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FDA Adds Three New Substances to its Inventory of Effective FCS Notifications January 4
Monday, January 4, 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.

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. 

FCN No.

Food Contact Substance

Manufacturer/Supplier

Effective Date

2089

Terephthalic acid polymer with 1,4:3,6-dianhydro-D-glucitol, 1,4-cyclohexanedimethanol and 1,2-ethanediol (CAS Reg. No. 1038843-64-9) and optionally prepared with trimellitic anhydride (CAS Reg. No. 552-30-7) as a branching agent. REPLACES FCNs 1075, 1444 and 1556

SK Chemicals Co., Ltd.

November 28, 2020

2087

Styrene block copolymers with 1,3-butadiene, fully hydrogenated (CAS Reg. No. 66070-58-4).

USI Corporation

November 20, 2020

2084

N1-(2-ethoxyphenyl)-N2-(2-ethylphenyl)ethanediamide (CAS Reg. No. 23949-66-8).

BASF Corporation

November 11, 2020

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