It’s all part of the agency’s implementation of the premarket notification process for FCSs established in the FDA Modernization Act. In most cases, FCNs are now used instead of the more detailed food additive petitions of the past. The guidance contains the agency’s current thinking on the data and information that should be included in an FCN, as well as how the agency will administer the program.
FDA also is asking for comments on whether or not it should establish regulations that would allow a manufacturer identified in an effective FCN to sell, license, or otherwise grant the right to manufacture and market a food contact substance. This is provided it is for the use intended in the FCN, and FDA is notified. The American Plastics Council asked for the regulations. Currently, any subsequent manufacturer must submit a new notification. Comments are due by Aug. 5, 2002.
To obtain a copy of “Preparation of Food Contact Notifications: Administrative,” go to www.cfsan.fda.gov/ ~dms/opa2pmna.html.