FDA Adds Nine More New Substances to its Inventory of Effective F

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FDA Adds Nine More New Substances to its Inventory of Effective FCS Notifications

by: Packaging Law at Keller and Heckman of Keller and Heckman LLP - Packaging Law Blog at Keller and Heckman

Thursday, May 11, 2017

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The U.S. Food and Drug Administration (FDA) recently added nine new substances to its Inventory of Effective Food Contact Substance (FCS) Notifications. The newly listed substances and the manufacturers are listed below.

FCN No.	Food Contact Substance	Manufacturer/Supplier	Effective Date
1740	Decanedioic acid, polymer with 11‐aminoundecanoic acid and 4,4'‐methylenebis[2‐methylcyclohexanamine] (CAS Reg. No. 1107603‐83‐7).	Arkema	Mar 31, 2017
1738	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-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9).REPLACES FCN 447	Enviro Tech Chemical Services, Inc.	Mar 28, 2017
1727	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-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9).	CraftChem, Inc.	Mar 18, 2017
1726	An aqueous mixture of peroxyacetic acid (PAA)(CAS Reg. No. 79-21-0), hydrogen peroxide (HP)(CAS Reg. No. 7722-84-l), acetic acid (CAS Reg. No. 64-19-7), l-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).	PeroxyChem, LLC	Jan 26, 2017
1725	SiO_xC_yH_z polymeric coatings formed by plasma enhanced chemical vapor deposition, utilizing tetramethylsilane (CAS Reg. No. 75-76-3) and oxygen as the starting materials.	Dart Industries Inc. and Affiliates	Mar 28, 2017
1718	Polyurethane adhesive formulated from: Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300 (b)(3)(vii); Isocyanate hardeners consisting of one or more of the following m-xylylene diisocyanate (CAS Reg. No. 3634-83-1), m-xylylene diisocyanate-trimethylol propane prepolymer (CAS Reg. No. 51852-81-4), 2-ethyl-1-hexanol reaction products with 1,6-diisocyanatohexane, 1,6-diisocyanatohexane (CAS Reg. No. 822-06-0), and prepolymers of them. Optional use, in either the urethane hardener or polyester resin portions of the resin, of trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups comprising not more than 3 percent by weight of the cured adhesive and/or the triethoxysilane coupling agent described in the notification. An inorganic filler must be included in the adhesive as described in the notification.	DIC Corporation	Feb 22, 2017
1716	Polymer of butyl acrylate and 4-hydroxybutyl acrylate, with a methylene diphenyl diisocyanate based crosslinker.	Avery Dennison Corporation	Mar 23, 2017
1715	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).	Seeler Industries, Inc.	Feb 4, 2017
1707	1,4-Benzenedicarboxylic acid, polymer with 5-amino-1,3,3-trimethylcyclohexanemethanamine and hexahydro-2H-azepin-2-one (CAS Reg. No. 1105025-82-8).	DSM Engineering Plastics B.V.	Mar 22, 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.