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FDA Adds 13 New Substances to its Inventory of Effective FCSs

The U.S. Food and Drug Administration (FDA) recently added 13 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.


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).

Ecolab Inc.

Feb 20, 2015


2-propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, butyl 2-propenoate and ethenylbenzene (CAS Reg. No. 25101-28-4).

Kaneka Belgium NV

Feb 19, 2015


Copolymer of polyethylene glycol dimethacrylate, trimethylolpropane trimethacrylate and 2-hydroxyethyl methacrylate.

Pall Corporation

Feb 19, 2015


Styrene block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4).

Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH

Feb 18, 2015


Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component, comprising not more than 63% percent by weight of the cured adhesive, prepared by the reaction of allophonate modified methane diphenyl diisocyanate (CAS Reg. No. 201615-11-4), 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), polypropylene glycol, toluene diisocyanate (CAS Reg. No. 26471-62-5), hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) and (b) Polyester/polyol component, a mixture of polyesters and polyether polyols prepared by the reaction of adipic acid, 1,3-benzenedicarboxylic acid, gallic acid, diethylene glycol, 1,2-propanediol, methyloxirane polymer, 1,1,1-tris(hydroxymethyl)propane, and 1,2,3-propanetriol.

Henkel, Inc.

Feb 5, 2015


1-hydroxy-4-(p-toluidino)anthraquinone (CAS Reg. No. 81-48-1).

Americas Styrenics, LLC

Feb 3, 2015


Styrene/butadiene/acrylonitrile (SBA) copolymers (CAS Reg. No., exclusive of minor monomers: 9003-56-9) containing no more than 30 weight percent acrylonitrile and no more than 10 weight percent of total polymer units from one or more of the following monomers: acrylic acid and itaconic acid.

BASF Corporation

Jan 30, 2015


N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide (CAS Reg. No. 57843-53-5).

The Dow Chemical Company

Jan 29, 2015


Copolymer of ethylene glycol dimethacrylate, butyl methacrylate, and glycidyl methacrylate (CAS Reg. No. 133396-60-8).

Alcresta Inc.

Jan 20, 2015


1-Pentene, 4-methyl-, polymer with 1-propene (CAS Reg. No. 25119-95-3).

Mitsui Chemicals, Inc.

Jan 16, 2015


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), dipicolinic acid (CAS Reg. No. 499-83-2) and sulfuric acid (CAS Reg. No. 7664-93-9).

Evonik Corporation

Jan 6, 2015


1-Naphthalenamine, N-phenyl-ar-(1,1,3,3-tetramethylbutyl)- (CAS Reg. No. 68259-36-9) (paraisomer).

Vanderbilt Chemicals, LLC

Jan 6, 2015


Hypochlorous acid (CAS Reg. No. 7790-92-3) electrolytically generated in dilute solution.

Sterilox Food Safety/Div. of PuriCore

Jan 1, 2015


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?"