Source: https://www.law.cornell.edu/cfr/text/21/172.320
Timestamp: 2017-04-30 03:25:27
Document Index: 561457204

Matched Legal Cases: ['art 172', '§ 172', 'art 51', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172']

21 CFR 172.320 - Amino acids. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter B › Part 172 › Subpart D › Section 172.320 21 CFR 172.320 - Amino acids.
§ 172.320 Amino acids.
(2) As found in “Specifications and Criteria for Biochemical Compounds,” NAS/NRC Publication, for the following:
(1) A reasonable daily adult intake of the finished food furnishes at least 6.5 grams of naturally occurring primarily intact protein (based upon 10 percent of the daily allowance for the “reference” adult male recommended by the National Academy of Sciences in “Recommended Dietary Allowances,” NAS Publication No. 1694.
L-Aspartic acid (including L-asparagine)
L-Cystine (including L-cysteine)
L-Glutamic acid (including L-glutamine)
L- and DL-Methionine
(d) Compliance with the limitations concerning PER under paragraph (c) of this section shall be determined by the method described in sections 43.212-43.216, “Official Methods of Analysis of the Association of Official Analytical Chemists.” Each manufacturer or person employing the additive(s) under the provisions of this section shall keep and maintain throughout the period of his use of the additive(s) and for a minimum of 3 years thereafter, records of the tests required by this paragraph and other records required to assure effectiveness and compliance with this regulation and shall make such records available upon request at all reasonable hours by any officer or employee of the Food and Drug Administration, or any other officer or employee acting on behalf of the Secretary of Health and Human Services and shall permit such officer or employee to conduct such inventories of raw and finished materials on hand as he deems necessary and otherwise to check the correctness of such records.
(g) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 1 CFR part 51. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(i) Sections 43.212-43.216, “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980).
(i) “Recommended Dietary Allowances,” NAS Publication No. 1694, 7th Ed. (1968).
(ii) “Specifications and Criteria for Biochemical Compounds,” NAS/NRC Publication, 3rd Ed. (1972).
(3) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org):
[ 78 FR 71461, Nov. 29, 2013]
Title 21 published on 13-Apr-2017 03:05The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 172 after this date.2016-07-18; vol. 81 # 137 - Monday, July 18, 201681 FR 46578 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D 2 and Vitamin D 3
typeregulations.gov FR Doc.2016-16738 RIN Docket No.FDA-2013-N-0888 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 18, 2016. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by August 17, 2016. The Director of the Federal Register approves the incorporation by reference of certain publications listed in the rule as of July 18, 2016. 21 CFR Part 172 SummaryThe Food and Drug Administration (FDA or we) is amending the food additive regulations to expand the safe uses of vitamin D 2 as a nutrient supplement in edible plant-based beverages intended for use as milk alternatives and in edible plant-based yogurt alternatives and vitamin D 3 as a nutrient supplement in milk at levels higher than those currently permitted. We are taking this action in response to a food additive petition filed by Dean Foods Company and WhiteWave Foods Company.
2016-06-15; vol. 81 # 115 - Wednesday, June 15, 201681 FR 38984 - Styrene Information and Research Center; Filing of Food Additive Petition
typeregulations.gov FR Doc.2016-14107 RIN Docket No.FDA-2016-F-1444 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. The food additive petition was filed on May 16, 2016. Submit either electronic or written comments by August 15, 2016. 21 CFR Part 172 SummaryThe Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Styrene Information and Research Center (SIRC), requesting that we amend our food additive regulations to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food because these uses of styrene have been abandoned.
2016-04-15; vol. 81 # 73 - Friday, April 15, 201681 FR 22176 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
typeregulations.gov FR Doc.2016-08792 RIN Docket No.FDA-2012-F-0480 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective April 15, 2016. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 16, 2016. The Director of the Federal Register approves the incorporation by reference of certain publications listed in the rule as of April 15, 2016. 21 CFR Part 172 SummaryThe Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of folic acid in corn masa flour. We are taking this action in response to a food additive petition filed jointly by Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza.
2016-02-23; vol. 81 # 35 - Tuesday, February 23, 201681 FR 8867 - Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids&apos; Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff; Filing of Food Additive Petition; Extension of Comment Period
typeregulations.gov FR Doc.2016-03708 RIN Docket No.FDA-2015-F-4317 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment period. We are extending the comment period on the notice of filing of a food additive petition published on January 4, 2016 (81 FR 42). Submit either electronic or written comments by May 3, 2016. 21 CFR Part 172 SummaryThe Food and Drug Administration (FDA or we) is extending the comment period for the notice of filing that appeared in the Federal Register of January 4, 2016. In the notice, FDA requested comments on a filed food additive petition (FAP 5A4810), submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids&apos; Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
2016-01-04; vol. 81 # 1 - Monday, January 4, 201681 FR 42 - Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids&apos; Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff; Filing of Food Additive Petition
typeregulations.gov FR Doc.2015-33011 RIN Docket No.FDA-2015-F-4317 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. The food additive petition was filed on August 17, 2015. Submit either electronic or written comments by March 4, 2016. 21 CFR Part 172 SummaryThe Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids&apos; Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives.
2015-10-28; vol. 80 # 208 - Wednesday, October 28, 201580 FR 65978 - Grocery Manufacturers Association; Filing of Food Additive Petition
2014-12-24; vol. 79 # 247 - Wednesday, December 24, 201479 FR 77385 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Advantame
2012-03-06; vol. 77 # 44 - Tuesday, March 6, 201277 FR 13232 - Abbott Laboratories; Filing of Food Additive Petition
typeregulations.gov FR Doc.2012-5314 RIN Docket No.FDA-2012-F-0138 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. 21 CFR Part 172 SummaryThe Food and Drug Administration (FDA) is announcing that Abbott Laboratories has filed a petition proposing that the food additive regulations be amended to provide for the expanded safe use of vitamin D 3 as a nutrient supplement in food.