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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2021-001

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: Amorphous hydrogenated carbon alloy, manufactured by plasma activated chemical vapor deposition using acetylene gas, optionally with a sublayer comprised of hydrogenated amorphous silicon-carbide alloy
Use Limitations*: As a ceramic coating, or a component of ceramic coatings, including multilayer coatings, on repeated-use component parts in food processing and food packaging machinery and equipment to reduce surface wear, friction, and sticking of food to materials. The FCS is not 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 exemption.
Requestor: IHI Ionbond AG and its affiliates

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

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