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CFSAN/Office of Food Additive Safety
December 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 Table 2. 2) At levels not to exceed 0.1 percent by weight of high density ethylene polymers and copolymers complying with 21 CFR 177.1520(c). The finished polymers may be used in contact with food types III, IV-A, V, VI-C, VII-A and IX identified in Table 1, under Condition of Use B as described in Table 2. Provided, that the finished food contact articles have a volume of at least 18.9 liters(5 gallons). 3) At levels not to exceed 0.1 percent by weight of linear low density ethylene polymers and copolymers complying with 21 CFR 177.1520(c). The finished polymers may be used in contact with food types III, IV-A, V, VI-C, VII-A and IX identified in Table 1, under Conditions of Use B through H as described in Table 2. The finished polymers containing the process stabilizer may be used alone or mixed with low density ethylene polymers and copolymers and used in accordance with the limitations in 21 CFR 178.2010(b), under item 4 for the FCS.

233

As a component of pigment dispersants coating the surface of paper and paperboard.

For use at levels not to exceed 1 percent by weight of pigment. The FCS will contact all food types, as discussed in Table 1, under Conditions of Use C through G, as described in Table 2.

234

As a stabilizer in PET (polyethylene terephthalate) polymers.

The food contact substance (FCS) is intended to be used as a stabilizer at levels not to exceed 0.20 weight percent of polyethylene terephthalate (complying with 177.1630). The FCS may be used in contact with aqueous and acidic food types I, II, IV(B), VI(B), VII(B) and VIII under Conditions of Use B through H and with alcoholic and fatty food types III, IV(A), V, VI(A and C), VII(A) and IX under Conditions of Use C through G as described in Tables 1 and 2.

235

As a pigment for all polyolefins for food contact applications.

This pigment is limited to use levels not to exceed 0.5 percent by weight of the polymer, and is subject to limitations and specifications in 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.

236

As a component of repeated-use articles in contact with all food types, under Conditions of Use A through H, as described in Table 2.

The polymer will have a dilute solution viscosity of at least 0.83 using differential viscometry.

237

As a pigment dispersant for use in all types of food-contact polymers.

For use at levels not to exceed 0.05 percent by weight 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 Tables 1 and 2, respectively. Use of the FCS in polymers is subject to the provisions and definitions set forth in 21 CFR 178.3297.

238

The FCS will be used as a component of adhesives complying with 21 CFR 175.105 Adhesives and with 21 CFR 177.1390 Laminate structures for use at temperatures of 250°F and above, paragraph (c)(2)(ii).

When used in compliance with 21 CFR 177.1390(c)(2)(ii), the required functional barrier must be aluminum foil.

239

The FCS will be used as an acetaldehyde scavenger in polyethylene phthalate (PET) water bottles.

(1) The FCS will be used in polyethylene phthalate (PET) water bottles at levels not to exceed 0.25 percent by weight of the polyethylene phthalate. (2) Tne finished polymer may be used in contact with nonacid food Type I as listed in Table 1 under Conditions of Use C through G as described in Table 2.

244

For use as a component of latex coatings for paper and paperboard in contact with all food types, complying with 21 CFR 176.170(b)(2).

The SBA latex copolymers shall contain no more than 100 ppm styrene and no more than 200 ppm 4-vinylcyclohexene in the wet latex.

245

In the fabrication of molded parts for food processing equipment, such as o-rings, gaskets, diaphragms and other materials, that function primarily in sealing applications.

The perfluorocarbon base polymer shall contain no less than 50 weight percent of polymer units derived from tetrafluoroethylene, no less than 40 weight percent of polymer units derived from perfluoromethyl vinyl ether and no more than 4 weight percent of polymer units derived from perfluoro-6,6-dihydro-6-iodo-3-oxa-1-hexene. The uncured elastomer shall be composed of no more than 6 weight percent of triallylisocyanurate, no more than 5 weight percent of 2,5-dimethyl-2,5-di(t-butylperoxy)hexane, and no more than 9 weight percent carbon black (produced by the furnace combustion process) (CAS Reg. No. 1333-86-4). The PCE must meet extractive limitations prescribed in 21 CFR 177.2400(d) Perfluorocarbon cured elastomers.

246

In the fabrication of molded parts for food processing equipment, such as o-rings, gaskets, diaphragms and other materials, that function primarily in sealing applications.

The fluorocarbon base polymer shall contain no less than 65 weight percent of polymer units derived from tetrafluoroethylene and no less than 25 weight percent of polymer units derived from propylene. The uncured elastomer shall be composed of no more than 6 weight percent of triallylisocyanurate and no more than 5 weight percent of 2,2'-bis(t-butylperoxy)diisopropylbenzene, and no more than 15 weight percent carbon black (produced by the furnace combustion process) (CAS Reg. No. 1333-86-4). The PCE must comply with the provisions of 21 CFR 177.2600(d) and (g) and the extractive limitations prescribed in 21 CFR 177.2600(e) and (f), and 21 CFR 177.2400(d)(2).

247

In the fabrication of molded parts for food processing equipment, such as o-rings, gaskets, diaphragms and other materials, that function being primarily in sealing applications.

The perfluorocarbon base polymer shall contain no less than 30 weight percent of polymer units derived from tetrafluoroethylene, no less than 60 weight percent of polymer units derived from perfluoro-2,5-dimethyl-3,6-dioxanonane vinyl ether and no more than 4 weight percent of polymer units derived from perfluoro-6,6-dihydro-6-iodo-3-oxa-1-hexene. The uncured elastomer shall be composed of no more than 6 weight percent of triallylisocyanurate, no more than 5 weight percent of 2,5-dimethyl-2,5-di(t-butylperoxy)hexane, and no more than 12 weight percent carbon black (produced by the furnace combustion process) (CAS Reg. No. 1333-86-4). The PCE must meet extractive limitations prescribed in 21 CFR 177.2400(d) Perfluorocarbon cured elastomers.

248

The food contact substance (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 food at levels not to exceed 3.0 percent by weight of the finished polymers. The silver content of the FCS shall not exceed 0.57 percent by weight.

250

For use only as strengthening agents, fixing agents, or retention aids prior to the sheet-forming operation in the manufacture of paper and paperboard.

For use at a level not to exceed 1.5 percent resin by weight of the finished dry paper or paperboard.

251

a) ethylene phthalate polymers complying with 21 CFR 177.1630(e)(4)(i) and 177.1630(e)(4)(ii), items 2 and 3; b) ethylene phthalate polymers complying with FCN numbers 000004 and 000085; c) ethylene phthalate-naphthalate polymers complying with FCN numbers 000008, 000009, and 000135; d) poly(oxy-1,2-ethanediyloxycarbonyl-2, 6-naphthalanedicarbonyl) resins complying with 21 CFR 177.1637 and FCN No. 000009; and e) ethylene phthalate polymers and copolymers modified with pyromellitic dianhydride according to FCN numbers 000010, 000145, 000151, and 000200.

The FCS will be used at a level not to exceed 5 weight percent of the finished food-contact article. The modified polymers may be used in the manufacture of containers for single-serve use under Conditions of Use C through G, as described in Table 2, and in contact with food types I, II, VI-A, VI-B, as described in Table 1.

253

For use as a component of fluid absorbent pads in contact with meat, poultry, fish and produce.

The finished article containing the FCS will be used in contact with: 1) meat, poultry, or fish at refrigerated temperatures or below (under Conditions of Use F through G, as described in Table 2) and 2) produce at room temperature or below (under Conditions of Use E through G, as described in Table 2).

254

For use in treating water and aqueous food only of the types identified under categories I, II, and VI-B in Table 1.

a) The temperature of the water or food passing through the FCS must be maintained at 50°C or less, and the flow rate of the water or food passing through the FCS must not be less than 0.5 gallon per cubic foot per minute; or b) Extracts of the FCS will be found to contain no more than 1 mg/kg dimethylaminopropylamine in each of the food simulants, distilled water and 10 percent ethanol, when, following washing and pretreatment of the resin in accordance with 21 CFR 173.25 (Ion- exchange resins)(c)(1), the resin is subjected to the test described in 21 CFR 173.25(b)(2)(ii)(B).

255

The FCS will be used as an oil repellent sizing agent in the production of paper and paperboard.

The FCS may be used at the wet-end (internal) or applied to the surface of paper (external), at levels not to exceed 0.55 percent actives by weight (equivalent to 0.33 percent fluoride) of finished paper and paperboard, where the paper or paperboard has a sheet basis weight of up to approximately 300 pounds per 3000 square feet. The FCS may contact all food types under Conditions of Use B through H as described in Tables 1 and 2, respectively.

256

For use as a cross-linking agent for polyester coatings on metal substrates for contact with food.

The FCS will be used at up to 6 percent by weight of the polyester. The finished coatings are intended for use in contact with all food types under Conditions of Use E through G, as described in 21 CFR 175.300(d), Table 2.

257

The food contact substance (FCS) will be used as an emulsifier in the production of acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard that contact aqueous and fatty foods.

The FCS will be used at a level not to exceed 2.0 percent by weight of the 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.

259

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

For use at levels not to exceed 2 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 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.

260

As a processing additive for polyolefins for use in contact with food.

The FCS may be used at levels up to 2000 parts per million (ppm) in food-contact polyolefins. The FCS may be used in contact with all food types, as described in Table 1 under Conditions of Use B through H, as described in Table 2. 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.

262

As a non-food-contact layer of a co-extruded multilayer film in accordance with the uses permitted for nylon 6/69 resins as set forth in 21 CFR 177.1395.

1) The FCS may be used in contact with all food types indentified in Table 1, except alcoholic foods, under Conditions of Use B through H as described in Table 2. 2) The resin shall meet the specifications set forth in 21 CFR 177.1500(b), item 14, except that the maximum extractable fraction in water may be up to 6 percent by weight of the resin. Laminate structures employing the resin shall meet the extractive limitations for nylon 6/69 resins in accordance with 21 CFR 177.1395.

263

As a surface modifier for all pigments in all polymers.

For use at levels not to exceed 0.015 percent by weight of the finished polymer under Conditions of Use A through H as described in Table 2. The finished polymer may be used in contact with all food types.

267

As a debonding agent in uncoated food-contact paper and paperboard at levels up to 0.25 percent by weight of the dry paper and paperboard.

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

268

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.

1) The FCS will be used at maximum level of 0.2 percent by weight of the finished copolymer. 2) The finished copolymers are intended to contact food types I, II, III, IV-B, VI, VII, VIII, and IX, under Conditions of Use A through H as described in Tables 1 and 2 respectively.

270

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

The FCS will be used in polyners at levels not to exceed 1.8 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.

273

For use as a wet-end sizing additive in the manufacture of paper and paperboard for contact with dry food.

The polymeric material is intended for use in the manufacture of paper and paperboard at a use level not to exceed 0.033 percent of the finished paper or paperboard on a dry weight basis.

274

As a colorant for all food-contact polymers.

This colorant is limited to use levels not to exceed 2 percent by weight of the polymer and subject to the limitations and specifications in 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.

275

The food contact substance (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 food at levels not to exceed 2.25 percent by weight of the finished polymers. The silver content of the FCS shall not exceed 1.77 percent by weight.

276

The FCS will be used as a wet-strength agent in uncoated containerboard.

The FCS may be used at levels up to 0.5 percent by weight of dry containerboard, as described in the FCN, in contact with all food types as described in Table 1 under Conditions of Use B through H of Table 2.

277

The FCS will be used as an ultraviolet (UV) stabilizer for all polymers intended for single and repeat use in contact with food.

The FCS will be used at levels up to 0.5 percent by weight of the polymer in contact with all food types identified in Table 1 and under Conditions of Use E through G, of Table 2, except beverages containing more than 15 percent ethanol.

278

REPLACED BY FCN 573

279

As a stabilizer in propylene homopolymers and copolymers.

The food contact substance (FCS) is intended to be used as a stabilizer at levels not to exceed 0.12 weight percent of propylene homopolymers and copolymers complying with 21 CFR 177.1520(c), items 1.1, 3.1, 3.2a and b. The FCS may be used in contact with alcoholic and fatty food types, III, IV(A), V, VI(A), VI(C), VII(A) and IX under Conditions of Use B and H as described in Tables 1 and 2.

280

The FCS will be used as a component of food contact articles intended to contact aqueous and fatty foods and alcoholic foods containing up to 15 percent ethanol by volume. Food-contact articles prepared from the FCS are intended for use under Conditions of Use C (see limitations on hot-fill temperature, below) through G as described in Table 2.

1. The sum of 1,4-cyclohexanedimethanol and diethylene glycol shall not exceed 35 mole percent of the total glycol component and diethylene glycol not to exceed 12 mole percent of the total glycol component. 2. The finished polymer shall meet the inherent viscosity specification in 21 CFR 177.1315(b)(1). 3. The copolymer may not be used as the base resin for single-use beverage bottles. 4. The copolymer may be used at hot fill temperature not to exceed 75°C.

282

As a pigment dispersant for titanium dioxide that is used as a filler in the manufacture of food-contact paper and paperboard.

For use in titanium dioxide at levels not to exceed 1 percent by weight of titanium dioxide in the paper and paperboard. The FCS will be used in single use food contact items. The FCS will contact all food types, as discussed in Table 1, under Conditions of Use C and G, as described in Table 2.

283

For use as an absorptive medium in absorbent pads employed in the packaging of refrigerated cubed tomatoes, refrigerated fresh-cut fruits and vegetables, refrigerated whole berries, and refrigerated or frozen fish fillets.

1) The finished FCS will be used in the manufacture of food-contact articles and the quantity used shall not exceed the least amount reasonably required to accomplish the intended effect. 2) The FCS will be used in contact with the foods identified above, under Conditions of Use F and G, as described in Table 2.

284

For use as a retention aid and/or drainage aid and/or dry-strength agent employed prior to the sheet forming operation in the manufacture of only recycled, food-contact paperboard at a maximum level of 1 percent by weight of the dry pulp.

The modified industrial starch must be used in compliance with 21 CFR 178.3520(a)(1), (b) and (c). The finished recycled paperboard may be used only under Conditions of Use A through H identified in Table 2.

285

2-Oxepanone, polymer with 1,4-butanediol is intended for use as a processing aid in all polyolefins for single and repeat use food-contact applications.

2-Oxepanone, polymer with 1,4-butanediol is intended for use at levels not to exceed 0.1 percent of the finished polymer. The copolymer is intended to contact all food types under conditions of Use A through H as described under Tables 1 and 2 depending on the clearance of the base polyolefin used to manufacture the food-contact article.

286

As an antimicrobial agent for preservation of latex emulsions destined for use in latex gloves intended to contact all types of food.

At a level not to exceed 250 ppm (based on 2-methyl-4-isothiazolin-3-one) in latex emulsion.

288

As a antioxidant in plasticized polyvinyl chloride polymers.

This antioxidant is limited for use at levels not to exceed 1 percent by weight of the finished plasticized polyvinyl chloride polymers in contact with all food types under Conditions of Use B through H, as described in Table 2.

289

The FCS will be used as a processing aid in the production of olefin polymers complying with the provisions 21 CFR 177.1520.

The FCS will be used as a component of olefin polymers in contact with all types of food, at a level not to exceed 0.1 weight percent, and under Conditions of Use B through H as described in Table 2

290

For use as an ion exchange resin to remove cationic substances from skim milk in order to manufacture milk protein concentrate (MPC).

The temperature of aqueous milk solutions passing through the FCS must be maintained at 20°C or less. The flow of the aqueous milk solutions passing through the FCS must not be less than 140 kg per liter resin, and the contact time must be less than 10 minutes.
The resin must be washed and preconditioned prior to use as follows:
1. Pre-washing of the resin prior to the first loading of the milk solution
  1. With water (60°C) at ≥ 20 kg/L of the resin.
  2. With 1.0-1.5 mol/L sodium chloride solution (10°C) at ≥ 5 kg/L of the resin.
  3. With water at (50°C) at ≥ 10 kg/L of the resin.
2. Washing of the resin after loading of the milk solution
  1. With water (10°C) at > 5 kg/L of the resin.
  2. With 1.0-1.5 mol/L sodium chloride solution (10°C) at > 5 kg/L of the resin.
  3. With water at (50°C) at > 10 kg/L of the resin.
  4. With 0.1 mol/L sodium hydroxide solution (40°C) at > 3 kg/L of the resin.
  5. With water (40°C) at > 4 kg/L of the resin.
  6. With 0.5 mol/L hydrochloric acid solution (40°C) at > 2 kg/L of the resin.
  7. With water (40°C) at > 2 kg/L of the resin.
  8. With 1.0 mol/L sodium chloride solution (40°C) at > 2 kg/L of the resin.
  9. With water (10-40°C) at > 22 kg/L of the resin.
The resin may not be used to process MPC for use in infant formula.

292

As a component of filter media, for removal of metals and sulfides in alcohol 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 media.

293

As a colorant in all food-contact polymers.

The FCS is used at levels not to exceed 0.5 percent by weight of all polymers in contact with all food types under Conditions of Use A through H.

294

As a dispersing agent for silver-magnesium-sodium-boron-phosphate-glasses in the manufacture of food-contact polymers.

The FCS will be used at levels not to exceed 0.75 percent by weight of the finished polymer.

295

As a component of an antimicrobial formulation for use on poultry carcasses, poultry parts, and whole and cut raw fruits and vegetables.

The ready-to-use concentration of hydrogen peroxide should not exceed 0.1 weight percent of the total formulation.

296

As a component of an antimicrobial formulation for use on poultry carcasses, poultry parts, and whole and cut raw fruits and vegetables.

The ready-to-use concentration of silver nitrate should not exceed 1.1 ppm of the total formulation.

297

The FCS will be used as a component of ceramic surface coating for repeat-use food processing and food packaging equipment.

The FCS will be used under Conditions of Use A through H as described in Table 2 and in contact with all types of food. The maximum thickness of the surface coating shall not exceed 5 micrometers.

298

The FCS will be used as a component of ceramic surface coating for repeat-use food processing and food packaging equipment.

The FCS will be used under Conditions of Use A through H as described in Table 2 and in contact with all types of food. The maximum thickness of the surface coating shall not exceed 5 micrometers.

299

The FCS will be used as components of repeat-use food processing and food packaging equipment as a double layered ceramic coating consisting of a functional tungsten carbide/carbon layer and an interface chromium layer.

The FCS will be used in contact with all food types under Conditions of Use A through H, as described in Table 2. The maximum thickness of the functional tungsten carbide/carbon layer shall not exceed 2 micrometers and the maximum thickness of the chromium interface layer shall not exceed 1 micrometer.

300

The FCS will be used as a component of ceramic surface coating on repeat-use food processing and food packaging equipment.

The FCS will be used under Conditions of Use A through H as described in Table 2 and in contact with all types of food. The maximum thickness of the surface coating shall not exceed 10 micrometers.

301

The FCS will be used as components of repeat-use food processing and food packaging equipment as a double layered ceramic coating consisting of a functional diamond-like carbon layer and an interface chromium layer.

The FCS will be used in contact with all food types under Conditions of Use A through H, as described in Table 2. The maximum thickness of the functional diamond-like layer shall not exceed 2 micrometers and the maximum thickness of the chromium interface layer shall not exceed 1 micrometer.

302

The FCS will be used as components of ceramic surface coating on repeat-use food processing and food packaging equipment.

The FCS will be used under Conditions of Use A through H as described in Table 2 and in contact with all types of food. The maximum thickness of the surface coating shall not exceed 5 micrometers.

