Skip to main content

FDA Adds 16 New Substances to its Inventory of Effective FCS Notifications

The U.S. Food and Drug Administration (FDA) recently added 16 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.


2-Propenoic acid, butyl ester, polymer with 1,3-butadiene, ethenylbenzene and 2-propenenitrile (CAS Reg. No. 26657-42-1).

Trinseo LLC

Apr 18, 2015


A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight, optionally stabilized with magnesium or sodium nitrate and further stabilized with 0.15% copper (II) nitrate.

Thor GmbH

Mar 6, 2015


Polyacrylic acid, partially neutralized sodium salt, polymer (CAS Reg. No. 68479-09-4).

Ecolab Inc.

Apr 28, 2015


Polymaleic acid, homopolymer (CAS Reg. No. 26099-09-2).

Ecolab Inc.

Apr 29, 2015


Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of dimethyl terephthalate or terephthalic acid and ethylene glycol with one or more of the following: dimethyl isophthalate, isophthalic acid, and diethylene glycol.

Nan Ya Plastics Corporation, America

Feb 26, 2015


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

Pall Corporation

Feb 19, 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


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


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

The Dow Chemical Company

Jan 29, 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), and 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. No. 02809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 766-93-9).

Arkema Inc. and Biosafe Systems

Mar 21, 2015


2-Propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, diethenylbenzene, ethenylbenzene and ethyl 2-propenoate (CAS Reg. No. 59858-50-3).

The Dow Chemical Company

Apr 2, 2015


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

Alcresta Inc.

Jan 20, 2015


2-oxiranone, 3-methylene, homopolymer (CAS Reg. No. 56385-15-0).

Kemira Oyj

Apr 4, 2015


Pyrophyllite (CAS Reg. No. 12269-78-2)

Trinity Resources Ltd.

Mar 6, 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?"