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