303

As defoamers, at levels up to 40 grams per metric ton of dry pulp (0.004 percent), in the pulping of lignocellulosic materials used to make food-contact paper and paperboard.

The FCS may be used in contact with all food types as described in Table 2.

307

For use as a pigment dispersant in food-contact articles.

For use, at levels not to exceed 0.35 percent by weight of the pigment. The pigmented articles may contact all food types, as discussed in Table 1, under Conditions of Use A through H, as described in Table 2.

308

The FCS will be used as a stabilizer for hypohalite slimicides used in the manufacture of food-contact paper and paperboard.

The FCS will be used at a level not to exceed 0.5 g DMH per kg of dry fiber.

310

For use as an antioxidant/stabilizer in olefin polymers and copolymers.

For use 1) at levels not to exceed 0.1 percent by weight in all polyolefins listed in 21 CFR 177.1520 in contact with aqueous, acidic and low-alcohol foods (i.e. 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 0.03 percent by weight in polypropylene homopolymers listed in 21 CFR 177.1520 for fatty and high-alcohol foods (i.e. food types III, IV-A, V, VI-C, VII-A, IX), under Conditions of Use A through H, as described in Tables 1 and 2, respectively; and 3) at levels not to exceed 0.0062 mg/in² in low density polyethylene polymers and linear low density polyethylene polymers and copolymers listed in 21 CFR 177.1520 where the average polymer thickness may be ≥ 50 um (2 mils) in contact with fatty and high-alcohol foods (i.e. food types III, IV-A, V, VI-C, VII-A, IX) under Conditions of Use A through H, as described in Tables 1 and 2, respectively.

311

For use as an oil or grease resistant treatment for paper and paperboard intended for single service use in microwave heat-susceptor packaging; the food-contact substance is intended to contact all food types.

The maximum level of the food-contact substance (FCS) will not exceed 0.18 weight percent of fluorine based on the weight of the paper. This level corresponds to 0.33 weight percent of the FCS based on the weight of the paper.

312

For use as a modifier of polyethylene phthalate polymers. The finished polymer may contact all food types under the Conditions of Use B or the Conditions of Use permitted for the compliant polymers, whichever is less severe.

For use at levels not exceeding 0.1 mole percent of the total alcoholic reactants used in the manufacture of polyethylene phthalate polymers complying with 21 CFR 177.1630 or applicable Food Contact Notifications (FCN).

314

As an oil/grease resistant sizing agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard for single use applications.

The FCS may be used at a level not to exceed 0.5 percent by weight of the dry paper and paperboard intended for use in contact with all food types (I-IX), under Conditions of Use B through H as described in Tables 1 and 2, respectively. 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.

315

As a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in poultry and meat processing plants.

For use at levels not to exceed 0.05 percent by weight of the latex solids.

316

For use as a stabilizer in polyolefin polymers and copolymers.

For use (1) at a maximum level of 0.12 percent in polyolefin, repeat-use, food-contact articles with no temperature limitation, (2) at a maximum level of 0.12 percent in high-density polyethylene (HDPE) under Conditions of Use B through H as described in Table 2, and (3) at a maximum level of 0.12 percent in polypropylene (PP) and PP copolymers under Conditions of Use B through H. The finished food-contact articles may contact all food types.

320

For the removal of heavy metal ions and sulfides from alcoholic beverages, including beer and wine.

The polymer is intended to be added directly to alcoholic beverages during the maturation process at levels not to exceed 80 grams per 100 liters of beverage. The polymer is to be completely removed from the beverage by filtration and is limited to single use applications.

321

As an article or component of articles intended to contact food.

The FCS may contact food types I, II, IVB, VIA, VIB and VIII under Conditions of Use A through H as described in Tables 1 and 2, and all other food types under Conditions of Use D through G, as described in Tables 1 and 2. The FCS may include adjuvant substances permitted for use in styrene block polymers in accordance with applicable food additive regulations and effective notifications.

323

The FCS will be used as an antimicrobial agent for meat and poultry carcasses.

The FCS will be added to (1) process water used for washing, rinsing, cooling or otherwise for processing meat carcasses, parts, trim, and organs; and (2) process water applied to poultry parts, organs, and carcasses as a spray, wash, rinse, dip, chiller water, or scald water. In either application, the level of peroxyacetic acid will not exceed 230 ppm, hydrogen peroxide will not exceed 165 ppm, and HEDP will not exceed 14.0 ppm.

324

For use as a polymerization control agent in styrene-butadiene latex coatings for food-contact paper and paperboard.

The finished paper and paperboard may contact all food types under Conditions of Use E through G, as specified in Tables 1 and 2. The level of the FCS may not exceed 12 µg/in² in finished food-contact paper and paperboard.

325

For repeated use as an ion exchange resin to absorb and purify enzymes and other proteins from sweet whey, nonfat milk, and milk at temperatures of 15°C or less.

I. The temperature of the sweet whey or milk passing through the FCS must be maintained at 15°C or less. The flow of the whey or milk passing through the FCS for each cycle must not be less than 100 volumes per volume of resin, and the contact time must be less than 8 hours. II. The FCS must be washed and preconditioned prior to use and after each cycle as described in detail in the notification.

326

The FCS will be used as a processing aid in rinse-aid products used in commercial dishwashing machines.

The FCS will be used at a concentration not to exceed 3.36 ppm in the final rinse water of commercial dishwashing machines.

327

As a diluent in defoamers used in the pulping of lignocellulosic materials that will be used to make food-contact paper and paperboard.

For use at levels not to exceed 8 grams per metric ton of dry pulp (0.0008 percent). The FCS may be used in contact with all food types as described in Table 1. The FCS may also be used in accordance with food additive regulations and effective notifications which incorporate by reference materials cleared in 21 CFR 176.210.

328

As an antioxidant and/or stabilizer in adhesives.

As an antioxidant and/or stabilizer in: 1) adhesives complying with the limitations of 21 CFR 175.105, paragraph (a)(2), in contact with all food types at temperatures not to exceed 120°F.
2) pressure-sensitive adhesives, at levels not to exceed 0.5 percent by weight of the finished adhesive, used as the food contact surface of labels and/or tapes applied to poultry, dry food and processed, frozen, dried or partially dehydrated fruits and vegetables as well as raw fruits and vegetables under Conditions of Use E through G (room temperature or below), as described in Table 2

329

To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles.

The maximum thickness of the double layered coating shall not exceed 100 nm. The coating may contact all food types, as described in Table 1, under Conditions of Use A through H, as described in Table 2 .

330

As a colorant for 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 500 g per metric ton of uncoated paper or 1000 g food contact substance per metric ton dry coating, in contact with aqueous, acidic, alcoholic, and fatty foods (as described in Table 1 ) under Conditions of Use E, F, and G as described in Table 2.

332

As an adhesive layer in a multi-layer film intended for use in packaging food.

The FCS will be used in contact with all types of food under retort packaging conditions.

333

For use in a non-food contact layer [to be separated from food by at least 50 micron (2 mil) thick polypropylene layer] in multilayer constructions intended for use in single-use packaging of food of all types (as defined in Table 1) under Conditions of Use A (as defined in Table 2), under retort packaging conditions only.

NONE

334

As an antimicrobial in chiller water used during poultry processing.

The FCS will be used at a level not to exceed that needed to provide the equivalent of 100 parts per million (ppm) of available bromine in the chiller water.

336

For use as components of printing inks or coatings that are applied to polyester 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, including contact with food during cooking (initial temperature covered by Condition of Use A, but without extended shelf storage).

337

As an antioxidant in linear low density polyethylene.

For use at levels not to exceed 0.25 percent by weight in linear low density polyethylene complying with 21 CFR 177.1520(c), items 3.1 and 3.2, where the density of the polymer is not greater than 0.94 gram per cubic centimeter. Linear low density polyethylene articles containing the FCS may be used in contact with food types I, II, IV-B, VI-A, VI-B, VI-C (up to 15 percent alcohol), VII-B, and VIII as described in Table 1, under Conditions of Use B through H as described in Table 2.

338

For use as an oil or grease resistant treatment for paper and paperboard intended for food-contact use.

The food contact substance (FCS) is intended to contact all food types under Conditions of Use B through H. The maximum level of the FCS will not exceed 0.37 weight percent fluorine (0.69 weight percent of the FCS) based on the weight of the paper. [The FCS may also be used in accordance with food additive regulations and effective notifications which incorporate by reference materials cleared for use in food-contact paper and paperboard.]

339

As a catalyst in the manufacture of pulp used to manufacture food-contact paper.

As an oxidation catalyst at a level not to exceed 2.0 mg FCS per kg of dry pulp. Paper manufactured with the FCS may contact aqueous and fatty foods (food types I, III, V, VII, VIII and IX), as described in Table 1, under Conditions of Use E through G, as described in Table 2.

340

The FCS will be used as a colorant for polymers.

The FCS will be used at levels not to exceed 0.5 percent by weight of the finished polymer. The FCS in finished articles is intended to contact all food types 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 paragraphs a and b of 21 CFR 178.3297.

341

As a stabilizer for adhesives, pressure-sensitive adhesives, and styrene-block polymers.

1. In adhesives complying with 21 CFR 175.105.
2. At levels not to exceed 1.0 percent by weight of pressure-sensitive adhesives complying with 21 CFR 175.125.
3. At levels not to exceed 0.2 percent by weight of styrene block polymers complying with 21 CFR 177.1810 in contact with food types I, II, IV-B, VI, VII-B, and VIII only under Conditions of Use C through H, as described in Table 2.

342

As a component of films used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2, respectively.

1) The food contact substance used in the films will have a maximum thickness of 1 mil (0.001 inch).
2) The polymer will have a relative viscosity in formic acid of 65 to 85 and will meet the specifications for Nylon 6/66 resins set forth under 21 CFR 177.1500(b)4.2.
3) Adjuvant substances permitted for use in Nylon 6/66 polymers complying with 21 CFR 177.1500(a)(4) and (b)4.2 may be used in the subject copolymers subject to any limitations regarding Conditions of Use or food types in the authorizing regulation or notification.

344

As a fluid absorbant in food-contact materials.

The cross-linked polyacrylate copolymer may contain optional adjuvant substances permitted for such use by regulation in 21 CFR Parts 170 through 179. The polyacrylate copolymer must meet the extractives limitations listed in 21 CFR 177.1211(c) and is limited to use as a fluid absorbent in food-contact materials used in the packaging of fruit and vegetables at room temperature and below.

345

The FCS will be used as an adjuvant at levels not to exceed 15 percent by weight in blends with high density polyethylene (HDPE) complying with 21 CFR 177.1520(c), item 2.1 and 2.2. The density of each of these polymers shall not be less than 0.94 gram per cubic centimeter.

The average thickness of the HDPE film is not to exceed 0.004 inches. The finished HDPE film may be used in contact with: (1) Food Types I, II, IV-B, VI-A, VI-B, VII-B and VIII as described in Table 1 and under Conditions of Use C through G as described in Table 2; and (2) Food Types III, IV-A, V, VI-C, VII-A and IX, as described in Table 1 and under Conditions of Use D through G, as described in Table 2.

346

As a stabilizer for use in linear low-density polyethylene food-contact films, coatings, and molded articles.

The stabilizer may be used with linear low density polyethylene not exceeding 0.008 weight percent, used in contact with all food types as described in Table 1, under Conditions of Use B through H as described in Table 2 .

348

For use in food-contact articles except bottles.

The FCS may be used in contact with all food types, except alcoholic foods, under Conditions of Use C through G, as described in Tables 1 and 2.

349

For use as an adhesive in laminate structures that are intended for use at retort temperatures.

For use in contact with all food types at temperatures not to exceed 121°C (250°F). This notification extends the present regulated use of the adhesive per 21 CFR 177.1390(c)(2)(vii) to include use in laminates in contact with fatty foods described as Food Types III, IV A and B, V, VII A, and IX in Table 1.

350

As a component of repeated-use articles for use in contact with Food Types III, IV-A, V, VII-A and IX identified in Table 1 at temperatures up to 100°C.

(1) The polymer will meet the specifications set forth under 21 CFR 177.1810(b), item (3)(i). (2) Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1810 may be used in the subject copolymers subject to any limitations regarding Conditions of Use or Food Types in the authorizing regulation or notification.

351

The function of the food contact substance (FCS) is to control microorganisms that may grow on the article and to thereby preserve the article.

The maximum percentage of the FCS in the article is 5 percent by weight. The FCS will be used in repeated use articles in contact with all types of food (I-IX) under Conditions of Use A through H as described in Tables 1 and 2, respectively.

352

As a clarifying agent for polypropylene homopolymers and copolymers complying with 21 CFR 177.1520.

355

As a coating or film.

The coating or film shall have a maximum thickness of 4 mils (0.004 inches) to fabricate food-contact articles in contact with 1) Food Types I, II, III, IV, VI-B, and VII for use up to 85°C for up to 15 minutes, up to 66°C for up to 30 minutes, or up to 40°C for up to 2 hours, 2) Food Type V and IX under Conditions of Use D through G, and 3) Food Type VIII under Conditions of Use A through H. Food Types and Conditions of Use are set forth in Tables 1 and 2, respectively.

356

As a colorant in single- and repeat-use polymeric, food-contact articles.

1) The colorant is limited to use levels not exceeding 1 percent by weight of the food contact polymers and is subject to the provisions and definitions set forth in title 21 CFR 178.3297 Colorants for polymers. The finished food-contact polymers may contact food types I, II, IVB, VIA, VIB, VIC (containing up to 15 percent (v/v) alcohol), VIIB, and VIII only under Conditions of Use D through G, as described in Table 2.
2) The colorant is limited to use levels not exceeding 0.5 percent by weight of the food contact polymers and is subject to the provisions and definitions set forth in title 21 CFR 178.3297 Colorants for polymers. The finished food-contact polymers may contact food types III, IVA, V, VIC (containing greater than 15 percent (v/v) alcohol), VIIA, and IX only under Conditions of Use D through G, as described in Table 2.
3) The colorant is limited to use levels not exceeding 0.2 percent by weight of the food contact polymers and is subject to the provisions and definitions set forth in title 21 CFR 178.3297 Colorants for polymers. The finished food-contact polymers may contact all food types under Conditions of Use A through H, as described in Table 2.

357

As an antimicrobial in water applied to poultry via an Inside-Outside Bird Washer (IOBW) and in water used for Off-Line Reprocessing (OLR) of poultry.

The FCS will be used at a level not to exceed that needed to provide the equivalent of 100 parts per million (ppm) of available bromine in the IOBW and OLR water.

358

As a cross linking agent in the manufacture of silicone release agents complying with 21 CFR 175.300, 175.320 and 176.170 and intended for use as:
1) a component of food packaging articles,
2) in molds used to manufacture food-contact materials, and
3) a component of release coatings (a dehesive) for use with pressure-sensitive labels.

The FCS will be used in accordance with good manufacturing practices. Additionally,
1) the food packaging articles will be used in contact with produce, meats and 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);
3) the labels will be used only on produce (fruits and vegetables).

359

For use as an anti-foulant on the interior surfaces of PVC polymerization autoclaves used to produce PVC intended for food contact.

To be used at levels not to exceed 6 ppm based on the weight of thr vinyl chloride.

360

For use as films intended for contact with all types of food under Conditions of Use A through H as described in Table 2, and in ovenable applications at temperatures up to 400°F.

The finished food-contact film must meet any applicable specifications, and is subject to all applicable Conditions of Use cited in title 21 CFR 177.1630(f), (g), (h) and/or (j). Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630, may be used in the copolyesters that are the subject of this notification, subject to any limitations in the authorizing regulation.

361

As a wet-end processing additive in the manufacture of paper pulp.

The FCS would be used at a level of about 1-2 kg/1000kg wood pulp (dry pulp basis).

362

As a resin blended with conventional polycarbonate.

The FCS is intended to be blended with conventional polycarbonate for use in articles or components of articles designed for single or repeat use in contact with all food types identified in Table 1 under Conditions of Use B through H as described in Table 2, but limited to levels not to exceed 33 percent by weight of currently regulated or effective polycarbonate.

363

As a component of articles intended to contact food.

The FCS is intended to be used in articles or components of articles designed for single or repeat use in contact with all food types identified in Table 1 under Conditions of Use B through H as described in Table 2.

365

The FCS will be used as an antioxidant in rubber articles intended for repeat-use in contact with food.

The FCS will be used in contact with all food types, under Conditions of Use A through H, as described in Table 2, and at levels not to exceed 4 weight percent of the finished article.

366

As an antioxidant in high density polyethylene (HDPE), polyethylene copolymers as described in 21 CFR 177.1520(c), item 3.2a, and in polyolefin repeat-use articles.

For use 1) in HDPE at levels up to 0.12 percent by weight of the finished article in contact with all food types under Conditions of Use B through H as described in Table 2,
2) in polyethylene copolymers as described in 21 CFR 177.1520(c), item 3.2a at levels up to 0.18 percent by weight of the finished article in contact with aqueous and acidic foods under Conditions of Use B through H, and
3) in polyolefin repeat-use articles at levels of up to 0.12 percent by weight of the finished article in contact with all foods under Conditions of Use A through H.

368

As a component of articles used in contact with all types of food.

Limitations:
Ethylene-butene copolymers may contain up to 40 weight percent polymer units derived from 1-butene. For use as a component of articles in contact with all foods under Conditions of Use C through G, as described in Table 2. Adjuvants substances permitted for use in olefin copolymers complying with 21 CFR 177.1520(c), item 3.1 may be used in the subject copolymers, provided that the limitations on the use of the adjuvant substances are met.
Specifications:
1) Density: 0.85-0.91 g/cm³
2) Melt Index (190°C/2.16kg): ≤42 g/10 minutes.

369

As coatings or components of coatings on polymeric substrates and on paper and paperboard, at a maximum level of 1.5 grams per square meter (g/m²), in contact with all food types under Conditions of Use E, F, G, and H as defined in Table 2.

1) The resins shall be cured by the use of 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).
2) The photoinitiator should be used at a maximum level not to exceed 3 percent by weight of the silicone acrylate resin in coatings.

370

As a dispersing agent for pigments used as colorants in all polymers.

For use at a maximum level of 0.015 percent by weight in the finished polymer under conditions of use A through H as described in Table 2. The finished polymer may be used in contact with all food types as described in Table 1.

371

As a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in contact with all types of food.

For use at levels not to exceed 0.05 percent by weight of the latex solids.

372

REPLACED BY FCN 780

373

For use in paper and paperboard.

For use as a dispersant for titanium dioxide pigment suspensions at a level not to exceed 0.68 percent by weight of titanium dioxide. Finished paper and paperboard containing the FCS may be used in contact with all types of food (I-IX) under Conditions of Use A through H as described in Tables 1 and 2, respectively.

374

The FCS will be used:
1) As a colorant dispersant at levels not to exceed 0.1 percent by weight in the manufacture of food-contact polymers.
2) As a nucleating agent at levels not to exceed 0.012 weight percent in olefin polymers complying with 21 CFR 177.1520(c), items 1,1, 3.1, and 3.2. The copolymers complying with items 3.1 and 3.2 shall contain not less than 85 weight percent of polymer units derived from propylene.

Finished articles containing the FCS may be used in contact with all food types and 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 paragraphs a and b of 21 CFR 178.3297.

375

As a plastic base resin to be employed in the manufacture of food-contact articles intended for repeat-use.

