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CFSAN/Office of Food Additive Safety
August 2008
Under section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 348 (h)(2)(C)) a notification is only effective for the manufacturer or supplier identified in the notification. Persons who market a food contact substance based on an effective notification must be able to demonstrate that the notification is effective for their food contact substance. All persons who purchase a food contact substance manufactured or supplied by a manufacturer or supplier identified in an effective notification may rely on that notification to legally market or use the food contact substance for the use that is the subject of the notification, consistent with any limitations in that notification. This table will be updated approximately monthly.
| Contact Us | Access to Regulations |
| FCN No. | Food Contact Substance (FCS) | Notifier
|
Intended Use | Limitations/ Specifi- cations |
Effective Date | Environ- mental Decision |
||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturer of the FCS |
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| 1 | Silver sodium hydrogen zirconium phosphate, rhombohedral framework
structure, of the general formula
AgxNayHzZr2(PO4)3
x=(0.1-0.5); y=(0.1-0.8); z=(0.1-0.8) |
Milliken & Company | Antimicrobial additive for polymeric food-contact materials | Limitations/
Specifi- cations |
Mar 1, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Toagosei Company, Ltd. | ||||||||||||||||||||||||||||||||
| 2 | GENOX TM EP, chemically identified as Amines, bis(hydrogenated rape-oil alkyl) methyl, N-oxides (CAS Reg. No. 204933-93-7) | GE Specialty Chemicals | An antioxidant and/or stabilizer | Limitations/
Specifi- cations |
Mar 9, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| GE Plastics | ||||||||||||||||||||||||||||||||
| 3 | Styrene-acrylic copolymers produced by polymerizing a minimum of 72 parts by weight of styrene with a minimum of 4 parts of methyl methacrylate and with up to 10 parts total of any one or more of the following monomers: butyl methacrylate, methacrylic acid, butyl acrylate, acrylic acid and allyl methacrylate | Rohm and Haas Company | As components of coatings for paper and paperboard in compliance with 21 CFR 176.170(b) | Limitations/
Specifi- cations |
Mar 9, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Rohm and Haas Company | ||||||||||||||||||||||||||||||||
| 4 | Isophthalic acid or dimethyl isophthalate | BP Amoco | As a monomer in the manufacture of ethylene terephthalate - isophthalate copolymers |
Limitations/ Specifi- cations |
Mar 15, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BP Amoco | ||||||||||||||||||||||||||||||||
| 5 | Polybutadiene - graft - poly(methyl acrylate- co- acrylonitrile) (CAS Reg. No. 27012-62-0) | BP Amoco Chemicals, Inc. | Fabricating beverage containers |
Limitations/ Specifi- cations |
Mar 14, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BP Amoco Chemicals, Inc. | ||||||||||||||||||||||||||||||||
| 6 | Completely hydrolyzed copolymer of acrylonitrile and trivinylcyclohexane ion-exchange resin (CAS Reg. No. 109961-42-4) | Rohm and Haas Company | Treating potable water |
Limitations/ Specifi- cations |
Mar 17, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Rohm and Haas Company | ||||||||||||||||||||||||||||||||
| 7 | Woven wool felt | Applied Fabric Technologies, Inc. | As a component of conveyor belts in contact with raw dough bakery products such as bread and croissants | None | Mar 21, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Applied Fabric Technologies, Inc. | ||||||||||||||||||||||||||||||||
| 8 | Ethylene terephthalate- 2,6-naphthalate copolymers | Shell Chemicals Company | As the base sheet or base polymer for manufacturing food contact articles |
Limitations/ Specifi- cations |
Mar 23, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| M&G Polymers USA, LLC | ||||||||||||||||||||||||||||||||
| 9 | Poly (oxy- 1,2-ethanediyloxycarbonyl- 2,6 -naphthalanedicarbonyl) homopolymer and copolymers with ethylene terephthalate | Shell Chemicals Company | As articles and films or components of articles and films in contact with food |
Limitations/ Specifi- cations |
Mar 23, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| M&G Polymers USA, LLC | ||||||||||||||||||||||||||||||||
| 10 | Pyromellitic dianhydride | Sekisui Plastics, Ltd. | As a modifier for ethylene terephthalate copolymers identified in 21 CFR 177.1630(e)(4)(i), item 2, and complying with all applicable provisions of 21 CFR 177.1630 |
Limitations/ Specifi- cations |
Mar 29, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Sekisui Plastics, Ltd. | ||||||||||||||||||||||||||||||||
| 11 | 4,5-dichloro- 2-n-octyl-3(2H)-isothiazolone | Rohm and Haas Company | As a preservative and slimicide in the manufacture of paper and paperboard intended to contact aqueous and fatty food. |
Limitations/ Specifi- cations |
Apr 1, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Rohm and Haas Company | ||||||||||||||||||||||||||||||||
| 12 | Industrial starch modified by treatment with greater than 5% and not more than 21% by weight 2,3-epoxypropyl trimethylammonium chloride (CAS Reg. No. 3033-77-0) | Sveriges Starkelse- producenter | For use as a retention aid and/or drainage aid and/or dry-strength agent employed prior to the sheet-forming operation in the manufacture of food-contact paper and paperboard |
Limitations/ Specifi- cations |
Mar 31, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Lyckeby Starkelsen Industrial Starches AB | ||||||||||||||||||||||||||||||||
| 13 | Dimethyl-2, 6-naphthalene dicarboxylate or 2,6-naphthalene dicarboxylic acid | BP Amoco Chemicals | As a chemically-bound component of ethylene terephthalate-2,6-naphthalate compolymers |
Limitations/ Specifi- cations |
Mar 23, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BP Amoco Chemicals | ||||||||||||||||||||||||||||||||
| 14 | Dimethyl-2, 6-naphthalene dicarboxylate or 2,6-naphthalene dicarboxylic acid | BP Amoco Chemicals | As a chemically-bound component of poly(oxy- 1,2-ethanediyloxy carbonyl- 2,6-naphthalenediyl carbonyl) homopolymer and copolymers with ethylene terephthalate |
Limitations/ Specifi- cations |
Mar 23, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BP Amoco Chemicals | ||||||||||||||||||||||||||||||||
| 15 | Benzenesulfonic acid, 2,2'- (1,2-ethenediyl)bis (5-((4-(bis(2-hydroxyethyl)amino)- 6-((4-sulfophyenyl)amino)-1,3,5-triazin-2-yl)amino)-, tetrasodium salt (CAS Reg. No. 16470-24-9) | Stilbene Whitening Agent Task Force | As an optical brightener in paper and paperboard. |
Limitations/ Specifi- cations |
Apr 1, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Kemira Chemicals, Inc., Ciba Specialty Chemicals Corporation and Clariant Corporaion | ||||||||||||||||||||||||||||||||
| 16 | Cemented carbide formulated as follows: Tungsten Carbide(WC) - 95%, Carbides of titanium, tantalum and niobium - 5%, Cobalt(Co) - 0.5%-1% | AB Sandvik Hard Materials | For use in seal rings and bearings for food processing equipment including pumps. |
Limitations/ Specifi- cations |
Apr 4, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Sandvik Hard Materials | ||||||||||||||||||||||||||||||||
| 17 | A perfluorocarbon-cured elastomer (PCE) produced by terpolymerizing tetrafluoroethylene (CAS Reg. No. 116-14-3), perfluoro (2,5-dimethyl- 3,6-dioxanone vinyl ether) (CAS Reg. No. 2599-84-0) and perfluoro (6,6-dihydro- 6-iodo- 3-oxa- 1-hexene) (CAS Reg. No. 106108-22-9) and subsequent curing of the terpolymer (CAS Reg. No. 106108-23-0) by crosslinking with triallylcyanurate (CAS Reg. No. 101-37-1) and vulcanizing with 2,5-dimethyl- 2,5-di (t-butylperoxy) hexane (CAS Reg. No. 78-63-7), as a 68% dispersion on finely divided silica | Greene, Tweed and Company, Inc. | In the fabrication of vulcanized molded parts for food processing equipment, such as o-rings, gaskets, diaphrams and other materials, that function primarily in sealing applications |
Limitations/ Specifi- cations |
Mar 30, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Greene, Tweed and Company, Inc. | ||||||||||||||||||||||||||||||||
| 18 | Sodium acrylate/styrene sulfonate copolymer | Nalco Chemical Company | As an antiscalant boiler water treatment where steam from treated boilers may contact food. |
Limitations/ Specifi- cations |
Apr 7, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Nalco Chemical Company | ||||||||||||||||||||||||||||||||
| 19 | Piperylene / 2-methyl-2-butene / alpha-methylstyrene terpolymers (Benzene, (1-methylethenyl)-, polymers with 2-methyl-2-butene and 1,3-pentadiene) (CAS Reg. No. 62258-49-5) | Goodyear Tire & Rubber Company | In the manufacture of can end cements complying with 21 CFR 175.300(b)(3)(xxxi) |
Limitations/ Specifi- cations |
Mar 31, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Goodyear Tire & Rubber Company | ||||||||||||||||||||||||||||||||
| 20 | 2,2'-Methylenebis (4,6-di-tert- butylphenyl) 2-ethylhexyl phosphite (CAS Reg. No. 126050-54-2) | Asahi Denka Kogyo K.K. | As an antioxidant and/or stabilizer in linear low-density polyethylene articles intended for contact with food. |
Limitations/ Specifi- cations |
Apr 7, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Asahi Denka Kogyo K.K. | ||||||||||||||||||||||||||||||||
| 21 | 2,2'-Methylenebis (4,6-di-tert- butylphenyl) 2-ethylhexyl phosphite (CAS Reg. No. 126050-54-2) | Asahi Denka Kogyo K.K. | As an antioxidant and/or stabilizer in high-density polyethylene articles intended for contact with food. |
Limitations/ Specifi- cations |
Apr 7, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Asahi Denka Kogyo K.K. | ||||||||||||||||||||||||||||||||
| 22 | Phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl) ester (CAS Reg. No. 80693-00-1) | Adeka Corporation | As an antioxidant and/or stabilizer in high-density polyethylene homopolymer and copolymers articles intended for contact with food. |
Limitations/ Specifi- cations |
Apr 8, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Adeka Corporation | ||||||||||||||||||||||||||||||||
