl phosphite (CAS Reg. No. 145650-60-8) | For use as a processing stabilizer at levels up to 0.2% by weight in polypropylene destined to contact aqueous, acidic and low alcohol food (8% or less) at temperatures at or below 212o F. |
| 96-007 | Center for Regulatory Services on behalf of Riken Vitamin Company Ltd., of Japan. | Polyglycerol esters of fatty acids regulated in 21 CFR 172.854 | As an adjuvant (e.g., antifogging agent, antistatic agent) in polypropylene films regulated in 21 CFR 177.1520 and having a maximum thickness of 100 um in contact with all types of food under Conditions of Use A through H (Table 2, 21 CFR 176.170). |
| 96-008 | Dover Chemical Corp. | Bis(2,4-dicumylphenyl) pentaerythritol diphosphite) (CAS Reg. No. 154862-43-8) | As an antioxidant/stabilizer at levels not exceeding 0.1% by weight in polypropylene polymers and copolymers complying with 21 CFR 177.1520 destined to contact aqueous, acidic and low alcohol foods (15% or less) under Condition of Use C (hot filled or pasteurized above 150oF)(Table 2, 21 CFR 176.170). This exemption would cover both single-service and repeat-use applications. |
| 96-009 | TAS Inc., on behalf of Johnson Matthey Chemicals | Silver chloride-coated titanium dioxide | As a component of preservative formulations for latex emulsions destined for use in the manufacture of repeat-use rubber articles regulated in 21 CFR 177.2600 provided the levels of silver chloride added to the latex emulsions do not exceed 10 ppm. |
| 97-001 | Chemtest Laboratories Inc., on behalf of Sunkyong Industries | Trimellitic anhydride | As a crosslinking agent at a use level of 0.04% by weight in the manufacture of polyethylene terephthalate/isophthalate copolymers containing 67.7 weight percent terephthalic acid, 2.7 weight percent isophthalic acid and 29.7 weight percent ethylene glycol destined for use in contact with all types of food at room temperature (120o F) or below. |
| 97-002 | Keller and Heckman on behalf of Reedspectrum | 2,4-dihydro-4-((2-methoxy phenyl)azo)-5-methyl-2- phenyl- 3H-pyrazol-3-one (CAS Reg. No. 4645-07-2) | As a colorant at levels up to 0.0228% by weight in foamed polystyrene used to package all types of food, including meat and poultry, at refrigerated temperatures or below (Conditions of Use F and G, Table 2, 21 CFR 176.170). |
| 97-003 | Texapol Corp. | Melamine (CAS Reg. No. 108-78-1) and triphenyl phosphine (CAS Reg. No. 603-35-0) | Melamine at a use level of 0.2% by weight and triphenylphosphine at a use level of 0.05% by weight as stabilizers in polyoxymethylene copolymers regulated in 21 CFR 177.2470 destined for use in the manufacture of repeat-use articles that may contact food. |
| 97-004 | Dow Chemical | An ion exchange resin manufactured by the reaction of divinyl benzene, methyl acrylate and butyl acrylate followed by complete hydrolysis of the methyl and butyl ester side chains (CAS Reg. No. 9052-45-3) | For repeated-use food-contact applications involving potable water and aqueous, acidic and alcoholic foods at temperatures of 82oC (180oF) or below. The resin must be prewashed in accordance with good manufacturing practice and meet all applicable specifications in 21 CFR 173.25(c). |
| 97-005 | National Starch and Chemical Co. | 3-Chloro-2 - sulfopropionic acid-treated starch | For use at levels up to 1.5% by weight in paper towels and napkins destined for single service food-contact applications at temperatures not to exceed 212o F. |
| 97-006 | Champion International Corporation | Pulp containing benzenesulfonic acid, 2,2'-(1,2-ethanediyl)bis (5-(4-(bis(2-hydroxyethyl) amino)-6-((4-sulfophenyl)amino)-1,3,5- triazine-2-yl)amino)-, tetrasodium salt, CAS Reg. No. 16470-24-9 | Pulp containing up to 20 ppb of benzenesulfonic acid, 2,2'-(1,2- ethanediyl)bis (5-(4-(bis(2-hydroxyethyl)amino)- 6-((4-sulfophenyl) amino)-1,3,5- triazine-2-yl)amino)-, tetrasodium salt, used in the manufacture of food-contact paper products. |
