FDA Adds 18 New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added 18 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 |
| 2045 | 2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, cyclohexyl 2-methyl-2-propenoate, methyl 2-methyl-2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate, 1,2-propanediol mono(2-methyl-2-propenoate) and 2-propen-1-yl 2-methyl-2-propenoate (CAS Reg. No. 1874228-60-0) | Akzo Nobel Coatings Inc. | April 28, 2020 |
| 2043 | Cellulose acetate (CAS Reg. No. 9004-35-7), and optionally modified with propionate to form cellulose acetate propanoate (CAS Reg. No. 9004-39-1) resulting in up to 49 weight-percent propionate esters | Eastman Chemical Company | April 14, 2020 |
| 2038 | Benzenesulfonic acid, 2-[2-(2,4-diamino-1,6-dihydro-6-oxo-5-pyrimidinyl)diazenyl]-5-methyl- (CAS Reg No. 1021701-36-9). | BASF Colors & Effects Korea Ltd. | April 9, 2020 |
| 2037 | Oleic acid, mono ester with oxybis(propanediol) (also known as diglyceryl monooleate) (CAS Reg. No. 49553-76-6) | DuPont Nutrition & Biosciences ApS and DuPont de Nemours, Inc. | April 4, 2020 |
| 2036 | 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-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (CAS Reg. No. 7664-93-9). REPLACES FCN 1639 | Biosan LLC | April 2, 2020 |
| 2034 | Copolymers of styrene (CAS Reg. No. 100-42-5), α-methylstyrene (CAS Reg. No. 98-83-9), butyl methacrylate (CAS Reg. No. 97-88-1), 2-ethylhexyl acrylate (CAS Reg. No. 103-11-7), methyl methacrylate (CAS Reg. No. 80-62-6), butyl acrylate (CAS Reg. No. 141-32-2), itaconic acid (CAS Reg. No. 97-65-4), methacrylic acid (CAS Reg. No. 79-41-4), hydroxypropyl acrylate (CAS Reg. No. 999-61-1 and CAS Reg. No. 2918-23-2), sodium methallyl sulfonate (CAS Reg. No. 1561-92-8), and sodium styrene sulfonate (CAS Reg. No. 2695-37-6). | Arakawa Chemical Industries, Ltd. | March 31, 2020 |
| 2033 | 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-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally dipicolinic acid (DPA) (CAS Reg. No. 499-83-2) and/or sodium hydroxide (NaOH) (CAS Reg. No. 1310-73-2). REPLACES FCN 1426 | Solvay Chemicals, Inc. | March 31, 2020 |
| 2031 | Zinc pyrithione (CAS Reg. No. 13463-41-7). | Symphony Environmental Technologies Plc. | February 25, 2020 |
| 2028 | Polyurethane resins (CAS Reg. No. 89097-02-9) derived from the reaction of diphenylmethane diisocyanate with 1,3-propanediol and polytetramethylene ether glycol. | BASF SE and its affiliates | February 12, 2020 |
| 2026 | Blocked isophorone diisocyanate (IPDI) polymer consisting of trimer, pentamer, heptamer, and nonamer oligomers, with the primary component of interest being the trimer (CAS Reg. No. 103170-26-9). REPLACES FCN 1039 | The Sherwin-Williams Company | March 25, 2020 |
| 2025 | Cellulose, triacetate (CAS Reg. No. 9012-09-3) | Eastman Chemical Company | January 31, 2020 |
| 2024 | Acetic acid ethenyl ester, polymer with ethene and ethenol (CAS Reg. No. 26221-27-2) | Kuraray Co., Ltd. Kuraray America, Inc. Kuraray Europe GmbH Kuraray Asia Pacific Pte. Ltd | January 28, 2020 |
| 2023 | A mixture of 35-60 percent hydroxysulfinoacetic acid, disodium salt (CAS Reg. No. 223106-41-0), 10-60 percent hydroxysulfoacetic acid, disodium salt (CAS Reg. No. 29736-24-1), and 0-40 percent sodium sulfite (CAS Reg. No. 7757-83-7) | Brüggemann Chemical US, Inc | January 22, 2020 |
| 2022 | Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4) | FIBERLEAN TECHNOLOGIES LIMITED | January 14, 2020 |
| 2021 | Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4) | Kemira Oyj | January 9, 2020 |
| 2020 | Mixed esters of C5-C12 fatty acids with pentaerythritol, dipentaerythritol, and polypentaerythritol | LANXESS Solutions US Inc. | January 3, 2020 |
| 2019 | Platinum 5,10,15,20-tetrakis(pentafluorophenyl)porphyrin (CAS Reg. No. 109781-47-7) | GEA Food Solutions Germany GmbH | January 2, 2020 |
| 2017 | Bis(hydrogenated palm-oil alkyl)hydroxy amines (CAS Reg. No. 1374859-51-4) | BASF Corporation | March 7, 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?