| 23 | C.I. Pigment Red 277, a solid solution of 1- naphthalenesulfonic acid, 2-((2-hydroxy-6 -sulfo-1 -naphthalenyl)azo)-, stronium salt (1:1)(CAS Reg. No. 250639-69-1) and 2-naphthalenesulfonic acid, 5-((4-chloro-5 -ethyl- 2-sulfophenyl) azo)-6-hydroxy-, strontium salt (1:1)(CAS Reg. No. 197566-90-8) | Engelhard Corporation | As a colorant in food-contact polymers. The colorant is to be used in compliance with 21 CFR 178.3297. |
Limitations/ Specifi- cations |
Apr 8, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Engelhard Corporation | ||||||||||||||||||||||||||||||||
| 24 | Tin-based alloy, ASTM B23-49 Grade 1, for filling bearings made from extruded or molded carbon and graphite, which has the following composition: Tin (Balance); Antimony (4.0-5.0%); Copper (4.0-5.0%); Lead (0.004% maximum); Iron (0.05% maximum); Aluminum (0.005% maximum); Zinc (0.005% maximum); Arsenic (0.005% maximum); Bismuth (0.005% maximum); Total other elements (<0.005% maximum). | Graphite Metallizing Corporation | For use to fill bearings, made from extruded or molded carbon and graphite, intended for use in pumps, baking ovens and equipment for transporting or handling of food products. |
Limitations/ Specifi- cations |
May 13, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Grant Manufacturing and Alloying Inc. | ||||||||||||||||||||||||||||||||
| 25 | 1-naphthalenesulfonic acid, 2-((4,5-dihydro- 3-methyl-5- oxo-1- (3-Sulfophenyl)- 1H-pyrazol- 4-yl) azo)-, calcium and/or strontium salt (1:1)(C.I. Pigment Yellow 209 and C.I. Pigment Yellow 209:1) | BASF Corporation | As colorants for all polymers intended for food-contact applications. |
Limitations/ Specifi- cations |
Apr 8, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BASF Corporation | ||||||||||||||||||||||||||||||||
| 26 | A solid solution of 2-naphthalenesulfonic acid, 5-(((5-chloro -4-methyl-2- sulfophenyl) azo) -6-hydroxy)-, strontium salt (1:1) and 2-naphthalenesulfonic acid, 5-((4-chloro -5-ethyl -2-sulfophenyl) azo) -6-hydroxy)-, strontium salt(1:1) (C.I. Pigment Red 276) | BASF Corporation | As a colorant for polymers intended for food-contact applications. |
Limitations/ Specifi- cations |
Apr 8, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BASF Corporation | ||||||||||||||||||||||||||||||||
| 27 | C.I. Pigment Orange 79 (Benzoic acid, 4-((2-hydroxy- 6-sulfo-1 -naphthalenyl)azo) -strontium salt (2:1)) | Engelhard Corporation | As a colorant in all types of food-contact polymers. |
Limitations/ Specifi- cations |
May 2, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Engelhard Corporation | ||||||||||||||||||||||||||||||||
| 28 | Hydrogenated styrene-butadiene block copolymers modified with maleic anhydride such that the basic polymers are composed of : 18 to 40 percent by weight of units derived from styrene, 58 to 80 percent by weight of units derived from hydrogenated 1,3-butadiene and 0.1 to 2 percent by weight of units derived from maleic anhydride. | Asahi Chemical Industry Co. | As a modifier (blending component) for polymers that are regulated in 21 CFR Part 177 or the subject of an effective notification. |
Limitations/ Specifi- cations |
May 3, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Asahi Chemical Industry Co. | ||||||||||||||||||||||||||||||||
| 29 | Tridecanol phosphite condensation product with butylidenebis (2-(1,1-dimethylethyl) -5-methyl-4,1-phenylene) (CAS Reg. No. 13003-12-8) | Asahi Denka Kogyo K.K. | As an antioxidant and/or stabilizer in accordance with 21 CFR 178.2010 in styrene-isoprene-styrene (SIS) copolymer. |
Limitations/ Specifi- cations |
Apr 19, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Asahi Denka Kogyo K.K. | ||||||||||||||||||||||||||||||||
| 30 | Copolymer of the sodium salt of acrylic acid with polyethyleneglycol allyl ether(CAS Reg. No. 137898-98-7) | BetzDearborn, Inc. | For use in boiler water additives complying with 21 CFR 173.310. |
Limitations/ Specifi- cations |
Apr 11, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BetzDearborn, Inc. | ||||||||||||||||||||||||||||||||
| 31 | Fluorescein, disodium salt or dipotassium salt (CAS Reg. No. 518-47-8) and (CAS Reg. No. 6417-85-2) | Nalco Chemical Co. | For use in boiler water additives complying with 21 CFR 173.310. |
Limitations/ Specifi- cations |
May 11, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Nalco Chemical Co. | ||||||||||||||||||||||||||||||||
| 32 | Alpha- (dinonylphenyl) -omega -hydroxypoly (oxy-1, 2-ethanediyl) containing not more than 21 moles of ethylene oxide per mole of dinonylphenyl (CAS Reg. No. 9014-93-1) | BASF Corporation | As a stabilizer in calcium stearate dispersions used in the manufacture of paper coatings complying with 21 CFR 176.170(b). |
Limitations/ Specifi- cations |
May 14, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BASF Corporation | ||||||||||||||||||||||||||||||||
| 33 | Silica, ((ethenyldimethylsilyl) oxy)- and ((trimethylsilyl) oxy)-modified (CAS Reg. No. 68988-89-6) | Dow Corning Corporation | To be used in combination with siloxane and silicone coating components permitted for use under 21 CFR 175.300 (b) (3) (xxviii) to manufacture silicone paper coatings intended for use in contact with pressure-sensitive, self-stick labels and tapes to adjust the force required to release the label/tapes which are to be applied to food surfaces. |
Limitations/ Specifi- cations |
May 18, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Dow Corning Corporation | ||||||||||||||||||||||||||||||||
| 34 | Nylon 6/12 resins manufactured by the copolymerization of at least 80 weight percent of epsilon-caprolactam and no more than 20 weight percent of omega-aminododecanoic acid. (CAS Reg. No. 25191-04-2) | UBE Industries, Ltd. | For use in the manufacture of multilaminate packaging films and not for use in direct contact with food. |
Limitations/ Specifi- cations |
May 21, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| UBE Industries, Ltd. | ||||||||||||||||||||||||||||||||
| 35 | Dimethyl dicarbonate | LANXESS Corporation | As a microbial control agent in non-carbonated juice beverages containing up to and including 100 percent juice. |
Limitations/ Specifi- cations |
June 9, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| LANXESS Corporation | ||||||||||||||||||||||||||||||||
| 36 | Gum rosin (CAS Reg. No. 8050-09-7) | Resinall Corporation | As a reactant in the production of polyester resins (such polyester resins to be otherwise made from materials regulated for production of such resins under 21 CFR 175.320) used as components of coatings applied to polypropylene (PP) films complying with 21 CFR 177.1520. |
Limitations/ Specifi- cations |
June 4, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Resinall Corporation | ||||||||||||||||||||||||||||||||
| 37 | Dimethylolbutanoic acid, (CAS Name: butanoic acid, 2,2-bis (hydroxymethyl)-, (CAS Reg. No. 10097-02-6) | Perstorp Polyols, Inc. | As a monomer in the production of polyurethane resins used in adhesives complying with 21 CFR 175.105. |
Limitations/ Specifi- cations |
June 3, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Perstorp Polyols, Inc. | ||||||||||||||||||||||||||||||||
| 38 | n-Octyl phosphonic acid (NOPA)-modified titanium dioxide (produced by chemically reacting NOPA (CAS Reg. No. 4724-48-5) with titanium dioxide to achieve a treatment level of 0.85 percent by weight of NOPA on the pigment). | Huntsman Tioxide | As a colorant in all types of food-contact polymers. |
Limitations/ Specifi- cations |
June 3, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Huntsman Tioxide | ||||||||||||||||||||||||||||||||
| 39 | 1,2-Bis (3,5-di-tert-butyl -4 -hydroxyhydrocinnamoyl) hydrazine (CAS Reg. No. 32687-78-8) | Ciba Specialty Chemicals Corporation | As a stabilizer in polypropylene polymers and copolymers complying with 21 CFR 177.1520(c). |
Limitations/ Specifi- cations |
July 22, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corporation | ||||||||||||||||||||||||||||||||
| 40 | Polyphenylene sulfide polymers (CAS Reg. No. 25212-74-2 or 26125-40-6) | Ticona | As a polymeric component of repeated use food-contact articles. |
Limitations/ Specifi- cations |
June 28, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Ticona | ||||||||||||||||||||||||||||||||
| 41 | Silicone acrylate resins produced by the addition of omega-hydroxyalkenes and/or propenyloxy -2,3-dihydroxypropane, mono- or diester with acrylic acid, acetic acid, or other saturated monocarboxylic acid, to dimethyl polysiloxane, methylhydrogen polysiloxane, or dimethyl-methylhydrogen polysiloxane. The cured resins may include substances permitted for use by regulation in 21 CFR 170-189, substances generally recognized as safe, substances used in accordance with prior sanction approval, and the following substances as photoinitiators: 2-hydroxy-2 -methyl-1-phenyl-1-propanone (CAS Reg. No. 7473-98-5) and/or oligomeric -2-hydroxy -2-methyl-1 -[4-(1-methylvinyl) phenyl] -1-propanone (CAS Reg. No. 163702-01-0). The total photoinitiator levels shall not exceed 3 percent by weight of silicone acrylate resin in coatings. | Goldschmidt Chemical Corporation | As coatings or components of coatings on polymeric substrates and on paper and paperboard, at a maximum level of 1.3 milligrams per square inch (mg/in2), in contact with all food types under conditions of use E, F, G, and H as defined in Table 2. |
Limitations/ Specifi- cations |
June 7, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Goldschmidt Chemical Corporation | ||||||||||||||||||||||||||||||||
| 42 | A grafted copolymer of cross-linked sodium polyacrylate identified as 2-propenoic acid, polymers with N,N-di-2 propenyl -2-propen -1-amine and hydrolyzed polyvinyl acetate, sodium salts, graft (CAS Reg. No. 166164-74-5) | Stockhausen, Inc. | For use as an absorptive medium in absorbent pads employed in the packaging of refrigerated or frozen red meat. |
Limitations/ Specifi- cations |
June 10, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Stockhausen, Inc. | ||||||||||||||||||||||||||||||||
| 43 | Nickel-iron alloy. Its composition is as follows: Ni (80-83 percent by weight), S (0-0.005 % by weight), C (0-0.005% by weight), Mo (1-3% by weight), Fe (14-19% by weight). | Marlen Research Corporation | Used in seals for food processing equipment. |
Limitations/ Specifi- cations |
June 7, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Ametek Specialty | ||||||||||||||||||||||||||||||||
