Threshold of Regulation (TOR) Exemptions
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FCN No. 2444
Kronos (US), Inc.
Threshold of Regulation Exemptions are generally applicable and are effective for the food contact substance (FCS) for the listed intended use regardless of manufacturer or supplier.
| Food Contact Substance: | n-Octyl phosphonic acid (NOPA)-modified titanium dioxide (produced by chemically reacting NOPA (CAS Reg. No. 4724-48-5) with titanium dioxide to achieve a treatment level of 0.85% by weight of NOPA on the pigment). |
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| Notifier: | Kronos (US), Inc. |
| Manufacturer/Supplier: | Kronos (US), Inc. |
| Intended Use: | For use as a colorant in food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS is for use at a maximum level of 20 percent by weight of finished polymers in contact with all food types under Conditions of Use A, B, and H; and a maximum use level of 30 percent by weight of finished polymers that are used in contact with all food types under Conditions of Use C-G. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297. 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: | Aug 19, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment244 kB |
| FDA Decision: | Finding of No Significant Impact (FONSI)188 kB |
*For references to food types and conditions of use, see Food Types & Conditions of Use for Food Contact Substances.
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