For repeat-use only. The finished polymer may be used in contact with all food types at temperatures not to exceed 250°F.

376

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 21 CFR 177.1630(f), (g), (h) and/or (j). Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the copolyesters that are the subject of this notification, subject to any limitations in the authorizing regulation.

377

The FCS will be used as an antioxidant for styrene block polymers complying with the provisions of 21 CFR 177.1810.

The FCS will be used at levels not to exceed 0.1 percent by weight of the finished article; and in contact with all types of foods under Conditions of Use A through H, as described in Tables 1 and 2, respectively.

379

As a component of polymer blends intended for use as films and coatings that consist predominantly of ethylene vinyl acetate copolymer.

The finished resin has a minimum softening point of 110°C (230°F) as determined by ASTM Method E 28-67 (Re-approved 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."
At least 50 percent by weight of the polymer components in the finished food-contact articles other than the FCS will consist of ethylene vinyl acetate. The FCS may be present at levels up to 20 percent by weight of the finished food-contact articles with a thickness not to exceed 30 microns (1.2 mils). Alternatively, the polymer blend may be used in thicker films and coatings provided the quantity of the FCS in the finished article does not exceed 3.6 mg per square inch. The finished article will contact food types III, IV-A, V, VII-A, and IX under Conditions of Use B through H as defined in Tables 1 and 2.

380

For use as a component of repeat-use food-contact articles.

For use in contact with all food types and under conditions of use A through H.

381

REPLACED BY FCN #449

384

As a component of a slimicide used in the production of paper and paperboard.

For use at levels not to exceed 0.14 gallons per ton of dry weight fiber. The other component of this antimicrobial system is sodium hypochlorite (CAS Registry No. 7681-52-9). The paper and paperboard may contact all food types under Conditions of Use A through H as described in Tables 1 and 2.

385

The FCS will be used as an antioxidant in the manufacture of olefin polymers complying with the provisions of 21 CFR 177.1520(c), items 3.2c and 3.6.

The FCS will be used as follows:
1) When used as components of olefin polymers complying with the provisions of 21 CFR 177.1520(c), item 3.2c, the FCS will be used at levels not to exceed 0.2 percent by weight of the finished articles; and in contact with all types of food under temperature Conditions of Use C through H as described in Tables 1 and 2, respectively.
2) When used as components of olefin polymers complying with the provisions of 21 CFR 177.1520(c), item 3.6, the FCS will be used at levels not to exceed 0.2 percent by weight of the finished articles; and in contact with all types of food under temperature Conditions of Use A through H as described in Tables 1 and 2, respectively.

386

As an antioxidant for olefin polymers.

As an antioxidant for olefin polymers complying with 21 CFR 177.1520(c), Section 3.6, at levels not to exceed 0.25 percent by weight of the finished article in contact with all food types described in Table 1 under Conditions of Use A through H as described in Table 2.

387

As a defoamer in the pulping of lignocellulosic materials that will be used to make food-contact paper and paperboard.

For use at levels not to exceed 2500 grams per metric ton of dry pulp (0.25 weight percent). The FCS may be used in contact with all food types, as described in Table 1.

388

For use as a finish component on poly(phenyleneterephthalamide) resins cleared in 21 CFR 177.1632 for repeated-use applications.

For use at a level not to exceed 1 percent by weight of the base polymer. The poly(phenyleneterephthalamide) resins employing the finish may be used as set forth in 21 CFR 177.1632.

389

The FCS may be used as a debonding agent in food-contact paper and paperboard at levels not to exceed 0.5 percent by weight of the dry paper and paperboard.

The FCS may be used at levels not to exceed 0.5 weight percent in paper and paperboard in contact with all food types under Conditions of Use B through H, as described in Tables 1 and 2, respectively.

391

The FCS will be used as a slimicide in process water during the manufacture of paper and paperboard intended to contact food.

The FCS will be used at levels not to exceed 20 ppm in the process water.

392

As a component of films used in contact with food and as a component of articles used in repeated use food-contact applications.

1) At a level not to exceed 5 percent by weight of finished plasticized vinyl chloride polymer formulations used in films in contact with all food types under Conditions of Use E through G as described in Table 2. The plasticized vinyl chloride polymer component of the films will not exceed a thickness of 0.0008 inch.
2) As a component of articles used in repeated use food-contact applications in contact with all types of food as described in Table 1.

393

As a chemically bound component of the polymeric backbone for use in polyethylene terephthalate homopolymers as described in 21 CFR 177.1630(e)(4)(ii) items 2 and 3, and complying with all applicable provisions of 21 CFR 177.1630.

For use as an antioxidant/stabilizer in food contact polyethylene terephthalate homopolymers at levels not to exceed 0.11 weight percent of the finished polymer. To be used, in accordance with existing polyethylene terephthalate regulations, in contact with all food types under Conditions of Use E through G as described in Table 2, with expanded Conditions of Use C through G when used in contact with aqueous and acidic foods.

395

As a pigment dispersant for use in all pigmented food-contact plastics.

The FCS is used at levels not to exceed 10 percent by weight in pigments that are used at levels not to exceed 1 percent by weight in food-contact polymers. The finished polymers may be used in contact with all foods (I-IX) under Conditions of Use A through H.

398

As an oil and water repellent in the manufacture of food-contact paper and paperboard.

To be used in the manufacture of paper and paperboard prior to sheet formation at a level not to exceed 1 percent by weight of the finished dry paper and paperboard. Paper containing the FCS is to be used in contact with all food types under Conditions of Use B through H as described in Table 2

399

The FCS will be used as a modifier of ethylene phthalate/naphthalate polymers and copolymers, excluding those modified with organic anhydrides.

Nylon MXD-6 will be used at a level not to exceed 3 weight percent of the finished food-contact article in conjunction with cobalt neodecanoate used at a level not to exceed 0.02 weight percent (measured as cobalt) of the finished food-contact article. The modified polymers may be used in the manufacture of containers for contact with food types I, II, VI-A (alcohol content up to 15%), and VI-B as described in Table 1, except for carbonated soft drinks and water, under use Conditions C through G as described in Table 2.

401

To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles.

The maximum thickness of the double layered coating shall not exceed 60 nm. The coating may contact all types of food under Conditions of Use C through G, as described in Tables 1 and 2.

402

As a gasket or seal for food processing equipment.

The finished copolymers are intended for repeat-use only as components of gaskets or seals used in food processing equipment intended to contact all food types at temperatures not to exceed 212°F.

403

1) As an antioxidant at levels not to exceed 0.16 percent by weight in linear low density polyethylene complying with 21 CFR 177.1520(c), items 3.1 and 3.2, where the density of the polymer is not greater than 0.94 gram per cubic centimeter.
2) As an antioxidant at levels not to exceed 0.16 percent by weight in repeated use food-contact articles.

Linear low density polyethylene articles containing the food contact substance, intended for single-use applications, may be used in contact with food types I, II, IV-B, VI-A(up to 15 percent alcohol), VI-B, VII-B, and VIII as described in Table 1, under Conditions of Use B through H as described in Table 2 .

404

The FCS will be used as a component of repeated-use food contact artivles intended for use in contact with all food types with no temperature limitations.

The FCS shall have a maximum melt index of 1.8 g/min.

405

As a basic polymer used in the production of articles intended to contact food.

Ethylene-2-norbornene copolymer (density 1.02+0.04 g/cm³) may contain not less than 20 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.

406

As an antistatic agent for polymers in contact with non-fatty dry foods.

The FCS will be used in polymers at concentrations of up to 15 percent by weight of the polymer, in contact with non-fatty dry foods, under Conditions of Use E through G, as described in Table 2.

407

As a preservative for boiler water additive formulations.

For use only as a preservative in boiler water additive formulations. The food-contact substance shall be added to the boiler feedwater, or the steam header, at levels not to exceed an initial concentration of 0.025 parts per million of the steam.

408

To be used as a lubricant/release agent in the manufacture of repeat-use, food-contact polycarbonate.

The FCS may be used at a maximum rate of 5 mg/g polycarbonate. The finished polycarbonate food-contact articles will have a maximum thickness of 3 mm and may contact all food types at temperatures not to exceed 100°C.

411

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

The FCS is to be used 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 C-G, as described in Table 2, and not to exceed temperatures of 70°C. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.

413

For use as an adhesive in laminate structures that are intended for use at retort temperatures.

For use in finished food-contact articles in contact with all food types at temperatures not to exceed 135°C (275°F). The food contact substance may be fabricated from the following:
1) Polyesterpolyurethanediol resins prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 21 C.F.R. 175.300(b)(3)(vii) and 3- isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg No. 4098-71-9). Additionally, 1,6-hexanediol may be used as a polybasic alcohol reactant.
2) Optional trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups not in excess of 3 percent by weight of the cured adhesive.
3) Urethane cross-linking agent, comprising not more than 12 percent by weight of the cured adhesive, and formulated from 3-isocyanatomethyl-3,5,5- trimethylcyclohexyl isocyanate and/or trimethylol propane (CAS Reg. No. 77-99-6 ) adduct of 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4).
4) Optional use of acid dianhydride formulated from 3a,4,5,7a-tetrahydro-7-methyl-5- (tetrahydro-2,5-dioxo-3-furanyl)-1,3-isobenzofurandione(CAS Reg. No. 73003- 90-4), comprising not more than 1 percent by weight of the cured adhesive.

415

For use in fabricating beverage containers.

The amount of VTMOS incorporated into the LDPE shall not exceed 0.48 moles VTMOS per 1000 moles of ethylene units. The finished copolymer blend is intended only for incidental contact with Food Types I, II, IVB and VIB in Table 1, at seams and edges under Condition of Use E, F, and G in Table 2.

416

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

For use at levels not to exceed 1.0 percent by weight of finished dry paper or paperboard, in contact with all food types, in microwave susceptor applications. Also 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 B through H, as described in Table 2.

417

As a component of non-food-contact layers of multilayer films.

The thickness of the FCS component of the non-food-contact layer will not exceed 25 μm and will be separated from food by one or more polymeric layers having a total thickness of at least 8 μm. For use in contact with all foods under conditions of use B through H as described in Table 2. Adjuvant substances permitted for use in nylon polymers complying with 21 CFR 177.1500 may be used in the subject copolymer subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification.

418

For use as an emulsifier in the production of acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard complying with 21 C.F.R. Sections 176.170 and 176.180 in contact with all types of food under Conditions of Use A through H.

419

For use as a colorant in all types of food-contact polymers.

The FCS is for use at a maximum level of up to 20 percent by weight of the polymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H described in Table 2. (In accordance with effective FCN 000038, the FCS may be used at levels up to 30 percent when used under Conditions of Use C and less severe conditions.) Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.

420

As a polyol monomer in the synthesis of polyester resins used to produce coatings, specifically coating binder resins, for use as can coatings and adhesives for single use in food contact applications.

1. Polyester resins containing the food contact substance for use in can coatings, intended for single-use applications, may be used in contact with all food types except high-alcoholic (>15 percent alcohol) food as described in Table 1, under conditions of use A through H as described in Table 2.
2. Polyester resins containing the food contact substance for use in adhesives, intended for single use applications, may be used in contact with all food types as described in Table 1, under Conditions of Use A through H as described in Table 2.

421

For use as a microwave susceptor base aramid paper having a maximum basis weight of 20 pounds per 1000 square feet.

For use under microwave susceptor conditions in contact with all food types as defined in Table 1.

423

As a basic polymer used in the production of articles (including bottles) intended to contact food.

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

424

As articles or components of articles used in contact with all types of food under Conditions of Use A through H, as described in Table 2.

Ethylene/octene copolymers have a density of 0.85-0.92 g/cc and a minimum Brookfield viscosity of 6,800 centipoise at 350°F, as determined by Brookfield DVII+ viscometer (or equivalent) using a No. 31 spindle. Adjuvant substances permitted for use in olefin copolymers complying with 21 CFR 177.1520(c), items 3.1 and 3.2 may be used in the subject copolymers, provided that the limitations on the use of the adjuvant substances are met.

425

As a sealing gasket for glass jars and bottles.

The FCS may be used in contact with all food types, excluding carbonated beverages, under Use Conditions A through H as described in Table 2.

426

As a colorant in food-contact polymers.

The FCS will be used at levels not to exceed 1.5 percent by weight in finished food-packaging polymer in contact with aqueous, acidic, and low-alcohol foods (food types I, II, IV-B, VI-A, VI-B, VI-C (containing up to 15 percent (v/v) alcohol), VII-B, and VIII as described in Table 1) under the 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 paragraphs a and b of 21 CFR 178.3297 ("Colorants for polymers").

427

For use as an absorbent in food-contact materials.

The finished copolymer must meet all the specifications and limitations prescribed in 21 CFR 177.121 (b) and (c) and is limited to use as a fluid absorbent in food-contact materials used in packaging of poultry, red meat, cubed tomatoes, fresh-cut fruits and vegetables, fresh whole berries, and fresh or frozen fish fillets.

428

REPLACED BY FCN 537

429

For use as a polymeric chain extender in repeated use polymers in contact with all food types and under conditions of use A through H.

The FCS shall be used at a maximum level of 0.5 percent by weight of the polymers to which it is added.

430

As a colorant for polymers in contact with food.

At levels up to 0.3 percent by weight in all types of food-contact polymers under Conditions of Use A through H as described in Table 2.

431

For use in combination with silicon dioxide and titanium dioxide as a colorant for food-contact polymers, paper and paperboard, coatings, and in printing inks applied to non-food-contact surfaces of food-contact articles.

The FCS will be used at a level not to exceed 6 percent of the total colorant weight. The finished food-contact articles may contact all food types with no temperature limitation.

432

As an antimicrobial agent in all polymers.

For use only at levels not to exceed 1 percent by weight of the finished article, in which the silver content of the finished article shall not exceed 0.022 percent by weight, under Conditions of Use A through H.

433

As an antimicrobial agent in all polymers.

For use only at levels not to exceed 2 percent by weight of the finished article, in which the silver content of the finished article shall not exceed 0.038 percent by weight, at temperature Conditions of Use A through H.

434

As an antimicrobial agent in all polymers.

For use only at levels not to exceed 1 percent by weight of the finished article, in which the silver content of the finished article shall not exceed 0.03 percent by weight, under Conditions of Use A through H.

435

For use as an adjuvant in the manufacture of polymer beverage container closures and beverage and food container seals.

The FCS is intended to be blended with polymers compliant with 21 CFR 177.1210 (Closures with sealing gaskets for food containers) and/or appropriate effective FCNs to form finished beverage container closures and beverage and food container seals. The maximum concentration of the FCS will not exceed 2.0 percent by weight of the cyclodextrins and 15 percent by weight of maleic-anhydride-polyethylene copolymer in the finished closure. The finished food-contact closures may contact beverages of food types I, II, VI-A, and VI-B identified in Table 3 of 21 CFR 177.1210(c) and under Conditions of Use C through G identified in Table 2.

436

As a catalyst in the manufacture of pulp used to manufacture food-contact paper.

This notification extends the present authorized use of the FCS as an oxidation catalyst under FCN 339 to include use levels greater than 2.0 mg but not more than 13.9 mg FCS per kg of dry pulp, and to include use in contact with all types of food. The FCS may be used under Conditions of Use E through G, as described in Table 2.

437

The FCS will be used as a surface active agent in polypropylene polymers at levels not to exceed 1.5 percent by weight of the finished article.

The finished food-contact article may be used in contact with aqueous foods and under Conditions of Use C (use at temperature of 150°F or less) through G as described in Tables 1 and 2, respectively.

438

For use as a dispersant for titanium dioxide pigment suspensions used in the manufacture of paper and paperboard at levels not to exceed 0.68 percent by weight of the titanium dioxide.

Finished paper and paperboard containing the FCS may be used in contact with all types of foods (I-IX) as described in Table 1, under microwave susceptor conditions.

439

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 FCS may be added to the paper manufacturing process at a maximum level of 2 percent by weight of the dry pulp when intended for use with paper and paperboard that will contact all food types under Conditions of Use E through H, identified in Table 2. In addition, the FCS may be added to the manufacturing process of finished paper and paperboard that is intended for use in contact with all food types under Conditions of Use A through D (identified in Table 2), provided that it is added to the manufacturing process of paper and paperboard made from recycled, food-contact paper and paperboard and that the level used does not exceed 1 percent by weight of dry pulp.

442

For use as a component of a mixture intended for use as a thickener for hand sanitizers used in food service establishments.

The FCS is to be included at up to 7 percent by weight in a mixture containing 1) a polyacrylic acid homopolymer or the copolymer of acrylic acid and up to 10 percent by weight alkyl (C₁₀-C₃₀) methacrylate, crosslinked with either allyl sucrose or allyl pentaerythritol, and (2) optionally containing up to 7 percent by weight of a block copolymer surfactant of fatty acid (C₁₂-C₁₈) and polyethylene glycol. The mixture will be used at levels no greater than 0.5 percent by weight in hand sanitizer formulations.

443

As an ion exchange resin.

444

For use as a microwave susceptor base material in aramid paper having a maximum basis weight of 20 pounds per 1000 square feet.

The FCS may be used at levels not to exceed 50 percent by weight in a mixture with poly(terephthaloyl chloride/p-phenylenediamine)(CAS Reg. No. 26125-61-1). The finished paper may be used under microwave susceptor conditions in contact with all food types as defined in Table 1.

445

As an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables that are not raw agricultural commodities in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500-ClO₂-E in the "Standard Methods for the Examination of Water and Wastewaters" 18th e.d., 1992, or an equivalent method.

The generator effluent contains at least 90 percent by weight of chlorine dioxide with respect to all chlorine species as determined by Method 4500-ClO₂-E, or an equivalent method.
1. When used in water to wash fruits and vegetables, treatment of the fruits and vegetables shall be followed by a potable water rinse or by blanching, cooking, or canning.

446

For use as a catalyst in the preparation of silicone elastomers complying with 21 CFR 177.2600.

The FCS will not exceed 0.01 percent (or 100 ppm) in the finished elastomer, corresponding to 41.7 ppm rhodium.

447

To control microbial growth in wash water that contacts fruits and vegetables that are not raw agricultural commodities.

The additive will be used in process water such that the level of hydrogen peroxide will not exceed 120 ppm, and the levels of peroxyacetic acid and HEDP will not exceed the limits specified in 21 CFR 173.315(a)(5).

448

For use as an adhesive in laminate structures that are intended for use at retort temperatures.
REPLACES FCN #381

For use in contact with all types of food, except those containing more than 8 percent alcohol, under retort packaging conditions at temperatures not to exceed 275°F. Laminate structures containing the FCS will meet all applicable provisions and test specifications in 21 CFR 177.1390, including 177.1390(c)(3)(i)(b)(3) and 177.1390(c)(3)(ii).

449

REPLACED BY FCN 708

450

As an antimicrobial agent in the processing of red meat, red meat parts and organs, and on processed, comminuted, and formed meat products as a component of a dip or a spray.

The additive is produced by mixing an aqueous solution of sodium chlorite with any generally recognized as safe acid to achieve a pH in the range of 2.2 to 3.0, then further diluting this solution with a pH elevating agent such that the resultant sodium chlorite concentration does not exceed 1200 mg/kg, and the chlorine dioxide concentration does not exceed 30 mg/kg. The pH of the use solution is between 5.0 and 7.5.

451

As a processing aid (filter aid) in the production of petroleum wax that will be used on food packaging for single use food contact applications.

