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

April 22, 2019

The U.S. Food and Drug Administration (FDA) recently added six 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

1950

An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No.79-21-0), hydrogen peroxide (HP) (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), and optionally sulfuric acid (CAS Reg. No. 7664-93-9). REPLACES FCN 1595

PeroxyChem LLC

March 29, 2019

1943

1,6-Hexanediol (CAS Reg. No. 629-11-8).

PPG Industries, Inc.

February 24 2019

1935

Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3).

TSRC Corporation

March 29, 2019

1931

1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(Et and Pr) derivs. (CAS Reg. No. 1613243-54-1).

Akzo Nobel Functional Chemicals, LLC
S.A. Akzo Nobel Chemicals N.V.

March 7, 2019

1929

Ethanaminium, N,N,N-trimethyl-2-[(1-oxo-2-propen-1-yl)oxy]-, chloride (1:1), polymer with 2-propenamide (CAS Reg. No. 69418-26-4) with up to 0.06 mol % of poly(oxy-1,2-ethanediyl), alpha-(2-methyl-1-oxo-2-propen-1-yl)-omega-hydroxy-, C16-18-alkyl ethers (CAS Reg. No. 70879-51-5).

NALCO Water, an Ecolab Company

March 11, 2019

1927

Phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS Reg. No. 939402-02-5). REPLACES FCN 1800

Addivant

March 15, 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?