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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2016-002

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: carbon black (CAS Reg. No. 1333-86-4) produced by furnace combustion
Use Limitations: For use at levels up to 50% by weight of rubber articles complying with 21 CFR 177.2600 (Rubber articles intended for repeat use). Rubber articles containing the FCS may contact milk and edible oils, except for infant formula and breast milk. Use in contact with infant formula and breast milk was not included as part of the intended use of the substance in the TOR submission.
Requestor: Freudenberg Sealing Technologies GmbH & Co. KG
Quick links to regulation: 177.2600

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

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