| 44 | Hexanedioic acid polymer with 1,3 -benzenedimethanamine meeting the specifications in 21 CFR 177.1500(b) item 10.2, when tested by the methods given in 21 CFR 177.1500(c) (CAS Reg. No. 25718-70-1). | Toyobo Co., Ltd. | As a modifier for polyethylene terephthalate (PET) polymers. |
Limitations/ Specifi- cations |
June 6, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Toyobo Co., Ltd. | ||||||||||||||||||||||||||||||||
| 45 | Two quaternary amine (QAE) cellulose ion exchange resins (IXRs): (1) high substitution QAE cellulose IXR (1.5-2.5 milliequivalents quaternary ammonium per dry g of resin); and (2) high protein capacity QAE cellulose IXR (1.0-1.5 milliequivalents quaternary ammonium per dry g resin). Both IXRs consist of a base matrix of regenerated cellulose, cross-linked and alkylated with epichlorohydrin and propylene oxide. Dimethyl hydroxyethyl ammonium groups are added to the polymer to provide binding sites. | Life Technologies, Inc. | For use in the isolation and purification of protein concentrates and isolates from aqueous process streams for food processing. |
Limitations/ Specifi- cations |
June 10, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Life Technologies, Inc. | ||||||||||||||||||||||||||||||||
| 46 | Salicylamide (CAS Reg. No. 65-45-2) | Lubrizol Corporation | For use as an anti-wear component of lubricants with incidental food contact. |
Limitations/ Specifi- cations |
June 12, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Lubrizol Corporation | ||||||||||||||||||||||||||||||||
| 47 | Zeolite A in which silver, zinc and ammonium ions have been exchanged for sodium ions. The silver content of the modified zeolite shall not exceed 2.5 percent by weight. | Sinanen Company, Ltd. | As an antimicrobial additive in all types of food-contact polymers. |
Limitations/ Specifi- cations |
June 9, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Sinanen Company, Ltd. | ||||||||||||||||||||||||||||||||
| 48 | Poly(ethylene-methyl acrylate-cyclohexenylmethyl acrylate) (CAS Reg. No. 223503-47-7). | Cryovac, Inc. | As a component of articles used in contact with dry food containing no surface fat or oil (i.e., food type VIII as described in Table 1) and as a component of multi-layer articles in contact with food. |
Limitations/ Specifi- cations |
June 4, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Cryovac, Inc. | ||||||||||||||||||||||||||||||||
| 49 | Nylon 6 polymers produced using benzoic acid as a blocking agent. | Unitika Ltd. | The Nylon 6 polymers would be used for food-contact applications as described in 21 CFR 177.1500(b)(6.1) and (6.2). |
Limitations/ Specifi- cations |
June 9, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Unitika Ltd. | ||||||||||||||||||||||||||||||||
| 51 | REPLACED BY FCN 232 |
Limitations/ Specifi- cations |
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| 52 | A high density agarose resin, crosslinked and alkylated with epichlorohydrin, followed by chemical binding of benzylamine. The agarose resin would be in the form of beads with a particle size of 100 to 300 um for not less than 90% of the particles. | Chr. Hansen A/S | As a chromatographic material for the isolation and purification of food enzymes. |
Limitations/ Specifi- cations |
August 2, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| UpFront Chromatography A/S | ||||||||||||||||||||||||||||||||
| 53 | The substance is a mixture consisting of 63-72% oxidized bis(hydrogenated tallow alkyl) amines (CAS Reg. No. 143925-92-2), 12-15% bis (hydrogenated tallow alkyl) amines, 4-8% (hydrogenated tallow alkyl) nitrones, and 5-12% (hydrogenated tallow alkyl) oximes. | Ciba Specialty Chemicals Corporation | As an antioxidant and/or stabilizer in olefin polymers. |
Limitations/ Specifi- cations |
June 15, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corporation | ||||||||||||||||||||||||||||||||
| 54 | alpha -sulfo -omega-(dodecyloxy) poly (oxyethylene) sodium salt (CAS Reg. No. 9004-82-4). | Cognis Corporation | For use as an emulsifier in the production of acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard that contact aqueous and fatty foods. |
Limitations/ Specifi- cations |
June 24, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Cognis Corporation | ||||||||||||||||||||||||||||||||
| 55 | Ion exchange resin which is a terpolymer of styrene, divinyl benzene and ethylvinyl benzene, aminomethylated, then quarternized with methyl chloride (CAS Reg. No. 113114-05-9). | LANXESS Corporation | For use in treating aqueous sugar solutions and hydrolyzed starch solutions. |
Limitations/ Specifi- cations |
July 13, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| LANXESS Corporation | ||||||||||||||||||||||||||||||||
| 56 | Petroleum hydrocarbon resins (cyclopentadiene-type), hydrogenated (CAS Reg. Name Naptha (petroleum), light steam-cracked, debenzenized, polymers, hydrogenated (CAS Reg. No. 68132-00-3). | ExxonMobil Chemical Company | 1. As a component of adhesive formulations complying with 21 CFR 175.125; 2. As a component of resinous and polymeric coatings complying with 21 CFR 175.320; 3. As a component of can-end cement formulations complying with 21 CFR 175.300(b)(3)(xxxi); 4. As a component of coatings for paper and paperboard complying with 21 CFR 176.170 and 21 CFR 176.180; 5. As a component of adhesives for seals of food-contact, glass containers complying with 21 CFR 177.1210. |
Limitations/ Specifi- cations |
August 24, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| ExxonMobil Chemical Company | ||||||||||||||||||||||||||||||||
| 57 | Aromatic modified aliphatic hydrocarbon resin. The FCS is also known as aromatic modified petroleum hydrocarbon resin. (CAS Reg. No. 68527-25-3). | ExxonMobil Chemical Company | 1. As a component of adhesive formulations complying with 21 CFR 175.105 and 21 CFR 175.125; 2. As a component of resinous and polymeric coatings complying with 21 CFR 175.320 applied to polyolefin films complying with 21 CFR 175.1520(c); 3. As a component of can-end cement formulations complying with 21 CFR 175.300(b)(3)(xxxi); 4. As a component of coatings for paper and paperboard complying with 21 CFR 176.170 and 21 CFR 176.180; 5. As a component of adhesives for seals of food-contact, glass containers complying with 21 CFR 177.1210 and 21 CFR 175.105. |
Limitations/ Specifi- cations |
August 24, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| ExxonMobil Chemical Company | ||||||||||||||||||||||||||||||||
| 58 | 2,2'-Methylenebis (4,6-di-tert-butylphenyl) 2-ethylhexyl phosphite (CAS Reg. No. 126050-54-2). | Asahi Denka Kogyo K.K. | As an antioxidant and/or stabilizer in styrene-butadiene block polymers. |
Limitations/ Specifi- cations |
June 29, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Asahi Denka Kogyo K.K. | ||||||||||||||||||||||||||||||||
| 59 | Glycine, N,N-bis[2-hydroxy -3-(2-propenyloxy) propyl]-, monosodium salt, reaction products with ammonium hydroxide and pentafluoroiodoethane-tetrafluoroethylene telomer (CAS Reg. No. 220459-70-1). | Ciba Specialty Chemicals Corporation | As a component of paper and paperboard in contact with nonalcoholic food. |
Limitations/ Specifi- cations |
August 16, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corporation | ||||||||||||||||||||||||||||||||
| 60 | GENOXTMEP, chemically identified as amines, bis(hydrogenated rape-oil alkyl)methyl, N-oxides (CAS Reg. No. 204933-93-7). | GE Specialty Chemicals | As an antioxidant in the manufacture of polypropylene homopolymer and copolymers complying with 21 CFR 177.1520. |
Limitations/ Specifi- cations |
July 15, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| GE Specialty Chemicals | ||||||||||||||||||||||||||||||||
| 62 | Amorphous hydrogenated carbon coating produced from acetylene as the carbon source in a microwave plasma. The coating is formed at reduced pressure with 0.1 mbar using acetylene microwave energy, followed by an air rinse. | Sidel S.A. (ACTIS Technology) | A technology used to produce an amorphous hydrogenated carbon coating for food-contact containers to provide an improved barrier to permeation of the polyethylene terephthalate (PET) bottle by oxygen, carbon dioxide, and other substances. |
Limitations/ Specifi- cations |
July 19, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Sidel S.A. (ACTIS Technology) | ||||||||||||||||||||||||||||||||
| 63 | Styrene block polymers with 2-methyl-1,3-butadiene and 1,3-butadiene, hydrogenated (CAS Reg. No.132778-07-5) in food contact applications. | Kuraray America, Inc., Kuraray Co., Ltd., Kuraray Europe, GmbH, and SEPTON Company of America | For use as a basic resin in food-contact articles. |
Limitations/ Specifi- cations |
July 22, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Kuraray America, Inc., Kuraray Co., Ltd., Kuraray Europe, GmbH, and SEPTON Company of America | ||||||||||||||||||||||||||||||||
| 64 | Diallyldimethylammonium chloride polymer with acrylamide (CAS Reg. No. 26590-05-6). The copolymers are produced by copolymerizing diallyldimethylammonium chloride with acrylamide in weight ratios ranging from 85/15 to up to but not including 50/50 diallyldimethylammonium chloride/acrylamide. | Nalco Chemical Company | For use only as a drainage and/or retention aid employed prior to the sheet-forming operation in the manufacture of food-contact paper and paperboard. |
Limitations/ Specifi- cations |
July 27, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Nalco Chemical Company | ||||||||||||||||||||||||||||||||
| 67 | 3,6,9-triethyl -3,6,9-trimethyl -1,2,4,5,7,8-hexoxonane (CAS Reg. No. 24748-23-0) . | Akzo Nobel Chemicals, Inc. | As a rheology modifier in the production of olefin polymers complying with either 21 CFR 177.1520 or 177.2600. |
Limitations/ Specifi- cations |
August 2, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Akzo Nobel Chemicals, Inc. | ||||||||||||||||||||||||||||||||
| 68 | Butene-1, polymer with propylene (CAS Reg. No. 29160-13-2), containing more than 15 but not greater than 35 weight percent of polymer units derived from butene-1. | Mitsui Chemicals Inc. | In blends with polypropylene-based olefin polymers complying with 21 CFR 177.1520(c), items 1.1, 3.1 and 3.2, at levels not to exceed 30 weight percent of the total blend. |
