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FDA Adds Seven New Substances to its Inventory of Effective FCS Notifications

December 31, 2019

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.

FCN No.

Food Contact Substance Manufacturer/Supplier Effective Date
2009

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
2006

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
2004

Carbamodithioic acid, N,N-dibutyl-, C,C'-methylene ester (CAS Reg. No. 10254-57-6).

MOL-LUB Kft Oct 9, 2019
2002

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
1998

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
1995

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
1993

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?