21 CFR 172.340 - Fish protein isolate.
(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.
(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.
(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.