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Electronic Code of Federal Regulations

e-CFR Data is current as of April 15, 2014

Title 21: Food and Drugs
Subpart D—Premarket Notifications

§170.100   Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA).

(a) An FCN is effective for the food contact substance manufactured or prepared by the manufacturer or supplier identified in the FCN submission. If another manufacturer or supplier wishes to market the same food contact substance for the same use, that manufacturer or supplier must also submit an FCN to 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.

(b) FDA may choose not to accept an FCN for either of the following:

(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.

(c) A petition must be submitted under §171.1 of this chapter to authorize the safe use of a food contact substance in either of the following circumstances, unless FDA agrees to accept an FCN for the proposed use.

(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.

(d) A manufacturer or supplier for which a notification is effective must keep a current address on file with FDA.

(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.

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