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FDA Adds 11 New Substances to its Inventory of Effective FCS Notifications

September 28, 2017

The U.S. Food and Drug Administration (FDA) recently added 11 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.

FCN No.
(sorted Z-A)

Food Contact Substance

Manufacturer/Supplier

Effective Date

1797

Copolymers of acrylamide, diallyldimethylammonium chloride, 2-methylenebutanedioic acid and propenoic acid. REPLACES FCN 1592

Harima Chemicals, Inc.
Plasmine Technology, Inc.

Aug 30, 2017

1794

N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide (CAS Reg. No. 57843-53-5). REPLACES FCNs 1353 and 1502

The Dow Chemical Company

Aug 23, 2017

1756

Ethanol, 2-amino- (CAS Reg. No. 141-43-5).

Omya International AG and its Affiliates

Aug 5, 2017

1790

Phosphoric acid, iron (2+) salt, (2:3:x) (CAS Reg. No. 14940-41-1 (anhydrous); (CAS Reg. No. 10028-23-6) (octahydrate).

Chemische Fabrik Budenheim KG, Germany
Budenheim Ibérica S.L.U., Spain
Budenheim USA Inc.

Aug 3, 2017

1767

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, compd. with 1,1',1''-nitrilotris[2-propanol] (CAS Reg. No. 1239020-50-8).

TOYOBO Co., Ltd.

Aug 3, 2017

1764

Chlorine dioxide (CAS Reg. No. 10049-04-4).

Selective Micro Technologies, LLC

Aug 2, 2017

1754

Butanoic acid, 3-hydroxy-, (R)-, homopolymer (CAS Reg. No. 29435-48-1).

Newlight Technologies, Inc.

Jul 22, 2017

1787

Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (CAS Reg. No. 24993-04-2).

BASF SE

Jul 18, 2017

1739

Benzene, diethenyl-, polymer with ethenylbenzene and ethenylethylbenzene, chloromethylated (CAS Reg. No. 69011-14-9).

Dow Chemical Company

Jul 11, 2017

1733

2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4).

LANXESS Corporation

Jul 7, 2017

1751

Carbonic dichloride, polymer with 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-1-H-isoindol-1-one and 4,4’-(1-methylethylidene)bis[phenol], bis[4-(1-methyl-1-phenylethyl)phenyl] ester (CAS Reg. No. 503834-43-3).

SABIC Innovative Plastics

Jul 7, 2017

 

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?