The FCS will be used as described in 21 CFR 178.3710 Petroleum wax. The petroleum wax will contain a total of not more than 40 ppm by weight of the FCS. The finished wax-coated paper, with a wax thickness of 0.3g/cm², would contact only alcoholic and fatty foods.

452

The FCS will be used as a base polymer in contact with food, excluding film or coating applications.

The FCS will be used in contact with
(1) all types of food, except Food Type VI C (beverages containing more than 8 percent alcohol), at room temperature for up to 10 days;
(2) aqueous and acidic foods (Food Types I, II, IVB, VIA, VIB, VIIB, and VIII) at room temperature for up to 15 days; and
(3) all food types under refrigerated or frozen storage (Conditions of Use F and G, as described in Table 2).

453

For general use as an antimicrobial agent in water used in poultry processing for disinfecting poultry carcasses and their parts and organs.

The FCS will be used at a level not to exceed that needed to provide the equivalent of 100 parts per million (ppm) of available bromine (90 mg DBDMH/kg water) in poultry process water.

454

The FCS will be used as a resin in the manufacture of molded repeat-use food-contact articles.

The finished FCS will have an average thickness range of 2 - 20 mm, and may be used in contact with all types of food and at temperatures not to exceed 204°C (400°F).

455

As an antioxidant/stabilizer in food-contact adhesives.

For use at levels not to exceed 1 percent by weight of adhesives complying with 21 CFR 175.105. The FCS may be used in contact with all food types as described in Table 1, at temperatures not to exceed 120°F.

456

For use as an emulsifier in the production of acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard complying with 21 CFR Sections 176.170 and 176.180 in contact with all types of food.

458

As a catalyst to accelerate the cross-linking reaction of vinyl-functionalized polydimethylsiloxanes with hydrogen-functionalized polydimethylsiloxanes in forming a silicone elastomer that will be used in repeat use articles such as baking molds and milk tubes, which may contact all food types under all conditions, consistent with the limitations of 21 CFR 177.2600(c)(4)(i).

The FCS will be used at levels not to exceed 30 ppm in the finished elastormer.

459

The FCS will be used as a surfactant in the manufacture of styrene-1,3 butadiene and styrene-1,3 butadiene, hydrogenated block copolymers.

For use in the manufacture of styrene-1,3 butadiene and styrene-1,3 butadiene, hydrogenated block copolymers as described in 21 CFR 177.1810 (b) items 1 and 3. The use level of the food contact substance (FCS) is not to exceed 3000 ppm in the finished food-contact article in contact with food types I, II, IV-B, VI, VII-B and VIII as described in Table 1 under Conditions of Use D through G as described in Table 2 in accordance with 21 CFR 177.1810(b) item 1(i) and Conditions of Use C through G in accordance with 21 CFR 177.1810(b) item 1(ii) and item 3(i). Also to be used in contact with food types III, IV-A, V, VII-A, VIII, and IX under Conditions of Use D in accordance with 21 CFR 177.1810(b) item 3(ii).

460

As an antimicrobial agent in no-rinse hand sanitizers for food handlers.

Benzethonium Chloride USP may be used at levels not to exceed 0.2 percent by weight of the finished hand sanitizer formulations.

461

As a non-food contact layer in multilayer films intended for use in packaging food of all types under the Conditions of Use B through H as defined in 21 CFR 176.170(c).

The FCS layer will be separated from the food by a 20 micron or thicker layer of low-density polyethylene (LDPE) or by a poly(ethylene terephthalate) (PET) or other polymer layer of a thickness sufficient to provide equivalent or better barrier properties than 20 microns of LDPE.

462

As a non-food contact layer in multilayer films intended for use in packaging food of all types under the Conditions of Use B through H as defined in 21 CFR 176.170(c).

The FCS layer will be separated from food by a 20-micron or thicker layer of low density polyethylene (LDPE) or a non-LDPE polymer layer of a thickness sufficient to provide equivalent or better barrier properties than 20 microns of LDPE.

463

The FCS may be used neat or in blends with polycarbonate resins, in articles or components of articles intended for single and repeat-use food contact applications.

The finished food contact article may be used in contact with all food types and under Conditions of Use B through H, as described in Tables 1 and 2, respectively.

464

As a colorant in single- and repeat-use polymeric, food-contact articles.

For use at levels not to exceed 2 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 maximum thickness of the polymers containing the food contact substance should not exceed 0.5 cm.

465

For use as a scavenger for acetaldehyde in polyethylene terephthalate (PET) beverage bottles.

The FCS may be used at levels up to 2000 ppm when added during melt-phase PET polymerization, or at levels up to 1000 ppm when added during PET extrusion. PET beverage bottles containing the FCS may be used in contact with aqueous, acidic, and low-alcohol foods under Conditions of Use C through G, as described in Table 2.

469

As a retention aid and/or drainage aid and/or dry strength agent employed prior to the sheet forming operation in the manufacture of food-contact paper and paperboard at a maximum level of 1 percent by weight of the dry pulp.

The modified industrial starch must be used in compliance with Title 21 CFR 178.3520(a)(1), (b), and (c). The finished paper and paperboard may be used only under Conditions of Use A through D identified in Table 2.

472

REPLACED BY FCN # 526

473

As an ultraviolet light absorber in polyethylene phthalate polymers complying with 21 CFR 177.1630 used in contact with foods.

For use only at levels not to exceed 3.3 percent by weight of the finished polyethylene phthalate polymers. The finished FCS may be used in contact with all food types, under conditions of use B through H, as described in Tables 1 and 2, respectively.

474

As a stabilizer for polypropylene polymers and copolymers complying with 21 CFR 177.1520(c), items 1.1, 3.1, and 3.2.

The stabilizer is to be used at levels not to exceed 0.1 percent by weight of the finished polypropylene polymers or copolymers. The finished articles containing the stabilizer may contact any type of food under Conditions of Use A through H, as described in Table 2.

475

As a component in the manufacture of articles intended to contact food.

The FCS is intended to contact all types of food under Conditions of Use C through G, as described in Table 2.

476

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

For use only at levels not to exceed 1.7 percent by weight of the finished article in which the silver content of the finished article shall not exceed 0.044 percent by weight, under Conditions of Use A through H.

477

For use as an antistatic agent in polypropylene polymers and copolymers.

For use at levels not to exceed 1.0 weight percent of the finished article in contact with aqueous foods under Conditions of Use C through G, as described in Table 2.

479

The FCS will be used in the manufacture of articles or components of articles intended to contact food.

The FCS has a weight average molecular weight in the range of 70,000-200,000 Daltons. Finished articles containing the FCS will have a thickness no greater than 3 mil (0.003 inch), and will be used in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2, respectively.

480

As an ultraviolet light stabilizer at levels not exceeding 0.3 percent by weight in olefin polymers complying with 21 CFR 177.1520 Olefin polymers, or an effective food contact substance notification.

Limited to use in contact with aqueous, acidic and low-alcohol foods under Conditions of Use E through G as described in Table 2.

481

The FCS will be used as a base resin or coating in repeat-use applications.

For use as a base resin or coating in repeat-use applications in contact with all food types at temperatures up to 302°F (150°C).

482

As a component of pressure-sensitive adhesives used as the food-contact surface of labels and tapes as provided in 21 CFR 175.125 (Pressure-sensitive adhesives).

The labels or tapes will be used at room temperature or below. The use level of the FCS is up to 47.5 percent by weight of the final adhesive formulation.

483

As a microbial control agent in carbonated beverages containing up to and including 100% juice and flavored water beverages (carbonated and non-carbonated) that contain low levels of juice or artificial or natural flavors.

For use only at levels not to exceed 250 ppm of DMDC. 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 the FCS.

484

For use as a process aid in the manufacture of styrene-maleic anhydride copolymers complying with 21 CFR 177.1820(b)(2).

Molecular weight (range): 150-6500
Viscosity (range): 200-235 cST (100°C)
Maximum bromine value: 90
At levels not to exceed 4 percent by weight of styrene-maleic anhydride resins used to fabricate non-film food-contact articles. The FCS is primarily intended for single-service applications. The FCS will be used in contact with:
(1) refrigerated or frozen food (Conditions of Use F and G);
(2) refrigerated or frozen food that may be microwave reheated;
(3) takeout food items that have been hot filled; and
(4) aqueous and acidic foods for use as components of food processing machinery at temperatures not to exceed 100°C for up to five minutes.

485

For use as a processing aid in rinse-aid products used in commercial dishwashing machines.

The FCS will be used in rinse-aid products at concentrations up to 2.14 ppm in the final rinse water of commercial dishwashing machines.

486

As the basic polymer used in the production of articles intended to contact food.

The finished polymer is intended for use in contact with all types of food under Conditions of Use A through H, as described in Tables 1 and 2, respectively. Polymeric additives permitted for use in olefin polymers complying 21 CFR 177.1520(c), items 1.1(a) and 3.2(a) may also be used in this food-contact substance, subject to the prescribed limitations and specifications.

487

As an oil/grease resistant sizing agent for paper and paperboard employed either prior to the sheet forming operation or at the size press.

The FCS may be used at a level not to exceed 0.5 percent by weight of dry paper and paperboard intended for use in contact with all food types under Conditions of Use B through H as defined in Table 2.

488

For repeated use in contact with all types of food.

For use in the manufacture of molded repeat-use articles with thicknesses not to exceed 20 mm (or 0.78 inch) in contact with all types of food.

489

As a processing aid in the production of vinyl acetate adhesives intended to be used to affix lables to the outside surface of food packaging.

The FCS will be used only in the preparation of ethylene-vinyl acetate copolymer dispersions used in adhesives that will be separated from food by the food packaging.

490

The FCS is intended for use as an antiblocking agent for linear low density polyethylene (LLDPE) films at a use level of 0.5 to 2 weight-percent (with a typical use level of 1 weight-percent).

The LLDPE films will have a thickness of 10 - 100 microns (0.4 - 4 mils) and will contact all types of food listed in Table 1 under the Conditions of Use B through G as described in Table 2.

491

For use as an emulsifier in the production of adhesives, pressure-sensitive adhesives, and in adhesives for laminate structures intended for use at temperatures of 250°F and above.

The finished emulsifier may be used in adhesives held at temperatures not to exceed 120°F. The adhesives used must comply with 21 CFR 175.105, 175.125, or be the subject of an effective food contact notification. The finished emulsifier may also be used in laminating adhesives when separated from the food by a functional barrier in compliance with 21 CFR 177.1390(c)(2)(ii).

493

REPLACED BY FCN 537

494

The FCS will be used as an stabilizer in polystyrene(PS) and rubber-modified polystyrene(RMPS) complying with 21 CFR 177.1640, styrene block copolymers(SB) complying with 21 CFR 177.1810, and PS, RMPS,or SB complying with an effective FCN.

Maximum use level of 1 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 unless otherwise restricted by the applicable limitations for styrene block polymers in 177.1810 or in an effective FCN.

495

For use as a slimicide in the manufacture of food-contact paper and paperboard.

As a slimicide complying with the provisions for slimicides cited in 21 CFR 176.300, at a maximum level of 3 pounds per ton of dry-weight fiber.

498

The FCS is intended for use as films or articles intended to contact food.

The finished food-contact material containing the FCS may be used in contact with food types I, II, IVB, VI (containing up to 15 percent alcohol), VIIB, and VIII, under Conditions of Use C through G, as described in Tables 1 and 2, respectively. Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the copolyesters that are the subject of this notification, subject to any applicable limitations.

500

To be used as a colorant in polypropylene films and molded articles that may contact all food types under Conditions of Use E through G as defined in 21 CFR 176.170(c).

The FCS will be used at levels not to exceed 0.25 percent by weight in the final product.

501

As an additive at levels up to 25 percent by weight in pressure-sensitive adhesives that comply with 21 CFR 175.125.

The FCS may be used in contact with all food types, as described in Table 1. The resulting polymers will have a viscosity no greater than 115cSt using ASTM D-445.

502

As a component of films used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2, respectively.

The films will have a maximum thickness of 1 mil (0.001 inch) of the FCS. Maximum extractable fraction in solvent (expressed in percent by weight of resin) are as follows: water (0.8); 95 percent ethyl alcohol (1.0); ethyl acetate (0.5); benzene (0.5). Adjuvant substances permitted for use in Nylon 6/66 polymers may be used in the subject copolymer subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification.

504

The notifier intends to use the FCS as a wet state preservative (biocide) for styrene/acrylic or polymer lattices used in the manufacture of coatings (lacquer) which will be applied to the food contact side of single use articles made from aluminum foil for use with all food types under Conditions of Use B through H (see Table 2,).

The FCS will not exceed 250 ppm in the wet emulsion. The wet coat weight will not exceed 1g/m² on the food contact side of aluminum foil.

505

For use as a colorant for food-contact polymers.

The FCS may be used at a level not to exceed 0.2 weight percent in food-contact polymers in contact with all foods 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.

506

As a component of repeat-use molded articles that may contact all types of food, including food trays, conveyor belts, bearings, utensils, containers and components of machinery.

The thickness of the molded article must be between 2-20 mm.

507

As a defoaming agent in the pulping of lignocellulosic materials that will be used in the manufacture of paper and paperboard.

508

The FCS will be used as an emulsifier/surfactant in the production of styrene-butadiene-acrylonitrile copolymer coatings for paper and paperboard.

The FCS may be used at levels not to exceed 0.3 weight percent in coatings composed of styrene-butadiene-acrylonitrile copolymers, that are the subject of FCN 106, intended for use as a coating for paper and paperboard.

509

For use as a clarifying agent in linear low and low density polyethylene (LLDPE and LDPE).

At levels not to exceed 0.2 percent by weight of the polymer in contact with all food types and under Conditions of Use C through G as described in Table 2.

510

For repeat-use in the fabrication of molded parts such as o-rings and gaskets for food processing equipment.

The base fluoropolymer may be compounded with no more than 3.0 weight-percent of triallyl isocyanurate and 2.5 weight-percent of 2,5-dimethyl-2,5-di(tert-butylperoxy)hexane. Articles containing the FCS are intended to contact all food types.

511

For repeat-use in the fabrication of molded parts such as o-rings and gaskets for food processing equipment.

512

As a retention aid and/or drainage aid and/or dry-strength agent employed prior to the sheet forming operation in the manufacture of food-contact paper and paperboard at a maximum level of 1 percent by weight of the dry pulp.

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

513

As a reducing agent in emulsion polymerization redox catalyst systems, with the produced polymer emulsions to be used as components of food-contact paper and paperboard complying with 21 CFR 176.170 or 176.180, adhesives complying with 21 CFR 175.105, and repeat use rubber articles complying with 21 CFR 177.2600.

For use at a maximum level of 1 percent based on total monomer weight used in the manufacture of the polymer emulsions. Food-contact articles containing the polymer emulsions may contact all food types under Conditions of Use A through H as described in Table 2.

514

As a stabilizing agent in polypropylene homo and copolymer.

At levels not to exceed 0.2 percent by weight of polypropylene homo and copolymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H.

515

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.

At levels not to exceed 0.3% by weight of the finished polymer under Conditions of Use A through H as defined in Table 2. The finished polymer may be used with all food types.

516

As a defoaming agent in printing inks and ink coatings applied to both the food contact side and non-food contact side of paper, paperboard, films, and foils used in food packaging.

For use at levels not to exceed 0.5 percent of the coating formulation. Coating thicknesses can vary from 0.5 to 10 microns. The finished FCS may be used in contact with all food types, under Conditions of Use B through H, as described in Tables 1 and 2, respectively.

517

As a component of repeat-use molded articles such as food trays, conveyor belts, bearings, utensils, containers, and components of machinery.

The thickness of the molded article must be between 2-20 mm. The FCS is intended to contact all types of food at temperatures not to exceed 204°C (400°F) for food trays and 191°C (375°F) for other uses.

518

As an oil/grease resistant sizing agent at levels up to 0.5 percent by weight employed either prior to the sheet forming operation or at the size press for paper and paperboard intended for use in microwave heat-susceptor packaging.

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

519

As an antioxidant/stabilizer in the processing of rosins and rosin esters for use as components of adhesives complying with 21 CFR 175.105.

For use at a level not to exceed 0.3 percent by weight of the adhesive formulation. The finished food-contact articles containing the adhesives may contact all food types under Conditions of Use E through G as described in Table 2.

522

The FCS will be used in the manufacture of food-contact films and coatings.

Finished articles containing the FCS may be used in finished articles in contact with all food types and under Conditions of Use C though G as described in Table 2. The thickness of the finished food contact article shall not exceed 2 mils.

524

As an antioxidant/stabilizer in styrene block copolymers complying with 21 CFR 177.1810 Styrene block polymers.

May be used at levels not to exceed 0.4 percent by weight of the finished styrene block polymer, and in contact with all types of food, and under Conditions of Use A through H for which such styrene block polymers are permitted by 21 CFR 177.1810

526

As a component of non-food-contact layers of multilayer films for packaging.
REPLACES FCN #472

Not to exceed 25 μm in thickness in contact with all food types under Conditions of Use A through H as described in Table 2. The FCS will be separated from food by one or more polymeric layers, not including low density polyethylene (LDPE), having a total thickness of at least 8 μm. Adjuvant substances permitted for use in nylon polymers complying with 21 CFR 177.1500 may be used in the subject copolymer subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification.

527

As a dispersant for pigments.
1) At levels up to 0.6 percent by weight of the pigment when the pigment is used as a colorant for all types of polymers complying with 21 CFR 178.3297.
2) At levels up to 1.0 percent by weight of the pigment when the pigment is used in inks that may come into contact with food.

The finished polymers and inks may contact all food types under Conditions of Use A through H, as described in Table 2.

528

As an ion exchange resin for adsorption of proteins from skim milk and whey.

For repeat use only. The diameter of the agarose beads is less than 250 μm, and the diameter of the tungsten carbide solid inner core of the beads is between 10-30 μm. The whey or skim milk should be adjusted to a pH range of 5.5-7.5 and a temperature range of 5-55°C before passing through the beads at a linear flow rate of 600-3000 cm/hr. The milk protein adsorbed by the FCS may be used widely in all food and feed applications.

529

The subject FCS is intended for use as an antioxidant/stabilizer in acrylonitrile/butadiene/styrene (ABS) polymers and methyl methacrylate-modified ABS (MABS) polymers.

At a level not to exceed 0.25 weight-percent in ABS and MABS articles intended for repeat-use applications.

531

As an ion exchange resin.

For repeated use in extracting individual proteins or substances present in similar low concentrations from liquid, water-based food materials, such as milk, whey, fruit juice, beer and wine.
For continuous use, the process conditions will be between pH 3 and 12 and temperatures below 40°C. Use at pH 12 up to 40°C is limited to a maximum of 2000 hours over the resin lifetime. Cleaning at 20°C may take place at up to pH 14, cleaning at 40°C conducted at up to pH 13.7, and cleaning at 60°C conducted at up to pH 13.3.

532

As an ultraviolet light absorber in polycarbonate food-contact articles complying with Title 21 CFR 177.1580 Polycarbonate resins.

For use at levels not to exceed 2.0 percent by weight of the polycarbonate food-contact article in contact with food types:
1) I, II, IV(B), VI(up to 15 percent alcohol), VII(B), and VIII under Conditions of Use B through H, and,
2) III, IV(A), V, VI, VII(A), and X under Conditions of Use C through G, as described in Tables 1 and 2 respectively.

