FCN No. 2478
Rianlon Corporation
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: |
Pentaerythritol tetra(3-dodecylthiopropionate) (CAS Reg. No. 29598-76-3)
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| Notifier: |
Rianlon Corporation
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| Manufacturer/Supplier: |
Rianlon Corporation
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| Intended Use: |
For use as an antioxidant/stabilizer in:- polypropylene polymers and copolymers compliant with 21 CFR 177.1520,
- styrene block copolymers compliant with 21 CFR 177.1810,
- adhesive and pressure-sensitive adhesive applications, complying with 21 CFR 175.105 (Adhesives) and 21 CFR 175.125 (Pressure-sensitive adhesives), except for contact with infant formula and human milk (see Limitations/Specifications).
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| Limitations/Specifications: |
- For use at levels not to exceed 0.2 weight-percent of propylene polymers and copolymers which meet the specifications in 21 CFR 177.1520 (c). The FCS may be used in contact with aqueous and acidic foods under Conditions of Use B through H and in contact with alcoholic foods under Conditions of Use C through G, as described in Tables 1 and 2.
- For use at levels not to exceed 0.3 weight-percent in the finished styrene block polymer. Finished articles containing the FCS are intended to contact all food types under Conditions of Use B through H, and use levels not to exceed 0.026 weight-percent of polymer and a maximum thickness of 9 microns for COU A and J (microwave-only, excluding susceptor applications), as described in Tables 1 and 2.
- For use with all food types at levels not to exceed 1.0 weight-percent of adhesives and pressure-sensitive adhesives.
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: |
Apr 8, 2026
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| National Environmental Policy Act (NEPA)** Submission: |
Environmental Assessment
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| FDA Decision: |
Finding of No Significant Impact (FONSI)
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