The U.S. Food and Drug Administration (FDA) recently added eight 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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Hexadecyltrimethylammonium bromide modified montmorillonite organoclay. |
Packaging, Transport and Logistic Center (ITENE) |
Apr 30, 2014 |
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Ethylene/propylene copolymers (CAS Reg. No. 9010-79-1) polymerized in the presence of propylene homopolymer (CAS Reg. No. 9003-07-0) complying with 21 CFR 177.1520(c) Item 1.1, to produce an inseparable blend of the two polymers. |
Propilco S.A. |
Apr 22, 2014 |
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Copolymer of polyethylene glycol dimethacrylate, trimethylolpropane trimethacrylate and 2-hydroxyethyl methacrylate. |
Pall Corporation |
Apr 17, 2014 |
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Silicon nitride ceramic. |
CERATIZIT S.A. |
Apr 15, 2014 |
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Heat-treatable steel alloy (FCN 1404) and low melting silver based brazing alloys (FCN 1405). |
CERATIZIT S.A. |
Apr 15, 2014 |
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Heat-treatable steel alloy (FCN 1404) and low melting silver based brazing alloys (FCN 1405). |
CERATIZIT S.A. |
Apr 15, 2014 |
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Copolymer of polyethylene glycol dimethacrylate, trimethylolpropane trimethacrylate and 2-hydroxyethyl methacrylate. |
Pall Corporation |
Apr 11, 2014 |
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Chlorine dioxide (CAS Reg. No. 10049-04-4). |
Clordisys Solutions, Inc. |
Apr 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?"