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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.

 

FCN No.

Food Contact Substance

Manufacturer/Supplier

Effective Date

1834

 

Hydroquinone (CAS Reg. No. 123-31-9). REPLACES FCNs 1246 and 1306

The Valspar Corporation

Dec 15, 2017

 

1833

 

Sorbic Acid (CAS Reg. No. 110-44-1). REPLACES FCN 1305

The Valspar Corporation

Dec 15, 2017

 

1832

 

Diethylene glycol (CAS Reg. No. 111-46-6).

Anderson Development Company

Dec 13, 2017

 

1831

 

Tripropylene glycol (CAS Reg. No. 24800-44-0).

Anderson Development Company

Dec 13, 2017

 

1830

 

Dipropylene glycol (CAS Reg. No. 25265-71-8).

Anderson Development Company

Dec 13, 2017

1825

 

Siloxanes and silicones, methyl-phenyl, methyl-3,3,3-trifluoropropyl (CAS Reg. No. 1643944-25-5).

Dow Corning Corporation

Dec 1, 2017

1824

 

Poly-1-butene polymers (CAS Reg. No. 9003-28-5) and butene/ethylene copolymers (CAS Reg. No. 25087-34-7).

LyondellBasell Industries

Dec 1, 2017

1823

 

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 dipicolinic acid (DPA) (CAS Reg. No. 449-83-2).

Brainerd Chemical Company, Inc.

Nov 29, 2017

1821

 

Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-(4-morpholinyl)-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, sodium salt (CAS Reg. No. 16090-02-1).

Zhejiang Hongda Chemicals Co. Ltd.

Nov 21, 2017

 

1820

 

Styrene-isobutylene block copolymer (CAS Reg. No. 9011-12-5).

Kaneka North America, LLC

Nov 15, 2017

1819

 

A mixture of 1-decene, polymer with sulfur dioxide (CAS Reg. No. 33990-98-6); 1,3-propanediamine, N1-(9Z)-9-octadecen-1-yl-, polymer with 2-(chloromethyl)oxirane (CAS Reg. No. 1010121-89-7); and dodecylbenzenesulfonic acid (CAS Reg. No. 27176-87-0).

Innospec Ltd.

Nov 7, 2017

1818

 

Poly[(butylenesuccinate)-co-adipate] cross-linked with malic acid. REPLACES FCN 1643

PTT MCC Biochem Company Ltd.

Dec 23, 2017

1817

 

Poly(1,4-butylene glycol-co-succinic acid), cross-linked with malic acid. REPLACES FCN 1574

PTT MCC Biochem Company Ltd.

Dec 23, 2017

1815

 

An aqueous solution of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), with oxalic acid (CAS Reg. No. 144-62-7) and/or maleic acid (CAS Reg. No. 110-16-7).

PeroxyChem, LLC

Dec 29, 2017

1810

 

An aqueous mixture of 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-hydroxyethylidine-1, 1-disphosphonic acid (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 766-93-9).

BioSafe Systems LLC

Nov 30, 2017

1809

 

Maleic anhydride-grafted polyethylene (CAS Reg. No. 9006-26-2).

The Dow Chemical Company

Dec 29, 2017

1808

 

1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(Et and Pr) derivs. (CAS Reg. No. 1613243-54-1)

Akzo Nobel Functional Chemicals, LLC
S.A. Akzo Nobel Chemicals N.V.

Dec 8, 2017

1805

 

A polymer produced from tetrafluoroethylene (CAS Reg. No. 116-14-3) and 1,1,2,2-tetrafluoro-2-((1,2,2-trifluoroethenyl)oxy)ethanesulfonyl fluoride (CAS Reg. No. 29514-94-1). The polymer is hydrolyzed and may optionally be further neutralized to its ammonium salt.

Solvay Specialty Polymers USA, LLC

Dec 20, 2017

1804

 

Chlorine dioxide (CAS Reg. No. 10049-04-4).

Selective Micro Technologies

Dec 6, 2017

1803

 

Maleic anhydride, polymer with ethene and 1-hexene (CAS Reg. No. 86286-09-1).

The Dow Chemical Company

Dec 29, 2017

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. 

© 2018 Keller and Heckman LLP

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