September 27, 2021

Volume XI, Number 270

Advertisement

September 24, 2021

Subscribe to Latest Legal News and Analysis
Advertisement

FDA Adds Seven New Substances to its Inventory of Effective FCS Notifications - 2021

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

2106

An aqueous solution of hydrogen peroxide (CAS Reg. No. 7722-84-1) stabilized with 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4). REPLACES FCN 2029

Agri-Neo Inc.

January 21, 2021

2104

2-Propenoic acid, 2-methyl-, polymer with 2-methyloxirane polymer with oxirane monoether with 1,2-propanediol mono(2-methyl-2-propenoate) and 2-propenoic acid, sodium salt (CAS Reg. No. 2272985-43-8)

Coatex and affiliates

January 19, 2021

2100

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), sulfuric acid (CAS Reg. No. 7664-93-9), and 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4). REPLACES FCN 2000

Agri-Neo Inc.

January 6, 2021

2099

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 (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9). REPLACES FCN 2060

Alex. C Fergusson, LLC (AFCO)

January 1, 2021

2097

Polymer of butyl acrylate and 4-hydroxybutyl acrylate, with a methylene diphenyl diisocyanate based crosslinker. REPLACES FCN 1716

Avery Dennison Corporation

December 29, 2020

2096

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-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and/or dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (SA) (CAS Reg. No. 7664-93-9)

Hydrite Chemical Co.

December 26, 2020

2090

Zinc pyrithione (CAS Reg. No. 13463-41-7)

Troy Corporation

December 12, 2020

 

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?

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 60
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

...

202-434-4100
Advertisement
Advertisement
Advertisement