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

October 10, 2018

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

 

1913

 

Tricyclodecanedimethanol (TCDM) (CAS Reg. Nos. 26896-48-0 and 26160-83-8).

The Sherwin-Williams Company

September 29, 2018

 

1912

 

Polypropylene (CAS Reg. No. 9003-07-0).

Idemitsu Kosan Co., Ltd.

September 21, 2018

1910

 

Ethylene phthalate polymers modified with 1,2,4,5-benzenetetracarboxylic dianhydride (pyromellitic dianhydride (PMDA; CAS Reg. No. 89-32-7)) and 1,3-butadiene, homopolymer, hydroxy-terminated (PBD; CAS Reg. No. 69102-90-5) used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0).

 

ProFusion Industries

September 19, 2018

1907

 

Dimethyl, methyl vinyl polysiloxane, vinyl group-terminated (CAS Reg. No. 68083-18-1), reaction products with poly(ethylene-co-methyl acrylate) (CAS Reg. No. 25103-74-6).

 

Dow Silicones Corporation

August 23, 2018

 

1902

 

2-hydroxyethyl methacrylate (HEMA; CAS Reg. No. 868-77-9).

PPG Industries, Inc.

August 8, 2018

1896

 

Polycyclooctene (CAS Reg. No. 25267-51-0), used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0).

 

Evonik Resource Efficiency GmbH

September 20, 2018

1888

 

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. 64-19-17), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9).

 

Evonik Corporation

August 30, 2018

1886

 

An aqueous mixture containing 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), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4), dipicolinic acid (DPA; CAS Reg. No. 499-83-2), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

 

Diversey Inc.

September 27, 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?