Food Contact Notification(FCN)News in February

Apr. 13th, 2017
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According to FDA official website, 2 food contact notifications (FCN) have been approved by FDA in February, and their information is shown in the table below:

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

Seeler Industries, Inc.

Feb 4, 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) and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4).

As an antimicrobial agent in process water or ice used in the processing of meat, poultry, fish and seafood, shell eggs, fruit and vegetables.

Components of the FCS mixture will not exceed:

  1. 2000 parts per million (ppm) PAA, 773 ppm HP, and 118 ppm HEDP 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 or in water for washing shell eggs;
  2. 460 ppm PAA, 177 ppm HP, and 27 ppm HEDP in spray, wash, rinse, dip, chiller water, or scald water for meat carcasses, parts, trim, and organs;
  3. 495 ppm PAA, 190 ppm HP, and 29 ppm HEDP in process water or ice for washing, rinsing, or cooling of processed and pre-formed meat products;
  4. 230 ppm PAA, 88 ppm HP, and 14 ppm HEDP in water or ice used for washing, rinsing, or cooling processed and pre-formed poultry products or in the commercial preparation of fish and seafood;
  5. 350 ppm PAA, 135 ppm HP, and 21 ppm HEDP in water or ice for washing or chilling fruits and vegetables in food processing facilities.

DIC Corporation

Feb 22, 2017

Polyurethane adhesive formulated from:

a. Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300 (b)(3)(vii);

b. Isocyanate hardeners consisting of one or more of the following

1. m-xylylene diisocyanate (CAS Reg. No. 3634-83-1),

2. m-xylylene diisocyanate-trimethylol propane prepolymer (CAS Reg. No. 51852-81-4),

3. 2-ethyl-1-hexanol reaction products with 1,6-diisocyanatohexane,

4. 1,6-diisocyanatohexane (CAS Reg. No. 822-06-0), and

5. prepolymers of them.

c. Optional use, in either the urethane hardener or polyester resin portions of the resin, of trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups comprising not more than 3 percent by weight of the cured adhesive and/or the triethoxysilane coupling agent described in the notification.

d. An inorganic filler must be included in the adhesive as described in the notification.

For use as an adhesive and oxygen barrier in laminate structures that are intended for use in contact with food, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The adhesive may be used at levels up to 5 g/m2 for conventional films, and up to 3.5 g/m2 for metalized films. A food-contact layer consisting of co-polymer polypropylene with a minimum thickness of 70 μm or another material with equivalent or greater barrier properties will separate the adhesive from food. The finished article may contact all types of food under Conditions of Use A through H. The finished food contact articles containing the FCS are 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.

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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