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

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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
2264 Tricyclodecanedimethanol (TCDM, CAS Reg. Nos. 26896-48-0 and 26160-83-8). Allnex Austria GmbH and its stewarded affiliates around the world March 31, 2023
2263 Polylactide (Polylactic acid; PLA) optionally containing up to 15 weight percent D-lactic acid polymer units (CAS Reg. No. 9051-89-2). Anhui BBCA Biochemical & Futerro PLA CO., LTD. March 22, 2023
2272 Poly[(butylenesuccinate)-co-adipate] cross-linked with malic acid. REPLACES FCN 1818 PTT MCC Biochem Company Limited March 3, 2023
2271 Poly(1,4-butylene glycol-co-succinic acid), cross-linked with malic acid. REPLACES FCN 1817 PTT MCC Biochem Company Limited March 2, 2023

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?