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

February 12, 2019

The U.S. Food and Drug Administration (FDA) recently added four 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

1926

 

(3R,6R)-3,6-dimethyl-1,4-dioxane-2,5-dione, polymer with rel-(3R,6S)-3,6-dimethyl-1,4-dioxane-2,5-dione and (3S,6S)-3,6-dimethyl-1,4-dioxane-2,5-dione (aka polylactide (PLA) polymers), optionally containing up to 16 weight percent D‐lactic acid polymer units (CAS Reg. No. 9051-89-2).

 

Total Corbion PLA bv

Nov 30, 2018

1921

 

A mixture of benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2- hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, disodium salt (CAS Reg. No. 17958-73-5), benzenesulfonic acid, 5-[[4-[bis(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-2-[2-[4-[[4-[(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]ethenyl]-, disodium salt (CAS Reg. No. 88358-71-8) and Benzenesulfonic acid,2,2'-(1,2-ethenediyl)bis[5-[[4-[(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, disodium salt (CAS Reg. No. 4193-55-9).

 

Archroma U.S., Inc.

Nov 9, 2018

1920

 

Polyurethane resin produced by reacting hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) with castor oil (CAS Reg. No. 8001-79-4).

 

Diam Bouchage SAS
Henkel AG & Co. KGaA

Nov 6, 2018

 

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?

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.