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

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

2119

Tin (IV) oxide (CAS Reg. No. 18282-10-5). REPLACES FCN 431

Merck KGaA, Darmstadt, Germany and its affiliated companies

April 27, 2021

2117

Fluorphlogopite-based pearlescent pigments

Merck KGaA, Darmstadt, Germany and its affiliated companies

April 7, 2021

2013

Acrylic copolymer derived from styrene, butyl methacrylate, acrylic acid, methacrylic acid, and ethyl acrylate

The Sherwin-Williams Company

April 22, 2021

2110

Reaction product of the three substances:
Coconut oil polymer with ethylene glycol, glycerol, and phthalic anhydride (CAS Reg. No. 68413-10-5);
1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- polymer with bis(isocyanatomethyl)benzene (CAS Reg. No. 51852-81-4); and
1-Propanamine 3-(triethoxysilyl)- (CAS Reg. No. 919-30-2)

DIC Corporation

April 15, 2021

 

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 152
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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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