FDA Adds Ten New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added ten 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|
|2224||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), 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).||AFCO||June 28, 2022|
|2214||Hydrogenated castor oil monoglycerides, acetylated (CAS Reg. No. 736150-63-3). REPLACES FCN 2047||DuPont Nutrition & Biosciences ApS||June 24, 2022|
|2213||Oleic acid, mono ester with oxybis(propanediol) (CAS Reg. No. 49553-76-6). REPLACES FCN 2037||DuPont Nutrition & Biosciences ApS||June 24, 2022|
|2223||A reactive mixture of ethylene acrylic acid copolymer (EAA; CAS Reg. No. 9010-77-9) and N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide (HAA; CAS Reg. No. 57843-53-5).||Akzo Nobel Coatings Inc.||June 23, 2022|
|2222||Lignosulfonic acid, sodium salt (CAS Reg. No. 8061-51-6).||CHEP USA||June 11, 2022|
|2221||Styrene block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4), as further described in your submission.||Kuraray GC Advanced Materials Co., Ltd. Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
|June 8, 2022|
|2220||Copolymer of styrene (CAS Reg. No. 100-42-5), α-methylstyrene (CAS Reg. No. 98-83-9), methacrylic acid (CAS Reg. No. 79-41-4), n-butyl acrylate (CAS Reg. No. 141-32-2), methyl methacrylate (CAS Reg. No. 80-62-6), and, optionally, acrylic acid (CAS Reg. No. 79-10-7) and/or α-methylstyrene dimer (CAS Reg. No. 6362-80-7).||Harima Chemicals, Inc., Plasmine Technology, Inc.||June 7, 2022|
|2219||β3,β3,β9,β9-Tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol (CAS Reg. No. 1455-42-1).||The Sherwin-Williams Company||May 25, 2022|
|2205||Naphtha (petroleum), light steam-cracked aromatic, piperylene concentrate, polymerized (CAS Reg. No. 68478-07-9).||ExxonMobil Chemical Company and its stewarded affiliates around the world.||May 20, 2022|
|2204||Phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl) ester (CAS Reg. No. 80693-00-1).||ADEKA Corporation||May 12, 2022|
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?