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FDA Adds Seven New Substances to its Inventory of Effective FCS

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


Copolymer of 2-(dimethylamino) ethyl methacrylate with 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate, N-oxide, acetate (CAS Reg. 1440528-04-0)

Archroma Management GmbH

Dec 31, 2014


Sodium alkyl (C10-16) ethoxylated sulfate

Solvay USA Inc.; Solvay, S.A.; Rhodia Operations; Solvay (Zhenjiang) Chemicals Co., Ltd.

Dec 26, 2014


Isophorone diisocyanate (CAS Reg. 4098-71-9)

The Valspar Corporation

Dec 25, 2014


N-ethyl-p-toluenesulfonamide (CAS Reg. 80-39-7)

Berry Plastics Corporation

Dec 12, 2014


N-ethyl-o-toluenesulfonamide (CAS Reg. 1077-56-1)

Berry Plastics Corporation

Dec 12, 2014


2-Propenoic acid, polymer with ethanedial and 2-propenamide (CAS Reg. 65505-03-5) containing acrylamide and acrylic acid which is then reacted with not more than 30 weight percent glyoxal.

Nalco, Ecolab Company

Dec 6, 2014


2-Propenoic acid, 2-methylpropyl ester, polymer with 1,1-dimethylethyl propionate (CAS Reg. 186454-07-9)

Watson Standard Company

Dec 3, 2015

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 article, "What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?"