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FDA Adds 20 New Substances to its Inventory of Effective FCS Notifications

The U.S. Food and Drug Administration (FDA) recently added 20 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.

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.

 

FCN No.

 

Food Contact Substance

Manufacturer/Supplier

Effective Date

1976

 

Copolymers of acrylamide, 2-(dimethylamino)ethyl methacrylate, itaconic acid, benzyl[2-(methacryloyloxy)ethyl](dimethyl)ammonium chloride, and benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride, optionally crosslinked with hexahydro-1,3,5-tris(1-oxoallyl)-1,3,5-triazine.

 

Arakawa Chemical Industries, Ltd.

May 31, 2019

1975

 

Oxirane, 2-methyl-, polymer with oxirane, ether with 1,2,3-propanetriol (3:1), polymer with 1,3-diisocyanato-2-methylbenzene and 2,4-diisocyanato-1-methylbenzene (CAS Reg. No. 68227-13-4).

 

Amorim & Irmãos, S.A.

May 31, 2019

1968

 

An aqueous mixture of peroxyacetic acid (PAA; CAS Reg. No. 79-21-0), hydrogen peroxide (HP; CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP; CAS Reg. No. 2809-21-4).

 

Ecolab Inc.

May 28, 2019

1967

 

2,2‐bis((pentanoyloxy)methyl)propane‐1,3‐diyl dipentanoate (CAS Reg. No. 15834‐04‐5).

 

Perstorp AB

May 28, 2019

1966

 

1,4-Benzenedicarboxylic acid, polymer with 2-methyl-1,8-octanediamine and 1,9-nonanediamine, reaction products with benzoic acid (CAS Reg. No. 1310362-57-2).

 

Kuraray Company, Ltd.

May 28, 2019

1965

 

Aluminum silicon silver oxide with sodium zeolite Y (CAS Re. No. 308081-05-2).

 

The Nikka Whisky Distilling Co., Ltd.

May 28, 2019

1963

 

Fatty acids, C14-C20, esters with pentaerythritol (CAS Reg. No. 68440-28-8).

 

Peter Greven GmbH & Co. KG

May 28, 2019

1962

 

Amines, hydrogenated tallow alkyl, acetates (CAS Reg. No. 61790-59-8).

 

Akzo Nobel Industrial Chemicals B.V.

May 28, 2019

1961

 

Nylon MXD-6 (CAS Reg. No. 25718-70-1) (also known as hexanedioic acid, polymer with 1,3-benzenedimethanamine) meeting the analytical specifications in 21 CFR 177.1500(b) item 10.1 and used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2) and/or cobalt propionate (CAS Reg. No. 1560-69-6).

 

Indorama Ventures USA Inc. and its stewarded affiliates around the world

May 28, 2019

1960

 

An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722 -84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9) and/or dipicolinic acid (DPA) (CAS Reg. No. 499-83-2).

 

Harcros Chemicals, Inc.

May 20, 2019

1959

Butanedioic acid, 2-methylene-, polymer with ethenyl acetate, hydrolyzed, sodium salts (CAS Reg. No. 122625-12-1).

 

Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
Kuraray Asia Pacific Pte. Ltd.

May 19, 2019

1956

 

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)).

 

Coatex and Affiliates

May 13, 2019

1955

 

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)).

 

Coatex and Affiliates

May 13, 2019

1953

 

Trimethylolpropane (CAS Reg. No. 77-99-6).

 

Tronox LLC

May 5, 2019

1952

 

1,4-benzenedicarboxylic acid, 1,4-dibutyl ester (CAS Reg. No. 1962-75-0).

 

Eastman Chemical Company

Apr 19, 2019

1951

 

Polyphenylene sulfide (CAS Reg. No. 26125-40-6 or 25212-74-2). REPLACES FCN 1731

 

DIC EP Corporation
DIC Corporation

Apr 14, 2019

1948

 

Acrylic resins derived from styrene (CAS Reg. No. 100-42-5), ethyl acrylate (CAS Reg. No. 140-88-5), 1,4-butanediol dimethacrylate (CAS Reg. No. 2082-81-7), acrylic acid (CAS Reg. No. 79-10-7), and 2-hydroxyethyl methacrylate (CAS Reg. No. 868-77-9).

 

The Sherwin-Williams Company

May 25, 2019

1946

An aqueous mixture of peroxylactic acid (PLA), hydrogen peroxide (HP), lactic acid, water, optional 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP), optionally sulfuric acid, and optionally phosphoric acid.

Valley Chemical Solutions

May 28, 2019

1945

 

Alcohols, C10-14-branched, C11-rich, reaction products with ethylene oxide, [(2-propenyloxy)methyl]oxirane and sulfamic acid (CAS Reg. No. 905843-50-7). The FCS is comprised primarily of poly(oxy-1,2-ethanediyl), α-sulfo-ω-[1-(hydroxymethyl)-2-(2-propen-1-yloxy)ethoxy]-, C11-rich, C10-14-branched alkyl ethers, ammonium salts (CAS Reg. No. 403983-53-9).

 

ADEKA Corporation

May 5, 2019

1944

 

Alcohols, C10-14 branched, C11 rich, reaction products with polyethylene glycol and 2-[(2-propen-1-yloxy)methyl]oxirane (CAS Reg. No. 403983-11-9 and 1000866-04-5).

 

ADEKA Corporation

May 5, 2019

 

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