Code of Federal Regulations Title 21. Food and Drugs § 21.170.100 Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA)

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

(2) An FCN may incorporate by reference any information in FDA's files provided that the manufacturer or supplier is authorized to reference the information. The FCN must include information establishing that the manufacturer or supplier is authorized to reference information in FDA's files.

(3) Any material submitted in or referenced by an FCN that is in a foreign language must be accompanied by an English translation verified to be complete and accurate.

(1) A use of a food contact substance that is the subject of a regulation in parts 173 through 189 of this chapter;  or

(2) A use of a food contact substance that is the subject of an exemption under the threshold of regulation process described in § 170.39.

(1) The use of the food contact substance increases the cumulative dietary concentration to a certain level. For a substance that is a biocide (e.g., it is intended to exert microbial toxicity), this level is equal to or greater than 200 parts per billion in the daily diet (0.6 milligram (mg)/person/day). For a substance that is not a biocide, this level is equal to or greater than 1 part per million in the daily diet (3 mg/person/day);  or

(2) There exists a bioassay on the food contact substance, FDA has not reviewed the bioassay, and the bioassay is not clearly negative for carcinogenic effects.

(1) The current address may be either the manufacturer's (or supplier's) address or the address of the manufacturer's (or supplier's) agent.

(2) FDA will deliver correspondence to the manufacturer's or supplier's current address.