FDA Adds 20 New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added 20 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.
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FCN No.
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Food Contact Substance |
Manufacturer/Supplier |
Effective Date |
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Copolymers of acrylamide, 2-(dimethylamino)ethyl methacrylate, itaconic acid, benzyl[2-(methacryloyloxy)ethyl](dimethyl)ammonium chloride, and benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride, optionally crosslinked with hexahydro-1,3,5-tris(1-oxoallyl)-1,3,5-triazine.
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Arakawa Chemical Industries, Ltd. |
May 31, 2019 |
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Oxirane, 2-methyl-, polymer with oxirane, ether with 1,2,3-propanetriol (3:1), polymer with 1,3-diisocyanato-2-methylbenzene and 2,4-diisocyanato-1-methylbenzene (CAS Reg. No. 68227-13-4).
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Amorim & Irmãos, S.A. |
May 31, 2019 |
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An aqueous mixture of peroxyacetic acid (PAA; CAS Reg. No. 79-21-0), hydrogen peroxide (HP; CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4).
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Ecolab Inc. |
May 28, 2019 |
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2,2‐bis((pentanoyloxy)methyl)propane‐1,3‐diyl dipentanoate (CAS Reg. No. 15834‐04‐5).
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Perstorp AB |
May 28, 2019 |
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1,4-Benzenedicarboxylic acid, polymer with 2-methyl-1,8-octanediamine and 1,9-nonanediamine, reaction products with benzoic acid (CAS Reg. No. 1310362-57-2).
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Kuraray Company, Ltd. |
May 28, 2019 |
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Aluminum silicon silver oxide with sodium zeolite Y (CAS Re. No. 308081-05-2).
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The Nikka Whisky Distilling Co., Ltd. |
May 28, 2019 |
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Fatty acids, C14-C20, esters with pentaerythritol (CAS Reg. No. 68440-28-8).
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Peter Greven GmbH & Co. KG |
May 28, 2019 |
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Amines, hydrogenated tallow alkyl, acetates (CAS Reg. No. 61790-59-8).
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Akzo Nobel Industrial Chemicals B.V. |
May 28, 2019 |
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Nylon MXD-6 (CAS Reg. No. 25718-70-1) (also known as hexanedioic acid, polymer with 1,3-benzenedimethanamine) meeting the analytical specifications in 21 CFR 177.1500(b) item 10.1 and used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2) and/or cobalt propionate (CAS Reg. No. 1560-69-6).
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Indorama Ventures USA Inc. and its stewarded affiliates around the world |
May 28, 2019 |
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An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722 -84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9) and/or dipicolinic acid (DPA) (CAS Reg. No. 499-83-2).
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Harcros Chemicals, Inc. |
May 20, 2019 |
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Butanedioic acid, 2-methylene-, polymer with ethenyl acetate, hydrolyzed, sodium salts (CAS Reg. No. 122625-12-1). |
Kuraray Co., Ltd. |
May 19, 2019 |
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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)).
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Coatex and Affiliates |
May 13, 2019 |
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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)).
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Coatex and Affiliates |
May 13, 2019 |
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Trimethylolpropane (CAS Reg. No. 77-99-6).
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Tronox LLC |
May 5, 2019 |
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1,4-benzenedicarboxylic acid, 1,4-dibutyl ester (CAS Reg. No. 1962-75-0).
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Eastman Chemical Company |
Apr 19, 2019 |
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Polyphenylene sulfide (CAS Reg. No. 26125-40-6 or 25212-74-2). REPLACES FCN 1731
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DIC EP Corporation |
Apr 14, 2019 |
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Acrylic resins derived from styrene (CAS Reg. No. 100-42-5), ethyl acrylate (CAS Reg. No. 140-88-5), 1,4-butanediol dimethacrylate (CAS Reg. No. 2082-81-7), acrylic acid (CAS Reg. No. 79-10-7), and 2-hydroxyethyl methacrylate (CAS Reg. No. 868-77-9).
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The Sherwin-Williams Company |
May 25, 2019 |
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An aqueous mixture of peroxylactic acid (PLA), hydrogen peroxide (HP), lactic acid, water, optional 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP), optionally sulfuric acid, and optionally phosphoric acid. |
Valley Chemical Solutions |
May 28, 2019 |
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Alcohols, C10-14-branched, C11-rich, reaction products with ethylene oxide, [(2-propenyloxy)methyl]oxirane and sulfamic acid (CAS Reg. No. 905843-50-7). The FCS is comprised primarily of poly(oxy-1,2-ethanediyl), α-sulfo-ω-[1-(hydroxymethyl)-2-(2-propen-1-yloxy)ethoxy]-, C11-rich, C10-14-branched alkyl ethers, ammonium salts (CAS Reg. No. 403983-53-9).
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ADEKA Corporation |
May 5, 2019 |
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Alcohols, C10-14 branched, C11 rich, reaction products with polyethylene glycol and 2-[(2-propen-1-yloxy)methyl]oxirane (CAS Reg. No. 403983-11-9 and 1000866-04-5).
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ADEKA Corporation |
May 5, 2019 |
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?