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CFSAN/Office of Food Additive Safety
June 2008

Inventory of Effective
Food Contact Substance Notifications
Limitations, Specifications, and Use

Inventory of Food Contact Substance Notifications | Food Types and Conditions of Use Tables 1 and 2 | Food Contact Substance Program

A notification for a food contact substance must contain sufficient information to demonstrate that the substance is safe for the intended use that is the subject of the notification (21 U.S.C. 348(h)(1)).This table will be updated approximately monthly.

FCN No.

Intended Use

Limitations/ Specifications

Antimicrobial additive for polymeric food-contact materials

For use only at levels not to exceed 2% by weight of the polymer. Conditions of use are limited to those for which the polymer has been established as safe with a silver content not to exceed 10% by weight of the compound.

Antioxidant in polypropylene

For use only at levels not to exceed 0.1 weight percent polypropylene complying with 21 CFR 177.1520. The finished copolymers may be safely used in single-use as well as repeated-use applications involving contact with food of types I, II, IV-B, VI, VII-B, and VIII, under Conditions of Use B through H, as described in Tables 1 and 2

Use of styrene...

For use at levels not to exceed 20 percent by weight of the total coating solids.

As a monomer in the manufacture of ethylene terephthalate-isophthalate copolymers.

The finished copolymers must contain from 3 to 17 weight percent ethylene isophthalate units. The finished copolymers must also meet specifications in 21 CFR 177.1630(f) - (j) appropriate to their intended use.

Fabricating beverage containers

Nitrile rubber modified acrylonitrile-methyl acrylate copolymers consist of 8 to 10.5 percent by weight of butadiene-acrylonitrile copolymers containing approximately 70 percent by weight of polymer units derived from butadiene. Adjuvant substances permitted for use in copolymers complying with 177.1480 may be used in the subject copolymers. The finished copolymers must meet any applicable specifications prescribed in 21 CFR 177.1480 and may be safely used as components of articles intended for food-contact use only under Conditions of Use E and F as described in Table 2. Paragraph 177.1480(d) not withstanding, the finished copolymers are authorized for use in fabricating bottles intended as containers for beverages as defined in 21 CFR 170.3(n)(3), (7) only under Conditions of Use E and F, (16), (35) and (36), with exception of soft drinks and coffee substitutes. The finished copolymers are to meet the following specifications: 1. residual acrylonitrile monomer content not more than 4 parts per million as determined by gas chromatography,
2. melt index in the range 2 to 6 grams per 10 minutes as determined by ASTM method D 1238-95 under the conditions 200 degrees C, 27.5 pounds, 0.0824 inches diameter x 0.3145 inches length.

Treating potable water

Adjuvant substances permitted for use in ion-exchange resins complying with 21 CFR 173.25 may be used in the subject ion-exchange resin subject to any limitations in the authorizing regulation or notification. The finished ion-exchange resin must meet any applicable specifications prescribed in 21 CFR 173.25

As a component of conveyor belts in contact with raw dough bakery products such as bread and croissants

None

As the base sheet or base polymer for manufacturing food contact articles.

The finished compolymers may contain from 0 to 50 weight percent of the polymer units derived from ethylene-2,6-naphthalate. The finished copolymers must meet any applicable specifications in 21 CFR 177.1630 appropriate to their intended use. The finished copolymers are prepared by the condensation of dimethyl terephthalate or terephthalic acid and imethyl-2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid with ethylene glycol and are used as the base sheet or base polymer for manufacturing articles and films intended to contact all food types under Conditions of Use A through H as described in Table 2. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the subject copolymers subject to any limitations in the authorizing regulation or notification.

As articles and films or components of articles and films in contact with food.

The finished compolymers may contain up to 50 weight percent of the polymer units derived from ethylene terephthalate. The finished homopolymer and copolymer must meet any applicable specifications in 21 CFR 177.1630 appropriate for their intended use. The finished homopolymer is prepared by condensation of dimethyl-2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid with ethylene glycol. The finished copolymers are prepared by the condensation of dimethyl-2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid and dimethyl terephthalate or terephthalic acid with ethylene glycol and are used as components of articles and films in contact with all food types under Conditions of Use A through H as described in Table 2. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the subject copolymers subject to any limitations in the authorizing regulation or notification.

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.

The level of pyromellitic dianhydride shall not exceed 0.5% by weight of the finished copolymer. Notwithstanding the limitations in 21 CFR 177.1630(e)(4)(i) item 2, for pyromellitic dianhydride modified polymers, the polymers that are the subject of this notification may be used without time or temperature limitations.

As a preservative and slimicide in the manufacture of paper and paperboard intended to contact aqueous and fatty food.

1. As a slimicide, in compliance with 21 CFR 176.300, at a maximum level of 0.034 pound per ton of dry weight fiber.
2. As a mold-proofing agent applied to the surface of uncoated paper and paperboard and in coatings for paper and paperboard, in compliance with 21 CFR 176.170(b), at a level not to exceed 100 parts per million (ppm) based on dry fiber weight.
3. As a preservative in wet lap and sheet pulp, in compliance with 21 CFR 176.170(a) prior to repulping to produce paper and paperboard, at a level not to exceed 100 parts per million (ppm) based on dry fiber weight.
4. As a preservative in pigment dispersions, in compliance with 21 CFR 176.170(b), at a level not to exceed 50 parts per million (ppm).

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.

The modified industrial starch must be used in compliance with 21 CFR 178.3520(a)(1), (b), and (c). The finished paper and paperboard shall be used only under conditions of use E through H identified in Table 2.

As a chemically-bound component of ethylene terephthalate-2, 6-napthalate copolymers.

The finished copolymers may contain from 0 to 50 weight percent of the polymer units derived from ethylene 2,6-naphthalate. The finished copolymers must meet any applicable specifications in 21 CFR 177.1630 appropriate to their intended use. The finished copolymers are prepared by the condensation of dimethyl terephthalate or terephthalic acid and dimethyl-2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid with ethylene glycol and are used as the base sheet or base polymer for manufacturing articles and films intended to contact all food types under Conditions of Use A through H as described in Table 2. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the subject copolymers subject to any limitations in the authorizing regulation or notification. Manufacturers of the copolymers may market the finished copolymers in accord with section 409(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act, provided the intended use is in conformity with this notification.

As a chemically-bound component of poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) homopolymer and copolymers with ethylene terephthalate.

The finished copolymers may contain up to 50 weight percent of the polymer units derived from ethylene terephthalate. The finished homopolymer and copolymers must meet any applicable specifications in 21 CFR 177.1630 appropriate to their intended use. The finished homopolymer is prepared by condensation of dimethyl 2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid with ethylene glycol. The finished copolymers are prepared by the condensation of dimethyl-2,6-naphthalenedicarboxylate or 2,6-naphthalenedicarboxylic acid and dimethyl terephthalate or terephthalic acid with ethylene glycol. The finished homopolymer and copolymers are used as components of the base sheet or base polymer for manufacturing articles and films in contact with all food types under Conditions of Use A through H as described in Table 2. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the subject polymers subject to any limitations in the authorizing regulation or notification. Manufacturers of the polymers may market the finished polymers in accord with section 409(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act, provided the intended use is in conformity with this notification.

As an optical brightener in paper and paperboard.

The food contact substance is intended as an optical brightener, at levels not to exceed that needed to achieve the desired technical effect, except in uncoated paper and paperboard in compliance with 21 CFR 176.170(a) at levels not to exceed 0.5 lb/ton of paper, and in clay coatings on paper and paperboard, in compliance with 21 CFR 176.170(b) at levels not to exceed 0.25 lb/ton of coated paper, where the uncoated and clay coated paper and paperboard containing the brightener is intended for use in contact with food types I, II, IV-B, VI, and VII-B, as described in Table 1.

For use in seal rings and bearings for food processing equipment including pumps.

For use in contact with all types of food, in the pH range >2.

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.

The perfluorocarbon base polymer shall contain no less than 30 weight-percent (wt.-%) of polymer units derived from tetrafluoroethylene, no less than 60 wt.-% of polymer units derived from perfluoro(2,4-dimethyl-3,6-dioxanone vinyl ether), and no more than 4 wt.-% polymer units derived from perfluoro(6,6-dihydro-6-iodo-3-1-hexane). The uncured elastomer shall be composed of no more than 6 parts per hundred of triallylcyanurate and no more than 5 parts per hundred of 2,5-dimethyl-2,5-di(t-butylperoxy)hexane. The PCE must meet any applicable specifications prescribed in 21 CFR 177.2400 Perfluorocarbon cured elastomers.

For use as an antiscalant boiler water treatment where steam from treated boilers may contact food.

The food contact substance contains not more than 15% styrene sulfonate and has a molecular weight greater than 20,000 and a polydispersity of 2.0 - 3.3, as measured by a method entitled "Molecular Weight Distribution of Aqueous Anionic Polymers by Size Exclusion Chromatography (SEC) Using Synchropak GPC Columns". The substance must not exceed 20 ppm in feed water, must not be used in boilers at pressures above 1000 pounds per square inch gauge (psig), and must meet any applicable specifications prescribed in 21 CFR 173.310.

In the manufacture of can end cements complying with 21 CFR 175.300(b)(3)(xxxi).

The finished can end cements may contain up to 30 percent by weight of the terpolymer and the finished cans produced with the use of these cements may be used in contact with all types of food under Conditions of Use A through H, defined under Table 2 of 21 CFR 175.300(d).

