The U.S. Food and Drug Administration (FDA) recently added 15 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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Ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers modified with up to 8 mol% 1,2-epoxypropane (CAS Reg. No. 482589-30-0). |
Kuraray Co., Ltd. |
Mar 29, 2014 |
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Polymer of 3-hydroxybutyric acid with up to 25% 3-hydroxyvaleric acid, 3-hydroxyhexanoic acid, 3-hydroxyoctanoic acid, and/or 3-hydroxydecanoic acid. |
Meredian, Inc. |
Mar 27, 2014 |
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Copolymer of polyethylene glycol dimethacrylate, trimethylol methacrylate and 2-hydroxyethyl methacrylate. |
Pall Corporation |
Mar 25, 2014 |
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Mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CIT; CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (MIT; CAS Reg. No. 2620-20-4), at a ratio of 3 parts to 1 part by weight, optionally stabilized with magnesium or sodium nitrate and copper (II) nitrate. |
Thor GmbH |
Mar 25, 2014 |
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1,3-Benzenedicarboxamide, N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) (CAS Reg. No. 42774-15-2). |
Clariant International AG |
Mar 21, 2014 |
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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 (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9). |
FMC Corporation |
Mar 20, 2014 |
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Amines, C10-C18-alkyldimethyl, N-oxides. |
Goulston Technologies, Inc. |
Mar 19, 2014 |
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Octadecanoic acid, 9(or 10)-hydroxyphenyl- (CAS Reg. No. 26102-12-5). |
Akzo Nobel Coatings Inc. |
Mar 19, 2014 |
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Styrene block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4) |
Kuraray Co., Ltd. |
Mar 14, 2014 |
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A 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). |
Alex C. Fergusson, LLC (AFCO) |
Mar 14, 2014 |
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Crosslinked 2-propenoic acid, homopolymer, sodium salt (2:1) (CAS Reg. No. 9003-04-7). |
McAirlaid's Inc. |
Mar 14, 2014 |
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An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), sodium hydroxide (CAS Reg. No. 1310-73-2), and glycerine (CAS Reg. No. 56-81-5). |
Enviro Tech Chemical Services, Inc. |
Mar 6, 2014 |
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Carbon black (amorphous, lamp black) (CAS Reg. No. 1333-86-4). |
Orion Engineered Carbons GmbH, Germany |
Mar 4, 2014 |
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An aqueous solution 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), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4). |
Brainerd Chemical Co. |
Mar 1, 2014 |
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1,4-Butanediol dimethacrylate (CAS Reg. No. 2082-81-7). |
GEO Specialty Chemicals UK Ltd. |
Mar 1, 2014 |
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?"