# 21 C.F.R. § 172.340 (2026): Fish protein isolate > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_340 ## Section - **Citation:** 21 C.F.R. § 172.340 (2026) - **Heading:** Fish protein isolate - **Jurisdiction:** Federal - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 172: FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION / Subpart D: Special Dietary and Nutritional Additives / § 172.340: § 172.340 Fish protein isolate. ## Text (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. tent, 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] ## Nearby sections - [21 C.F.R. § 172.310 (2026) § 172.310 Aluminum nicotinate.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_310.md) - [21 C.F.R. § 172.315 (2026) § 172.315 Nicotinamide-ascorbic acid complex.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_315.md) - [21 C.F.R. § 172.320 (2026) § 172.320 Amino acids.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_320.md) - [21 C.F.R. § 172.325 (2026) § 172.325 Bakers yeast protein.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_325.md) - [21 C.F.R. § 172.330 (2026) § 172.330 Calcium pantothenate, calcium chloride double salt.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_330.md) - [21 C.F.R. § 172.335 (2026) § 172.335 D-Pantothenamide.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_335.md) - [21 C.F.R. § 172.340 (2026) § 172.340 Fish protein isolate.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_340.md) - [21 C.F.R. § 172.345 (2026) § 172.345 Folic acid (folacin).](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_345.md) - [21 C.F.R. § 172.350 (2026) § 172.350 Fumaric acid and salts of fumaric acid.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_350.md) - [21 C.F.R. § 172.365 (2026) § 172.365 Kelp.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_365.md) - [21 C.F.R. § 172.370 (2026) § 172.370 Iron-choline citrate complex.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_370.md) - [21 C.F.R. § 172.372 (2026) § 172.372 N -Acetyl-L-methionine.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_372.md) - [21 C.F.R. § 172.375 (2026) § 172.375 Potassium iodide.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_375.md) - [21 C.F.R. § 172.379 (2026) § 172.379 Vitamin D 2 .](https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_379.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P172_S172_340. 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