As an antioxidant and/or stabilizer in linear low density polyethylene articles intended for contact with food.

The food contact substance shall be used at levels not to exceed 0.15 percent by weight of linear low density polyethylene complying with 21 CFR 177.1520(c), items 3.1 and 3.2. The finished polymers may only be used in contact with food types I, II, IV-B, VI-B, VII-B, and VIII under Conditions of Use B through H as described in Tables 1 and 2, and with food types III, IV-A, V, VI-A, VI-C, VII-A, and IX under Conditions of Use C through G as described in Tables 1 and 2.

As an antioxidant and/or stabilizer in high-density polyethylene articles intended for contact with food.

The food contact substance shall be used at levels not to exceed 0.15 percent by weight of high-density polyethylene homo- and copolymers complying with 21 CFR 177.1520 (where the density of the polymer is not less than 0.94 g/cc). The finished polymers may only be used in contact with food types I, II, IV-B, VI-B, VII-B, and VIII under Conditions of Use B through H as described in Tables 1 and 2, and with food types III, IV-A, V, VI-A, VI-C, VII-A, and IX under Conditions of Use C through G as described in Tables 1 and 2.

As an antioxidant and/or stabilizer in high-density polyethylene homopolymer and copolymers articles intended for contact with food.

The food contact substance (FCS) is to be used at levels not to exceed 0.15 percent by weight of the high-density polyethylene homopolymer and copolymers complying with 21 CFR 177.1520. The finished homopolymer and copolymers are to be used in contact with food types I, II, IV-B, VI-B, VII-B, and VIII, under Conditions of Use B through H, as described in Tables 1 and 2, and with food of types III, IV-A, V, VI-A, VI-C, VII-A, and IX, under Conditions of Use C through G, as described in Tables 1 and 2.

As a colorant in food-contact polymers. The colorant is to be used in compliance with 21 CFR 178.3297.

At levels up to 2 percent by weight in all types of food-contact polymers under Conditions of Use A through H as described in Table 2.

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.

None.

As colorants for all polymers intended for food-contact applications.

The colorants are limited to use levels not exceeding 1 percent by weight of the polymer and are subject to the provisions and definitions set forth in title 21 CFR 178.3297 Colorants for polymers. The finished food-contact articles may contact food under Conditions of Use A through H, as described in Table 2.

As a colorant for polymers intended for food-contact applications.

The colorants are limited to use levels not exceeding 2 percent by weight of the polymer and are subject to the provisions and definitions set forth in title 21 CFR 178.3297 Colorants for polymers. The finished food-contact articles may contact food under Conditions of Use A through H, as described in Table 2.

As a colorant in all types of food-contact polymers.

For use at levels not to exceed 1% by weight as a colorant in all types of food-contact polymers. The finished polymers are intended to contact all types of food under Conditions of Use A through H, as described in Table 2. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.

As a modifier (blending component) for polymers that are regulated in 21 CFR Part 177 or the subject of an effective notification.

As a modifier (blending component) for polymers that are regulated in 21 CFR Part 177 or the subject of an effective notification at levels no greater than 10 weight-percent of the blend. The blend is intended for use as a component of articles that contact food of the types I, II, IVB, VI (<13% alcohol), VIIB and VIII under Conditions of Use A through H, as described in Tables 1 and 2. The subject copolymers shall conform to the following specifications based on the analytical methods in 21 CFR 177.1810(c): a minimum molecular weight of 25,000, complete solubility in toluene, glass transition points of -50°C (-58°F) to -20°C (-4°F) and 85°C (185°F) to 105°C (221°F), maximum extractable fraction of 0.010 mg/cm² (0.06 mg/in²) of surface with testing at reflux temperature for 2 hr on a 0.071 cm (0.028 in) thick sample in distilled water, and maximum extractable fraction in 50 percent ethanol of 0.008 mg/cm² (0.05 mg/in²) of surface with testing at 66°C (150°F) for 2 hr on a 0.071 cm (0.028 in) thick sample.

As an antioxidant and/or stabilizer in accordance with 21 CFR 178.2010 in styrene-isoprene-styrene (SIS) copolymer.

The antioxidant will be limited for use at levels not to exceed 0.1 by weight of the SIS copolymer, as a component of pressure-sensitive adhesives complying with 21 CFR 175.125. The adhesives are to be used as components of tape for food packaging and for labels placed on fruits and food containers at room temperature or below.

For use in boiler water additives complying with 21 CFR 173.310.

The mole ratio of the sodium salt of acrylic acid to polyethyleneglycol allyl ether in the copolymer must not exceed 2.5 to 1. In addition, the additive must not exceed 200 parts per million (ppm) in boiler water. Further, this product must meet any applicable specifications under 21 CFR 173.310.

For use in boiler water additives complying with 21 CFR 173.310.

For use only as an inert tracer chemical in boiler systems and must not exceed 900 parts per billion (ppb) in boiler water. In addition, this product must meet any applicable specifications under 21 CFR 173.310.

As a stabilizer in calcium stearate dispersions used in the manufacture of paper coatings complying with 21 CFR 176.170(b).

At levels not to exceed 0.05 percent by weight of the finished coating.

The FCS is 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.

The silicone coatings may contain the subject silicone resin at up to 50 percent by weight of the total coating solids. The self stick labels and/or tapes are to be used in accordance with 21 CFR 175.125 Pressure sensitive adhesives.

For use in the manufacture of multilaminate packaging films and not for use in direct contact with food.

The finished resins may safely be used with: non-alcoholic foods at temperatures not to exceed 100°C (212°F); Laminate structures with authorized food-contact materials yield no more than 0.15 milligram of epsilon-caprolactam and 0.04 milligram for both omega-laurolactam and omega-aminododecanoic acid per square inch when extracted with water at 100°C (212°F) for 5 hours (complying with 177.1395).

As a microbial control agent in non-carbonated juice beverages containing up to and including 100 percent juice.

No more than 250 ppm of DMDC may be added to non-carbonated juice beverages containing up to and including 100 percent juice. The DMDC complies with the requirements listed in 21 CFR 172.133(a) and (c). The beverages must be produced under good manufacturing conditions and their microbial load must first be reduced by current technologies such as heat treatment, filtration, etc., prior to the addition of DMDC.

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.

The polyester resin may be used at levels not to exceed 0.05 milligrams per square inch in coating applied to the film surface area. The coated films may be used in contact with all types of food and under conditions of use A through H in accordance with 21 CFR 175.320.

As a monomer in the production of polyurethane resins used in adhesives complying with 21 CFR 175.105.

The finished polyurethane resins are prepared by the reaction of dimethylolbutanoic acid with disocyanates and with one or more of the polyols and polyesters listed in 21 CFR 175.105 and optionally with any of the amines listed in 21 CFR 175.105 for use in polyurethane resins. The finished polyurethane resins may safely be used as components of adhesives used in food contact materials held at temperatures not to exceed 120°F, except when separated from the food by a functional barrier in compliance with 21 CFR 177.1390(e)(2)(ii). Manufacturers of the polyurethane resins may market the finished polyurethane resins in accord with section 409(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act, provided the intended use is in conformity with this notification.

As a colorant in all types of food-contact polymers.

Maximum use level of 30 percent by weight of the polymer. The finished polymers are intended to contact all types of food under Condition of Use C, as described in Table 2, or less severe conditions. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.

As a stabilizer in polypropylene polymers and copolymers complying with 21 CFR 177.1520(c).

Maximum use level of 0.12% by weight of the polymer. The finished polymers are intended to contact all types of food under Conditions of Use B through H, as described in Table 2, unless otherwise restricted by the applicable limitations for the polypropylene polymers and copolymers complying with 21 CFR 177.1520(c).

As a polymeric component of repeated use food-contact articles.

The polyphenylene sulfide polymers are to be manufactured by the equimolar reaction of sodium sulfide and p-dichlorobenzene using the synthetic scheme described in your notification. The finished polymer has a melt temperature (T_m) of 272-283°C and an average molecular weight ranging from 25,000 to 100,000 Daltons. The polymer will be used under conditions of use A through H and in contact with all types of food.

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.

The resins shall be cured by the use of electron beam or ultraviolet light such that the finished coating, when extracted with 50 percent ethanol at 100°C for 2 hours, yields total chloroform-soluble nonvolatile extractives not to exceed 0.02 milligram per square inch (mg/in²).

For use as an absorptive medium in absorbent pads employed in the packaging of refrigerated or frozen red meat.

The finished copolymer must meet all specifications and limitations prescribed in 21 CFR 177.1211(b) and (c).

Used in seals for food processing equipment.

This metal would be used in a fine powder form in acrylonitrile/butadiene resin contacting meat products at up to 35°F, and fruit and vegetable products at up to 180°F.

As a modifier for polyethylene terephthalate (PET) polymers.

(a) At levels not to exceed 30 percent by weight of the modified PET in contact with food types I, II, IVB, VIA, VIB, VIIB and VIII as described in Table 1 of this chapter, and under conditions of use C through G as described in Table 2 of this chapter. Chloroform soluble extractives shall not exceed 0.08 milligrams/centimeter² (0.5 mg/inch²) of food-contact surface of the modified polyethylene terephthalate article when exposed to water at 95°C (203°F) for 1 hour followed by 49°C (120°F) for 24 hours. (b) At levels not to exceed 10 percent by weight of the modified PET in contact with foods containing greater than 8 percent ethanol, at temperatures not exceeding 71°C (160°F). Chloroform soluble extractives shall not exceed 0.08 milligrams/centimeter² (0.5 mg/inch²) of food-contact surface of the modified polyethylene terephthalate article when exposed to 50 percent ethanol at 71°C (160°F) for one hour followed by 49°C (120°F) for 24 hours.

