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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2325

Carbios S.A. and its affiliates

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Food Contact Substance: Subtilisin from Alkalihalobacillus clausii produced by a genetically modified strain of Bacillus licheniformis.
Notifier: Carbios S.A. and its affiliates
Manufacturer/Supplier: Carbios S.A. and its affiliates
Intended Use: For use as an additive to polylactic acid (PLA) polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at a maximum level of 0.3% by weight of the finished PLA polymer. The finished PLA polymers containing the FCS may contact all food types under Conditions of Use E through G, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Feb 29, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 129 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 176 kB)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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