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FDA Adds Six New Substances to its Inventory of Effective FCS Notifications

November 7, 2017

The U.S. Food and Drug Administration (FDA) recently added six new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.

FCN No.
(sorted Z-A)

Food Contact Substance

Manufacturer/Supplier

Effective Date

1801

Acrylonitrile-methacrylonitrile-methyl acrylate-trimethylolpropane trimethacrylate copolymer (CAS Reg. No. 945921-84-6).

Akzo Nobel Pulp and Performance Chemicals AB, Expancel

Sep 19, 2017

1789

High-purity furnace black (CAS Reg. No. 1333-86-4).

Cabot Corporation

Sep 16, 2017

1800

Phosphorous acid, mixed 2,4-bis(1,1,-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS Reg. No. 939402-02-5).

Addivant

Sep 13, 2017

1799

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

Biosan, LLC

Sep 13, 2017

1783

An aqueous mixture of peroxyacetic acid, (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), glycerol (CAS Reg. No. 56-81-5), and optionally acetic acid (CAS Reg. No. 64-19-7) or sulfuric acid (CAS Reg. No. 7664-93-9).

Eltron Research & Development, LLC.

Sep 8, 2017

1798

2,2′-(1,4-phenylene)bis-[4H-3,1-benzoxazin-4-one] (CAS Reg. No. 18600-59-4). REPLACES FCN 1652

Danxia Chemicals Factory Co., Ltd.

Sep 1, 2017

 

The Food and Drug Administration Modernization Act of 1997 amended the Federal Food, Drug, and Cosmetic Act to provide for the submission of food-contact notifications (FCNs). Under the FCN system, a manufacturer or supplier of a food-contact material may submit an FCN to FDA regarding the identity and use of a new food-contact substance (FCS), along with information supporting the conclusion that the substance is safe for the intended use.

If FDA does not object in writing within 120 days to the substance's use based on safety grounds, the submitter and its customers may market the substance. Once the notification becomes effective, FDA will add it to its Inventory of Effective FCS Notifications. For more background on submission of FCNs, please see the PackagingLaw.com article, What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?