For use in the isolation and purification of protein concentrates and isolates from aqueous process streams for food processing.

The amount of epichlorohydrin plus propylene oxide employed in manufacture of the resins does not exceed 400 percent by weight of the starting quantity of cellulose. The resins comply with the requirements listed in 21 CFR 173.25(c) and 21 CFR 173.25(d)(2)(ii). The resins shall be used only in the pH range from 2 to 10. The temperatures of water and food passing through the resins shall not exceed 50°C.

For use as an anti-wear component of lubricants with incidental food contact.

For use at a level not to exceed 0.5 percent by weight of lubricants for incidental food contact.

As an antimicrobial additive in all types of food-contact polymers.

Maximum use level of 5 percent by weight of the polymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H, as described in Table 2.

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.

1. The polymer is produced by the transesterification of ethylene-methyl acrylate copolymer complying with 21 CFR 177.1340 with cyclohexenyl methanol (CAS Reg. No. 1679-51-2).
2. The polymer shall contain a minimum of 65 weight percent ethylene, no more than 28 weight percent cyclohexenylmethyl acrylate, with the remainder being methyl acrylate units.
3. The polymer may contain up to 0.1 percent benzoylated triphenylbenzene (CAS Reg. No. 227099-60-7). For use only: 1. As a component of articles in contact with dry food containing no surface fat or oil (i.e., food type VIII as described in Table 1).
2. As a non-food contact layer of laminate structures. The multi-layer articles shall be flexible films, rigid polypropylene containers, or containers made of paper or paperboard. The food-contact substance will be separated from the food by one or more polymeric layers permitted for this use that have a total thickness no less than 0.25 mil (0.00025 in): (a) aqueous, acidic and low alcohol-content food (food types I, II, IV-B, VI-A, VI-B, VII-B, as described in Table 1), under Conditions of Use C through G, as described in Table 2, provided that the FCS layer does not exceed 1.5 mil (0.0015 inch) in thickness. (b) fatty and high alcohol-content food (food types III, IV-A, V, VI-C, VII-A, and IX, as described in Table 1), under Conditions of Use E through G, as described in Table 2, provided that the FCS layer does not exceed 0.75 mil (0.00075 inch) in thickness.

The Nylon 6 polymers would be used for food-contact applications as described in 21 CFR 177.1500(b)(6.1) and (6.2).

Maximum use level of 0.15 percent by weight of benzoic acid in the finished polymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H, as described in Table 2. The finished Nylon 6 polymers must meet the applicable specifications prescribed in 21 CFR 177.1500(b) when tested by the methods described in 21 CFR 177.1500(c).

REPLACED BY FCN 232

As a chromatographic material for the isolation and purification of food enzymes.

For use only in contact with aqueous food enzyme solutions. The resins shall be used and stored (long term storage) at pH values that do not exceed 12. The water, buffers, and food passing through the resins shall have temperatures that do not exceed 30°C and linear flow rates that are not less than 150 centimeters/hour. The resins must comply with the applicable limitations for ion exchange resins in 21 CFR 173.25(c).

As an antioxidant and/or stabilizer in olefin polymers.

1. At levels not to exceed 0.1 percent by weight of polypropylene polymers complying with 21 CFR 177.1520(c), item 1.1, 1.2, 1.3, 3.1a (with density of 0.85-0.91 gram per cubic centimeter), 3.2b, 3.4 and 3.5. The finished polymers may be used in contact with: (a) food types I, II, IV-B, VII-B and VIII described in Table 1, under Condition of Use A described in Table 2; (b) food types VI-A and VI-B described in Table 1, under Conditions of Use A through C described in Table 2; and food types III, IV-A, V, VI-C, VII-A, and IX described in Table 1, under Conditions of Use B and C described in Table 2.
2. At levels not to exceed 0.1 percent by weight of high density polyethylene polymers and copolymers complying with 21 CFR 177.1520(c), item 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.6 (with a density not less than 0.94 gram per cubic centimeter) and 5. The finished polymers may be used in contact with food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H as described in Tables 1 and 2, and with food types III, IV-A, V, VI-C, VII-A and IX under Conditions of Use B through H as described in Tables 1 and 2.
3. At levels not to exceed 0.1 percent by weight of polyethylene polymers and copolymers complying with 21 CFR 177.1520(c), item 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, and 3.6 (with a density less than 0.94 gram per cubic centimeter). The finished polymers may be used under Conditions of Use B through H described in Table 2.

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.

At levels not to exceed 2.0 percent by weight of acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard complying with 21 CFR 176.170.

For use in treating aqueous sugar solutions and hydrolyzed starch solutions.

The temperature of the sugar solution or hydrolyzed starch solution passing through the resin bed is maintained at 80°C (176°F) or less. The flow rate of the sugar solution or hydrolyzed starch solution passing through the bed is not less than 50 liters per cubic meter (0.37 gallons per cubic foot) of resin bed volume per minute.

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; and
5. as a component of adhesives for seals of food-contact, glass containers complying with 21 CFR 177.1210.

At levels not to exceed 60 percent by weight of total polymer/formulation weight in contact with all types of food under Conditions of Use B throught H, as described in Table 2. The average thickness of polyolefin films containing the food contact substance should not exceed 1.25 mils (0.00125 inch).

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 177.1520(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; and
5. as a component of adhesives for seals of food-contact, glass containers complying with 21 CFR 177.1210 and 21 CFR 175.105.

At levels not to exceed 60 percent by weight of total polymer/formulation weight in contact with all types of food under Conditions of Use B through H, as described in Table 2.

As an antioxidant and/or stabilizer in styrene-butadiene block polymers.

The food contact substance shall be used at levels not to exceed 0.20 percent by weight of styrene-butadiene block polymers complying with the specifications in 21 CFR 177.1810(b), item 1(i), when tested by the methods described in 21 CFR 177.1810(c). The finished copolymers may only be used in contact with food typesI, II, IV-B, VI, VII-B and VIII under conditions of use D through G as described in Tables 1 and 2.

As a component of paper and paperboard in contact with nonalcoholic food.

For use only as an oil and water repellant in paper and paperboard complying with 21 CFR 176.170 and 176.180 at a level not to exceed 15 pounds of actives (7.8 pounds of fluorine) per ton of treated paper of a sheet basis weight of up to 300 lbs per 3,000 square feet as determined by analysis for total fluorine in the treated paper and paperboard without correction for any fluorine that might be present in the untreated paper or paperboard, when such paper is used in contact with nonalcoholic food under Conditions of Use B through H, as described in Table 2.

As an antioxidant in the manufacture of polypropylene homopolymer and copolymers complying with 21 CFR 177.1520.

The FCS will be used at levels not to exceed 0.1 weight percent in polypropylene homopolymers and copolymers. The finished homopolymers and copolymers may be used in contact with food types III, IV-A, V, VII-A, and IX (i.e., fatty foods) and VI-C (foods containing up to 15 percent alcohol), under Conditions of Use B through H as described in Tables 1 and 2, respectively.

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.

The amorphous hydrongenated carbon coating is intended for use at a level not to exceed approximately 0.15 microns thick (0.006 mil) and may be used in contact with food types I through IX, under Conditions of Use A through H, as described in Tables 1 and 2.

For use as a basic resin in food-contact articles

For use in contact with food of Types I, II, IVB, VIA, VIB, VIIB, and VIII identified in Table 1 under conditions of use B, C, D, E, F, G, and H as described in Table 2, and food of Types III, IVA, V, VIC, VIIA, and IX under conditions of use D, E, F, and G.

The finished resin must comply with the following specifications:

	Molecular weight (minimum) 68,000 (as the minimum number average molecular weight)
	Solubility Completely soluble in toluene.
	Glass transition points -57°C (-70°F) to -51°C(-59.8°F) and 91°C(195.8°F) to 102°C(215°F).
	Maximum extractable fraction in distilled water at specified temperatures, times, and thicknesses 0.001 mg/cm²(0.01 mg/in²) of surface at reflux temperature for 2 hr on a 0.1 cm (0.04 in) thick sample.
	Maximum extractable fraction in 50% ethanol at specified temperatures, times, and thicknesses 0.001 mg/cm²(0.01 mg/in²) of surface at 66°C (150° F) for 2 hr on a 0.1 cm (0.04 in) thick sample.

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.

The finished resins in a 1 percent by weight aqueous solution (active polymer) have a viscosity of 10 centipoises or more at 22°C (72°F) as determined by an LVF-series Brookfield Viscometer using a No. 2 spindle at 60 rpm (or by other equivalent methods). For use at a level not to exceed 0.05 percent by weight of the finished paper and paperboard.

As a rheology modifier in the production of olefin polymers complying with either 21 CFR 177.1520 or 177.26.00.

The 3,6,9-triethyl-3,6,9-trimethyl-1,2,4,5,7,8-hexoxonane modifier is to be used at a level not to exceed 0.15 percent by weight of the olefin polymers. Food contact articles manufactured with the olefin polymers modified with the food contact substance shall be used in contact with all types of food under conditions of use A - H as described in Tables 1 and 2, unless restricted by applicable regulations for the olefin polymers.

