Source: https://www.govregs.com/regulations/21/170.39
Timestamp: 2020-04-05 13:59:34
Document Index: 650918574

Matched Legal Cases: ['§ 170', 'art 170', '§ 170', '§ 170', '§ 170', '§ 10', '§ 25', '§ 25', '§ 25', 'art 20', '§ 20', '§ 10']

21 CFR 170.39 - Threshold of regulation for substances used in food-contact articles. § 170.39 - Threshold of regulation for substances used in food-contact articles.
All TitlesTitle 21Chapter IPart 170Subpart B - Food Additive Safety
View all text of Subpart B [§ 170.20 - § 170.39]
§ 170.39 - Threshold of regulation for substances used in food-contact articles.
(c) A request for the Food and Drug Administration to exempt a use of a substance from regulation as a food additive shall include three copies of the following information (If part of the submitted material is in a foreign language, it must be accompanied by an English translation verified to be complete and accurate in accordance with § 10.20(c)(2) of this chapter):
(6) Information on the environmental impact that would result from the proposed use of the substance. The request should contain either a claim for categorical exclusion as specified in § 25.32 of this chapter or an environmental assessment as specified in § 25.40 of this chapter.
(e) The Food and Drug Administration will inform the requestor by letter whether the specific food-contact application is exempt from regulation as a food additive or not. Although a substance that migrates to food at a level that results in a dietary concentration at or below the threshold of regulation will not be the subject of a regulation published in the Federal Register and will not appear in the Code of Federal Regulations, the Food and Drug Administration will maintain a list of substances exempted from regulation as food additives under this section on display at the Division of Dockets Management. This list will include the name of the company that made the request, the chemical name of the substance, the specific use for which it has received an exemption from regulation as a food additive, and any appropriate limitations on its use. The list will not include any trade names. This list will enable interested persons to see the types of uses of food-contact materials being exempted under the regulation. Interested persons may also obtain a copy of the list of exempted substances by contacting the Food and Drug Administration's Office of Premarket Approval (HFS-200), 5001 Campus Dr., College Park, MD 20740. For actions requiring an environmental assessment, the agency's finding of no significant impact and the evidence supporting that finding, contained in the petitioner's environmental assessment, also will be available for public inspection at the Division of Dockets Management in accordance with § 25.51(b)(2) of this chapter. Requests for copies of releasable information contained in submissions requesting exemptions from the food additive regulations will be handled in accordance with the Food and Drug Administration's Freedom of Information Act procedures, as described in part 20 of this chapter. In particular, data and information that fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure in accordance with § 20.61(c) of this chapter.
(f) If the request for an exemption from regulation as a food additive is not granted, the requestor may submit a petition to the Food and Drug Administration for reconsideration of the decision in accordance with the provisions of § 10.33 of this chapter.