533

As an additive at levels up to 10 percemt in propylene homopolymers and copolymers that comply with 21 CFR 177.1520(c) or are the subject of an effective food contact notification.

The FCS has a minimum kinematic viscosity at 100°C of 9.4 centistokes. The FCS may be used in contact with food types I, II, IVB, VIA, VIB, VIC (up to 15 percent alcohol), VIIB and VIII under Conditions of Use C through G as described in Tables 1 and 2.

534

The FCS will be used as a modifier in the production of high melt strength polypropylene (HMS-PP). The primary applications for the HMS-PP are in foaming, thermoforming and blow molding. The HMS-PP will comply with 21 CFR 177.1520.

The FCS is added to polypropylene (PP) at a maximum level of 2.0 percent. The FCS will be used in contact with all types of food under Conditions of Use A through H, as described in Tables 1 and 2 unless restricted by applicable regulations for the PP polymer.

535

To control microorganisms that may grow on the article and to thereby preserve the article.

The maximum percentage of the FCS in the article is 5 percent by weight. The silver content of the modified zeolite shall not exceed 5 percent by weight. The FCS will be used in repeat-use articles in contact with all types of food (I-IX) under Conditions of Use A through H as described in Tables 1 and 2, respectively.

537

To be used as an ultraviolet (UV) light stabilizer in ethylene phthalate (PET) polymers complying with 21 CFR 177.1630 (Polyethylene phthalate polymers), 21 CFR 177.1315 (Ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers), or that are the subject of an effective FCN.

REPLACES FCNs 428 and 493

The substance will be used at levels not to exceed 1.0 percent by weight in the polymer for single and repeat use in contact with food types I, II, III, IVA, IVB, V, VIA, VIB, VIC (containing up to 15 percent alcohol), VIIA, VIIB, VIII, IX under Conditions of Use C through G, as described in Tables 1 and 2.

538

As an oil and water repellent employed in the manufacture of food-contact paper and paperboard either prior to the sheet-forming operation or at the size press.

When applied prior to the sheet-forming operation the FCS is to be used at a level not to exceed 1 percent by weight of the finished dry paper and paperboard to be used in contact with all food types. When applied at the size press the total use level of the FCS is not to exceed 0.5 percent by weight of the finished dry paper and paperboard to be used in contact with aqueous foods and 1 percent by weight of the finished dry paper and paperboard to be used in contact with all other food types. Paper and paperboard containing the FCS are to be used under Conditions of Use B through H as described in Table 2.

539

For repeat-use in the fabrication of molded parts such as o-rings and gaskets for food processing equipment.

540

For use as a starting material in the production of 2,3-epoxypropyltrimethylammonium chloride (CAS Reg. No. 3033-77-0) that will be used to modify industrial starch at a treatment level of greater than 5 percent and not more than 21 percent by weight of the starch to form high cationic starch (HCS). The finished HCS is intended for use as a retention aid and/or drainage aid and/or dry-strength agent employed prior to the sheet forming operation in the manufacture of only recycled food-contact paperboard.

The modified industrial starch must be used in compliance with 21 CFR 178.3520(a)(1), (b) and (c). The finished recycled paperboard may contact all types of food under Conditions of Use A through H identified in Table 2.

541

As an antioxidant/stabilizer for use in polyethylene polymers identified in 21 CFR 177.1520(c), items 2.1, 2.2, and 2.3, having a density greater than or equal to 0.94 grams per cubic centimeter.

Not to exceed 0.3 percent by weight in the finished food-contact article.

542

As an oil/grease resistant sizing agent employed prior to the sheet forming operation in the manufacture of paper and paperboard.

544

As an antioxidant and/or stabilizer in polystyrene and impact polystyrene, compliant with 21 CFR 177.1640, in contact with all food types.

The FCS will be used at levels not to exceed 0.1 percent by weight in the finished product under Conditions of Use B through H.

545

The FCS will be used as a polymeric chain extender in the manufacture of polylactide polymers in contact with all food types (except in foods with an alcohol content greater than 15 percent) and under Conditions of Use E through G.

The FCS shall be used at a maximum level of 0.2 percent by weight of polylactide polymers complying with FCNs 178 and 475.

546

The FCS is intended for use as a modifier of ethylene phthalate polymers regulated under 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN.

At levels not to exceed 0.6 percent by weight of the finished food-contact articles. The modified polymers may be used in the manufacture of bottles under Conditions of Use C through G, as described in Table 2 and in contact with food types I, II, VI-A, VI-B and VI-C (to 15 percent alcohol), as described in Table 1. The finished modified polyester must meet any specifications applicable to the unmodified polyester that are appropriate to its intended use.

547

For finished polymers containing up to 12 mole-percent of total diethylene glycol and isophthalate units, for use as films or articles intended for contact with aqueous, acidic, low-alcohol (up to 50 percent alcohol by volume), dry and fatty foods under Conditions of Use A through H as described in Table 2, and for use in contact with high-alcohol foods (greater than 50 percent alcohol by volume) under Conditions of Use E through G as described in Table 2. For finished polymers containing between 12 and 16 mole-percent total diethylene glycol and isophthalate units, for use as films or articles intended for contact with aqueous, acidic, low-alcohol (up to 50 percent alcohol by volume), dry, and fatty foods under Conditions of Use B through H as described in Table 2.

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). Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the copolyesters that are the subject of this notification, subject to any limitations in the authorizing regulation.

548

REPLACED BY FCN 614

549

To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles.

The maximum thickness of the three layered coating shall not exceed 60 nm. The coating may contact all types of food under Conditions of Use C through G, as described in Tables 1 and 2.

550

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

The FCS is to be used at levels not to exceed 1 percent by weight of the food-contact polymer. The finished polymers are intended to contact all types of food under Conditions of Use C through G, as described in Table 2 , and not to exceed temperatures of 70°C. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.

551

As a 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 types under Conditions of Use A through H, as described in Table 2.

553

As a colorant in polypropylene food-contact polymers.

The FCS is to be used at levels not to exceed 0.1 percent by weight of the food-contact polymer. The finished polymers are intended to contact all types of food under Conditions of Use C through G, as described in Table 2. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.

554

To control the formation of mineral scale during evaporation of beet or cane sugar juice.

The FCS is to be used to control the mineral scale formed during the evaporation of beet or cane sugar juice liquor, at an addition rate not to exceed 3.6 mg/kg (ppm) of active sodium polyacrylate to the sugar juice liquor, in compliance with 21 CFR 173.73 (with the exception of subparagraphs (a)(1) and (a)(2)).

555

As a monomeric component of acrylic polymers complying with 21 CFR 177.1010, used only in the manufacture of resinous and polymeric coatings.

The monomer shall not exceed 8.4 percent by weight of the acrylic component of the finished coating. Acrylic coatings containing 2 hydroxyethyl methacrylate monomers are limited to applications on metal substrates.

556

The FCS is intended for use as an antioxidant/stabilizer in (a) ethylene phthalate polymers compliant with 21 CFR 177.1630 and
(b) ethylene phthalate polymers compliant with the specifications in 21 CFR 177.1630(f) for which there is an effective food contact notification.

The FCS will be used at levels not to exceed 1100 ppm (0.11 weight percent) in the finished ethylene phthalate polymers, in contact with all food types as listed in Table 1 under the Conditions of Use A through H as described in Table 2.

558

For use in blends with food-contact polylactide polymers used to produce single use food-contact trays.

The FCS will be used at levels not to exceed 25 percent by weight of the finished food-contact trays. The finished food-contact trays may be used in contact with all types of food under Conditions of Use D through G as described in Table 2.

560

For use as an antimicrobial preservative in lubricants with incidental food contact.

The FCS is for use at a level not to exceed 1 percent by weight of lubricants for incidental food contact.

561

The FCS will be used as a part of the process to treat food-contact surfaces to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR Part 113.

After application of the mixture (solution) to the food contact surfaces of the food packaging, the surface is rinsed with sterile water. The maximum concentration of HEDP in the treatment solution will not exceed 1 percent. Processed foods packaged in materials treated with the FCS shall conform with 21 CFR Parts 108, 110, 113, and 114, as applicable.

563

For use as a modifier in polyethylene terephthalate (PET).

The FCS may be used at a maximum level of 1.0 mole percent based on total diacids (diesters), or 0.5 mole percent based on the finished PET, where the modified PET may be blended with up to 30 percent of hexanedioic acid polymer with 1,3 benezenedimethanamine (MXD-6) at levels not exceeding those specified in 21 CFR 177.1630(e)(4)(v). The finished blend is intended to be used in contact with all food types under Conditions of Use C through G, as described in Table 2.

564

The FCS is used to remove organic substances from all alcoholic beverages, food types VIA and VIC as described in Table 1.

The finished resin must meet the applicable specifications prescribed in 21 CFR 173.65(a) and (b), and the temperature of the alcoholic beverage stream contacting the polymer may not exceed 40°C.

566

As strengthening agents, fixing agents, or retention aids prior to the sheet-forming operation in the manufacture of paper and paperboard.

For use at a level not to exceed 1.5 percent by weight of the finished paper and paperboard.

567

The FCS is intended for use as a slimicide in the manufacture of food-contact paper and paperboard.

The FCS will be added in sufficient quantity to achieve a residual bromine level of 4 -10 ppm in the process water. The finished articles will contact all food types under all Conditions of Use.

569

As an antimicrobial agent in polymer latex solutions intended for use in adhesives complying with 21 CFR 175.105.

For use at temperatures not to exceed 120°F.

571

As a repeat-use clarifying agent during the manufacture of alcoholic and non-alcoholic beverages.

Good manufacturing practice level of use of the FCS in beverages (commonly used at 80 -150 g/100 L, depending on the characteristics of the beverage). The FCS is subsequently removed from the final product by filtration. The FCS is expected to serve 100 cycles.

572

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

1. For use only at levels not to exceed 0.1 weight percent high density polyethylene polymers and copolymers complying with 21 CFR 177.1520(c), items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.6 (with density not less than 0.94 grams per cubic meter) and 5. The finished polymers may be safely used in applications involving contact with all food types under Conditions of Use B through H, as described in Tables 1 and 2.
2. For use only at levels not to exceed 0.1 weight percent polypropylene polymers and copolymers complying with 21 CFR 177.1520. The finished polymers may be safely used in applications involving contact with all food types under Conditions of Use B through H, as described in Tables 1 and 2.

573

As an O-ring or gasket in food-processing machinery.

For use in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2, respectively.

574

As the non food-contact layer of multi-layer, polyethylene terephthalate (PET) beverage bottles.

The FCS shall be no more than 28 μm thick and separated from food by a layer of PET having a thickness of at least 90 μm, which will contact non-fatty food types (i.e., I, II, IV-B, VI-A, VI-B, VI-C (up to 15 percent alcohol content) VIIB, and VIII under Conditions of Use C through G, as described in Table 2.

575 - 577

The food contact substances will be used in the manufacture of food processing equipment (e.g. seal rings, bearings, parts in conveying systems, parts in crushers and mills).

The FCS will be used in contact with all types of foods and under Conditions of Use A through H as described in Table 2.

578 - 585

The food contact substances will be used in the manufacture of food processing equipment (e.g. seal rings, bearings, parts in conveying systems, parts in crushers and mills).

The FCS will be used in contact with all types of foods and under Conditions of Use A through H as described in Table 2.

586 - 591

The food contact substances will be used in the manufacture of food processing equipment (e.g. seal rings, bearings, parts in conveying systems, parts in crushers and mills).

The FCS will be used in contact with all types of foods and under Conditions of Use A through H as described in Table 2.

592

1. As a non-food-contact layer in multilayer constructions intended for use in packaging food of all types under Conditions of Use B through H as specified in Table 2 in our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html, and at higher temperatures only in retort packaging processes.
2. When used under Condition of Use B through H, the food-contact substance layer will be separated from food by at least a 20 micron thick layer of low density polyethylene or other polymer layer sufficiently thick so as to provide equivalent or better barrier properties than 20 microns of low density polyethylene.
3. When used in retort packaging processes, the food-contact substance layer will be separated from food by at least a 50 micron thick layer of polypropylene or other polymer layer sufficiently thick so as to provide equivalent or better barrier properties than 50 microns of polypropylene.

SEE INTENDED USE

594

For use as a polymeric chain extender in foamed polylactide polymers.

The FCS shall be used at a maximum level of 1.2 percent by weight of foamed polylactide polymers, where the polylactide polymers are cleared by FCNs 178 and 475. The FCS may contact all food types (except >15 percent alcohol) under Conditions of Use E through G, as described in Table 2.

595

597

As a plasticizer for repeat-use vinyl chloride polymers that may contact food, including vinyl chloride polymer-based gloves used in processing food and as a component of coatings for paper and paperboard intended to contact dry food.

The FCS will be used at a level not to exceed 10 percent by weight of the finished, repeat-use vinyl chloride polymers and at temperatures not to exceed 100°C. The FCS will also be used in coatings for paper and paperboard that may contact Food Type VIII (dry solids with the surface containing no free fat or oil) as described in Table 1.

598

For repeat use in the fabrication of molded parts such as o-rings and gaskets for food.

The base fluoropolymer may be compounded with no more than 3.0 weight-percent of the salt of a quarternary ammonium compound and phenol, 4,4'-(2,2,2-trifluoro-1-(trifluoromethyl)ethylidene)bis- which is identified in the FCN. Articles containing the FCS are intended to contact all food types.

599

As an oil, grease, and water resistant treatment for paper and paperboard employed either prior to the sheet forming operation or at the size press.

The FCS may be used at a level not to exceed 1.2 percent by weight of dry paper and paperboard intended for use in contact with all food types under Conditions of Use B through H as defined in Tables 1 and 2.

602

The FCS is intended as a colorant for use in authorized poly(ethylene phthalate) polymers, including those modified with 1,4-cyclohexanedimethanol.

The FCS will be used at levels not to exceed 0.1 percent by weight in the finished poly(ethylene phthalate) polymers, for contact with all food types under the Conditions of Use D through G as described in Tables 1 and 2.

604

As an oil, grease, and water resistant treatment for paper and paperboard employed either prior to the sheet forming operation or at the size press.

The FCS may be used at a level not to exceed 1.2 percent by weight of dry paper and paperboard intended for use in microwave susceptor applications in contact with all food types.

607

As a colorant for all polymers.

At levels up to 0.5 percent by weight in all types of food-contact polymers under Conditions of Use A through H as described in Tables 1 and 2, respectively.

608

As a nucleating or clarifying agent in all polyolefins.

The FCS will be used at levels not to exceed 2500 ppm (0.25 wt percent) in all polyolefins that may contact all food types under Conditions of Use A through H as described in Tables 1 and 2.

614

As a component for use in paper and paperboard coatings and as a filler.
REPLACES FCN 548

For use at levels not to exceed 3 percent of the weight of paper and paperboard intended for use in contact with all food types, under Conditions of Use B through H identified in Tables 1 and 2.

615

For use as a clarifier for polypropylene (PP) homo- and copolymers.

The FCS may be used at levels not to exceed 210 ppm in the finished article and may contact all food types under Conditions of Use A through H, as described Table 2.

616

The FCS is intended for use as a component of food contact articles in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.

The FCS may be used alone, as a blend, or may be co-extruded with other resins. The FCS, when blended, will be mixed with only non-polyolefins. The FCS concentration would not exceed 0.057 g FCS/in² of the final food contact article. The FCS will not be used as a component of bottles.

617

The FCS is intended for use as a component of food contact articles in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.

The FCS may be used alone, as a blend, or may be co-extruded with other resins. The FCS, when blended, will be mixed with only non-polyolefins. The FCS concentration would not exceed 0.059 g FCS/in² of the final food contact article. The FCS will not be used as a component of bottles.

618

As a processing agent in the production of polyethylene terephthalate (PET) food-contact materials.

At a level not to exceed 2.0 percent-by-weight of PET under Conditions of Use C through G, as described in Table 2.

619

For use as a catalyst in the crosslinking reaction of vinyl functional polysiloxanes with hydrogen functional polysiloxanes to form silicone elastomers complying with 21 CFR 177.2600(c)(4)(i) for repeated use food contact articles.

The maximum use level of the FCS is 45 ppm in finished silicone elastomers that may contact with food under all Conditions of Use, consistent with the limitations as described in 21 CFR 177.2600(c)(4)(i).

621

As a component of repeat-use articles intended to contact all food types at all temperatures up to and including oven cooking temperatures.

624

As a component of food contact articles.

Intended to contact all types of food under Conditions of Use A through H as described in Tables 1 and 2.

625

As an antimicrobial additive that may be used alone or in combination with other processes in the commercial sterilization of polyethylene terephthalate (PET) food packaging prior to filling.

1. The composition of the food-contact substance mixture will not exceed 1 percent (by weight) 1-hydroxyethylidine-1,1-diphosphonic acid with or without 1500 parts per million (by weight) of the sum components of the adjuvant solution.
2. The surfaces of the polyethylene terephthalate (PET) packaging will be drained, rinsed, and drained again following the application of the food-contact substance mixture.
3. Packaging treated with the food-contact substance mixture is limited to contact with the dairy foods described in 21 CFR 170.3(n)(10) and (31).

626

As an antioxidant in vinyl chloride polymers and linear low density polyethylene.

(1) For use at levels not to exceed 1 percent by weight of finished vinyl chloride polymers in contact with all food types under Conditions of Use B through H, as described in Table 2.
(2) For use at levels not to exceed 0.25 percent by weight in linear low density polyethylene complying with 21 CFR 177.1520(c), items 3.1 and 3.2, where the density of the polymer is not greater than 0.94 gram per cubic centimeter. Linear low density polyethylene articles containing the FCS may be used in contact with dry (with no free surface fat or oil), aqueous, acidic, and alcoholic food (up to 15 percent alcohol), under Conditions of Use B through H, as described in Table 2. The food contact substance may contain no more than 1 percent by weight triisopropanolamine (CAS Reg. No. 122-20-3).

627

As a component in the manufacture of articles intended to contact food.

The FCS is intended to contact all types of food under Conditions of Use A through H, as described in Table 2. Adjuvant substances permitted for use in rubber-modified polystyrene complying with 21 CFR 177.1640 may be used in the copolymer that is the subject of this notification, subject to any limitations in the authorizing regulation or notification.

628

For use as an oil and grease repellent in the manufacture of paper and paperboard.

The FCS may be added during the paper making process:
(1) to the pulp slurry (wet-end) at a level not to exceed 0.5 weight percent of dry, finished paper, for use in contact with food under Conditions of Use A through H, as described in Table 2 or
(2) at the size press at a level not to exceed 0.7 weight percent of dry, finished paper, for use in contact with food under Conditions of Use C through G, as described in Table 2.

629

As a flow agent for sorbitol acetal clarifying agents complying with 21 CFR 178.3295 Clarifying agents for polymers, or an effective food-contact notification. The FCS will be used at levels not to exceed 200 parts per million in polypropylene homopolymers and copolymers complying with 21 CFR 177.1520 Olefin polymers.

The polymers in which the FCS will be used are intended to contact all food types under Condition of Use A through H.

630

For use as a blowing agent for polystyrene food-contact articles.

The FCS will be used at levels not to exceed 3 weight-percent of the foaming formulation.

631

As a component in blends with polypropylene (homopolymers and copolymers) for use in contact with food.

The FCS is intended to contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is used such that the level of the FCS (fraction by weight of polypropylene) multiplied by the thickness of the polypropylene layer containing the FCS in micrometers (μm) does not exceed the value of 3.7.

