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U.S. Department of Health and Human Services
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CFSAN/Office of Food Additive Safety
December 2008

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Inventory of Effective
Food Contact Substance (FCS) Notifications

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 UsAccess to Regulations

FCN No. Food Contact Substance (FCS) Notifier

 

Intended Use Limitations/ Specifi-
cations
Effective Date Environ-
mental Decision
Manufacturer
of the FCS
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
 
 
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:
Compo-
nent
Percent by Weight
Grade 1 Grade 2
Cr 0.5 max 3.25-5.0
Mo 0.5 max 0.4-0.6
Cu 0.5 max 0.5 max
Si 14.2-14.75 14.2-14.75
Mn 1.5 max 1.5 max
C 0.7-1.1 0.75-1.15
Fe Bal-
ance
Bal-
ance
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. 200013-65-6). This substance is also known as: phosphate esters of ethoxylated perfluoroether, prepared by reaction of ethoxylated perfluoroether diol (CAS Reg. No. 162492-15-1) with phosphorous pentoxide (CAS Reg. No. 1314-56-3) or pyrophosphoric acid (CAS Reg. No. 2466-09-3). Solvay Solexis S.p.A. As a water and oil repellent in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
May 14, 2002 CAT. EXCL.
21 CFR 25.32 (i)
Solvay Solexis S.p.A.
196 1-Dodecene (CAS Reg. No. 112-41-4). Wacker Chemie/Wacker Silicones The FCS will be used in the manufacture of a vinyl-functional resin, which is a component of a primer used to aid in the adherence of silicone coatings to corks used as wine bottle closures. Limitations/ Specifi-
cations
May 14, 2002 CAT. EXCL.
21 CFR 25.32 (i)
Wacker Chemie/Wacker Silicones
197 Copolymers (polyurethanes) produced from 4,4'-methylenebis(cyclohexylisocyanate), polytetramethylene glycol, and polyethylene glycol (CAS Reg. No. 375387-19-2). UCB Films PLC As coatings on cellophane film. Limitations/ Specifi-
cations
March 8, 2002 CAT. EXCL.
21 CFR 25.32 (i)
UCB Films PLC
198 A copolymer of dimethyl terephthalate (CAS Reg. No. 120-61-6), 1,3-dimethyl-5-sulfo-1,3-benzenedicarboxylate, sodium salt (CAS Reg. No. 3965-55-7), and 1,6-hexanediol (CAS Reg. No. 629-11-8). Teijin Ltd. The FCS will be used as a nucleating agent in (a) polyethylene terephthalate (PET) polymers complying with 21 CFR 177.1630 and (b) polyethylene terephthalate (PET) polymers complying with the specifications in 21 CFR 177.1630(f) for which there is an effective food contact notification. Limitations/ Specifi-
cations
March 13, 2002 CAT. EXCL.
21 CFR 25.32 (i)
Teijin Ltd.
199 A mixture of imidazolium and imidazoline compounds, 9-Octadecenoic acid (9Z)-, reaction products wirh diethylenetriamine, cyclized, diethyl sulfate quaternized (CAS Reg. No. 68511-92-2) and Amides, C18 and C18unsaturated, N-(2-(2-(C17 and C17unsaturated alkyl)-4,5-dihydro-1H-imidazol-1-yl)ethyl) (CAS Reg. No. 71808-32-7). Hercules Inc. As a debonding agent in food-contact paper and paperboard at levels up to 0.5 percent by weight of the dry paper and paperboard. The FCS may also be used in accordance with food additive regulations and effective notifications which incorporate by reference materials cleared in 21 CFR 176.170 and 176.180. Limitations/ Specifi-
cations
April 20, 2002 CAT. EXCL.
21 CFR 25.32 (i)
Hercules Inc.
200 Pyromellitic dianhydride (CAS Reg. No. 89-32-7). Gruppo Mossi & Ghisolfi As a modifier for ethylene phthalate polymers identified in 21 CFR 177.1630(e)(4)(i) 21 CFR 177.1630(e)(4)(ii), items 2 and 3; poly(ethylene terephthalate-2,6-naphthalate) polymers identified in FCN numbers 8 and 9; poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalanedicarbonyl) polymers identified in 21 CFR 177.1637 and FCN 9, and polyethylene terephthalate-isophthalate-2,6-naphthalate) polymers identified in FCN 135. Limitations/ Specifi-
cations
March 20, 2002 Contact
Nippon Shokubai Co. Ltd.
Gruppo Mossi & Ghisolfi
201 2H-benzimidazole-2-thione, 1,3-dihydro-, 4(or 5)-methyl-, zinc salt(2:1) containing up to 4 percent by weight petroleum process oil. R. T. Vanderbilt Company, Inc. As an antioxidant synergist in natural or synthetic rubber gloves intended for repeat use in the meat packing industry. Limitations/ Specifi-
cations
May 30, 2002 EA/ FONSI
R. T. Vanderbilt Company, Inc.
202 Aluminum, hydroxybis(2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-12H-dibenzol(d,g)(1,3,2)dioxaphosphocin 6-oxidato)-, (CAS Reg. No. 151841-65-5). The FCS will be manufactured and characterized as described in the notification. Asahi Denka Kogyo K.K. For use as a clarifying and nucleating agent in polypropylene polymers and copolymers complying with 21 CFR 177.1520(c), items 1.1, 3.1 and 3.2. Limitations/ Specifi-
cations
May 4, 2002 CAT. EXCL.
21 CFR 25.32 (i)
Asahi Denka Kogyo K.K.
203 Acetic acid ethenyl ester, polymer with alpha-hydro-omega-hydroxypoly(oxy-1,2-ethanediyl), hydrolyzed. Harlow Chemical Company, Ltd. As a secondary stabilizer in the suspension polymerization of polyvinyl chloride. Limitations/ Specifi-
cations
May 24, 2002 CAT. EXCL.
21 CFR 25.32 (i)
Harlow Chemical Company, Ltd.
204 A mixture of the lithium salts of stearic acid (69.5 weight percent), palmitic acid (25.8 weight percent), myristic acid (1.6 weight percent), arachidonic acid (1 weight percent), and other carboxylic acids (2.1 weight percent). Asahi Denka Kogyo K.K. The FCS will be used as a stabilizer in polypropylene and olefin copolymers for use in food containers. Limitations/ Specifi-
cations
May 28, 2002 CAT. EXCL.
21 CFR 25.32 (i)
Asahi Denka Kogyo K.K.
206 Copolymer of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate. DuPont Chemical Solutions Enterprise The FCS will be used as an oil and grease-resistant treatment for paper and paperboard intended for food-contact use. Limitations/ Specifi-
cations
June 12, 2002 EA/ FONSI
DuPont Chemical Solutions Enterprise
208 Acetic acid ethenyl ester, polymer with ethenol and dimethyl maleate (DMM). This material is equivalent to poly(vinyl acetate-vinyl alcohol) (CAS Reg. No. 25213-24-5), polymerized with DMM (CAS Reg. No. 624-48-6)). Harlow Chemical Co. Ltd. As a stabilizer in the suspension polymerization of polyvinyl chloride (PVC). Limitations/ Specifi-
cations
April 3, 2002 CAT. EXCL.
21 CFR 25.32 (i)
Harlow Chemical Co. Ltd.
211 Isophthalic acid (CAS Reg. No. 121-91-5). Eastman Chemical Company As a monomer in the manufacture of ethylene terephthalate-isophthalate copolymers. Limitations/ Specifi-
cations
May 25, 2002 EA/ FONSI
Eastman Chemical Company
212 2-Cyano-3,3-diphenyl-2-propenoic acid ethyl ester (CAS Reg. No. 5232-99-5). BASF Aktiengesellschaft The FCS will be used as an ultraviolet-stabilizer for polyvinyl chloride (PVC). Limitations/ Specifi-
cations
April 26, 2002 CAT. EXCL.
21 CFR 25.32 (i)
BASF Aktiengesellschaft
215 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 as specified. Limitations/ Specifi-
cations
April 30, 2002 EA/ FONSI
Cryovac, Inc.
217 2-Cyano-3,3-diphenyl-2-propenoic acid 2-ethylhexyl ester (CAS Reg. No. 6197-30-4). BASF Aktiengesellschaft For use as a UV stabilizer in the manufacture of unplasticized polyvinyl chloride (PVC) and of polyethylene terephthalate (PET) polymers and copolymers complying with 21 CFR 177.1315, or 21 CFR 177.1630. Limitations/ Specifi-
cations
May 3, 2002 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
220 Methylmethacrylate-trimethylolpropane trimethacrylate copolymers (CAS Reg. No. 28931-67-1). Nippon Shokubai Ltd. The FCS will be used as an antiblocking agent in linear low-density polyethylene (LLDPE) copolymers intended for food-contact applications. Limitations/ Specifi-
cations
June 4, 2002 CAT. EXCL.
21 CFR 25.32(i) and (j)
Nippon Shokubai Ltd.
221 An approximately 1:1 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 residual 5,5-dimethylhydantoin on a dry basis (DMH)(CAS Reg. No. 77-71-4) or up to 5.5 percent in the formulated product. Lonza, Inc. As a preservative for mineral (pigment) slurries (clay, kaolin clay, calcium carbonate or titanium dioxide) that are used as paper fillers and/or components of paper coatings used in the manufacture of food-contact paper and paperboard. Limitations/ Specifi-
cations
May 24, 2002 EA/ FONSI
Lonza, Inc.
222 1,5-Cyclooctadiene (CAS Reg. No. 111-78-4). UBE Industries, Ltd. As a molecular weight modifier in the manufacture of polybutadiene which will be used in the production of high-impact polystyrene for food-contact use. Limitations/ Specifi-
cations
June 1, 2002 EA/ FONSI
Degussa-Huls Corp.
224 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate (TXIB) (CAS Reg. No. 6846-50-0). Eastman Chemical Co. The FCS will be used as a plasticizer in vinyl chloride polymers for use in repeated-use food-contact applications and in vinyl chloride polymer-based gloves used to process food. Limitations/ Specifi-
cations
June 7, 2002 EA/ FONSI
Eastman Chemical Co.
228 Silaneamine, 1,1,1-trimethyl-N-(trimethylsylyl)-, hydrolysis products with silica (CAS Reg. No. 68909-20-6) or Silica ((dimethylvinylsilyl)oxy)- and ((trimethylsily)oxy)-modified (CAS Reg. No. 68988-89-6). Wacker Silicones Corp. As a filler for silicone elastomers complying with 21 CFR 177.2600. Limitations/ Specifi-
cations
June 12, 2002 CAT. EXCL.
21 CFR 25.32(j)
Wacker Silicones Corp.
229 Trilauryl phosphite (CAS Reg. No. 3076-63-9). General Electric As an antioxidant in non-plasticized polyvinyl chloride polymers. Limitations/ Specifi-
cations
August 16, 2002 CAT. EXCL.
21 CFR 25.32(i) and (j)
General Electric
231 Styrene-acrylic copolymers. BASF Corporation For use as components of printing inks or coatings that are applied to polyolefin films intended for contact with food. Limitations/ Specifi-
cations
June 25, 2002 CAT. EXCL.
21 CFR 25.32(i)
BASF Corporation
232 Phosphorous acid, bis(2,4-bis(1,1-dimethylethyl)-6-methylphenyl)ethyl ester (CAS Reg. No. 145650-60-8). The FCS is also known as bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphite.
REPLACES FCN #51
Ciba Specialty Chemicals Corporation As a process stabilizer in olefin polymers. Limitations/ Specifi-
cations
July 10, 2002 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
233 2-propenoic acid, homopolymer, calcium sodium salt (CAS Reg. No. 35830-10-5). Polacryl, Inc. As a component of pigment dispersants coating the surface of paper and paperboard. Limitations/ Specifi-
cations
August 23, 2002 CAT. EXCL.
21 CFR 25.32(i)
Polacryl, Inc.
234 Phenol,2,2'-methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyly)- (CAS Reg. No. 103597-45-1). Asahi Denka Kogyo K.K. As a stabilizer in PET (polyethylene terephthalate) polymers. Limitations/ Specifi-
cations
July 16, 2002 CAT. EXCL.
21 CFR 25.32(i)
Asahi Denka Kogyo K.K.
235 Tin antimony oxide (CAS Reg. No. 12673-86-8). The food contact substance is also known as tin antimony gray cassiterite. BASF Corporation As a pigment for all polyolefins for food contact applications. Limitations/ Specifi-
cations
September 12, 2002 CAT. EXCL.
21 CFR 25.32(i)
BASF Corporation
236 Poly(1,4-cyclohexylenedimethylene-1,4-cyclohexanedicarboxylate) (CAS Reg. No. 219566-57-1). SABIC Innovative Plastics As a component of repeated-use articles in contact with all food types, under Conditions of Use A through H, as described in Table 2. Limitations/ Specifi-
cations
July 19, 2002 CAT. EXCL.
21 CFR 25.32(j)
SABIC Innovative Plastics
237 Quino(2,3-b)acridine-7,14-dione,5,12-dihydro-,(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl derivatives (CAS Reg. No. 332142-67-3). This FCS is a mixture of phthalimidomethyl derivatives of quinacridone. Ciba Specialty Chemicals Corp. As a pigment dispersant for use in all types of food-contact polymers. Limitations/ Specifi-
cations
July 26, 2002 CAT. EXCL.
21 CFR 25.32(i)
Ciba Specialty Chemicals Corp.
238 Diethylene glycol monobenzoate (CAS Reg. No. 20587-61-5). Velsicol Chemical Corp. The FCS will be used as a component of adhesives complying with 21 CFR 175.105 Adhesives and with 21 CFR 177.1390 Laminate structures for use at temperatures of 250°F and above, paragraph (c)(2)(ii). Limitations/ Specifi-
cations
July 31, 2002 CAT. EXCL.
21 CFR 25.32(i)
Velsicol Chemical Corp.
239 A mixture consisting of 63-72 percent oxidized bis(hydrogenated tallow alkyl)amines, 12-15 percent bis(hydrogenated tallow alkyl)amines, 4-8 percent (hydrogenated tallow alkyl)nitrones, and 5-12 percent (hydrogenated tallow alkyl)oximes. Ciba Specialty Chemicals Corp. The FCS will be used as an acetaldehyde scavenger in polyethylene phthalate (PET) water bottles. Limitations/ Specifi-
cations
July 31, 2002 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corp.
244 Styrene/butadiene/acrylonitrile copolymers (SBA) (CAS Reg. No., exclusive of minor monomers: 9003-56-9) containing no more than 30 weight percent acrylonitrile and no more than 10 weight percent of total polymer units from one or more of the following monomers: acrylic acid, 2-hydroxyethyl acrylate, itaconic acid, and methacrylic acid. OMNOVA Solutions Inc. For use as a component of latex coatings for paper and paperboard in contact with all food types, complying with 21 CFR 176.170(b)(2). Limitations/ Specifi-
cations
September 26, 2002 CAT. EXCL.
21 CFR 25.32(i)
OMNOVA Solutions Inc.
245 A perfluorocarbon cured elastomer (PCE) produced by terpolymerizing tetrafluoroethylene, (CAS Reg. No. 116-14-3), perfluoromethyl vinyl ether (CAS Reg. No. 1187-93-5), and perfluoro-6,6-dihydro-6-iodo-3-oxa-1-hexane (CAS Reg. No. 106108-22-9), and subsequent curing of the terpolymer (CAS Reg. No. 193018-53-0) with triallylisocyanurate (CAS Reg. No. 1025-15-6) and 2,5-dimethyl-2,5-di(t-butylperoxy)hexane (CAS Reg. No. 78-63-7). Greene, Tweed and Company, Inc. In the fabrication of molded parts for food processing equipment, such as o-rings, gaskets, diaphragms and other materials, that function primarily in sealing applications. Limitations/ Specifi-
cations
August 13, 2002 CAT. EXCL.
21 CFR 25.32(j)
Greene, Tweed and Company, Inc.
246 Fluorocarbon cured elastomer produced by copolymerizing tetrafluoroethylene (CAS Reg. No. 116-14-3) and propylene (CAS Reg. No. 115-07-01) and subsequent curing of the copolymer (CAS Reg. No. 27029-05-6) with triallylisocyanurate (CAS Reg. No. 1025-15-6) and 2,2'bis-(t- butylperoxy)diisopropylbenzene (CAS Reg. No. 25155-25-3). Greene, Tweed and Company, Inc. In the fabrication of molded parts for food processing equipment, such as o-rings, gaskets, diaphragms and other materials, that function primarily in sealing applications. Limitations/ Specifi-
cations
August 13, 2002 CAT. EXCL.
21 CFR 25.32(j)
Greene, Tweed and Company, Inc.
247 A perfluorocarbon cured elastomer (PCE) produced by terpolymerizing tetrafluoroethylene, (CAS Reg. No. 116-14-3), perfluoro-2,5-dimethyl-3,6-dioxanonane 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) with triallylisocyanurate (CAS Reg. No. 1025-15-6) and 2,5-dimethyl-2,5-di(t-butylperoxy)hexane (CAS Reg. No. 78-63-7). Greene, Tweed and Company, Inc. In the fabrication of molded parts for food processing equipment, such as o-rings, gaskets, diaphragms and other materials, that function being primarily in sealing applications. Limitations/ Specifi-
cations
August 13, 2002 CAT. EXCL.
21 CFR 25.32(j)
Greene, Tweed and Company, Inc.
248 Silver zinc glass, of nominal composition silver (0.47 percent +/- 0.1 percent)-zinc (21 percent +/- 2.0 percent)-aluminum-boron phosphate (=/> 76.4 percent) glass. Ciba Specialty Chemicals Corporation The food contact substance (FCS) will be used as an antimicrobial agent in all types of food-contact polymers. Limitations/ Specifi-
cations
August 16, 2002 CAT. EXCL.
21 CFR 25.32(i) and (j)
Kanebo Chemical Industries, Ltd.
250 Poly(N-vinylformamide), 20-100 percent hydrolyzed, chloride or sulfate salts. The FCS is specifically known as one of the following: a) formamide, N-ethenyl-, polymer with ethanamine, hydrochloride (CAS Reg. No. 111616-55-8); b) formamide, N-ethenyl-, polymer with ethanamine, sulfate (CAS Reg. No. 117985-59-8); and c) formamide, ethenyl-, homopolymer, hydrolyzed, hydrochlorides, (CAS Reg. No. 183815-54-5). BASF Corporation For use only as strengthening agents, fixing agents, or retention aids prior to the sheet-forming operation in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
October 5, 2002 CAT. EXCL.
21 CFR 25.32(i)
BASF AG/BASF Corporation
251 Hexanedioic acid, polymer with 1,3-benzenedimethanamine (CAS Reg. No. 25718-70-1), meeting the specifications in 21 CFR 177.1500(b) item 10.2, when tested by the method given in 21 CFR 177.1500(c). The FCS is also known as Nylon MXD-6. Gruppo Mossi & Ghisolfi a) ethylene phthalate polymers complying with 21 CFR 177.1630(e)(4)(i) and 177.1630(e)(4)(ii), items 2 and 3; b) ethylene phthalate polymers complying with FCN numbers 000004 and 000085; c) ethylene phthalate-naphthalate polymers complying with FCN numbers 000008, 000009, and 000135; d) poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalanedicarbonyl) resins complying with 21 CFR 177.1637 and FCN No. 000009; and e) ethylene phthalate polymers and copolymers modified with pyromellitic dianhydride according to FCN numbers 000010, 000145, 000151, and 000200. Limitations/ Specifi-
cations
August 24, 2002 CAT. EXCL.
21 CFR 25.32(i)
FCS: Mitsubishi Gas Chemical Company, Inc., Tokyo, Japan; Polymers modified with the FCS: Gruppo Mossi & Ghisolfi
253 Iso-butylene/maleic anhydride copolymer, sodium salt (CAS Reg. No. 39612-00-5) cross-linked with 1.9 percent by weight glycerol and 1.25 percent by weight 1,4-butanediol. Camelot Technologies, Ltd. For use as an component of fluid absorbent pads in contact with meat, poultry, fish and produce. Limitations/ Specifi-
cations
August 28, 2002 CAT. EXCL.
21 CFR 25.32(i)
Camelot Technologies, Ltd.
254 Methyl acrylate-divinylbenzene-diethylene glycol divinyl ether terpolymer, aminolyzed with dimethylaminopropylamine and partially quaternized with methyl chloride. (CAS Reg. No. 65997-24-2). Rohm and Haas Company For use in treating water and aqueous food only of the types identified under categories I, II, and VI-B in Table 1. Limitations/ Specifi-
cations
August 31, 2002 CAT. EXCL.
21 CFR 25.32(j)
Rohm and Haas Company
255 3-cyclohexane-1-carboxylic acid, 6-((di-2-propenylamino)carbonyl)-,(1R,6R), reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, ammonium salts. Ciba Specialty Chemicals Corporation The FCS will be used as an oil repellent sizing agent in the production of paper and paperboard. Limitations/ Specifi-
cations
September 5, 2002 CAT. EXCL.
21 CFR 25.32(i)
Ciba Specialty Chemicals Corporation
256 N,N,N',N'-tetrakis(2-hydroxyethyl)hexanediamide (CAS Reg. No. 6334-25-4). EMS Chemie AG/EMS Primid For use as a cross-linking agent for polyester coatings on metal substrates for contact with food. Limitations/ Specifi-
cations
October 19, 2002 CAT. EXCL.
21 CFR 25.32(i) and (j)
EMS Chemie AG/EMS Primid
257 Alpha-sulpho-omega-(dodecyloxy)poly(oxyethylene)sodium salt (CAS Reg. No. 9004-82-4). The FCS is also known as sodium lauryl ether sulfate. Stepan Company The food contact substance (FCS) will be used 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
November 30, 2002 CAT. EXCL.
21 CFR 25.32(i)
Stepan Company
259 C.I. Pigment Yellow 189 (Nickel titanium tungsten oxide)(CAS Reg. No. 69011-05-8). BASF Corporation As a colorant in all types of food-contact polymers. Limitations/ Specifi-
cations
October 25, 2002 CAT. EXCL.
21 CFR 25.32(i)
BASF Corporation
260 Tetrafluoroethylene-hexafluoropropylene-vinylidene fluoride copolymers (CAS Reg. No. 25190-89-0). Dyneon LLC As a processing additive for polyolefins for use in contact with food. Limitations/ Specifi-
cations
October 3, 2002 CAT. EXCL.
21 CFR 25.32(i)
Dyneon LLC
262 Nylon 6/69 (CAS Reg. No. 51995-62-1), manufactured by the condensation of 49.5+ 0.5 weight percent epsilon-caprolactam, 19.4+0.2 weight percent hexamethylenediamine, and 31.2+0.3 weight percent azelaic acid. EMS Chemie AG As a non-food-contact layer of a co-extruded multilayer film in accordance with the uses permitted for nylon 6/69 resins as set forth in 21 CFR 177.1395. Limitations/ Specifi-
cations
October 11, 2002 EA/ FONSI
EMS Chemie AG
263 Pyrrolo(3,4-c)pyrrole-1,4-dione,2,5-dihydro-3,6-bis(4-(octadecylthio)phenyl)- (CAS Reg. No. 247089-62-9). Ciba Specialty Chemicals Corporation As a surface modifier for all pigments in all polymers. Limitations/ Specifi-
cations
November 26, 2002 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
267 A mixture of: 1) imidazolium compounds, 2-(C17 and C17 unsaturated alkyl)-1-(2-(C18 and C18 unsaturated amido)ethyl)-1-ethyl-4, 5-dihydro-, ethyl sulfates (CAS Reg. No. 91053-16-6); and 2) amides, C18 and C18-unsaturated, N-(2-(2-(C17 and C17-unsaturated alkyl)-4, 5-dihydro-1H-imidazol-1-yl)ethyl) (CAS Reg. No. 71808-32-7). Hercules Inc. As a debonding agent in uncoated food-contact paper and paperboard at levels up to 0.25 percent by weight of the dry paper and paperboard. Limitations/ Specifi-
cations
October 18, 2002 CAT. EXCL.
21 CFR 25.32(i)
Hercules Inc.
268 Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4). Great Lakes Chemical Corporation 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
October 18, 2002 CAT. EXCL.
21 CFR 25.32(i)
Great Lakes Chemical Corporation
270 A silver-zinc-sodium aluminosilicate zeolite containing up to 2.9 percent by weight of silver and 19 percent by weight of zinc. The finished zeolite will also contain small amounts of calcium metaphosphate, zinc oxide and silica. Ciba Specialty Chemicals Corporation As an antimicrobial agent in all types of food-contact polymers. Limitations/ Specifi-
cations
December 18, 2002 CAT. EXCL.
21 CFR 25.32(i) and (j)
Kanebo Chemical Industries, Ltd.
273 2-Propen-1-aminium, N,N-dimethyl-N-2-propenyl-, chloride, polymer with 2-propenoic acid and N-2-propen-1-amine hydrochloride, 2,2'-azobis(2-methylpropanimidamide) dihydrochloride- initiated. (CAS Reg. No. 343837-39-8). Hercules, Inc. For use as a wet-end sizing additive in the manufacture of paper and paperboard for contact with dry food. Limitations/ Specifi-
cations
November 13, 2002 CAT. EXCL.
21 CFR 25.32(i)
Hercules, Inc.
274 2-Naphthalenesulfonic acid, 6-hydroxy-5((4-methoxy-2-sulfophenyl)azo)-, strontium salt (1:1) (CAS Reg. No. 380304-86-9; C.I. Pigment Violet 52). BASF Corporation As a colorant for all food-contact polymers. Limitations/ Specifi-
cations
November 14, 2002 CAT. EXCL.
