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. |
Food Contact Substance |
Manufacturer/Supplier |
Effective Date |
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Hydroquinone (CAS Reg. No. 123-31-9). REPLACES FCNs 1246 and 1306
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The Valspar Corporation |
Dec 15, 2017 |
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Sorbic Acid (CAS Reg. No. 110-44-1). REPLACES FCN 1305 |
The Valspar Corporation |
Dec 15, 2017 |
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Diethylene glycol (CAS Reg. No. 111-46-6). |
Anderson Development Company |
Dec 13, 2017 |
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Tripropylene glycol (CAS Reg. No. 24800-44-0). |
Anderson Development Company |
Dec 13, 2017 |
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Dipropylene glycol (CAS Reg. No. 25265-71-8). |
Anderson Development Company |
Dec 13, 2017 |
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Siloxanes and silicones, methyl-phenyl, methyl-3,3,3-trifluoropropyl (CAS Reg. No. 1643944-25-5).
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Dow Corning Corporation |
Dec 1, 2017 |
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Poly-1-butene polymers (CAS Reg. No. 9003-28-5) and butene/ethylene copolymers (CAS Reg. No. 25087-34-7).
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LyondellBasell Industries |
Dec 1, 2017 |
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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 dipicolinic acid (DPA) (CAS Reg. No. 449-83-2).
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Brainerd Chemical Company, Inc. |
Nov 29, 2017 |
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Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-(4-morpholinyl)-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, sodium salt (CAS Reg. No. 16090-02-1).
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Zhejiang Hongda Chemicals Co. Ltd. |
Nov 21, 2017 |
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Styrene-isobutylene block copolymer (CAS Reg. No. 9011-12-5). |
Kaneka North America, LLC |
Nov 15, 2017 |
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A mixture of 1-decene, polymer with sulfur dioxide (CAS Reg. No. 33990-98-6); 1,3-propanediamine, N1-(9Z)-9-octadecen-1-yl-, polymer with 2-(chloromethyl)oxirane (CAS Reg. No. 1010121-89-7); and dodecylbenzenesulfonic acid (CAS Reg. No. 27176-87-0).
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Innospec Ltd. |
Nov 7, 2017 |
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Poly[(butylenesuccinate)-co-adipate] cross-linked with malic acid. REPLACES FCN 1643
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PTT MCC Biochem Company Ltd. |
Dec 23, 2017 |
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Poly(1,4-butylene glycol-co-succinic acid), cross-linked with malic acid. REPLACES FCN 1574
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PTT MCC Biochem Company Ltd. |
Dec 23, 2017 |
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An aqueous solution of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), with oxalic acid (CAS Reg. No. 144-62-7) and/or maleic acid (CAS Reg. No. 110-16-7).
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PeroxyChem, LLC |
Dec 29, 2017 |
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An aqueous mixture of 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-hydroxyethylidine-1, 1-disphosphonic acid (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 766-93-9).
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BioSafe Systems LLC |
Nov 30, 2017 |
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Maleic anhydride-grafted polyethylene (CAS Reg. No. 9006-26-2).
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The Dow Chemical Company |
Dec 29, 2017 |
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1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(Et and Pr) derivs. (CAS Reg. No. 1613243-54-1)
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Akzo Nobel Functional Chemicals, LLC |
Dec 8, 2017 |
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A polymer produced from tetrafluoroethylene (CAS Reg. No. 116-14-3) and 1,1,2,2-tetrafluoro-2-((1,2,2-trifluoroethenyl)oxy)ethanesulfonyl fluoride (CAS Reg. No. 29514-94-1). The polymer is hydrolyzed and may optionally be further neutralized to its ammonium salt.
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Solvay Specialty Polymers USA, LLC |
Dec 20, 2017 |
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Chlorine dioxide (CAS Reg. No. 10049-04-4).
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Selective Micro Technologies |
Dec 6, 2017 |
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Maleic anhydride, polymer with ethene and 1-hexene (CAS Reg. No. 86286-09-1).
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The Dow Chemical Company |
Dec 29, 2017 |
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?