FDA Announces Threshold of Regulation Exemption for Metal Carbides in Food Processing Equipment
The U.S. Food and Drug Administration (FDA) has issued a Threshold of Regulation (TOR) exemption for the use of metal carbides and metal carbide alloys as a component or ceramic coating in repeat-use applications such as parts in food processing equipment.
A TOR exemption can be issued if the dietary exposure level from the intended use of the food contact substance (FCS) is below 0.5 parts per billion and the FCS itself is not a known carcinogen. TOR exemptions may be used by any manufacturer or supplier for the intended uses of the FCS. Federal law requires companies that wish to use a food additive obtain pre-market authorization from FDA. Authorization for FCSs is typically obtained through the submission of a FCSs Notification (FCN) to FDA. A FCN authorization applies only to the FCS prepared by the manufacturer identified in the FCN.