Food Contact Notification(FCN)News in October

Dec. 26th, 2016
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According to FDA official website, 7 food contact notifications (FCN) have been approved by FDA in October, and their information is shown in the table below:

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Alex C. Fergusson, LLC (AFCO)

Oct 13, 2016

An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4) and optionally sulfuric acid (CAS Reg. No. 7664-93-9).

As an antimicrobial agent in process water, brine, or ice for meat products.

The components of the FCS mixture in process water, brine, or ice will not exceed:

  1. 1800 ppm peroxyacetic acid (PAA), 600 ppm hydrogen peroxide (HP), and 12 ppm 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) for washing, rinsing, or cooling meat carcasses, parts, trim, and organs;
  2. 495 ppm PAA, 165 ppm HP, and 6 ppm HEDP for washing, rinsing, or cooling processed and pre-formed meat.

Ecolab, Inc.

Oct 13, 2016

2-Pyridinethiol-1-oxide, sodium salt (CAS Reg. No. 15922-78-8; 3811-73-2)

As a preservative for a rinse aid for use on food preparation, storage, and eating utensils in commercial facilities such as restaurants, delis, cafeterias, bars, residential dining facilities, and medical institutions. Application will be by machine ware washing, (i.e., sprayed onto plates, cups, silverware, pots, and pans as a last step in the washing process, no water rinse afterwards.)

The FCS will be used at concentration not to exceed 3 ppm in the final rinse water of commercial dishwashing machines.

The Valspar Corporation

Oct 19, 2016

Pyromellitic dianhydride (CAS Reg. No. 89-32-7).
REPLACES FCNs 1140 and 1238

The FCS in intended for use as a monomer in the production of polyester coating resins, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS may be safely reacted with monomers listed in 21 CFR 175.300 (b) (3) (vii) (a, b, c, and d) and polybasic acids and their anhydrides, monobasic acids, polyhydric alcohols, and monohydric alcohols that are authorized through an effective FCN for use as components of polyester coating resins. The above materials that are reacted with the FCS to form a polyester coating resin must be authorized for the intended conditions of use for the final coating. The FCS shall not exceed 3.7 percent by weight of the dry coating formulation. Coatings containing the FCS may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The finished food contact articles will not be used 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.

Clariant Plastics & Coatings USA Inc.

Oct 19, 2016

1,3-Benzenedicarboxamide, N,N’-bis(2,2,6,6-tetramethyl-4-piperidinyl) (CAS Reg. No. 42774-15-2).

The FCS is intended for use as a processing stabilizer in polyamide (PA) and ethylene/vinyl alcohol (EVOH) copolymers complying with applicable authorizations, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS is intended for use at:

  1. levels up to 0.3% in polyamide food-contact films not exceeding 100 μm thickness when used in contact with fatty foods;
  2. levels up to 0.2% in polyamide food-contact films not exceeding 50 µm thickness when used in contact with aqueous, acidic and alcohol containing foods; and,
  3. levels up to 0.2% in ethylene/vinyl alcohol copolymers used as the nonfood-contact layer in multilayer films.

The FCS/EVOH layer will not exceed 12 µm. The food-contact layer shall be any polymer that is authorized for such use by regulation or effective FCN. The finished food-contact articles containing the FCS may be used 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.

Valley Chemical Solutions

Oct 20, 2016

An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), water, and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), water, and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

The components of the FCS mixture in process water, brine, or ice, will not exceed:

  1. 2000 parts per million (ppm) PAA, 750 ppm HP, and 10 ppm HEDP in spray, mist, wash, rinse, dip, chiller water, and scald water for meat and poultry carcasses, parts, trim, and organs.
  2. 495 ppm PAA, 186 ppm HP, and 2.5 ppm HEDP for washing, rinsing, or cooling processed and pre-formed meat and poultry products.

The Dow Chemical Company

Oct 21, 2016

Tetrakis(hydroxymethyl)phosphonium sulfate (THPS) (CAS Reg. No. 55566-30-8).

As a preservative in coatings intended for use on paper and paperboard that may contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS may be used at levels not to exceed 400 ppm in water-based coatings, starches, pigments, and filler slurries that may contact all food types, except for infant formula and human milk, under all Conditions 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.

Idemitsu Kosan Co., Ltd.

Oct 26, 2016

Polypropylene (CAS Reg. No. 9003-07-0).

As an additive to single-use polyolefin films in contact with foods, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The melting point of the FCS is between 70 and 80°C, and the softening point is between 85 and 105°C as determined by the ring and ball method. The FCS may be used at a level not to exceed 50 weight percent in polyolefin films complying with 21 CFR 177.1520. The finished film will have a thickness of no more than 500 µm (0.02 inches) and may be used in contact with food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII, except for infant formula and breast milk, 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.

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