Food Contact Notification(FCN)News in September

Oct. 27th, 2016
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According to FDA official website, 8 food contact notifications (FCN) have been approved by FDA in September, and their information is shown in the table below:

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Victrex Plc

Sep 2, 2016

2,4,4′-Trifluorobenzophenone (TFBP) (CAS Reg. No. 80512-44-3)

As a co-monomer in the manufacture of polymers complying with 21 CFR 177.2415, except for use in contact with infant formula and breast milk (see Limitations/Specifications), except for use in contact with infant formula and breast milk (see Limitations/Specifications).

The finished polymers may be used as components of repeated-use articles and may contact all food types under Conditions of Use A-H and J (at temperatures not to exceed 175 °C), as described in Table 2. The FCS is not for use in contact with infant formula and breast milk. Such use was not included as part of the intended use of the substance in the FCN.

Alex C. Fergusson, LLC (AFCO)

Sep 15, 2016

An aqueous mixture containing 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).

The FCS will be used as an antimicrobial agent in process water and wash water used in the production and preparation of shell eggs.

The components of the FCS mixture will not exceed 2000 ppm peroxyacetic acid (PAA), 800 ppm hydrogen peroxide (HP), and 96 ppm 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) in shell egg washes.

Kuraray Company, Ltd

Sep 20, 2016

Polycyclooctene (PCOE; CAS Reg. No. 25267-51-0) used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0). REPLACES FCN 1432.

The FCS is intended for use in blends with ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers as a non-food contact layer of multilayered packaging, except for use in contact with infant formula and human milk (see Limitations/Specifications).

PCOE will be used at a maximum level of 8 percent in blends with authorized EVOH copolymers. Cobalt stearate will be present in the PCOE/EVOH blend at a maximum level of 0.04 percent as cobalt (0.42 percent as cobalt stearate). The maximum thickness of the FCS/EVOH blend will be 100 microns (μm). The finished food-contact packaging containing the FCS may contact all food types under conditions of use A through H, 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.

BASF Corporation

Sep 20, 2016

N,N”’-l,2-Ethanediylbis[N-[3-[[4,6-bis[butyl(1,2,2,6,6-pentamethyl-4-piperidinyl)amino]-1,3,5-triazin-2-yl]amino]propyl]-N’,N”-dibutyl-N’,N”-bis(1,2,2,6,6-pentamethyl-4-piperidinyl)-1,3,5-triazine-2,4,6-triamine] (CAS Reg. No. 106990-43-6).

As a light and thermal stabilizer in high density polyethylene (HDPE, density not less than 0.94 grams per cubic centimeter) copolymers complying with 21 CFR 177.1520 (c), item 3.1a, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS will be used at levels not to exceed 0.2 percent by weight of HDPE copolymers complying with 21 CFR 177.1520(c), item 3.1a. The finished polymers may be used in contact with food of the Types III, IV-A, V, VI-A, VI-C, VII-A, and IX under conditions of use D through G 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.

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

Sep 21, 2016

2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, sodium salt (CAS Reg. No. 1878204-24-0).

As an oil, water and grease proofing agent in paper and paperboard, except for use in contact with infant formula and breast milk (see Limitations/Specifications).

For use at a maximum level of 1.2 % by weight of the finished paper, in contact with all food types under Conditions of Use B through H, as described in Table 2. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.

CraftChem, Inc

Sep 21, 2016

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

As an antimicrobial agent for use in process water and ice used in the production and preparation of meat and processed and pre-formed meat.

The components of the FCS mixture will not exceed:
(1) 1800 ppm peroxyacetic acid (PAA), 600 ppm hydrogen peroxide (HP), and 22.5 ppm 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) in process water or ice used for washing, rinsing, or cooling whole or cut meat including carcasses, parts, trim and organs;
(2) 495 ppm PAA, 165 ppm HP, and 14 ppm HEDP in process water, brine, or ice used for washing, rinsing, or cooling processed and pre-formed meat.

Evonik Corporation

Sep 29, 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-hydroxyethylidine-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4), dipicolinic acid (DPA, CAS Reg. No. 499-83-2) and sulfuric acid (CAS Reg. No. 7664-93-9).

As an antimicrobial agent in the production of poultry.

For use in process water and ice in spray, wash, rinse, dip, chiller, or scald water for poultry carcasses, parts, and organs, where the maximum concentration will not exceed: 2000 ppm PAA, 403 ppm HP, 5 ppm HEDP, and 0.88 ppm DPA.

SK Chemicals Co., Ltd.
INITZ Co., Ltd

Sep 29, 2016

As a component of repeated-use food-contact articles, except for use in contact with infant formula and breast milk (see Limitations/Specifications).

Polyphenylene sulfide (CAS Reg. No. 25212-74-2).

The FCS will be used in contact with all types of foods under Conditions of Use A through H, and J. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.

REACH24H has rich experience in dealing with United States food contact materials (FDA /FCN / 21 CFR) and EU food contact materials (EU 10/2011/BfR) and can make custom-made compliance service for enterprises.

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