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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2021-003

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: Metal carbides and metal carbide alloys, including: tungsten carbide with or without nickel, cobalt, chromium, iron, boron, silicon, or aluminum; molybdenum carbide; silicon carbide; titanium carbide; chromium carbide; tantalum carbide; niobium carbide; and vanadium carbide
Use Limitations*: As a component or ceramic coating in repeat-use applications such as parts in food processing equipment (e.g., wear parts such as nozzles, bearings, seal rings, pumps, etc.) and in saws, cutting tools, and other uses where these substances are used as a durable, abrasion- and corrosion-resistant coating. The FCS will be used in contact with all types of foods and under Conditions of Use A through H as described in Table 1. The FCS is not intended to be used on food packaging used in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the TOR exemption.
Requestor: FDA

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