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

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The U.S. Food and Drug Administration (FDA) recently added six new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed FCN numbers, substances, manufacturers and effective dates are listed below.


1. 1592; Copolymers of acrylamide, diallyldimethylammonium chloride, 2-methylenebutanedioic acid and propenoic acid; Plasmine Technology, Inc./Harima Chemicals, Inc.; Dec 9, 2015.

2. 1590; Chromium Nitride (CAS Reg. No. 24094-93-7); Euclid Refinishing Inc. DBA Surftech Inc.; Nov 25, 2015.

3. 1589; 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs. (CAS Reg. No. 68784-12-3); Omya International AG and its affiliates; Nov 24, 2015.

4. 1588; Diphosphoric acid, copper (2+) salt, hydrate (1:2:x) (CAS Reg. No. 16570-28-8) (Note: where x is unspecified, therefore this submission can cover both the anhydrous and hydrated versions of copper pyrophosphate.); Chemische Fabrik Budenheim KG; Nov 19, 2015.

5. 1582; Microfibrillated cellulose pulp; Imerys Minerals, Inc.; Nov 6, 2015.

6. 1579; Benzoic acid, 4-[(4-chlorobenzoyl)amino]-, sodium salt (1:1) (CAS Reg. No. 1489170-67-3); Milliken & Company; Nov 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?"