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.
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FCN No.
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Food Contact Substance |
Manufacturer/Supplier |
Effective Date |
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N,N,N',N',-tetrakis(2-hydroxyethyl)hexanediamide (CAS Reg. No. 6334-25-4).
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SIR Industriale S.p.A. |
Jan 9, 2019 |
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Copolymer of vinyl acetate (CAS Reg No. 108-05-4), butyl acrylate (CAS Reg No 141-32-2), glycidyl methacrylate (CAS Reg. No. 106-91-2), itaconic acid (CAS Reg. No. 97-65-4), and sodium vinylsulfonate (CAS Reg. No. 3039-83-6).
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BASF Corporation |
Dec 26, 2018 |
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An aqueous mixture containing 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-hydroxyethylidene-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4), dipicolinic acid (DPA, CAS Reg. No. 499-83-2), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).
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Diversey Inc. |
Dec 26, 2018 |
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Isononanoic and 2-ethylhexanoic acid esters with pentaerythritol
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Performance Fluids, Ltd. |
Dec 21, 2018 |
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Isononanoic acid esters with dipentaerythritol
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Performance Fluids, Ltd. |
Dec 21, 2018 |
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Fatty acids, C18-unsatd., dimers, polymers with caprolactam and hexamethylenediamine [Nylon 6/6.36] (CAS Reg. No 2068097-08-3).
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BASF SE |
Dec 5, 2018 |
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2-Propen-1-aminium, N,N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with ethanedial and 2-propenamide (CAS Reg. No. 32555-39-8).
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SNF SAS |
Jan 23, 2019 |
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2,6-Pyridinedicarboxylic acid (dipicolinic acid) (CAS Reg. No. 499-83-2).
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Enviro Tech Chemical Services, Inc. |
Dec 28, 2018 |
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Tetrafluoroethylene-ethylene-3,3,4,4,5,5,6,6,6-nonafluoro-1-hexene terpolymer (CAS Reg. No. 68258-85-5).
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Asahi Glass Co., Ltd. |
Dec 13, 2018 |
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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-hydroxyethane 1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally, sulfuric acid (CAS Reg. No. 7664-93-9).
|
Xgenex, LLC |
Dec 6, 2018 |
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?