Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Dow Corning Corporation

Dec 1, 2017

Siloxanes and silicones, methyl-phenyl, methyl-3,3,3-trifluoropropyl (CAS Reg. No. 1643944-25-5).

As an incidental lubricant to be used as, or a component of, bearing grease to lubricate facer roll bearings in paper and paperboard manufacturing, except for use in contact with infant formula and human milk (see Limitations/ Specifications).

The FCS may be used as, or a component of, bearing grease to lubricate only facer roll bearings in paper and paperboard equipment. The paper and paperboard may be in contact with all food types under Conditions of Use A through H, as described in Table 2. The FCS will not be used in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the FCN.

LyondellBasell Industries

Dec 1, 2017

Poly-1-butene polymers (CASReg.No.9003-28-5) and butene/ethylene copolymers (CAS Reg. No. 25087-34-7).

As the basic polymer in the production of articles intended to contact food, including infant formula and human milk.

The FCS will contain no more than 7.5 weight percent of polymer units derived from ethylene and may be used in contact with all types of food under Conditions of Use A through H as described in Tables 1 and 2. The density of the FCS will range from 0.87-0.93 g/cm3. The melt index will range from 0.1 – 3000. The intrinsic viscosity will not exceed 3.2 dl/g. Additives permitted for use in butene polymers complying with 21 CFR 177.1570 or in olefin polymers complying with 21 CFR 177.1520(c), items 3.1 and 3.2 may also be used in the FCS, provided that the limitations and specifications on the use of the additives are met. The FCS polymers may be used in repeat-use articles (excluding baby bottle nipples) intended to contact infant formula and human milk.

Selective Micro Technologies

Dec 6, 2017

Chlorine dioxide (CAS Reg. No. 10049-04-4).

As an antimicrobial agent in water used to wash fruits and vegetables that are raw agricultural commodities (RAC).

The FCS will be used in an amount not to exceed 3 ppm residual chlorine dioxide as determined by methods specified in 21 CFR 173.300. The chlorine dioxide solution will contain at least 90 percent by weight of chlorine dioxide with respect to all chlorine species as determined by Method 4500-ClO2-E. When used on RAC, the FCS will be applied in the preparing, packing, 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)(1)(B)(i)(III).

Akzo Nobel Functional Chemicals, LLC

Dec 8, 2017

1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(Et and Pr) derivs. (CAS Reg. No. 1613243-54-1)

As a rheology modifier in the production of polypropylene polymers complying with 21 CFR 177.1520 for repeat-use applications only, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS will be used at a level not to exceed 0.15% by weight of the polypropylene polymer. Repeat-use food contact articles manufactured with polypropylene polymers modified with the food contact substance may be used in contact with all Food Types under all use conditions unless restricted by applicable regulations for the polypropylene polymer. The finished polypropylene polymer must comply with the specifications and use limitations in 21 CFR 177.1520(c). The finished product is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN.

Anderson Development Company

Dec 13, 2017

Diethylene glycol (CAS Reg. No. 111-46-6).

As a monomer used in the manufacture of polyurethane resins complying with 21 CFR 177.1680, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The final article containing the FCS is intended for repeat-use applications in contact with bulk quantities of dry food (Type VIII) as described in Table 1. The finished food contact articles are not for use in contact with infant formula and human milk.

Anderson Development Company

Dec 13, 2017

Tripropylene glycol (CAS Reg. No. 24800-44-0).

As a monomer used in the manufacture of polyurethane resins complying with 21 CFR 177.1680, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The final article containing the FCS is intended for repeat-use applications in contact with bulk quantities of dry food (Type VIII) as described in Table 1. The finished food contact articles are not for use in contact with infant formula and human milk.

Anderson Development Company

Dec 13, 2017

Dipropylene glycol (CAS Reg. No. 25265-71-8).

As a monomer used in the manufacture of polyurethane resins complying with 21 CFR 177.1680, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The final article containing the FCS is intended for repeat-use applications in contact with bulk quantities of dry food (Type VIII) as described in Table 1. The finished food contact articles are not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

The Valspar Corporation

Dec 15, 2017

Hydroquinone (CAS Reg. No. 123-31-9).

For use as a monomer in the production of epoxy coatings resins as described in 21 CFR 175.300(b)(3)(viii). The resin may be used in the production of coatings on metal substrates for can-ends only, except for use in contact with infant formula and human milk (see Limitations/Specifications). The FCS may be used in combination with other substances authorized for use in epoxy can coatings under FDA’s food additive regulations and effective Food Contact Substance Notifications.

