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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.

1495An 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
15082-propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, butyl 2-propenoate and ethenylbenzene (CAS Reg. No. 25101-28-4).Kaneka Belgium NVFeb 19, 2015
1509Copolymer of polyethylene glycol dimethacrylate, trimethylolpropane trimethacrylate and 2-hydroxyethyl methacrylate.Pall CorporationFeb 19, 2015
1507Styrene 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
1505Polyester-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
15031-hydroxy-4-(p-toluidino)anthraquinone (CAS Reg. No. 81-48-1).Americas Styrenics, LLCFeb 3, 2015
1481Styrene/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 CorporationJan 30, 2015
1502N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide (CAS Reg. No. 57843-53-5).
REPLACES FCN 1245
The Dow Chemical CompanyJan 29, 2015
1498Copolymer of ethylene glycol dimethacrylate, butyl methacrylate, and glycidyl methacrylate (CAS Reg. No. 133396-60-8).Alcresta Inc.Jan 20, 2015
14791-Pentene, 4-methyl-, polymer with 1-propene (CAS Reg. No. 25119-95-3).Mitsui Chemicals, Inc.Jan 16, 2015
1477An 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 CorporationJan 6, 2015
14941-Naphthalenamine, N-phenyl-ar-(1,1,3,3-tetramethylbutyl)- (CAS Reg. No. 68259-36-9) (paraisomer).Vanderbilt Chemicals, LLCJan 6, 2015
1470Hypochlorous acid (CAS Reg. No. 7790-92-3) electrolytically generated in dilute solution.
REPLACES FCN 692
Sterilox Food Safety/Div. of PuriCoreJan 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 PackagingLaw.com article, "What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?"