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FDA Adds 15 New Substances to its Inventory of Effective FCS

The U.S. Food and Drug Administration (FDA) recently added 15 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.



D-Glucitol, 1-deoxy-1-(methylamino)-, reaction products with 4-ethenylphenol homopolymer and formaldehyde,1-hydroxyethylidene-1,1-diphosphonic acid, manganous oxide, phosphate, fluorotitanic and fluorozirconic salts.

Henkel Adhesive Technologies

Oct 31, 2014


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

PeroxyChem LLC

Oct 30, 2014


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 or sodium nitrate at a 1 to 1 ratio (weight/weight) with the sum of isothiazolones and further stabilized with 0.15 percent copper (II) nitrate.

Thor GmbH

Oct 29, 2014


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


Oct 23, 2014


An aqueous mixture of peroxyacetic acid (CAS Reg. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. 64-19-7), and 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. 02809-21-4).

CraftChem, Inc.

Oct 22, 2014


Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4).

Everspring Chemical Co., Ltd.

Oct 21, 2014


Copolymer of 1,2,4-benzenetricarboxylic anhydride, 4,4'-diphenylmethane diisocyanate, and 3,3'-dimethyl-4,4'-biphenylene diisocyanate (CAS Reg. No. 133078-67-8).

Hitachi Chemical Co., Ltd.

Oct 21, 2014


Tricyclodecanedimethanol (CAS Reg. No. 26160-83-8).

Oxea GmbH

Oct 14, 2014


Hydroquinone (CAS Reg. No. 123-31-9).

The Valspar Corporation

Oct 14, 2014


Benzenesulfonic acid, 2, 2'-(1,2-ethenediyl)bis(5-((4-(bis(2-hydroxyethyl)amino)-6-((4-sulfophenyl)amino)-1, 3, 5-triazin-2-yl)amino)-, tetrasodium salt (CAS Reg. No. 16470-24-9).

Verso Paper Corporation

Oct 1, 2014


2-((1-(((2,3-Dihydro-2-oxo-1H-benzimidazol-5-yl)amino)carbonyl)-2-oxopropyl)azo)benzoic acid (CAS Reg. No. 31837-42-0).

Clariant International AG

Sep 18, 2014


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

Thor GmbH

Sep 5, 2014


Hydroquinone (CAS Reg. No. 123-31-9).

The Valspar Corporation

Sep 4, 2014


2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, polymer with 1-ethenyl-2-pyrrolidinone and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate, acetate (CAS Reg. No. 1334473-84-5).

Daikin America, Inc.

Sep 4, 2014


2-Propen-1-aminium,N,N-dimethyl-N-2-propenyl-,chloride, polymer with 2-propenamide and 2-propenoic acid (CAS Reg. No. 25136-75-8).

BASF Corporation

Oct 21, 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? "