Limitations/ Specifi- cations |
July 27, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Mitsui Chemicals Inc. | ||||||||||||||||||||||||||||||||
| 69 | (1) Styrene -butadiene -methacrylic acid terpolymer (CAS Reg. No. 9010-93-9), (2) 1,2 -benzisothiazolin -3-one (CAS Reg. No. 2634-33-5), and (3) sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether, disodium salt (CAS Reg. No. 39354-45-5). | W.R. Grace, Ltd. | As components of can end cements. |
Limitations/ Specifi- cations |
July 13, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| W.R. Grace, Ltd. | ||||||||||||||||||||||||||||||||
| 70 | Carbon monoxide-ethylene copolymer (CAS Reg. No. 111190-67-1); and Carbon monoxide - ethylene -propylene terpolymer (CAS Reg. No. 88995-51-1) containing no more than 8 mole-percent of propylene. | Shell Chemical Company | For use in articles intended for repeated-use in food processing establishments, for multilayer flexible packaging for refrigerated food products, and for reheatable or microwavable rigid retort packaging for food. |
Limitations/ Specifi- cations |
July 14, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Shell Chemical Company | ||||||||||||||||||||||||||||||||
| 71 | Partially hydrolyzed (40-50%) polyvinyl alcohol, modified with up to 2 percent by weight crotonic acid (i.e. a terpolymer of vinyl acetate, vinyl alcohol and crotonic acid). | Harlow Chemical Company, Ltd. | For use as a secondary stabilizer in the suspension polymerization of polyvinyl chloride. |
Limitations/ Specifi- cations |
July 28, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Harlow Chemical Company, Ltd. | ||||||||||||||||||||||||||||||||
| 72 | Ethylene terephthalate-isophthalate copolymers. | KoSa | As the base sheet in the manufacture of repeat-use food-contact articles intended to contact aqueous, acidic and low-alcohol food at temperatures 49°C. |
Limitations/ Specifi- cations |
August 10, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| KoSa | ||||||||||||||||||||||||||||||||
| 73 | Epoxy resin coatings otherwise complying with 21 CFR 175.300(b)(3)(viii) that also contain polyoxypropylenediamine (CAS Reg. No. 9046-10-0) as a cross linking component. | Belzona, Inc. | As a coating that is intended for repeated use in contact with beer. |
Limitations/ Specifi- cations |
August 17, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Belzona, Inc. | ||||||||||||||||||||||||||||||||
| 74 | Completely hydrolyzed tetra-polymer of divinyl benzene, ethyl vinyl benzene, acrylonitrile, and 1,7-octadiene as an ion exchange resin. (CAS Reg. No. 130353-60-5). | LANXESS Corporation | For use in demineralizing sugar solutions prior to recrystallization, and to soften water for food and beverage production. | Limitations/ Specifi- cations |
August 16, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| LANXESS Corporation | ||||||||||||||||||||||||||||||||
| 75 | Ethylene-2-norbornene copolymer (CAS Reg. No. 26007-43-2). The CAS nomenclature is bicyclo{2.2.1} hept-2-ene, polymer with ethene. | Topas Advanced Polymers Incorporated | To manufacture films, sheets, and articles made therefrom for food-contact applications; not for use in making bottles. |
Limitations/ Specifi- cations |
August 22, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Topas Advanced Polymers Incorporated | ||||||||||||||||||||||||||||||||
| 76 | A modified, branched poly dimethyl hydrogen methylsiloxane (containing small amounts of trivinyl cyclohexane, CAS Reg. No. 2855-27-8), synthesized as described in the notification, from trivinylcyclohexane and sigma, omega' -dihydropolydimethyl siloxane with platinum catalysis followed by reaction with polyhydrogen methyl dimethylsiloxane. | Wacker Silicones/ Wacker Chemie GmbH | As a cross linking agent in the manufacture of poly dimethyl hydrogen methylsiloxane complying with 21 CFR 175.300 and 175.320 and intended for use: 1) as a component of food packaging articles; 2) in molds used to manufacture food-contact material; and 3) as a component of release coatings (a dehesive) for use with pressure-sensitive labels. |
Limitations/ Specifi- cations |
August 24, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Wacker Silicones/ Wacker Chemie GmbH | ||||||||||||||||||||||||||||||||
| 78 | Sebacic acid (1,8-octanedicarboxylic acid, as a component of lubricants that otherwise comply with 21 CFR 178.3570 (CAS Reg. No. 111-20-6). | Lubrizol Corporation | Incidental food-contact lubricants made with sebacic acid (added as a corrosion inhibitor). |
Limitations/ Specifi- cations |
August 31, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Lubrizol Corporation | ||||||||||||||||||||||||||||||||
| 79 | High silicon iron. The formulation is as follows:
|
Flowserve Corporation | Pump and pipe material used in transporting food. | Limitations/ Specifi- cations |
September 2, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Flowserve Corporation | ||||||||||||||||||||||||||||||||
| 80 | 2,6-di-tert-butyl -4-sec-butylphenol (CAS Reg. No. 17540-75-9). | Schenectady International, Inc. | As an antioxidant in plasticized PVC. |
Limitations/ Specifi- cations |
September 20, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Schenectady International, Inc. | ||||||||||||||||||||||||||||||||
| 83 | Poly (oxy(1,1'-biphenyl) -4,4'-diyloxy -1,4-phenylenesulfonyl -1,4-phenylene) (CAS Reg. No. 25839-81-0). | BP Amoco Chemicals, Inc. | For repeated use in contact with food. |
Limitations/ Specifi- cations |
September 23, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BP Amoco Chemicals, Inc. | ||||||||||||||||||||||||||||||||
| 84 | Color Index (C.I.) Pigment Yellow 212 Chemical Name: Benzoic acid, 2-((4,5-dihydro -3-methyl -5-oxo -1-(3-sulfophenyl)-1H-pyrazol-4-yl)azo)-,strontium salt (1:1) (CAS Reg. No. 250640-73-4). | BASF Corporation | As a colorant in all food-contact polymers. |
Limitations/ Specifi- cations |
October 3, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BASF Corporation | ||||||||||||||||||||||||||||||||
| 85 | Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of dimethyl terephthalate or terephthalic acid and ethylene glycol with one or more of the following: dimethyl isophthalate, isophthalic acid, and diethylene glycol. The finished polymer shall contain a total of not more than 10 mole-percent of diethylene glycol and isophthalate units, with the diethylene glycol content expressed as a mole-percent of the total glycol units and the isophthalate content expressed as a mole-percent of the total isophthalate/terephthalate units. | M&G Polymers USA, LLC; Eastman Chemical Company; E.I. duPont de Nemours & Co., DuPont Polyester Enterprise and DuPont Teijin Films; Wellman, Inc.; KoSa | For use as films or articles intended for contact with aqueous, acidic, low-alcohol, and fatty foods under Conditions of Use A through H as described in Table 2, and for use in contact with high-alcohol foods under conditions of use E through G as described in Table 2. |
Limitations/ Specifi- cations |
October 5, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| M&G Polymers USA, LLC; Eastman Chemical Company; E.I. duPont de Nemours & Co., DuPont Polyester Enterprise and DuPont Teijin Films; Wellman, Inc.; KoSa | ||||||||||||||||||||||||||||||||
| 87 | 1,4 -cyclohexanedimethanol | Eastman Chemical Company | As a polyhydric alcohol for use in the manufacture of polyester resins intended for use in coatings complying with 21 CFR 175.300(b)(3)(vii)(c). |
Limitations/ Specifi- cations |
October 7, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Eastman Chemical Company | ||||||||||||||||||||||||||||||||
| 88 | Terephthaloyl dichloride (CAS Reg. No. 100-20-9). | Huntsman Polyurethanes | As an acidifier or stabilizer for diphenyl methane-4,4'-diisocyanate prepolymer used in the manufacture of polyurethane for further manufacture of adhesives complying with 21 CFR 175.105. |
Limitations/ Specifi- cations |
October 17, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Huntsman Polyurethanes | ||||||||||||||||||||||||||||||||
| 89 | Polyethylene glycol mono-isotridecyl ether sulfate, sodium salt (CAS Reg. No. 150413-26-6). | CONDEA Servo | As a surfactant in latex formulations used in pigment binders for paper and paperboard intended to contact aqueous, acidic, and low-alcohol foods. |
Limitations/ Specifi- cations |
October 12, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| CONDEA Servo | ||||||||||||||||||||||||||||||||
| 90 | Epoxy resin coatings otherwise complying with 21 CFR 175.300(b)(3)(viii) that also contain 9,10-anthracenedione, 1-hydroxy -4-((4-methylphenyl) amino)- (C.I. Solvent Violet 13) as a pigment (CAS Reg. No. 81-48-1). | Belzona, Inc. | As a coating that is intended for repeated use in contact with beer. |
Limitations/ Specifi- cations |
August 17, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Belzona, Inc. | ||||||||||||||||||||||||||||||||
| 91 | Epoxy resin coatings otherwise complying with 21 CFR 175.300(b)(3)(viii) that also contain 1-(2-aminoethyl) piperazine as a crosslinking component (CAS Reg. No. 140-31-8). | Belzona, Inc. | As a coating that is intended for repeated use in contact with beer. |
Limitations/ Specifi- cations |
August 17, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Belzona, Inc. | ||||||||||||||||||||||||||||||||
| 92 | Trimethylolpropane (CAS Reg. No. 77-99-6). | Kerr-McGee Chemical, LLC | Milling aid and dispersant for pigments used as components of food-contact articles. |
Limitations/ Specifi- cations |
October 25, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| LANXESS Corporation and Polioli s.p.a. | ||||||||||||||||||||||||||||||||
| 93 | Vinyl neodecanoate (CAS Reg. No. 51000-52-3). | Resolution Performance Products, LLC | As the monomeric component of vinyl neodecanoate homopolymers and as the comonomer in copolymers manufactured using the monomers listed under the substance heading entitled "Polymers: Homopolymers and copolymers of the following monomers" in 21 CFR 175.105(c)(5) and 21 CFR 176.180(b)(2). The finished homopolymers and copolymers would be used as components of adhesive formulations complying with 21 CFR 175.105 and as components of coatings of paper and paperboard complying with 21 CFR 176.180. |
