21 CFR 172.385 - Whole fish protein concentrate.

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§ 172.385 Whole fish protein concentrate.
The food additive whole fish protein concentrate may be safely used as a food supplement in accordance with the following prescribed conditions:
(a) The additive is derived from whole, wholesome hake and hakelike fish, herring of the genera Clupea, menhaden, and anchovy of the species Engraulis mordax, handled expeditiously and under sanitary conditions in accordance with good manufacturing practices recognized as proper for fish that are used in other forms for human food.
(b) The additive consists essentially of a dried fish protein processed from the whole fish without removal of heads, fins, tails, viscera, or intestinal contents. It is prepared by solvent extraction of fat and moisture with isopropyl alcohol or with ethylene dichloride followed by isopropyl alcohol, except that the additive derived from herring, menhaden and anchovy is prepared by solvent extraction with isopropyl alcohol alone. Solvent residues are reduced by conventional heat drying and/or microwave radiation and there is a partial removal of bone.
(c) The food additive meets the following specifications:
(1) Protein content (N × 6.25) shall not be less than 75 percent by weight of the final product, as determined by the method described in section 2.057 in “Official Methods of Analysis of the Association of Official Analytical Chemists” (AOAC), 13th Ed. (1980). Protein quality shall not be less than 100, as determined by the method described in sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by reference, and copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined 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/code_of_federal_regulations/ibr_locations.html.
(2) Moisture content shall not exceed 10 percent by weight of the final product, as determined by the method described in section 24.003 of the AOAC. See paragraph (c)(1) of this section for availability of the material incorporated by reference.
(3) Fat content shall not exceed 0.5 percent by weight of the final product, as determined by the method described in section 24.005 of the AOAC. See paragraph (c)(1) of the this section for availability of the material incorporated by reference.
(4) The additive may contain residues of isopropyl alcohol and ethylene dichloride not in excess of 250 parts per million and 5 parts per million, respectively, when used as solvents in the extraction process.
(5) Microwave radiation meeting the requirements of § 179.30 of this chaptermay be used to reduce residues of the solvents used in the extraction process.
(6) The additive shall contain not in excess of 100 parts per million fluorides (expressed as F).
(7) The additive shall be free of Escherichia coli and pathogenic organisms, including Salmonella, and shall have a total bacterial plate count of not more than 10,000 per gram.
(8) The additive shall have no more than a faint characteristic fish odor and taste.
(d) When the additive is used or intended for use in the household as a protein supplement in food for regular consumption by children up to 8 years of age, the amount of the additive from this source shall not exceed 20 grams per day (about one heaping tablespoon).
(e) When the additive is used as a protein supplement in manufactured food, the total fluoride content (expressed as F) of the finished food shall not exceed 8 ppm based on the dry weight of the food product.
(f) To assure safe use of the additive, in addition to the other information required by the Act:
(1) The label of consumer-sized or bulk containers of the additive shall bear the name “whole fish protein concentrate”.
(2) The label or labeling of containers of the additive shall bear adequate directions for use to comply with the limitations prescribed by paragraphs (d) and (e) of this section.
(3) Labels of manufactured foods containing the additive shall bear, in the ingredient statement, the name of the additive, “whole fish protein concentrate” in the proper order of decreasing predominance in the finished food.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-08-12; vol. 79 # 155 - Tuesday, August 12, 2014
    1. 79 FR 46993 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D 3
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective August 12, 2014. See section VII “Objections” for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by September 11, 2014. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of August 12, 2014.
      21 CFR Part 172

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 172 after this date.

  • 2014-09-02; vol. 79 # 169 - Tuesday, September 2, 2014
    1. 79 FR 51922 - Richard C. Theuer; Withdrawal of Food Additive Petition and Citizen Petition
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Withdrawal of petitions.
      The food additive petition and the citizen petition were withdrawn on July 30, 2014.
      21 CFR Parts 172 and 182