| 97-007 | Betz Laboratories | Sodium molybdate | For use at an equilibrium concentration of 2 ppm in boiler water used to produce steam destined to cook food. |
| 97-008 | Carter, Ledyard and Milburn on behalf of Sweetheart Cup Co. | Acetone | As a blowing agent at levels up to 1.1% by weight in the manufacture of polystyrene food-contact articles. |
| 97-009 | ACC Consulting Group, Inc., on behalf of Adhesives Research Inc. | Acrylic copolymers (consisting of isooctyl acrylate (CAS Reg. No. 29590-42-9), ethoxylated hydroxyethyl methacrylate (CAS Reg. No. 25736-86-1) and monomers regulated in 21 CFR 177.1010 (a)(1), (2) and (3)) and D&C Green No. 5 (CAS Reg. No. 4403-90-1) | As adhesive components in pressure-sensitive tape for use in splicing paper that will subsequently be repulped and used in the manufacture of food-contact paper complying with 21 CFR 176.170. The isooctyl acrylate and ethoxylatedhydroxyethyl methacrylate monomers must not make up more than 25% and 30% by weight, respectively, of the acrylic copolymer units and at least 50% by weight of the finished acrylic acid copolymer units must be derived from one or more of the following monomers (isooctyl acrylate, ethoxylated hydroxyethyl methacrylate, and the monomers listed in 21 CFR 177.1010 (a)(1)). The use level of the D&C Green No. 5 must not exceed 500 ppm in the dry adhesive. |
| 97-010 | Courtaulds Coatings. Ltd | Aromatic petroleum resins (CAS Reg. No. 71302-83-5) manufactured from indene, α-methylstyrene and vinyl toluene. | As a component of coatings complying with 21 CFR 175.300 for contact with dry food provided the level of the resin in the cured coatings does not exceed 1.5% by weight. |
| 97-011 | Keller and Heckman on behalf of DuPont Dow Elastomers | 4,4'-(Hexafluoroisopropylidene) - diphenol (bisphenol AF) (CAS Reg. No. 1478-61-1) and benzyltriphenylphosphonium bisphenol AF salt (CAS Reg. No. 75768-65-9) | Bisphenol AF at a use level of 2% by weight and benzyltriphenyl phosphonium bisphenol AF salt at a use level of 1.9% by weight as vulcanization agents in the manufacture of vinyl fluoride-hexa - fluoropropylene and vinyl fluoride-hexa - fluoropropylene - tetrafluoroethylene copolymers regulated in 21 CFR 177.2600 destined for use in the manufacture of repeat-use rubber articles that may contact all types of food at temperatures up to 250oF |
| 97-012 | Inter - American Nexus, Inc. | Dimethylpolysiloxane (CAS Reg. No. 9016-00-6), polyethylene glycol monostearate (CAS Reg. No. 9004-99-3) and xanthan gum (CAS Reg. No. 11138-66-2) | Dimethylpolysiloxane, polyethylene glycol monostearate and xanthan gum at maximum use levels of 24%, 3% and 0.08% by weight, respectively, as components of release coatings for metal substrates that are reapplied as frequently as every eight hours and are used in oven baking of large quantities of food. |
| 97-013 | Washington Trading Company, Inc. | Benzyl alcohol, isobutyl alcohol, amyl alcohol and benzyl acetate | Benzyl alcohol, isobutyl alcohol, amyl alcohol and benzyl acetate at maximum use levels of 1.9%, 1.7 %, 4.5% and 0.1% by weight, respectively, as components of lubricants for incidental food contact complying with 21 CFR 178.3570. |
| 97-014 | Withdrawn | ----------------- | -------------------- |
| 97-015 | NA Industries, Inc. | Copolymer of methyl methacrylate (90% by weight) and trimethylolpropane trimethacrylate (10% by weight) | As an antiblocking agent at a maximum use level of 1% by weight in thin polypropylene films (i.e., a maximum thickness of 4 mils ) destined for use in contact with all types of food under Conditions of Use A through H (Table 2, 21 CFR 176.170). |
| 97-016 | Keller and Heckman on behalf of Hydranautics | Polyvinyl alcohol crosslinked with 1,3,5-benzenetricarbonyl trichloride and 1,3-benzenediamine | 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. |
