Food Contact Notification(FCN)News in December 2016

Feb. 17th, 2017
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According to FDA official website, 4 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

Shanghai Miken Biotech Co., Ltd.

Dec 1, 2016

1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).

As a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in contact with all types of food, except for use in contact with infant formula and human milk (see Limitations/ Specifications).

For use at levels not to exceed 0.05 percent by weight of the latex solids. 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.

Arkema

Dec 13, 2016 1,3-Benzenedicarboxylic acid, polymer with azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid and 4,4′-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 62694-40-0). For use in repeat-use food contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications). The final product will be used in contact with all food types at a maximum temperature of 250°F. 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.

Dec 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), and 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4). As an antimicrobial agent in process water and ice used in the production and preparation of whole or cut poultry and meat.

The components of the FCS mixture will not exceed:

  1. 2000 ppm peroxyacetic acid (PAA), 750 ppm hydrogen peroxide (HP), and 136 ppm 1‐hydroxyethylidine‐1,1‐diphosphonic acid (HEDP) in spray, wash, rinse, dip, chiller water, low temperature (i.e., less than 40°F) immersion baths, or scald water for whole or cut poultry carcasses, parts, trim, and organs;
  2. 1800 ppm PAA, 675 ppm HP, and 33 ppm HEDP in process water or ice used for washing, rinsing, or cooling whole or cut meat, including carcasses, parts, trim, and organs.

Henkel, Inc.

Dec 17, 2016

Polyester-polyurethane adhesive formulated as follows:

  1. polyurethane component prepared from isophthalic acid, diethylene glycol, adipic acid, 4,4′-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8) and hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2); and
  2. Polyester-polyol component prepared from isophthalic acid, diethylene glycol, castor oil, propoxylated glycerol, propoxylated trimethylolpropane and caprolactam.
As an adhesive in laminate structures for use at high temperatures, including microwave reheating, except for use in contact with infant formula and human milk (see Limitations/Specifications). The adhesive may be applied at a maximum rate of 2.5 pounds per 3000 square feet of food-contact surface. A food-contact layer will separate the adhesive from food and will consist of low density polyethylene with a minimum thickness of 1 mil or another material with equivalent or greater barrier properties under the intended conditions of use. Laminate structures using the FCS as an adhesive may be used in contact with all food types under Conditions of Use B 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.

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