632

As a processing aid during extrusion and molding of polymer articles in contact with food.

The FCS will be used at levels not to exceed 0.5 percent by weight in the finished articles in contact with all food types and Conditions of Use A through H, as described in Tables 1 and 2.

633

The FCS will be used as a processing aid in the manufacture of paper and paperboard intended to contact food.

The FCS will be used at a maximum level of 2 kg per ton of dry paperboard. The finished paperboard containing the FCS will be used in paperboard coated with a regulated polymeric film or polymeric film/aluminum foil which will contact only food types I, II, IV-B at room temperature or below (i.e., 120°F or below).

634

As a component of an adjuvant solution mixed with a peroxyacetic acid solution intended for use in sterilizing polymeric food-contact packaging.

(1) The final peroxyacetic acid mixture shall contain not more than 2200 milligrams per liter of the FCS.
(2) After application of the final peroxyacetic acid mixture to the food-contact surfaces of the food packaging, these surfaces will be rinsed with sterile water.
(3) The peroxyacetic acid mixture containing the FCS may be used by itself or in combination with other processes to treat food packaging to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR 113.
(4) Packaging materials treated with the final peroxyacetic acid mixture may be used for packaging all commercially sterile foods under Conditions of Use A through H as described in Table 2.
(5) Processed foods packaged in materials treated with the final peroxyacetic acid mixture shall conform with 21 CFR 108, 110, 113, and 114 as applicable.

635

For use as films or articles intended for contact with aqueous, acidic, low-alcohol (up to 15 percent alcohol), and fatty foods under Conditions of Use A through H as described in Table 2, and for use in contact with high-alcohol foods under Conditions of Use E through G as described in Table 2.

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).

636

For use as an optical brightener in paper and paperboard.

The food-contact substance is intended for use as an optical brightener in paper and paperboard 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 pound per ton of paper; and (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, the brightener is limited to use at levels not to exceed 0.25 pound per ton of coated paper.

637

As a component in the manufacture of articles intended to contact food.

The FCS is intended to contact all types of food under Conditions of Use A through H, as described in Table 2.

638

As a colorant for use in authorized poly(ethylene phthalate) polymers, including those modified with 1,4-cyclohexanedimethanol.

The FCS will be used at levels not to exceed 0.1 percent by weight in the finished poly(ethylene phthalate) polymers, for contact with food under Conditions of Use D through G as described in Table 2.

639

As an antioxidant/stabilizer for use in (1) styrene block polymers, and (2) polystyrene and rubber-modified polystyrene.

1. At levels not to exceed 0.3 percent by weight of styrene block polymers complying with 21 CFR 177.1810 in contact with Food Types I, II, IV-B, VI, VII-B, and VIII under Conditions of Use C through H, as described in Tables 1 and 2.
2. At levels not to exceed 0.1 percent by weight of polystyrene and rubber-modified polystyrene complying with 21 CFR 177.1640 in contact with all Food Types under Conditions of Use A through H as described in Tables 1 and 2.

641

As an antimicrobial to control microorganisms in wash water used to manufacture lactose.

The components of the food-contact substance are limited to use in wash water at levels not exceeding: 30 parts per million peroxyacetic acid; 140 parts per million hydrogen peroxide; and, 3.2 parts per million hydroxyethylidine-1,l-diphosphonic acid.

642

As an electron beam (EB) curable laminating adhesive, for use in multilayer films when separated from food by a barrier layer.

The barrier layer must have barrier properties equal to or greater than 0.0015 inch thick low density polyethylene (LDPE). The adhesive will be applied at a maximum thickness of 1.5 pounds per 3000 square feet of packaging area and will be cured by exposure to EB radiation at a dosage ranging from 3.2 to 3.7 Mrads. The EB-cured adhesive may be used in contact with all Food Types under temperature conditions equivalent to FDA's Conditions of Use C through G as described in Tables 1 and 2.

643

For use as a dispersant for pigments used as colorants for all food-contact polymers.

The FCS will be used at levels not to exceed 1 percent by weight of pigment. The pigmented articles may contact all Food Types under the Conditions of Use A through H, as described in Table 2.

644

As an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables that are not raw agricultural commodities.

(1) For use in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500-ClO₂-D, Modified for use with the Hach Spectrophotometer, or UV absorbance at 360 nm.
(2) Chlorine dioxide produced through the CLOSURE™ process produces a concentrated solution that contains at least 600 ppm chlorine dioxide, and no greater than 10 ppm chlorite and 90 ppm chlorate.
(3) When used in water to wash fruits and vegetables, treatment of the fruits and vegetables shall be followed by a potable water rinse or by blanching, cooking, or canning.

645

As an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables that are not raw agricultural commodities in an amount not to exceed 3ppm residual chlorine dioxide as determined by methods specified in 21 CFR 173.300. The treated fruits or vegetables will be further processed by blanching, canning or cooking, or consumed as fresh-cut fruits and vegetables.

The chlorine dioxide solution contains at least 90 percent by weight of chlorine dioxide with respect to all chlorine species as determined by Method 4500- C10₂E.

646

As an oil and grease resistant treatment for paper and paperboard employed either prior to the sheet forming operation or at the size press.

The FCS may be used at a level not to exceed 0.69 percent by weight (0.37 percent by weight fluorine) of dry paper and paperboard intended for use in contact with all Food Types under Conditions of Use B through H as described in Table 2.

647

For use as a UV light stabilizer in Polystyrene complying with 21 CFR 177.1640, styrene block copolymers complying with 21 CFR 177.1810, acrylonitrile copolymers and resins complying with 21 CFR 181.32 and Polypropylene(PP) complying with 21 CFR 177.1520.

a. Polystyrene complying with 21 CFR 177.1640, styrene block copolymers complying with 21 CFR 177.1810 acrylonitrile copolymers and resins complying with 21 CFR 181.32 at levels not to exceed 0.5 weight percent of the finished polymers in contact with all foods under Conditions of Use E through G as described in Tables 1 and 2 and
b. Polypropylene (PP) complying with 21 CFR 177.1520, at a level not to exceed 0.25 weight percent of the finished polymer in contact with all foods except high-alcohol foods, under Conditions of Use E through G as described in Tables 1 and 2.

649

For use as a basic resin in food-contact articles.

The modifier shall not exceed 5 percent by weight of the final polymer. Used in contact with all types of foods under Conditions of Use C through G as described in Table 2.

650

The FCS is intended for use as a component of a linear low-density polyethylene (LLDPE) oxygen scavenging barrier layer, which is used as a non-food contact layer in multilayer LDPE bottles.

The non-food contact oxygen scavenging LLDPE layer will contain hydrogenated styrene butadiene at a level not to exceed 5 weight percent and cobalt stearate at a level not to exceed 250 ppm and will be used in multilayer LDPE bottles for contact with all food types under the Conditions of Use C through G, as described in Tables 1 and 2.

652

As an ultraviolet light absorber in polyethylene phthalate polymers intended for use in contact with food.

For use at levels not to exceed 0.7 percent by weight of polyethylene terephthalate polymers complying with either 21 CFR 177.1630, or an effective Food Contact Notification. The finished polymers may be used in contact with aqueous and acidic foods under Conditions of Use B through H, and in contact with alcoholic and fatty foods under Conditions of Use C through G as described in Table 2.

653

As a fluid absorbent in food contact materials.

The FCS may be used in contact with poultry, red meat, fish, fruits and vegetables under Conditions of Use E through G as described in Table 2.

654

The FCS is intended for use as a dry-strength agent, fixing agent, or retention aid in paper and paperboard.

The FCS will be applied prior to the sheet-forming operation during the manufacture of paper and paperboard, at a level not to exceed 1.0 percent polymer by weight of the finished dry paper or paperboard. The FCS will be used in contact with all food types under Conditions of Use B through G as described in Table 2.

656

As a surface modifier in colorants for polymers.

The FCS may be used at a level not to exceed 0.06 percent by weight of the finished polymer, in contact with all types of food under Conditions of Use A through H, as described in Table 2.

657

As an anionic surfactant, hydrotrope, and coupling agent in commercial, single use dishwashing rinse-aid products to be used in commercial establishments.

The FCS will be used at levels not to exceed 300 ppm in the final rinse water.

659

The FCS is intended for use as a thin coating for food packaging materials, especially for plastic film and paper.

The FCS will have a maximum thickness of 50 μm and will be applied as a coating to food packaging materials contacting all food types under Conditions of Use A through H as described in Table 2. Adjuvant substances permitted for use in nylon polymers complying with 21 CFR 177.1500 may be used in the subject copolymer subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification.

660

As a processing aid in rinse-aid products used in commercial dishwashing machines.

The FCS will be used at a concentration not to exceed 37 ppm in the final rinse water of commercial dishwashing machines.

662

For use as a clarifying agent in polypropylene and high-polypropylene olefin copolymers.

For use at a level not to exceed 5000 ppm (0.5%) by weight of the finished polymer, in contact with all types of food under Conditions of Use C through H, as described in Table 2. The polymers containing the FCS will be used only in the form of molded articles.

663

As a plasticizer for polyvinyl chloride (PVC) polymers, for single and repeated-use food-contact articles.

For use at a maximum level not to exceed 46 weight-percent in finished PVC polymers, for direct contact with Food Types I, II, IVB, VIA, VIB, VIIB, and VIII, under the Conditions of Use E through G, as described in Tables 1 and 2.

664

The FCS will be used as a modifier of ethylene phthalate/naphthalate polymers and copolymers, excluding those modified with organic anhydrides.

N,N'-bis(phenylmethy1)hexanediamide will be used at a level not to exceed 3 weight percent of the finished food-contact article in conjunction with cobalt neodecanoate used at a level not to exceed 0.0075 weight percent (measured as cobalt) of the finished food contact article. The modified polymers may be used in the manufacture of containers for ketchup under Conditions of Use C through G as described in Table 2.

665

For use as a modifier of ethylene phthalate polymers complying with 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN.

The FCS will be used at a level not to exceed 5 weight percent of the finished food-contact article. The modified polymer may be used to manufacturre wine containers for use under the Conditions of Use C through G and in contact with Food Types VI-C (alcohol content to 15 percent) as described in Tables 1 and 2.

666

The FCS is intended for use as a dry-strength agent, fixing agent, and/or retention aid, in the manufacture of paper and paperboard.

The FCS will be applied prior to the sheet-forming operation at a level not to exceed 0.5 percent polymer by weight of the finished dry paper or paperboard. The FCS will be used in contact with all food types under Conditions of Use B through G, as described in Tables 1 and 2.

668

As an antimicrobial agent to be applied to red meat (including meat parts and organs), raw agricultural commodities, processed, comminuted or formed meat products, and seafood.

The FCS is to be manufactured as described in the notification. The FCS will be applied to food commodities in accordance with current industry GMPs, in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500-C102-E (referenced at 21 CFR 173.300(a)(2)) or an equivalent method. The following conditions apply according to use:

Food Commodity Type	Conditions of Use
Red meat (including meat parts and organs)	The FCS will be applied as a spray to red meat, meat parts and organs or as a dip to red meat parts and organs.
Processed, comminuted or formed meat products	The FCS will be applied as a spray or dip, unless precluded by standards of identity in 9 CFR 319, prior to the packaging of food for commercial purposes. The FCS will not be used on ready-to-eat meats.
Raw agricultural commodities	The FCS will be applied as a spray or dip in the preparing, packaging or holding of food for commercial purposes, consistent with the FD&C Act section 201(q)(1)(B)(i) but not applied for use under 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II) or (q)(I)(B)(i)(III) of the FD&C Act. Treatment of raw agricultural commodities shall be followed by a potable water rinse or by blanching, cooking or canning.
Seafood	The FCS will be used in water and ice that are used to rinse, wash, thaw, transport or store seafood. Treatment of seafood products that will be consumed raw shall be subjected to a potable water rinse prior to consumption.

669

As a colorant in food-contact polypropylene (PP).

The finished food-contact PP may contain up to 0.1 percent by weight of the colorant and contact all food types under Conditions of Use E through G, as described in Table 2.

670

As an antimicrobial additive that may be used alone or in combination with other processes in the commercial sterilization of polyethylene terephthalate and high density polyethylene food packaging prior to filling.

1. The composition of the food-contact substance mixture will not exceed 1 percent (by weight) 1-hydroxyethylidine-1,1-diphosphonic acid with or without 1500 parts per million (by weight) of the sum components of the adjuvant solution.
2. The surfaces of the polyethylene terephthalate and high density polyethylene packaging will be drained, rinsed, and drained again following the application of the food-contact substance mixture.
3. Packaging treated with the food-contact substance mixture is limited to contact with low acid foods as defined in 21 CFR 113.3(n) and described in 21 CFR 170.3(n)(3),(7),(l0),(31),(33), and (35).

671

As a component of adhesives used in contact with food, compliant with 21 CFR 175.105; and as a component of pressure-sensitive adhesives used as the food-contact surface of labels and/or tapes applied to food, compliant with 21 CFR 175.125(a) or (b).

For single and repeated use at a level not to exceed 10 percent by weight in the adhesive product, which constitutes less than 50 percent by weight of the finished food-contact article.

673

The FCS is intended for use as a stabilizer for bleach used in the production of food-contact paper and paperboard, added at the wet end.

The FCS shall be used at levels not to exceed 0.18 percent as active ingredient by weight of the dry pulp. Food-contact paper and paperboard containing the FCS are intended to contact all food types, subject to no temperature restriction.

675

The FCS is intended for use as a preservative in aqueous coatings formulated using components permitted for use in coatings and/or in coating components complying with 21 CFR 175.300.

The FCS will be used at a level not to exceed 45 milligrams per kilogram (based on isothiazolone active ingredient) in the aqueous coating formulation. For use with aqueous, acidic, and low-alcoholic foods under Conditions of Use A through H and with fatty food under Conditions of Use C through G, as described in Tables 1 and 2.

676

As a pigment in food-contact polymers.

Octyltriethoxysilane-modified titanium dioxide will be used at levels not to exceed 25 percent by weight of the food-contact article under Conditions of Use A through H, as described in Table 2.

677

The FCS will be used as a modifier for polyethylene terephthalate copolyesters described in Food-Contact Notification No. 72 and Food-Contact Notification No. 498.

The FCS is intended for use at levels up to 5 percent by weight of the finished food-contact article, in conjunction with up to 0.015 percent by weight cobalt stearate (measured as cobalt) of the finished food-contact article, in contact with Food Types I, II, VI-A, VI-B, and VI-C (up to 15 percent alcohol), except for carbonated soft drinks and water, as described in Table 1, under Conditions of Use C through G, as described in Table 2.

678

The FCS is to be used as an antifogging agent anchor in multi-layer polyolefin lettuce bags.

The FCS is to be used at a level not to exceed 1 weight percent in the finished food contact article under Condition of Use F as described in Table 2. The maximum amount intended to be used in the seal layer (food-contact layer) is 1 weight percent of the polymer. The maximum thickness of the seal layer is 20 microns.

679

The FCS will be blended with other polymers to improve the flexibility and durability of polymeric food-contact articles.

The FCS may be used 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.

680

As a component in the manufacture of repeated-use food-contact articles.

For substitutional use of the SAN copolymers listed in 21 CFR 182.32.

681

For use as a starting material in the production of 2,3-epoxypropyltrimethylammonium chloride (EPTAC) (CAS Reg. No. 3033-77-0) that will be used to modify industrial starch at a treatment level of greater than 5 percent and not more than 21 percent by weight of the starch to form high cationic starch (HCS). The finished HCS is intended for use as a retention aid and/or drainage aid and/or dry-strength agent employed prior to the sheet forming operation in the manufacture of all food-contact paper and paperboard.

Paper or paperboard containing the finished HCS may contact all types of food, at use levels not to exceed 1 percent by weight of the paper or paperboard under Conditions of Use A through D, and at use levels not to exceed 2 percent by weight of the paper or paperboard under Conditions of Use E through H, as described in Table 2. The modified industrial starch must be used in compliance with 21 CFR 178.3520(a)(1), (b) and (c).

684

For use as an adhesive in food contact articles.

The FCS is either separated from the food by a functional barrier or used subject to the additional limitations in 21 CFR 175.105(a)(2) and (b). The FCS may be used in contact with all food types under Conditions of Use E through G, as described in Table 2.

685

The FCS is intended for use as an optical brightener in food-contact paper and paperboard, complying with 21 CFR 176.170 (Components of paper and paperboard in contact with aqueous and fatty foods).

The FCS will be used in contact with all food types at levels not to exceed those needed to achieve the desired technical effect, except for the following:
1) when used in uncoated paper and paperboard intended for contact with food types I, II, IVB, VI, and VII-B as described in Table 1, the brightener is limited to use at levels not to exceed 0.5 lbs per ton of paper, and
2) when 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, the brightener is limited to use at levels not to exceed 0.25 lbs per ton of paper.

686

The FCS is intended for use as a nucleating agent for polypropylene homo- and copolymers.

The FCS will be used at levels not to exceed 0.32 percent by weight of the finished polymer. The finished polymer may be used in contact with all types of food under Conditions of Use B through H, as descnbed in Tables 1 and 2.

687

As a modifier in the manufacture of polylactide(PLA) polymers for single-use food-contact articles.

For use at levels not to exceed 20 weight percent in PLA polymers in contact with all food types under Conditions of Use B through H, as described in Table 2.

688

As a polymerization regulator in the polymerization of vinyl chloride homopolymers and copolymers used in contact with food.

The maximum use level of the FCS is 500 ppm by weight of vinyl chloride monomer. The FCS is intended to contact all types of food under Conditions of Use A through H described in Table 2.

689

As articles or component of articles intended to contact food.

For use in contact with all types of food excluding foods containing greater than 13 percent by volume alcohol under Conditions of Use C through G, and for use in foods containing up to 25 percent by volume alcohol under conditions of use E through G, as descnbed in Table 2.

691

1) The composition of the food-contact substance mixture will not exceed 1 percent (by weight) 1-hydroxyethylidine-1,1-diphosphonic acid with or without 1500 parts per million (by weight) of the sum components of the adjuvant solution.
2) The surfaces of the polyethylene terephthalate and high density polyethylene packaging will be drained, rinsed, and drained again following the application of the food-contact substance mixture.

692

For use as an antimicrobial agent in a solution for the re-hydrating of fresh fruits and vegetables including leafy green vegetables.

The pH of the FCS will be controlled and kept between 6.0 and 7.3. On-site generation of the hypochlorous acid solution will occur every 24 hours. The concentration of available free chlorine will be limited to 60 ppm, and the FCS will be replaced after use if the concentration falls below 25 ppm available free chlorine. Leafy greens or other uncut fruits and vegetables will be soaked in a 20 gallon solution of the FCS in five pound loads for a minimum of five minutes and a maximum of ten minutes. The FCS solution will drain off of the fresh produce for a minimum of ten minutes before the produce is used for display or prepared for consumption.

694

As a colorant dispersant for use in all food-contact polymers.

For use at levels not to exceed 0.1 percent by weight of the finished polymer, in contact with all types of food under Conditions of Use A through H as described in Table 2.

695

To be used as a reactant with one or more of the polybaslc actds or polyhydric alcohols m the formation of coatmgs on metal substrates intended for use m food-contact apphcatlons, complymg with 21 CFR 175 300(b)(3)(vii).

The FCS will be used in contact with all food types under Conditions of Use A through H, as descrthed in Tables 1 and 2.