Limitations/ Specifi- cations |
November 7, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Resolution Performance Products, LLC | ||||||||||||||||||||||||||||||||
| 96 | Polyoxymethylene copolymer (CAS Reg. No. 24969-26-4) produced from the reaction of trioxane (cyclic trimer of formaldehyde) and 1,3-dioxolane. | Mitsubishi Engineering-Plastics Corp. | As a component of articles intended for repeat use complying with 21 CFR 177.2470. |
Limitations/ Specifi- cations |
November 22, 2000 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Mitsubishi Engineering-Plastics Corp. | ||||||||||||||||||||||||||||||||
| 97 | Polyethylene glycol (400) monooleate (CAS Reg. No. 9004-96-0). | BetzDearborn, Inc. | As an anti-corrosive agent in the steam header and steam lines of boiler systems in which the steam will contact food. |
Limitations/ Specifi- cations |
November 23, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| BetzDearborn, Inc. | ||||||||||||||||||||||||||||||||
| 98 | 2-Propenoic acid, 2-methyl, monoester with 1,2-propanediol, polymer with methyl 2-propenoate, 2-propenoic acid and sodium 2-propenoate (CAS Reg. No. 117675-55-5), manufactured and characterized as described in the notification. | Ciba Specialty Chemicals Corp. | As a fluid absorbent in food-contact materials. |
Limitations/ Specifi- cations |
December 8, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Technical Absorbents, Inc. | ||||||||||||||||||||||||||||||||
| 99 | Hydroxymethyl-5,5-dimethylhydantoin (MMDMH)(CAS Reg. No. 27636-82-4), mixture with 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMDMH) (CAS Reg. No. 6440-58-0). | Lonza, Inc. | As adjuvants in the bleaching of recycled paper and paperboard intended to contact food. |
Limitations/ Specifi- cations |
December 9, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Lonza, Inc. | ||||||||||||||||||||||||||||||||
| 100 | Polyvinyl alcohol (CAS Reg. No. 9002-89-5), manufactured as described in the FCN. | Agway, Inc. | As a component of coatings applied to fruits and vegetables with inedible peels, excluding citrus fruits. |
Limitations/ Specifi- cations |
December 15, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| Agway, Inc. | ||||||||||||||||||||||||||||||||
| 101 | Perfluorocarbon cured elastomers produced by polymerizing perfluoro(methyl vinyl ether) (CAS Reg. No. 1187-93-5) with tetrafluoroethylene (CAS Reg. No. 116-14-3) and perfluoro(8-cyano -5-methyl -3,6-dioxa -1-octene) (CAS Reg. No. 69804-19-9), followed by curing with trimethylallyl isocyanurate (CAS Reg. No. 6291-95-8) and/or triallyl isocyanurate (CAS Reg. No. 1025-15-6), and with 2,5 -dimethyl -2,5-di (t-butylperoxy) hexane (CAS Reg. No. 78-63-7) and as further described in this notification. | DuPont Performance Elastomers L.L.C. | For use in the fabrication of articles intended for repeated use in contact with food. |
Limitations/ Specifi- cations |
December 19, 2000 | EA/ FONSI | ||||||||||||||||||||||||||
| DuPont Performance Elastomers L.L.C. | ||||||||||||||||||||||||||||||||
| 102 | Phenol, 2-(1,1-dimethylethyl)-6-methyl-4-(3-((2,4,8,10-tetrakis(1,1-dimethylethyl)dibenzo(d,f)(1,3,2)dio xaphosphepin-6-yl)oxy)propyl) (CAS Reg. No. 203255-81-6). | Sumitomo Chemical Company, Ltd. | As an antioxidant and/or stabilizer for olefin polymers for use in contact with food. |
Limitations/ Specifi- cations |
February 27, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Sumitomo Chemical Company, Ltd. | ||||||||||||||||||||||||||||||||
| 103 | Copolymers produced by the polymerization of 6-hydroxy-2-naphthoic acid with one or more of the following monomers: 4-hydroxybenzoic acid; 4,4'-biphenol; N-(4-hydroxyphenyl)acetamide; terephthalic acid; resorcinol; and isophthalic acid such that a minimum of 55 percent of the polymer units are derived from 6-hydroxy-2-naphthoic acid alone or in combination with 4-hydroxybenzoic acid, not more than 25 percent of the polymer units are derived individually from 4,4'-biphenol, N-(4-hydroxyphenyl)acetamide and terephthalic acid, and not more than 15 percent of the polymer units are derived individually from resorcinol and isophthalic acid. The copolymers should be manufactured and characterized as described in the notification. | Ticona | In the production of films, sheets and articles made therefrom used in the fabrication of food packaging materials. Does not include use of the food contact substance in the manufacture of bottles intended for food-contact applications. |
Limitations/ Specifi- cations |
February 21, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Ticona | ||||||||||||||||||||||||||||||||
| 104 | Hydroxymethyl-5,5-dimethylhydantoin (DMDMH) (CAS Reg. No. 27636-82-4), mixture with 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (MMDMH) (CAS Reg. No. 6440-58-0). | Lonza, Inc. | As preservatives for mineral (pigment) slurries (clay, kaolin clay, calcium carbonate or titanium dioxide) that are used as components of paper coatings used in the manufacture of food-contact paper and paperboard and as preservatives in mineral slurries of calcium carbonate or titanium dioxide that are used as fillers in the manufacture of food-contact paper and paperboard. |
Limitations/ Specifi- cations |
February 27, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Lonza, Inc. | ||||||||||||||||||||||||||||||||
| 105 | Sodium acrylate/styrene sulfonate copolymer. | Nalco Chemical Company | As an antiscalant boiler water treatment where steam from treated boilers may contact food. |
Limitations/ Specifi- cations |
February 3, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Nalco Chemical Company | ||||||||||||||||||||||||||||||||
| 106 | Styrene/ butadiene/ acrylonitrile copolymers (SBAN) (CAS Reg. No., exclusive of minor monomers, is 9003-56-9), copolymerized with not more than 10 percent of one or more of the monomers of acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid and methacrylic acid, manufactured according to the method described in this notification. | The Dow Chemical Company | As a component of paper and paperboard in contact with aqueous and fatty foods, complying with 21 CFR 176.170(b)(2). |
Limitations/ Specifi- cations |
December 27, 2000 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| The Dow Chemical Company | ||||||||||||||||||||||||||||||||
| 107 | Polyethylene glycol (CAS Reg. No. 25322-68-3). | Mitsubishi Engineering-Plastics Corp. | As a lubricant in repeat use poly oxymethylene copolymers as described in FCN 96. |
Limitations/ Specifi- cations |
November 22, 2000 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Mitsubishi Engineering-Plastics Corp. | ||||||||||||||||||||||||||||||||
| 109 | ((1,2,5,6-eta.) -1,5-cyclooctadiene) bis((4-(trimethylsilyl) phenyl)ethynyl)-platinum (CAS Reg. No. 234112-62-0). | Wacker Silicones Corporation | The platinum catalyst is used at low levels in the polymerization of precursors leading to the formation of silicone elastomers in repeated-use applications that contact food. |
Limitations/ Specifi- cations |
January 24, 2001 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Wacker Silicones Corporation | ||||||||||||||||||||||||||||||||
| 110 | Nitrile rubber-modified acrylonitrile-methyl acrylate copolymers (CAS Name: Polybutadiene-graft-poly(methyl acrylate-co-acrylonitrile), CAS Reg. No. 27012-62-0). | BP Chemicals, Inc. | For use in fabricating beverage containers and in film or sheet packaging. |
Limitations/ Specifi- cations |
February 17, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| BP Chemicals, Inc. | ||||||||||||||||||||||||||||||||
| 111 | 2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) as a 20 percent solution. | Thor GmbH | As an antimicrobial agent in adhesives and in components of adhesives for food-contact articles. As an antimicrobial agent in coating formulations and in additives used in the manufacture of paper and paperboard intended for use in contact with all food types. |
Limitations/ Specifi- cations |
February 20, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Thor GmbH | ||||||||||||||||||||||||||||||||
| 112 | Tris (2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4). | Ciba Specialty Chemicals Corp. | For use as a stabilizer in olefin copolymers described in 21 CFR 177.1520(a)(3)(iii) and meeting the specifications in 21 CFR 177.1520(c), item 3.4. |
Limitations/ Specifi- cations |
February 20, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corp. | ||||||||||||||||||||||||||||||||
| 113 | 2,4-dimethyl-6-(1-methylpentadecyl)phenol (CAS Reg. No. 134701-20-5). | Ciba Specialty Chemicals Corp. | As a stabilizer for flexible polyvinyl chloride films. |
Limitations/ Specifi- cations |
February 20, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corp. | ||||||||||||||||||||||||||||||||
| 115 | 2,9-bis(3,5-dimethylphenyl)anthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2 H, 9H)-tetrone (C.I. Pigment Red 149; CAS Reg. No. 4948-15-6). | BASF Corporation | As a colorant for all polymers intended for use in contact with food. |
Limitations/ Specifi- cations |
May 9, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| BASF Corporation | ||||||||||||||||||||||||||||||||
| 116 | Benzene propanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy, C13-C15 branched and linear alkyl esters (CAS Reg. No. 171090-93-0). | Great Lakes Chemical Corp. | As a stabilizer in food-contact polymers. |
Limitations/ Specifi- cations |
March 15, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Great Lakes Chemical Corp. | ||||||||||||||||||||||||||||||||
| 117 | Styrene-butyl acrylate copolymers. | Rohm and Haas Company | Components of coatings for paper and paperboard in compliance with 21 CFR 176.170(b). |
Limitations/ Specifi- cations |
May 17, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Rohm and Haas Company | ||||||||||||||||||||||||||||||||
| 118 | 2,9-bis(4-(phenylazo)phenyl)anthra (2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H, 9H)-tetrone (C.I. Pigment Red 178; CAS Reg. No. 3049-71-6). | BASF Corp. | As a colorant for all polymers intended for use in contact with food. |
Limitations/ Specifi- cations |
March 9, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| BASF Corp. | ||||||||||||||||||||||||||||||||
