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Volume XI, Number 109

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FDA Adds Eleven New Substances to its Inventory of Effective FCS Notifications March 2021

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

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?

FCN No.

Food Contact Substance

Manufacturer/Supplier

Effective Date

2088

1H-Azepine-1-carboxamide, N,N',N''-[(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)triyl)tris[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)]]tris[hexahydro-2-oxo- (CAS Reg. No. 68975-83-7)

PPG Industries, Inc.

January 30, 2021

2082

Aluminum oxide (CAS Reg. No. 1344-28-1)

Merck KGaA, Darmstadt, Germany and its affiliated companies

December 23, 2020

2081

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

LANXESS Corporation

January 7, 2021

2055

Ethylene glycol dipalmitate (CAS Reg. No. 624-03-3)

Emery Oleochemicals GmbH

October 9, 2020

2051

Bis(4-tert-butylbenzoate-O)hydroxyl aluminum (CAS. Reg. No. 13170-05-3)

Shanghai Xinxin Chemical Co., Ltd.

July 29, 2020

2046

An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and/or dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (SA) (CAS Reg. No. 7664-93-9). REPLACES FCNs 1968, 1745, 1495, 1236, 1096, 921 and 140

Ecolab Inc.

July 21, 2020

2044

Siloxanes and Silicones, di-Me, Me hydrogen, polymers with di-Me, Me vinyl siloxanes, 1,1'-(1-methylethylidene)bis[4-(2-propen-1-yloxy)benzene]-2,4,6,8-tetramethylcyclotetrasiloxane reaction products and vinyl group-terminated di-Me siloxanes (CAS Reg. No. 2305613-79-8)

Shin-Etsu Chemical Co., Ltd.

July 30, 2020

2035

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

BASF Corporation

April 2, 2020

2032

1,4-benzenedicarboxylic acid, (or dimethyl ester) polymer with 1,4-butanediol, adipic or sebacic acid, hexamethylene diisocyanate and further reacted with no more than 1 percent by weight of the polyhydric alcohol described in the notification. REPLACES FCN 907 and FCN 916

BASF SE

May 29, 2020

2029

REPLACED BY FCN 2106

-

-

2027

Silicic acid, aluminum magnesium sodium salt, (CAS Reg. No. 12040-43-6)

W. R. Grace & Co.-Conn.

May 13, 2020

 

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© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 63
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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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