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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.