Source: https://www.federalregister.gov/articles/2016/01/04/2015-33026/indirect-food-additives-paper-and-paperboard-components
Timestamp: 2016-08-24 16:10:22
Document Index: 740324781

Matched Legal Cases: ['§\u2009171', '§\u2009171', 'art 176', 'ART 176', 'art 176', '§\u2009176', '§\u2009176']

Federal Register | Indirect Food Additives: Paper and Paperboard Components
Dates: This rule is effective January 4, 2016. Submit either electronic or written objections and requests for a hearing by February 3, 2016. See section VIII for further information on the filing of objections.
-8 (4 pages)
Document Number: 2015-33026
Shorter URL: https://federalregister.gov/a/2015-33026 Related Topics
Instructions: All submissions received must include the Docket No. FDA- 2015-F-0714 for “Indirect Food Additives: Paper and Paperboard Components.” Received objections will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Under section 409(c)(3) of the FD&C Act we will not establish a regulation for the use of a food additive if a fair evaluation of the data fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe. Our regulations, at 21 CFR 170.3(h)(i), define safety as “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” In order for FDA to grant a petition that seeks an amendment to a food additive regulation based upon new data concerning the toxicity of the food additive, such data must be adequate for FDA to conclude that there is no longer a reasonable certainty of no harm for the intended use of the substance.
In accordance with § 171.1(h), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 171.1(h), we will delete from the documents any materials that are not available for public disclosure.
2. International Agency for Research on Cancer, http://monographs.iarc.fr/ENG/Monographs/vol81/mono81-8.pdf.
List of Subjects in 21 CFR Part 176 Back to Top
PART 176—INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS Back to Top
1.The authority citation for 21 CFR part 176 continues to read as follows: Authority:
§ 176.170 [Amended]
2.Amend § 176.170 in the table in paragraph (a)(5) by removing the entries for “Diethanolamine salts of mono- and bis,” “Pentanoic acid,” and “Perfluoroalkyl substituted phosphate ester acids.” end regulatory text