FDA Adds Seven New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added seven new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.
|Food Contact Substance||Manufacturer/Supplier||Effective Date|
An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), and, optionally, sulfuric acid (SA) (CAS Reg. No. 7664-93-9).
|Hydrite Chemical Co.||Oct 30, 2019|
An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), sulfuric acid (SA) (CAS reg. No. 7664-93-9), and 1-hydroxyethylidine-1,1- diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4).
|DeLaval Inc.||Oct 23, 2019|
Carbamodithioic acid, N,N-dibutyl-, C,C'-methylene ester (CAS Reg. No. 10254-57-6).
|MOL-LUB Kft||Oct 9, 2019|
Polyurethane resin produced by reacting a mixture of 2,4-toluene diisocyanate (CAS Reg. No. 584-84-9) and 2,6-toluene diisocyanate (CAS Reg. No. 91-08-7) with polyoxyethylene-polyoxypropylene glyceryl ether (CAS Reg. No. 9082-00-2) and 1,4-butanediol (CAS Reg. No. 110-63-4).
|Flexpur – Polímeros de Poliuretano, S.A.||Oct 3, 2019|
Triphenyl phosphite, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10-16 alkyl esters (CAS Reg. No. 1821217-71-3).
|Dover Chemical Corporation||Oct 29, 2019|
An aqueous mixture of peroxylactic acid (PAA) (CAS Reg. No. 75033-25-9), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), lactic acid (LA) (CAS Reg. No. 50-21-5), optionally 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), optionally sulfuric acid (SA) (CAS
Reg. No. 7664-93-9), optionally dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally phosphoric acid (PA) (CAS Reg. No. 7664-38-2).
|Valley Chemical Solutions||Oct 30, 2019|
1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt (1:1), polymer with dimethyl 1,4-benzenedicarboxylate and 1,2-ethanediol (CAS Reg. No. 27937-63-9).
Matsumura Sangyo Co., Ltd.
Goo Chemical Co., Ltd.
|Oct 29, 2019|
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?