Food Contact Notification (FCN) News in November 2017

Feb. 27th, 2018
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According to FDA official website, 5 food contact notifications (FCN) have been approved by FDA in November, and their information is shown in the table below:

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Innospec Ltd.

Nov 7, 2017

A mixture of 1-decene, polymer with sulfur dioxide (CAS Reg. No. 33990-98-6); 1,3-propanediamine, N1-(9Z)-9-octadecen-1-yl-, polymer with 2-(chloromethyl)oxirane (CAS Reg. No. 1010121-89-7); and dodecylbenzenesulfonic acid (CAS Reg. No. 27176-87-0).

The FCS is intended for use as an antistatic agent in polyethylene and polypropylene polymers and copolymers except for use in contact with infant formula and human milk (see Limitations/Specifications).

For use at levels not to exceed 20 parts per million (ppm) in polyethylene and polypropylene polymers and copolymers intended to be used in contact with all food types under all Conditions of Use. The FCS is not intended 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.

Kaneka North America, LLC

Nov 15, 2017

Styrene-isobutylene block copolymer (CAS Reg. No. 9011-12-5).

As a component of blended polymers that will be used in the manufacture of single-use food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).

For use in food packaging applications in contact with all food types under Conditions of Use A through H and J. 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.

Zhejiang Hongda Chemicals Co. Ltd.

Nov 21, 2017

Benzenesulfonic acid, 2,2′-(1,2-ethenediyl)bis[5-[[4-(4-morpholinyl)-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, sodium salt (CAS Reg. No. 16090-02-1).

As an optical brightener in paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The FCS is intended for use as an optical brightener in clay-coated and uncoated paper and paperboard in contact with all food types at a level not to exceed 0.048 pounds/metric ton of paper (1000 kg). 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.

Brainerd Chemical Company, Inc.

Nov 29, 2017

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) and dipicolinic acid (DPA) (CAS Reg. No. 449-83-2).

As an antimicrobial agent in water used in the production and preparation of whole and cut poultry and meat, fruits and vegetables, and processed and pre‐formed poultry and meat. (See Limitations/Specifications).

When used as intended, the components of the FCS mixture will not exceed:

1. 2000 ppm PAA, 1474 ppm HP, 14 ppm HEDP, and 0.88 ppm DPA in spray, wash, rinse, dip, chiller water, low temperature (e.g., less than 40 °F) immersion baths, or scald water for whole or cut poultry carcasses, parts, trim, and organs;

2.1800 ppm PAA, 1215 ppm HP, 12 ppm HEDP, and 0.5 ppm DPA in process water or ice used for washing, rinsing, or cooling whole or cut meat, including carcasses, parts, trim, and organs;

3.350 ppm PAA, 1000 ppm HP, 10 ppm HEDP, and 0.25 ppm DPA in water for washing or chilling fruits and vegetables in food processing facilities;

4.230 ppm PAA, 186 ppm HP, 14 ppm HEDP, and 0.1 ppm DPA in water, brine, or ice used for washing, rinsing, or cooling processed and pre‐formed poultry; and

5.495 ppm PAA, 335 ppm HP, 14 ppm HEDP, and 0.1 ppm DPA in water, brine, or ice used for washing, rinsing, or cooling processed and pre‐formed meat.

BioSafe Systems LLC

Nov 30, 2017

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-hydroxyethylidine-1, 1-disphosphonic acid (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 766-93-9).

As an antimicrobial in process water, brine, and ice used in the production and preparation of whole or cut meat.

The components of the FCS mixture will not exceed 1800 ppm peroxyacetic acid (PAA), 675 ppm hydrogen peroxide (HP), and 51.4 ppm 1-hydroxyethylidine-1, 1-disphosphonic acid (HEDP) in process water, brine, or ice used for washing, rinsing, or cooling whole or cut meat, including carcasses, parts, trim, and organs.

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. If you have further questions, please consult

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