| 97-017 | Lifelast, Inc. | Methylene-bis - cyclohexamine (CAS Reg. No. 1761-71-3) and sucrose amine polyether polyol (CAS Reg. No. 25214-63-5) | Methylene-bis - cyclohexamine and sucrose amine polyether polyol as components of polyurethane coatings at maximum use levels of 1.15% and 3.75% by weight, respectively. The polyurethane coatings would be limited to repeat-use applications involving dry food at room temperature (120o F or below). |
| 97-018 | McDermott, Will and Emery | Phenol red (CAS Reg. No. 143-74-8), cresol red (CAS Reg. No. 1733-12-6) and m-cresol purple (CAS Reg. No. 2303-01-7) | Phenol red, cresol red, and m-cresol purple, either alone or as a mixture at a maximum level of 2 ug, as components of "freshness sensor" labels that would contact meat, fish, and poultry as well as juice and dairy beverages at refrigerated temperatures. Before use, the backing would be removed and the label applied to food packaging composed of either polyvinyl chloride (PVC) or linear low density polyethylene (LDPE). Therefore, under the intended use conditions, the dye would always be separated from food by PVC or LDPE. |
| 98-001 | Keller and Heckman on behalf of Tioxide Group PLC. | N-Octylphosphonic acid-modified titanium dioxide | As a colorant at levels not exceeding 5% by weight in polymers contacting all types of food under Condition of Use C, Table 2, 21 CFR 176.170 (hot filled or pasteurized above 150o F) or less severe conditions. |
| 98-002 | Nutra Sweet Kelco Company | Gellan gum | For use as a sizing agent or as a component of coatings for paper and paperboard destined to contact all types of food provided: (1) The gellan gum meets the specifications in paragraphs (a) through (d) in 21 CFR 172.665; (2) its use levels are restricted to GMP levels; and (3) the finished paper products meet applicable extractive limitations in 21 CFR 176.170. |
| 98-003 | BetzDearborn Inc. | Sodium molybdate | As a tracer, at an equilibrium concentration of 5 ppm for molybdate ion, in boiler water used to produce steam destined to cook food. |
| 98-004 | Englehard Corp. | Tin Oxide | At a maximum level of 1.1% by weight in colorants composed of mica and titanium dioxide, provided the maximum loading rate for the colorant in the food-contact article does not exceed 3% by weight for polymers, 5% for paper and paperboard, 15% for coatings or 30% for ink formulations. |
| 98-005 | Keller and Heckman | Polyglycerol esters of fatty acids regulated in 21 CFR 172.854 | As antifogging agents in all types of films at a maximum use level of 0.14 mg/in2. |
| 98-006 | Keller and Heckman on behalf of ReedSpectrum | C.I. Pigment Red 187 (CAS Reg. No. 59487-23-9) | As a colorant at levels up to 0.18 % by weight in polyethylene terephthlate articles, including dual-ovenable trays, used in contact with all types of food under Conditions of Use A through H (Table 2, 21 CFR 176.170). |
| 98-007 | Keller and Heckman on behalf of ReedSpectrum | C.I. Pigment Red 254 (CAS Reg. No. 84632-65-5) | As a colorant at levels up to 0.70 % by weight in polyethylene terephthlate articles, ncluding dual-ovenable trays, used in contact with all types of food under Conditions of Use A through H (Table 2, 21 CFR 176.170). |
| 98-008 | Keller and Heckman on behalf of ReedSpectrum | C.I. Solvent Red 23 (CAS Reg. No. 85-86-9) | As a colorant at levels up to 0.055 % by weight in foam 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). |
| 98-009 | Center For Regulatory Services on behalf of Unitika Composite Films Ltd. | Polyoxypropylene ethers of 4,4'- isopropylidene diphenol (CAS Reg. No. 37353-75-6) | As a component of adhesive formulations, at a maximum use level of 0.03% by weight in composite films complying with §177.1390 and §177.1395, provided the adhesive is separated from food by a polyolefin layer with a thickness not less than 1.6 mils. |
| 98-010 | Keller and Heckman on behalf of Englehard Corp. | C.I. Pigment Green 50 (CAS Reg. No. 68186-85-6), C.I. Pigment Yellow 53 (CAS Reg. No. 8007-18-9), and C.I. Pigment Brown 24 (CAS Reg. No. 68186-90-3) | As colorants at levels up to 2% by weight in all types of food-contact polymers. |