21 CFR 25.32(i)
BASF Corporation
275 Silver-magnesium-sodium-boron-phosphate glass (silver glass). Ciba Specialty Chemicals Corporation The food contact substance (FCS) will be used as an antimicrobial agent in all types of food-contact polymers. Limitations/ Specifi-
cations
January 3, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ishizuka Glass Company, Ltd. (manufacturer); Kanebo Chemical Industries, Ltd. (supplier)
276 Hexanedioic acid, polymer with N-(2-aminoethyl)-1,2-ethanediamine, N-acetyl derivative, epichlorohydrin quaternized (CAS Reg. No. 344612-00-6). Hercules, Inc. The FCS will be used as a wet-strength agent in uncoated containerboard. Limitations/ Specifi-
cations
November 20, 2002 CAT. EXCL.
21 CFR 25.32(i)
Hercules, Inc.
277 2-Propenoic acid, 2-cyano-3,3-diphenyl-,2,2-bis{[(2-cyano-1-oxo-3, 3-diphenyl-2-propenyl)oxy]methyl}-1,3-propanediyl ester (CAS Reg. No. 178671-58-4). BASF Aktiengesellschaft The FCS will be used as an ultraviolet (UV) stabilizer for all polymers intended for single and repeat use in contact with food. Limitations/ Specifi-
cations
January 21, 2003 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
278 REPLACED BY FCN 573     Limitations/ Specifi-
cations
   
 
279 Tetradecanoic acid, lithium salt (CAS Reg. No. 20336-96-3). Asahi Denka Co., Ltd. As a stabilizer in propylene homopolymers and copolymers. Limitations/ Specifi-
cations
December 10, 2002 CAT. EXCL.
21 CFR 25.32(i)
Asahi Denka Co., Ltd.
280 Copolyesters of dimethyl terephthalate or terephthalic acid with ethylene glycol, 1,4-cyclohexanedimethanol and diethylene glycol (CAS Reg. No. 148105-13-9 and 156209-91-5). Eastman Chemical Company The FCS will be used as a component of food contact articles intended to contact aqueous and fatty foods and alcoholic foods containing up to 15 percent ethanol by volume. Food-contact articles prepared from the FCS are intended for use under Conditions of Use C (see limitations on hot-fill temperature, below) through G as described Table 2. Limitations/ Specifi-
cations
February 1, 2003 EA/ FONSI
Eastman Chemical Company
282 2-propenoic acid, homopolymers, calcium sodium salt (CAS Reg. No. 35830-10-5). Polacryl, Inc. As a pigment dispersant for titanium dioxide that is used as a filler in the manufacture of food-contact paper and paperboard. Limitations/ Specifi-
cations
January 10, 2003 CAT. EXCL.
21 CFR 25.32(i)
Polacryl, Inc.
283 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 cubed tomatoes, refrigerated fresh-cut fruits and vegetables, refrigerated whole berries, and refrigerated or frozen fish fillets. Limitations/ Specifi-
cations
March 1, 2003 EA/ FONSI
Stockhausen, Inc.
284 Industrial starch modified by treatment with greater than 5 percent and not more than 21 percent by weight 2,3-epoxypropyl trimethylammonium chloride (CAS Reg. No. 3033-77-0). Penford Products Company 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 only recycled, food-contact paperboard at a maximum level of 1 percent by weight of the dry pulp. Limitations/ Specifi-
cations
February 21, 2003 CAT. EXCL.
21 CFR 25.32(i)
Penford Products Company
285 2-Oxepanone, polymer with 1,4-butanediol (CAS Reg. No. 31831-53-5). DuPont Performance Elastomers, LLC 2-Oxepanone, polymer with 1,4-butanediol is intended for use as a processing aid in all polyolefins for single and repeat use food-contact applications. Limitations/ Specifi-
cations
January 9, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
DuPont Performance Elastomers, LLC
286 2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4). Rohm and Haas Company As an antimicrobial agent for preservation of latex emulsions destined for use in latex gloves intended to contact all types of food. Limitations/ Specifi-
cations
January 16, 2003 CAT. EXCL.
21 CFR 25.32(q)
Rohm and Haas Company
288 Trilauryl phosphite (CAS Reg. No. 3076-63-9). General Electric As an antioxidant in plasticized polyvinyl chloride polymers. Limitations/ Specifi-
cations
January 22, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
General Electric
289 Boron nitride (CAS Reg. No. 10043-11-5). Saint-Gobain Advanced Ceramics Corporation The FCS will be used as a processing aid in the production of olefin polymers complying with the provisions 21 CFR 177.1520. Limitations/ Specifi-
cations
April 1, 2003 CAT. EXCL.
21 CFR 25.32(i)
Saint-Gobain Advanced Ceramics Corporation
290 2-propenoic acid, 2-methyl-,1,2-ethanediyl ester, polymer with oxiranylmethyl 2-methyl-2-propenoate, hydrogen sulfate (CAS Reg. No. 117163-06-1). TOSOH Corporation For use as an ion exchange resin to remove cationic substances from skim milk in order to manufacture milk protein concentrate (MPC). Limitations/ Specifi-
cations
January 29, 2003 CAT. EXCL.
21 CFR 25.32(j)
TOSOH Corporation
292 Cross-linked terpolymer of 1-vinylimidazole, 1-vinylpyrrolidone and 1,3-divinylimidazolidinone (CAS Reg. No. 87865-40-5). The FCS is also known as Polyvinylimidazole (PVI). Gordon Burns and Robert Ellsworth As a component of filter media, for removal of metals and sulfides in alcoholic beverages using repeat-usage filtering equipment. Limitations/ Specifi-
cations
February 6, 2003 EA /Fonsi
Gusmer-Cellulo Corporation
293 Pyrimido(5,4-g)pteridine-2,4,6,8-tetramine,4-methylbenzenesulfonate, base-hydrolyzed (Pigment Yellow 382E; CAS Reg. No. 346709-25-9), which is a mixture consisting of approximately 65.3 percent Pyrimido(5,4-g)pteridine-2,4,6,9-tetramine (CAS Reg. No. 207283-64-5), approximately 7.5 percent 2,6,8-triamino-pyrimido(5,4-g)pteridine-4(1H)-one (CAS Reg. No. 335356-94-0), approximately 16.7 percent 2,8-diamino-pyrimido(5,4-g)pteridine-4,6(1H, 7H)-dione (CAS Reg. No. 207283-72-5), and approximately 0.3 percent 8-amino-pyrimido(5,4-g)pteridine-2,4,6(1H,3H,7H)-trione (CAS Reg. No. 207283-92-9). Ciba Specialty Chemicals Corporation As a colorant in all food-contact polymers. Limitations/ Specifi-
cations
February 13, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
294 Zinc zeolite A (zinc sodium aluminosilicate). Ciba Specialty Chemicals Corporation As a dispersing agent for silver-magnesium-sodium-boron-phosphate-glasses in the manufacture of food-contact polymers. Limitations/ Specifi-
cations
February 13, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Kanebo Chemical Industries, Ltd.
295 Hydrogen peroxide Dr. Kareem I. Batarseh As a component of an antimicrobial formulation for use on poultry carcasses, poultry parts, and whole and cut raw fruits and vegetables. Limitations/ Specifi-
cations
February 15, 2003 EA /FONSI
Dr. Kareem I. Batarseh
296 Silver nitrate Dr. Kareem I. Batarseh As a component of an antimicrobial formulation for use on poultry carcasses, poultry parts, and whole and cut raw fruits and vegetables. Limitations/ Specifi-
cations
February 15, 2003 EA /FONSI
Dr. Kareem I. Batarseh
297 BALINIT A, chemically identified as titanium nitride (CAS Reg. No. 25583-20-4). Balzers Aktiengesellschaft The FCS will be used as a component of ceramic surface coating for repeat-use food processing and food packaging equipment. Limitations/ Specifi-
cations
December 25, 2002 CAT. EXCL.
21 CFR 25.32(i)
Balzers Aktiengesellschaft
298 BALINIT B, chemically identified as titanium carbonitride. Balzers Aktiengesellschaft The FCS will be used as a component of ceramic surface coating for repeat-use food processing and food packaging equipment. Limitations/ Specifi-
cations
December 25, 2002 CAT. EXCL.
21 CFR 25.32(i)
Balzers Aktiengesellschaft
299 BALINIT C, chemically identified as tungsten carbide/carbon +Chromium. Balzers Aktiengesellschaft The FCS will be used as components of repeat-use food processing and food packaging equipment as a double layered ceramic coating consisting of a functional tungsten carbide/carbon layer and an interface chromium layer. Limitations/ Specifi-
cations
December 25, 2002 CAT. EXCL.
21 CFR 25.32(i)
Balzers Aktiengesellschaft
300 BALINIT D, BALINIT CNI, and BALINIT CROVEGA, chemically identified as chromium nitride (CAS Reg. No. 24094-93-7). Balzers Aktiengesellschaft The FCS will be used as a component of ceramic surface coating on repeat-use food processing and food packaging equipment. Limitations/ Specifi-
cations
December 25, 2002 CAT. EXCL.
21 CFR 25.32(i)
Balzers Aktiengesellschaft
301 BALINIT DLC, BALINIT TRITON, chemically identified as diamond-like carbon. Balzers Aktiengesellschaft The FCS will be used as components of repeat-use food processing and food packaging equipment as a double layered ceramic coating consisting of a functional diamond-like carbon layer and an interface chromium layer. Limitations/ Specifi-
cations
December 25, 2002 CAT. EXCL.
21 CFR 25.32(i)
Balzers Aktiengesellschaft
302 BALINIT FUTURA, BALINIT FUTURA NANO, and BALINIT X.TREME, chemically identified as titanium aluminum nitride. Balzers Aktiengesellschaft The FCS will be used as a component of ceramic surface coating on repeat-use food processing and food packaging equipment. Limitations/ Specifi-
cations
December 25, 2002 CAT. EXCL.
21 CFR 25.32(i)
Balzers Aktiengesellschaft
303 Siloxanes and silicones, dimethyl, methylhydrogen reaction products with polyethylene glycol and/or polyethylene-polypropylene glycol monoallyl ether, methyl ether terminated. Crompton Corporation As defoamers, at levels up to 40 grams per metric ton of dry pulp (0.004 percrnt), in the pulping of lignocellulosic materials used to make food-contact paper and paperboard. Limitations/ Specifi-
cations
March 5, 2003 EA /FONSI
Crompton Corporation
307 Butanedioic acid, compd. with 1,1',1"-nitrilotris[2-propanol] (CAS Reg. No.462110-48-1; also called salt of triisopropanolamine and succinic acid). Kerr-McGee Chemical LLC For use as a pigment dispersant in food-contact articles. Limitations/ Specifi-
cations
March 19, 2003 CAT. EXCL.
21 CFR 25.32(i)
Kerr-McGee Chemical LLC
308 5,5-Dimethylhydantoin (DMH) (CAS Reg. No. 77-71-4). Lonza, Inc. The FCS will be used as a stabilizer for hypohalite slimicides used in the manufacture of food-contact paper and paperboard. Limitations/ Specifi-
cations
March 21, 2003 EA /FONSI
Lonza, Inc.
310 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 Corporation For use as an antioxidant/stabilizer in olefin polymers and copolymers. Limitations/ Specifi-
cations
April 12, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
311 Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate. DuPont Chemical Solutions Enterprise For use as an oil or grease resistant treatment for paper and paperboard intended for single service use in microwave heat-susceptor packaging; the food-contact substance is intended to contact all food types. Limitations/ Specifi-
cations
April 15, 2003 EA /FONSI
DuPont Chemical Solutions Enterprise
312 2-Ethyl-2-(hydroxymethyl)-1,3-propanediol (Trimethylolpropane, TMP, CAS Reg. No. 77-99-6). Mitsui Chemical, Inc. For use as a modifier of polyethylene phthalate polymers. The finished polymer may contact all food types under the Conditions of Use B or the Conditions of Use permitted for the complaint polymers, whichever is less severe. Limitations/ Specifi-
cations
April 15, 2003 CAT. EXCL.
21 CFR 25.32(i)
Mitsui Chemical, Inc.
314 2-Propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-90-3). Hercules, Inc. As an oil/grease resistant sizing agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard for single use applications. Limitations/ Specifi-
cations
April 23, 2003 CAT. EXCL.
21 CFR 25.32(i)
Hercules, Inc.
315 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5). Avecia, Inc. As a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in poultry and meat processing plants. Limitations/ Specifi-
cations
April 25, 2003 CAT. EXCL.
21 CFR 25.32(q)
Avecia, Inc.
316 1,2-bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hydrazine. (CAS Reg. No. 32687-78-8). Great Lakes Chemical Corporation For use as a stabilizer in polyolefin polymers and copolymers. Limitations/ Specifi-
cations
July 8, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Great Lakes Chemical Corporation
320 Copolymer of 2-Imidazolidinone, 1,3-diethenyl-,polymer with 1-ethenyl-1H-imidazole and 1-ethenyl-2-pyrrolidinone (CAS Reg. No. 87865-40-5). BASF Corporation For the removal of heavy metal ions and sulfides from alcoholic beverages, including beer and wine. Limitations/ Specifi-
cations
July 5, 2003 EA /FONSI
BASF Corporation
321 Styrene block polymer with 2-methyl-1,3-butadiene, hydrogenated (CAS Reg. No. 68648-89-5). Septon Company of America
Kuraray America, Inc.
Kuraray Co., Ltd.
Kuraray Europe, GmbH
As an article or component of articles intended to contact food. Limitations/ Specifi-
cations
July 1, 2003 EA /FONSI
Septon Company of America
Kuraray America, Inc.
Kuraray Co., Ltd.
Kuraray Europe, GmbH
323 A mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-81-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and water. FMC Corporation The FCS will be used as an antimicrobial agent for meat and poultry carcasses. Limitations/ Specifi-
cations
May 27, 2003 EA /FONSI
FMC Corporation
324 Alpha-methylstyrene dimer (2,4-Diphenyl-4-methyl-1-pentene; Benzene, 1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bis-; (CAS Reg. No. 6362-80-7). JSR Corporation
Asahi Kasei Corporation
Goi Chemical Company, Ltd.
For use as a polymerization control agent in styrene-butadiene latex coatings for food-contact paper and paperboard. Limitations/ Specifi-
cations
June 13, 2003 CAT. EXCL.
21 CFR 25.32(i)
JSR Corporation
Asahi Kasei Corporation
Goi Chemical Company, Ltd.
325 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]-, monosodium salt, polymer with N,N'-methylene bis[2-propenamide], peroxydisulfuric acid ([(OH)S(O)2]2O2) diammonium salt-initiated (CAS Reg. No. 388567-01-9). Biosepra SA, Division of Ciphergen Biosystems Inc. For repeated use as an ion exchange resin to absorb and purify enzymes and other proteins from sweet whey, nonfat milk, and milk at temperatures of 15°C or less. Limitations/ Specifi-
cations
August 2, 2003 CAT. EXCL.
21 CFR 25.32(j)
Ciphergen Biosystems Inc.
326 N-(2-Hydroxyethyl)octadecanamide (CAS Reg. No. 111-57-9). Ecolab Inc. (Research Center) The FCS will be used as a processing aid in rinse-aid products used in commercial dishwashing machines. Limitations/ Specifi-
cations
July 4, 2003 EA /FONSI
Degussa Goldschmidt Chemical Corporation
327 Polypropylene glycol monobutyl ether
CAS name: Poly(oxy(methyl-1,2-ethanediyl)), alpha-butyl-omega-hydroxy- (CAS Reg. No. 9003-13-8).
Crompton Corporation As a diluent in defoamers used in the pulping of lignocellulosic materials that will be used to make food-contact paper and paperboard. Limitations/ Specifi-
cations
July 12, 2003 EA /FONSI
Crompton Corporation
328 Phosphorous acid, bis[2,4-bis(1,1-dimethylethyl)-6-methylphenyl]ethyl ester (CAS Reg. No. 145650-60-8). The FCS is also known as bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphite. Ciba Specialty Chemicals Corporation As an antioxidant and/or stabilizer in adhesives. Limitations/ Specifi-
cations
July 17, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
329 Silicon Dioxide (CAS Reg. No. 7631-86-9). Schott HiCotec, Division of Schott Spezialglas GmbH To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles. Limitations/ Specifi-
cations
July 17, 2003 CAT. EXCL.
21 CFR 25.32(i)
Schott HiCotec, Division of Schott Spezialglas GmbH
330 Quino(2,3-b)acridine-7,14-dione,5,12-dihydro- (6CI, 8CI, SCI), (C.I. Pigment Violet 19) (CAS Reg. No. 1047-16-1). Ciba Specialty Chemicals Corporation As a colorant for paper and paperboard. Limitations/ Specifi-
cations
July 24, 2003 CAT. EXCL.
21 CFR 25.32(i)
Ciba Specialty Chemicals Corporation
332 The FCS is the cross-linked reaction product of (1) an acrylic resin, consisting of a copolymer of styrene (CAS Reg. No. 100-42-5), methyl methacrylate (CAS Reg. No. 80-62-6), methacrylic acid (CAS Reg. No. 79-41-4), t-butyl methacrylate (CAS Reg. No. 585-07-9), and hydroxyethyl methacrylate (CAS Reg. No. 868-77-9); (2) a silane coupling agent, consisting of y-isocyanatopropyltrimethoxysilane (CAS Reg. No. 15396-00-6); and (3) a urethane prepolymer which is an isocyanate-terminated polymer consisting of trimethylol propane (CAS Reg. No. 77-99-6) adducts of isophorone diisocyanate (CAS Reg. No. 4098-71-9) and m-xylylene diisocyanate (CAS Reg. No. 3634-83-1). Toppan Printing Co., Ltd. As an adhesive layer in a multi-layer film intended for use in packaging food. Limitations/ Specifi-
cations
August 1, 2003 CAT. EXCL.
21 CFR 25.32(i)
Toppan Printing Co., Ltd.
333 The reaction product of polyvinyl alcohol (PVOH) and tetraethoxysilane (TEOS), (CAS Reg. No. 9002-89-5 and 78-10-4 respectively). Toppan Printing Co., Ltd. For use in a non-food contact layer [to be separated from food by at least 50 micron (2 mil) thick polypropylene layer] in multilayer constructions intended for use in single-use packaging of food of all types (as defined in Table 1) under Conditions of Use A (as defined in Table 2), under retort packaging conditions only. Limitations/ Specifi-
cations
August 1, 2003 CAT. EXCL.
21 CFR 25.32(i)
Toppan Printing Co., Ltd.
334 1,3-dibromo-5,5-dimethylhydantoin (DBDMH; CAS Reg. No. 77-48-5). Albemarle Corporation As an antimicrobial in chiller water used during poultry processing. Limitations/ Specifi-
cations
August 6, 2003 EA /FONSI
Albemarle Corporation
336 Styrene-acrylic copolymers as further described in your submission (FCN 336). BASF Corporation For use as components of printing inks or coatings that are applied to polyester films intended for contact with food. Limitations/ Specifi-
cations
August 12, 2003 CAT. EXCL.
21 CFR 25.32(i)
BASF Corporation
337 Trilauryl phosphite (CAS Reg. No. 3076-63-9) containing not more than 1 percent by weight triisopropanolamine (CAS Reg. No. 122-20-3). General Electric As an antioxidant in linear low density polyethylene. Limitations/ Specifi-
cations
August 12, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
General Electric
338 Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate. DuPont Chemical Solutions Enterprise For use as an oil or grease resistant treatment for paper and paperboard intended for food-contact use. Limitations/ Specifi-
cations
August 19, 2003 EA /FONSI
DuPont Chemical Solutions Enterprise
339 1,4-Dioxa-8-azaspiro[4.5]decane, 7,7,9,9-tetramethyl- (CAS Reg. No. 36793-27-8). Degussa Corporation As a catalyst in the manufacture of pulp used to manufacture food-contact paper. Limitations/ Specifi-
cations
August 26, 2003 EA /FONSI
Degussa Corporation
340 Quino[2,3-b]acridine-7,14-dione,5,12-dihydro-2,9-dimethyl- (also known as Pigment Red 122) (CAS Reg. No. 980-26-7). Ciba Specialty Chemicals Corporation The FCS will be used as a colorant for polymers. Limitations/ Specifi-
cations
November 7, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
341 2,4-bis[(dodecylthio)methyl]-6-methylphenol (CAS Reg. No. 110675-26-8). Ciba Specialty Chemicals Corporation As a stabilizer for adhesives, pressure-sensitive adhesives, and styrene-block polymers. Limitations/ Specifi-
cations
August 28, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
342 Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine [Nylon 6/66] (CAS Reg. No. 24993-04-2). Honeywell International Inc. As a component of films used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2, respectively. Limitations/ Specifi-
cations
November 18, 2003 EA /FONSI
Honeywell International Inc.
344 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). Ciba Specialty Chemicals Corporation As a fluid absorbant in food-contact materials. Limitations/ Specifi-
cations
September 19, 2003 EA /FONSI
Technical Absorbents, Inc.
345 Hydrogenated petroleum hydrocarbon resin (cyclopentadiene-type) (CAS Reg. No. 68132-00-3). Eastman Chemical Company The FCS will be used as an adjuvant at levels not to exceed 15 percent by weight in blends with high density polyethylene (HDPE) complying with 21 CFR 177.1520(c), item 2.1 or 2.2. The density of each of these polymers shall not be less than 0.94 gram per cubic centimeter. Limitations/ Specifi-
cations
September 25, 2003 EA /FONSI
Eastman Chemical Company
346 2,2,5,7,8-Pentamethyl-6-chromanol (CAS Reg. No. 950-99-2) Other name: 2,2,5,7,8-Pentamethyl-6-hydroxy chroman. API Corporation As a stabilizer for use in linear low-density polyethylene food-contact films, coatings and molded articles. Limitations/ Specifi-
cations
October 2, 2003 CAT. EXCL.
21 CFR 25.32(i)
API Corporation
348 1,3-benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt, polymer with dimethyl 1,4-benzenedicarboxylate, dimethyl pentanedioate and 1,2-ethanediol (CAS Reg. No. 65072-10-8). E.I. duPont de Nemours and Company For use in food-contact articles except bottles. Limitations/ Specifi-
cations
December 11, 2003 EA /FONSI
E.I. duPont de Nemours and Company
349 Polyester-polyurethane resin-acid dianhydride adhesive as described at 21 CFR 177.1390(c)(2)(vii). Dainippon Ink and Chemicals, Inc. For use as an adhesive in laminate structures that are intended for use at retort temperatures. Limitations/ Specifi-
cations
November 25, 2003 EA /FONSI
Dainippon Ink and Chemicals, Inc.
350 Hydrogenated styrene butadiene block copolymers (CAS Reg. No. 66070-58-4). SABIC Innovative Plastics As a component of repeated-use articles for use in contact with Food Types III, IV-A, V, VII-A, and IX identified in Table 1 at temperatures up to 100°C. Limitations/ Specifi-
cations
October 9, 2003 CAT. EXCL.
21 CFR 25.32(j)
SABIC Innovative Plastics
351 A type of zeolite in which silver, zinc and ammonium ions have been exchanged for sodium ions. The silver content of the modified zeolite shall not exceed 5 percent by weight. AgIon Technologies The function of the food contact substance (FCS) is to control microorganisms that may grow on the article and to thereby preserve the article. Limitations/ Specifi-
cations
October 21, 2003 EA /FONSI
AgIon Technologies
352 Di-(para-methylbenzylidene) sorbitol (CAS Reg. No. 81541-12-0, 54686-97-4 and 197809-37-3) alone or containing up to 1 percent triisopropanolamine (CAS Reg. No. 122-20-3). Ciba Specialty Chemicals Corporation As a clarifying agent for polypropylene homopolymers and copolymers complying with 21 CFR 177.1520. Limitations/ Specifi-
cations
October 29, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
355 1,3-benzenedicarboxylic acid, 5-sulfo-1, 3-dimethyl ester, sodium salt, polymer with dimethyl 1,4-benzenedicarboxylate, dimethyl pentanedioate, poly(ethylene glycol), and 1,2-ethanediol. E.I. duPont de Nemours and Company As a coating or film. Limitations/ Specifi-
cations
December 27, 2003 EA /FONSI
E.I. duPont de Nemours and Company
356 5,12-Dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione (C.I. Pigment Red 122, CAS Reg. No. 980-26-7) also known as 2,9-Dimethylquinacridone. Clariant Corporation, Pigments and Additives Division As a colorant in single- and repeat-use polymeric, food-contact articles. Limitations/ Specifi-
cations
November 14, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Clariant Corporation, Pigments and Additives Division
357 1,3-dibromo-5,5-dimethylhydantoin (DBDMH; CAS Reg. No. 77-48-5). Albemarle Corporation As an antimicrobial in water applied to poultry via an Inside-Outside Bird Washer (IOBW) and in water used for Off-Line Reprocessing (OLR) of poultry. Limitations/ Specifi-
cations
November 14, 2003 EA /FONSI
Albemarle Corporation
358 Polysiloxane di-methyl, vinyl-terminated, reaction product with 1,2,4-trivinylcyclohexane polymer with polydimethylsiloxane, hydrogen terminated. Wacker Silicones Corporation As a cross-linking agent in the manufacture of silicone release agents complying with 21 CFR 175.300, 175.320 and 176.170 and intended for use as:
1) a component of food packaging articles,
2) in molds used to manufacture food-contact materials, and
3) a component of release coatings (a dehesive) for use with pressure-sensitive labels.
Limitations/ Specifi-
cations
November 14, 2003 CAT. EXCL.
