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FDA Adds Three New Substances to its Inventory of Effective FCS

Jan 23, 2012

The U.S. Food and Drug Administration (FDA) added three substances to its Inventory of Effective Food Contact Substances (FCS) Notifications in December 2011. The new substances and the manufacturers are listed below.

FCN Number	FCS	Manufacturer	Effective Date
1120	Ethylene/1-butene copolymer (CAS Reg. No. 25087-34-7)	Mitsui Chemicals, Inc.	12/31/11
1118	1,3-dibromo-5,5-dimethylhydantoin (DBDMH; CAS Reg. No. 77-48-5)	Albemarle Corporation	12/01/11
1117	2-Propenoic acid, 2-methyl-, ethyl ester, polymer with 2-oxiranylmethyl 2-methyl-2-propenoate (CAS Reg. No. 40081-37-6)	Valspar Corporation	12/01/11

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?"