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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2015-003

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: sodium fluorescein (CAS Reg. No. 518-47-8)
Use Limitations*: For use as an inert tracer chemical for use in boiler water additives complying with 21 CFR 173.310. The food contact substance (FCS) will be used at a maximum use level 500 parts per billion in the boiler water and must meet any applicable specifications under 21 CFR 173.310. The FCS is not for use in boiler water systems involved in the processing of infant formula or its ingredients. Such use was not included as part of the intended use of the substance in the TOR submission.
Requestor: ChemCal, Inc.
Quick links to regulation: 173.310

*For references to food types and conditions of use, see Food Types & Conditions of Use for Food Contact Substances.