Federal Register - June 11, 2021

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Fuente: Federal Register

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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations
Products and Yogurt Products; Final Rule to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend the Standard for Yogurt.
Received objections, those filed in a timely manner see ADDRESSES, will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https www.regulations.gov or at the Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo 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. We will review this copy, including the claimed confidential information, in our 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 https
www.regulations.gov. Submit both copies to the Dockets Management Staff.
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 FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Andrea Krause, Center for Food Safety and Applied Nutrition HFS820, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240402
2371, or Joan Rothenberg, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy HFS

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20740, 2404022378.
SUPPLEMENTARY INFORMATION:
Table of Contents I. Executive Summary A. Purpose of the Final Rule B. Summary of the Major Provisions of the Final Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Commonly Used Acronyms in This Document III. Background A. Legal Authority B. History of the Current Standards of Identity for Yogurt, Lowfat Yogurt, and Nonfat Yogurt C. Description of the Proposed Rule IV. Comments on the Proposed Rule, FDA
Responses, and Description of the Final Rule A. Introduction B. General Comments C. Section 131.200aDescription D. Section 131.200bBasic Dairy Ingredients E. Section 131.200cOptional Dairy Ingredients F. Section 131.200dOther Optional Ingredients G. Section 131.200eMethods of Analysis H. Section 131.200fNomenclature I. Revoking the Standards of Identity for Lowfat Yogurt and Nonfat Yogurt J. Compliance Date K. Amendments in 21 CFR 130.10
L. Incorporation by Reference V. Economic Analysis of Impacts VI. Federalism VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995
IX. Consultation and Coordination With Indian Tribal Governments X. Objections XI. References
130.10 21 CFR 130.10, which sets out requirements for foods that deviate from other standardized foods due to compliance with a nutrient content claim. The final rule provides a modern yogurt standard to allow for technological advances, preserves but simplifies the basic nature and essential characteristics of yogurt, and promotes honesty and fair dealing in the interest of consumers.
The final rule amends the standard of identity for yogurt by making certain technical changes, permitting reconstituted forms of basic dairy ingredients cream, milk, partially skimmed milk, and skim milk used alone or in combination and the use of any optional safe and suitable milkderived ingredient under certain conditions. The final rule also establishes functional classes of safe and suitable ingredients including cultures, flavoring, color additives, stabilizers, emulsifiers, and preservatives, and replaces the list of nutritive sweeteners with the term nutritive carbohydrate sweeteners. The final rule permits the optional labeling statement contains live and active cultures or similar statement if the yogurt contains specified amounts of live and active cultures. For yogurt treated to inactivate viable microorganisms, the final rule requires a statement of does not contain live and active cultures on the label.

B. Summary of the Major Provisions of the Final Rule
C. Legal Authority This final rule is issued pursuant to our authority under sections 401, 403a1, 201n, and 701e of the Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C. 341, 343a1, 321n, and 371e.
Under section 701e of the FD&C Act, any action for the amendment or repeal of any definition and standard of identity under section 401 of the FD&C
Act for any dairy product e.g., yogurt must be begun by a proposal made either by FDA under our own initiative or by petition of any interested persons, showing reasonable grounds therefore, filed with the Secretary. The NYA
submitted such a citizen petition on February 18, 2000, requesting that we, among other things, revoke the standards of identity for lowfat yogurt 131.203 21 CFR 131.203 and nonfat yogurt 131.206 21 CFR 131.206 and amend the standard of identity for yogurt 131.200 21 CFR 131.200.

The final rule revokes the standards for lowfat yogurt and nonfat yogurt.
Consequently, lowfat yogurt and nonfat yogurt are covered under the general definition and standard of identity in
D. Costs and Benefits Because we are publishing this rule in accordance with the formal rulemaking provisions of 5 U.S.C. 556 and 557, this rule is exempt from the economic
I. Executive Summary A. Purpose of the Final Rule We are issuing a final rule to revoke the standards of identity for lowfat yogurt and nonfat yogurt and amend the standard of identity for yogurt in numerous respects. This action is in response, in part, to a citizen petition submitted by the NYA. This action modernizes the yogurt standard to allow for technological advances while preserving the basic nature and essential characteristics of yogurt and promotes honesty and fair dealing in the interest of consumers.

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Federal Register - June 11, 2021

TítuloFederal Register

PaísEstados Unidos de América

Fecha11/06/2021

Nro. de páginas349

Nro. de ediciones7798

Primera edición14/03/1936

Ultima edición18/06/2026

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