FDA Adds Ten New Substances to its 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.
|
FCN No. |
Food Contact Substance |
Manufacturer/Supplier |
Effective Date |
|
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), dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (SA) (CAS Reg. No. 7664-93-9) |
PeroxyChem, LLC |
Dec. 23, 2021 |
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Methacrylic acid, polymer with cyclohexyl methacrylate, 2-ethylhexyl acrylate, itaconic acid, acrylamide tert-butylsulfonic acid, acrylamide, and acrylic acid, sodium salt |
SEIKO PMC Corporation |
Dec. 18, 2021 |
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Styrene block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4) as further described in your submission |
Kuraray Co., Ltd. |
Dec. 11, 2021 |
|
|
Phenol, 4,4’-sulfonylbis-, polymer with 1,1’-sulfonylbis(4-chlorobenzene) (CAS Reg. No. 25667-42-9 and 25608-63-3) |
Sumitomo Chemical Co., Ltd. |
Dec. 7, 2021 |
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Poly(acrylic acid-co-ethyl acrylate-co-glycidyl methacrylate-co-styrene) (CAS Reg. No. 27968-38-3). REPLACES FCN 1212 |
PPG Industries, Inc. |
Dec. 3, 2021 |
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Cross-linked 2-propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7) |
Pactiv LLC |
Nov. 30, 2021 |
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5-Chloro-2-methyl-4-isothiazolin-3-one (CIT; CAS Reg. No. 26172-55-4) |
THOR GmbH |
Nov. 17, 2021 |
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[1,1-Biphenyl]-4,4-diol, polymer with 1,1-sulfonylbis[4-chlorobenzene] (CAS Reg. No. 25608-64-4 and 25839-81-0) |
Chang Chun Plastics Co., Ltd. |
Nov. 12, 2021 |
|
|
2-propenoic acid, polymer with sodium phosphinate (1:1), neutralized with sodium, calcium, and/or magnesium (including CAS Reg. No. 129898-01-7 (Na salt), CAS Reg. No. 935545-65-6 (Mg Na salt), and CAS Reg. No. 2144395-83-3 (Ca Na salt)) |
SNF SA, SNF Inc. |
Nov. 9, 2021 |
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Copolymer of acrylonitrile, methacrylonitrile, methyl methacrylate, methacrylic acid, and trimethylolpropane trimethacrylate (CAS Reg. No. 1173902-42-5) |
Tapi S.p.A. |
Nov. 6, 2021 |
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?