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U.S. Department of Health and Human Services

Inventory of Environmental Impact Decisions for Food Contact Substance Notifications

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FCN No. 1926

Food Contact Substance: (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).
Environmental Assessment NEPA Submission: Environmental Assessment (in PDF, 275 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 123 kB)
FCN Premarket Authorization Issued: FCN description
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