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FDA Issues TOR Exemption for Metal Carbides in Food Processing Equipment

The U.S. Food and Drug Administration (FDA) has issued a Threshold of Regulation (TOR) exemption (TOR-2021-003) for the use of metal carbides and metal carbide alloys as components of ceramic coatings in repeat-use applications. These applications include food processing equipment parts – such as nozzles, bearings, seal rings, pumps, etc. – and cutting tools, saws, and other applications where these substances provide a durable, abrasion- and corrosion-resistant coating.

By way of background, a TOR exemption is based on evidence that the dietary exposure level from the intended use of the food contact substance (FCS) is below 0.5 parts per billion (ppb) and the FCS is not a known carcinogen. TOR exemptions may be used by any manufacturer or supplier for the specified uses of the FCS under the intended conditions of use (without the need for an FCN).

The FDA stated that this action was taken because the Agency has reviewed the use of metal carbides in food processing equipment through numerous food contact notifications (FCNs) and has received other inquiries on its use. Based on these reviews, FDA concluded that “metal carbides remain stable and intact, chemically inert, and resistant to corrosion and abrasion under their intended conditions of use” and that “[t]here is little or no likelihood that components of metal carbides would migrate to food at other than insignificant amounts, nor would the metal carbides otherwise affect food…”  Additionally, the Agency noted that it “is not aware of any study showing these food contact substances to be carcinogenic in humans or in animals.” (See FDA Issues Threshold of Regulation Exemption for Metal Carbides in Food Processing Equipment.)

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 193
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About this Author

PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

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