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Volume X, Number 193

July 10, 2020

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July 09, 2020

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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?

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 154

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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

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