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.

The FCS shall comply with the specifications of 21 CFR 177.1520(c), item 3.2b, except the thickness limitation shall not apply to the polymer blend. Additionally, optional adjuvant substances listed in 21 CFR 177.1520(b) may be used in the manufacture of the FCS in accordance with the limitations/specifications as specified for the subject adjuvant.

As components of can end cements.

1. Styrene-butadiene-methacrylic acid terpolymer: shall contain no more than 1.5 weight-percent of monomer units derived from methacrylic acid and no more than 50 weight-percent of monomer units derived from butadiene; for use at levels not to exceed 75 percent by weight of the cement solids in can-end cements complying with 21 CFR 175.300(b)(3)(xxxi).
2. 1,2-benzisothiazolin-3-one: for use at levels not to exceed 113 ppm in the finished can-end cements complying with 21 CFR 175.300(b)(3)(xxxi).
3. Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether, sodium salt: for use at levels not to exceed 1 percent in the finished can-end cements complying with 21 CFR 175.300(b)(3)(xxxi).

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.

For use in contact with all foods except beverages containing more than 8 volume percent alcohol, under Conditions of Use A - H, as described in Table 2.

The basic polymers shall meet the following specifications:

Density (ASTM D1505)	1.2
Molecular weight	30,000 (typical), relative to poly (methyl methacrylate)
Melting point (ASTM D2117)	250-260°C (Copolymer) 210-260°C (Terpolymer)
Extractable fraction	Not to exceed 0.5 milligram per square inch when the polymer, in the form of plaques, 25 to 30 mil in thickness, is refluxed in n-butanol at the boiling point (118°C) for 2 hours.

For use as a secondary stabilizer in the suspension polymerization of polyvinyl chloride.

The stabilizer is limited to use in polyvinyl chloride articles of thickness of 0.25 mm or less, and is used at a level not to exceed 0.05 percent by weight of the vinyl chloride monomer.

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.

The FCS is manufactured from ethylene glycol, dimethyl terephthalate, and isophthalate acid and the finished polymer shall contain at least 88 weight percent of polymer units derived from ethylene terephthalate and must meet specifications in 21 CFR 177.1630 appropriate to its intended use.

As a coating that is intended for repeated use in contact with beer.

Polyoxypropylenediamine is limited to use as a cross linking component at a maximum level of 20 percent by weight of the cured epoxy coating at temperatures not to exceed 40°C. The finished coating is intended for repeated use in contact with beer only.

For use in demineralizing sugar solutions prior to recrystallization, and to soften water for food and beverage production.

The ion-exchange resin must comply with all the applicable specifications prescribed in 21 CFR 173.25(b).

To manufacture films, sheets, and articles made therefrom for food-contact applications; not for use in making bottles.

Ethylene-2-norbornene copolymer (density 1.02+0.04 g/cm³) may contain not less than 30 but no more than 70 mole percent of polymer units derived from norbornene in contact with all food types under conditions of use A through H. Manufacture, purification and specifications as described in this notification.

As a cross linking agent in the manufacture of polydimethylhydrogen 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 (adhesive) for use with pressure-sensitive labels.

The FCS will be used in accordance with good manufacture practices. Additionally,
1. the food packaging articles will be used in contact with only produce, meats, poultry, and seafood;
2. the molds will be used in contact with only fatty foods such as chocolates and/or sticky substances (i.e., candy); and
3. the labels will be used only on produce (fruits and vegetables).

Incidental food-contact lubricants made with sebacic acid (added as a corrosion inhibitor.

Maximum use level of 0.5 percent of sebacic acid by weight in the lubricant. The FCS shall contain no less than 85 percent sebacic acid and no less than 95 percent total sebacic, un- and dodecanedioic acids.

Pump and pipe material used in transporting food.

None.

As an antioxidant in plasticized PVC.

For use as an antioxidant at a maximum level of 0.06 percent by weight of the finished polymer in plasticized vinyl chloride homo- and copolymers (PVC) used in contact with all types of food under Conditions of Use C through G as described in Tables 1 and 2, respectively .

For repeated use in contact with food.

1. The basic resins are produced by reacting 4,4'-biphenol and 4,4'-dichlorodiphenylsulfone according to the process described in the notification, so that the finished resin has a weight average molecular weight of at least 43,000.
2. The basic resins are to be used in contact with all food types under Conditions of Use B through H as described in Tables 1 and 2.

As a colorant in all food-contact polymers.

For use as a colorant at levels not to exceed one percent by weight of the finished polymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H, as described in Table 2. The average thickness of the polymers containing the food contact substance should not exceed 0.5 cm.

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.

The finished food-contact film or article must meet any applicable specifications, and is subject to all applicable conditions of use cited in title 21 CFR 177.1630(f), (g), and/or (j).

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).

For use in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2, respectively. Polyester resins manufactured from the food contact substance are subject to the applicable limitations/specifications in and crossed references to 21 CFR 175.300 as appropriate for their intended use.

As an acidifier or stabilizer for diphenylmethane-4,4'-diisocyanate prepolymer used in the manufacture of polyurethane for further manufacture of adhesives complying with 21 CFR 175.105.

For use in adhesives complying with 21 CFR 175.105, as a component of food packaging intended for use at temperatures of less than 120°F. The level of residual terephthaloyl dichloride shall not exceed 9 ppm in the finished adhesive.

As a surfactant in latex formulations used in pigment binders for paper and paperboard intended to contact aqueous, acidic, and low-alcohol foods.

For use only as a surfactant at a level not to exceed 1 percent by weight of solids in latex formulations used in pigment binders for paper and paperboard used in contact with food of Types I, II, IVB, VI (beverages below 15% alcohol by volume), VIIB, and VIII only, as described in Table 1. The polyethylene glycol mono-isotridecyl ether sulfate, sodium salt, solids may contain up to 15 weight percent of polyethylene glycol mono-isotridecyl ether (CAS Reg. No. 69011-36-5). The paper and paperboard containing this food contact substance must comply with the extractives limitations prescribed in 21 CFR 176.170(c).

As a coating that is intended for repeated use in contact with beer.

C.I. Solvent Violet 13 is limited to use at a maximum level of 1 percent by weight of the cured epoxy coating at temperatures not to exceed 40°C. The finished coating is intended for repeated use in contact with beer only.

As a coating that is intended for repeated use in contact with beer.

1-(2-Aminoethyl) piperazine is limited to use at a maximum level of 5 percent by weight of the cured epoxy coating at temperatures not to exceed 40°C. The finished coating is intended for repeated use in contact with beer only.

Milling aid and dispersant for pigments used as components of food-contact articles.

For use at levels not to exceed 0.45 percent by weight of pigment. The pigmented articles may contact all food under conditions of use A through H as described in Table 2.

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.

The finished homopolymers and copolymers would be used as components of adhesive formulations complying with 21 CFR 175.105 in contact with all types of food at temperatures that do not exceed 120°F and as components of coatings of paper and paperboard complying with 21 CFR 176.180 in contact with dry food at temperatures that do not exceed 120°F.

As a component of articles intended for repeat use complying with 21 CFR 177.2470.

Polyoxymethylene copolymers shall contain no more than 5 percent by weight of the polymer units derived from 1,3-dioxolane. The maximum use temperature is 250°F.

As an anti-corrosive agent in the steam header and steam lines of boiler systems in which the steam will contact food.

The FCS is to be continuously added into the steam header to maintain a maximum concentration of 2 ppm in the steam. The FCS shall contain no more than 100 ppm and 800 ppm residual ethylene oxide and 1,4-dioxane, respectively, and must meet any applicable specifications prescribed in 21 CFR 173.310.

As a fluid absorbent in food-contact materials.

The cross-linked polyacrylate copolymer may contain optional adjuvant substances that are required in its production. The optional adjuvant substances may include substances permitted for such use by regulation in 21 CFR Parts 170 through 179. The polyacrylate copolymer must meet the extractives limitations in 21 CFR 177.1211(c) and is limited to use as a fluid absorbent in food-contact materials used in the packaging of poultry, meat and fish at refrigerated and frozen temperatures.

As adjuvants in the bleaching of recycled paper and paperboard intended to contact food.

1. A mixture of MMDMH and DMDMH will be applied to process water during the bleaching of recycled paper at a maximum rate of 200 parts per million (ppm) combined hydantoins.
2. Paper and paperboard manufactured with MMDMH and DMDMH can be used under conditions of use D through H as described in Table 2.

100

As a component of coatings applied to fruits and vegetables with inedible peels, excluding citrus fruits.

The FCS will be used at levels not to exceed 5 percent of the coating formulation.

101

For use in the fabrication of articles intended for repeated use in contact with food.

The perfluorocarbon base polymer shall contain no less than 40 weight-percent of polymer units derived from perfluoro(methyl vinyl ether), no less than 30 weight-percent of polymer units derived from tetrafluoroethylene, and no more than 5 weight-percent polymer units derived from perfluoro(8-cyano-5-methyl-3,6-dioxa-1-octene). The uncured elastomer shall be compounded with no more than 4 parts per hundred of rubber (phr) of trimethylallyl isocyanurate and/or triallyl isocyanurate and no more than 4 phr of 2,5-dimethyl-2,5-di(t-butylperoxy)hexane. The elastomer may also contain up to 1.0 phr of N, N, N', N'-tetramethyl-1-8-naphthalenediamine (CAS Reg. No. 20734-58-1). The perfluorocarbon cured elastomers must meet the total extractive limitations prescribed in 21 CFR 177.2400(d)(1).

