US FDA Adds 10 Substances to Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added ten new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.
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.
Reference Links
- Inventory of Effective Food Contact Substance (FCS) Notifications – US FDA
- About the FCS Review Program – US FDA
- More news on food regulatory compliance
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