CFR Subpart D

CFR Subpart D
in effect

21 C.F.R. § 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.

21 C.F.R. § 170.101 Information in a premarket notification for a food contact substance (FCN).

An FCN must contain the following: (a) A comprehensive discussion of the basis for the manufacturer's or supplier's determination that the use of the food contact substance is safe. This discussion must: (1) Discuss all information and data submitted in the notification; and (2) Address any information and data that may appear to be inconsistent with the determination that the proposed use of the food contact substance is safe. (b) All data and other information that form the basis of the determination that the food contact substance is safe under the intended conditions of use. Data must include primary biological data and chemical data. (c) A good laboratory practice statement for each nonclinical laboratory study, as defined under § 58.3(d) of this chapter, that is submitted as part of the FCN, in the form of either: (1) A signed statement that the study was conducted in compliance with the good laboratory practice regulations under part 58 of this chapter; or (2) A brief signed statement listing the reason(s) that the study was not conducted in compliance with part 58 of this chapter. (3) Data from any study conducted after 1978 but not conducted in compliance with part 58 of this chapter must be validated by an independent third party prior to submission to the Food and Drug Administration (FDA), and the report and signed certification of the validating party must be submitted as part of the notification. (d) Information to address FDA's responsibility under the National Environmental Policy Act, in the form of either: (1) A claim of categorical exclusion under § 25.30 or § 25.32 of this chapter; or (2) An environmental assessment complying with § 25.40 of this chapter. (e) A completed and signed FDA Form No. 3480.

21 C.F.R. § 170.102 Confidentiality of information related to premarket notification for a food contact substance (FCN).

(a) During the 120-day period of the Food and Drug Administration (FDA) review of an FCN, FDA will not disclose publicly any information in that FCN. (b) FDA will not disclose publicly the information in an FCN that is withdrawn prior to the completion of FDA's review. (c) Once FDA completes its review of an FCN, the agency will make its conclusion about the FCN publicly available. For example, if FDA objects to a notification 90 days after the date of receipt, the agency would make available its objection at that time. (d) By submitting an FCN to FDA, the manufacturer or supplier waives any claim to confidentiality of the information required to adequately describe the food contact substance and the intended conditions of use that are the subject of that FCN. (e) The following data and information are available for public disclosure, unless extraordinary circumstances are shown, on the 121st day after receipt of the notification by FDA, except that no data or information are available for public disclosure if the FCN is withdrawn under § 170.103; and on the date of publication in the Federal Register of an FDA determination that an FCN is no longer effective. (1) All safety and functionality data and information submitted with or incorporated by reference into the notification, or submitted in reference to an effective FCN. Safety and functionality data include all studies and tests of a food contact substance on animals and humans and all studies and tests on a food contact substance for establishing identity, stability, purity, potency, performance, and usefulness. (2) A protocol for a test or study, unless it is exempt from disclosure under § 20.61 of this chapter. (3) A list of all ingredients contained in a food contact substance, excluding information that is exempt from disclosure under § 20.61 of this chapter. Where applicable, an ingredient list will be identified as incomplete. (4) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is exempt from disclosure under § 20.61 of this chapter. (5) All correspondence and written summaries of oral discussions relating to the notification or to FDA's determination that an FCN is no longer effective, except information that is exempt under § 20.61 of this chapter. (6) All other information not subject to an exemption from disclosure under subpart D of part 20 of this chapter.

21 C.F.R. § 170.103 Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

A manufacturer or supplier may withdraw an FCN without prejudice to a future submission to the Food and Drug Administration (FDA) if FDA has not completed review of the FCN. For the purpose of this section, FDA's review is completed when FDA has allowed 120 days to pass without objecting to the FCN or FDA has issued an objection letter.

21 C.F.R. § 170.104 Action on a premarket notification for a food contact substance (FCN).

(a) If the Food and Drug Administration (FDA) does not object to an FCN within the 120-day period for FDA review, the FCN becomes effective. (b) If an FCN is complete when received, the 120-day review period begins on the date FDA receives the FCN. (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. (2) If FDA accepts an FCN, then FDA will acknowledge in writing its receipt of that FCN. (c) Objection to an FCN: (1) If FDA objects to an FCN, then FDA will send an FCN objection letter. The date of the letter will be the date of FDA's objection for purposes of section 409(h)(2)(A) of the act. (2) If FDA objects to an FCN within the 120-day period for FDA review, the FCN will not become effective. (3) FDA may object to an FCN if any part of FDA's 120-day review occurs during a period when this program is not funded as required in section 409(h)(5) of the act. (d) If FDA and a manufacturer or supplier agree that the notifier may submit a food additive petition proposing the approval of the food contact substance for the use in the manufacturer's or supplier's FCN, FDA will consider that FCN to be withdrawn by the manufacturer or supplier on the date the petition is received by FDA.