21 CFR 25.32(i)
Wacker Silicones Corporation
359 Benzoic acid, 2,4-dihydroxy-, polymer with formaldehyde and 1-naphthalenol, sodium salt (CAS Reg. No. 209119-35-7). 3V, Inc. For use as an anti-foulant on the interior surfaces of PVC polymerization autoclaves used to produce PVC intended for food contact. Limitations/ Specifi-
cations
January 7, 2004 EA /FONSI
3V, Inc.
360 Polyethylene terephthalate copolymers (diethylene glycol-azelaic acid modified) prepared by the condensation of terephthalate acid (or dimethyl terephthalate) and ethylene glycol with azelaic acid and diethylene glycol. The copolymers shall be manufactured and characterized as described in the notification. DuPont Teijin Films For use as films intended for contact with all types of food under Conditions of Use A through H as described in Table 2, and in ovenable applications at temperatures up to 400°F. Limitations/ Specifi-
cations
November 20, 2003 EA /FONSI
DuPont Teijin Films
361 Tetraethylenepentamine (CAS Reg. No. 112-57-2). Huntsman Ethyleneamines Ltd. As a wet-end processing additive in the manufacture of paper pulp. Limitations/ Specifi-
cations
December 4, 2003 EA /FONSI
Huntsman Ethyleneamines Ltd.
362 Siloxanes and silicones, di-methyl, 3-(4-hydroxy-3-methoxyphenyl)propyl group-terminated, polymers with bisphenol A, carbonic dichloride and 4-(1-methyl-1-phenylethyl)phenol (CAS Reg. No. 202483-49-6; also known as siloxane-modified polycarbonate) where the siloxane-modified portion of the FCS is approximately 22 percent by weight of the FCS. SABIC Innovative Plastics As a resin blended with conventional polycarbonate. Limitations/ Specifi-
cations
January 7, 2004 EA /FONSI
SABIC Innovative Plastics
363 Siloxanes and silicones, di-methyl, 3-(4-hydroxy-3-methoxy-3-methoxyphenyl)propyl group-terminated, polymers with bisphenol A, carbonic dichloride and 4-(1-methyl-1-phenylethyl)phenol (CAS Reg. No. 202483-49-6; also known as siloxane-modified polycarbonate) where the siloxane-modified portion of the FCS is approximately 7 percent by weight of the FCS. SABIC Innovative Plastics As a component of articles intended to contact food. Limitations/ Specifi-
cations
January 7, 2004 EA /FONSI
SABIC Innovative Plastics
365 1,4-Benzenediamine, N-(1-3-dimethylbutyl)-N'-phenyl-, reaction products with ethylene oxide mono[[C12-richC10-13-branched alkyl thio]methyl] derivatives (CAS Reg. No. 4449992-04-5). Ciba Specialty Chemicals Corporation The FCS will be used as an antioxidant in rubber articles intended for repeat-use in contact with food. Limitations/ Specifi-
cations
December 9, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
366 1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hydrazine (CAS Reg. No. 32687-78-8). Ciba Specialty Chemicals Corporation As an antioxidant in high density polyethylene (HDPE), polyethylene copolymers as described in 21 CFR 177.1520(c) item 3.2a, and in polyolefin repeat-use articles. Limitations/ Specifi-
cations
December 11, 2003 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
368 Ethylene/1-butene copolymers (CAS Reg. No. 25087-34-7). DuPont Dow Elastomers LLC
The Dow Chemical Company
As a component of articles used in contact with all types of food. Limitations/ Specifi-
cations
December 17, 2003 EA /FONSI
The Dow Chemical Company
K-Dow Petrochemicals BV
369 Siloxanes and silicones, di-Me, hydrogen-terminated, reaction products with acrylic acid and 2-ethyl-2-[(2-propenyloxy)methyl]-1,3-propanediol (CAS Reg. No. 155419-56-0). The cured resins may include the photoinitiator 2-hydroxy-2-methyl-1-phenyl-propanone (CAS Reg. No. 7473-98-5). Goldschmidt Chemical Corporation As coatings or components of coatings on polymeric substrates and on paper and paperboard, at a maximum level of 1.5 grams per square meter (g/m2), in contact with all food types under Conditions of Use E, F, G, and H as defined in Table 2. Limitations/ Specifi-
cations
December 18, 2003 CAT. EXCL.
21 CFR 25.32(i)
Goldschmidt Chemical Corporation
370 Dibutyl sebacate (CAS Reg. No. 000109-43-3). Ciba Specialty Chemicals Corporation As a dispersing agent for pigments used as colorants in all polymers. Limitations/ Specifi-
cations
December 23, 2003 EA /FONSI
Ciba Specialty Chemicals Corporation
371 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5). Avecia, Inc. As a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in contact with all types of food. Limitations/ Specifi-
cations
December 23, 2003 CAT. EXCL.
21 CFR 25.32(q)
Avecia, Inc.
372 REPLACED BY FCN 780 Limitations/ Specifi-
cations
373 Monoisopropanolamine (MIPA) (CAS Reg. No. 78-96-6). E.I. duPont de Nemours and Company Inc. For use in paper and paperboard. Limitations/ Specifi-
cations
December 24, 2003 CAT. EXCL.
21 CFR 25.32(i)
E.I. duPont de Nemours and Company Inc.
374 Poly(12-hydroxystearic acid) end-capped with stearic acid (CAS Reg. No. 58128-22-6). Lubrizol, Ltd. The FCS will be used:
1. As a colorant dispersant at levels not to exceed 0.1 percent by weight in the manufacture of food-contact polymers.
2. As a nucleating agent at levels not to exceed 0.012 weight percent in olefin polymers complying with 21 CFR 177.1520(c), items 1.1, 3.1, and 3.2. The copolymers complying with items 3.1 and 3.2 shall contain not less than 85 weight percent of polymer units derived from propylene.
Limitations/ Specifi-
cations
December 25, 2003 CAT. EXCL.
21 CFR 25.32(i)
Lubrizol, Ltd.
375 Poly(tricyclo[5.2.1.0(2,6)]decane-3,5-diyl-ethylene)-co-(bicyclo[3.3.0]octane-2,4-diyl-ethylene)- co-(tricyclo[6.4.0.0(2,6)]dodecane-3,5-diyl-ethylene)]. ZEON Corporation As a plastic base resin to be employed in the manufacture of food-contact articles intended for repeat-use. Limitations/ Specifi-
cations
March 6, 2004 CAT. EXCL.
21 CFR 25.32(j)
ZEON Corporation
376 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. The Dow Chemical Company
Equipolymers s.r.1.
Dow Olefinverbund GmbH
Equipolymers GmbH
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
December 31, 2003 EA /FONSI
The Dow Chemical Company
Equipolymers s.r.1.
Dow Olefinverbund GmbH
377 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 Corporation The FCS will be used as an antioxidant for styrene block polymers complying with the provisions of 21 CFR 177.1810. Limitations/ Specifi-
cations
January 1, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
379 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 that 220°C (428°F), and the subsequent catalytic reduction of the resulting aromatic petroleum hydrocarbon resin. Arakawa Chemical Industries, Ltd. As a component of polymer blends intended for use as films and coatings that consist predominantly of ethylene vinyl acetate copolymer. Limitations/ Specifi-
cations
January 7, 2004 EA /FONSI
Arakawa Chemical Industries, Ltd.
380 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid and 1,6-hexanediamine (CAS Reg. No. 25750-23-6). The FCS is manufactured according to the monomer composition specified in the notification. EMS-Chemie AG For use as a component of repeat-use food-contact articles. Limitations/ Specifi-
cations
January 7, 2004 CAT. EXCL.
21 CFR 25.32(j)
EMS-Chemie AG
381 REPLACED BY FCN #449          
 
384 35 percent Ammonium Bromide Solution (CAS Reg. No. 12124-97-9). AmeriBrom, Inc. As a component of a slimicide used in the production of paper and paperboard. Limitations/ Specifi-
cations
January 9, 2004 CAT. EXCL.
21 CFR 25.32(q)
AmeriBrom, Inc.
385 Tris (2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4). Ciba Specialty Chemicals Corporation The FCS will be used as an antioxidant in the manufacture of olefin polymers complying with the provisions of 21 CFR 177.1520(c), items 3.2c and 3.6. Limitations/ Specifi-
cations
January 13, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
386 Octadecyl, 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3). Ciba Specialty Chemicals Corporation As an antioxidant for olefin polymers. Limitations/ Specifi-
cations
January 13, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
387 Siloxanes and silicones, di-Me, polymers with silica-1,1,1-trimethyl-N-(trimethylsilyl)silanamine hydrolysis products and silicic acid trimethylsilyl ester (CAS Reg. No. 159002-21-8). General Electric Company As a defoamer in the pulping of lignocellulosic materials that will be used to make food-contact paper and paperboard. Limitations/ Specifi-
cations
January 14, 2004 EA /FONSI
General Electric Company
388 Mixture of potassium stearyl phosphate (CAS Reg. No. 68987--29-1), polyoxyethylene lauryl ether phosphate potassium salt, and polyoxyethylene tridecyl ether phosphate potassium salt. E.I. du Pont de Nemours and Company, Inc. For use as a finish component on poly(phenyleneterephthalamide) resins cleared in 21 CFR 177.1632 for repeated-use applications. Limitations/ Specifi-
cations
January 30, 2004 EA /FONSI
E.I. du Pont de Nemours and Company, Inc.
389 A mixture of imidazolium and imidazoline compounds, 1H-imidazolium, 1-ethyl-2-(8Z)-8-heptadecenyl-4,5-dihydro-1- [2-[[(9Z)-1-oxo-9-octadecenyl]amino]ethyl]-, ethyl sulfate (CAS Reg. No. 67846-14-4) and 9-octadecenamide, N-[2-[2-(8Z)-8-heptadecenyl-4,5-dihydro- 1H-imidazol-1-yl]ethyl]-, (9Z)- (CAS Reg. No. 63441-26-9). Goldschmidt Chemical Corporation The FCS may be used as a debonding agent in food-contact paper and paperboard at levels not to exceed 0.5 percent by weight of the dry paper and paperboard. Limitations/ Specifi-
cations
February 4, 2004 CAT. EXCL.
21 CFR 25.32(i)
Goldschmidt Chemical Corporation
391 Chlorine dioxide (CAS Reg. No. 10049-04-4). Eka Chemicals, Inc., an Akzo Noble Company The FCS will be used as a slimicide in process water during the manufacture of paper and paperboard intended to contact food. Limitations/ Specifi-
cations
February 20, 2004 CAT. EXCL.
21 CFR 25.32(q)
Eka Chemicals, Inc., an Akzo Noble Company
392 Acrylonitrile-butadiene copolymer crosslinked with divinylbenzene (CAS Reg. No. 9003-18-3). Eliokem, Inc. As a component of films used in contact with food and as a component of articles used in repeated use food-contact applications. Limitations/ Specifi-
cations
April 2, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Eliokem, Inc.
393 Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, diethyl ester (CAS Reg. No. 976-56-7). Ciba Specialty Chemicals Corporation As a chemically bound component of the polymeric backbone for use in polyethylene terephthalate homopolymers as described in 21 CFR 177.1630(e)(4)(ii) items 2 and 3, and complying with all applicable provisions of 21 CFR 177.1630. Limitations/ Specifi-
cations
February 25, 2004 Contact
Ciba Specialty Chemicals Corporation
395 Copolymer of n-butyl methacrylate and iso-butyl methacrylate (CAS Reg. No. 9011-53-4). Lucite International UK, Ltd. As a pigment dispersant for use in all pigmented food-contact plastics. Limitations/ Specifi-
cations
March 18, 2004 CAT. EXCL.
21 CFR 25.32(i)
Lucite International UK, Ltd.
398 Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991-62-4), ammonium salt. Solvay Solexis S.p.A. As an oil and water repellent in the manufacture of food-contact paper and paperboard. Limitations/ Specifi-
cations
April 13, 2004 CAT. EXCL.
21 CFR 25.32(i)
Solvay Solexis S.p.A.
399 Nylon MXD-6 (CAS Reg. No. 25718-70-1) (also known as hexanedioic acid, polymer with 1,3-benzenedimethanamine) meeting the analytical specifications in 21 CFR 177.1500(b) item 10.1 and used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2). Constar International, Inc. The FCS will be used as a modifier of ethylene phthalate/naphthalate polymers and copolymers, excluding those modified with organic anhydrides. Limitations/ Specifi-
cations
June 12, 2004 CAT. EXCL.
21 CFR 25.32(i)
Constar International, Inc.
401 Silicon Dioxide (CAS Reg. No. 7631-86-9). Toyo Seikan Kaisha, Ltd. To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles. Limitations/ Specifi-
cations
April 29, 2004 CAT. EXCL.
21 CFR 25.32(i)
Toyo Seikan Kaisha, Ltd.
402 A copolymer of tetrafluoroethylene and perfluoromethylvinyl ether (CAS Reg. No. 26425-79-6) \ modified with 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-1,9-diene and 1,3,5-triallyl cyanurate or 1,3,5-triallyl isocyanurate. Precision Polymer Engineering, Ltd. As a gasket or seal for food processing equipment. Limitations/ Specifi-
cations
July 2, 2004 CAT. EXCL.
21 CFR 25.32(j)
Precision Polymer Engineering, Ltd.
403 2-[2,4-bis(1,1-dimethylethyl)phenoxy]5-butyl-5-ethyl-1,3,2-dioxaphosphorinane,(CAS Reg. No. 180071-71-0), which may contain not more than 1 percent by weight triisopropanolamine (CAS Reg. No. 122-20-3). Crompton Corporation 1) As an antioxidant at levels not to exceed 0.16 percent by weight in linear low density polyethylene complying with 21 CFR 177.1520(c), items 3.1 and 3.2, where the density of the polymer is not greater than 0.94 gram per cubic centimeter.
2) As an antioxidant at levels not to exceed 0.16 percent by weight in repeated use food-contact articles.
Limitations/ Specifi-
cations
April 29, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Crompton Corporation
404 4,4'-[Isopropylidenebis(p-phenyleneoxy)]diphthalic dianhydride/4,4'-diaminodiphenyl sulfone copolymer (CAS Reg. No. 77699-82-2). SABIC Innovative Plastics The FCS will be used as a component of repeated-use food contact articles intended for use in contact with all food types with no temperature limitation. Limitations/ Specifi-
cations
May 13, 2004 CAT. EXCL.
21 CFR 25.32(j)
SABIC Innovative Plastics
405 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 As a basic polymer used in the production of articles intended to contact food. Limitations/ Specifi-
cations
May 20, 2004 EA /FONSI
Topas Advanced Polymers Incorporated
406 Hexanedioic acid, polymer with azacyclotridecan-2-one and alpha-hydro-omega-hydroxypoly(oxy- 1,2-ethanediyl) (CAS Reg. No. 70290-02-7). Ciba Specialty Chemicals Corporation As an antistatic agent for polymers in contact with non-fatty dry foods. Limitations/ Specifi-
cations
July 12, 2004 EA /FONSI
ATOFINA Chemicals
407 2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52-51-7). GE Betz As a preservative for boiler water additive formulations. Limitations/ Specifi-
cations
June 19, 2004 CAT. EXCL.
21 CFR 25.32(q)
GE Betz
408 C16-18 fatty acid esters of a branched C20 alcohol as described in the notification. COGNIS Deutschland GmbH & Co KG To be used as a lubricant/release agent in the manufacture of repeat-use, food-contact polycarbonate. Limitations/ Specifi-
cations
June 22, 2004 CAT. EXCL.
21 CFR 25.32(j)
COGNIS Deutschland GmbH & Co KG
411 Copper,(1,3,8,16,24-hexabromo-2,4,9,10,11,15,17,22,23,25- decachloro-29H,31H-phthalocyanato(2-)-N29,N30,N31,N32)-,(SP-4-2)- (CAS Reg. No. 14302-13-7). BASF Corporation As a colorant in all types of food-contact polymers. Limitations/ Specifi-
cations
October 2, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
BASF Corporation
413 Polyester-polyurethane resin-acid dianhydride adhesives. Dainippon Ink and Chemicals, Inc. For use as an adhesive in laminate structures that are intended for use at retort temperatures. Limitations/ Specifi-
cations
July 6, 2004 EA /FONSI
Dainippon Ink and Chemicals, Inc.
415 A blend of LDPE and LDPE grafted with vinyltrimethoxysilane (LDPE/VTMOS-LDPE) containing up to 50 percent LDPE grafted with vinyltrimethoxysilane (VTMOS-LDPE). Tetra Pak, Inc. For use in fabricating beverage containers. Limitations/ Specifi-
cations
September 11, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Tetra Pak, Inc.
416 Diphosphoric acid, polymers with ethoxylated reduced methyl esters of reduced polymerized oxidized tetrafluoroethylene (CAS Reg. No. 200013-65-6). This substance is also known as phosphate esters of ethoxylated perfluoroether, prepared by reaction of ethoxylated perfluoroether diol (CAS Reg. No. 162492-15-1) with phosphorous pentoxide (CAS Reg. No. 1314-56-3) or pyrophosphoric acid (CAS Reg. No. 2466-09-3). Solvay Solexis S.p.A. As a water and oil repellent in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
July 27, 2004 CAT. EXCL.
21 CFR 25.32(i)
Solvay Solexis S.p.A.
417 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,6-hexanediamine and 4,4'-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 112754-95-7). EMS-Chemie AG/EMS Chemie (North America) Inc. As a component of non-food-contact layers of multilayer films. Limitations/ Specifi-
cations
July 30, 2004 EA /FONSI
EMS-Chemie AG/EMS Chemie (North America) Inc.
418 Alpha-sulfo-omega (dodecyloxy) poly (oxyethylene) sodium salt (CAS Reg. No. 9004-82-4). BASF Aktiengesellschaft 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 complying with 21 CFR Sections 176.170 and 176.180 in contact with all types of food under Conditions of Use A through H. Limitations/ Specifi-
cations
July 30, 2004 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
419 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% by weight of NOPA on the pigment). Huntsman Tioxide/Tioxide Europe S.A.S./Tioxide Europe S.L. For use as a colorant in all types of food-contact polymers. Limitations/ Specifi-
cations
July 31, 2004 EA /FONSI
Huntsman Tioxide/Tioxide Europe S.A.S./Tioxide Europe S.L.
420 2-butyl-2-ethyl-1,3-propanediol (CAS Reg. No. 115-84-4). Perstorp Polyols, Inc. As a polyol monomer in the synthesis of polyester resins used to produce coatings, specifically coating binder resins, for use as can coatings and adhesives for single use in food contact applications. Limitations/ Specifi-
cations
August 4, 2004 CAT. EXCL.
21 CFR 25.32(i)
Perstorp Polyols, Inc.
421 Poly(terephthaloyl chloride/p-phenylenediamine) (CAS Reg. No. 26125-61-1). E.I. du Pont de Nemours and Company, Inc. For use as a microwave susceptor base aramid paper having a maximum basis weight of 20 pounds per 1000 square feet. Limitations/ Specifi-
cations
August 4, 2004 EA /FONSI
E.I. du Pont de Nemours and Company, Inc.
423 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 As a basic polymer used in the production of articles (including bottles) intended to contact food. Limitations/ Specifi-
cations
August 11, 2004 EA /FONSI
Ticona
424 Ethylene/octene copolymers containing up to 50 weight percent polymer units derived from 1-octene (CAS Reg. No. 26221-73-8). The Dow Chemical Company As articles or components of articles used in contact with all types of food under Conditions of Use A through H, as described in Table 2. Limitations/ Specifi-
cations
October 7, 2004 EA /FONSI
The Dow Chemical Company
K-Dow Petrochemicals BV
425 Hexanedioic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl), 3-methyl-1,5-pentanediol and 1-methyl-1,3-propanediyl bis [(6-isocyanatohexyl)carbamate] (CAS Reg. No. 622366-97-6). Japan Crown Cork Co. Ltd. As a sealing gasket for glass jars and bottles. Limitations/ Specifi-
cations
August 20, 2004 CAT. EXCL.
21 CFR 25.32(i)
Japan Crown Cork Co. Ltd.
426 Quino[2,3-b]acridine-7,14-dione,5,12-dihydro-2,9-dimethyl, also known as diemethylquinacridone and C.I. Pigment Red 122 (CAS Reg. No. 980-26-7). Sun Chemical Corporation As a colorant in food-contact polymers. Limitations/ Specifi-
cations
August 27, 2004 CAT. EXCL.
21 CFR 25.32(i)
Sun Chemical Corporation
427 Propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7). Stockhausen, Inc. For use as an absorbent in food-contact materials. Limitations/ Specifi-
cations
September 1, 2004 EA /FONSI
Stockhausen, Inc.
428 REPLACED BY FCN 537 Limitations/ Specifi-
cations
429 Copolymer of styrene (CAS Reg. No. 100-42-5), methyl methacrylate (CAS Reg. No.80-62-6), and glycidyl methacrylate (CAS Reg. No. 106-91-2). SABIC Innovative Plastics and
BASF Corporation
For use as a polymeric chain extender in repeated use polymers in contact with all food types and under conditions of use A through H. Limitations/ Specifi-
cations
October 30, 2004 CAT. EXCL.
21 CFR 25.32(j)
SABIC Innovative Plastics and
BASF Corporation
430 Metallic pigment comprised of borosilicate glass flakes, 70 to 95 percent, coated with pure silver metal, 5 to 30 percent by weight. The Shepherd Color Company As a colorant for polymers in contact with food. Limitations/ Specifi-
cations
September 2, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Energy Strategy Associates/
The Shepherd Color Company
431 Tin(IV) Oxide (CAS Reg. No. 18282-10-5). EMD Chemicals Inc. For use in combination with silicon dioxide and titanium dioxide as a colorant for food-contact polymers, paper and paperboard, coatings, and in printing inks applied to non-food-contact surfaces of food-contact articles. Limitations/ Specifi-
cations
September 8, 2004 CAT. EXCL.
21 CFR 25.32(i)
EMD Chemicals Inc.
432 Silver-magnesium-calcium-phosphate-borate-glass. Ishizuka Glass Co., Ltd. As an antimicrobial agent in all polymers. Limitations/ Specifi-
cations
October 13, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ishizuka Glass Co., Ltd.
433 Silver-magnesium-aluminum-phosphate glass. Ishizuka Glass Co., Ltd. As an antimicrobial agent in all polymers. Limitations/ Specifi-
cations
October 12, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ishizuka Glass Co., Ltd.
434 Silver-magnesium-calcium-phosphate-borate-glass. Ishizuka Glass Co., Ltd. As an antimicrobial agent in all polymers. Limitations/ Specifi-
cations
October 12, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ishizuka Glass Co., Ltd.
435 Poly (ethylene-maleic anhydride) grafted cyclodextrin(s). Cellresin Technologies, LLC
Equistar Chemicals, LP
For use as an adjuvant in the manufacture of polymer beverage container closures and beverage and food container seals. Limitations/ Specifi-
cations
September 14, 2004 CAT. EXCL.
21 CFR 25.32(i)
Cellresin Technologies, LLC
Equistar Chemicals, LP
436 1,4-Dioxa-8-azaspiro[4.5]decane, 7,7,9,9-tetramethyl- (CAS Reg. No. 36793-27-8) Degussa Corporation As a catalyst in the manufacture of pulp used to manufacture food-contact paper. Limitations/ Specifi-
cations
November 20, 2004 EA /FONSI
Degussa Corporation
437 Ethoxylated primary linear alcohols of greater than 10% ethylene oxide by weight, having molecular weights of 390 - 7,000 (CAS Reg. No. 97953-22-5). Baker Petrolite - Polymers Division The FCS will be used as a surface active agent in polypropylene polymers at levels not to exceed 1.5 percent by weight of the finished article. Limitations/ Specifi-
cations
October 15, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Baker Petrolite - Polymers Division
438 Monoisopropanolamine (MIPA) (CAS Reg. No. 78-96-6) E.I. du Pont de Nemours and Company, Inc. For use as a dispersant for titanium dioxide pigment suspensions used in the manufacture of paper and paperboard at levels not to exceed 0.68 percent by weight of the titanium dioxide. Limitations/ Specifi-
cations
September 17, 2004 CAT. EXCL.
21 CFR 25.32(i)
The Dow Chemical Company
439 Industrial starch modified by treatment with greater than 5 percent and not more than 21 percent by weight 2,3-epoxypropyltrimethyl-ammonium chloride (CAS Reg. No. 56780-58-6). Roquette Frères 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
October 27, 2004 CAT. EXCL.
21 CFR 25.32(i)
Roquette Frères
442 Alcohol ethoxylate in which the alcohol contains from 12 to 22 carbon atoms and the ethoxylate chain contains from 4 to 20 repeating ethoxylate units. Lubrizol Advanced Materials For use as a component of a mixture intended for use as a thickener for hand sanitizers used in food service establishments. Limitations/ Specifi-
cations
November 23, 2004 EA /FONSI
Lubrizol Advanced Materials
443 Agarose, polymer with (chloromethyl)oxirane, 2-hydroxy-3(3-sulfopropoxy)propyl ethers, sodium salts (CAS Reg. No. 676618-71-6). Amersham Biosciences As an ion exchange resin. Limitations/ Specifi-
cations
September 29, 2004 CAT. EXCL.
21 CFR 25.32(j)
Amersham Biosciences
444 Poly(isophthaloyl chloride/m-phenylenediamine) (CAS Reg. No. 25765-47-3) E.I. du Pont de Nemours and Company, Inc. For use as a microwave susceptor base material in aramid paper having a maximum basis weight of 20 pounds per 1000 square feet. Limitations/ Specifi-
cations
August 4, 2004 EA /FONSI
E.I. du Pont de Nemours and Company, Inc.
