Answer: Congress mandated in FDAMA that, during the 120-day review period, FDA cannot release any information contained in the FCN. However, after the expiration of 120 days, information must be made available to the public in response to a request under the Freedom of Information Act (FOIA), except for any matter that is a trade secret or confidential commercial information. Also, FDA will not release information contained in an FCN that is withdrawn by the notifier before it becomes effective. When submitting an FCN, we recommend submitting an additional ?sanitized? copy (with trade secret and confidential commercial information deleted) that can be used in responding to FOIA requests.
However, by submitting an FCN, the notifier waives any claim to confidentiality of the information required adequately to describe the FCS and the intended conditions of use. This information would include, at a minimum:
the ?complete chemical identity? of the substance, the maximum use level in food-contact materials, any limitations on the types of food that may contact materials containing the substance, and limitations on time and temperature conditions of use for the material containing the substance.
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