Six food contact notifications (FCN) have been approved by FDA in August
Oct. 08th, 2016
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According to FDA official website, 6 food contact notifications (FCN) have been approved by FDA in August, and their information is shown in the table below
|
Notifier |
Effective Date |
Name of The Substance |
Intended Use |
Limitations/Specifications |
| Troy Corporation | Aug 4, 2016 | A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CMIT; CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (MIT; CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight, stabilized with magnesium nitrate (CAS Reg. No.: 10377-60-3) and/or magnesium chloride (CAS Reg. No. 7786-30-3), and further stabilized with 0.15% copper (II) nitrate (CAS Reg. No.: 19004-19-4). | As an antimicrobial agent in polymer latex solutions used in adhesives complying with 21 CFR 175.105; as a preservative in resinous and polymeric coatings and/or coating components complying with 21 CFR 175.300; as a preservative in resinous and polymeric coatings for polyolefin films complying with 21 CFR 175.320; as an antimicrobial for polymer latex emulsions in paper coatings complying with 21 CFR 176.170; and as an antimicrobial for finished coating formulations and for additives used in the manufacture of paper and paperboard, including fillers, binders, pigment slurries, and sizing solutions, complying with 21 CFR 176.170; except for use in contact with infant formula and human milk (see Limitations/Specifications). | For use at CMIT and MIT levels equivalent to those specified in the referenced regulations, further stabilized with up to 0.15% copper (II) nitrate. The mixture may contain magnesium nitrate up to 2.04% and/or magnesium chloride up to 0.9%. 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. |
| Sumitomo Chemical Co., Ltd. | Aug 6, 2016 | Copolymer of 4-hydroxybenzoic acid, 4,4′-dihydroxybiphenyl, terephthalic acid, and isophthalic acid (CAS Reg. No. 60088-52-0), manufactured as described in the notification. | As a component of articles used in contact with all types of food, except for use in contact with infant formula and human milk (see Limitations/Specifications). | For use as a component of articles in contact with all foods under Conditions of Use A through H and J, 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. |
| Danxia Chemicals Factory Co., Ltd. | Aug 18, 2016 | 2,2’-(1,4-phenylene)bis-[4H-3,1-benzoxazin-4-one] (CAS Reg. No. 18600-59-4). | As an ultraviolet (UV) light stabilizer in ethylene phthalate (PET) polymers, complying with 21 CFR 177.1630 (Polyethylene phthalate polymers), except for use in contact with infant formula and human milk (see Limitations/ Specifications). | The substance will be used at levels not to exceed 1.0% by weight in PET polymers for single and repeat use in, contact with Foods Types I, II, III, IVA, VIB, VIC (containing up to 15% alcohol), VIIA, VIIB, VIII, and IX, under Conditions of Use C through G, as described in Tables 1 and 2. The PET polymers will comply with 21 CFR 177.1315, 177.1630, or effective FCNs. The finished food contact articles 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. |
| Own Shining Industrial Co., Ltd. | Aug 19, 2016 | Tungsten suboxide (CAS Reg. No. 12037-57-9). | As a processing aid in food-contact polyethylene phthalate (PET), except for use in contact with infant formula and human milk (see Limitations / Specifications). | The FCS may be used at a level not to exceed 50 parts per million by weight in PET. The finished food-contact material is intended to contact all food types under Conditions of Use C through G. The FCS is not for use in contact with infant formula and human milk. Such uses are not included as part of the intended use of the substance in the FCN. |
| LANXESS Corporation | Aug 27, 2016 | 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4). | As a preservative in: (1) coatings that comply with 21 CFR 175.300 (Resinous and polymeric coatings) and 175.320 (Resinous and polymeric coatings for polyolefin films) and (2) can-end and side-seam cements that comply with 21 CFR 175.300. The FCS is not for use in contact with infant formula and human milk (see Limitations/Specifications). | The FCS may be used in contact with all food types under Conditions of Use A through H as described in Table 1. The maximum level of the FCS in aqueous emulsions for can coatings or polymeric coatings on polyolefin film is 100 ppm. The maximum level of the FCS in aqueous emulsions of can-end or side-seam cement is 150 ppm. The FCS 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. |
| SEIKO PMC Corporation | Aug 31, 2016 | Benzenemethanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl]-, chloride (1:1), polymer with 2-(dimethylamino)ethyl 2-methyl-2-propenoate, N,N-dimethyl-N-[2-[(1-oxo-2-propen-1-yl)oxy]ethyl]benzenemethanaminium chloride (1:1), 2-methylenebutanedioic acid, 2-propenamide and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethanaminium chloride (1:1), cross-linked with dialkylacrylamide and alkylenebisacrylamide, as identified in the notification. | The FCS is intended for use as a dry strength agent added prior to the sheet forming process in the manufacture of paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications). | The FCS is for use at levels not to exceed 0.5% by dry weight of the finished paper and paperboard in contact with all food types under Conditions of Use A through H and J 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. |
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