445 Chlorine Dioxide Selective Micro Technologies, LLC As an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables that are not raw agricultural commodities in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500-ClO2-E in the "Standard Methods for the Examination of Water and Wastewaters" 18th e.d., 1992, or an equivalent method. Limitations/ Specifi-
cations
October 1, 2004 EA /FONSI
Selective Micro Technologies, LLC
446 Di-µ-chlorobis((1,2,5,6-eta)-1,5-cyclooctadiene)dirhodium (CAS Reg. No. 12092-47-6). Wacker Chemical Corporation (formerly known as Wacker Silicones Corporation) For use as a catalyst in the preparation of silicone elastomers complying with 21 CFR 177.2600. Limitations/ Specifi-
cations
October 5, 2004 CAT. EXCL.
21 CFR 25.32(j)
Wacker Chemical Corporation (formerly known as Wacker Silicones Corporation)
447 An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No.7722-84-1), acetic acid (CAS Reg. No. 64-19-7), sulfuric acid (CAS Reg. No. 7664-93-9), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4) Enviro Tech Chemical Services, Inc. To control microbial growth in wash water that contacts fruits and vegetables that are not raw agricultural commodities. Limitations/ Specifi-
cations
October 14, 2004 CAT. EXCL.
21 CFR 25.32(q)
Enviro Tech Chemical Services, Inc.
448 Polyester-polyurethane resin formulated from:
(a)(1) Polyester-polyurethanediol resins prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii) and 1,6-hexanediol (CAS Reg. No. 629-11-8), dimethylolbutanoic acid (CAS Reg. No. 10097-02-6), 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg No. 4098-71-9), and/or 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4). The FCS will be manufactured and characterized as described in the notification.
(2) An optional trimethoxysilane coupling agent containing an epoxy group, as described in the notification, not to exceed 3 percent by weight of the cured adhesive.
(b) Urethane cross-linking agent comprising not more than 20 percent by weight of the cured adhesive, and formulated from trimethylolpropane (CAS Reg. No. 77-99-6) adduct of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate and/or trimethylolpropane adduct of 1,3-bis(isocyanatomethyl)benzene and/or 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate cyanurate (CAS Reg. No. 53880-05-0). The content of the 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate cyanurate shall not exceed 14 percent by weight of the cured adhesive.
Perstorp Polyols, Inc.
Rock Paint Co., Ltd.
For use as an adhesive in laminate structures that are intended for use at retort temperatures. Limitations/ Specifi-
cations
October 15, 2004 CAT. EXCL.
21 CFR 25.32(i)
Perstorp Polyols, Inc.
Rock Paint Co., Ltd.
449 REPLACED BY FCN #708 Limitations/ Specifi-
cations
450 An aqueous solution of sodium chlorite and chlorine dioxide containing up to 1200 mg/kg sodium chlorite and up to 30 mg/kg chlorine dioxide. Bio-cide International, Inc. As an antimicrobial agent in the processing of red meat, red meat parts and organs, and on processed, comminuted, and formed meat products as a component of a dip or a spray. Limitations/ Specifi-
cations
November 4, 2004 EA /FONSI
Bio-cide International, Inc.
451 2-Propenoic acid, 2-methyl-, dodecyl ester, polymer with docosyl 2-propenoate, eicosyl 2-propenoate, octadecyl 2-propenoate and tetradecyl 2-methyl-2-propenoate (CAS Reg. No. 470469-55-7) Toho Chemical Industry Company, Ltd. As a processing aid (filter aid) in the production of petroleum wax that will be used on food packaging for single use food contact applications. Limitations/ Specifi-
cations
January 21, 2005 EA /FONSI
Toho Chemical Industry Company, Ltd.
452 Styrene-methyl methacrylate-butyl acrylate-butadiene copolymer. INEOS NOVA LLC The FCS will be used as a base polymer in contact with food, excluding film or coating applications. Limitations/ Specifi-
cations
November 10, 2004 EA /FONSI
INEOS NOVA LLC
453 1,3-dibromo-5,5-dimethylhydantoin (DBDMH; CAS Reg. No. 77-48-5) Albemarle Poultry Sciences, LLC For general use as an antimicrobial agent in water used in poultry processing for disinfecting poultry carcasses and their parts and organs. Limitations/ Specifi-
cations
November 10, 2004 EA /FONSI
Albemarle Poultry Sciences, LLC
454 [1,1'-biphenyl]-4,4'-diol, polymer with 1,1'-sulfonylbis[4-chlorobenzene] (CAS Reg. No. 25608-64-4). Solvay Advanced Polymers, LLC The FCS will be used as a resin in the manufacture of molded repeat-use food-contact articles. Limitations/ Specifi-
cations
November 10, 2004 CAT. EXCL.
21 CFR 25.32(j)
Solvay Advanced Polymers, LLC
455 N-phenylbenzenamine reaction products with 2,4,4-trimethylpentene (CAS Reg. No. 68411-46-1). Ciba Specialty Chemicals Corporation As an antioxidant/stabilizer in food-contact adhesives. Limitations/ Specifi-
cations
November 16, 2004 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
456 Sodium sulfate salt of ethoxylated (7 moles of ethylene oxide) n- and iso-undecyl alcohol (C11) (CAS Reg. No. 219756-63-5). Clariant GmbH 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 complying with 21 C.F.R. Sections 176.170 and 176.180 in contact with all types of food. Limitations/ Specifi-
cations
November 25, 2004 CAT. EXCL.
21 CFR 25.32(i)
Clariant GmbH
458 Tetracarbonyl di-µ-chlorodirhodium (I) (CAS Reg. No. 14523-22-9)
Trade name: Rhodium carbonyl chloride dimer
Formula: (Rh(CO)2Cl)2
Wacker Chemical Corporation As a catalyst to accelerate the cross-linking reaction of vinyl-functionalized polydimethylsiloxanes with hydrogen-functionalized polydimethylsiloxanes in forming a silicone elastomer that will be used in repeat use articles such as baking molds and milk tubes, which may contact all food types under all conditions, consistent with the limitations of 21 CFR177.2600(c)(4)(i). Limitations/ Specifi-
cations
November 30, 2004 CAT. EXCL.
21 CFR 25.32(j)
Wacker Chemical Corporation
459 Styrene-maleic anhydride copolymer, sodium salt (CAS Reg. No. 25736-61-2). Asahi Kasei Chemicals Corporation The FCS will be used as a surfactant in the manufacture of styrene-1,3 butadiene and styrene-1,3 butadiene, hydrogenated block copolymers. Limitations/ Specifi-
cations
December 3, 2004 EA /FONSI
Asahi Kasei Chemicals Corporation
460 Benzenemethanaminium, N,N-dimethyl-N-(2-(2-(4-(1,1,3,3,-tetramethylbutyl)phenoxy)ethoxy)-ethyl)-,chloride (CAS Reg. No. 121-54-0) also known as Benzethonium Chloride USP Lonza, Inc. As an antimicrobial agent in no-rinse hand sanitizers for food handlers. Limitations/ Specifi-
cations
December 7, 2004 EA /FONSI
Lonza, Inc.
461 The FCS is a cross-linked reaction product of an acrylic resin, a silane coupling agent, and a urethane polymer. This reaction product is formed in situ as a layer applied to an appropriate base film.
The acrylic resin consists of a copolymer of styrene (CAS Reg. No. 100-42-5), methyl methacrylate (CAS Reg. No.80-62-6), methacrylic acid(CAS Reg. No. 79-41-4), t-butyl methacrylate (CAS Reg. No.585-07-9), and hydroxyethyl methacrylate (CAS Reg. No.868-77-9).
The silane coupling agent consists of γ-isocyanatopropyl-trimethoxysilane (IPSi) (CAS Reg. No. 15396-00-6).
The urethane prepolymer is an NCO-terminated prepolymer consisting of trimethylol propane (CAS Reg. No. 77-99-6) adducts of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (isophorone diisocyanate, or IPDI) and 1,3-bis(isocyanatomethyl)benzene (m-xylylene diisocyanate, m-XDI).
Toppan Printing Company, Ltd. As a non-food contact layer in multilayer films intended for use in packaging food of all types under the Conditions of Use B through H as defined in Table 2. Limitations/ Specifi-
cations
December 9, 2004 CAT. EXCL.
21 CFR 25.32(i)
Toppan Printing Company, Ltd.
462 Cross-linked reaction product of polyvinyl alcohol (PVOH; CAS Reg. No. 9002-89-5) and tetraethoxysilane (TEOS; CAS Reg. No. 78-10-4). Toppan Printing Company, Ltd. As a non-food contact layer in multilayer films intended for use in packaging food of all types under the Conditions of Use B through H as defined in Table 2. Limitations/ Specifi-
cations
December 9, 2004 CAT. EXCL.
21 CFR 25.32(i)
Toppan Printing Company, Ltd.
463 1,3-Benzenedicarbonyl dichloride, polymer with 1,4-benzenedicarbonyl dichloride, 1,3-benzenediol, carbonic dichloride and 4,4'-(1-methylethylidene) bisphenol, 4-(1-methyl-1-phenylethyl)phenyl ester (CAS Reg. No. 235420-85-6). SABIC Innovative Plastics The FCS may be used neat or in blends with polycarbonate resins, in articles or components of articles intended for single and repeat-use food contact applications. Limitations/ Specifi-
cations
February 12, 2005 EA/FONSI
SABIC Innovative Plastics
464 C.I. Pigment Yellow 163 (CAS Reg. No. 68186-92-5). BASF Corporation As a colorant in single- and repeat-use polymeric, food-contact articles. Limitations/ Specifi-
cations
December 17, 2004 CAT. EXCL.
21 CFR 25.32(i)
BASF Corporation
465 N,N'-1,6-hexanediylbis[2-amino-benzamide] (CAS Reg. No. 103956-07-6) The Coca-Cola Company
Clariant Life Science Molecules (America), Inc.
INVISTA S.àr.1.
For use as a scavenger for acetaldehyde in polyethylene terephthalate (PET) beverage bottles. Limitations/ Specifi-
cations
December 17, 2004 CAT. EXCL.
21 CFR 25.32(i)
The Coca-Cola Company
Clariant Life Science Molecules (America), Inc.
INVISTA S.àr.1.
469 Industrial starch modified by treatment with greater than 5 percent and not more than 21 percent by weight of 2,3-epoxypropyl trimethylammonium chloride (CAS Reg. No. 3303-77-0). Lyckeby Stärkelsen Industrial Starches AB
Penford Products Company
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 at a maximum level of 1 percent by weight of the dry pulp. Limitations/ Specifi-
cations
February 25, 2005 CAT. EXCL.
21 CFR 25.32(i)
Lyckeby Stärkelsen Industrial Starches AB
Penford Products Company
472 REPLACED BY FCN #526     Limitations/ Specifi-
cations
   
 
473 2,6-naphthalenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol and 4,4'-(1,3,6,8-tetrahydro-1,3,6,8-tetraoxobenzo[lmn][3,8]phenanthroline-2,7-diyl)bis[benzoic acid]. Mitsubishi Chemical Corporation As an ultraviolet light absorber in polyethylene phthalate polymers complying with 21 CFR 177.1630 used in contact with foods. Limitations/ Specifi-
cations
February 3, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Mitsubishi Chemical Corporation
474 Tetradecanoic acid; lithium salt (CAS Reg. No. 20336-96-3). ASAHI DENKA Co., Ltd. As a stabilizer for polypropylene polymers and copolymers complying with 21 CFR 177.1520(c), items 1.1, 3.1, and 3.2. Limitations/ Specifi-
cations
February 9, 2005 CAT. EXCL.
21 CFR 25.32(i)
ASAHI DENKA Co., Ltd.
475 Polylactide (PLA) polymers containing from 6 to 16 weight percent D-lactic acid polymer units (High D PLA; CAS Reg. No. 9051-89-2). The polymers will be manufactured and characterized as further described in the notification. NatureWorks LLC As a component in the manufacture of articles intended to contact food. Limitations/ Specifi-
cations
February 11, 2005 EA/FONSI
NatureWorks LLC
476 Silver-zinc-magnesium-aluminum-calcium-sodium-borate-phosphate glass. Ishizuka Glass Co. Ltd. As an antimicrobial agent in all types of food contact polymers. Limitations/ Specifi-
cations
February 15, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ishizuka Glass Co. Ltd.
477 Poly(oxy-1,2-ethanediyl), alpha-eicosyl-omega-hydroxy- (CAS Reg. No. 26636-39-5). Dr. W. Kolb AG For use as an antistatic agent in polypropylene polymers and copolymers. Limitations/ Specifi-
cations
February 15, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Dr. W. Kolb AG
479 Copolymer of vinylidene chloride and butyl acrylate (CAS Reg. No. 9011-09-0), containing up to 10 weight percent polymer units derived from butyl acrylate. The Dow Chemical Company The FCS will be used in the manufacture of articles or components of articles intended to contact food. Limitations/ Specifi-
cations
March 1, 2005 EA/FONSI
The Dow Chemical Company
480 Alpha alkene (C20-C24) polymers with maleic anhydride reaction products with 2,2,6,6-tetramethyl-4-piperidinamine (CAS Reg. No. 152261-33-1). BASF AG As an ultraviolet light stabilizer at levels not exceeding 0.3 percent by weight in olefin polymers complying with 21 CFR 177.1520 Olefin polymers, or an effective food contact substance notification. Limitations/ Specifi-
cations
March 22, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
BASF AG
481 Tetrafluoroethylene-ethylene-3,3,4,4,5,5,6,6,6-nonafluoro-1-hexene terpolymer (CAS Reg. No. 68258-85-5). Asahi Glass Company, Ltd. The FCS will be used as a base resin or coating in repeat-use applications. Limitations/ Specifi-
cations
May 10, 2005 CAT. EXCL.
21 CFR 25.32(j)
Asahi Glass Company, Ltd.
482 Hydrogenated aromatic petroleum hydrocarbon resin (CAS Reg. No. 88526-47-0), which may be partially hydrogenated. Eastman Chemical Company As a component 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
April 5, 2005 EA/FONSI
Eastman Chemical Company
483 Dimethyl dicarbonate (DMDC) Lanxess Corporation As a microbial control agent in carbonated beverages containing up to and including 100 percent juice and flavored water beverages (carbonated and non-carbonated) that contain low levels of juice or artificial or natural flavors. Limitations/ Specifi-
cations
April 5, 2005 CAT. EXCL.
21 CFR 25.32(k)
Lanxess Corporation
484 Isobutylene-butene copolymer (CAS Reg. No. 9044-17-1). NOVA Chemicals Inc. For use as a process aid in the manufacture of styrene-maleic anhydride copolymers complying with 21 CFR 177.1820(b)(2). Limitations/ Specifi-
cations
April 6, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
NOVA Chemicals Inc.
485 Polybetaine polysiloxane copolymer (CAS Reg. No. 102523-96-6). Ecolab, Inc. For use as a processing aid in rinse-aid products used in commercial dishwashing machines. Limitations/ Specifi-
cations
April 21, 2005 EA/FONSI
Ecolab, Inc.
486 Ethylene/propylene copolymers (CAS Reg. No. 9010-79-1) polymerized in the presence of propylene homopolymer (CAS Reg. No. 9003-07-0) complying with 21 CFR 177.1520(c) Item 1.1, to produce an inseparable blend of the two polymers. Sunoco, Inc. As the basic polymer used in the production of articles intended to contact food. Limitations/ Specifi-
cations
April 15, 2005 EA/FONSI
Sunoco, Inc.
487 2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-90-3). Hercules Incorporated As an oil/grease resistant sizing agent for paper and paperboard employed either prior to the sheet forming operation or at the size press. Limitations/ Specifi-
cations
July 14, 2005 CAT. EXCL.
21 CFR 25.32(i)
Hercules Incorporated
488 4-(4-phenoxyphenoxy) benzoic acid homopolymer (CAS Reg. No. 88049-74-5). Solvay Advanced Polymers, LLC For repeated use in contact with all types of food. Limitations/ Specifi-
cations
May 6, 2005 CAT. EXCL.
21 CFR 25.32(j)
Solvay Advanced Polymers, LLC
489 Tert-Butylperoxy-3,5,5-trimethylhexanoate (CAS Reg. No. 13122-18-4). Akzo Nobel Polymer Chemicals LLC As a processing aid in the production of vinyl acetate adhesives intended to be used to affix lables to the outside surface of food packaging. Limitations/ Specifi-
cations
May 10, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Akzo Nobel Polymer Chemicals LLC
490 2-Propenoic acid, 2-methyl-, 2-ethyl-2-[{(2-methyl-1-oxo-2-propenyl) oxy} methyl]-1, 3-propenediyl ester, polymer with ethyl-2-propenoate and methyl 2-methyl-2-propenoate (CAS Reg. No. 59779-17-8). Ganz Chemical Company, Ltd. The FCS is intended for use as an antiblocking agent for linear low density polyethylene (LLDPE) films at a use level of 0.5 to 2 weight-percent (with a typical use level of 1 weight-percent). Limitations/ Specifi-
cations
August 2, 2005 CAT. EXCL.
21 CFR 25.32(i)
Ganz Chemical Company, Ltd.
491 Sodium sulfate salt of ethoxylated (7 moles of ethylene oxide) - and iso-undecyl alcohol (C11) (CAS Reg. No. 219756-63-5). Clariant GmbH For use as an emulsifier in the production of adhesives, pressure-sensitive adhesives, and in adhesives for laminate structures intended for use at temperatures of 250°F and above. Limitations/ Specifi-
cations
May 31, 2005 CAT. EXCL.
21 CFR 25.32(i)
Clariant GmbH
493 REPLACED BY FCN 537 Limitations/ Specifi-
cations
494 2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl) ethyl]phenyl acrylate (CAS Reg. No. 123968-25-2). Sumitomo Chemical Company, Ltd. The FCS will be used as a stabilizer in polystyrene(PS) and rubber-modified polystyrene(RMPS) complying with 21CFR 177.1640, styrene block copolymers(SB) complying with 21CFR 177.1810, and PS, RMPS, or SB complying with an effective FCN. Limitations/ Specifi-
cations
July 27, 2005 CAT. EXCL.
21 CFR 25.32(i)
Sumitomo Chemical Company, Ltd.
495 Sodium dichloroisocyanurate (CAS Reg. No. 2893-78-9) and sodium bromide mixture containing 85-94 weight-percent sodium dichloroisocyanurate, and 5-9 weight-percent sodium bromide. Occidental Chemical Corporation For use as a slimicide in the manufacture of food-contact paper and paperboard. Limitations/ Specifi-
cations
June 18, 2005 CAT. EXCL.
21 CFR 25.32(q)
Occidental Chemical Corporation
498 Polyethylene terephthalate copolyesters (including isophthalic acid and/or diethylene glycol modified) that otherwise comply with 21 CFR 177.1630 or an applicable effective Food Contact Notification, containing up to 0.85 weight percent sodium dimethyl 5-sulfoisophthalate units. INVISTA S.à r.l. The FCS is intended for use as films or articles intended to contact food. Limitations/ Specifi-
cations
June 24, 2005 EA/FONSI
INVISTA S.à r.l.
500 1,4-Cyclohexanedicarboxylic acid, polymer with 1,4-cyclohexanedimethanol, 2-(3-hydroxypropyl)-6-[(3-hydroxylpropyl)amino]-1H-benz[de]isoquinoline-1,3-(2H)-dione and 1,3-pentanediamine, 2-hydroxy-3-phenoxypropyl ester (CAS Reg. No. 519050-54-5). Day-Glo Color Corporation To be used as a colorant in polypropylene films and molded articles that may contact all food types under Conditions of Use E through G as defined in Table 2. Limitations/ Specifi-
cations
July 1, 2005 CAT. EXCL.
21 CFR 25.32(i)
Day-Glo Color Corporation
501 Hydrogenated polymers prepared from one or more of the following: 1-decene (CAS Reg. No. 872-05-9), 1-dodecene, (CAS Reg. No. 112-41-4), and 1-octene (CAS Reg.No.111-66-0). ExxonMobil Chemical Company As an additive at levels up to 25 percent by weight in pressure-sensitive adhesives that comply with 21 CFR 175.125 Limitations/ Specifi-
cations
September 3, 2005 EA/FONSI
ExxonMobil Chemical Company
502 Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (CAS Reg. No. 24993-04-2). BASF Corporation As a component of films used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2, respectively. Limitations/ Specifi-
cations
July 5, 2005 EA/FONSI
BASF AG / BASF Corporation
504 1,2-benzisothiazolin-3-one (CAS Reg. No. 2634-33-5). Arch Chemicals, Inc. The notifier intends to use the FCS as a wet state preservative (biocide) for styrene/acrylic or polymer lattices used in the manufacture of coatings (lacquer) which will be applied to the food contact side of single use articles made from aluminum foil for use with all food types under Conditions of Use B through H (see Table 2). Limitations/ Specifi-
cations
July 2, 2005 CAT. EXCL.
21 CFR 25.32(q)
Arch Chemicals, Inc.
505 Benzamide, 3,3'-[(2-chloro-5-methyl-1,4-phenylene)bis[imino(1-acetyl-2-oxo-2,1-ethanediyl)azo]]bis[4-chloro-N-(3-chloro-2-methylphenyl)-(9Cl) (CAS Reg. No. 5580-57-4). Ciba Specialty Chemicals Corporation For use as a colorant for food-contact polymers. Limitations/ Specifi-
cations
July 12, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
506 Polyether sulfone-polyphenylene sulfone block copolymer CAS name: [1,1'-Biphenyl]-4,4'-diol, polymer with 1,1'-sulfonylbis[4-chlorobenzene] and 4,4'-sulfonylbis [phenol] (CAS Reg. No. 83094-08-0). Solvay Advanced Polymers, LLC As a component of repeat-use molded articles that may contact all types of food, including food trays, conveyor belts, bearings, utensils, containers, and components of machinery. Limitations/ Specifi-
cations
July 15, 2005 CAT. EXCL.
21 CFR 25.32(j)
Solvay Advanced Polymers, LLC
507 Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, ethers with polyoxyethylene mono-Me ether and polyoxypropylene mono-Me ether (CAS Reg. No. 472975-82-9). Dow Corning Corporation As a defoaming agent in the pulping of lignocellulosic materials that will be used in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
July 21, 2005 EA/FONSI
Dow Corning Corporation
508 Alpha-sulfo-omega-(dodecyloxy)(polyoxyethylene) sodium, salt (CAS Reg. No. 9004-82-4). The Dow Chemical Company The FCS will be used as an emulsifier/surfactant in the production of styrene-butadiene-acrylonitrile copolymer coatings for paper and paperboard. Limitations/ Specifi-
cations
July 27, 2005 CAT. EXCL.
21 CFR 25.32(i)
The Dow Chemical Company
509 Bis(p-ethylbenzylidene) sorbitol (CAS Reg. No. 79072-96-1). Ampacet Corporation For use as a clarifying agent in linear low and low density polyethylene (LLDPE and LDPE). Limitations/ Specifi-
cations
July 27, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ampacet Corporation
510 Copolymer of 1,1-difluoroethylene, hexafluoropropene, tetrafluoroethylene, and a halogenated alkene, optionally cured with triallyl isocyanurate and 2,5-dimethyl-2,5-di(tert-butylperoxy)hexane. DuPont Performance Elastomers L.L.C. For repeat-use in the fabrication of molded parts such as o-rings and gaskets for food processing equipment. Limitations/ Specifi-
cations
October 13, 2005 CAT. EXCL.
21 CFR 25.32(j)
DuPont Performance Elastomers L.L.C.
511 Copolymer of 1,1-difluoroethylene, tetrafluoroethylene, trifluoromethyl trifluorovinyl ether and a halogenated alkene, optionally cured with triallyl isocyanurate and 2,5-dimethyl-2,5-di(tert-butylperoxy)hexane. DuPont Performance Elastomers L.L.C. For repeat-use in the fabrication of molded parts such as o-rings and gaskets for food processing equipment. Limitations/ Specifi-
cations
October 13, 2005 CAT. EXCL.
21 CFR 25.32(j)
DuPont Performance Elastomers L.L.C.
512 Industrial starch modified (CAS Reg. No. 56780-58-6) by treatment with greater than 5 percent, and not more than 21 percent by weight 2,3-epoxypropyl trimethylammonium chloride (CAS Reg. No. 3033-77-0). Penford Products Company 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 at a maximum level of 1 percent by weight of the dry pulp. Limitations/ Specifi-
cations
October 8, 2005 CAT. EXCL.
21 CFR 25.32(i)
Penford Products Company
513 A mixture of 35-60 percent hydroxysulfinoacetic acid, disodium salt (CAS Reg. No. 223106-41-0), 10-60 percent hydroxysulfoacetic acid, disodium salt (CAS Reg. No. 29736-24-1), and 0-40 percent sodium sulfite (CAS Reg. No. 7757-83-7). Brüggemann Chemical US, Inc. As a reducing agent in emulsion polymerization redox catalyst systems, with the produced polymer emulsions to be used as components of food-contact paper and paperboard complying with 21 CFR 176.170 or 176.180, adhesives complying with 21 CFR 175.105, and repeat use rubber articles complying with 21 CFR 177.2600. Limitations/ Specifi-
cations
October 1, 2005 CAT. EXCL.
21 CFR 25.32(i)
Brüggemann Chemical US, Inc.
514 Lithium 12-hydroxystearate Asahi Denka Co., Ltd. As a stabilizing agent in polypropylene homo and copolymer. Limitations/ Specifi-
cations
August 23, 2005 CAT. EXCL.
21 CFR 25.32(i)
Asahi Denka Co., Ltd.
