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

September 16, 2019
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The U.S. Food and Drug Administration (FDA) recently added eight 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 Manufacturer/Supplier Effective Date
1996 Acrylic resin derived from styrene (CAS Reg. No. 100-42-5), ethyl acrylate (CAS Reg. No. 140-88-5), and acrylic acid (CAS Reg. No. 79-10-7).  The Sherwin-Williams Company Aug 31, 2019
1991 Polyester-polyurethane adhesive formulated from the following: 1,3-benzenecarboxylic acid (CAS Reg. No. 121-91-5); 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (CAS Reg. No. 77-99-6); hexanedioic acid (CAS Reg. No. 124-04-9); 1,2-propanediol (CAS Reg. No. 57-55-6); diphenylmethane 4,4'-diisocyanate (CAS Reg. No. 101-68-8); bis(isocyanatophenyl) methane (CAS Reg. No. 26447-40-5); castor oil (CAS Reg. No. 8001-79-4); 1-propanamine, 3-(trimethoxysilyl)-N-[3-(trimethoxysilyl)propyl]- (CAS Reg. No. 82985-35-1); poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy- (CAS Reg. No. 25322-69-4); ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis- (CAS Reg. No.112-27-6); poly[oxy(methyl-1,2-ethanediyl)], α,α',α''-1,2,3-propanetriyltris[ω-hydroxy- (CAS Reg. No. 25791-96-2). 

COIM USA, Inc.

COIM S.p.A., Italy

Coim Brasil Ltda

Coim Asia Pacific Pte Ltd.

Coim India Pvt., Ltd.

Aug 21, 2019
1989 Cellulose acetate (CAS Reg. No. 9004-35-7), and optionally modified with propionate to form cellulose acetate propanoate (CAS Reg. No. 9004-39-1) resulting in up to 49 weight-percent propionate esters. Eastman Chemical Company Jul 11, 2019
1977 2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, ethenylbenzene, 2-ethylhexyl 2-propenoate, methyl 2-methyl-2-propenoate and 2-methylpropyl 2-methyl-2-propenoate (CAS Reg. No. 1515850-94-8).  BASF Corporation Aug 9, 2019
1974 2-Propenoic acid, 2-methyl-, methyl ester, polymer with butyl 2-propenoate, ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-methylpropyl 2-methyl-2-propenoate and 2-propenoic acid (CAS Reg. No. 103235-87-6 BASF Corporation Aug 9, 2019
1970 2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52-51-7).  DPP Specialty Electronic Materials, Inc. Aug 1, 2019
1958 Fluorocarbon cured elastomer produced by copolymerizing tetrafluoroethylene (CAS Reg. No. 116-14-3) and propylene (CAS Reg. No. 115-07-1) and subsequent curing with triallylisocyanurate (CAS Reg. No. 1025-15-6) or triallylcyanurate (CAS Reg. No. 101-37-1) and 2,2’-bis(tert-butylperoxy)diisopropylbenzene (CAS Reg. No. 25155-25-3).  AGC Chemicals Americas, Inc. Jul 17, 2019
1957

The FCS is a reaction product of three polymers:

  1. 2-propenoic acid, 2-methyl-, methyl ester, polymer with 4,5-dihydro-2-(1-methylethenyl)oxazole and ethyl 2-propenoate (CAS Reg. No. 57460-65-8);
  2. methyl methacrylate, ethyl acrylate, methacrylic acid, butanoic acid 3-oxo-2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl ester, 3-(trimethoxysilyl)propyl methacrylate with poly(oxy-1,2-ethanediyl), alpha-sulfo-omega-[4-nonyl-2-(1-propen-1-yl)phenoxy]-, branched, ammonium salts copolymer; and
  3. 1,3-benzenedicarboxylic acid, polymer with 2-[(2-aminoethyl)amino]ethanol, 1,3-bis(isocyanatomethyl)cyclohexane, decanedioic acid, 1,3-diisocyanatomethylbenzene, 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol and 3-hydroxy-2-(hydroxymethyl)-2- methylpropanoic acid, compound with 1,1',1''-nitrilotris[2-propanol] (CAS Reg. No. 1239020-50-8).

REPLACES FCN 1767

TOYOBO Co., Ltd. Jul 3, 2019

 

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?