697

As an antimicrobial agent used to preserve food contact polymers intended for repeat use articles.

The silver content of the FCS shall not exceed 5.0 percent by weight. The finished, repeat-use polymer may contain up to 5.0 percent by weight of the FCS and contact all food types under Conditions of Use A through H as described in Table 2.

698

The FCS is intended for use as an antimicrobial active ingredient of industrial technical formulations for use in preserving polymeric latex emulsion products destined for use in the manufacture of paper and paperboard.

The FCS will be used as a preservative in latex emulsions used as a component in paper/paperboard in compliance with 21 CFR 176.170 and 176.180. The use level will not exceed 35 ppm in latex emulsions. For use with aqueous, acidic, and low-alcoholic foods under Conditions of Use A through H and with fatty food under Conditions of Use C through G as described in Tables 1 and 2. More specifically, the FCS will be added to polymer emulsions to prevent fungal growth during storage and shipment of the polymer emulsion.

699

As an antimicrobial to control microorganisms in ice and wash water used to commercially prepare fish and seafood.

The components of the food-contact substance are limited to use in ice and wash water at levels not exceeding: 190 parts per million peroxyacetic acid; 75 parts per million hydrogen peroxide; and, 10 parts per million hydroxyethylidine-1,l-diphosphonic acid.

701

To be used as an inhibitor for platinum catalysts to prevent premature cross linking of vinyl functionalized polysiloxanes with hydrogen hctionalized polysiloxanes to form silicone elastomers in compliance with 21 CFR 177.2600 (Rubber articles intended for repeated use).

The finished, repeat-use polysiloxane article may be used in contact with all food types under Conditions of Use A through H and J as described in Tables 1 and 2. Ththmel F.C S may be used at levels not to exceed 1000 ppm in the finished article that has a thickness no greater than 2 mm.

702

As a component in the manufacture of articles intended to contact food.

The FCS may be used in contact with all food types under Conditions of Use B through H, as described in Table 2. Adjuvant substances permitted for use in polycarbonate resin complying with 21 CFR 177.1580 may be used in the polymer that is the subject of this notification, subject to any limitations in the authorizing regulation or notification.

704

The FCS is intended for use as a preservative in resinous and polymeric coatings for polyolefin films complying with 21 CFR 175.3201.

705

As a finish component on polyolefin and polyethylene phthalate resins that are constructed into non-woven fabric for meat pads.

The FCS will be used at a level not to exceed 18 micrograms per square inch of the meat pad in contact with red meat, poultry, and seafood under Conditions of Use E through G as described in Table 2

706

As a finish component on polyolefin and polethylene phthalate resins that are constructed into non-woven fabric for meat pads.

The FCS will be used at a level not to exceed 18 micrograms per square inch of the meat pad in contact with red meat, poultry, and seafood under Conditions of Use E through G as described in Table 2

707

The FCS is intended for use as (1) a dispersant for fillers (e.g., clay, calcium carbonate, etc.) in the wet-end during the manufacture of paper and paperboard intended for food-contact use, and (2) as an anti-scale additive during the processing /evaporation of raw beet and cane sugar juice.

(1) The FCS shall be used at levels not to exceed 0.5% by weight of the fiber in the wet-end of manufacture of paper and paperboard. The finished food-contact paper and paperboard containing the FCS are intended to contact all food types, under conditions of use A through H as described in Tables 1 and 2. (2) The concentration of the FCS in the finished sugar(s) shall not exceed 5 parts per million (ppm) by weight.

708

As articles or components of articles used in contact with food.
REPLACES FCN 449

The FCS will be used in contact with all food types under Conditions of Use A-H, as described in Tables 1 and 2. Propylene/ethylene copolymers having a density of 0.85-0.91 and a minimum number-average molecular weight of 35,000 Daltons. Adjuvant substances permitted for use in olefin copolymers complying with 21 CFR 177.1520(c), items 3.1 or 3.2 may be used in the subject copolymers, provided that the limitations on the use of the adjuvant substances are met.

709

As an aid for grinding calcium carbonate filler to be used in food-contact polyolefin food-contact materials.

For use at levels not to exceed 0.25 percent by weight of the finished polymer, in contact with non-acidic, non-alcoholic foods, including food types I, IVA, IVB, V, VIB, VIIA, VIIB, VIII, and non-acidic type III foods, under Conditions of Use E through G as described in Tables 1 and 2.

710

As a colorant component in the top coat for paper and paper board which are used for packaging all kinds of foodstuff for marking paper.

The FCS level in paper will not exceed 0.5 g/in². The FCS is intended to contact all types of food under Conditions of Use E through G described in Table 2.

711

The FCS is intended for use in the manufacture of food-contact polymer films and coatings.

Finished articles containing the FCS may be used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2, respectively.

712

To be used in an aqueous dispersion (about 33 percent by weight of the solids content) where the FCS exists as highly crosslinked poIy(methy1 methacrylate)/l,4-butanediol diacrylate microspheres, which contains fluorescence colorants. The FCS is to be used as a top coat for paper and paperboard to enable the authentication of paper and paperboard products.

The FCS will be used for paper and paperboard that may contact all food types under Conditions of Use E through G as described in Tables 1 and 2. The paper additive is added in amounts not to exceed 0.9 percent in the final solid coating on paper. The paper and paperboard will be coated with 10 - 15 g/m² corresponding to 0.64 - 0.967 g/100 in² of the topcoat.

713

As a nucleating agent in propylene homopolymers complying with 21 CFR 177.1520(a)(l)(i) and (ii) and in propylene copolymers complying with 21 CFR 177.1520(a)(3)(i) or in propylene homopolymers and copolymers that are the subject of an effective notification.

For use at levels not to exceed 0.2 percent by weight of the finished polypropylene food-contact material. Food-contact articles containing the FCS can be used in contact with all food under Conditions of Use A through H as described in Table 2.

715

The FCS is intended to be used as a component of repulpable tape adhesives used in the manufacture of food-contact paper and paperboard.

The FCS will be used for the manufacture of food-contact paper and paperboard products. 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.

716

REPLACED BY FCN 818

717

For use as an anti-scaling or release agent, applied to the internal parts of reactors employed in the production of ethylene-vinyl acetate food-contact copolymers.

The residual level of the formaldehyde polymer with 1-naphthalenol in the ethylene-vinyl acetate food-contact copolymers will not exceed 4 parts per million..

719

As a stabilizer in propylene polymers and copolymers compliant with 21 CFR 177,1520

The FCS may be used at levels not to exceed 0. 20 parts per hundred of propylene polymers and copolymers which meet the specifications in 21 CFR 177.1520(c). The FCS may be used in contact with aqueous and acidic foods under Conditions of Use B through H and in contact with alcoholic foods under Conditions of Use C through G, as described in Tables 1 and 2.

720

To be used in ethylene vinyl alcohol (EVOH) polymers complying with 21 CFR 177.1360 and in polyolefin polymers complying with 21 CFR 177.1520, which may contact food.

The FCS will be used at levels not to exceed 5% by weight in EVOH polymers and in polyolefin polymers, which may contact all food types under Conditions of Use B through H as described inTables 1 and 2.

721

For use as a component of non-food-contact layers of multilayer articles; the thickness of the FCS component of the non-food-contact layer will not exceed 85 µm and will be separated from food by one or more layers of PET having a total thickness of at least 85 µm.

(1) In contact with all food types under all conditions of use as described in Tables 1 and 2. (2) Adjuvant substances permitted for use in nylon polymers complying with 21 CFR §177.1500 may be used in the subject copolymer subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification.

722

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

The FCS may represent 100% of the coating formulation and is applied at a level not to exceed the amount required to achieve the desired technical effect.

724

As an antimicrobial agent to control microbial growth in wash and chilling water that contacts fruits and vegetables that are not raw agricultural commodities.

The FCS will be used in process water such that the level of hydrogen peroxide will not exceed 120 ppm, peroxyacetic acid will not exceed 80 ppm and HEDP will not exceed 9.6 ppm.Tables 1 and 2.

725

The FCS is intended for use as a resin in the manufacture of food contact articles intended for single and repeat-use.

The food contact substance (FCS) is intended to be used in articles intended for single and repeat-use in contact with food types I-IX under Conditions of Use A through H, and J (cooking temperatures above 250^oC) as described in Tables 1 and 2.

726

As food-contact articles or components of food-contact articles.

For use in direct contact with all food types, including ready-cooked food such as baby food which will be heated in a microwave oven at temperatures exceeding 250^oF, i.e., under the Conditions of Use A through H, and J, as described in Table 2.

727

As a component of repeat-use food contact articles including bakeware.

The FCS may be used in contact with all food at temperatures up to 260^oC (500^oF).

728

The FCS will be used as a part of the process to treat food-contact surfaces of polymeric food packaging to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for by 21 CFR Part 113, and as an antimicrobial on all polymers used to package acidic foods.

The maximum concentration of 1-hydroxyethylidine-1,1-diphosphonic acid in the food-contact substance solution will not exceed one percent of the solution. After application of the solution to the food packaging, the solution is rinsed from the package surface with sterile water. If the packaging surface is a film, the solution may be mechanically stripped in accordance with good manufacturing practice rather than rinsed from the food-contact surface. If the excess solution is to be mechanically stripped rather than rinsed, the concentration of the food-contact substance in the treatment bath must be reduced at least 37.5 fold (i.e. from 15 percent to 4,000 parts per million or less peroxyacetic acid), maintained at that dilution during operations, and drained and recharged with fresh solution when the total volume of the food-contact substance added as makeup reaches 90% of the volume of the solution bath reservoir.

729

The FCS will be used as a component in the manufacture of repeated use food-contact articles.

The finished food contact article containing the FCS is intended to contact all types of food at temperatures up to and including 100°C Tables 1 and 2.

730

The FCS is intended for use as an antimicrobial agent for finished coating formulations for paper and for additives to the finished coating formulations including starch slurries, sizing solutions, pigments, fillers, and binders used in the manufacture of paper and paperboard.

For use at levels not to exceed 0.0085 gallons (0.032 liter) per metric ton of coating formulation.

731

As a component of films intended to contact food

The FCS may be used in contact with all food types under Conditions of Use A through H and J (for dual-ovenable containers), as described inTables 1 and 2. The FCS may be used in cook-in-bag/packaging film applications and in multi-layer film applications at temperatures up to 375°F for 4 hours. The films will have a maximum thickness of 1 mil (0.001 inch) of the FCS. Adjuvant substances permitted for use in Nylon 6/66 polymers may be used in the subject copolymer subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification.

732

As a processing aid in the manufacture of petroleum wax that may be used as a direct food ingredient in compliance with CFR 172.886 and as a food-contact substance in compliance with 21 CFR 178.3710.

The concentration of the FCS remaining in the finished wax will not exceed 1,050 ppm.

733

For use as an adhesive in laminate structures that are intended for use at retort temperatures.

For use only in retort pouches intended for use in contact with all food types at temperatures not to exceed 135^oC (275^oF).

734

For use as an antioxidant in lubricants with incidental food contact under conditions of use A through H as described in 21 CFR 176.170(c), Table 2

Not to exceed a maximum concentration of 0.5 percent by weight of the lubricant.

735

The FCS is a special-shaped molded ring (seal) that prevents processed food from contacting other moving parts of machinery (e.g., pistons, rods, etc.).

For repeat use as a molded article (seal) in single use applications under conditions of use B-H with all food types except VI-A and VI-C inTables 1 and 2.

736

As a processing additive for all polymers for use in contact with food.

The FCS may be used at levels up to 1000ppm in the finished polymer. The FCS will be manufactured as described in the notification. The FCS will be used in contact with all food types and under Conditions of Use A through H, as described in Table 2.

737

As a component of food contact articles.

Intended to contact all types of food under Conditions of Use J, as described in Tables 1 and 2.

739

For use on poultry carcasses, carcass parts, poultry meat, organs, or related parts or trim as an antimicrobial agent in poultry processing waters, as a component of a carcass spray or a dip solution.

The additive is produced by mixing an aqueous solution of sodium chlorite with any generally recognized as safe acid to achieve a pH in the range of 2.2 to 3.0, then further diluting this solution with a pH elevating agent to achieve the final sodium chlorite concentration.
When used as a carcass spray or dip on poultry carcasses, carcass parts, poultry meat, organs or related parts or trim, the final sodium chlorite concentration does not exceed 1200 mg/kg, and the chlorine dioxide concentration does not exceed 30 mg/kg. The pH of the use solution is between 5.0 and 7.5.
When used in a pre-chiller or chiller solution on poultry carcasses and poultry carcass parts, the additive is used at a level that results in sodium chlorite concentrations between 50 and 150 parts per million. Contact times may be up to several minutes at temperatures between 0 and 15^oC.

740

As a component of UV-cured pressure-sensitive adhesives used as the food-contact surface of labels and/or tapes applied to food, compliant with 21 CFR 175.125(a) or (b).

For use in UV-cured pressure-sensitive adhesives for food-contact under the Conditions of Use D through G, as desribed in Table 2.

741

The FCS will be used as articles or components of articles intended to contact all food types under Conditions of Use A through H, as described in Table 2.

Ethylene/hexene copolymers shall have a density of 0.87 - 0.93 and a minimum number-average molecular weight of 14,000 Daltons. Adjuvant substances permitted for use in olefin copolymers complying with 21 CFR 177.1520(c), items 3.1 or 3.2 may be used in the manufacture of the subject copolymers, provided the limitations on the use of the adjuvant substances are met.

742

As a basic polymer used in the production of articles (including non-PET bottles) intended to contact food.

The FCS may be used in contact with all food types under Conditions of Use A through H and J (for dual-ovenable containers) as described in Table 2.

743

As a friction reduction additive in polyethylene terephthalate (PET) resins used in the production of containers and packaging films that may contact food.

The finished PET resins may be used in contact with all Food Types under Conditions of Use E through G as described in Tables 1 and 2. The maximum use level of the FCS is 0.5 percent by weight in the final PET product.

744

The FCS is intended for use as a plasticizer in polymers for use:
1) in adhesives that comply with 21 CFR 175.105,
2) in pressure sensitive adhesives that comply with 21 CFR 175.125, and
3) as a coating or component of paper or paperboard intended for use in contact with dry foods with no free surface fat or oil in compliance with 21 CFR 176.180.

The FCS may be used in contact with:
1) all food types when used in adhesives,
2) all food types when used in pressure sensitive adhesives, and
3) with food type VIII as described in , Table 1, when used as a coating or component of paper or paperboard.

745

As a component in the manufacture of articles, except bottles, intended to contact food.

For use in contact with all food types under Conditions of Use C through H as described in Tables 1 and 2.

746

As an oil/grease resistant sizing agent employed prior to the sheet forming operation and/or at the size press in the manufacture of paper and paperboard.

For use at a level not to exceed 0.75 percent by weight of dry paper and paperboard intended for use in contact with all foods under Conditions of Use A through H, as described in Table 2.

748

The FCS is intended for use as a UV absorber in polyethylene terephthalate (PET) polymers complying with 21 CFR 177.1630.

The food contact substance (FCS) would be used at a level not to exceed 0.5 weight percent of the finished polymer in contact with aqueous, acidic, and alcoholic food used under Conditions of Use E through G, and fatty foods used under Conditions of Use C through G as described in Table 2.

749

For use as a component of food-contact articles.

The FCS may be used in contact with fatty foods under Conditions of Use C through G as described in Table 2. The FCS may be used alone, as a blend, or may be co-extruded with other resins. The FCS use level will not exceed 0.024g FCS/in² of the final food contact article. Adjuvant substances permitted for use in ethylene-vinyl acetate-vinyl alcohol copolymers complying with 21 CFR 177.1360 may be used in the copolymer that is the subject of this notification, subject to any limitations in the authorizing regulation or notification.

750

For use as:
1. a plasticizer at levels up to 34 percent by weight in polyvinylchloride bottle cap sealing rings for use in contact with all foods under Conditions of Use B through H, as described in Table 2;
2. a plasticizer at levels up to 3 percent by weight in polymers used to manufacture articles intended for repeated-use in contact with all foods under Conditions of Use E through H, as described in Table 2; and,
3. a colorant carrier or dispersant at levels up to 0.5 percent by weight in polymers used to manufacture articles intended for repeated-use in contact with all foods.

SEE INTENDED USE

751

To control the formation of mineral scale during evaporation of beet or cane sugar juice.

752

For use only as an antiscaling or release agent, applied on the internal parts of reactors employed in the production of ethylene-vinyl chloride food-contact copolymers.

The residual level of the FCS in the copolymers will not exceed 4 parts per million.

757

1) As an additive in pressure-sensitive adhesives that comply with 21 CFR 175.125, and
2) As an additive in propylene homopolymers and copolymers complying with 21 CFR 177.1520(c) or that are the subject of an effective food contact notification.

1) When used as an additive in pressure-sensitive adhesives, the FCS is intended to be used at levels up to 25 percent and it is intended to contact all types of food as described in Table 1
2) When used as an additive in propylene homopolymers and copolymers, the FCS has a minimum kinematic viscosity at 100^oC of 3.8 centistokes. The FCS is intended to be used at levels up to 10 percent in propylene homopolymers and copolymers and it is intended to contact food types I, II, IVB, VIA, VIB, VIC (up to 15 percent alcohol), VIIB and VIII under Conditions of Use A through H as described in Tables 1 and 2.

758

As a component of lubricants with incidental food contact in repeat use applications.

For use at a level not to exceed the minimum amount needed to achieve the desired technical effect.

759

As a lubricant/release agent in the manufacture of repeat-use, food-contact polycarbonate.

762

For use as a lubricant on bakery oven chains with incidental food contact.

The FCS is to be used in ovens making baked goods at temperatures up to 1000^oF.

765

To be used as a colorant in films, bottles, or tubes that may store food made of low-density polyethylene, high-density polyethylene, polyethylene terephthalate, acrylonitrile-butadiene-styrene terpolymer, polypropylene, polycarbonate, polystyrene, and nylon resins.

The FCS is to be used in repeat-use plastic containers at levels not to exceed 1 percent by weight of the final product that may contact all food types under Conditions of Use E through G, as described in Tables 1 and 2. The usage temperature would not exceed 70^oC.

766

The FCS will be used as an adhesive in laminate structures that are intended for use at retort temperatures.

The finished FCS will be used only in the manufacture of retort pouches at temperatures up to 275^oF and in contact with all food types, except those containing more than 8 percent alcohol.

767

The FCS will be used as an antioxidant in the manufacture of olefin polymers complying with the provisions of 21 CFR 177.1520(c), items 3.2c, 3.4, and 3.6.

The FCS will be used at levels not to exceed 0.2 percent by weight of the finished articles. The FCS may be used in contact with all types of food under Conditions of Use C through H (in olefin copolymers complying with 21 CFR 177.1520(c), item 3.2c) or A through H (in olefin copolymers complying with 21 CFR 177.1520(c), items 3.4 and 3.6), as described in Tables 1 and 2.

768

As an antioxidant for olefin polymers.

As an antioxidant for olefin polymers complying with 21 CFR 177.1520(c), Section 3.6, at levels not to exceed 0.25 percent by weight of the finished article in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.

769

As a modifier of ethylene phthalate/naphthalate polymers and copolymers excluding those modified with organic anhydrides.