515 12H-Dibenzo[d,g][1,3,2]dioxaphosphocin, 2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-,6-oxide, lithium salt (CAS Reg. No. 85209-93-4). Asahi Denka, Company, Ltd. For use as a clarifying and nucleating agent in polypropylene polymers and copolymers complying with 21 CFR 177.1520(c) items 1.1, 3.1, and 3.2. Limitations/ Specifi-
cations
August 23, 2005 CAT. EXCL.
21 CFR 25.32(i)
Asahi Denka, Company, Ltd.
516 Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, ethers with polyoxyethylene mono-Me ether and polyoxypropylene mono-Me ether (CAS Reg. No. 472975-82-9). Dow Corning Corporation As a defoaming agent in printing inks and ink coatings applied to both the food contact side and non-food contact side of paper, paperboard, films, and foils used in food packaging. Limitations/ Specifi-
cations
October 13, 2005 CAT. EXCL.
21 CFR 25.32(i)
Dow Corning Corporation
517 Polysulfone-polyphenylene sulfone block copolymer CAS name: [1,1'-Biphenyl]-4,4'-diol, polymer with 4,4'-(1-methylethylidene) bis[phenol] and 1,1'-sulfonylbis[4-chlorobenzene] (CAS Reg. No. 27757-21-7). Solvay Advanced Polymers, LLC As a component of repeat-use molded articles such as food trays, conveyor belts, bearings, utensils, containers, and components of machinery. Limitations/ Specifi-
cations
August 31, 2005 CAT. EXCL.
21 CFR 25.32(j)
Solvay Advanced Polymers, LLC
518 2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No 464178-90-3). Hercules Inc. As an oil/grease resistant sizing agent at levels up to 0.5 percent by weight employed either prior to the sheet forming operation or at the size press for paper and paperboard intended for use in microwave heat-susceptor packaging. Limitations/ Specifi-
cations
October 20, 2005 CAT. EXCL.
21 CFR 25.32(i)
Hercules Inc.
519 Phenol,4-(1,1-dimethylethyl)-, polymer with sulfur chloride (CAS Reg. No. 60303-68-6). Arkema Inc. As an antioxidant/stabilizer in the processing of rosins and rosin esters for use as components of adhesives complying with 21 CFR 175.105. Limitations/ Specifi-
cations
September 1, 2005 CAT. EXCL.
21 CFR 25.32(i)
Arkema Inc.
522 Styrene-1,3-butadiene block copolymer containing 60 - 75 weight - percent of polymer units derived from styrene (CAS Reg. No. 106107-54-4). BASF Aktiengesellschaft The FCS will be used in the manufacture of food-contact films and coatings. Limitations/ Specifi-
cations
October 26, 2005 EA/FONSI
BASF Aktiengesellschaft
524 Tris (2,4-di-tert-butylphenyl) phosphite (CAS Reg. No. 31570-04-4). Ciba Specialty Chemicals Corporation As an antioxidant/stabilizer in styrene block copolymers complying with 21 CFR 177.1810 Styrene block polymers Limitations/ Specifi-
cations
September 30, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
526 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid (CAS Reg. No. 28628-75-3).
REPLACES FCN #472
EMS-Chemie AG/EMS-Chemie (North America) Inc. As a component of non-food-contact layers of multilayer films for packaging. Limitations/ Specifi-
cations
October 5, 2005 EA/FONSI
EMS-Chemie AG/EMS-Chemie (North America) Inc.
527 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)(CAS Reg. No. 77-99-6). Tioxide Group, Unlimited As a dispersant for pigments.
1) At levels up to 0.6 percent by weight of the pigment when the pigment is used as a colorant for all types of polymers complying with 21 CFR 178.3297.
2) 2. At levels up to 1.0 percent by weight of the pigment when the pigment is used in inks that may come into contact with food.
Limitations/ Specifi-
cations
October 20, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Tioxide Group, Unlimited
528 Agarose, cross-linked with epichlorohydrin and derivatized with 1,4-butane sultone, supported on tungsten carbide beads. UpFront Chromatography A/S As an ion exchange resin for adsorption of proteins from skim milk and whey. Limitations/ Specifi-
cations
November 15, 2005 CAT. EXCL.
21 CFR 25.32(j)
UpFront Chromatography A/S
529 Phosphorous acid, cyclic neopentanetetrayl-bis(2,4-di-tert-butylphenyl)ester (CAS Reg. No. 26741-53-7) containing not more than 1 percent by weight triisopropanolamine (CAS Reg. No. 122-20-3). SABIC Innovative Plastics The subject FCS is intended for use as an antioxidant/stabilizer in acrylonitrile/butadiene/styrene (ABS) polymers and methyl methacrylate-modified ABS (MABS) polymers. Limitations/ Specifi-
cations
October 19, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
SABIC Innovative Plastics
531 Agarose, polymer with (chloromethyl)oxirane, 2-hydroxy-3-(2-hydroxy-3-(trimethylammonio)propoxy)propyl ethers, sulfate salts (CAS Reg. No. 846053-13-2). GE Healthcare As an ion exchange resin. Limitations/ Specifi-
cations
October 26, 2005 CAT. EXCL.
21 CFR 25.32(j)
GE Healthcare
532 2,2'-methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) (CAS Reg. No. 103597-45-1). Asahi Denka Company, Ltd. As an ultraviolet light absorber in polycarbonate food-contact articles complying with Title 21 CFR 177.1580 Polycarbonate resins. Limitations/ Specifi-
cations
October 28, 2005 CAT. EXCL.
21 CFR 25.32(i)
Asahi Denka Company, Ltd.
533 Hydrogenated polymers prepared from one or more of the following monomers: 1-decene (CAS Reg. No. 872-05-9), 1-dodecene (CAS Reg. No. 112-41-4), and 1-octene (CAS Reg.No.111-66-0). ExxonMobil Chemical Company As an additive at levels up to 10 percent in propylene homopolymers and copolymers that comply with 21 CFR 177.1520(c) or are the subject of an effective food contact notification. Limitations/ Specifi-
cations
November 3, 2005 EA/FONSI
ExxonMobil Chemical Company
534 Dicetyl peroxydicarbonate (CAS Reg. No. 26322-14-5) Akzo Nobel Polymer Chemicals LLC The FCS will be used as a modifier in the production of high melt strength polypropylene (HMS-PP). The primary applications for the HMS-PP are in foaming, thermoforming and blow molding. The HMS-PP will comply with 21 CFR 177.1520. Limitations/ Specifi-
cations
November 5, 2005 CAT. EXCL.
21 CFR 25.32(i)
Akzo Nobel Polymer Chemicals LLC
535 A type of zeolite in which silver, copper and ammonium ions have been exchanged for sodium ions. AgIon Technologies To control microorganisms that may grow on the article and to thereby preserve the article. Limitations/ Specifi-
cations
November 11, 2005 CAT. EXCL.
21 CFR 25.32(j)
AgIon Technologies
537 2,2'-(1,4-Phenylene)bis[4H-3,1-benzoxazin-4-one] (CAS Reg. No. 18600-59-4).

REPLACES FCNs 428 and 493
Cytec Industries Incorporation To be used as an ultraviolet (UV) light stabilizer in ethylene phthalate (PET) polymers complying with 21 CFR 177.1630 (Polyethylene phthalate polymers), 21 CFR 177.1315 (Ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers), or that are the subject of an effective FCN. Limitations/ Specifi-
cations
November 17, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Cytec Industries Incorporation
538 Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991-62-4), ammonium salt. Solvay Solexis S.p.A As an oil and water repellent employed in the manufacture of food-contact paper and paperboard either prior to the sheet-forming operation or at the size press. Limitations/ Specifi-
cations
November 19, 2005 CAT. EXCL.
21 CFR 25.32(i)
Solvay Solexis S.p.A
539 A copolymer of 4-bromo-3,3,4,4-tetrafluoro-1-butene, ethylene, tetrafluoroethylene and trifluoromethyl trifluorovinyl ether optionally cured with triallyl isocyanurate and 2,5-dimethyl-2,5-di(tert-butylperoxy)hexane. (CAS Reg. No. 105656-63-1) DuPont Performance Elastomers LLC For repeat-use in the fabrication of molded parts such as o-rings and gaskets for food processing equipment. Limitations/ Specifi-
cations
November 22, 2005 CAT. EXCL.
21 CFR 25.32(j)
DuPont Performance Elastomers LLC
540 3-Chloro-2-hydroxypropyltrimethylammonium chloride (CAS Reg. No. 3327-22-8). Grain Processing Corporation For use as a starting material in the production of 2,3-epoxypropyltrimethylammonium chloride (CAS Reg. No. 3033-77-0) that will be used to modify industrial starch at a treatment level of greater than 5 percent and not more than 21 percent by weight of the starch to form high cationic starch (HCS). The finished HCS is intended 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 only recycled food-contact paperboard. Limitations/ Specifi-
cations
November 13, 2005 CAT. EXCL.
21 CFR 25.32(i)
Grain Processing Corporation
541 Poly[[6-[(1,1,3,3- tetramethybutyl) amino]-s- triazine-2,4-diyl][2,2,6,6- tetramethyl-4- piperidyl)imino]hexamethylene[( 2,2,6,6-tetramethyl-4- piperidyl)imino]] (CAS Reg. No. 70624 18-9) Ciba Specialty Chemicals Corporation As an antioxidant/stabilizer for use in polyethylene polymers identified in 21 CFR 177.1520(c), items 2.1, 2.2, and 2.3, having a density greater than or equal to 0.94 grams per cubic centimeter. Limitations/ Specifi-
cations
November 24, 2005 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
542 2-propen-1-ol, reaction products with 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-6-iodohexane, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-94-7). Hercules Incorporated As an oil/grease resistant sizing agent employed prior to the sheet forming operation in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
November 25, 2005 CAT. EXCL.
21 CFR 25.32(i)
Hercules Incorporated
544 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 Corporation As an antioxidant and/or stabilizer in polystyrene and impact polystyrene, compliant with 21 CFR 177.1640, in contact with all food types. Limitations/ Specifi-
cations
February 16, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
545 Styrene (CAS Reg. No. 100-42-5), methyl methacrylate (CAS Reg. No. 80-62-6) and glycidyl methacrylate (CAS Reg. No. 1-6-91-2) copolymers. BASF Corporation and
Nature Works LLC
The FCS will be used as a polymeric chain extender in the manufacture of polylactide polymers in contact with all food types (except in foods with an alcohol content greater than 15 percent) and under Conditions of Use E through G. Limitations/ Specifi-
cations
February 3, 2006 EA/FONSI
BASF Corporation and
Nature Works LLC
546 1,3-Benzenedicarboxylic acid, 5-sulfo-, monolithium salt (CAS Reg. No. 46728-75-0). Gruppo Mossi & Ghisolfi
M&G Polymers USA LLC
The FCS is intended for use as a modifier of ethylene phthalate polymers regulated under 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN. Limitations/ Specifi-
cations
January 28, 2006 EA/FONSI
Gruppo Mossi & Ghisolfi
M&G Polymers USA LLC
547 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 up to 16 mole-percent of total 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. Futura Polymers
A division of Futura Polyesters Limited
For finished polymers containing up to 12 mole-percent of total diethylene glycol and isophthalate units, for use as films or articles intended for contact with aqueous, acidic, low-alcohol (up to 50 percent alcohol by volume), dry and fatty foods under Conditions of Use A through H as described in Table 2, and for use in contact with high-alcohol foods (greater than 50 percent alcohol by volume) under Conditions of Use E through G as described in Table 2. For finished polymers containing between 12 and 16 mole-percent total diethylene glycol and isophthalate units, for use as films or articles intended for contact with aqueous, acidic, low-alcohol (up to 50 percent alcohol by volume), dry, and fatty foods under Conditions of Use B through H as described in Table 2. Limitations/ Specifi-
cations
January 26, 2006 EA/FONSI
Futura Polymers
A division of Futura Polyesters Limited
548 REPLACED BY FCN 614 Limitations/ Specifi-
cations
549 Silicon Dioxide (CAS Reg. No. 7631-86-9), with a topcoat of a polymer of hexamethyldisiloxane (CAS Reg. No. 26298-61-3). Toyo Seikan Kaisha, Ltd. To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles. Limitations/ Specifi-
cations
December 21, 2005 CAT. EXCL.
21 CFR 25.32(i)
Toyo Seikan Kaisha, Ltd.
550 Copper, [C,C,C,C-tetrachloro-29H, 31H-phthalocyaninato(2-)-N29, N30, N31,N32] (CAS Reg. No. 27614-71-7). BASF Corporation As a colorant in all types of food-contact polymers. Limitations/ Specifi-
cations
March 7, 2006 CAT. EXCL.
21 CFR 25.32(i)
BASF Corporation
551 Trimethylolpropane (CAS Reg. No. 77-99-6). E.I. du Pont de Nemours and Company, Incorporated As a milling aid and dispersant for pigments used as components of food-contact articles. Limitations/ Specifi-
cations
December 30, 2005 CAT. EXCL.
21 CFR 25.32(i)
E.I. du Pont de Nemours and Company, Incorporated
553 Ethanedioic acid, diethyl ester, polymer with 2,3-dihydro-9,10-dihydroxy-1,4-anthracenedione, 1,4-dihydroxy-9,10 anthracenedione and 1,3-pentanediamine (CAS Reg. No. 725685-53-0). Day-Glo Color Corporation As a colorant in polypropylene food-contact polymers. Limitations/ Specifi-
cations
March 18, 2006 CAT. EXCL.
21 CFR 25.32(i)
Day-Glo Color Corporation
554 2-Propenoic acid, homopolymer, sodium salt (with a weight average molecular weight of 2300 to 5700 Daltons and a weight average molecular weight to number average molecular weight ratio of not more than 6.3) (CAS Reg. No. 9003-04-7). Ciba Specialty Chemicals Corporation To control the formation of mineral scale during evaporation of beet or cane sugar juice. Limitations/ Specifi-
cations
April 13, 2006 EA/FONSI
Ciba Specialty Chemicals Corporation
555 2-Hydroxyethyl methacrylate (CAS Reg. No. 868-77-9). PPG Industries (UK) As a monomeric component of acrylic polymers complying with 21 CFR 177.1010, used only in the manufacture of resinous and polymeric coatings. Limitations/ Specifi-
cations
January 28, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
PPG Industries (UK)
556 Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, diethyl ester (CAS Reg. No. 976-56-7). Ciba Specialty Chemicals Corporation The FCS is intended for use as an antioxidant/stabilizer in (a) ethylene phthalate polymers compliant with 21 CFR 177.1630 and (b) ethylene phthalate polymers compliant with the specifications in 21 CFR 177.1630(f) for which there is an effective food contact notification. Limitations/ Specifi-
cations
April 19, 2006 EA/FONSI
Ciba Specialty Chemicals Corporation
558 1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-butanediol, adipic acid, hexamethylene diisocyanate and not more than 1 percent by weight of a polyhydric alcohol, as described in FCN 372. Stanelco Plc For use in blends with food-contact polylactide polymers used to produce single use food-contact trays. Limitations/ Specifi-
cations
February 10, 2006 EA/FONSI
Stanelco Plc
560 p-chloro-m-cresol (CAS Reg. No. 59-50-7). LANXESS Corporation For use as an antimicrobial preservative in lubricants with incidental food contact. Limitations/ Specifi-
cations
February 15, 2006 CAT. EXCL.
21 CFR 25.32(j)
LANXESS Corporation
561 A mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-l), acetic acid (CAS Reg. No. 64-19-7), l-hydroxyethylidene-1,l-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and water. FMC Corporation The FCS will be used as a part of the process to treat food-contact surfaces to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR Part 113. Limitations/ Specifi-
cations
February 22, 2006 EA/FONSI
FMC Corporation
563 Dimethyl sulfoisophthalate, sodium salt (DMSIP) (CAS Reg. No. 3965-55-7). [The CAS nomenclature is 1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt.] Wellman Incorporated For use as a modifier in polyethylene terephthalate (PET). Limitations/ Specifi-
cations
April 28, 2006 EA/FONSI
Wellman Incorporated
564 Copolymer of divinylbenzene and ethylvinylbenzene (CAS Reg. No. 9043-77-0). Rohm and Haas Company The FCS is used to remove organic substances from all alcoholic beverages, food types VIA and VIC as described in Table 1. Limitations/ Specifi-
cations
March 7, 2006 CAT. EXCL.
21 CFR 25.32(j)
Rohm and Haas Company
566 Poly(N-vinylformamide), 20-100 percent hydrolyzed, chloride or sulfate salts. The FCS is specifically known as one of the following:
1. formamide, N-ethenyl-, polymer with ethanamine, hydrochloride (CAS Reg. No. 111616-55-8)
2. formamide, N-ethenyl-, polymer with ethanamine sulfate (CAS Reg. No. 117985-59-8)
3. formamide, ethenyl-, homopolymer, hydrolyzed, hydrochlorides, (CAS Reg. No. 183815-54-5).
Hercules Incorporated As strengthening agents, fixing agents, or retention aids prior to the sheet-forming operation in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
March 15, 2006 EA/FONSI
Hercules Incorporated
567 Bromine chloride (BrCl) (CAS Reg. No. 13863-41-7). Albemarle Corporation The FCS is intended for use as a slimicide in the manufacture of food-contact paper and paperboard. Limitations/ Specifi-
cations
April 28, 2006 CAT. EXCL.
21 CFR 25.32(q)
Albemarle Corporation
569 A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight. The mixture may contain magnesium or sodium nitrate at a 1 to 1 ratio (weight/weight) with the sum of the isothiazolinone ingredients. Thor GmbH As an antimicrobial agent in polymer latex solutions intended for use in adhesives complying with 21 CFR 175.105. Limitations/ Specifi-
cations
March 21, 2006 CAT. EXCL.
21 CFR 25.32(q)
Thor GmbH
571 Extruded polystyrene (CAS Reg. No. 9003-53-6) and cross-linked polyvinylpyrrolidone (CAS Reg. No. 9003-39-8). BASF Aktiengesellschaft As a repeat-use clarifying agent during the manufacture of alcoholic and non-alcoholic beverages. Limitations/ Specifi-
cations
May 12, 2006 EA/FONSI
BASF Aktiengesellschaft
572 Amines, bis(hydrogenated rape oil alkyl) methyl, N-oxides (CAS Reg. No. 204933-93-7). Chemtura Corporation As an antioxidant in the manufacture of polyethylene and polypropylene homopolymer and copolymers complying with 21 CFR 177.1520(c). Limitations/ Specifi-
cations
March 28, 2006 CAT. EXCL.
21 CFR 25.32(i)
Chemtura Corporation
573 Copolymer of tetrafluoroethylene, perfluoromethylvinylether and 1-iodo-2- bromo- tetrafluoroethane intended to be cross-linked with triallylisocyanurate.
REPLACES FCN #278
Unimatec Company, Ltd. As an O-ring or gasket in food-processing machinery. Limitations/ Specifi-
cations
March 30, 2006 CAT. EXCL.
21 CFR 25.32(j)
Unimatec Company, Ltd.
574 Polyglycolic acid (CAS Reg. No. 26124-68-5). Kureha Corporation As the non food-contact layer of multi-layer, polyethylene terephthalate (PET) beverage bottles. Limitations/ Specifi-
cations
April 14, 2006 EA/FONSI
Kureha Corporation
575
-
577
Silicon nitride containing up to 14.5 percent aluminum oxide, yttrium oxide, and/or titanium dioxide. CERATIZIT Austria Gesellschaft m.b.H. The food contact substances will be used in the manufacture of food processing equipment (e.g. seal rings, bearings, parts in conveying systems, and parts in crushers and mills). Limitations/ Specifi-
cations
March 31, 2006 CAT. EXCL.
21 CFR 25.32(j)
CERATIZIT S.A. and subsidiaries
578
-
585
Tungsten carbide containing up to 16.0 percent cobalt with up to 6.5 percent chromium, titanium carbide, tantalum carbide, niobium carbide, and/or vanadium carbide. CERATIZIT Austria Gesellschaft m.b.H. The food contact substances will be used in the manufacture of food processing equipment (e.g. seal rings, bearings, parts in conveying systems, and parts in crushers and mills). Limitations/ Specifi-
cations
March 31, 2006 CAT. EXCL.
21 CFR 25.32(j)
CERATIZIT S.A. and subsidiaries
586
-
591
Tungsten carbide containing up to 11.5 percent nickel with up to 1.9 percent chronium, tantalum carbide, niobium carbide, molybdenum carbide, and/or vanadium carbide. CERATIZIT Austria Gesellschaft m.b.H. The food contact substances will be used in the manufacture of food processing equipment (e.g. seal rings, bearings, parts in conveying systems, and parts in crushers and mills). Limitations/ Specifi-
cations
March 31, 2006 CAT. EXCL.
21 CFR 25.32(j)
CERATIZIT S.A. and subsidiaries
592 Cross-linked reaction product of polyvinyl alcohol (PVOH) (CAS Reg. No. 9002-89-5) and tetraethoxysilane (TEOS) (CAS Reg. No. 78-10-4), coupled with the trimethoxysilane-based coupling agent described in the notification. Toppan Printing Company, Ltd. 1. As a non-food-contact layer in multilayer constructions intended for use in packaging food of all types under Conditions of Use B through H as specified in Table 2, and at higher temperatures only in retort packaging processes.
2. When used under Condition of Use B through H, the food-contact substance layer will be separated from food by at least a 20 micron thick layer of low density polyethylene or other polymer layer sufficiently thick so as to provide equivalent or better barrier properties than 20 microns of low density polyethylene.
3. When used in retort packaging processes, the food-contact substance layer will be separated from food by at least a 50 micron thick layer of polypropylene or other polymer layer sufficiently thick so as to provide equivalent or better barrier properties than 50 microns of polypropylene.
Limitations/ Specifi-
cations
March 31, 2006 CAT. EXCL.
21 CFR 25.32(i)
Toppan Printing Company, Ltd.
594 Copolymer of styrene (CAS Reg. No. 100-42-5), methyl methacrylate (CAS Reg. No.80-62-6), and glycidyl methacrylate (CAS Reg. No. 106-91-2). BASF Corporation and
NatureWorks LLC
For use as a polymeric chain extender in foamed polylactide polymers. Limitations/ Specifi-
cations
April 18, 2006 EA/FONSI
BASF Corporation and
NatureWorks LLC
595 Industrial starch modified (CAS Reg. No. 56780-58-6) by treatment with greater than 5 percent, and not more than 21 percent by weight 2,3-epoxypropyl trimethylammonium chloride (CAS Reg. No. 3033-77-0). Penford Corporation (USA); Penford Products Company; Penford Holdings Pty Ltd.; Penford Australia Ltd.; and Penford New Zealand Ltd. 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 at a maximum level of 1 percent by weight of the dry pulp. Limitations/ Specifi-
cations
April 26, 2006 CAT. EXCL.
21 CFR 25.32(i)
Penford Products Company; Penford Australia Ltd.; and Penford New Zealand Ltd.
597 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate (CAS Reg. No. 6846-50-0). Eastman Chemical Company As a plasticizer for repeat-use vinyl chloride polymers that may contact food, including vinyl chloride polymer-based gloves used in processing food and as a component of coatings for paper and paperboard intended to contact dry food. Limitations/ Specifi-
cations
April 29, 2006 EA/FONSI
Eastman Chemical Company
598 A copolymer of propylene (CAS Reg. No. 115-07-1), tetrafluoroethylene (CAS Reg. No. 116-14-3), and 3,3,3-trifluoropropene (CAS Reg. No. 677-21-4) cured with a salt of a quarternary ammonium compound and phenol, 4,4'-(2,2,2-trifluoro-1-(trifluoromethyl)ethylidene)bis-. DuPont Performance Elastomers L.L.C. For repeat use in the fabrication of molded parts such as o-rings and gaskets for food. Limitations/ Specifi-
cations
April 29, 2006 CAT. EXCL.
21 CFR 25.32(j)
DuPont Performance Elastomers L.L.C.
599 Copolymer of polyfluorooctyl methacrylate, 2-N,N-diethylaminoethylmethacrylate, 2-hydroxyethylmethacrylate, and 2,2'-ethylenedioxydiethyldimethacrylate (CAS Reg. No. 863408-19-9). AGC Chemicals Americas, Incorporated As an oil, grease, and water resistant treatment for paper and paperboard employed either prior to the sheet forming operation or at the size press. Limitations/ Specifi-
cations
June 29, 2006 CAT. EXCL.
21 CFR 25.32(i)
Asahi Glass Co., Ltd. (Manufacturer) and
AGC Chemicals Americas, Incorporated
602 3-pyridinecarbonitrile, 4-methyl-2,6-bis[(4-methylphenyl)amino]-5-[[2-(trifluoromethyl)- phenyl]azo]- (CAS Reg. No. 669005-94-1). Ciba Specialty Chemicals Corporation The FCS is intended as a colorant for use in authorized poly(ethylene phthalate) polymers, including those modified with 1,4-cyclohexanedimethanol. Limitations/ Specifi-
cations
July 5, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
604 Copolymer of polyfluorooctyl methacrylate, 2-N,N-diethylaminoethylmethacrylate, 2-hydroxyethylmethacrylate, and 2,2'-ethylenedioxydiethyldimethacrylate (CAS Reg. No. 863408-19-9). AGC Chemicals Americas, Incorporated As an oil, grease, and water resistant treatment for paper and paperboard employed either prior to the sheet forming operation or at the size press. Limitations/ Specifi-
cations
August 5, 2006 CAT. EXCL.
