Food Contact Notification(FCN)News in January 2017

Feb. 17th, 2017
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According to FDA official website, 5 food contact notifications (FCN) have been approved by FDA in December, and their information is shown in the table below:

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Dover Chemical Corporation

Jan 24, 2017

Phosphorous acid, triphenyl ester, polymer with α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters (CAS Reg. No. 1227937-46-3).

As a thermal stabilizer in polymeric food contact articles. The FCS is not intended for use in substances in contact with infant formula and human milk (see Limitations/Specifications). For use at levels not to exceed 0.20% by weight in linear low density polyethylene (LLDPE), high density polyethylene (HDPE), polypropylene (PP), and high impact polystyrene (HIPS) used as components of finished food packaging and repeated-use articles in contact with all types of food under Conditions of Use A through H. Triisopropanolamine (TIPA) (CAS Reg. No. 122-20-3) may be used in conjunction with the FCS at a maximum use level of 1.5% by weight of the FCS. 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.

Akzo Nobel Industrial Chemicals, b.v.

Jan 17, 2017 Dimethyl ether (CAS Reg. No. 115-10-6). As a solvent/processing aid in the production of poultry collagen used in processed meat products. The residual amount of the FCS in collagen is no more than 3 ppm.

Asahi Glass Co., Ltd.
AGC Chemicals Europe
AGC Chemicals Americas, Inc.

Jan 13, 2017 1-hexene, 3,3,4,4,5,5,6,6,6-nonafluoro-, polymer with 1,1,2,2-tetrafluoroethene (CAS Reg. No. 82606-24-4).
REPLACES FCN 1065
As a base resin or coating in repeat-use applications. For use with all food types without temperature limitation.

Tata Steel IJmuiden B.V.; Tata Steel UK Ltd; thyssenkrupp Rasselstein GmbH

Jan 10, 2017

Chromium metal, chromium (III) oxide, chromium (III) hydroxide and chromium carbide material obtained by electrodeposition onto low carbon mild steel.

The FCS is applied to a low carbon mild steel substrate for use in the manufacture of food-packaging articles.

The FCS may be applied at a level resulting in 100 to 250 milligrams total chromium per square meter of steel strip (0.065 mg/in2 – 0.16 mg/in2). a) For use with aqueous acidic food (pH below 5.0), the FCS will be top-coated with an FDA authorized thermoplastic polymer (e.g., polyethylene terephthalate polymer, PET) with a minimum thickness of 20 μm, or other coating with equal or greater barrier properties (as indicated by the expected comparative level of iron migration into food or food simulants) that is authorized for the intended conditions of use. b) For other foods, the FCS will be top-coated with an FDA authorized epoxy resin (minimum thickness 6 μm) or other coating with equivalent or greater barrier properties (as indicated by the expected comparative level of iron migration into food or food simulants) that is authorized for the intended conditions of use. Within the above limitations, the finished articles may contact (1) all food types, except infant formula and human milk, under Conditions of Use A through H, as described in Tables 1 and 2, respectively, and (2) powdered infant formula (i.e., excluding ready-to-consume infant formula and liquid infant formula concentrate) at room temperature conditions and below.

Lonza, Inc.

Jan 5, 2017

A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CIT; 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, optionally stabilized with magnesium nitrate or sodium nitrate and optionally further stabilized with 0.15 percent copper (II) nitrate.

The FCS is intended for use as:

  1. an antimicrobial agent in polymer latex solutions used in adhesives complying with 21 CFR 175.105;
  2. a preservative in resinous and polymeric coatings for polyolefin films complying with 21 CFR 175.320 and in coatings and/or coating components complying with 21 CFR 175.300; and
  3. a biocide in polymer latex emulsions, coating formulations and additives for paper manufacture used for food packaging, except for use in contact with infant formula and human milk (see Limitations and Specifications.

For use at CIT and MIT levels:

  1. equivalent to levels specified in 21 CFR 175.105, stabilized with magnesium nitrate, sodium nitrate and up to 0.15 percent copper(II) nitrate as an antimicrobial agent in polymer latex solutions used in adhesives;
  2. equivalent to levels specified in 21 CFR 175.300 and 21 CFR 175.320, stabilized with magnesium nitrate, sodium nitrate and up to 0.15 percent copper(II) nitrate as a preservative in resinous and polymeric coatings for polyolefin films and in coatings and/or coating components;
  3. equivalent to levels specified in 21 CFR 176.170, stabilized with magnesium nitrate, sodium nitrate and up to 0.15 percent copper(II) nitrate as a biocide in polymer latex emulsions, coating formulations and additives for paper manufacture used for food packaging. 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.

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