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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2017-001

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: 4,4'-diphenylmethane diisocyanate (MDI)(CAS Reg. No. 101-68-8)
Use Limitations: For use as a cross-linker for adhesives used in repeat use articles under the use conditions specified by 21 CFR 175.105(a)(2). The FCS is not intended for use in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the TOR submission.
Requestor: GRAS Associates, LLC on behalf of REMA TIP TOP/North America, Inc.
Quick links to regulation: 175.105

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