21 CFR 25.32(i)
Asahi Glass Company, Ltd. (Manufacturer)
AGC Chemicals Americas, Incorporated
607 Benzenesulfonic acid, 4-[[1-[[(2-methylphenyl)amino)]carbonyl]-2-oxopropyl]azo]-3-nitro-, calcium salt (2:1). (C.I. Pigment Yellow 62). Dominion Colour Corporation As a colorant for all polymers. Limitations/ Specifi-
cations
May 30, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Dominion Colour Corporation
608 1,2-Cyclohexanedicarboxylic acid, calcium salt (1:1), (1R, 2S)-rel- (CAS Reg. No. 491589-22-1) Milliken Chemical As a nucleating or clarifying agent in all polyolefins. Limitations/ Specifi-
cations
June 6, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Milliken Chemical
614 Zeolite Na-P
REPLACES FCN #548
Ineos Silicas Group As a component for use in paper and paperboard coatings and as a filler. Limitations/ Specifi-
cations
June 14, 2006 CAT. EXCL.
21 CFR 25.32(i)
Ineos Silicas Group
615 N-[3,5-Bis-(2,2-dimethyl-propionylamino)-phenyl]-2,2-dimethyl-propionamide Ciba Specialty Chemicals Corporation For use as a clarifier for polypropylene (PP) homo- and copolymers. Limitations/ Specifi-
cations
August 4, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
616 Poly(1,4-benzene dicarboxylic acid dimethyl ester, 1,3-benzene dicarboxylic acid dimethyl ester, 1,4-butanediol, ethylene oxide, propylene oxide) (CAS Reg. No. 64811-38-7). E. I. du Pont de Nemours and Company, Incorporated The FCS is intended for use as a component of food contact articles in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. Limitations/ Specifi-
cations
June 28, 2006 EA/FONSI
E. I. du Pont de Nemours and Company, Incorporated
617 Poly(1,4-benzene dicarboxylic acid dimethyl ester, 1,4-butanediol, ethylene oxide, propylene oxide) (CAS Reg. No. 64811-37-6). E. I. du Pont de Nemours and Company, Incorporated The FCS is intended for use as a component of food contact articles in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. Limitations/ Specifi-
cations
June 28, 2006 EA/FONSI
E. I. du Pont de Nemours and Company, Incorporated
618 Fatty acids, C14-20, esters with pentaerythritol (CAS Reg. No. 68440-28-8). Cognis Deutschland GmbH and Company, KG As a processing agent in the production of polyethylene terephthalate (PET) food-contact materials. Limitations/ Specifi-
cations
August 26, 2006 CAT. EXCL.
21 CFR 25.32(i)
Cognis Deutschland GmbH and Company, KG
619 Platinum, [(2,5,6-.eta.)-3-(1-acetyl-2-oxopropyl)bicyclo[2.2.1]hept-5-en-2-yl](2,4-pentanedionato-O,O'). Wacker Chemical Corporation For use as a catalyst in the crosslinking reaction of vinyl functional polysiloxanes with hydrogen functional polysiloxanes to form silicone elastomers complying with 21 CFR 177.2600(c)(4)(i) for repeated use food contact articles. Limitations/ Specifi-
cations
September 12, 2006 CAT. EXCL.
21 CFR 25.32(j)
Wacker Chemical Corporation
621 Poly(1,4-phenylenecarbonyl-1,4-phenyleneoxy (CAS Reg. No. 27380-27-4). ICI Measurement Science Group As a component of repeat-use articles intended to contact all food types at all temperatures up to and including oven cooking temperatures. Limitations/ Specifi-
cations
July 7, 2006 CAT. EXCL.
21 CFR 25.32(j)
Victrex plc
624 Poly[(bis(isoindol-2-yl-1,3-dione)-1,3-phenylene)-4,4'-(l-methylethylidene)bisphenol]. SABIC Innovative Plastics As a component of food contact articles. Limitations/ Specifi-
cations
September 16, 2006 EA/FONSI
SABIC Innovative Plastics
625 A mixture of peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidine-1,1-diphosphonic acid, with or without an optional adjuvant system composed of a mixture dimethyl sebacate (up to 20 percent), dimethyl succinate (up to 0.8 percent), dimethyl adipate (68-76 percent) and dimethyl glutarate (4- 12 percent). Ecolab, Incorporated As an antimicrobial additive that may be used alone or in combination with other processes in the commercial sterilization of polyethylene terephthalate (PET) food packaging prior to filling. Limitations/ Specifi-
cations
September 24, 2006 EA/FONSI
Ecolab, Incorporated
626 Trilauryl phosphite (CAS Reg No. 3076-63-9). Dover Chemical Corporation As an antioxidant in vinyl chloride polymers and linear low density polyethylene. Limitations/ Specifi-
cations
August 3, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Dover Chemical Corporation
627 A copolymer of styrene and butadiene having a styrene monomer unit content of 60 percent - 74 percent. Chevron Phillips Chemical Company LP As a component in the manufacture of articles intended to contact food. Limitations/ Specifi-
cations
August 12, 2006 EA/FONSI
Chevron Phillips Chemical Company LP
628 Copolymer of 2-perfluoroalkylethyl acrylate, 2-(dimethylamino)ethyl methacrylate, and oxidized 2-(dimethylamino)ethyl methacrylate (CAS Reg. No. 479029-28-2). Clariant Corporation For use as an oil and grease repellent in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
October 10, 2006 CAT. EXCL.
21 CFR 25.32(i)
Clariant Corporation
629 Silane, dichlorodimethyl-, reaction products with silica (CAS Reg. No. 68611-44-9). Milliken Chemical As a flow agent for sorbitol acetal clarifying agents complying with 21 CFR 178.3295 Clarifying agents for polymers, or an effective food-contact notification. The FCS will be used at levels not to exceed 200 parts per million in polypropylene homopolymers and copolymers complying with 21 CFR 177.1520 Olefin polymers. Limitations/ Specifi-
cations
August 16, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Milliken Chemical
630 Methyl formate (CAS Reg. No. 107-31-3). Pactiv Corporation For use as a blowing agent for polystyrene food-contact articles. Limitations/ Specifi-
cations
August 22, 2006 CAT. EXCL.
21 CFR 25.32(r)
Pactiv Corporation
631 2,5-Furandione, polymer with 1-propene (CAS Reg. No. 25722-45-6). Mitsui Chemicals, Incorporated As a component in blends with polypropylene (homopolymers and copolymers) for use in contact with food. Limitations/ Specifi-
cations
August 24, 2006 EA/FONSI
Mitsui Chemicals, Incorporated
632 Magnesium(2+) 12-hydroxyoctadecanoate (CAS Reg. No. 91697-37-9). Katsuta Kako K.K. As a processing aid during extrusion and molding of polymer articles in contact with food. Limitations/ Specifi-
cations
August 25, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Katsuta Kako K.K.
633 Aluminum hydroxide magnesium hydroxide carbonate (Hydrotalcite) (CAS Reg. No. 12304-65-3). Eka Chemicals Incorporated The FCS will be used as a processing aid in the manufacture of paper and paperboard intended to contact food. Limitations/ Specifi-
cations
August 30, 2006 EA/FONSI
Eka Chemicals Incorporated
634 Benzoic acid, 2-hydroxy, monosodium salt (CAS Reg. No. 54-21-7). FMC Corporation As a component of an adjuvant solution mixed with a peroxyacetic acid solution intended for use in sterilizing polymeric food-contact packaging. Limitations/ Specifi-
cations
October 7, 2006 EA/FONSI
FMC Corporation
635 Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of dimethyl terephthalate or terephthalic acid with ethylene glycol and 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. DAK Americas, LLC For use as films or articles intended for contact with aqueous, acidic, low-alcohol (up to 15 percent 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
August 30, 2006 EA/FONSI
DAK Americas, LLC
636 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). Igcar Productos Quimicos S.L. For use as an optical brightener in paper and paperboard. Limitations/ Specifi-
cations
September 6, 2006 CAT. EXCL.
21 CFR 25.32(i)
Igcar Productos Quimicos S.L.
637 Copolymer of 2,6-xylenol and 2,3,6-trimethylphenol(CAS Reg. No. 58295-79-7). SABIC Innovative Plastics As a component in the manufacture of articles intended to contact food. Limitations/ Specifi-
cations
September 8, 2006 EA/FONSI
SABIC Innovative Plastics
638 Benzoic acid, 2,2'-[(benzoylimino)bis [2,1-ethanediyl (5-cyano-2-hydroxy-4-methyl-6-oxo-1,3(6H)-pyridinediyl)azo]] bis-, diethyl ester (9CI) (CAS Reg. No. 459856-74-7). Ciba Specialty Chemicals Corporation As a colorant for use in authorized poly(ethylene phthalate) polymers, including those modified with 1,4-cyclohexanedimethanol. Limitations/ Specifi-
cations
October 21, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
639 2,4-bis[(dodecylthio)methyl]-6-methylphenol (CAS Reg. No. 110675-26-8). Ciba Specialty Chemicals Corporation As an antioxidant/stabilizer for use in (1) styrene block polymers, and (2) polystyrene and rubber-modified polystyrene. Limitations/ Specifi-
cations
September 19, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Ciba Specialty Chemicals Corporation
641 A mixture of peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidine-1,1-diphosphonic acid. Enviro Tech Chemical Services, Incorporated As an antimicrobial to control microorganisms in wash water used to manufacture lactose. Limitations/ Specifi-
cations
November 4, 2006 EA/FONSI
Enviro Tech Chemical Services, Incorporated
642 Copolymer of monoacryloxyethyl succinate (MAES) (CAS Reg. No. 50940-49-3) and monoacryloxyethyl hexahydrophthalate (MAHP) (CAS Reg. No. 57043-35-3), and lauryl acrylate (LA) (CAS Reg. No. 2156-97-0). The ratio of the MAES: MAHP is in the range of 75:25 percent to 50:50 percent by weight. LA may be used at 0-10 percent by weight of the total monomer units. Northwest Coatings As an electron beam (EB) curable laminating adhesive, for use in multilayer films when separated from food by a barrier layer. Limitations/ Specifi-
cations
September 29, 2006 CAT. EXCL.
21 CFR 25.32(i)
Northwest Coatings
643 Siloxanes and silicones, di-Me (CAS Reg. No. 63148-62-9). E.I. du Pont de Nemours and Company, Incorporated For use as a dispersant for pigments used as colorants for all food-contact polymers. Limitations/ Specifi-
cations
September 29, 2006 CAT. EXCL.
21 CFR 25.32(i)
E.I. du Pont de Nemours and Company, Incorporated
644 Chlorine Dioxide (CAS Reg. No. 10049-04-4) JohnsonDiversey As an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables that are not raw agricultural commodities. Limitations/ Specifi-
cations
December 15, 2006 EA/FONSI
JohnsonDiversey
645 Chlorine Dioxide Selective Micro Technologies, LLC As an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables that are not raw agricultural commodities in an amount not to exceed 3ppm residual chlorine dioxide as determined by methods specified in 21 CFR 173.300. The treated fruits or vegetables will be further processed by blanching, canning or cooking, or consumed as fresh-cut fruits and vegetables. Limitations/ Specifi-
cations
December 22, 2006 EA/FONSI
Selective Micro Technologies, LLC
646 Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, glycidyl methacrylate, acrylic acid, and methacrylic acid (CAS Reg. No. 870465-08-0). DuPont Chemical Solutions Enterprise As an oil and grease resistant treatment for paper and paperboard employed either prior to the sheet forming operation or at the size press. Limitations/ Specifi-
cations
September 30, 2006 CAT. EXCL.
21 CFR 25.32(i)
and EA
DuPont Chemical Solutions Enterprise
647 Formamide, N,N-1,6-hexanediylbis[N-(2,2,6,6-tetramethyl-4-piperidinyl)]- (CAS Reg. No. 124172-53-8). BASF Aktiengesellschaft For use as a UV light stabilizer in Polystyrene complying with 21 CFR 177.1640, styrene block copolymers complying with 21 CFR 177.1810, acrylonitrile copolymers and resins complying with 21 CFR 181.32 and Polypropylene (PP) complying with 21 CFR 177.1520. Limitations/ Specifi-
cations
October 3, 2006 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
649 Polyethylene terphthalate, modified with a derivative of hexamethyldisilazane and tetraethyl orthosilicate. PTP Plastic Technologies & Products B.V. For use as a basic resin in food-contact articles. Limitations/ Specifi-
cations
October 3, 2006 EA/FONSI
PTP Plastic Technologies & Products B.V.
650 Hydrogenated styrene butadiene (15 percent styrene to 85 percent butadiene, 67 percent styrene to 33 percent butadiene, or both grades in combination) (CAS Reg. No. 66070-58-4) used in conjuhction with cobalt stearate (CAS Reg. No. 13586-84-0). Toyo Seikan Kaisha, Ltd. The FCS is intended for use as a component of a linear low-density polyethylene (LLDPE) oxygen scavenging barrier layer, which is used as a non-food contact layer in multilayer LDPE bottles. Limitations/ Specifi-
cations
October 5, 2006 CAT. EXCL.
21 CFR 25.32(i)
Toyo Seikan Kaisha, Ltd.
652 2,2'-Methylenebis(6-(2H-benzotriazol-2-y1)-4-(1 ,1,3,3-tetramethylbutyl)phenol) (CAS Reg. No. 103597-45-1). Adeka Corporation As an ultraviolet light absorber in polyethylene phthalate polymers intended for use in contact with food. Limitations/ Specifi-
cations
October 20, 2006 CAT. EXCL.
21 CFR 25.32(i)
Adeka Corporation
653 Crosslinked 2-propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7). BASF Aktiengesellschaft As a fluid absorbent in food contact materials. Limitations/ Specifi-
cations
October 25, 2006 EA/FONSI
BASF Aktiengesellschaft
654 2-Propenoic acid, polymer with N-ethenylformamide, sodium salt (CAS Reg. No.865535-22-4). BASF Aktiengesellschaft The FCS is intended for use as a dry-strength agent, fixing agent, or retention aid in paper and paperboard. Limitations/ Specifi-
cations
November 9, 2006 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
656 Pyrrolo[3,4-c]pyrrole-1,4-dione,3,6-bis[3-(dodecylsulfonyl) phenyl]-2,5-dihydro- (CAS Reg. No. 884862-07-1). Clariant Corporation As a surface modifier in colorants for polymers. Limitations/ Specifi-
cations
November 14, 2006 CAT. EXCL.
21 CFR 25.32(i)
Clariant Corporation
657 Sodium Xylene Sulfonate (CAS Reg. No. 1300-72-7). Ecolab Incorporated As an anionic surfactant, hydrotrope, and coupling agent in commercial, single use dishwashing rinse-aid products to be used in commercial establishments. Limitations/ Specifi-
cations
November 17, 2006 EA/FONSI
Ecolab Incorporated
659 Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one, bis(4-aminocyclohexyl)methane and 1,6-hexanediamine (Nylon 6/66/136) (CAS Reg. No. 25053-13-8). BASF Aktiengesellschaft The FCS is intended for use as a thin coating for food packaging materials, especially for plastic film and paper. Limitations/ Specifi-
cations
November 22, 2006 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
660 C10-C12 Ethoxylated Alcohol (CAS Reg. No. 68002-97-1). Ecolab Incorporated As a processing aid in rinse-aid products used in commercial dishwashing machines. Limitations/ Specifi-
cations
November 28, 2006 EA/FONSI
Ecolab Incorporated
662 Nonitol, 1,2,3-trideoxy-4,6:5,7-bis-O-[(4-propylphenyl)methylene]- (CAS Reg. No. 882073-43-0). Milliken Chemical For use as a clarifying agent in polypropylene and high-polypropylene olefin copolymers. Limitations/ Specifi-
cations
December 14, 2006 CAT. EXCL.
21 CFR 25.32(i) and (j)
Milliken Chemical
663 Sulfonic acids, C10-C18 alkane, phenyl esters (CAS Reg. No. 70775-94-9). Lanxess Deutschland GmbH As a plasticizer for polyvinyl chloride (PVC) polymers, for single and repeated-use food-contact articles. Limitations/ Specifi-
cations
February 7, 2007 EA/FONSI
Lanxess Deutschland GmbH
664 N,N'-bis(phenylmethy1)hexanediamide (CAS Reg. No. 25344-24-5), used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2). Constar International The FCS will be used as a modifier of ethylene phthalate/naphthalate polymers and copolymers, excluding those modified with organic anhydrides. Limitations/ Specifi-
cations
January 5, 2007 CAT. EXCL.
21 CFR 25.32(i)
Constar International
665 Hexanedioic acid, polymer with 1,3-benzenedimethanamine (CAS Reg No. 25718-70-1), meeting the analytical specifications in 21 CFR 177.1500(b) item 10.2, when tested by the method given in 21 CFR 177.1500(d). Gruppo Mossi & Ghisolfi For use as a modifier of ethylene phthalate polymers complying with 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN. Limitations/ Specifi-
cations
January 10, 2007 CAT. EXCL.
21 CFR 25.32(i)
Gruppo Mossi & Ghisolfi
M&G Polymers USA LLC
666 2-Propenoic acid, polymer with N-ethenylformamide, sodium salt, hydrolyzed, hydrochlorides (CAS Reg. No. 865596-61-8). BASF Aktiengesellschaft The FCS is intended for use as a dry-strength agent, fixing agent, and/or retention aid, in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
January 18, 2007 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
668 Chlorine dioxide (CAS Reg. No. 10049-04-4) Drew Industrial Division,
Ashland Specialty Chemical Company,
Ashland, Incorporated
As an antimicrobial agent to be applied to red meat (including meat parts and organs), raw agricultural commodities, processed, comminuted or formed meat products, and seafood. Limitations/ Specifi-
cations
March 16, 2007 EA/FONSI
Drew Industrial Division,
Ashland Specialty Chemical Company,
Ashland, Incorporated
669 1,4-cyclohexanedicarboxylic acid, polymer with 1,5-bis[[1-(hydroxymethyl)propyl]amino]-9,10- anthracenedione, 1,4-cyclohexanedirnethanol, hexanedioic acid and 2-methyl-l,5-pentanediamine, reaction products with phenyl ether (CAS Reg. No. 867303-34-2). DAY-GLO Color Corporation As a colorant in food-contact polypropylene (PP). Limitations/ Specifi-
cations
January 26, 2007 CAT. EXCL.
21 CFR 25.32(i)
DAY-GLO Color Corporation
670 A mixture of peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidine-1, 1-diphosphonic acid, with or without an optional adjuvant system composed of a mixture dimethyl sebacate (up to 20 percent), dimethyl succinate (up to 0.8 percent), dimethyl adipate (68-76 percent) and dimethyl glutarate (4-12 percent). Ecolab, Incorporated As an antimicrobial additive that may be used alone or in combination with other processes in the commercial sterilization of polyethylene terephthalate and high density polyethylene food packaging prior to filling. Limitations/ Specifi-
cations
January 30, 2007 EA/FONSI
Ecolab, Incorporated
671 Poly(oxy-1, 2-ethanediyl), alpha-hydro-omega-hydroxy-(CAS Reg. No. 25322-68-3). Greenwich Chemical Consulting, Incorporated As a component of adhesives used in contact with food, compliant with 21 CFR 175.105; and as a component of pressure-sensitive adhesives used as the food-contact surface of labels and/or tapes applied to food, compliant with 21 CFR 175.125(a) or (b). Limitations/ Specifi-
cations
January 31, 2007 CAT. EXCL.
21 CFR 25.32(i) and (j)
Meisei Chemical Works, Ltd./Kowa American Corporation
673 D,L-Aspartic acid, N-(1,2-dicarboxyethyl)-,tetrasodium salt (CAS Reg. No. 144538-83-0). LANXESS Deutschland GmbH The FCS is intended for use as a stabilizer for bleach used in the production of food-contact-paper and paperboard, added at the wet end. Limitations/ Specifi-
cations
March 21, 2007 EA/FONSI
LANXESS Deutschland GmbH
675 Mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight. Thor GmbH, Germany The FCS is intended for use as a preservative in aqueous coatings formulated using components permitted for use in coatings and/or in coating components complying with 21 CFR 175.300. Limitations/ Specifi-
cations
February 8, 2007 CAT. EXCL.
21 CFR 25.32(i)
Thor GmbH, Germany
676 Octyltriethoxysilane-modified titanium dioxide where the addition of octyltriethoxysilane does not exceed 1.6 percent by weight of the pigment. E I du Pont de Nemours and Company, Incorporated As a pigment in food-contact polymers. Limitations/ Specifi-
cations
February 8, 2007 EA/FONSI
E I du Pont de Nemours and Company, Incorporated
677 Nylon MXD-6 (also known as hexanedioic acid, polymer with 1,3-benzenedimethanamine) (CAS Reg. No. 25718-70-1) meeting the analytical specifications in 21 CFR 177.1500(b), item 10.2 and used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0). INVISTA S.à.r.l.
Mitsubishi Gas Chemical Company Incorporated
The FCS will be used as a modifier for polyethylene terephthalate copolyesters described in Food-Contact Notification No. 72 and Food-Contact Notification No. 498. Limitations/ Specifi-
cations
February 20, 2007 CAT. EXCL.
21 CFR 25.32(i) and (j)
INVISTA S.à.r.l.
Mitsubishi Gas Chemical Company Incorporated
678 Sulfonic acids, C10-18-alkane, sodium salts (CAS Reg. No. 68037-49-0). Goulston Technologies, Incorporated The FCS is to be used as an antifogging agent anchor in multi-layer polyolefin lettuce bags. Limitations/ Specifi-
cations
February 20, 2007 CAT. EXCL.
21 CFR 25.32(i)
Goulston Technologies, Incorporated
679 Benzene, ethenyl-, polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4). Kraton Polymers LLC The FCS will be blended with other polymers to improve the flexibility and durability of polymeric food-contact articles. Limitations/ Specifi-
cations
April 7, 2007 EA/FONSI
and
CAT. EXCL.
21 CFR 25.32(j)
Kraton Polymers LLC
680 Styrene-acrylonitrile copolymers (SAN) (CAS Reg. No. 9003-54-7) containing 30-35 percent by weight polymer units derived from acrylonitrile. SABIC Innovative Plastics As a component in the manufacture of repeated-use food-contact articles. Limitations/ Specifi-
cations
February 27, 2007 CAT. EXCL.
21 CFR 25.32(j)
SABIC Innovative Plastics
681 3-Chloro-2-hydroxypropyltrimethylammonium chloride (CAS Reg. No. 3327-22-8). Grain Processing Corporation For use as a starting material in the production of 2,3-epoxypropyltrimethylammonium chloride (EPTAC) (CAS Reg. No. 3033-77-0) that will be used to modify industrial starch at a treatment level of greater than 5 percent and not more than 21 percent by weight of the starch to form high cationic starch (HCS). The finished HCS is intended 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 all food-contact paper and paperboard. Limitations/ Specifi-
cations
February 28, 2007 CAT. EXCL.
21 CFR 25.32(i)
Grain Processing Corporation
684 Poly(buty1)acrylate containing no more than 10 weight percent of total polymer units from one or more of the following monomers: methyl methacrylate, methacrylic acid, ethylene glycol dimethacrylate and N-methylolmethacrylamide. Omnova Solutions, Incorporated For use as an adhesive in food contact articles. Limitations/ Specifi-
cations
March 20, 2007 CAT. EXCL.
21 CFR 25.32(i)
Omnova Solutions, Incorporated
685 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). Teh Fong Min International Co., Ltd. The FCS is intended for use as an optical brightener in food-contact paper and paperboard, complying with 21 CFR 176.170 (Components of paper and paperboard in contact with aqueous and fatty foods). Limitations/ Specifi-
cations
March 20, 2007 CAT. EXCL.
21 CFR 25.32(i)
Teh Fong Min International Co., Ltd.
686 Di(p-toly1idene)sorbitol (DPTS) (CAS Reg. No. 54686-97-4; 81541-12-0; 197809-37-3). New Japan Chemical Company Ltd. The FCS is intended for use as a nucleating agent for polypropylene homo- and copolymers. Limitations/ Specifi-
cations
June 5, 2007 CAT. EXCL.
21 CFR 25.32(i) and (j)
New Japan Chemical Company Ltd.
687 Decanedioic acid polymer with 2-hydroxypropanoic acid and 1,2-propanediol, block- (CAS Reg. No. 329223-54-3). Dainippon Ink and Chemicals, Incorporated As a modifier in the manufacture of polylactide (PLA) polymers for single-use food-contact articles. Limitations/ Specifi-
cations
May 24, 2007 EA/FONSI
Dainippon Ink and Chemicals, Incorporated
688 N-ethyl-N-hydroxy-ethanamine (CAS Reg. No. 3710-84-7). Arkema Incorporated As a polymerization regulator in the polymerization of vinyl chloride homopolymers and copolymers used in contact with food. Limitations/ Specifi-
cations
May 30, 2007 EA/FONSI
Taminco Higher Amines, Inc.
689 1,4-benzenedicarhoxylic acid polymer with 1,4-cyclohexanedimethanol and 1,2-ethanediol (CAS Reg. No. 25038-91-9), with 1,4-cyclohexanedimethanol(consisting of 70 percent trans isomer and 30 percent cis isomer) representing 35 to 80 mole percent of the diol units and 1,2-ethanediol representing 65 to 20 mole percent of the diol units. SK Chemicals As articles or component of articles intended to contact food. Limitations/ Specifi-
cations
April 3, 2007 EA/FONSI
SK Chemicals
691 A mixture of peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidine-1,l-diphosphonic acid, with or without an optional adjuvant system composed of a mixture dimethyl sebacate (up to 20 percent by weight), dimethyl succinate (up to 0.8 percent by weight), dimethyl adipate (68-76 percent by weight) and dimethyl glutarate (4-12 percent by weight). Ecolab, Incorporated As an antimicrobial additive that may be used alone or in combination with other processes in the commercial sterilization of polyethylene terephthalate and high density polyethylene food packaging prior to filling. Limitations/ Specifi-
cations
April 4, 2007 EA/FONSI
Ecolab, Incorporated
692 Hypochlorous acid (CAS Reg. No. 7790-92-3) eletrolytically generated in dilute solution with pH control. Sterilox Food Safety/Div. of PuriCore For use as an antimicrobial agent in a solution for the re-hydrating of fresh fruits and vegetables including leafy green vegetables. Limitations/ Specifi-
cations
May 24, 2007 EA/FONSI
Sterilox Food Safety/Div. of PuriCore
694 Poly(l2-hydroxystearic acid)-polyethyleneimine copolymer (CAS Reg. No. 124578-12-7). Lubrizol, Ltd. As a colorant dispersant for use in all food-contact polymers. Limitations/ Specifi-
cations
April 17, 2007 CAT. EXCL.