The FCS will be used at a level not to exceed 3 weight percent of the finished food-contact article in conjunction with cobalt neodecanoate used at a level not to exceed 0.0075 weight percent (measured as cobalt) of the finished food contact article. Finished food-contact articles containing the FCS may be used in the manufacture of containers for contact with food types I, II, VI-A (alcohol content up to 15 percent) and VI-B, except carbonated beverages and water, under Conditions of Use C through G, as described in Tables 1 and 2.

770

(1) At a level not to exceed 35 percent by weight of finished plasticized vinyl chloride polymer formulations used in repeated-use food contact applications at temperatures no greater than 100^oC;
(2) As a component of a paper or paperboard, or coatings for such paper and paperboard intended for use in contact with dry foods with no free surface fats or oil in compliance with 21 CFR 176.180 Components of Paper and paperboard in contact with dry food;
(3) As a component of adhesives complying with the provisions of 21 CFR 175.105 Adhesives; and,
(4) As a component of pressure sensitive adhesives complying with the provisions of 21 CFR 175.125 Pressure-sensitive adhesives.

SEE INTENDED USE

771

For use as a colorant in all food-contact polymers.

The FCS is to be used at a level not to exceed 0.2 weight percent in the finished food contact article and in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2.

772

To be used as coatings (including inks) or components of coatings (including inks) on polymeric substrates, paper and paperboard, metal substrates, or as a component in adhesives.

The cured resins may include other substances permitted for the intended use by regulation under 21 CFR. The finished coating, when tested according to the compliance test protocol set forth in the FCN, shall yield a migration level for each monomer and photoinitiator used that is the subject of this FCN that does not exceed 10 micrograms per square inch (μg/in²) and the total level of nonvolatile extractables derived from the finished coating will not exceed 10 μg/in², after correction for the migration levels for each monomer and photoinitiator used. For use in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. The food contact articles containing the coatings will meet all applicable regulations under 21 CFR.

773

As an antimicrobial agent used to preserve food-contact polymers.

The finished polymers contain the FCS at not more than 5 percent by weight. The silver content shall 1) not exceed 0.125 percent by weight in polymers to be used in aseptic packaging, 2) not exceed 0.05 percent by weight in single-use polymers other than aseptic packaging , and 3) not exceed 0.25 percent by weight in repeat-use polymers. The finished polymers are intended to contact all types of food under Conditions of Use A through H as described in Table 2.

774

The FCS will be used as a coating applied to food contact metal substrates.

The FCS may be used in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2.

775

The FCS will be used as an antimicrobial in water supplied to ice machines to make ice intended for general use in the poultry processing industry.

The FCS will be used at a level not to exceed that needed to provide the equivalent of 100 ppm of available bromine (corresponding to a maximum level of 90 mg DBDMH/kg water) in the water supplied to ice machines.

776

The FCS is a wet-strength agent, dry-strength agent, fixing agent, or retention aid, which is applied prior to the sheet-forming operation in the manufacture of paper and paperboard.

For use at a level not to exceed 1.5 percent polymer (pure polymer without water) by weight of the finished dry paper or paperboard. The FCS is intended to contact all food types under Conditions of Use B through G as defined in Table 2.

778

For use as an adjuvant for coatings applied to food-contact paper and paperboard, as described in the notification.

The FCS may be used at levels not to exceed 167 μg/in² of the finished paper and paperboard. The finished paper and paperboard may contact all food types under Conditions of Use C through G as described in Table 2.

780

As a polyester film and coating.
REPLACES FCN 372

The FCS will be used as a film or coating in contact with all food types under Conditions of Use C through G, as described in Tables 1 and 2. The maximum film thickness is not to exceed 4.7 mils (0.0047 inch).

783

As an oil/grease resistant sizing agent employed either prior to the sheet forming operation and/or at the size press in the manufacture of paper and paperboard.

For use at levels not to exceed 0.75 percent by weight of dry paper and paperboard for food-contact under Condition of Use J (microwave heat-susceptor packaging applications only), as described in Table 2.

784

As a component of emulsion-based defoamers that are used in the pulping of lignocellulosic materials that can be used in the manufacture of food-contact paper and paperboard.

The FCS shall be applied at levels ranging from 3.5 to 14 grams per metric ton of dry pulp. The FCS may be used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.

785

The FCS will be used as a modifier for polyethylene terephthalate copolyesters described in Food-Contact Notification No. 72 and Food-Contact Notification No. 498.

The FCS is intended for use in:
(1) polyethylene terephthalate copolyesters described in FCN No.72, at levels up to 5 weight percent of the finished food-contact article, in the making of repeat-use food-contact articles intended to contact aqueous, acidic, and low-alcohol food at temperatures ≤49^oC, and
(2) polyethylene terephthalate copolyesters described in FCN No. 498, at levels up to 5 weight percent of the finished food-contact article, in the making of single and repeat-use food-contact articles intended to contact Food Types I, II, IV-B, VI-A, VI-B, VI-C (up to 15 percent alcohol), VII-B, and VIII, under Conditions of Use C through G, as described in Tables 1 and 2, respectively.

787

For use as a sanitizing solution on beverage containers.

The food-contact substance is produced by mixing an aqueous alkaline solution of sodium chlorite with a GRAS acid, followed by dilution with potable water to provide a concentration of available chlorine dioxide of at least 50 parts per million and not more than 200 parts per million as determined by the method titled “Iodometric Method for the Determination of Available Chlorine Dioxide (50-250 ppm available ClO₂), copies available from Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. Treatment of the beverage containers will be followed by adequate draining.

788

The FCS will be used as a preservative in latex emulsions used as a component in paper/paperboard in compliance with 21 CFR 176.170 and 176.180. The use level will not exceed 128 ppm in latex emulsions. For use with aqueous, acidic, and low-alcoholic foods under Conditions of Use A through H and with fatty food under Conditions of Use C through G as described in Tables 1 and 2. More specifically, the FCS will be added to polymer emulsions to prevent fungal growth during storage and shipment of the polymer emulsions.

790

The FCS is to be used as an antifogging anchor agent in multi-layer polyolefin film structures for use in produce bags and for lid seals for formed trays, specifically for raw and fresh fruits and vegetables, and for lid seals where meats are packaged in formed trays.

The FCS is to be used at a level not to exceed 1 weight-percent by weight of the finished food contact polymer. The maximum thickness of the seal layer is 20 microns.

792

The FCS will be used as an antimicrobial in water applied to beef hides, carcasses, heads, trim, parts and organs.

The FCS will be used at a level not to exceed that needed to provide the equivalent of 300 parts per million (ppm) of available bromine in the water.

793

The FCS will be used as a nucleating agent in the manufacture of polypropylene food-contact articles.

The FCS will be used in the manufacture of single and repeat-use food contact articles at levels not to exceed 0.15 percent by weight of the finished food-contact article, in contact with all food types, and under Conditions of use A through H, as described in Table 2.

794

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 FCS may be added to the paper manufacturing process at a maximum level of 2 percent by weight of the dry pulp when intended for use with paper and paperboard that will contact all food types under Conditions of Use E through H described in Table 2. In addition, the FCS may be added to the manufacturing process at a maximum level of 1 percent by weight of the dry pulp when intended for use with paper and paperboard that is intended for use in contact with all food types under Conditions of Use A through H described in Table 2.

798

As a colorant for use in polyethylene terephthalate polymers complying with 12 CFR 177.1630.

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

799

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

Present in the headbox at no more than 0.31 percent by weight of the dry fiber.

800

As a strengthening agent, fixing agent, or retention aid employed prior to the sheet forming operation in the manufacture of paper and paperboard that will be used in contact with all food types under all conditions of use.

The FCS may be used at levels up to 0.4 percent by weight of the dry pulp.

801

The FCS will be used to treat food-contact surfaces of plastic containers and their enclosures to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR Part 113 or as an antimicrobial on packaging for any acidic food. The peroxyacetic acid PAA solutions will contain equilibrium concentrations of peroxyacetic acid, hydrogen peroxide (CAS Reg. No. 7722-84-l), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and water.

The targeted PAA concentration for treatment solutions applied to containers/closures is 4000 ppm or less. Treatment solution need not be rinsed from container/closure surfaces prior to introduction of food provided that the maximum application rate in terms of milliliters of treatment solution per ounce of container capacity does not exceed the value determined by dividing the PAA concentration of the treatment solution (expressed in parts per million) into an empirically determined constant value of 70 and no recycle of PAA or more concentrated makeup to the feed tank is allowed. If treatment solution is applied at a rate exceeding the amount determined by dividing the PAA concentration of the treatment solution (expressed in parts per million) into an empirically determined constant value of 70, or if PAA solution with a concentration of greater than 4000 ppm PAA is added to the treatment solution reservoir as makeup, treatment solution must be drained from the container surface and rinsed with sufficient water to achieve a theoretical 60-fold dilution of the treatment solution residue (assumed to be 1 mg/cm2, on the interior container surface following draining).

802

As a component of an adjuvant solution mixed with a peroxyacetic acid solution intended for use in treating food-contact surfaces of polymeric food containers to reduce or eliminate microbial contamination.

(1) The final peroxyacetic acid mixture shall not contain more than 2200 milligrams per liter of the FCS at the time of application to food packaging.
(2) After application of the final peroxyacetic acid mixture to the food-contact surfaces of food packaging, these surfaces will be rinsed with sterile water.
(3) The peroxyacetic acid mixture containing the FCS may be used by itself or in combination with other processes to treat polymeric food containers prior to fill to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR 113 or as an antimicrobial on packaging for any acidic food.
(4) Packaging materials treated with the final peroxyacetic acid mixture may be used for packaging all acidic foods under Conditions of Use A through H as described in Tables 1 and 2.

804

As a milling aid and dispersant for titanium dioxide used as a light stabilizer in food contact articles.

For use at levels not to exceed 2.4 percent by weight of titanium dioxide. The titanium dioxide containing the food-contact substance will be used at levels not to exceed 5 percent by weight of the food-contact article. The final articles may contact all food types under Conditions of Use A through H, as described in Table 2.

805

As a lubricant with incidental food contact.

For repeated use, in food processing machinery, such as oven-chain and conveyor belt mechanisms.

806

As a component of articles used in contact with all types of food.

Ethylene-butene copolymers may contain up to 34 weight percent polymer units derived from 1-butene, and have a density of not less than 0.86 g/cm³ and melt flow rate (190^oC) of no more than 50g/10 min. For use as a component of articles in contact with all food under Conditions of Use B through H, as described in Table 2. Adjuvant substances permitted for use in olefin copolymers complying with 21 CFR 177.1520 (c), item 3.1 may be used in the subject copolymers, provided that the limitations on the use of the adjuvant substances are met.

807

As an antimicrobial agent in water and ice that are used to rinse, wash, thaw, transport, or store seafood in accordance with current industry standards of good manufacturing practice.

The FCS is produced by diluting an aqueous solution of sodium chlorite at pH 12-13 with water to achieve an actual at use concentration of 12.5 to 25 ppm sodium chlorite. Any seafood that is intended to be consumed raw shall be subjected to a potable water rinse prior to consumption.

808

The FCS is to be used as a nucleating agent in food contact articles, specifically, single use film wrap and bottle caps and repeat use food trays and containers.

The FCS is to be used at a level not to exceed 0.32 percent by weight of finished propylene homopolymers and copolymers used for single- and repeat use articles intended to contact all food types under Conditions of Use A through H as described in Tables 1 and 2.

810

As a preservative for boiler water additive formulations.

To be used in the boiler feedwater or in the steam header, at levels not to exceed an initial concentration of 0.05 parts per million of the steam.

812

As a colorant carrier/dispersant for use in polymeric food packaging articles, e.g. beverage bottles, molded storage containers, etc.

For use in polyester, polyamide, polystyrene, polylactic acid, and acrylic polymers at levels up to 0.5 percent by weight of finished articles. For use only in contact with aqueous, acidic, and alcoholic foods containing up to 15 percent alcohol under Conditions of Use B through H as described in Table 2.

813

As a component in defoamer formulations to be used in food-contact coatings.

The FCS may be used at a level not to exceed 0.008 weight percent of the finished food-contact coating. Finished food-contact coatings containing the FCS may be used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.

814

As an antioxidant in olefin copolymers complying with 21 CFR 177.1520(c), items 3.2c, 3.4, or 3.6, or in styrene block copolymers complying with 21 CFR 177.1810.

For use at levels not to exceed 0.2 weight percent of the finished articles. Copolymers containing the FCS are used in contact with food under the Condition of Use C through H, as described in Table 2.

815

The FCS is a polyurethane coating which is used as an adhesive applied on plastics, films, paper and paperboard, and metal or coated metal used for packaging and holding all food types intended for single- and repeat-use articles.

The FCS will be used in single- and repeat-use articles in contact with all Food Types (I-IX) under Conditions of Use C through G as described in Tables 1 and 2. The application rate of the FCS will be no greater than 0.039 g/in².

816

The FCS is for use as an antioxidant for lubricants with incidental food contact.

To be used at a maximum concentration of 0.5 weight percent of the lubricant in contact with all food types under Conditions of Use A through H, as described in Table 2.

817

The FCS will be used as a modifier of ethylene phthalate polymers regulated under 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN, including those modified with 1,3-benzenedicarboxylic acid, 5-sulfo-, monolithium salt according to FCN 546.

The FCS will be used at a level up to 5 weight percent of the finished food-contact article in conjunction with up to 0.015 weight percent cobalt neodecanoate (measured as cobalt) of the finished food-contact article. The modified polymers may be used in the manufacture of containers for contact with food types I, II, VI-A, VI-B, and VI-C (alcohol content up to 15 percent), except for carbonated soft drinks and water, under Conditions of Use C through G as described in Tables 1 and 2.

818

As an additive in food-contact polyethylene terephthalate (PET) bottles.
REPLACES FCN 716

For use at a maximum level not to exceed 20 ppm (w/w) in finished PET bottles, for direct contact with food types I through VI, under the Conditions of Use C through G, as described in Tables 1 and 2.

820

For use as an oil or grease resistant treatment for paper and paperboard intended for food-contact use.

The polymer additive is intended to be used in paper and paperboard at levels not exceeding 0.2 percent of the finished food-contact paper.

821

As a modifier of propylene polymers and copolymers for use in contact with food.

The FCS may be used at a level not to exceed 40 percent by weight of the polymer blend. The FCS meets all specifications of 21 CFR 177.1810(b)(3)(i) except for the high glass transition point. For use in contact with all types of food under Conditions of Use A through H, as described in Table 2.

822

The FCS is to be used as a component of lubricants with incidental food contact in repeat use applications.

The FCS is to be used at a level not to exceed the minimum amount needed to achieve the desired technical effect.

823

The FCS will be used as a component of surface coating on repeat-use food processing and food packaging equipment to prevent abrasive wear to the components of the equipment.

The FCS will be applied at a maximum thickness of 10 µm and the finished food-contact equipment will be used in contact with all food types, and under Conditions of Use A through H, as described in Table 2.

824

For use as a clarifier for polypropylene (PP) homo- and copolymers used in food-packaging materials.

The FCS may be used at levels not to exceed 250 ppm in the finished article and may contact all food types under Conditions of Use A through H, as described in Table 2.

825

For use as a clarifying agent in polypropylene homopolymer and high-propylene olefin copolymers.

For use at a level not to exceed 0.5 percent by weight of the finished polymer, in contact with all food types under Conditions of Use A through H, as described in Table 2. Polymers containing the FCS may be used in both films and molded articles.

826

The FCS is intended for use as an anchor agent in silicone release coatings that are currently regulated for food contact applications.

For single use and formulated into silicone coatings at a level not to exceed 4 weight percent. The FCS will be used in pressure sensitive adhesives (PSAs) on fruits and vegetables (under food types (I and II) under Conditions of Use E and F and in PSAs for beverage and food containers under Conditions of Use E through G with food types I, II, III, VI-A, VI-B, and VI-C as described in Table 2.

827

As an oil and grease resistant treatment for paper and paperboard employed at the size press.

The FCS may be used at a level not to exceed 0.4 weight percent of dry paper and paperboard intended for use in contact with all food types under Conditions of Use A through H as described in Table 2.

828

As a nucleating/clarifying agent.

For use at levels not to exceed 0.3 percent by weight in polypropylene homopolymer and high propylene olefin copolymers molded articles (non-film). The final articles may contact all food types under Conditions of Use A through H, as described in Table 2.

829

As an antioxidant/stabilizer in olefin copolymers complying with 21 CFR 177.1520(c), items 3.2c, 3.4, or 3.6, or in styrene block copolymers complying with 21 CFR 177.1810.

At levels not to exceed 0.2 weight percent of the finished articles when used in olefin copolymers and at levels not to exceed 0.4 weight percent of the finished articles when used in styrene block copolymers. The finished articles containing the FCS may be used in contact with all food under Conditions of Use A through H as described in Table 2, subject to limitations of the base polymer.

830

As a stabilizer for flexible polyvinyl chloride (PVC) and as an antioxidant for olefin polymers.

The FCS will be used as: (1) a stabilizer at levels not to exceed 0.006 percent by weight of flexible PVC film (maximum thickness shall not exceed 1 mil) that may contact 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 and (2) an antioxidant for olefin polymers complying with 21 CFR 177.1520(c), item 3.6, at levels not to exceed 0.25 percent by weight of the finished articles that may contact all food types under Conditions of Use A through H as described in Tables 1 and 2.

831

As a polymer for making repeat-use food contact articles.

The FCS may be used in contact with all food types under Conditions of Use A through H, as described in Table 2.

832

As a component of articles used in contact with all types of food.

Propylene-ethylene copolymers may contain up to 18 weight percent of polymer units derived from ethylene and have a maximum Melt Flow Rate (230^oC/2.16 kg) of 24 g/10 minutes. For use as a component of articles in contact with all foods under Conditions of Use B through H, as described in Table 2. Adjuvant substances permitted for use in olefin copolymers complying with 21 CFR 177.1520(c), items 3.1 or 3.2, may be used in the copolymers subject to any limitations on the use of the adjuvant substances.

834

As a component of a coating on articles used in contact with food.

1,4-Butanediol dimethacrylate used in the manufacture of LDPE, incorporated at a level not to exceed 0.10 mol percent relative to the ethylene concentration. The LDPE may be used as a coating on food contact articles with a coating thickness not to exceed 100 μm, in contact with all food types and under Conditions of use C through G, as described in Tables 1 and 2.

836

As a component of a non food-contact layer of multilayered food-contact articles at levels up to 10 percent in blends with polyolefins complying with 21 CFR 177.1520 or ethylene-vinyl acetate-vinyl alcohol copolymers complying with 21 CFR 177.1360.

The FCS may comprise up to 5 percent by weight of articles intended for use in contact with all food under Conditions of Use B through H as described in Table 2.

837

The FCS is intended for use as an optical brightener in paper and paperboard complying with 21 CFR 176.170.

The FCS will be used in contact with all food types at levels not to exceed those needed to achieve the desired technical effect, except for the following:
(1) when 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 pound per ton of paper, and
(2) when 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, the brightener is limited to use at levels not to exceed 0.25 pound per ton of coated paper.

839

As an antistatic agent in polymer films, compliant with existing authorizations.

For use at levels not to exceed 20 weight percent of the finished article in contact with non-fatty, dry foods (i.e., Food Type VIII) under Conditions of Use E through G, as described in Tables 1 and 2.

Food Ingredients and Packaging | Food Contact Substance Notification Program

FDA/Center for Food Safety & Applied Nutrition
Hypertext updated by dms/hrw/msl/cjm/sdp/emw December 8, 2008

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

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