| 98-011 | National Starch and Chemical Co. | Industrial starch-modified (i.e., starch manufactured with up to 5% 2,3-epoxypropyltrimethyl - ammonium chloride in accordance with 21 CFR 178.3520 and further modified with up to 4.5% glycidoxypropyl- trimethoxysilane. | For use in the manufacture of : (1) Paper towels and napkins destined for single service food-contact applications at temperatures not to exceed 212o F; and (2) Paper/paperboard containers destined to hold food at room temperature (120o F) or below, provided the level of the modified starch in the paper products does not exceed 1% by weight and the finished paper products meet applicable extractive limitations in 21 CFR 176.170. |
| 98-012 | AntiSeize Technology | Zeeospheres (CAS Reg.No. 66402-68-4) | At maximum levels up to 40% by weight in anti-seize lubricants intended for incidental food contact. |
| 98-013 | Carpenter Advanced Ceramics, Inc. | Hafnium and strontium oxides | Hafnium and strontium oxides, at levels up to 3% and 0.5% by weight, respectively, in zirconium-based ceramics used as components of food-processing equipment |
| 98-014 | Keller and Heckman on behalf of ReedSpectrum | C.I. Solvent Orange 60 (CAS Reg. No. 6925-69-5) | As a colorant at levels up to 0.015 % by weight in foam 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). |
| 98-015 | Keller and Heckman on behalf of NOVA Chemical Inc. | 1-hydroxy-4-((4 - methylphenyl)amino) - 9,10-anthracenedione (CAS Reg. No. 81-48-1). | At levels not to exceed 0.2 ppm in polystyrene food-contact articles. |
| 98-016 | TAS-Environ on behalf of ICI Polyurethanes | A mixture of polymeric diphenylmethane diisocyanate (PMDI; CAS Reg. No. 9016-87-9) and modified PMDI (PMDI modified with either methoxypolyethylene glycol (PMDI/MPG; CAS Reg. No. 70644-56-3) or ethoxylated, propoxylated ethylenediamine (PMDI/EDA/EO/PO, CAS Reg. No. 68403-89-4)) | As a dry-strength agent in paper and paperboard intended to contact dry foods only, provided the concentration does not exceed 5 percent by weight of the dry paper and paperboard and the temperature does not exceed 120o F). |
| 98-017 | Keller and Heckman on behalf of Engelhard Corporation | The strontium salts of the azo coupling reaction products formed between either: (1) 6-hydroxy - naphthalene - 2-sulfonic acid (CAS Reg. No. 93-01-6) and a mixture of 2-amino-4 - ethyl-5 - chloro-benzene-sulfonic acid (CAS Reg. No. 88-56-2) and 2-chloro-4-amino toluene-5 - sulfonic acid (CAS Reg. No. 88-51-7 )); or (2) 6-hydroxy - naphthalene-2 - sulfonic acid and p-aminobenzoic acid (CAS Reg. No. 150-13-0) | For use as colorants at levels up to 1% by weight in all polymers contacting non-fatty food under Conditions of Use A through H (Table 2, 21 CFR 176.170) and in all polymers contacting fatty food under Condition of Use C or below. |
| 98-018 | S.I. Graham and Associates on behalf of FTI Inc. | N,N'-ethylene bis-12-hydroxystearamide (CAS Reg. No. 123-26-6) | At a maximum use level of 0.35% by weight in lubricants intended for incidental food contact (21 CFR 178.3570). |
| 98-019 | Paper Chemicals Inc. | Oxirane, methyl-, polymer with oxirane, ether with (1,2-ethanediyl dinitrilo) 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. |
| 98-020 | 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. |
| 98-021 | 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. |
| 98-022 | 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. |
| 98-023 | 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. |
| 98-024 | 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. |
| 98-025 | 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. |
| 98-026 | 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). |
| 99-001 | 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. |
| 99-002 | Keller and Heckman on behalf of Solvay Interox Inc. | 1-Hydroxy - ethylidene-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. |
