September 17, 2021

Volume XI, Number 260

Advertisement

September 17, 2021

Subscribe to Latest Legal News and Analysis

September 16, 2021

Subscribe to Latest Legal News and Analysis

September 15, 2021

Subscribe to Latest Legal News and Analysis

FDA Adds Three New Substances to its Inventory of Effective FCS Notifications - July 8, 2021

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

2124

Hexanedioic acid, polymer with 1,4-butanediol, 1,6-hexanediol, and 1,1’-methylenebis[4-isocyanatobenzene] (CAS Reg. No. 30662-91-0).

COIM S.p.A., Italy

May 15, 2021

2123

xanedioic acid, polymer with 1,4-butanediol, 2,2-dimethyl-1,3-propanediol, and 1,1’- methylenebis[4-isocyanatobenzene] (CAS Reg. No. 56815-45-3).

COIM S.p.A., Italy

May 15, 2021

2122

Styrene-maleic anhydride copolymer (CAS Reg. No. 9011-13-6).

Rock Paint Co., Ltd.

May 21, 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.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 190
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

202-434-4100
Advertisement
Advertisement
Advertisement