21 CFR 172.340 - Fish protein isolate.

§ 172.340 Fish protein isolate.

(a) The food additive fish protein isolate may be safely used as a food supplement in accordance with the following prescribed conditions:

(1) The additive shall consist principally of dried fish protein prepared from the edible portions of fish after removal of the heads, fins, tails, bones, scales, viscera, and intestinal contents.

(2) The additive shall be derived only from species of bony fish that are generally recognized by qualified scientists as safe for human consumption and that can be processed as prescribed to meet the required specifications.

(3) Only wholesome fresh fish otherwise suitable for human consumption may be used. The fish shall be handled expeditiously under sanitary conditions. These conditions shall be in accordance with recognized good manufacturing practice for fish to be used as human food.

(4) The additive shall be prepared by extraction with hexane and food-grade ethanol to remove fat and moisture. Solvent residues shall be reduced by drying.

(b) The food additive meets the following specifications: (Where methods of determination are specified, they are Association of Official Analytical Chemists Methods, 13th ed., 1980, which are incorporated by reference). 1

1 Copies are available from: AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or 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.

(1) Protein content, as N × 6.25, shall not be less than 90 percent by weight of the final product, as determined by the method described in section 2.057, Improved Kjeldahl Method for Nitrate-Free Samples (20) - Official Final Action.

(2) Moisture content shall not be more than 10 percent by weight of the final product, as determined by the method described in section 24.003, Air Drying (1) - Official First Action.

(3) Fat content shall not be more than 0.5 percent by weight of the final product, as determined by the method described in section 24.005, Crude Fat or Ether Extract - Official Final Action.

(4) Solvent residues in the final product shall not be more than 5 parts per million of hexane and 3.5 percent ethanol by weight.

[ 46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, 1989]

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United States Code

Title 21 published on 10-May-2017 03:43

The 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, 2016
    1. 81 FR 46578 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D 2 and Vitamin D 3
      GPO FDSys XML | Text
      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