| 99-003 | Keller and Heckman on behalf of FMC Corporation | 1-Hydroxy - ethylidene-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. |
| 99-004 | 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. |
| 99-005 | 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. |
| 99-006 | 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-dimethyl-hydantoin, 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. |
| 99-007 | 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 120o F. |
| 99-008 | Frederick Brewing Co. | Diabase rocks (Blue Stone) | For use in the manufacture of beer. |
| 99-009 | 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.) |
| 99-010 | National Starch and Chemical Company | Manganese(2+), bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine (N1, N4, N7), tri-micro -oxodi-, bis(hexafluoro-phosphate(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 ug/in2 in the finished paper. |
| 99-011 | 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. |
| 99-012 | 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). |
| 99-013 | 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) |
| 99-014 | 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). |
| 99-015 | 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 140o F. |
| 99-016 | 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. |
| 99-017 | 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. |
| 99-018 | 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). |
| 99-019 | 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). |
| 99-020 | 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. |
| 99-021 | 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'-methylene diphenyl 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 120o F. |
| 99-022 | 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. |
| 00-001 | 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 49oC. |
| 00-002 | 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 120o 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. |
| 00-003 | 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. |
| 03-001 | Keller and Heckman | A mixture of parafinic oil (CAS Reg.. No. 64742-65-0) and sulfonated paraffinic oil (CAS Reg. No. 64742-20-2) | 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. |
| 04-001 | 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). |
| 04-002 | 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. |
| 04-003 | 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. |
| 05-001 | 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. |
| 05-002 | 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. |
| 05-003 | 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. |
| 05-004 | 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. |
| 05-005 | 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. |
| 05-006 | Ciba Specialty Chemical Corp. | Sodium perchlorate monohydrate (CAS Reg. No. 7791-07-3) | As a conductivity enhancer in the manufacture of antistatic agents at a maximum concentration of 4 percent by weight in the finished article for use in contact with dry foods. |
| 05-007 | 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: 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). 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). |
| 05-008 | 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: 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) |
| 06-001 | General Electric | Phenol, 4-methyl, reaction products with dicyclopentadiene and isobutylene (CAS Reg. No. 6861-51-5) | As an antioxidant/stabilizer to inhibit thermo-oxidative degradation, in methylmethacrylate modified acrylonitrile/butadiene/styrene (ABS) polymers which are the subject of FCN 190 and acrylonitrile/styrene copolymers complying with 21CFR 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). |
| 06-002 | 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 |
