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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2016-001

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: hexamethylenediamine (CAS Reg. No. 124-09-4), 1,2-diaminocyclohexane (CAS Reg. No. 694-83-7), and 4,4-methylenebis(2-ethylbenzamine) (CAS Reg. No. 19900-65-3)
Use Limitations: For use as curing agents in epoxy resins complying with 21 CFR 175.300(b)(3)(viii). The final coating will be used on the food contact surface of repeat use bulk food containers (i.e., railcars, ship holds, tanker trailers, etc.) only, in contact with all foods under conditions of use C through G (including hot-fill applications above 66°C (150°F)). The final coating should meet the extractives specifications in §175.300(c) and be thoroughly cleansed prior to its first use in contact with food in accordance with §175.300(g).
Requestor: NSF International on behalf of Carboline Company
Quick links to regulation: 175.300

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

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