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

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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.

FCN No.  

Food Contact Substance


Effective Date


Phosphorous acid, triphenyl ester, polymer with α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters (CAS Reg. No. 1227937-46-3).

Dover Chemical Corporation

Jan 24, 2017


1-hexene, 3,3,4,4,5,5,6,6,6-nonafluoro-, polymer with 1,1,2,2-tetrafluoroethene (CAS Reg. No. 82606-24-4).

Asahi Glass Co., Ltd.
AGC Chemicals Europe
AGC Chemicals Americas, Inc.

Jan 13, 2017


A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CIT; CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (MIT; CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight, optionally stabilized with magnesium nitrate or sodium nitrate and optionally further stabilized with 0.15 percent copper (II) nitrate.

Lonza, Inc.

Jan 5, 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), and 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4).

Brainerd Chemical Company, Inc.

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).


Dec 13, 2016


Dimethyl ether (CAS Reg. No. 115-10-6).

Akzo Nobel Industrial Chemicals, b.v.

Jan 17, 2017


Chromium metal, chromium (III) oxide, chromium (III) hydroxide and chromium carbide material obtained by electrodeposition onto low carbon mild steel.

Tata Steel IJmuiden B.V.; Tata Steel UK Ltd; thyssenkrupp Rasselstein GmbH

Jan 10, 2017


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.

Henkel, Inc.

Dec 17, 2016


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

Shanghai Miken Biotech Co., Ltd.

Dec 1, 2016


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?