FCN No. 2413
Fiberlean Technologies Limited
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: |
Microfibrillated cellulose pulp (CAS Reg. No.: 65996-61-4). REPLACES FCN 2022
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| Notifier: |
Fiberlean Technologies Limited
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| Manufacturer/Supplier: |
Fiberlean Technologies Limited
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| Intended Use: |
- As an additive, a raw material component, or coating in the manufacture of uncoated food-contact paper and paperboard;
- As a coating on food-contact polymers under a polymer barrier layer;
- As a component of adhesives used in the manufacture of multi-layer food contact materials; and
- As a component of coatings applied to fruits and vegetables with inedible peels, excluding citrus fruits.
The FCS is not for use in contact with infant formula and human milk (see Limitations/Specifications).
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| Limitations/Specifications: |
- The FCS is intended for use: (1) as an additive, a raw material component, or coating in the manufacture of uncoated food-contact paper and paperboard, (2) as a coating on food-contact polymers, and (3) as a component of adhesives at levels up to 100% in contact with all food types under Conditions of Use B through H, as described in Tables 1 and 2.
- The FCS is intended for use as a component of coatings applied to fruits and vegetables with inedible peels at a level up to 100% of the coating.
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.
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| Effective Date: |
Feb 12, 2025
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| National Environmental Policy Act (NEPA)** Submission: |
Categorical Exclusion 25.32 (r)
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| FDA Decision: |
Categorical Exclusion Memo
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