Food Contact Notification(FCN)News in March 2017

May. 22nd, 2017
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According to FDA official website, 6 food contact notifications (FCN) have been approved by FDA in March, and their information is shown in the table below:

Notifier

Effective Date

Name of The Substance

Intended Use

Limitations/Specifications

CraftChem, Inc.

Mar 18, 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-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9).

As an antimicrobial agent in process water used to wash raw and processed fruits and vegetables in food processing facilities.

The components of the FCS mixture will not exceed 350 ppm peroxyacetic acid, 117 ppm hydrogen peroxide, and 4 ppm HEDP.

DSM Engineering Plastics B.V.

Mar 22, 2017

1,4-Benzenedicarboxylic acid, polymer with 5-amino-1,3,3-trimethylcyclohexanemethanamine and hexahydro-2H-azepin-2-one (CAS Reg. No. 1105025-82-8).

The FCS will be used as a component of articles used in contact with food for single- and repeat-use applications. (see Limitations/Specifications)

1.For single-use articles: The FCS will be used at a maximum thickness of 2 mils (approximately 50 μm) in contact with all food types under Conditions of Use A through H and J.

2.For repeat-use articles: The FCS will be for use in contact with all food types under Conditions of Use A through H and J.

Adjuvant substances permitted for use in Nylon 6 polymers complying with 21 CFR 177.1500 may be used in the FCS, provided that any limitations on the use of the adjuvant substance are met. 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.

Avery Dennison Corporation

Mar 23, 2017

Polymer of butyl acrylate and 4-hydroxybutyl acrylate, with a methylene diphenyl diisocyanate based crosslinker.

As an adhesive for reclosure labels used with packaging, except for use in contact with infant formula and human milk (see Limitations/Specifications).

For use at a coat weight up to 23 g/m2 in contact with all food types under Condition of Use C 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.

Enviro Tech Chemical Services, Inc.

Mar 28, 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-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9).REPLACES FCN 447

As an antimicrobial agent in process water or ice used in the production, processing and preparation of meat, fruits, and vegetables.

The components of the FCS mixture will not exceed: (1) 1200 ppm PAA, 275 ppm hydrogen peroxide, and 33 ppm HEDP in process water or ice used for washing, rinsing, or cooling whole or cut meat, including hides, carcasses, parts, trim and organs; (2) 500 ppm PAA, 115 ppm hydrogen peroxide, and 14 ppm HEDP in process water or ice used for washing or chilling fruits and vegetables in food processing facilities.

Dart Industries Inc.

Mar 28, 2017

SiOxCyHz polymeric coatings formed by plasma enhanced chemical vapor deposition, utilizing tetramethylsilane (CAS Reg. No. 75-76-3) and oxygen as the starting materials.

The FCS is applied to the food-contact surfaces of repeated-use polyolefin food containers to impart stain resistance, except for use in contact with infant formula and human milk (see Limitations/Specifications).

The finished coating is for use at a thickness below 40 nm on linear low density polyethylene and polypropylene repeated-use food containers. The finished coating 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 finished coating in the FCN.

Arkema

Mar 31, 2017

Decanedioic acid, polymer with 11‐aminoundecanoic acid and 4,4’‐methylenebis[2‐methylcyclohexanamine] (CAS Reg. No. 1107603‐83‐7).

As a repeat-use food-contact article, except for use in contact with infant formula and human milk(see Limitations/Specifications).

The final article may contact with 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.

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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