US FDA Adds 10 Substances to Inventory of Effective FCS Notifications

The U.S. Food and Drug Administration (FDA) recently added 10 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.

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10 Food Contact Substances Newly Added to the Inventory

FCN No.	Food Contact Substance	Manufacturer/Supplier	Effective Date
2224	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).	AFCO	Jun 28, 2022
2214	Hydrogenated castor oil monoglycerides, acetylated (CAS Reg. No. 736150-63-3). REPLACES FCN 2047	DuPont Nutrition & Biosciences ApS	Jun 24, 2022
2213	Oleic acid, mono ester with oxybis(propanediol) (CAS Reg. No. 49553-76-6). REPLACES FCN 2037	DuPont Nutrition & Biosciences ApS	Jun 24, 2022
2223	A reactive mixture of ethylene acrylic acid copolymer (EAA; CAS Reg. No. 9010-77-9) and N,N,N’,N’-tetrakis(2-hydroxypropyl)adipamide (HAA; CAS Reg. No. 57843-53-5).	Akzo Nobel Coatings Inc.	Jun 23, 2022
2222	Lignosulfonic acid, sodium salt (CAS Reg. No. 8061-51-6).	CHEP USA	Jun 11, 2022
2221	Styrene block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4), as further described in your submission.	Kuraray GC Advanced Materials Co., Ltd. Kuraray Co., Ltd. Kuraray America, Inc. Kuraray Europe GmbH	Jun 8, 2022
2220	Copolymer of styrene (CAS Reg. No. 100-42-5), α-methylstyrene (CAS Reg. No. 98-83-9), methacrylic acid (CAS Reg. No. 79-41-4), n-butyl acrylate (CAS Reg. No. 141-32-2), methyl methacrylate (CAS Reg. No. 80-62-6), and, optionally, acrylic acid (CAS Reg. No. 79-10-7) and/or α-methylstyrene dimer (CAS Reg. No. 6362-80-7).	Harima Chemicals, Inc., Plasmine Technology, Inc.	Jun 7, 2022
2219	β3,β3,β9,β9-Tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol (CAS Reg. No. 1455-42-1).	The Sherwin-Williams Company	May 25, 2022
2205	Naphtha (petroleum), light steam-cracked aromatic, piperylene concentrate, polymerized (CAS Reg. No. 68478-07-9).	ExxonMobil Chemical Company and its stewarded affiliates around the world.	May 20, 2022
2204	Phosphorous acid, cyclic neopentanetetrayl bis(2,6-di-tert-butyl-4-methylphenyl) ester (CAS Reg. No. 80693-00-1).	ADEKA Corporation	May 12, 2022

About the FCS and FCN

The U.S. Food and Drug Administration (FDA) established the Division of Food Contact Substances (FCS) within the Office of Food Additive Safety to ensure components of food contact articles, including food packaging and processing equipment, are safe for their intended use. These articles are composed of food contact materials, that contain or are made of food contact substances (FCSs).

FCSs are typically included in coatings, plastics, paper, adhesives, colourants, antimicrobials, and antioxidants. FCSs are evaluated primarily through the food contact notification (FCN) program. Federal law requires companies who wish to use a food contact substance to submit Food Contact Substance Notifications (FCNs) to FDA prior to marketing the product.

The FDA has a mandated 120-day time-period to review that submission. If the agency does not express any objections about the safety of the substance in that time-period, then the company can legally market the product. Once the notification becomes effective, FDA will add it to its Inventory of Effective FCS Notifications.

An effective FCN applies only to the food contact substance that is the subject of the FCN and is applicable to the manufacturer/supplier listed within the notification.

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