| 119 | Xanthan Gum (CAS Reg. No. 11138-66-2). | Avecia Inc. | As a thickener in antimicrobial formulations for use in food packaging adhesives. |
Limitations/ Specifi- cations |
March 21, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Avecia Inc. | ||||||||||||||||||||||||||||||||
| 123 | Polyester-epoxy-urethane adhesives formulated from: 1. Polyester resins described in 21 CFR 177.1390(c)(2)(v)(a). 1,6-Hexanediol may also be used as an optional polyhydric alcohol. 2. Optional epoxy resin listed in 21 CFR 175.300(b)(3)(viii)(a) and comprising up to 30 percent by weight of the cured adhesive. 3. Urethane cross-linking agent, as described in 21 CFR 177.1390(c)(2)(v)(c). 4. Optional trimethoxysilane coupling agents containing epoxy and/or ether groups not to exceed 3 percent by weight of the cured adhesive. | Toyo-Morton, Limited | The FCS may be used as an adhesive for laminate constructions intended for packaging all food types, except those containing more than 8 percent alcohol. The FCS may be used only for construction of retort pouches intended for use at a maximum temperature 135°C (275°F). The FCS may also be used as permitted by other regulatory clearances which incorporate by reference, materials cleared in 21 CFR 177.1390 provided such use is in retort pouch applications. |
Limitations/ Specifi- cations |
April 11, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Toyo-Morton, Limited | ||||||||||||||||||||||||||||||||
| 124 | Styrene block copolymers with 1,3-butadiene, containing not less than 71 weight percent of polymer units derived from styrene, to which may be optionally added octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3) at levels not to exceed 0.25 percent by weight of the styrene block polymer. | ATOFINA Petrochemicals, Inc. | As articles or components of articles intended for contact with all types of food. |
Limitations/ Specifi- cations |
July 4, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| ATOFINA Petrochemicals, Inc. | ||||||||||||||||||||||||||||||||
| 125 | Polyphenylene ether (CAS Reg. No. 25134-01-4). | SABIC Innovative Plastics | To be used as a component of adhesives (at a use level of 3-7 percent by weight) that are in compliance with 21 CFR 175.105, which are used to attach tapes and labels to boxes or other paper or paperboard packages that contain food items. Single use is intended. |
Limitations/ Specifi- cations |
April 27, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| SABIC Innovative Plastics | ||||||||||||||||||||||||||||||||
| 126 | 1,9-Decadiene,3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-, polymer with tetrafluoroethene and trifluoro(trifluoromethoxy)ethene (CAS Reg. No. 190062-24-9), manufactured and characterized as further described in the notification. | Solvay Solexis S.p.A. | As a gasket or seal for food processing equipment. |
Limitations/ Specifi- cations |
July 21, 2001 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Solvay Solexis S.p.A. | ||||||||||||||||||||||||||||||||
| 127 | 1-Propene,1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene and tetrafluoroethene (CAS Reg. No. 25190-89-0) modified with triallyl isocyanurate and 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-1,9-diene, manufactured and characterized as further described in the notification. | Solvay Solexis S.p.A. | As a gasket or seal for food processing equipment. |
Limitations/ Specifi- cations |
July 21, 2001 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Solvay Solexis S.p.A. | ||||||||||||||||||||||||||||||||
| 128 | A copolymer of tetrafluoroethylene (TFE) and perfluoromethylvinyl ether (PFMVE) (CAS Reg. No. 26425-79-6) modified with 1,3,5-triallyl isocyanurate (TAIC) and 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-1,9-diene, manufactured and characterized as further described in the notification. | Solvay Solexis S.p.A. | As a gasket or seal for food processing equipment. |
Limitations/ Specifi- cations |
July 21, 2001 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Solvay Solexis S.p.A. | ||||||||||||||||||||||||||||||||
| 129 | Ethene, tetrafluoro-, polymer with 1,1-difluoroethene and trifluoro(trifluoromethoxy)ethene (CAS Reg. No. 56357-87-0) modified with 1,3,5-triallyl isocyanurate (TAIC) and 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-1,9-diene, manufactured and characterized as further described in the notification. | Solvay Solexis S.p.A. | As a gasket or seal for food processing equipment. |
Limitations/ Specifi- cations |
July 21, 2001 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Solvay Solexis S.p.A. | ||||||||||||||||||||||||||||||||
| 130 | Styrene-acrylic copolymers. | BASF Corporation | Components of printing inks or coatings for paper and paperboard. |
Limitations/ Specifi- cations |
May 3, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| BASF Corporation | ||||||||||||||||||||||||||||||||
| 131 | 2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4). | Rohm and Haas Company | 1. As an antimicrobial agent for adhesives and components of adhesives used in accordance with 21 CFR 175.105. 2. as an antimicrobial agent for polymer latex emulsions in paper coatings complying with 21 CFR 176.170(b) at a level not to exceed 250 ppm (based on 2-methyl-4-isothiazolin-3-one), and 3. as an antimicrobial agent for finished paper and paperboard coating formulations complying with 21 CFR 176.170(b) and for additives used in the manufacture of paper and paperboard complying with 21 CFR 176.170 including latex emulsions, fillers, binders, pigment slurries, and sizing solutions at a level not to exceed 150 ppm (based on 2-methyl-4-isothiazolin-3-one) in the individual additives and not to exceed 150 ppm in the finished coating formulation. | None | April 17, 2001 | CAT. EXCL. 21 CFR 25.32 (q) | ||||||||||||||||||||||||||
| Rohm and Haas Company | ||||||||||||||||||||||||||||||||
| 132 | Quino(2,3-b)acridine-7, 14-dione,4,11-dichloro-5,12-dihydro- (CAS Reg. No. 3089-16-5). | Ciba Specialty Chemicals Corp. | As a colorant in all types of food-contact polymers. |
Limitations/ Specifi- cations |
May 19, 2001 | EA/FONSI | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corp. | ||||||||||||||||||||||||||||||||
| 133 | Bis-1,2-((N,N-diacetyl)amino-)ethane (CAS Reg. No. 10543-57-4). | Warwick International, Ltd. | As a bleaching agent in the manufacture of food-contact paper and paperboard products complying with 21 CFR 176.170. |
Limitations/ Specifi- cations |
May 30, 2001 | EA/FONSI | ||||||||||||||||||||||||||
| Warwick International, Ltd. | ||||||||||||||||||||||||||||||||
| 134 | Sodium zeolite A (CAS Reg. No. 68989-22-0). | John G. Blumbert, Esquire | As a costabilizer for polyvinyl chloride plastics intended for single and repeated use in contact with food, at levels not to exceed 5 percent by weight of the finished food-contact article. |
Limitations/ Specifi- cations |
May 30, 2001 | CAT. EXCL. 21 CFR 25.32 (i) and (j) | ||||||||||||||||||||||||||
| PQ Corporation | ||||||||||||||||||||||||||||||||
| 135 | Dimethyl-2,6-naphthalene dicarboxylate (NDC, CAS Reg. No. 840-65-3) or 2,6-naphthalene dicarboxylic acid (NDA, CAS Reg. No. 1141-38-4). | BP Amoco Chemical Company | As a chemically bound component in poly(ethylene terephthalate-isophthalate-2,6-naphthalate) (PET/I/N) copolymers. The PET/I/N copolymers will be used to manufacture articles or films intended for single serve or repeat use at temperatures up to and including Conditions of Use C through H as described in Table 2, in contact with food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII as defined in Table 1. |
Limitations/ Specifi- cations |
May 30, 2001 | Contact | ||||||||||||||||||||||||||
| BP Amoco Chemical Company | ||||||||||||||||||||||||||||||||
| 137 | Anthranilamide. The Chemical Abstracts Service (CAS) name is 2-aminobenzamide (CAS Reg. No. 88-68-6). | Coca-Cola Co., ColorMatrix Corp. and KoSa | As a scavenger for acetaldehyde in polyethylene terephthalate (PET) beverage bottles. |
Limitations/ Specifi- cations |
June 6, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Coca-Cola Co., ColorMatrix Corp. and KoSa | ||||||||||||||||||||||||||||||||
| 140 | A mixture of Peroxyacetic Acid, Acetic Acid, Hydrogen Peroxide, and 1-Hydroxyethylidene-1,1-Diphosphonic Acid (HEDP). | Ecolab Inc. | As an antimicrobial agent for red meat carcasses. |
Limitations/ Specifi- cations |
June 15, 2001 | EA/FONSI | ||||||||||||||||||||||||||
| Ecolab Inc. | ||||||||||||||||||||||||||||||||
| 141 | Cross-linked terpolymer of 1-vinylimidazole,1-vinylpyrrolidone and 1,3-divinylimidazolidinone (CAS Reg. No. 87865-40-5). The FCS is also known as Polyvinylimidazol. | Gordon Burns and Robert Ellsworth | As a component of matrix filter sheets, for removal of metals and sulfides in alcoholic beverages using repeat-usage filtering equipment. |
Limitations/ Specifi- cations |
July 10, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Gordon Burns and Robert Ellsworth | ||||||||||||||||||||||||||||||||
| 142 | Silicones and siloxanes, dimethyl, methylhydrogen, reaction products with polyethylene glycol monoallyl ether acetate (CAS Reg. No. 70914-12-4). | Dow Corning Corporation | As a defoaming agent in the manufacture of food-contact paper and paperboard. |
Limitations/ Specifi- cations |
July 19, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Dow Corning Corporation | ||||||||||||||||||||||||||||||||
| 143 | Octadecanoic acid, methyl ester, reaction products with 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinol (CAS Reg. No. 300711-92-6). | Ciba Specialty Chemicals Corporation | For use as a light stabilizer in polypropylene polymers and copolymers, and polyethylene polymers and copolymers (with a density not less than 0.94 grams per cubic centimeter), complying with 21 CFR 177.1520. |
Limitations/ Specifi- cations |
July 20, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corporation | ||||||||||||||||||||||||||||||||
| 144 | 5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt (CAS Reg. No. 6362-79-4). | Eastman Chemical Company | As a monomer to be copolymerized with monomers listed in 21 CFR 175.300(b)(3)(vii) to prepare polyester resins that may be used as coatings or components of coatings on any substrate contacting dry foods with surfaces containing no free fat or oil. |
