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

April 6, 2021

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.

FCN No. Food Contact Substance Manufacturer/Supplier Effective Date
2112 An aqueous mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), and 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4). Diversey, Inc. February 20, 2021
2111 Methacrylic acid, polymer with butyl acrylate, styrene, itaconic acid and acrylamide, sodium salt. SEIKO PMC Corporation February 24, 2021
2108 Silicic acid, aluminum magnesium sodium salt, CAS Reg. No. 12040-43-6. REPLACES FCN 2027 W. R. Grace & Co.-Conn February 6, 2021
2107 Hydroquinone (CAS Reg. No. 123-31-9). REPLACES FCN 1460 The Sherwin-Williams Company February 5, 2021
2095 Bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, calcium salt (1:1), (1R,2R,3S,4S)-rel- (CAS Reg. No. 839683-04-4) Milliken Chemical, Division of Milliken & Co February 13, 2021
2039 Diallyldimethylammonium chloride polymer with acrylamide (CAS Reg. No. 26590-05-6) produced by copolymerizing up to 5 weight percent of acrylamide and up to 95 weight percent of diallyldimethylammonium chloride. Buckman Laboratories, Inc. June 20, 2020
2007 2-Propenoic acid, polymer with sodium phosphinate (1:1), neutralized with sodium, calcium, and/or magnesium (including CAS Reg. No. 129898-01-7 (Na salt), CAS Reg. No. 935545-65-6 (Mg Na salt)) Coatex and Affiliates January 3, 2020

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?