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

August 1, 2019

The U.S. Food and Drug Administration (FDA) recently added six 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
1988 Phosphorous acid, cyclic neopentanetetrayl bis(2,4-di-tert-butylphenyl) ester (CAS Reg. No. 26741-53-7). Addivant Jun 25, 2019
1986 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), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (SA) (CAS Reg. No. 7664-93-9). LPR Technologies Jun 25, 2019
1985 2-(dimethylamino)ethanol (CAS Reg. No. 108-01-0). The Dow Chemical Company Jun 15, 2019
1981 Silver-magnesium-zinc-aluminum-calcium-sodium-borate-phosphate glass. Ishizuka Glass Co., Ltd. Jun 5, 2019
1980 N,N-bis(2-hydroxyethyl)alkyl(C13-C15) amine (CAS Reg. No. 70955-14-5).

Braskem S.A.

Braskem Affiliates

Braskem Netherlands B.V.

Tetra Pak Inc.

Tetra Pak Canada Inc.

Jun 4, 2019
1979 N,N-bis(2-hydroxyethyl)alkyl(C13-C15) amine (CAS Reg. No. 70955-14-5).

Braskem S.A.

Braskem Affiliates

Braskem Netherlands B.V.

Tetra Pak Inc.

Tetra Pak Canada Inc.

Jun 4, 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?