21 C.F.R. § 170.105 The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective.

(a) FDA may determine that an FCN is no longer effective if: (1) Data or other information available to FDA, including data not submitted by the manufacturer or supplier, demonstrate that the intended use of a food contact substance is no longer safe. (i) FDA will inform the affected manufacturer or supplier specified in the FCN, in writing, of FDA's concerns regarding the safety of the intended use of the food contact substance. FDA will specify the date by which the manufacturer or supplier must provide FDA with data or other information to respond to FDA's safety concerns. (ii) If the manufacturer or supplier fails, by the specified date, to supply either the data or other information necessary to address the safety concerns regarding the notified use or a request described in paragraph (a)(2)(i) of this section, FDA may determine that the FCN is no longer effective because there is no longer a basis to conclude that the intended use is safe. (iii) If FDA denies a request described in paragraph (a)(2)(i) of this section, and FDA had previously informed the manufacturer or supplier of FDA's concerns regarding the safety of the intended use of the food contact substance as described in paragraph (a)(1)(i) of this section, FDA may determine that an FCN is no longer effective because there is no longer a basis to conclude that the intended use is safe. Alternatively, FDA may provide the manufacturer or supplier with additional time to provide FDA with data or other information to respond to FDA's safety concerns. If the manufacturer or supplier fails, by the specified date, to supply the data or other information necessary to address the safety concerns regarding the notified use, FDA may determine that the FCN is no longer effective because there is no longer a basis to conclude that the intended use is safe. (2) Data or other information available to FDA demonstrate that the manufacturer or supplier specified in the FCN has ceased or intends to cease producing, supplying, or using a food contact substance for the intended use. Such data or other information includes, but is not limited to: (i) A request from the manufacturer or supplier. (A) The manufacturer or supplier specified in the FCN may request in writing that FDA determine that an FCN is no longer effective on the basis that it has ceased producing, supplying, or using a food contact substance for the intended food contact use in the United States or that it intends to cease producing, supplying, or using a food contact substance for the intended food contact use in the United States by a specified date. The request must include information or a basis to support the estimated date for the food contact substance, as well as food contact articles that contain such food contact substance, produced, supplied, or used by the manufacturer or supplier to clear the U.S. market. FDA will notify the manufacturer or supplier whether FDA is granting the request. (B) If FDA grants the request, FDA may determine that the FCN is no longer effective on the basis that the manufacturer or supplier has ceased producing, supplying, or using a food contact substance for the intended use in the United States or that it intends to cease producing, supplying, or using a food contact substance for the intended food contact use in the United States by a specified date. When such a request is based on the intent to cease producing, supplying, or using a food contact substance for the intended food contact use in the United States at a future date, FDA will include in the notice described in paragraph (b) of this section the date specified in the request as the compliance date by which the manufacturer or supplier will cease producing, supplying, or using the food contact substance for the intended food contact use in the United States. (ii) Other data or information available to FDA. (A) If other data or information available to FDA demonstrate that a manufacturer or supplier specified in the FCN has ceased producing, supplying, or using a food contact substance for the intended use in the United States, FDA will inform the affected manufacturer or supplier in writing. FDA will include a specified time period by which the manufacturer or supplier must respond in writing indicating whether the manufacturer or supplier continues, or intends to continue in the future, to produce, supply, or use a food contact substance for the intended use in the United States. (B) If the manufacturer or supplier fails, by the specified date, to respond in writing indicating that the manufacturer or supplier continues, or intends to continue in the future, to produce, supply, or use a food contact substance for the intended use in the United States; or if the manufacturer or supplier confirms that it has ceased producing, supplying, or using the food contact substance for the intended food contact use in the United States, FDA may determine that the FCN is no longer effective. (3) The intended use of the food contact substance identified in the FCN is authorized by a food additive regulation. (i) FDA will inform the manufacturer or supplier specified in the FCN in writing that the intended use of the food contact substance identified in the FCN is authorized by a food additive regulation. FDA will include a specified time period by which the manufacturer or supplier must respond to FDA with data or other information about whether the food contact substance and its intended use meet the identity limitations and specifications authorized by the cited food additive regulation. (ii) If a manufacturer or supplier fails, by the specified date, to supply data or other information that demonstrates that the intended use of the food contact substance identified in the FCN is not authorized by a food additive regulation, FDA may determine that the FCN is no longer effective on the basis that the intended use of the food contact substance is authorized under a food additive regulation. (4) The intended use of the food contact substance identified in the FCN is the subject of an issued threshold of regulation exemption. (i) FDA will inform the manufacturer or supplier specified in the authorizing FCN in writing that the intended use of the food contact substance identified in the FCN is the subject of an issued threshold of regulation exemption. FDA will include a specified time period by which the manufacturer or supplier must respond to FDA with data or other information about whether the food contact substance and its intended use meet the identity limitations and specifications listed in the cited threshold of regulation exemption. (ii) If a manufacturer or supplier fails, by the specified date, to supply data or other information that demonstrates that the intended use of the food contact substance identified in the FCN is not exempt through an issued threshold of regulation exemption, FDA may determine that the FCN is no longer effective on the basis that the intended use of the food contact substance is the subject of an issued threshold of regulation exemption. (b) If FDA determines that an FCN is no longer effective, FDA will publish a notice of its determination in the Federal Register, stating that a detailed summary of the basis for FDA's determination that the FCN is no longer effective has been placed on public display and that copies are available upon request. If FDA determines it would be protective of public health, FDA may include a separate compliance date for the use of the food contact substance in food contact articles, including food contact substances that were produced, supplied, or used by the manufacturer or supplier before publication of the notice in the Federal Register or before the compliance date described in paragraph (a)(2)(i)(B) of this section. The date that the notice publishes in the Federal Register is the date on which the notification is no longer effective. FDA's determination that an FCN is no longer effective is final Agency action subject to judicial review. (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.

21 C.F.R. § 170.106 Notification for a food contact substance formulation (NFCSF).

(a) In order for the Food and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the formulation must be authorized for its intended use in that NFCSF. (b) FDA may publish a notice in the Federal Register stating that the agency has insufficient resources to review NFCSFs. From the date that this notice publishes in the Federal Register, FDA will no longer accept NFCSFs. (c) An NFCSF must contain the following: (1) A completed and signed FDA Form No. 3479; and (2) Any additional documentation required to establish that each component of the formulation already may be marketed legally for its intended use.

Starting a business? Corpus forms LLCs in all 50 states and DC.