| 07-001 | Kraska Consultants, Inc. | A. 1,2-Benzisothiazolin-3-one (BIT); (CAS Reg. No. 2634-33-5), B. 1,1,3-tris(5-tert-butyl-4-hydroxy-2-methylphenyl)butane;(CAS Reg. No.1843-03-4), and C. 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. |
| 07-002 | REPLACED BY TOR 10-002 | ----------- | -------- |
| 07-003 | Keller and Heckman on behalf of Owens-Illinois Closure Inc. | Hydrogen peroxide (CAS Reg. No. 7722-84-1) | To sterilize food-contact surfaces that have an appropriate regulatory status for its intended use in the production of aseptic packaging and meet the requirements and limitations of 21 CFR 178.1005 Hydrogen peroxide, |
| 07-004 | Kraska Consultants, Inc on behalf of Omnova Solutions | A. 3(2H)-Isothiazolon-3-one, 2-methyl- (CAS Reg. No. 2682-20-4), and B. 3(2H)-Isothiazolon-3-one, 5-chloro-2-methyl- (CAS Reg. No. 26172-55-4) | Used as components of pressure sensitive adhesives. These substances are used as a biocide preservative according to their FIFRA registrations as product preservatives in water based adhesive products. Also, the adhesive shall be used at GMP levels (i.e., the minimum amount needed to accomplish the intended technical effect) and the use of these biocides in the adhesive formulation shall be 1 percent or less by weight. These substances shall be used in formulations with modified butadiene/styrene copolymers. |
| 07-005 | Ciba Specialty Chemicals Corporation | Tin oxide (Sn02), (CAS Reg. No. 18282-10-5), | For use at a maximum concentration of 2.0% by weight as a component in mica-based mineral colorants, provided the maximum loading level for the mica-based colorants in the food-contact article does not exceed 3% by weight for polymers, 5% for paper and paperboard, 15% for coatings or 30% for ink formulations, in contact with all food types and under temperature conditions of use A through H. |
| 07-006 | Kraska Consultants, Inc on behalf of Omnova Solutions, | 1,1’-Oxybisbenzene tetrapropylene derivatives, sulfonated, sodium salts (CAS Reg. No. 119345-04-0) | For use as components of adhesives under use conditions as specified in 21 CFR 175.105(a)(2)(i)(ii) and in pressure sensitive adhesives as specified in 21 CFR 175.125(b) on labels and tape applied to raw fruits and raw vegetables. The temperature of use should not exceed 120° F. |
| 08-001 | H.B. Fuller | Polyurethane (PUR) resin (CAS Reg. No. 82602-41-3 ) | For use as an adhesive between layers in the fabrication of laminate food-contact articles used for microwave cooking at temperatures not to exceed 212 ° F, in contact with aqueous food (food type I, Table 1, 21 CFR 176.170(c).) |
| 09-001 | Eric F. Greenberg, P.C. on behalf of Wacker Chemical Corporation | Polysiloxane (di-methyl, 3-hydroxypropyl methyl), ethoxylated propoxylated, polymer with hexamethylenediisocyanate, which is the reaction product resulting from a mixture of two polymeric starting materials with hexamethylenediisocyanate. | The FCS shall be added to the pulp water at a level not to exceed 4 mg/kg of pulp. The food contact substance will act as an antifoaming agent in the production of food contact paper that will contact all types of food. |
| 09-002 | Korea Engineering Plastics Co., Ltd. | Dimethoxymethane (Methylal) (CAS Number: 109-87-5) | For use as a chain transfer agent in the polymerization of polyoxymethylene copolymers in the manufacture of repeat use food-contact articles, at temperatures below 250°F, and in contact with all food types, except those containing more than 15% alcohol. |
| 09-003 | Hitachi Chemical Company, Ltd. | Triethylamine (CAS No. 121-44-8) | For use in the manufacture of polyamide-imide resin intended for use as a component in primer coatings between the metal surface and the fluorocarbon layer of non-stick surfaces of cooking utensils. The final food contact article will be used in repeat-use cooking applications in contact with all food types at a maximum temperature of 290°C. |
