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

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

1941

 

N,N,N',N',-tetrakis(2-hydroxyethyl)hexanediamide (CAS Reg. No. 6334-25-4).

SIR Industriale S.p.A.

Jan 9, 2019

1937

 

Copolymer of vinyl acetate (CAS Reg No. 108-05-4), butyl acrylate (CAS Reg No 141-32-2), glycidyl methacrylate (CAS Reg. No. 106-91-2), itaconic acid (CAS Reg. No. 97-65-4), and sodium vinylsulfonate (CAS Reg. No. 3039-83-6).

BASF Corporation

Dec 26, 2018

1936

 

An aqueous mixture containing 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-hydroxyethylidene-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4), dipicolinic acid (DPA, CAS Reg. No. 499-83-2), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

Diversey Inc.

Dec 26, 2018

1934

 

Isononanoic and 2-ethylhexanoic acid esters with pentaerythritol

Performance Fluids, Ltd.

Dec 21, 2018

1933

 

Isononanoic acid esters with dipentaerythritol

Performance Fluids, Ltd.

Dec 21, 2018

1928

 

Fatty acids, C18-unsatd., dimers, polymers with caprolactam and hexamethylenediamine [Nylon 6/6.36] (CAS Reg. No 2068097-08-3).

BASF SE

Dec 5, 2018

1922

 

2-Propen-1-aminium, N,N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with ethanedial and 2-propenamide (CAS Reg. No. 32555-39-8).

SNF SAS
SNF Inc.

Jan 23, 2019

1919

 

2,6-Pyridinedicarboxylic acid (dipicolinic acid) (CAS Reg. No. 499-83-2).

Enviro Tech Chemical Services, Inc.

Dec 28, 2018

1914

 

Tetrafluoroethylene-ethylene-3,3,4,4,5,5,6,6,6-nonafluoro-1-hexene terpolymer (CAS Reg. No. 68258-85-5).

Asahi Glass Co., Ltd.
AGC Chemicals Europe

Dec 13, 2018

1911

 

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-hydroxyethane 1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

Xgenex, LLC

Dec 6, 2018

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. 

© 2019 Keller and Heckman LLP

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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

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