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FDA Adds Two New Substances to its Inventory of Effective FCS Notifications

July 31, 2017

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

FCN No.
(sorted Z-A)

Food Contact Substance

Manufacturer/Supplier

Effective Date

1778

1,4-Bis(2-ethylhexyl) benzenedicarboxylate (CAS Reg. No. 6422-86-2).

BASF Corporation

Jun 14, 2017

1775

2-Propenoic acid, sodium salt, homopolymer (CAS Reg. No. 9003-04-7). REPLACES FCN 946

Coatex SAS
Coatex Netherlands BV
Coatex, Inc.
Changshu Coatex Additive
COATEX Latin America Industria e Comérico Ltda

Jun 2, 2017

 

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?"