Limitations/ Specifi- cations |
July 25, 2001 | CAT. EXCL. 21 CFR 25.32 (I) and (j) | ||||||||||||||||||||||||||
| Eastman Chemical Company | ||||||||||||||||||||||||||||||||
| 145 | Ethylene phthalate polymers identified in 21 CFR 177.1630(e)(4)(i) and 177.1630(e)(4)(ii), items 2 and 3, 177.1637 and FCN numbers 4, 13, 14, and 135 modified with 1,2,4,5-benzenetetracarboxylic dianhydride (pyromellitic dianhydride (PMDA)) (CAS Reg. No. 89-32-7). | BP Amoco Chemical Company | As a component of ethylene phthalate polymers complying with 21 CFR 177.1630(e)(4)(i) and in 177.1630(e)(4)(ii), items 2 and 3, and FCN Numbers 4, 13, 14, and 135, and ethylene naphthalate polymers complying with 21 CFR 177.1637. |
Limitations/ Specifi- cations |
July 31, 2001 | Contact | ||||||||||||||||||||||||||
| BP Amoco Chemical Company | ||||||||||||||||||||||||||||||||
| 146 | Poly-1-butene polymers (CAS Reg. No. 009003-28-5) and butene/ethylene copolymers (CAS Reg. No. 25087-34-7) as identified in 21 CFR 177.1570(a). | Basell Polyolefins N.V. | As articles or components of articles intended to contact food. |
Limitations/ Specifi- cations |
August 2, 2001 | EA/FONSI | ||||||||||||||||||||||||||
| Basell Polyolefins N.V. | ||||||||||||||||||||||||||||||||
| 147 | Ethylene phthalate polymers identified in 21 CFR 177.1630(e)(4)(i) and 177.1630(e)(4)(ii), items 2 and 3, 177.1637 and FCN numbers 4, 13, 14, 135 and 145 modified with polybutadienediol (PBD) (CAS Reg. Name: 1,3-Butadiene, homopolymer, hydroxy-terminated) (CAS Reg. No. 69102-90-5). | BP Amoco Chemical Company | As a component of ethylene phthalate polymers complying with 21 CFR 177.1630(e)(4)(i) and in 177.1630(e)(4)(ii), items 2 and 3, and FCN Numbers 4, 13, 14, 135 and 145, and ethylene naphthalate polymers complying with 21 CFR 177.1637. |
Limitations/ Specifi- cations |
August 4, 2001 | Contact | ||||||||||||||||||||||||||
| BP Amoco Chemical Company | ||||||||||||||||||||||||||||||||
| 148 | 2-Acrylamido-2-methylpropanesulfonic acid, in its free acid form (CAS Reg. No. 15214-89-8), and its sodium (CAS Reg. No. 5165-97-9), calcium (CAS Reg. No. 95176-15-1), potassium (CAS Reg. No. 52825-28-2), ammonium (CAS Reg. No. 58374-69-9), and lithium (CAS Reg. No. 77817-87-9) salts. | Lubrizol Corporation | The FCS will be used as a comonomer in the production of homopolymers and copolymers polymerized with other monomers listed in 21 CFR 175.105(c)(5) and 21 CFR 176.180(b)(2) under the subcategory for "Polymers: Homopolymers and copolymers of the following monomers" or with other monomers authorized for use in the manufacture of polymers intended for use in adhesives or in paper and paperboard intended to contact dry foods. The finished FCS will be used as components of adhesives complying with the provisions of 21 CFR 175.105 and as components of paper and paperboard in contact with dry foods complying with the provisions of 21 CFR 176.180. |
Limitations/ Specifi- cations |
August 7, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Lubrizol Corporation | ||||||||||||||||||||||||||||||||
| 150 | Quinacridone red (Alternate names: (1) Quino(2,3-b)acridine-7,14-dione, 5, 12-dihydro- and (2) C.I. Pigment violet 19, C.I. 73900) (CAS Reg. No. 1047-16-1). | Ciba Specialty Chemicals Corporation | As a colorant in paper and paperboard. |
Limitations/ Specifi- cations |
August 24, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corporation | ||||||||||||||||||||||||||||||||
| 151 | Pyromellitic dianhydride (CAS Reg. No. 89-32-7). | Gruppo Mossi & Ghisolfi | The FCS will be used as a modifier for polyethylene phthalate polymers prepared by the condensation of dimethyl terephthalate or terephthalic acid and dimethyl isophthalate or isophthalic acid with ethylene glycol. |
Limitations/ Specifi- cations |
August 29, 2001 | Contact | ||||||||||||||||||||||||||
| Gruppo Mossi & Ghisolfi | ||||||||||||||||||||||||||||||||
| 155 | Silicon dioxide (CAS Reg. No. 7631-86-9). | Tetra Pak, Inc. | The FCS will be used as an amorphous plasma-deposited silicon coating on the food-contact surface of polyethylene terephthalate (PET) food packaging articles. |
Limitations/ Specifi- cations |
August 31, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Tetra Pak, Inc. | ||||||||||||||||||||||||||||||||
| 156 | Cellulose, regenerated polymer with epichlorohydrin, carboxymethyl 2-hydroxypropyl ether (CAS Reg. No. 343844-23-5). The FCS is also referred to as carboxymethyl (CM) ion exchange cellulose resin. | Invitrogen Corporation | The CM ion exchange cellulose resin is used to isolate and purify soluble protein from aqueous process streams for food processing. |
Limitations/ Specifi- cations |
September 4, 2001 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Invitrogen Corporation | ||||||||||||||||||||||||||||||||
| 157 | 1. Cellulose, regenerated, polymer with epichlorohydrin, 2-(diethylamino) ethyl 2-hydroxypropyl ether, (CAS Reg. No. 343845-30-7) (High Capacity). The FCS is also referred to as diethylaminoethyl (DEAE) ion exchange cellulose resin (High Capacity). 2. Cellulose, regenerated, polymer with epichlorohydrin, 2-(diethylamino) ethyl ether, (CAS Reg. No. 343846-01-5) (Medium Capacity). The FCS is also referred to as diethylaminoethyl (DEAE) ion exchange cellulose resin (Medium Capacity). | Invitrogen Corporation | The DEAE ion exchange resins are used to isolate and purify soluble proteins from aqueous process streams for food processing. |
Limitations/ Specifi- cations |
September 13, 2001 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Invitrogen Corporation | ||||||||||||||||||||||||||||||||
| 161 | Piperylene/2-methyl-2-butene copolymer resins (CAS Reg. No. 26813-14-9) and Piperylene/2-methyl-2-butene/alpha-methylstyrene terpolymer resins (CAS Reg. No. 62258-49-5), and as further described in the identity and manufacturing sections of the notification. | The Goodyear Tire & Rubber Company | As components of pressure-sensitive adhesives used as the food-contact surface of labels and tapes as provided in 21 CFR 175.125 Pressure-sensitive adhesives. |
Limitations/ Specifi- cations |
October 2, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| The Goodyear Tire & Rubber Company | ||||||||||||||||||||||||||||||||
| 162 | 2-Propenoic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters (CAS Reg. No. 174254-23-0). | Goldschmidt Chemical Corporation | As a stabilizer and/or dispersant for olefin polymers intended for use in contact with food. The FCS may also be used in accordance with food additive regulations and effective notifications which incorporate by reference materials cleared in 21 CFR 177.1520, 178.2010, and 178.3725, provided such use is in olefin polymers. |
Limitations/ Specifi- cations |
October 4, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Goldschmidt Chemical Corporation | ||||||||||||||||||||||||||||||||
| 163 | A mixture of ca. 49 percent by weight of polyethylene glycol (400) monooleate and ca. 34 percent by weight of polyethylene glycol (400) dioleate. | Lonza, Inc. | The FCS will be used as an anti-corrosive agent in the steam header and steam lines of boiler systems where the steam will contact food. |
Limitations/ Specifi- cations |
October 11, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Lonza, Inc. | ||||||||||||||||||||||||||||||||
| 164 | Phenol, 2-(5-chloro-2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylethyl)- (CAS Reg. No. 3864-99-1). | Ciba Specialty Chemicals | As an ultraviolet light absorber in polyethylene phthalate polymers. |
Limitations/ Specifi- cations |
October 16, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals | ||||||||||||||||||||||||||||||||
| 165 | Polyphenylene sulfide (CAS Reg. No. 25212-74-2 or 26125-40-6). | Polyplastics | Component of repeated use food-contact articles. |
Limitations/ Specifi- cations |
October 16, 2001 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Polyplastics and Kureha | ||||||||||||||||||||||||||||||||
| 166 | Aromatic petroleum hydrocarbon resin, hydrogenated (CAS Reg. No. 88526-47-0), produced by the catalytic polymerization of aromatic substituted olefins from low boiling distillates of cracked petroleum stocks with a boiling point no greater than 220°C (428°F), and the subsequent catalytic reduction of the resulting aromatic petroleum hydrocarbon resin. | Arakawa Chemical Industries, Ltd. | As a component in blends with other polymers that are used in the manufacture of food-contact materials. |
Limitations/ Specifi- cations |
November 13, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Arakawa Chemical Industries, Ltd. | ||||||||||||||||||||||||||||||||
| 168 | An approximately 1:1 ratio mixture of hydroxymethyl-5,5-dimethylhydantoin (MMDMH) (CAS Reg. No. 27636-82-4) and 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMDMH) (CAS Reg. No. 6440-58-0), containing up to 8.5 percent by weight dimethylhydantoin. | Lonza, Inc. | As adjuvants in the bleaching of recycled paper and paperboard. |
Limitations/ Specifi- cations |
November 28, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Lonza, Inc. | ||||||||||||||||||||||||||||||||
| 172 | 5,7-bis(1,1-dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-xylene (CAS Reg. No. 181314-48-7). | Ciba Specialty Chemicals | As an antioxidant and/or stabilizer for adhesives and polymers. |
Limitations/ Specifi- cations |
December 11, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals | ||||||||||||||||||||||||||||||||
| 173 | Polyacrylic acid homopolymer, or copolymer of acrylic acid and up to 10 percent alkyl (C10-C30) methacrylate, crosslinked with either allyl sucrose (CAS Reg. No. 68784-14-5) or allyl pentaerythritol (CAS Reg. No. 91648-24-7); optionally contains up to 7 percent block copolymer surfactant of fatty acid (C12-C18) and polyethylene glycol. | Lubrizol Advanced Materials | As a thickener for hand sanitizers intended for use in food service establishments. |
Limitations/ Specifi- cations |
February 16, 2002 | EA/ FONSI | ||||||||||||||||||||||||||
| Lubrizol Advanced Materials | ||||||||||||||||||||||||||||||||
