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

May 1, 2018

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

1866

 

2-Propen-1-aminium, N,N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with 2-propenamide, decarboxylated, hydrochlorides (CAS Reg. No. 913068-94-7).
REPLACES FCN 971

SNF S.A.S.

Apr 21, 2018

1865

Isophthalic acid (CAS Reg. No. 121-91-5).

 

Indorama Ventures USA Inc. and its stewarded affiliates around the world.

Apr 21, 2018

1864

 

Microfibrillated cellulose pulp.

BillerudKorsnäs AB

Apr 15, 2018

1862

 

Glycidyl methacrylate polymer with styrene and methyl methacrylate (CAS Reg. No. 29564-58-7).

 

The Sherwin-Williams Company

Apr 2, 2018

1851

 

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. 64-19-7), 1-hydroxyethylidene-1,1-disphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).

 

Enviro Tech Chemical Services, Inc.

Apr 1, 2018

1843

 

2-propenoic acid, methyl ester, polymer with 1,7-octadiene, diethenylbenzene, ethenylethylbenzene and 2-propenenitrile, modified with N1,N1-dimethyl-1,3-propanediamine.

 

LANXESS Corporation

Apr 9, 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?