| 10-001 | Tronox, LLC | 1,1,1’-trimethylolpropane (CAS Registry No. 77-99-6) and zirconium dioxide (CAS Registry No. 1314-23-4) | For use as modifying agents for titanium dioxide pigments. Each subject of the TOR request would be used at a maximum level of 0.7% of the titanium dioxide pigment formulation. The resulting titanium dioxide pigment would be used at a level not to exceed 5% by weight of finished repeat-use polymers or coatings intended for use in contact with all foods under use conditions up to and including cooking. |
| 10-002 | Sadex, Inc. | The food additives listed in: (a) Title 21 CFR Parts 174 through 186, (b) the inventory of effective food-contact substance notifications, and (c) the inventory of Threshold of Regulation exemptions issued under Title 21 CFR 170.39. | In the manufacture of food-contact articles that will be irradiated, incidental to the radiation processing of prepackaged foods. This exemption applies only when: 1. The radiation processing is done in compliance with Title 21 CFR Part 179; 2. The packaging materials are subjected to radiation doses not exceeding 4.5 kGy; and 3. The packaged food is irradiated either in a verifiably oxygen-free environment or while frozen and contained under vacuum. |
| 10-003 | Engineered nanoProducts Germany AG | Vitreous silica coating prepared by sol-gel polycondensation reaction of tetraethoxysilane and methyl-triethoxysilane | For use as a permanent or semi-permanent coating of metal substrates intended for cooking food in repeat-use applications. The final food contact article will be used in repeat-use cooking applications in contact with all food types at a maximum temperature of 300 °C. |
| 11-001 | Nanobiomatters BactiBlock S.L. | Silver (CAS Reg. No. 7440-22-4) and cetyl trimethylammonium bromide (CAS Reg. No. 57-09-0) | For use as components of an antimicrobial formulation to be used to preserve composite countertops consisting of a polymeric binder and inorganic filler. The antimicrobial formulation will contain up to 0.5 % by weight of silver and up to 30 % by weight of cetyl trimethylammonium bromide with the remainder consisting of a suitable substance regulated for the intended use. The antimicrobial formulation will be incorporated into the polymeric binder at a level not to exceed 1 % by weight. The final composite countertop will incorporate the polymeric binder at a level not to exceed 10 % by weight with the remainder consisting of inorganic filler of a quality suitable for food-contact use. The final food contact article will be used in contact with all foods at room temperature and below. |
| 11-002 | Keller and Heckman, LLP. | Polyethylene glycol with a minimum molecular weight of 400 Daltons (CAS Registry No. 25322-68-3) | For use as a modifier for polyethylene terephthalate films with a maximum thickness of 2 mils. The subject of the TOR request may be used at a level not to exceed 12 % by weight of the final film. The resulting finished article may be used in contact with all food types (or according to other applicable limitations/specifications as appropriate) under Conditions of Use E through G. |
| 12-001 | Ecolab | a mixture of 1,3-propanediamine, n-9-octadecenyl-, (z)- (CAS. Reg. No. 7173-62-8), amines, n-coco alkyltrimethylenedi- (CAS. Reg. No. 61791-63-7), cocamine (CAS. Reg. No. 61788-46-3), poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-hydroxy- (CAS. Reg. No. 9043-30-5), poly(oxy-1,2-ethanediyl), α-tridecyl-ω-hydroxy-, branched (CAS. Reg. No 69011-36-5), poly(oxy-1,2-ethanediyl), α-(carboxymethyl)-ω-[(9Z)-9- octadecen-1-yloxy]- (CAS. Reg. No. 57635-48-0), and potassium acetate (CAS. Reg. No 127-08-2) | For use as a lubricant for use in the conveyance of beverage containers. The subjects of the TOR request can be used at a combined total level not to exceed 0.75 weight % in dispersions applied to the conveyor belt below the bottle opening. |
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