Skip to main content

FDA Adds Four New Substances to its Inventory of Effective FCS

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


1,3-Benzenedicarboxylic acid, polymer with azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid and 4,4'-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 62694-40-0)

EMS-Chemie AG

May 26, 2015


Cross-linked 2-propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7)

McAirlaid's Inc.

May 23, 2015


Acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone (CAS Reg. No. 25086-89-9)

Nestlé Infant Nutrition and Sartorius Stedim Biotech GmbH

May 15, 2015


Silanediol, 1,1-dimethyl-, polymer with ethene, triblock (CAS Reg. No. 837387-70-9)

Mitsui Fine Chemicals, Inc.

May 5, 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?"