102

As an antioxidant and/or stabilizer for olefin polymers for use in contact with food.

1. In polypropylene and high density polyethylene, including homopolymers and copolymers, at levels not to exceed 0.1 percent by weight in contact with aqueous, acidic, fatty and dry foods, and at levels not to exceed 0.2 percent by weight in contact with alcoholic foods, under conditions for use A through H as described in Table 2.
2. In low density polyethylene and linear low density polyethylene, and all other olefin polymers permitted for use in contact with food, but not included in (1), above, at levels not to exceed 0.1 percent by weight, under conditions of use A through H as described in Table 2, in contact with all food types; provided that when used with fatty food, the finished food contact material does not exceed 0.002 inches (2 mil) in thickness, or alternatively, the concentration of the food-contact substance shall not exceed a total of 0.03 milligrams per square inch of food contact surface.

103

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.

The finished copolymers are intended to contact all types of food under Conditions of Use A through H, as described in Tables 1 and 2, respectively.

104

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.

1. The subject methylhydantoins may be used as intended, at a combined level not to exceed 1200 parts per million (ppm) in the slurry.
2. Paper and paperboard manufactured with DMDMH and MMDMH can be used under Conditions of Use D through H as described in Table 2.

105

As an antiscalant boiler water treatment where steam from treated boilers may contact food.

The polymer must be used at levels not to exceed 20 ppm in the feed water. The polymer must not be used at pressures above 1,000 pounds per square inch gauge (psig). The polymer has a molecular weight range of 7,500 to 15, 000. The polymer comprises at least 99 mole percent acrylic acid and 1 mole percent sodium styrene sulfonate. Specific substances permitted for use as boiler water additives complying with 21 CFR 173.310 may be used in the subject boiler water additives subject to any limitations in the authorizing regulation or notification. The finished boiler water additive must meet any applicable specifications prescribed in 21 CFR 173.310.

106

As a component of paper and paperboard in contact with aqueous and fatty foods, complying with 21 CFR 176.170(b)(2).

The copolymers are intended for use in latex coatings. The finished polymer will contain no more than 30 weight percent acrylonitrile and not more than 10 weight percent of total polymer units derived from minor monomers listed above. The SBAN latex copolymers shall contain no more than 100 ppm of residual styrene monomer in the wet latex.

107

As a lubricant in repeat use polyoxymethylene copolymers as described in FCN 96.

Polyethylene glycol (PEG) shall have a minimum number average molecular weight of 20,000. PEG will be used as a lubricant at a maximum level of 0.15 percent by weight of repeat use polyoxymethylene copolymer as described in FCN 96 at temperatures not to exceed 250°F. Additionally, hydroquinone monomethyl ether may be used as a stabilizer in PEG at a maximum level of 20 ppm.

109

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.

1. The platinum-containing catalyst will be present in the finished elastomer at a maximum level of 36 ppm (w) corresponding to 11 ppm platinum.
2. The platinum catalyst itself will not come in contact with food.

110

For use in fabricating beverage containers and in film or sheet packaging.

Nitrile rubber-modified acrylonitrile-methyl acrylate copolymers consisting of 8 to 18 percent by weight of butadiene-acrylonitrile copolymers containing approximately 70 percent by weight of polymer units derived from butadiene intended for use in beverage containers (with the exception of containers for carbonated soft drinks and coffee substitutes) under Conditions of Use E and F as described in Table 2, and in food-contact film and sheet packaging under Conditions of Use D through G. The finished copolymers are to meet the following specifications: 1) residual acrylonitrile monomer content not more than 4 parts per million as determined by gas chromatography, 2) melt index in the range 2 to 6 grams per 10 minutes as determined by ASTM method D 1238-95 under the conditions 200°C, 27.5 pounds, 0.0824 inches diameter x 0.3145 inches length. Adjuvant substances permitted for use in copolymers complying with 21 CFR 177.1480 may be used in the subject copolymers.

111

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.

2-Methyl-4-isothiazolin-3-one is not to exceed 150 mg/kg in the coating formulations and additives; except for use as an antimicrobial agent for polymer latex emulsions in paper coatings, 2-methyl-4-isothiazolin-3-one shall not exceed 250 mg/kg. The use of 2-methyl-4-isothiazolin-3-one in adhesives shall be in accordance with 21 CFR 175.105.

112

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.

Maximum use level of 0.2 percent by weight of the finished copolymer. The finished copolymers are intended to contact Food Types I, II, III, IVB, VI, VII, VIII and IX under Conditions of Use A through H, as described in Tables 1 and 2, respectively.

113

As a stabilizer for flexible polyvinyl chloride films.

For use as a stabilizer at levels not to exceed 0.024 percent by weight of the flexible polyvinyl chloride film intended for use in contact with food types I, II, IV-B, VI-B, VII-B, and VIII as described in Table 1. The thickness of film shall not exceed 1 mil.

115

As a colorant for all polymers intended for use in contact with food.

For use at levels not to exceed 1 percent by weight of the finished food-contact article. C. I. Pigment Red 149 will be used to color food-contact articles that contact all food types under Conditions of Use B through H. The maximum thickness of the finished food-contact articles will be 50 mils, when used as bottles or tubs.

116

As a stabilizer in food-contact polymers.

1. At levels not to exceed 1 percent by weight of all polymers in contact with Food Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII under Conditions of Use A through H, as described in Tables 1 and 2, respectively.
2. At levels not to exceed 0.2 percent by weight of all repeat-use polymers (except low-density and linear low-density polyethylene) in contact with Food Types III, IV-A, V, VII-A, and IX under Conditions of Use A through H as described in Tables 1 and 2, respectively.

117

Components of coatings for paper and paperboard in compliance with 21 CFR 176.170(b).

1. Styrene-butyl acrylate acrylic copolymers are produced by the emulsion polymerization of a minimum of 68 parts by weight styrene with a maximum of 26 parts butyl acrylate and up to 12 parts of any one or more of the following monomers: acrylic acid, methacrylic acid, methyl methacrylate, allyl methacrylate and butyl methacrylate, as further described in the notification.
2. The subject copolymers are for use in pigmented coatings that contain mixtures of other components such as inorganic pigments (e.g., clay, titanium dioxide, calcium carbonate) and binders applied to paper and paperboard at levels not to exceed 20 percent by weight based on total coating solids.
3. The copolymers may also be used in coatings applied to the interior, food contact paper and paperboard surface at levels not to exceed 50 percent by weight of total coating solids levels.
4. The finished copolymers must be used in accordance with 21 CFR 176.170(c).

118

As a colorant for all polymers intended for use in contact with food.

For use at a level not to exceed 1 percent by weight of the finished food-contact article. The FCS (C.I. Pigment Red 178) will be used to color food-contact articles that contact all Food Types under Conditions of Use B through H.

119

As a thickener in antimicrobial formulations for use in food packaging adhesives.

The finished packaging is intended for use at temperatures no greater than 120°F. The level of xanthan gum shall not exceed 0.01 percent by weight of the finished adhesive.

123

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.

The FCS will meet the test specifications outlined in 21 CFR 177.1390(c)(3)(i)(b)(2) and 21 CFR 177.1390(c)(3)(ii).

124

As articles or components of articles intended for contact with all types of food.

The finished copolymer containing the optional adjuvant is intended for contact with all types of food under Conditions of Use E through G as described in Tables 1 and 2, respectively. The finished copolymers shall have a) a minimum number-average molecular weight (Mn) and weight-average (Mw) of 69,000 and 70,000, respectively; and b) glass transition points ranging from -98° to -20° and 86° to 122°.

125

To be used as a component of adhesives (at a 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.

As stated in 21 CFR 175.105, the adhesive must be used in compliance with 21 CFR 175.105 paragraph (a)(2).

126

As a gasket or seal for food processing equipment.

The finished copolymers are intended for use as components of repeat-use, food-contact articles intended to contact food types I through VII as described in Table 1.

127

As a gasket or seal for food processing equipment.

The finished copolymers are intended for use as components of gaskets or seals used in food processing equipment intended to contact food Types I through VII as described in Table 1.

128

As a gasket or seal for food processing equipment.

The finished copolymers are intended for repeat use as components of gaskets or seals used in food processing equipment intended to contact food Types I through VII as described in Table 1.

129

As a gasket or seal for food processing equipment.

The finished copolymers are intended for repeat use as components of gaskets or seals used in food processing equipment intended to contact food Types I through VII as described in Table 1.

130

Components of printing inks or coatings for paper and paperboard.

1. Styrene-acrylic copolymers are produced by the polymerization of the following monomers in various combinations with the maximum use levels as noted: 100 percent styrene, 48 percent butyl acrylate, 21 percent methyl methacrylate, 39 percent alpha methyl styrene, 39 percent acrylic acid, and 50 percent 2-ethylhexyl acrylate.
2. The finished co-polymers may contact all food types under Conditions of Use B through H as described in Table 2, and including contact with food during cooking (initial temperature covered by Conditions of Use A, but without extended shelf storage).

131

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

132

As a colorant in all types of food-contact polymers.