21 CFR 25.32(i) and (j)
Lubrizol, Ltd.
695 lH-Azepine-1-carboxamide,N,N’,N”-[(2,4,6-trioxo-l,3,5-triazine-l,3,5(2H,4H,6H)- triyl)tris[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)]]trls[hexahydro-2-oxo-] (CAS Reg. No. 68975-83-7). Bayer MaterialScience AG To be used as a reactant with one or more of the polybasic acids or polyhydric alcohols in the formation of coatings on metal substrates intended for use in food-contact applications, complying with 21 CFR 175.300(b)(3)(vii). Limitations/ Specifi-
cations
June 15, 2007 CAT. EXCL.
21 CFR 25.32(i) and (j)
Bayer MaterialScience AG
697 Zeolite A in which silver and zinc ions have been exchanged for sodium ions. Cosmo Advanced Material Company, Ltd. As an antimicrobial agent used to preserve food contact polymers intended for repeat use articles. Limitations/ Specifi-
cations
April 27, 2007 CAT. EXCL.
21 CFR 25.32(i) and (j)
Cosmo Advanced Material Company, Ltd.
698 2-n-octyl-4-isothiazolin-3-one(OIT) (CAS Reg. No. 26530-20-1). Thor GmbH, Germany The FCS is intended for use as an antimicrobial active ingredient of industrial technical formulations for use in preserving polymeric latex emulsion products destined for use in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
June 15, 2007 CAT. EXCL.
21 CFR 25.32(q)
Thor GmbH, Germany
699 A mixture of peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidine-1,1-diphosphonic acid. Enviro Tech Chemical Services, Incorporated As an antimicrobial to control microorganisms in ice and wash water used to commercially prepare fish and seafood. Limitations/ Specifi-
cations
May 8, 2007 EA/FONSI
Enviro Tech Chemical Services, Incorporated
701 1-Ethynyl-1-cyclohexanol (CAS Reg. No. 78-27-3). Wacker Chemical Corporation To be used as an inhibitor for platinum catalysts to prevent premature cross linking of vinyl functionalized polysiloxanes with hydrogen functionalized polysiloxanes to form silicone elastomers in compliance with 21 CFR 177.2600 (Rubber articles intended for repeated use). Limitations/ Specifi-
cations
May 10, 2007 CAT. EXCL.
21 CFR 25.32(j)
Wacker Chemical Corporation
702 Carbonic dichloride, polymer with 4,4’-cyclohexylidenebis[2-methylphenol] and 4,4’-(1- methylethylidene)bis[phenol], bis[4-(1-methyl-1-phenylethyl)phenyl] ester (CAS Reg. No. 411234-34-9). SABIC Innovative Plastics As a component in the manufacture of articles intended to contact food. Limitations/ Specifi-
cations
May 19, 2007 EA/FONSI
SABIC Innovative Plastics
704 Mixture of 5-chloro-2-methyl-4-isothiazolin-3-one(CAS Reg. No. 26172-55-4) and 2-methyl-4- isothiazolin-3-one (CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight. Thor GmbH, Germany The FCS is intended for use as a preservative in resinous and polymeric coatings for polyolefin films complying with 21 CFR 175.320. Limitations/ Specifi-
cations
May 22, 2007 CAT. EXCL.
21 CFR 25.32(i)
Thor GmbH, Germany
705 1-Octadecanol, phosphate, potassium salt (CAS Reg. No. 68987-29-1) Goulston Technologies, Inc.; Takemoto Oil & Fat Co., Ltd. As a finish component on polyolefin and polyethylene phthalate resins that are constructed into non-woven fabric for meat pads. Limitations/ Specifi-
cations
July 14, 2007 CAT. EXCL.
21 CFR 25.32(i)
Goulston Technologies, Inc.; Takemoto Oil & Fat Co., Ltd.
706 Potassium laury1 phosphate (CAS Reg. No. 39322-78-6) Goulston Technologies, Inc. As a finish component on polyolefin and polethylene phthalate resins that are constructed into non-woven fabric for meat pads. Limitations/ Specifi-
cations
July 14, 2007 CAT. EXCL.
21 CFR 25.32(i)
Goulston Technologies, Inc.; Takemoto Oil & Fat Co., Ltd.
707 2-Butenedioic (Z)-, ammonium salt, homopolymer, hydrolyzed, sodium salts (CAS Reg. No. 181828-06-8). LANXESS Deutschland GmbH The FCS is intended for use as (1) a dispersant for fillers (e.g., clay, calcium carbonate, etc.) in the wet-end during the manufacture of paper and paperboard intended for food-contact use, and (2) as an anti-scale additive during the processing /evaporation of raw beet and cane sugar juice. Limitations/ Specifi-
cations
July 27, 2007 EA/FONSI
LANXESS Deutschland GmbH
708 Propylene/ethylene copolymers containing up to 28 weight percent polymer units derived from ethylene (CAS Reg. No. 9010-79-1).
REPLACES FCNs #381 AND 449
The Dow Chemical Company As articles or components of articles used in contact with food. Limitations/ Specifi-
cations
June 5, 2007 EA/FONSI
The Dow Chemical Company
K-Dow Petrochemicals BV
709 2-Propenoic acid, sodium salt, homopolymer (CAS Reg. No. 9003-04-7). Coatex S.A.S. As an aid for grinding calcium carbonate filler to be used in food-contact polyolefin food-contact materials. Limitations/ Specifi-
cations
June 5, 2007 CAT. EXCL.
21 CFR 25.32(i)
Coatex S.A.S.
Coatex Netherlands BV
Coatex Incorporated
710 Anthra[2,1,9-def:6,5,10-d’e’f’]diisoquinoline-1,3,8,10(2H,9H)-tetrone,2,9-bis [2,6-bis (1- methylethyl)phenyl]-5,6,12,13-tetraphenoxy- (CAS Reg. No. 112100-07-9). BASF Aktiengesellschaft As a colorant component in the top coat for paper and paper board which are used for packaging all kinds of foodstuff for marking paper. Limitations/ Specifi-
cations
June 8, 2007 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
711 Styrene-1,3-butadiene block copolymer containing 60 - 75 weight-percent of polymer units derived from styrene (CAS Reg. No. 106107-54-4). BASF Aktiengesellschaft The FCS is intended for use in the manufacture of food-contact polymer films and coatings. Limitations/ Specifi-
cations
June 8, 2007 EA/FONSI
BASF Aktiengesellschaft
712 2-Propionic acid, 2-methyl-, methyl ester, polymer with 1,4-butanediyl di-2-propenoate (CAS Reg. No. 81565-33-5). BASF Aktiengesellschaft To be used in an aqueous dispersion (about 33 percent by weight of the solids content) where the FCS exists as highly crosslinked poly(methy1 methacrylate)/l,4-butanediol diacrylate microspheres, which contains fluorescence colorants. The FCS is to be used as a top coat for paper and paperboard to enable the authentication of paper and paperboard products. Limitations/ Specifi-
cations
June 8, 2007 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
713 2,6-Naphthalenedicarboxamide,N,N'-dicyclohexyl- (CAS Reg. No. 153250-52-3). New Japan Chemical Company, Ltd. As a nucleating agent in propylene homopolymers complying with 21 CFR 177.1520(a)(l)(i) and (ii) and in propylene copolymers complying with 21 CFR 177.1520(a)(3)(i) or in propylene homopolymers and copolymers that are the subject of an effective notification. Limitations/ Specifi-
cations
June 12, 2007 CAT. EXCL.
21 CFR 25.32(i) and (j)
New Japan Chemical Company, Ltd.
715 Amines, tallow alkyl, ethoxylated (CAS Reg. No. 61791-26-2). 3M, Industnal Adhesives and Tapes Division The FCS is intended to be used as a component of repulpable tape adhesives used in the manufacture of food-contact paper and paperboard. Limitations/ Specifi-
cations
June 20, 2007 EA/FONSI
Akzo Nobel
716 REPLACED BY FCN #818 Limitations/ Specifi-
cations
717 Formaldehyde polymer with 1-naphthalenol (CAS Reg. No. 25359-91-5) Akzo Nobel Polymer Chemicals, LLC For use as an anti-scaling or release agent, applied to the internal parts of reactors employed in the production of ethylene-vinyl acetate food-contact copolymers. Limitations/ Specifi-
cations
June 21, 2007 EA/FONSI
Akzo Nobel Polymer Chemicals, LLC
719 Pentaerythritol tetra(3-dodecylthiopropionate) (CAS Reg. No. 29598-76-3) Adeka Corporation As a stabilizer in propylene polymers and copolymers compliant with 21 CFR 177.1520. Limitations/ Specifi-
cations
July 6, 2007 CAT. EXCL.
21 CFR 25.32(i)
Adeka Corporation
720 Benzene, ethenyl-, polymer with 1,3-butadiene, hydrogenated, 4-methyl-1,3,2- dioxaborinan-2-yl 4-methyl-1,3,2-dioxaborolan-2-yl derivatives (CAS Reg. No. 500224-31-7) Kuraray Company Ltd. To be used in ethylene vinyl alcohol (EVOH) polymers complying with 21 CFR 177.1360 and in polyolefin polymers complying with 21 CFR 177.1520, which may contact food. Limitations/ Specifi-
cations
July 13, 2007 CAT. EXCL.
21 CFR 25.32(i)
Kuraray Company Ltd.
721 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid (CAS Reg. No. 28628-75-3) EMS-CHEMIE AG/EMS-CHEMIE (NORTH AMERICA) INC. For use as a component of non-food-contact layers of multilayer articles; the thickness of the FCS component of the non-food-contact layer will not exceed 85 µm and will be separated from food by one or more layers of PET having a total thickness of at least 85 µm. Limitations/ Specifi-
cations
August 30, 2007 EA/FONSI
EMS-CHEMIE AG/EMS-CHEMIE (NORTH AMERICA) INC.
722 Vinylidene chloride/vinyl chloride/methyl acrylate copolymer (CAS Reg. No. 28572-91-0). BASF Corporation As a component of coatings applied to fresh fruits and vegetables with inedible peels, excluding citrus fruits. Limitations/ Specifi-
cations
August 28, 2007 EA/FONSI
BASF Corporation
724 An equilibrium mixture of peroxyacetic acid, hydrogen peroxide, acetic acid, and 1-hydroxyethylidene-diphosphonic acid (HEDP) Degussa Corporation As an antimicrobial agent to control microbial growth in wash and chilling water that contacts fruits and vegetables that are not raw agricultural commodities. Limitations/ Specifi-
cations
July 26, 2007 CAT. EXCL.
21 CFR 25.32(q)
Degussa Corporation
725 Poly(oxy[1,1'-biphenyl]-4,4'-diyloxy-1,4-phenylenesulfonyl-1,4-phenylene)(CAS Reg. No. 25839-81-0). BASF Aktiengesellschaft The FCS is intended for use as a resin in the manufacture of food contact articles intended for single and repeat use. Limitations/ Specifi-
cations
October 9, 2007 EA/FONSI
BASF Aktiengesellschaft
726 Poly(oxy-p-phenylenesulfonyl-p-phenylene) resin (CAS Reg. No. 25667-42-9). BASF Aktiengesellschaft As food-contact articles or components of food-contact articles. Limitations/ Specifi-
cations
October 9, 2007 EA/FONSI
BASF Aktiengesellschaft
727 1,4-Benzenedicarboxylic acid compound with 1,6-hexanediamine (1:1), polymer with hexahydro-2H-azepin-2-one [Nylon 6/6T] (CAS Reg. No. 51025-80-0). BASF Aktiengesellschaft As a component of repeat-use food contact articles including bakeware. Limitations/ Specifi-
cations
October 12, 2007 EA/FONSI
BASF Aktiengesellschaft
728 Peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809- 21-4), and water. FMC Corporation The FCS will be used as a part of the process to treat food-contact surfaces of polymeric food packaging to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for by 21 CFR Part 113, and as an antimicrobial on all polymers used to package acidic foods. Limitations/ Specifi-
cations
September 12, 2007 EA/FONSI
FMC Corporation
729 Polymer of dimethyl terephthalate, 1,4-cyclohexanedimethanol, and 2,2,4,4-tetramethyl- 1,3- cyclobutanediol (CAS Reg. No. 261716-94-3) containing 2,2,4,4-tetramethyl- 1,3- cyclobutanediol at up to 40 mole percent (expressed as mole % of the glycol component of the finished copolyesters) and 1,4-cyclohexanedimethanol at no less than 60 mole percent. Eastman Chemical Company The FCS will be used as a component in the manufacture of repeated use food-contact articles. Limitations/ Specifi-
cations
August 8, 2007 CAT. EXCL.
21 CFR 25.32(j)
Eastman Chemical Company
730 35 percent ammonium bromide solution (CAS Reg. No. 12124-97-9). AmeriBrom Inc. The FCS is intended for use as an antimicrobial agent for finished coating formulations for paper and for additives to the finished coating formulations including starch slurries, sizing solutions, pigments, fillers, and binders used in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
August 9, 2007 CAT. EXCL.
21 CFR 25.32(q)
AmeriBrom Inc.
731 Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine [Nylon 6/66] (CAS Reg. No. 24993-04-2) BASF Aktiengesellschaft As a component of films intended to contact food. Limitations/ Specifi-
cations
August 14, 2007 EA/FONSI
BASF Aktiengesellschaft
732 Poly(alkyl methacrylates) made from one or more C12 - C17 alkyl methacrylates (where the alkyl groups may be branched or linear and may be even- or odd-numbered in chain length), polymerized alone or in combination with one or more of the C18 - C22 alkyl methacrylate monomers permitted as reactants for poly(alkylmethacrylate) under 21 CFR 172.886(c)(2). RohMax U.S.A., LP
RohMax Canada Inc.
RohMax France S.A.S.
RohMax Additives GmbH
RohMax Asia Pacific Pte Ltd.
As a processing aid in the manufacture of petroleum wax that may be used as a direct food ingredient in compliance with CFR 172.886 and as a food-contact substance in compliance with 21 CFR 178.3710. Limitations/ Specifi-
cations
October 1, 2007 EA/FONSI
RohMax U.S.A., LP
RohMax Canada Inc.
RohMax France S.A.S.
RohMax Additives GmbH
RohMax Asia Pacific Pte Ltd.
733 Polyester-polyurethane adhesive formulated from the following:
(a) Urethane cross-linking agent, comprising not more than 75 percent by weight of the cured adhesive, prepared by the reaction of a mixture of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, homopolymer (CAS Reg. No. 53880-05-0) and 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4), and a polyester prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300(b)(3)(vii),
(b) Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300 (b)(3)(vii). Additionally, 1,6-hexanediol may be used as an alcohol reactant.
(c) Optional use, in either the urethane cross-linking agent or polyester resin portions of the resin, of:
1) acid anhydride formulated from 3a, 4, 5, 7a-tetrahydro-7-methyl-5- (tetrahydro-2,5-dioxo-3-furanyl) -1,3-isobenzofurandione (CAS Reg. No. 73003-90-4), comprising not more than 3 percent by weight of the cured adhesive, and/or
2) trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups comprising not more than 3 percent by weight of the cured adhesive.
Dainippon Ink and Chemicals, Inc. For use as an adhesive in laminate structures that are intended for use at retort temperatures. Limitations/ Specifi-
cations
October 3, 2007 EA/FONSI
Dainippon Ink and Chemicals, Inc.
734 1-Naphaleneamine, N-phenyl-ar-(1,1,3,3-tetramethylbutyl)- (CAS Reg. No. 68259-36-9) (para isomer) Ciba Specialty Chemicals Corporation For use as an antioxidant in lubricants with incidental food contact under conditions of use A through H as described in 21 CFR 176.170(c), Table 2 Limitations/ Specifi-
cations
August 23, 2007 CAT. EXCL.
21 CFR 25.32(j)
Ciba Specialty Chemicals Corporation
735 A thermoplastic polyurethane formulated from 1,6-hexanediolpolycarbonate (CAS Reg. No. 101325-00-2), 4,4’-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8) and 2,2’-p-phenylenedioxydiethanol (CAS Reg. No. 104-38-l). Dichtungs-und Maschinenhandelsges.m.b.H. The FCS is a special-shaped molded ring (seal) that prevents processed food from contacting other moving parts of machinery (e.g., pistons, rods, etc.). Limitations/ Specifi-
cations
August 24, 2007 CAT. EXCL.
21 CFR 25.32(j)
Dichtungs-und Maschinenhandelsges.m.b.H.
736 1-Propene,1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene (CAS Reg. No. 9011-17-0) modified with a halogenated ethylene as described in the food contact notification. Dyneon (a 3M Company) As a processing additive for all polymers for use in contact with food. Limitations/ Specifi-
cations
October 26, 2007 CAT. EXCL.
21 CFR 25.32(i)
Dyneon (a 3M Company)
737 Poly[bis(isoindol-2-yl-1,3-dione)-1,3-phenylene-4,4'-(1-methylethylidene)bisphenol]. SABIC Innovative Plastics As a component of food contact articles. Limitations/ Specifi-
cations
September 5, 2007 EA/FONSI
SABIC Innovative Plastics
739 An aqueous solution of sodium chlorite and chlorine dioxide containing up to 1200 mg/kg sodium chlorite and up to 30 mg/kg chlorine dioxide. Bio-Cide International, Inc. For use on poultry carcasses, carcass parts, poultry meat, organs, or related parts or trim as an antimicrobial agent in poultry processing waters, as a component of a carcass spray or a dip solution. Limitations/ Specifi-
cations
October 26, 2007 EA/FONSI
Bio-Cide International, Inc.
740 Acrylate copolymers containing up to 2 percent by weight of 2-propenoic acid, 4-(((4-benzoylphenoxy)carbonyl)oxy)butyl ester (CAS Reg. No. 131513-00-3) along with 2-propenoic acid, n-butyl-2-propenoate, 2-ethylhexyl 2-propenoate, methyl 2-propenoate, and/or 2-methyl-2-propenoic acid methyl ester (CAS Reg. Nos. 25265-15-0; 98060-25-4; 25119-83-9). BASF Aktiengesellschaft As a component of UV-cured pressure-sensitive adhesives used as the food-contact surface of labels and/or tapes applied to food, compliant with 21 CFR 175.125(a) or (b). Limitations/ Specifi-
cations
September 14, 2007 EA/FONSI
BASF Aktiengesellschaft
741 Ethylene/hexene copolymers containing up to 25 weight percent polymer units derived from hexene (CAS Reg. No. 25213-02-9). The Dow Chemical Company The FCS will be used as articles or components of articles intended to contact all food types under Conditions of Use A through H, as described in Table 2. Limitations/ Specifi-
cations
September 28, 2007 EA/FONSI
The Dow Chemical Company
K-Dow Petrochemicals BV
742 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 50 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. Ticona As a basic polymer used in the production of articles (including non-PET bottles) intended to contact food. Limitations/ Specifi-
cations
September 28, 2007 EA/FONSI
Ticona
743 Mixture of saturated linear aliphatic esters produced from C12 - C18 alcohols and C12 - C18 fatty acids. Croda Chemicals Europe As a friction reduction additive in polyethylene terephthalate (PET) resins used in the production of containers and packaging films that may contact food. Limitations/ Specifi-
cations
October 2, 2007 CAT. EXCL.
21 CFR 25.32(i)
Croda Chemicals Europe
744 1,4-benzenedicarboxylic acid,1-4-dibutyl ester (CAS Reg. No. 1962-75-0). Eastman Chemical Company The FCS is intended for use as a plasticizer in polymers for use:
1) in adhesives that comply with 21 CFR 175.105,
2) in pressure sensitive adhesives that comply with 21 CFR 175.125, and
3) as a coating or component of paper or paperboard intended for use in contact with dry foods with no free surface fat or oil in compliance with 21 CFR 176.180.
Limitations/ Specifi-
cations
October 12, 2007 EA/FONSI
Eastman Chemical Company
745 1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with 1,3-propanediol (CAS Reg. No. 36619-23-5) or 1,4-benzenedicarboxylic acid, polymer with 1,3-propanediol (CAS Reg. No. 26590-75-0). E. I. du Pont de Nemours and Co., Inc. As a component in the manufacture of articles, except bottles, intended to contact food. Limitations/ Specifi-
cations
September 29, 2007 EA/FONSI
E. I. du Pont de Nemours and Co., Inc.
746 2-propen-1-ol, reaction products with 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-6-iodohexane, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-94-7) as manufactured in accordance with the description in the FCN. Hercules Incorporated As an oil/grease resistant sizing agent employed prior to the sheet forming operation and/or at the size press in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
October 4, 2007 CAT. EXCL.
21 CFR 25.32(i)
Hercules Incorporated
748 1H-benz[de]isoquinoline-1,3(2H)-dione, 2-[2,6-bis(1-methylethyl)phenyl]-6-[4-(1,1,3,3-tetramethylbutyl)phenoxy] (CAS Reg. No. 852282-89-4). BASF Aktiengesellschaft The FCS is intended for use as a UV absorber in polyethylene terephthalate (PET) polymers complying with 21 CFR 177.1630. Limitations/ Specifi-
cations
October 11, 2007 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
749 Acetic acid ethenyl ester, polymer with ethene and 1,1'-(1-ethenyl-1,2-ethanediyl) diacetate, hydrolyzed (CAS Reg. No. 917249-65-1). The Nippon Synthetic Chemical Industry Co., Ltd. For use as a component of food-contact articles. Limitations/ Specifi-
cations
October 16, 2007 EA/FONSI
The Nippon Synthetic Chemical Industry Co., Ltd.
750 Octadecanoic acid, 1-(12-acetyloxy)-, 2,3-bis(acetyloxy) propyl ester; 1-(12-acetoxystearoyl)- 2,3-diacetyl glycerol (CAS Reg. No. 736150-63-3). Danisco A/S For use as:
1. a plasticizer at levels up to 34 percent by weight in polyvinylchloride bottle cap sealing rings for use in contact with all foods under Conditions of Use B through H, as described in Table 2;
2. a plasticizer at levels up to 3 percent by weight in polymers used to manufacture articles intended for repeated-use in contact with all foods under Conditions of Use E through H, as described in Table 2; and,
3. a colorant carrier or dispersant at levels up to 0.5 percent by weight in polymers used to manufacture articles intended for repeated-use in contact with all foods.
Limitations/ Specifi-
cations
October 18, 2007 EA/FONSI
Danisco A/S
751 2-propenoic acid, homopolymer, sodium salt (with a weight average molecular weight of 2300 to 5700 Daltons and a weight average molecular weight to number average molecular weight ratio of not more than 6.3) (CAS Reg. No. 9003-04-7). Alco Chemical To control the formation of mineral scale during evaporation of beet or cane sugar juice. Limitations/ Specifi-
cations
October 26, 2007 EA/FONSI
Alco Chemical
752 Formaldehyde, polymer with 1-naphthalenol (CAS Reg. No. 25359-91-5). Akzo Nobel Polymer Chemicals LLC For use only as an antiscaling or release agent, applied on the internal parts of reactors employed in the production of ethylene-vinyl chloride food-contact copolymers. Limitations/ Specifi-
cations
November 13, 2007 EA/FONSI
Akzo Nobel Polymer Chemicals LLC
757 Hydrogenated polymers prepared from one or more of the following: 1-hexene (CAS Reg. No. 592-41-6), 1-octene (CAS Reg. No. l11-66-0), 1-decene (CAS Reg. No. 872-05-9), 1-dodecene (CAS Reg. No. 112-41-4), and 1-tetradecene (CAS Reg. No. 1120-36-1). ExxonMobil Chemical Company 1) As an additive in pressure-sensitive adhesives that comply with 21 CFR 175.125.
2) As an additive in propylene homopolymers and copolymers complying with 21 CFR 177.1520(c) or that are the subject of an effective food contact notification.
Limitations/ Specifi-
cations
November 30, 2007 EA/FONSI
ExxonMobil Chemical Company
758 1-Dodecene, reaction products with naphthalene (CAS Reg. No. 939823-19-5). King Industries As a component of lubricants with incidental food contact in repeat use applications. Limitations/ Specifi-
cations
December 1, 2007 CAT. EXCL.
21 CFR 25.32(j)
King Industries
759 C16-18 fatty acid esters of a branched C20 alcohol as described in the notification. International Specialty Products As a lubricant/release agent in the manufacture of repeat-use, food-contact polycarbonate. Limitations/ Specifi-
cations
December 7, 2007 CAT. EXCL.
21 CFR 25.32(j)
International Specialty Products
762 Boron nitride (CAS Reg. No. 10043-11-5). Acheson Industries Inc. For use as a lubricant on bakery oven chains with incidental food contact. Limitations/ Specifi-
cations
December 25, 2007 CAT. EXCL.
21 CFR 25.32(j)
Acheson Industries Inc.
