§170.101. Information in a premarket notification for a food contact substance (FCN). — Inbound Citations

(1) An FCN must contain all of the information described in § 170.101.

(1) If any element required under § 170.101 is missing from an FCN, then FDA will not accept that FCN and FDA will send an FCN nonacceptance letter to the manufacturer or supplier. If the manufacturer or supplier submits the missing information before FDA sends an FCN nonacceptance letter, the 120-day review period begins on the date of receipt of the missing information.

(c) FDA's determination that an FCN is no longer effective does not preclude any manufacturer or supplier from submitting a new FCN for the same food contact substance, including for the same intended use, after FDA has determined that an FCN is no longer effective, unless the intended use of the food contact substance is authorized by a food additive regulation or the subject of an issued threshold of regulation exemption. The new submission must be made under §§ 170.100 and 170.101.