For use at levels not to exceed 0.025 percent by weight as a colorant in all types of food-contact polymers. The finished polymers are intended to contact all types of food under Conditions of Use B through H as described in Table 2. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.

133

The FCS will be used as a bleaching agent in the manufacture of food-contact paper and paperboard products complying with 21 CFR 176.170.

The FCS will be used at levels not to exceed 0.4 weight percent bis-1,2((N,N-diacetyl)amino-)ethane in pulp (on a dry weight basis). The finished food-contact articles may be used in contact with all types of food, and under Conditions of Use D through H as described in Table 2.

134

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.

None.

135

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.

The finished PET/I/N copolymers will incorporate not more than 2.5 mole percent (3.1 weight percent) of polymer units derived from ethylene 2,6-naphthalate.

137

As a scavenger for acetaldehyde in polyethylene terephthalate (PET) beverage bottles.

Anthranilamide is present in the finished container at levels not to exceed 500 mg/kg (ppm) in bottles used to hold water and at levels not to exceed 250 mg/kg (ppm) in bottles used for non-water, aqueous, acidic, and low-alcohol food applications.

140

As an antimicrobial agent for red meat carcasses.

The additive will be used in process water such that the level of peroxyacetic acid and hydrogen peroxide will not exceed the values specified in 21 CFR 173.370 (Peroxyacids): maximum concentration of peroxyacids is 220 mg/kg as peroxyacetic acid, and the maximum concentration of hydrogen peroxide is 75 mg/kg. Additionally, the maximum concentration of HEDP is 13 mg/kg.

141

As a component of matrix filter sheets, for removal of metals and sulfides in alcoholic beverages using repeat-usage filtering equipment.

1. The FCS may only be used in contact with food types VI-A and VI-C as identified in Table 1, under Conditions of Use E as described in Table 2.
2. The FCS is incorporated at a maximum level of 40 percent by weight of the filter sheet.

142

As a defoaming agent in the manufacture of food-contact paper and paperboard.

At levels not to exceed 0.009 percent by weight of the dry pulp. The finished food-contact article may be used in contact with all food types and under Conditions of Use A through H, as described in Table 2, under Conditions of Use E as described in Table 2.

143

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.

Maximum use level of 0.1 percent by weight of the finished polypropylene and polyethylene polymers and copolymers (as described) in contact with non-fatty food (food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII) under Conditions of Use B through H, as described in Tables 1 and 2, respectively. Maximum use level of 0.01 percent by weight of the finished polypropylene and polyethylene polymers and copolymers (as described) in contact with fatty food (food types III, IV-A, V, VI-C, VII-A, and IX) under Conditions of Use B through H, as described in Tables 1 and 2, respectively.

144

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.

5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt shall not exceed 20 mole percent of the diacid component of the polyester resins.

145

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.

The level of PMDA in finished articles and films manufactured from the subject modified polyesters may not exceed 0.1 weight percent. Such articles and films may be used in contact with aqueous, acidic and low-alcohol food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H, as described in Table 2. The finished PMDA modified polyesters must meet any specifications applicable to the unmodified polyester that is appropriate to its intended use. Adjuvant substances permitted for use in ethylene phthalate polymers complying with 21 CFR 177.1630, or ethylene naphthalate polymers complying with 21 CFR 177.1637 may be used in the pyromellitic dianhydride modified copolymers subject to any limitations in the regulation or notification authorizing the use of the adjuvant substance.

146

As articles or components of articles intended to contact food.

1. The finished polymers shall have no more than 100 mg/kg residual tertiary butyl alcohol. 2. The finished polymers, complying with all of the specifications of 21 CFR 177.1570(b)(1), may be used in contact with all types of food under Conditions of Use A through H, as described in Table 2. Such polymers shall yield maximum extractables not to exceed 0.8 percent by weight of the polymer when film samples 0.1 to 0.2 millimeters (0.004 to 0.008) in thickness are extracted for 6 hours with refluxing 95 percent ethanol in a soxhlet extractor. 3. The finished polymers, complying with the specifications of 21 CFR 177.1570(b)(1)(i) and (iii), may be used in contact with all types of food under Conditions of Use B through H, as described in Table 2, provided the polymers have an intrinsic viscosity less than 3.2 as determined by ASTM Method D1601-78, "Standard Test Method for Dilute Solution Viscosity of Ethylene Polymers"; a Brookfield viscosity at 176.6°C (350°F) greater than 10,000 centipoises as determined by ASTM Method D 1084-63 (Reapproved 1981), "Standard Test Methods for Viscosity of Adhesives"' and a melt index of 0.1 to 240 as determined by ASTM Method D1238-85, Condition E, "Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer." (In the event of a conflict between the melt index and viscosity measurements, which may occur with high melt index polymers, compliance will be determined by the Brookfield viscosity alone.) Such polymers shall yield maximum extractables not to exceed 2.0 percent by weight of the polymer when film samples 0.1 to 0.2 millimeters (0.004 to 0.008) in thickness are extracted for 6 hours with refluxing 95 percent ethanol in a soxhlet extractor.

147

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, ethylene naphthalate polymers complying with 21 CFR 177.1637.

The level of PBD in finished articles and films manufactured from the subject modified polyesters may not exceed 0.5 weight percent. Such articles and films may be used in contact with aqueous, acidic and low-alcohol food types I, II, IV-B, VI-A, VI-B, VII-B and VIII under Conditions of Use A through H, as described in Table 2. The finished polybutadienediol modified polyesters must meet any specifications applicable to the unmodified polyester that is appropriate to its intended use. Adjuvant substances permitted for use in ethylene phthalate polymers complying with 21 CFR 177.1630, or ethylene naphthalate polymers complying with 21 CFR 177.1637 may be used in the polybutadienediol modified copolymers subject to any limitations in the regulation or notification authorizing the use of the adjuvant substance.

148

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.

The finished homopolymers and copolymers will be used as components of adhesives complying with the provisions of 21 CFR 175.105 Adhesives in contact with all types of food at temperatures not to exceed 120°F and as components of paper and paperboard in contact with dry foods complying with the provisions of 21 CFR 176.180 Components of paper and paperboard in contact with dry foods at temperatures not to exceed 120°F.

150

As a colorant in paper and paperboard.

For use only as a colorant in paper and paperboard complying with 21 CFR 176.170 at a level not to exceed 200 g per ton of uncoated paper, in contact with all types of food under Conditions of Use E, F, and G as described in Table 2.

151

The FCS will be used as a modifier for polyethylene phthalate polymers prepared by the condensation of dimethyl terephthalate or terephthalatic acid and dimethyl isophthalate or isophthalic acid with ethylene glycol.

The finished copolymers will contain no more than 5 weight percent of polymer units derived from ethylene isophthalate and the level of pyromellitic dianhydride shall not exceed 0.5 percent by weight of the finished polymer. The finished copolymers shall comply with any applicable specifications in 21 CFR 177.1630 appropriate to their intended use. The finished copolymers are prepared by the condensation of dimethyl terephthalate or terephthalic acid, dimethyl isophthalate or isophthalic acid with ethylene glycol. The copolymers are to be used as the base sheet or base polymer for manufacturing articles and films intended to contact all food types. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the subject polymers subject to any limitations in the authorizing regulation.

155

The FCS will be used as an amorphous plasma-deposited silicon coating on the food-contact surface of polyethylene terephthalate (PET) food packaging articles.

The finished FCS will be used as a thin coating for PET articles complying with the provisions of applicable food additive regulations or FCNs, in contact with all types of food under Conditions of Use C through G, as described in Tables 1 and 2. The average thickness of the coating shall not exceed 440 angstroms and the maximum thickness of the coating shall not exceed 500 angstroms.

156

The CM ion exchange cellulose resin is used to isolate and purify soluble protein from aqueous process streams for food processing.

The temperature of water and food passing through the CM ion exchange cellulose resin should not exceed 40°C. The operating pH of the column is between a pH of 2 and 10. The columns should be washed and preconditioned prior to use according to the manufacturers specifications as described in detail in the notification.

157

The DEAE ion exchange resins are used to isolate and purify soluble proteins from aqueous process streams for food processing.

The temperature of water and food passing through the DEAE ion exchange cellulose resin (High and Medium Capacity) should not exceed 50°C. The operating pH of the columns are between a pH of 2 and 10. The columns should be washed and preconditioned prior to use according to the manufacturers specifications as described in detail in the notification.

161

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.

The labels or tapes may be applied to poultry, dry food, processed, frozen, dried, or partially dehydrated fruits and vegetables, raw fruits, and raw vegetables. The tapes and labels will be used at room temperature or below. The maximum use level for either of the two food contact substances is 47.5 percent by weight of the final adhesive formulation.

162

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.

The FCS may be used in polypropylene, including homopolymers and copolymers, at levels not to exceed 0.5 percent by weight; in low density polyethylene and linear low density polyethylene at levels not to exceed 0.2 percent by weight; in high density polyethylene, including homopolymers and copolymers, at levels not to exceed 0.3 percent by weight. The finished polymers may be used in contact with all food types under Conditions of Use B through H, as described in Table 2.

163

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.

The FCS is to be continuously added into the steam header to maintain a maximum concentration of 2 ppm in the steam. The FCS shall contain no more than 1 ppm and 10 ppm residual ethylene oxide and 1,4-dioxane, respectively, and must meet any applicable specifications prescribed in 21 CFR 173.310.

164

As an ultraviolet light absorber in polyethylene phthalate polymers.

