FDA Adds Three New Substances to its Inventory of Effective FCS N

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

by: Packaging Law at Keller and Heckman of Keller and Heckman LLP - Packaging Law Blog at Keller and Heckman

Thursday, June 8, 2017

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The U.S. Food and Drug Administration (FDA) recently added three 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
1753	Phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS Reg. No. 939402-02-5).	Addivant	Apr 21, 2017
1749	2,2,4,4-Tetramethylcyclobutane-1,3-diol (CAS Reg. No. 3010-96-6).	Eastman Chemical Company	Apr 18, 2017
1746	Polyester-polyurethane adhesive formulated from the following: Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2), and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0) and Polyester/polyether/polyol component prepared from adipic acid (CAS Reg. No. 124-04-0), 1,3-benzenedicarboxylic acid (CAS Reg. No. 121-91-5), diethylene glycol (CAS Reg. No. 111-46-6), 1,2-propanediol (CAS Reg. No. 57-55-6), polypropylene glycol (CAS Reg. No. 25322-69-4), and 1,2,3-propanetriol (CAS Reg. No. 56-81-5).	Henkel, Inc.	Mar 21, 2017

FCN No.

Food Contact Substance

Manufacturer/Supplier

Effective Date

1753

Phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS Reg. No. 939402-02-5).

Addivant

Apr 21, 2017

1749

2,2,4,4-Tetramethylcyclobutane-1,3-diol (CAS Reg. No. 3010-96-6).

Eastman Chemical Company

Apr 18, 2017

1746

Polyester-polyurethane adhesive formulated from the following:

Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2), and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0) and
Polyester/polyether/polyol component prepared from adipic acid (CAS Reg. No. 124-04-0), 1,3-benzenedicarboxylic acid (CAS Reg. No. 121-91-5), diethylene glycol (CAS Reg. No. 111-46-6), 1,2-propanediol (CAS Reg. No. 57-55-6), polypropylene glycol (CAS Reg. No. 25322-69-4), and 1,2,3-propanetriol (CAS Reg. No. 56-81-5).

Henkel, Inc.

Mar 21, 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.