Share

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

February 4, 2020

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
2014

2-propenoic acid, 2-methyl-, 1-methyl-1,3-propanediyl ester, polymer with 1,3-butadiene, butyl 2-propenoate, ethenylbenzene, and methyl-2-methyl-2-propenoate (CAS Reg. No. 143646-08-6 or 25101-28-4).REPLACES FCN 1508

Kaneka Belgium NV Nov 20, 2019
2013

Butyl acrylate (CAS Reg. No. 141-32-2).

PPG Industries, Inc. Nov 16, 2019
2011

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), dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (CAS Reg. No. 7664-93-9).

LPR Technologies Nov 6, 2019
1997

Polycyclooctene (CAS Reg. No. 25267-51-0), used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0) REPLACES FCN 1896

Evonik Resource Efficiency GmbH Nov 5, 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?