For use only at levels not to exceed 0.5 percent by weight of polyethylene phthalate polymers complying with 21 CFR 177.1630. The finished polymers may be used in contact with all food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII, under Conditions of Use C through G, as described in Tables 1 and 2, respectively.

165

Component of repeated use food-contact articles.

The polyphenylene sulfide polymers are to be manufactured by the equimolar reaction of sodium sulfide and p-dichlorobenzene using the synthetic scheme described in the notification. The finished polymer has a melt temperature (T_m) of 272-283°C and an average molecular weight ranging from 25,000 to 100,000 Daltons. The polymer will be used under conditions of use A through H and in contact with all types of food.

166

As a component in blends with other polymers that are used in the manufacture of food-contact materials.

The finished resin has a minimum softening point of 110°C (230°F) as determined by ASTM Method E 28-67 (Reapproved 1982), "Standard Test Method for Softening Point by Ring-and-Ball Apparatus", and a minimum aniline point of 107°C (224.5°F) as determined by ASTM Method D 611-82, "Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydrocarbon Solvents." The resin may be blended with other polymers at levels not to exceed 25 percent by weight of the total polymer, used in contact with food types I, II, IV-B, VI-A, VI-B, VI-C, VII-B and VIII, identified in Table 1, under Conditions of Use A through H identified in Table 2.

168

As adjuvants in the bleaching of recycled paper and paperboard.

1. A mixture of MMDMH and DMDMH containing up to 8.5 percent dimethylhydantoin will be applied to process water during the bleaching of recycled paper at a maximum rate of 180 parts per million (ppm) combined hydantoins. 2. Recycled paper and paperboard manufactured with MMDMH and DMDMH containing up to 8.5 percent dimethylhydantoin can be used in contact with all types of food under Conditions of Use D through H , as described in Tables 1 and 2 respectively.

172

As an antioxidant and/or stabilizer for adhesives and polymers.

As an antioxidant and/or stabilizer in the following: 1) adhesives complying with 21 CFR 175.105, 2) pressure-sensitive adhesives complying with 21 CFR 175.125 at levels not to exceed 0.2 weight percent of the finished adhesive, and 3) ethylene-vinyl acetate copolymers complying with 21 CFR 177.1350 at levels not to exceed 0.02 weight percent of the ethylene-vinyl acetate in all types of food.

173

As a thickener for hand sanitizers intended for use in food service establishments.

The crosslinked polymers may be used at levels no greater than 0.5 percent in hand sanitizer formulations.

174

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.

The finished copolymers are intended to contact all types of food under Conditions of Use A through H , as described in Tables 1 and 2 respectively.

175

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.

The FCS will be used as a 40 percent aqueous solution added to the adhesives at a level of 1000 ppm (wet/wet). The maximum level of the FCS in paper towels (on average) will not exceed 10 nanograms/cm².

176

As an antioxidant and/or stabilizer for olefin polymers for use in contact with food.

The FCS will be used in the following olefin polymers that are intended to contact food under Conditions of Use A through H as described in Table 2, without limitation on the thickness of the food-contact article: 1. In low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), and polypropylene (PP), including homopolymers and copolymers, at levels not to exceed 0.2 percent by weight in contact with all food types. 2. In high-density polyethylene (HDPE), including homopolymers and copolymers, at levels not to exceed 0.12 percent by weight in contact with aqueous, acidic, and fatty foods, and at levels not to exceed 0.2 percent by weight in contact with alcoholic foods.

177

As an additive in the production of polypropylene complying with 21 CFR 177.1520 Olefin polymers.

The substance is used at a level not exceeding 2000 parts per million in polypropylene complying with 21 CFR 177.1520. The finished food-contact articles are films and molded articles that may be used in contact with all food types under Conditions of Use A through H as described in Table 2.

178

As components of articles intended to contact food.

The finished polymers are intended to contact all types of food under Conditions of Use B through H , as described in Table 2.

179

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.

The finished polymer shall meet the inherent viscosity specification in 21 CFR 177.1315(b)(1) and shall meet the following extractives specifications, based on the intended use, using the analytical method specified in 21 CFR 177.1315(c): (1) for use in contact with aqueous, acidic, and low alcohol (up to 13 percent by volume) foods under Conditions of Use C through G, the finished article shall meet the maximum extractable fractions as specified in 21 CFR 177.1315(b)(1) when tested with water and 3 percent acetic acid; (2) for use in contact with fatty foods under Conditions of Use C through G, the finished article shall meet the maximum extractable fractions as specified in 21 CFR 177.1315(b)(1) when tested with n-heptane. Dimethyl terephthalate may be used as an alternative reference standard; and (3) for use in contact with alcoholic foods containing more than 13 percent but not more than 25 percent by volume alcohol under Conditions of Use E through G, the maximum extractable fraction shall not exceed 2 micrograms per square inch when tested using 25 percent ethanol as described in 21 CFR 177.1315(b)(1). The above description does not affect the authorization of those compositions and uses currently permitted in 21 CFR 177.1315.

180

As an optical brightener in paper and paperboard.

The food contact substance is intended for use as an optical brightener in paper and paperboard complying with 21 CFR 176.170 in contact with all food types at levels not to exceed those needed to achieve the desired technical effect, except for the following: (a) when the substance is used in uncoated paper and paperboard intended for contact with food types I, II, IV-B, VI, and VII-B, as described in Table 1, the brightener is limited to use at levels not to exceed 0.5 pounds per ton of paper; (b) when the substance is used in clay coatings for paper and paperboard intended for use in contact with food types I, II, IV-B, VI, and VII-B, as described in Table 1; and (c) brightener is limited to use at levels not to exceed 0.25 pounds per ton of coated paper.

181

As a stabilizer for flexible polyvinyl chloride (PVC). The FCS is added to vinyl chloride monomer during the polymerization process.

For use as a stabilizer, at levels not to exceed 0.006 percent by weight of the flexible polyvinyl chloride film intended for use in contact with food types I, II, IV-B, VI-B, VII-B and VIII, under Conditions of Use A through H , as described in Tables 1 and 2 respectively. The maximum thickness of the film shall not exceed 1 mil.

182

For use as a retention aid employed prior to the sheet-forming operation in the manufacture of paper and paperboard.

For use at a level not to exceed 0.12 percent resin by weight of the finished dry paper or paperboard.

183

For use as a stabilizer for rubber articles complying with 21 CFR 177.2600 (Rubber articles intended for repeated use).

At levels not to exceed 0.5 percent by weight of the finished product. The FCS will be limited to use in conveyor belts at room temperature or below. The conveyor belts may contact foods of all types.

184

For use as a stabilizer in rubber articles intended for repeat use complying with 21 CFR 177.2600.

The FCS may be used in conveyor belts in contact with all food types at room temperature or below, at levels not to exceed 0.5 percent by weight the finished rubber product.

185

As a coating on the interior of polyethylene terephthalate (PET) bottles used in single-use food-contact applications.

The amorphous hydrogenated carbon coating is intended for use at a thickness not to exceed 0.04 microns (0.0016 mil) and may be used in contact with food types I through IX, under Conditions of Use B through H , as described in Tables 1 and 2.

186

As a nucleating agent in polypropylene and high density polyethylene, including homopolymers and copolymers, and in linear low density polyethylene polymers.

For use as a nucleating agent, at a maximum level of 0.25 weight percent in polypropylene and high density polyethylene polymers in contact with all food types, under Conditions of Use A through H , as described in Table 2, and at a maximum level of 0.25 weight percent in linear low density polyethylene polymers in contact with all food types, under Conditions of Use B through H , as described in Table 2.

187

As a water and oil repellent in the manufacture of paper and paperboard.

The FCS will be used in the manufacture of paper and paperboard, at a level not to exceed 1.5 percent by weight of the finished dry paper and paperboard. Paper containing the FCS may contact all food types under Conditions of Use B through H , as described in Tables 1 and 2 respectively.

189

As a clarifying agent for polypropylene homopolymers complying with 21 CFR 177.1520(c), items 1.1a and 1.1b.

For use at levels not to exceed 0.32 percent by weight of the finished polymer under Conditions of Use B through H as described in Table 2. The finished polymer may be used in contact with all food types.

190

As components of repeated-use food-contact articles.

Articles containing the finished copolymers may be used in contact with all types of food at room temperature or below. The copolymers shall have a weight average molecular weight of at least 72,000 daltons as determined by gel permeation chromatography.

191

As a component of a cork primer used to aid in the adherence of silicone coatings to wine bottle closures.

Not to exceed 9.22 percent by weight of a primer formulation that is applied at levels not exceeding 0.1 g primer per wine bottle closure.

192

As an antioxidant and/or stabilizer in rubber modified polystyrene.

Use level in rubber modified polystyrene is not to exceed 0.2 weight percent of the rubber modified polystyrene complying with 21 CFR 177.1640. The food contact substance will be used in food containers under Conditions of Use D, E, F, and G as described in Table 2. The food contact substance will be used in containers that contact food types: I, II, IV(B), VI(A,B,C), VII(B), and VIII as listed in Table 1.

193

The FCS will be used as an antimicrobial agent in all types of food-contact polymers.

The FCS will be used in contact with all types of foods at levels not to exceed 3.0 percent by weight of the finished polymers, in which the silver content of the FCS shall not exceed 0.55 percent by weight.

194

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.