765 Anthra[2",1",9":4,5,6;6",5",10":4',5',6']diisoquino[2,1-a:2',1'-a']diperimidine-12,25-dione (CAS Reg. No. 6859-32-1) and Phenanthro[2",1",10":4,5,6,7",8",9":4',5',6']diisoquino[2,1-a:2',1'-a']diperimidine-8,13-dione (CAS Reg. No. 41635-87-4). BASF Aktiengesellschaft To be used as a colorant in films, bottles, or tubes that may store food made of low-density polyethylene, high-density polyethylene, polyethylene terephthalate, acrylonitrile-butadiene-styrene terpolymer, polypropylene, polycarbonate, polystyrene, and nylon resins. Limitations/ Specifi-
cations
March 20, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
BASF Aktiengesellschaft, Germany/BASF Corporation, USA
766 Polyester-urethane adhesive formulated from:
1) Polyester-urethanediol resins described in 21 CFR 177.1390(c)(2)(iv)(a). In addition, 2,2-bis(hydroxymethyl) butanoic acid (CAS Reg. No. 10097-02-6) may be used as an optional polyhydric alcohol, and 2,2-dimethyl-1,3-propanediol (CAS Reg. No. 126-30-7) may be used as a polyhydric alcohol in structures that are intended to contact alcoholic foods containing up to 8 percent ethyl alcohol.
2) Urethane cross-linking agent consisting of 1,3-butanediol reaction products with 1,6-diisocyanatohexane (CAS Reg. No. 187852-79-5).
Nippon Polyurethane Industry Co., Ltd. The FCS will be used as an adhesive in laminate structures that are intended for use at retort temperatures. Limitations/ Specifi-
cations
April 4, 2008 EA/FONSI
Nippon Polyurethane Industry Co., Ltd.
767 Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4). Songwon International - Americas, Inc. The FCS will be used as an antioxidant in the manufacture of olefin polymers complying with the provisions of 21 CFR 177.1520(c), items 3.2c, 3.4, and 3.6. Limitations/ Specifi-
cations
January 11, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
Songwon International - Americas, Inc.
768 Octadecyl, 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3). Songwon International - Americas, Inc. As an antioxidant for olefin polymers. Limitations/ Specifi-
cations
January 11, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
Songwon International - Americas, Inc.
769 N,N'-bis(phenylmethyl)hexanediamide (CAS Reg. No. 25344-24-5) used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2). Constar International, Inc. As a modifier of ethylene phthalate/naphthalate polymers and copolymers excluding those modified with organic anhydrides. Limitations/ Specifi-
cations
January 15, 2008 CAT. EXCL.
21 CFR 25.32(i)
Constar International, Inc.
770 1,4-bis(2-ethylhexyl) benzenedicarboxylate (CAS Reg. No. 6422-86-2). Eastman Chemical Company (1) At a level not to exceed 35 percent by weight of finished plasticized vinyl chloride polymer formulations used in repeated-use food contact applications at temperatures no greater than 100oC;
(2) As a component of a paper or paperboard, or coatings for such paper and paperboard intended for use in contact with dry foods with no free surface fats or oil in compliance with 21 CFR 176.180 Components of Paper and paperboard in contact with dry food;
(3) As a component of adhesives complying with the provisions of 21 CFR 175.105 Adhesives; and,
(4) As a component of pressure sensitive adhesives complying with the provisions of 21 CFR 175.125 Pressure-sensitive adhesives.
Limitations/ Specifi-
cations
January 12, 2008 EA/FONSI
Eastman Chemical Company
771 The FCS is a mixture of 3,6-di-p-tolyl-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione (88.6 percent), 3-p-octadecyloxyphenyl-6-p-tolyl-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione (11.1 percent), and 3,6-di-p-octadecyloxyphenyl-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione (0.3 percent). Ciba Specialty Chemicals Corporation For use as a colorant in all food-contact polymers. Limitations/ Specifi-
cations
March 6, 2008 CAT. EXCL.
21 CFR 25.32(i)
Ciba Specialty Chemicals Corporation
772 A mixture of one or more of tripropylene glycol diacrylate (CAS Reg. No. 42978-66-5), trimethylolpropane triacrylate (CAS Reg. No. 15625-89-5), trimethylolpropane ethoxylate triacrylate (CAS Reg. No. 28961-43-5), and bisphenol A diglycidyl ether diacrylate (CAS Reg. No. 4687-94-9, 53814-24-7, 55127-80-5, 55818-57-0 or 37625-93-7), and optionally the difunctional alpha-hydroxy ketone described in the notification as a photoinitiator. The mixture will be cured by either ultraviolet (UV) or electron beam (EB) irradiation. Alcan Packaging, Alcoa, Inc., Amgraph Packaging, Inc., Ashland Specialty Chemical Company, Bayer Polymers LLC, Bostik-Findley, Bryce Corporation, Coating and Adhesives Corporation, Cognis Corporation, Crown Cork & Seal, Cytec Industries, Dart Container, Dixie Packaging, Energy Sciences Inc., Fujihunt, Fusion UV Systems, Inc., Gidue SpA, Graphic Packaging Inc., H.B Fuller Company, INX International Ink Co., Lamberti, s.p.a., Liofol, MeadWestvaco, Nordson Corporation, Petroferm Inc., Pliant Corporation, PPG Industries, Inc., Printpack Inc., Rahn USA Corporation, Rock-Tenn Company, Rohm and Haas Company, Sartomer Company, Sealed Air, Siegwerk Group, Valspar Corporation To be used as coatings (including inks) or components of coatings (including inks) on polymeric substrates, paper and paperboard, metal substrates, or as a component in adhesives. Limitations/ Specifi-
cations
March 8, 2008 EA/FONSI
Alcan Packaging, Alcoa, Inc., Amgraph Packaging, Inc., Ashland Specialty Chemical Company, Bayer Polymers LLC, Bostik-Findley, Bryce Corporation, Coating and Adhesives Corporation, Cognis Corporation, Crown Cork & Seal, Cytec Industries, Dart Container, Dixie Packaging, Energy Sciences Inc., Fujihunt, Fusion UV Systems, Inc., Gidue SpA, Graphic Packaging Inc., H.B Fuller Company, INX International Ink Co., Lamberti, s.p.a., Liofol, MeadWestvaco, Nordson Corporation, Petroferm Inc., Pliant Corporation, PPG Industries, Inc., Printpack Inc., Rahn USA Corporation, Rock-Tenn Company, Rohm and Haas Company, Sartomer Company, Sealed Air, Siegwerk Group, Valspar Corporation
773 Zeolite A (CAS Reg. No. 68989-22-0) in which silver and ammonium ions have been exchanged for sodium ions. AgIon Technologies, Inc. As an antimicrobial agent used to preserve food-contact polymers. Limitations/ Specifi-
cations
January 22, 2008 CAT. EXCL.
21 CFR 25.32(i)
Sinanen Zeomic Company, Ltd.
774 A copolymer of 1, 2-bis(triethoxysilyl)ethane (CAS Reg. No. 16068-37-4) and 3-aminopropyltriethoxysilane (CAS Reg. No. 919-30-2). Chemetall GmbH The FCS will be used as a coating applied to food contact metal substrates. Limitations/ Specifi-
cations
January 25, 2008 CAT. EXCL.
21 CFR 25.32(i)
Chemetall GmbH
775 1,3-dibromo-5,5-dimethylhydantoin (DBDMH; CAS Reg. No. 77-48-5). Albemarle Corporation The FCS will be used as an antimicrobial in water supplied to ice machines to make ice intended for general use in the poultry processing industry. Limitations/ Specifi-
cations
January 28, 2008 EA/FONSI
Albemarle Corporation
776 Formamide, N-ethenyl-, homopolymer, and formamide, N-ethenyl-, copolymer with ethenamine, hydrochloride or sulfate. BASF Aktiengesellschaft The FCS is a wet-strength agent, dry-strength agent, fixing agent, or retention aid, which is applied prior to the sheet-forming operation in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
April 4, 2008 CAT. EXCL.
21 CFR 25.32(i)
BASF Aktiengesellschaft
778 2-Propenoic acid, 2-methyl, polymer with alpha-(2-methyl-1-oxo-2-propenyl)-omega-methoxypoly(oxy-1,2-ethanediyl) and 2-propenoic acid, graft, sodium salt (CAS Reg. No. 381686-36-8). Coatex S.A.S. For use as an adjuvant for coatings applied to food-contact paper and paperboard, as described in the notification. Limitations/ Specifi-
cations
February 22, 2008 CAT. EXCL.
21 CFR 25.32(i)
Coatex S.A.S., Coatex Inc., Coatex B.V.
780 1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-butanediol, adipic acid, hexamethylene diisocyanate and not more than 1 percent by weight of the polyhydric alcohol described in the notification.
REPLACES FCN 372
BASF Aktiengesellschaft As a polyester film and coating. Limitations/ Specifi-
cations
February 26, 2008 EA/FONSI
BASF Aktiengesellschaft
783 2-propen-1-ol, reaction products with 1,l,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-6-iodohexane, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-94-7) as manufactured in accordance with the description in the FCN. Hercules Incorporated As an oil/grease resistant sizing agent employed either prior to the sheet forming operation and/or at the size press in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
March 6, 2008 CAT. EXCL.
21 CFR 25.32(i)
Hercules Incorporated
784 Siloxanes and silicones, 3-[3-diethylmethylammonio)-2-hydroxypropoxyl] propyl Me, di-Me, chlorides (CAS Reg. No. 588707-20-4). Siltech Corporation As a component of emulsion-based defoamers that are used in the pulping of lignocellulosic materials that can be used in the manufacture of food-contact paper and paperboard. Limitations/ Specifi-
cations
March 6, 2008 EA/FONSI
Siltech Corporation
785 Nylon MXD-6 (also known as hexanedioic acid, polymer with 1,3- benzenedimethanamine) (CAS Reg. No.25718-70-1) meeting the analytical specifications in 21 CFR 177.1500(b), item 10.2. INVISTA S.à.r.l.
Mitsubishi Gas Chemical Company Inc.
The FCS will be used as a modifier for polyethylene terephthalate copolyesters described in Food Contact Notification No. 72 and Food Contact Notification No. 498. Limitations/ Specifi-
cations
March 7, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
INVISTA S.à.r.l.
Mitsubishi Gas Chemical Company Inc.
787 An aqueous solution of sodium chlorite and chlorine dioxide containing no less than 50 parts per million and not more than 200 parts per million of available chlorine dioxide. Bio-Cide International, Inc. For use as a sanitizing solution on beverage containers. Limitations/ Specifi-
cations
June 20, 2008 EA/FONSI
Bio-Cide International, Inc.
788 2-n-octyl-4-isothiazolin-3-one (CAS Reg. No. 26530-20-1). Thor GmbH, Germany The FCS is intended for use as an antimicrobial active ingredient of industrial technical formulations for use in preserving polymeric latex emulsion products destined for use in the manufacture of paper and paperboard. Limitations/ Specifi-
cations
March 14, 2008 CAT. EXCL.
21 CFR 25.32(q)
Thor GmbH, Germany
790 Sulfonic acids, C10-18-alkane, sodium salts (CAS Reg. No. 68037-49-0). Goulston Technologies, Inc. The FCS is to be used as an antifogging anchor agent in multi-layer polyolefin film structures for use in produce bags and for lid seals for formed trays, specifically for raw and fresh fruits and vegetables, and for lid seals where meats are packaged in formed trays. Limitations/ Specifi-
cations
March 19, 2008 CAT. EXCL.
21 CFR 25.32(i)
Goulston Technologies, Inc.
792 1,3-dibromo-5,5-dimethylhydantoin (DBDMH; CAS Reg. No. 77-48-5). Albemarle Corporation The FCS will be used as an antimicrobial in water applied to beef hides, carcasses, heads, trim, parts, and organs. Limitations/ Specifi-
cations
March 26, 2008 EA/FONSI
Albemarle Corporation
793 1,5-Pentanedicarboxylic acid, calcium salt (CAS Reg. No. 19455-79-9). Borealis Polyolefine GmbH The FCS will be used as a nucleating agent in the manufacture of polypropylene food-contact articles. Limitations/ Specifi-
cations
April 1, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
ISOCHEM SA/Borealis Polyolefine GmbH
794 Industrial starch modified by treatment with greater than 5 percent and not more than 21 percent by weight 2,3-epoxypropyltrimethylammonium chloride (CAS Reg. No. 3033-77-0). National Starch and Chemical Company 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
April 10, 2008 CAT. EXCL.
21 CFR 25.32(i)
National Starch and Chemical Company
798 12H-Phthaloperin-12-one, 8,9,10, 11-tetrachloro- (CAS Reg. No. 20749-68-2). Ciba Corporation As a colorant for use in polyethylene terephthalate polymers complying with 12 CFR 177.1630. Limitations/ Specifi-
cations
April 19, 2008 CAT. EXCL.
21 CFR 25.32(i)
Modern Chemical Corporation Limited
799 [S,S]-Ethylenediaminedisuccinic acid, trisodium salt (CAS Reg. No. 178949-82-1). Innospec Limited As a chelating agent in the manufacture of food-contact paper and paperboard. Limitations/ Specifi-
cations
April 25, 2008 EA/FONSI
Innospec Limited
800 Formamide, N-ethenyl-, homopolymer, hydrolyzed, N-(3-carboxy-1-oxopropyl)N-[2-hydroxy-3-(trimethylammonio)-propyl] derivatives, chlorides (CAS Reg. No. 945630-11-5). Hercules Inc. As a strengthening agent, fixing agent, or retention aid employed prior to the sheet forming operation in the manufacture of paper and paperboard that will be used in contact with all food types under all conditions of use. Limitations/ Specifi-
cations
May 1, 2008 CAT. EXCL.
21 CFR 25.32(i)
Hercules Inc.
801 Peroxyacetic acid (CAS Reg. No. 79-21-0), solution containing 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4). FMC Corporation The FCS will be used to treat food-contact surfaces of plastic containers and their enclosures to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR Part 113 or as an antimicrobial on packaging for any acidic food. The peroxyacetic acid PAA solutions will contain equilibrium concentrations of peroxyacetic acid, hydrogen peroxide (CAS Reg. No. 7722-84-l), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and water. Limitations/ Specifi-
cations
May 1, 2008 EA/FONSI
FMC Corporation
802 Benzoic acid, 2-hydroxy-, monosodium salt (CAS Reg. No. 54-21-7). FMC Corporation As a component of an adjuvant solution mixed with a peroxyacetic acid solution intended for use in treating food-contact surfaces of polymeric food containers to reduce or eliminate microbial contamination. Limitations/ Specifi-
cations
May 1, 2008 EA/FONSI
FMC Corporation
804 Trimethylolpropane (CAS Reg. No. 77-99-6). E. I. du Pont de Nemours and Company, Inc. As a milling aid and dispersant for titanium dioxide used as a light stabilizer in food contact articles. Limitations/ Specifi-
cations
May 18, 2008 CAT. EXCL.
21 CFR 25.32(i)
E. I. du Pont de Nemours and Company, Inc.
805 Carboxylic acids, C5-9, hexaesters with dipentaerythritol (CAS Reg. No. 67762-52-1). Inolex Chemical Company As a lubricant with incidental food contact. Limitations/ Specifi-
cations
June 4, 2008 CAT. EXCL.
21 CFR 25.32(j)
Inolex Chemical Company
806 Ethylene/1-butene copolymer (CAS Reg. No. 25087-34-7). Mitsui Chemicals, Inc. As a component of articles used in contact with all types of food. Limitations/ Specifi-
cations
June 4, 2008 EA/FONSI
Mitsui Chemicals, Inc.
807 Mixture of sodium chlorite (CAS Reg. No. 7758-19-2) and sodium chloride (CAS Reg. No. 7647-14-5). Xyrex Ltd. As an antimicrobial agent in water and ice that are used to rinse, wash, thaw, transport, or store seafood in accordance with current industry standards of good manufacturing practice. Limitations/ Specifi-
cations
June 5, 2008 EA/FONSI
Xyrex Ltd.
808 D-Glucitol, bis-O-[(4-methylphenyl)methylene)- (CAS Reg. No. 54686-97-4). New Japan Chemical Company Ltd. The FCS is to be used as a nucleating agent in food contact articles, specifically, single use film wrap and bottle caps and repeat use food trays and containers. Limitations/ Specifi-
cations
July 26, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
New Japan Chemical Company Ltd.
810 2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52-51-7). GE Betz As a preservative for boiler water additive formulations. Limitations/ Specifi-
cations
June 11, 2008 CAT. EXCL.
21 CFR 25.32(q)
GE Betz
812 Octadecanoic acid, 1 -( 12-acetyloxy)-, 2,3-bis(acetyloxy) propyl ester; 1 -( 12-acetoxystearoy1)- 2,3-diacetyl glycerol (CAS Reg. No. 736150-63-3). Danisco A/S As a colorant carrier/dispersant for use in polymeric food packaging articles, e.g. beverage bottles, molded storage containers, etc. Limitations/ Specifi-
cations
June 19, 2008 CAT. EXCL.
21 CFR 25.32(i)
Danisco A/S
813 Urea, N,N"-1,3-propanediylbis[N'-octadecyl-] (CAS Registry No. 35674-65-8). BYK-Chemie GmbH As a component in defoamer formulations to be used in food-contact coatings. Limitations/ Specifi-
cations
June 27, 2008 CAT. EXCL.
21 CFR 25.32(i)
BYK-Chemie GmbH
814 Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4). Rich Yu Chemical As an antioxidant in olefin copolymers complying with 21 CFR 177.1520(c), items 3.2c, 3.4, or 3.6, or in styrene block copolymers complying with 21 CFR 177.1810. Limitations/ Specifi-
cations
July 2, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
Rich Yu Chemical
815 β-Alanine, N-(2-aminoethyl)-, monosodium salt, polymer with 1,4-butanediol, 1,6-diisocyanatohexane, 1,3-diisocyanatomethylbenzene and hexanedioic acid (CAS Reg. No. 141073-56-5). BASF SE The FCS is a polyurethane coating which is used as an adhesive applied on plastics, films, paper and paperboard, and metal or coated metal used for packaging and holding all food types intended for single- and repeat-use articles. Limitations/ Specifi-
cations
August 14, 2008 EA/FONSI
BASF SE
816 Carbamodithioic acid, dibutyl-, methylene ester (CAS Reg. No. 10254-57-6). R.T. Vanderbilt Company, Inc. The FCS is for use as an antioxidant for lubricants with incidental food contact. Limitations/ Specifi-
cations
July 29, 2008 CAT. EXCL.
21 CFR 25.32(j)
R.T. Vanderbilt Company, Inc.
817 Hexanedioic acid, polymer with 1,3-benzenedimethanamine (CAS Reg. No. 25718-70-1) meeting the analytical specifications in 21 CFR 177.1500(b), item 10.2, and used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2). Gruppo Mossi & Ghisolfi The FCS will be used as a modifier of ethylene phthalate polymers regulated under 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN, including those modified with 1,3-benzenedicarboxylic acid, 5-sulfo-, monolithium salt according to FCN 546. Limitations/ Specifi-
cations
July 29, 2008 CAT. EXCL.
21 CFR 25.32(i)
Gruppo Mossi & Ghisolfi
M&G Polymers USA, LLC
818 Titanium nitride (CAS Reg. No. 25583-20-4).
REPLACES FCN #716
ColorMatrix Group Inc. As an additive in food-contact polyethylene terephthalate (PET) bottles. Limitations/ Specifi-
cations
July 29, 2008 EA/FONSI
ColorMatrix Group Inc.
820 2-Propenoic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl ester, polymer with alpha-(1-oxo-2- propen-1-yl)-omega-hydroxypoly(oxy-1,2-ethanediyl). Daikin America, Inc. For use as an oil or grease resistant treatment for paper and paperboard intended for food-contact use. Limitations/ Specifi-
cations
July 31, 2008 CAT. EXCL.
21 CFR 25.32(i)
Daikin America, Inc.
821 Styrene block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4). Asahi Kasei Chemicals Corporation As a modifier of propylene polymers and copolymers for use in contact with food. Limitations/ Specifi-
cations
August 6, 2008 EA/FONSI
Asahi Kasei Chemicals Corporation
822 1-Tetradecene reaction products with Naphthalene (CAS Reg. No. 132983-41-6). King Industries The FCS is to be used as a component of lubricants with incidental food contact in repeat use applications. Limitations/ Specifi-
cations
August 14, 2008 CAT. EXCL.
21 CFR 25.32(j)
King Industries
823 Chromium Nitride (CAS Reg. No. 24094-93-7). Phygen Coatings, Inc. The FCS will be used as a component of surface coating on repeat-use food processing and food packaging equipment to prevent abrasive wear to the components of the equipment. Limitations/ Specifi-
cations
August 20, 2008 CAT. EXCL.
21 CFR 25.32(j)
Phygen Coatings, Inc.
824 N-[3,5-Bis-(2,2-dimethyl-propionylamino)-phenyl]-2,2-dimethyl-propionamide (CAS Reg. No. 745070-61-5). Ciba Corporation For use as a clarifier for polypropylene (PP) homo- and copolymers used in food-packaging materials. Limitations/ Specifi-
cations
September 11, 2008 CAT. EXCL.
21 CFR 25.32(i)
Ciba Corporation
825 Nonitol, 1,2,3-trideoxy-4,6:5,7-bis-O-[(4-propylphenyl)methylene]- (CAS Reg. No. 882073-43-0). Milliken Chemical, a Division of Milliken and Company For use as a clarifying agent in polypropylene homopolymer and high-propylene olefin copolymers. Limitations/ Specifi-
cations
August 28, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
Milliken Chemical, a Division of Milliken and Company
826 Siloxanes and Silicones, di-Me vinyl, hydroxy-terminated, reaction products with trimethoxy[3-(oxiranylmethoxy)propyl]silane (CAS Reg. No. 102782-94-5). Dow Corning Corporation The FCS is intended for use as an anchor agent in silicone release coatings that are currently regulated for food contact applications. Limitations/ Specifi-
cations
September 3, 2008 CAT. EXCL.
21 CFR 25.32(i)
Dow Corning Corporation
827 2-propenoic acid, 2-hydroxyethyl ester, polymer with α-(l-oxo-2-propen-l-yl)-ω-hydroxypoly(oxy-l,2-ethanediyl), α-(1-oxo-2-propen-l-yl)-ω-[(l-oxo-2-propen-l-yl)oxy]poly(oxy-l,2-ethanediyl) and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate (CAS Reg. No. 1012783-70-8). Daikin America, Inc. As an oil and grease resistant treatment for paper and paperboard employed at the size press. Limitations/ Specifi-
cations
September 9, 2008 CAT. EXCL.
21 CFR 25.32(i)
Daikin America, Inc.
828 1,3:2,4-di-O-(p-chlorobenzylidene)-D-sorbitol (CAS Reg. No. 82203-23-4). GCH Technology Company Ltd. As a nucleating/clarifying agent. Limitations/ Specifi-
cations
September 27, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
GCH Technology Company Ltd.
829 Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4) Albemarle Corporation As an antioxidant/stabilizer in olefin copolymers complying with 21 CFR 177.1520(c), items 3.2c, 3.4, or 3.6, or in styrene block copolymers complying with 21 CFR 177.1810. Limitations/ Specifi-
cations
October 8, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
Albemarle Corporation
830 Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3). Albemarle Corporation As a stabilizer for flexible polyvinyl chloride (PVC) and as an antioxidant for olefin polymers. Limitations/ Specifi-
cations
October 8, 2008 CAT. EXCL.
21 CFR 25.32(i) and (j)
Albemarle Corporation
831 Poly (tetramethylene terephthalate) (CAS Reg. No. 24968-12-5). SABIC Innovative Plastics As a polymer for making repeat-use food contact articles. Limitations/ Specifi-
cations
October 15, 2008 CAT. EXCL.
21 CFR 25.32(j)
SABIC Innovative Plastics
832 Propylene-ethylene copolymers (CAS Reg. No. 9010-79-1). ExxonMobil Chemical Company As a component of articles used in contact with all types of food. Limitations/ Specifi-
cations
October 21, 2008 EA/FONSI
ExxonMobil Chemical Company and its stewarded affiliates around the world.
834 1,4-Butanediol dimethacrylate (CAS Reg. No. 2082-81-7). FCS: Evonik Röhm GmbH
Polymer made with the FCS: SABIC Petrochemical B.V.
As a component of a coating on articles used in contact with food. Limitations/ Specifi-
cations
October 29, 2008 EA/FONSI
FCS: Evonik Röhm GmbH
Polymer made with the FCS: SABIC Petrochemical B.V.
836 Polycyclooctene (CAS Reg. No. 25267-51-0). Kuraray Company, Ltd. As a component of a non food-contact layer of multilayered food-contact articles at levels up to 10 percent in blends with polyolefins complying with 21 CFR 177.1520 or ethylene-vinyl acetate-vinyl alcohol copolymers complying with 21 CFR 177.1360. Limitations/ Specifi-
cations
November 12, 2008 CAT. EXCL.
21 CFR 25.32(i)
Kuraray Company, Ltd.
837 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). Sun Rise Chemical Ind. Co., Ltd. (Taiwan) The FCS is intended for use as an optical brightener in paper and paperboard complying with 21 CFR 176.170. Limitations/ Specifi-
cations
November 12, 2008 CAT. EXCL.
21 CFR 25.32(i)
Sun Rise Chemical Ind. Co., Ltd. (Taiwan); Sun Rise Chemical Ind. Co. (China)
839 Dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene (CAS Reg. No. 287916-86-3). Toyota Tsusho Corporation As an antistatic agent in polymer films, compliant with existing authorizations. Limitations/ Specifi-
cations
November 21, 2008 EA/FONSI
Sanyo Chemical Industries, Ltd.

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