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FDA Adds Nine New Substances to its Inventory of Effective FCS

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


Tin antimony oxide (CAS Reg. No. 12673-86-8), also known as tin antimony gray cassiterite.

Nyacol Nano Technologies, Inc.

Jul 26, 2014


Calcium aluminum hydroxyl carbonate (CAS Reg. No. 65997-16-2).

Nabaltec AG

Jul 24, 2014


[4-tert-butyl-2-(5-tert-butyl-2-oxo-3H-benzofuran-3-yl)phenyl] 3,5-di-tert-butyl-4-hydroxybenzoate (CAS Reg. No. 1261240-30-5).

Chitec Technology Co., Ltd.
Double Bond Chemical Ind., Co., Ltd.
FDC, Lees Chemical Industry Co., Ltd.

Jul 10, 2014


Polycyclooctene (PCOE, CAS Reg. No. 25267-51-0) used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0).

Kuraray Company, Ltd.

Jul 3, 2014


An aqueous solution of hydrogen peroxide (CAS Reg. No. 7722-81-1) containing hydrogen peroxide at levels of up to 50%, manufactured and characterized as further described in the notification.

PeroxyChem, LLC

Jun 27, 2014


Copolymers of ethylene glycol and isophthalic acid with dimethyl terephthalate (CAS Reg. No. 26006-30-4) or terephthalic acid (CAS Reg. No. 24938-04-3).

INVISTA Resins & Fibers GmbH

Jun 3, 2014


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


Jun 3, 2014


Chlorine dioxide (CAS Reg. No. 10049-04-4).

Clordisys Solutions, Inc.

Jul 1, 2014


2,6-Pyridinedicarboxylic Acid (CAS Reg. No. 499-83-2).

Ecolab, Inc.

Jul 14, 2014



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 article, "What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?"