FDA Adds Five New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added five 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 |
Effective Date |
|---|---|---|---|
|
2,6-naphthalenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, [1,1'-biphenyl]-4,4'-diol and 4-hydroxybenzoic acid (CAS Reg. No. 126710-16-5). |
Chang Chun Plastics Co., Ltd. |
Feb 5, 2016 |
|
|
Hexanoic acid, 3,5,5-trimethyl-, 1,1-[oxybis[2,2-bis[[(3,5,5-trimethyl-1-oxohexyl)oxy]methyl]-3,1-propanediyl]] ester (CAS Reg. No. 65870-97-5). |
NYCO |
Feb 3, 2016 |
|
|
Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from polypropylene glycol, toluene diisocyanate, allophanate-modified methane diphenyl diisocyanate and 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8). (b) Polyester component (CAS Reg. No. 1429057-80-6) prepared by the reaction of 1,3-benzenedicarboxylic acid and diethylene glycol, trans-esterified with castor oil. |
Henkel, Inc. |
Feb 18, 2016 |
|
|
Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0). (b) Polyester component (CAS Reg. No. 1429057-80-6) prepared by the reaction of 1,3-benzenedicarboxylic acid and diethylene glycol, trans-esterified with castor oil. |
Henkel, Inc. |
Feb 18, 2016 |
|
|
An aqueous mixture containing 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-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9). |
PeroxyChem LLC |
Feb 16, 2016 |
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?"