| 174 | Copolymers produced by the polymerization of 6-hydroxy-2-naphthoic acid and 4-hydroxybenzoic acid. The copolymers have the CAS name 2-naphthalenecarboxylic acid, 6-hydroxy-, polymer with 4-hydroxybenzoic acid (CAS Reg. No. 81843-52-9). The copolymers should be manufactured and characterized as described in the notification. | Polyplastics | In the production of films, sheets and articles made therefrom, and in molded articles in contact with food. Does not include use of the food contact substance in the manufacture of bottles intended for beverages or similar food-contact applications. |
Limitations/ Specifi- cations |
December 20, 2001 | EA/ FONSI | ||||||||||||||||||||||||||
| Polyplastics | ||||||||||||||||||||||||||||||||
| 175 | 2-Pyridinethiol-1-oxide, sodium salt (CAS Reg. No. 3811-73-2). | Arch Chemicals, Inc. | To be used as an antimicrobial agent in adhesives and in components of adhesives in paper towels for use in contact with aqueous and fatty foods. |
Limitations/ Specifi- cations |
February 7, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Arch Chemicals, Inc. | ||||||||||||||||||||||||||||||||
| 176 | Phenol, 2-(1,1-dimethylethyl)-6-methyl-4-(3-((2,4,8,10-tetrakis(1,1-dimethylethyl)dibenzo(d,f)(1,3,2)dio xaphosphepin-6-yl)oxy)propyl)(CAS Reg. No. 203255-81-6). | Sumitomo Chemical Company, Ltd. | As an antioxidant and/or stabilizer for olefin polymers for use in contact with food. |
Limitations/ Specifi- cations |
December 27, 2001 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Sumitomo Chemical Company, Ltd. | ||||||||||||||||||||||||||||||||
| 177 | Aluminum lithium carbonate hydroxide trihydrate (CAS Reg. No. 150607-28-6). | Mizusawa Industrial Chemicals, Ltd., Tokyo, Japan | As an additive in the production of polypropylene complying with 21 CFR 177.1520 Olefin polymers. |
Limitations/ Specifi- cations |
February 19, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Mizusawa Industrial Chemicals, Ltd., Tokyo, Japan | ||||||||||||||||||||||||||||||||
| 178 | Polylactide polymers (CAS Reg. No. 9051-89-2). The polymers will be manufactured and characterized as described in the notification. | NatureWorks LLC | As components of articles intended to contact food. |
Limitations/ Specifi- cations |
January 3, 2002 | EA/ FONSI | ||||||||||||||||||||||||||
| NatureWorks LLC | ||||||||||||||||||||||||||||||||
| 179 | Copolymers and polymers made from the reaction of dimethyl terephthalate or terephthalic acid with a mixture containing 99 to 0 mole percent of ethylene glycol and 1 to 100 mole percent of 1,4-cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer). The FCS is further identified as follows: Ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25640-14-6), manufactured from dimethylterephthalate (DMT), ethylene glycol (EG), and 1,4-cyclohexanedimethanol (CHDM). Ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25038-91-9), manufactured from terephthalic acid (TPA), EG, and CHDM. 1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25135-20-0), manufactured with DMT and CHDM. 1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25037-99-4), manufactured with TPA and CHDM. | Eastman Chemical Company | The FCS will be used as films or articles or components of films or articles, in either a non-oriented or oriented finished form, intended for contact with aqueous, acidic, low-alcohol (up to 13 percent by volume), and fatty foods under Conditions of Use C through G as described in Table 2, and for use in foods containing up to 25 percent, by volume, alcohol under conditions of use E through G as described in Table 2. |
Limitations/ Specifi- cations |
January 3, 2002 | EA/ FONSI | ||||||||||||||||||||||||||
| Eastman Chemical Company | ||||||||||||||||||||||||||||||||
| 180 | Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis(5-((4-(bis(2-hydroxyethyl)amino)-6-((4-sulfophenyl)amino)-1,3,5-triazin -2-yl)amino)-, tetrasodium salt (CAS Reg. No. 16470-24-9). | 3V, Inc. | As an optical brightener in paper and paperboard. |
Limitations/ Specifi- cations |
March 6, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| 3V, Inc. | ||||||||||||||||||||||||||||||||
| 181 | Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-,octadecyl ester (CAS Reg. No. 2082-79-3). The FCS is also known as octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate. | Ciba Specialty Chemicals | As a stabilizer for flexible polyvinyl chloride (PVC). The FCS is added to vinyl chloride monomer during the polymerization process. |
Limitations/ Specifi- cations |
January 15, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals | ||||||||||||||||||||||||||||||||
| 182 | Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared by reacting hexanedioic acid, 1,2-ethanediamine, N-(2-aminoethyl)-1,3-propanediamine, N,N"-1,2-ethanediylbis-1,3-propanediamine, (chloromethyl)oxirane, ethyleneimine(aziridine), and polyethylene glycol, and partly neutralized with sulfuric acid (CAS Reg. No. 167678-43-5) or formic acid (CAS Reg. No. 114133-44-7). | BASF Corporation | For use as a retention aid employed prior to the sheet-forming operation in the manufacture of paper and paperboard. |
Limitations/ Specifi- cations |
January 17, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| BASF AG/BASF Corporation | ||||||||||||||||||||||||||||||||
| 183 | Butanedioic acid, dimethyl ester, polymer with 4-hydroxy-2,2,6,6-tetramethyl-1-piperidineethanol (CAS Reg. No. 65447-77-0). | Ciba Specialty Chemicals | For use as a stabilizer for rubber articles complying with 21 CFR 177.2600 (Rubber articles intended for repeated use). |
Limitations/ Specifi- cations |
January 26, 2002 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals | ||||||||||||||||||||||||||||||||
| 184 | Phenol, 2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)- (CAS Reg. No. 70321-86-7). | Ciba Specialty Chemicals Corp. | For use as a stabilizer in rubber articles intended for repeat use complying with 21 CFR 177.2600. |
Limitations/ Specifi- cations |
January 26, 2002 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corp. | ||||||||||||||||||||||||||||||||
| 185 | Amorphous hydrogenated carbon coating produced from acetylene as the carbon source in a radio-frequency plasma as described in the notification. | Mitsubishi Shoji Plastics Corp. | As a coating on the interior of polyethylene terephthalate (PET) bottles used in single-use food-contact applications. |
Limitations/ Specifi- cations |
January 29, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Mitsubishi Shoji Plastics Corp. | ||||||||||||||||||||||||||||||||
| 186 | Cis-endo-bicyclo(2.2.1)heptane-2,3-dicarboxylic acid, disodium salt (CAS Reg. No. 351870-33-2). | Milliken Chemical, Division of Milliken & Co. | As a nucleating agent in polypropylene and high density polyethylene, including homopolymers and copolymers, and in linear low density polyethylene polymers. |
Limitations/ Specifi- cations |
January 30, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Milliken Chemical, Division of Milliken & Co. | ||||||||||||||||||||||||||||||||
| 187 | Fluorinated polyurethane anionic resin (CAS Reg. No. 328389-91-9) prepared by reacting perfluoropolyether diol (CAS Reg. No. 88645-29-8), isophorone diisocyanate (CAS Reg. No. 4098-71-9), 2,2-dimethylolpropionic acid (CAS Reg. No. 4767-03-7), and triethylamine (CAS Reg. No. 121-44-8). | Solvay Solexis S.p.A. | As a water and oil repellent in the manufacture of paper and paperboard. |
Limitations/ Specifi- cations |
March 23, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Solvay Solexis S.p.A. | ||||||||||||||||||||||||||||||||
| 189 | Di-(para-methylbenzylidene)sorbitol (CAS Reg. No. 54686-97-4, 197809-37-3 and 81541-12-0) containing up to 1 percent triisopropanolamine. | Ciba Specialty Chemicals Corporation | As a clarifying agent for polypropylene homopolymers complying with 21 CFR 177.1520(c) Items 1.1a and 1.1b | Limitations/ Specifi- cations |
May 24, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Ciba Specialty Chemicals Corporation | ||||||||||||||||||||||||||||||||
| 190 | Copolymers of methyl methacrylate, acrylonitrile, butadiene and styrene (CAS Reg. No. 9010-94-0). The polymers will be manufactured and characterized as described in the notification. | SABIC Innovative Plastics | As components of repeated-use food-contact articles. | Limitations/ Specifi- cations |
February 16, 2002 | CAT. EXCL. 21 CFR 25.32 (j) | ||||||||||||||||||||||||||
| SABIC Innovative Plastics | ||||||||||||||||||||||||||||||||
| 191 | Hydrolized tetraethyl silicate (CAS Reg. No. 68412-37-3) | Wacker Chemie/Wacker Silicones | As a component of a cork primer used to aid in the adherence of silicone coatings to wine bottle closures. | Limitations/ Specifi- cations |
April 20, 2002 | CAT. EXCL. 21 CFR 25.32(i) | ||||||||||||||||||||||||||
| Wacker Chemie/Wacker Silicones | ||||||||||||||||||||||||||||||||
| 192 | 12H-dibenzol(d,g)(1,3,2)dioxaphosphocin, 2,4,8,10-tetrakis(1,1-dimethylethyl)-6-((2-ethylhexyl)oxy)- (CAS Reg. No. 126050-54-2). | Asahi Denka Kogyo K.K. | As an antioxidant and/or a stabilizer in rubber modified polystyrene. | Limitations/ Specifi- cations |
February 27, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Asahi Denka Kogyo K.K. | ||||||||||||||||||||||||||||||||
| 193 | Silver zinc zeolite, a mixture of silver-magnesium-zinc-calcium phosphate sodium alumino silicate, zinc oxide (CAS Reg. No. 1314-13-2), and hydrotalcite (CAS Reg. No. 12304-65-3). | Ciba Specialty Chemicals Corp. | The FCS will be used as an antimicrobial agent in all types of food-contact polymers. | Limitations/ Specifi- cations |
March 6, 2002 | CAT. EXCL. 21 CFR 25.32 (i) and (j) | ||||||||||||||||||||||||||
| Kanebo Chemical Industries, Ltd. | ||||||||||||||||||||||||||||||||
| 194 | Di-tert-amyl peroxide (CAS Reg. No. 10508-09-5). | Crompton Corporation | For use as a molecular weight modifier in the manufacture of polypropylene complying with 21 CFR 177.1520(a)(1), propylene copolymers complying with 21 CFR 177.1520(a)(3)(i), or propylene copolymers complying with applicable Food Contact Notifications. | Limitations/ Specifi- cations |
March 6, 2002 | CAT. EXCL. 21 CFR 25.32 (i) | ||||||||||||||||||||||||||
| Crompton Corporation | ||||||||||||||||||||||||||||||||
| 195 | Diphosphoric acid, polymers with ethoxylated reduced Me esters of reduced polymerized oxidized tetrafluoroethylene (CAS Reg. No. | |||||||||||||||||||||||||||||||