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FDA Adds Eight New Substances to its Inventory of Effective FCS Notifications - May 2021

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

2116

Pentaerythritol (CAS Reg. No. 115-77-5).

Meredian, Inc.

March 24, 2021

2115

Ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers modified with up to 8 mol% 1,2-epoxypropane (CAS Reg. No. 482589-30-0).

Kuraray Co., Ltd.

March 12, 2021

2114

Chromium(3+) iron(3+) trioxidandiide (C.I. Pigment Brown 29; CAS Reg. No. 109414-04-2 and CAS Reg No. 12737-27-8).

Al-Farben, S.A.

March 5, 2021

2112

An aqueous mixture containing 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-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4).

Diversey, Inc.

February 20, 2021

2105

Alkyl(C10-16)benzenesulfonic acid (CAS Reg. No. 68584-22-5).

CHEP

March 19, 2021

2102

1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).

Lanxess Corporation

March 10, 2021

2101

1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).

Lanxess Corporation

March 10, 2021

2098

Phosphoric acid, zirconium(4+) salt (2:1) (CAS Reg. No. 13772-29-7).

Jinda Nano Tech. (Xiamen) Co., Ltd.

March 10, 2021

 

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?

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 123
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About this Author

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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