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

June 12, 2018

The U.S. Food and Drug Administration (FDA) recently added four 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

1872

 

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).

 

Hydrite Chemical Co.

May 5, 2018

1854

 

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).

 

Amorim & Irmãos, S.A.

May 8, 2018

1847

 

Carbon monoxide-ethylene-propylene terpolymer (CAS Reg. No. 88995-51-1). REPLACES FCN 1562

 

Hyosung Corporation

May 13, 2018

 

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?