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

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The U.S. Food and Drug Administration (FDA) recently added twelve 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
2148 Magnesium sodium fluoride silicate (CAS Reg. No. 56450-90-9) Topy Industries, Limited July 31, 2021
2142 Copolymer of styrene (CAS Reg. No. 100-42-5), methyl methacrylate (CAS Reg. No. 80-62-6), and glycidyl methacrylate (CAS Reg. No. 106-91-2) REPLACES FCNs 853 AND 1109 BASF Corporation July 22, 2021
2139 Zinc pyrithione (CAS Reg. No. 13463-41-7) REPLACES FCN 2031 Symphony Environmental Technologies Plc July 13, 2021
2138 Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of dimethyl terephthalate or terephthalic acid and ethylene glycol with one or more of the following: dimethyl isophthalate, isophthalic acid, and diethylene glycol M&G Polímeros México, S.A. de C.V. July 10, 2021
2137 Chromium nitride IKEA of Sweden AB July 7, 2021
2136 Polyethylene terephthalate-azelate copolyester resin (CAS Reg. No. 25609-72-7) DuPont Teijin Films July 8, 2021
2133 Hypochlorous acid (CAS Reg. No. 7790‐92‐3) Cougar Creek Electrolysed Water, LLC June 29, 2021
2130 Acetic acid ethenyl ester, polymer with N-ethenylformamide, hydrolyzed, amine-containing (CAS Reg. No. 163879-68-3 Sekisui Specialty Chemicals America, LLC June 16. 2021
2127 Poly(tetramethylene terephthalate)(CAS Reg. No. 24968-12-5 and 26062-94-2) as manufactured from terephthalic acid and 1,4-butanediol Mitsubishi Engineering-Plastics Corporation June 5, 2021
2125 1,6-Hexanediol (CAS Reg. No. 629-11-8) Polynt Composites USA Inc. June 1, 2021
2121 Octyltriethoxysilane-modified titanium dioxide Anhui Gold Star Titanium Dioxide (Group) Co., Ltd. June 26, 2021
2120 Paraffin waxes and hydrocarbon waxes, oxidized (CAS Reg. No. 68153-22-0) Sasol Limited July 7, 2021

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 article, What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?