For use at levels not to exceed 0.2 percent by weight of the finished polymer intended to contact all food types under Conditions of Use A through H, as described in Table 2.

195

As a water and oil repellent in the manufacture of paper and paperboard.

For use at levels not to exceed 1.5 percent by weight of finished dry paper or paperboard in contact with all food types, under Conditions of Use C through H, as described in Table 2.

196

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.

The FCS will be used at a level not to exceed 1.22 percent by weight of a primer formulation that is applied at levels not exceeding 0.1 g primer per wine bottle closure.

197

As coatings on cellophane film.

The polymers may be applied at a maximum weight of 0.52 mg/in² on cellophane films used in contact with aqueous, acidic, low alcohol (up to 15 percent alcohol), and dry foods under Conditions of Use E through G, as described in Table 2.

198

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.

1. The copolymer will be used at levels up to 0.002 percent by weight of the PET polymer in contact with all food types under all conditions of use, including dual-ovenable applications. 2. The finished copolymer contains no more than 3 mole percent of the acid-based monomeric units derived from 1,3-dimethyl-5-sulfo-1,3-benzenedicarboxylate, sodium salt (CAS Reg. No. 3965-55-7)

199

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.

The FCS may be used in contact with all food types as described in Table 1.

200

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.

The level of pyromellitic dianhydride in finished articles and films shall not exceed 0.05 percent by weight of the finished polymer. The modified polymers arer intended for use in the manufacture of containers for single serve or repeated use at temperatures up to and including Conditions of Use A through H as described in Table 2. Such articles and films may be used in contact with aqueous, acidic and low-alcohol food types I, II, IV-B, VI-A, VI-B, VII-B and VIII. The finished pyromellitic dianhydride-modified polyesters must meet any specifications applicable to the unmodified polyester that are appropriate to their intended use. Adjuvant substances permitted for use in ethylene phthalate polymers complying with 21 CFR 177.1630, or ethylene naphthalate polymers complying with 21 CFR 177.1637 may be used in the pyromellitic dianhydride-modified copolymers.

201

As an antioxidant synergist in natural or synthetic rubber gloves intended for repeat use in the meat packing industry.

Used in equal amounts with the primary currently regulated antioxidant, at no greater than 1 percent by weight of the rubber gloves.

202

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.

Maximum use level of 0.18 percent by weight of the finished polypropylene polymers and copolymers (as described above) in contact with alcoholic and fatty food (Food Types III, IVA, V, VIA, VIC, VIIA and IX) under Conditions of Use B through H, as described in Tables 1 and 2, respectively.

203

As a secondary stabilizer in the suspension polymerization of polyvinyl chloride.

At a level not exceed 0.1 percent by weight of the starting vinyl chloride monomer used in the manufacture of polyvinyl chloride films. The films will have a maximum thickness of 0.25 mm and will be used only in single-use applications.

204

The FCS will be used as a stabilizer in polypropylene and olefin copolymers for use in food containers.

1) The FCS will be used at levels not to exceed 0.1 percent by weight of polypropylene and olefin copolymers complying with 21 CFR 177.1520(c), items 1.1, 3.1, and 3.2. 2) The FCS will be used in contact with aqueous and acidic food types I, II, IV(B), VI(B), VII(B), and VIII as listed in Table 1 under Conditions of Use B through H as described in Table 2. 3) The FCS will be used in contact with alcoholic and fatty food types III, IV(A), V, VI(A and C), VII(A) and IX as listed in Table 1 under Conditions of Use C through G as described in Table 2.

206

The FCS will be used as an oil and grease-resistant treatment for paper and paperboard intended for food-contact use.

The finished FCS will be used in contact with all types of food under Conditions of Use B through H as described in Table 2. The FCS will be used at levels not to exceed 0.18 weight percent fluorine (0.33 weight percent of the FCS) based on the weight of paper.

208

As a stabilizer in the suspension polymerization of polyvinyl chloride (PVC).

At a level not to exceed 0.1 percent by weight of the vinyl chloride monomer in single use PVC articles of a thickness not to exceed 0.25 mm (10 Mil).

211

As a monomer in the manufacture of ethylene terephthalate-isophthalate copolymers.

The finished copolymers must contain from 3 to 17 weight percent ethylene isophthalate units. The finished copolymers must also meet specifications as described in 21 CFR 177.1630(f)-(j) appropriate to their intended use. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the finished copolymers subject to any limitations in the authorizing regulation.

212

The FCS will be used as an ultraviolet-stabilizer for polyvinyl chloride (PVC).

The FCS will be used in single-use unplasticized PVC articles at a level not to exceed 0.3 percent by weight of the unplasticized PVC material in contact with aqueous, acidic, low alcoholic, fatty and dry foods for storage at room temperature without thermal treatment in the container.

215

(1) The polymer is produced by the transesterification of ethylene-methyl acrylate copolymer complying with 21 CFR 177.1340 with cyclohexenyl methanol (CAS Reg. No. 1679-51-2). (2) The polymer shall contain a minimum of 65 weight percent ethylene, no more than 28 weight percent cyclohexenylmethyl acrylate, with the remainder being methyl acrylate units. (3) The layer containing the polymer may contain up to 0.1 percent benzolylated triphenylbenzene (CAS Reg. No. 227099-60-7). For use only: (1) As a component of articles in contact with dry food containing no surface fat or oil (i.e., food type VIII as described in Table 1). (2) As a non-food contact layer of laminate structures. The multi-layer articles shall be flexible films, containers made of paper and paperboard, or rigid containers, except for bottles consisting primarily of polyethylene phthalate polymers complying with 21 CFR 177.1630, 177.1315, or effective food contact substance notifications or bottles consisting primarily of polyethylene complying with 21 CFR 177.1520 having a density greater than 0.94 grams per cubic centimeter. The food-contact substance will be separated from the food by one or more polymeric layers permitted for this use that have a total thickness no less than 0.25 mil (0.00025 in): (a) aqueous, acidic and low alcohol-content food (food types I, II, IV-B, VI-A, VI-B, VII-B, as described in Table 1), under Conditions of Use C through G, as described in Table 2, provided that the FCS layer does not exceed 1.5 mil (0.0015 inch) in thickness. (b) fatty and high alcohol-content food (food types III, IV-A, V, VI-C, VII-A, and IX, as described in Table 1), under Conditions of Use E through G, as described in Table 2, provided that the FCS layer does not exceed 0.75 mil (0.00075 inch) in thickness.

217

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.

For use at levels not to exceed 0.3 percent by weight of the PVC and at levels not to exceed 0.5 percent by weight of the PET polymers and copolymers in contact with food types I through IX, as discussed in Table 1, except beverages containing more than 15 percent ethanol, under Conditions of Use E through G, as described in Table 2.

220

The FCS will be used as an antiblocking agent in linear low-density polyethylene (LLDPE) copolymers intended for food-contact applications.

The finished FCS will be used at levels not to exceed 2.0 percent by weight of ethylene copolymers complying with 21 CFR 177.1520(c), items 3.1, 3.2(a), and 3.2(b), and having a density of less than 0.94 g/cm³. The finished copolymers may be used in contact with all types of food as identified in Table 1 under Conditions of Use D through G as described in Table 2.

221

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.

(1) The subject methylhydantoins may be used as intended, at a combined level not to exceed 1100 mg/kg in the mineral slurry. (2) Paper and paperboard manufactured with the FCS may be used in contact with all types of food under Conditions of Use A through H as described in Tables 1 and 2, respectively.

222

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.

As a component of polystyrene and rubber modified polystyrene as provided in 21 CFR 177.1640(a)(2). The finished rubber modified polystyrene food contact articles will not contain more than 8 weight percent polybutadiene and be no thicker than 0.07 cm. The residual level of 1,5-Cyclooctadiene in the polybutadiene will not exceed 250 ppm.

224

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.

The FCS will be used at a level not to exceed 10 percent by weight of the finished plasticized vinyl chloride polymer formulation and will be used at temperatures not to exceed 40°C.

228

As a filler for silicone elastomers complying with 21 CFR 177.2600.

For use at levels between 33 and 50 percent by weight of the silicone elastomer.

229

As an antioxidant in non-plasticized polyvinyl chloride polymers.

For use at a level not to exceed 1.0 percent by weight in non-plasticized polyvinyl chloride polymers in contact with all food types, under Conditions of Use B through H, as described in Table 2.

231

For use as components of printing inks and coatings that are applied to polyolefin films intended for contact with food.

The styrene-acrylic copolymers are produced by the polymerization of the following monomers in various combinations with the maximum use levels as noted: 100 percent styrene, 48 percent butyl acrylate, 21 percent methyl methacrylate, 39 percent alpha methyl styrene, 39 percent acrylic acid, and 50 percent 2-ethylhexyl acrylate. The finished copolymers may contact all food types under Conditions of Use B through H as described in Table 2 and including contact with food during cooking (initial temperature covered by Conditions of Use A, but without extended shelf storage).

232

As a stabilizer in olefin polymers.
REPLACES FCN 51

1) At levels not to exceed 0.5 percent by weight of olefin polymers complying with 21 CFR 177.1520(c). The finished polymers may only be used in contact with food types I, II, IV-B, VI-A, VI-B, VII-B and VIII identified in Table 1, under Condition of Use A as described in

Inventory of Effective Food Contact Substance Notifications Limitations, Specifications, and Use

Inventory of Effective
Food Contact Substance Notifications
Limitations, Specifications, and Use