Coatings containing the FCS at no more than 16.6 weight percent may contact all food types under Conditions of Use A through H. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

The Valspar Corporation

Dec 15, 2017

Sorbic Acid (CAS Reg. No. 110-44-1). REPLACES FCN 1305

For use as a monomer in the production of epoxy coatings resins as described in 21 CFR 175.300(b)(3)(viii). The resin may be used in the production of coatings on metal substrates for can-ends only, except for use in contact with infant formula and human milk (see Limitations/Specifications). The FCS may be used in combination with other substances authorized for use in epoxy can coatings under FDA’s food additive regulations and effective Food Contact Substance Notifications.

Coatings containing the FCS may contact all food types under Conditions of Use A through H. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

Solvay Specialty Polymers USA, LLC

Dec 20, 2017

A polymer produced from tetrafluoroethylene (CAS Reg. No. 116-14-3) and 1,1,2,2-tetrafluoro-2-((1,2,2-trifluoroethenyl)oxy)ethanesulfonyl fluoride (CAS Reg. No. 29514-94-1). The polymer is hydrolyzed and may optionally be further neutralized to its ammonium salt.

As a component of coatings for repeat-use food filtration membranes, except for use in contact with infant formula or ingredients used for making infant formula (see Limitations/Specifications).

The FCS will be used as a coating for food filtration membranes in contact with all food types as described in Table 1. The coatings comprised of the FCS shall have a thickness not to exceed 0.5 microns. The FCS is not for use in contact with infant formula or ingredients used for making infant formula. Such uses were not included as part of the intended use of the substance in the FCN.

PTT MCC Biochem Company Ltd.

Dec 23, 2017

Poly[(butylenesuccinate)-co-adipate] cross-linked with malic acid

The FCS is intended for use in coatings, films, molded articles, and thermoformed articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS may be used in contact with all food types, except alcoholic foods, under Conditions of Use C (Hot filled or pasteurized above 150°F) through G (Frozen storage (no thermal treatment in the container) as defined in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

PTT MCC Biochem Company Ltd.

Dec 23, 2017

Poly(1,4-butylene glycol-co-succinic acid), cross-linked with malic acid. REPLACES FCN 1574

The FCS is intended for use in coatings, films, molded articles, and thermoformed articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).

For contact with all food types, except alcoholic foods, under Conditions of Use B (Boiling water sterilized) through H (Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container at time of use) as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

PeroxyChem, LLC

Dec 29, 2017

An aqueous solution of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), with oxalic acid (CAS Reg. No. 144-62-7) and/or maleic acid (CAS Reg. No. 110-16-7).

The FCS will be used as an antimicrobial agent for the commercial sterilization of aseptic filling equipment and polymeric food packaging prior to filling, except for use on food packaging used in contact with infant formula or human milk or on aseptic filling equipment used to fill such packaging.

The FCS may be used in the following applications. For each application, the concentration of PAA may not exceed 4000 parts per million (ppm) in the FCS.

1.The FCS is applied as a fine mist or vapor on polymeric food packaging containers and closures without a rinse prior to filling with food. For this application of the FCS, the sum of the concentrations of oxalic and maleic acid may not exceed 267 ppm in the FCS. The maximum application rate in milliliters of FCS per packaging container is given by the formula: 70 x (container capacity in fluid ounces)/[PAA ppm] in the FCS.

2.Food packaging containers and closures are filled with the FCS, drained, and rinsed with sufficient sterile water to achieve a theoretical 60-fold dilution of the FCS residue assumed to be 1 mg/cm2 on the interior container surface following draining.

3.The FCS is applied as a spray to sterilize the non-food contact surfaces of aseptic filling equipment and subsequently rinsed with sterile water. FDA’s review of the use of the FCS to sterilize aseptic filling systems is limited to the extent that the FCS residues may transfer from the non-food contact surfaces of the aseptic filling system to food packaging materials.
The FCS is not intended for use on food packaging used in contact with infant formula or human milk or on aseptic filling equipment used to fill such packaging. Such uses were not included as part of the intended use of the substance in the FCN.

The Dow Chemical Company

Dec 29, 2017

Maleic anhydride-grafted polyethylene (CAS Reg. No. 9006-26-2).

As a component of coatings on food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS has a saponification number above 6 after 24-hour Soxhlet extraction with anhydrous ethanol. The level of maleic anhydride used to produce the FCS may not exceed 7.5 percent by weight of the FCS. The FCS may be used at a level not to exceed 10 percent by weight in high-density polyethylene (HDPE) coatings on paper and paperboard for use in contact with all food types under Conditions of Use A through H, as described in Table 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

The Dow Chemical Company

Dec 29, 2017

Maleic anhydride, polymer with ethene and 1-hexene (CAS Reg. No. 86286-09-1).

As a component of coatings on food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The level of maleic anhydride used to produce the FCS may not exceed 1.6 percent by weight of the FCS. The FCS may be used at a level not to exceed 20 percent by weight of coating solids in high-density polyethylene (HDPE) coatings on paper and paperboard for use in contact with all food under Conditions of Use A through H, as described in Table 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.