###### Editorial Note on Part 184

#### Editorial Note:

Nomenclature changes to part 184 appear at 66 FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 69 FR 13717, Mar. 24, 2004; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005; and 81 FR 49897, July 29, 2016.

#### § 184.1472 Menhaden oil.

(a) *Menhaden oil.*

(1) Menhaden oil is prepared from fish of the genus *Brevoortia,* commonly known as menhaden, by cooking and pressing. The resulting crude oil is then refined using the following steps: Storage (winterization), degumming (optional), neutralization, bleaching, and deodorization. Winterization may separate the oil and produce a solid fraction.

(2) Menhaden oil meets the following specifications:

(i) *Color and state.* Yellow liquid to white solid.

(ii) *Odor.* Odorless to slightly fishy.

(iii) *Saponification value.* Between 180 and 200 as determined by the American Oil Chemists' Society Official Method Cd 3-25—“Saponification Value” (reapproved 1989), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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/code_of_federal_regulations/ibr_locations.html.*

(iv) *Iodine number.* Not less than 120 as determined by the American Oil Chemists' Society Recommended Practice Cd 1d-92—“Iodine Value of Fats and Oils, Cyclohexane—Acetic Acid Method,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section.

(v) *Unsaponifiable matter.* Not more than 1.5 percent as determined by the American Oil Chemists' Society Official Method Ca 6b-53—“Unsaponifiable Matter” (reapproved 1989), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section.

(vi) *Free fatty acids.* Not more than 0.1 percent as determined by the American Oil Chemists' Society Official Method Ca 5a-40—“Free Fatty Acids” (reapproved 1989), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section.

(vii) *Peroxide value.* Not more than 5 milliequivalents per kilogram of oil as determined by the American Oil Chemists' Society Official Method Cd 8-53—“Peroxide Value, Acetic Acid—Chloroform Method” (updated 1992) or Recommended Practice Cd 8b-90—“Peroxide Value, Acetic Acid—Isooctane Method” (updated 1992), which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section.

(viii) *Lead.* Not more than 0.1 part per million as determined by the American Oil Chemists' Society Official Method Ca 18c-91—“Determination of Lead by Direct Graphite Furnace Atomic Absorption Spectrometry” (revised 1992), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section.

(ix) *Mercury.* Not more than 0.5 part per million as determined by the method entitled “Biomedical Test Materials Program: Analytical Methods for the Quality Assurance of Fish Oil,” published in the “NOAA Technical Memorandum NMFS-SEFC-211,” F. M. Van Dolah and S. B. Galloway, editors, National Marine Fisheries Service, U. S. Department of Commerce, pages 71-88, November, 1988, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section.

(3) In accordance with § 184.1(b)(2), the ingredient may be used in food only within the following specific limitations to ensure that total intake of eicosapentaenoic acid or docosahexaenoic acid does not exceed 3.0 grams/person/day:

| Category of food | Maximum level of use in food (as served) |
| --- | --- |
| Baked goods, baking mixes, § 170.3(n)(1) of this chapter | 5.0 percent |
| Cereals, § 170.3(n)(4) of this chapter | 4.0 percent |
| Cheese products, § 170.3(n)(5) of this chapter | 5.0 percent |
| Chewing gum, § 170.3(n)(6) of this chapter | 3.0 percent |
| Condiments, § 170.3(n)(8) of this chapter | 5.0 percent |
| Confections, frostings, § 170.3(n)(9) of this chapter | 5.0 percent |
| Dairy product analogs, § 170.3(n)(10) of this chapter | 5.0 percent |
| Egg products, § 170.3(n)(11) of this chapter | 5.0 percent |
| Fats, oils, § 170.3(n)(12) of this chapter, but not in infant formula | 12.0 percent |
| Fish products, § 170.3(n)(13) of this chapter | 5.0 percent |
| Frozen dairy desserts, § 170.3(n)(20) of this chapter | 5.0 percent |
| Gelatins, puddings, § 170.3(n)(22) of this chapter | 1.0 percent |
| Gravies, sauces, § 170.3(n)(24) of this chapter | 5.0 percent |
| Hard candy, § 170.3(n)(25) of this chapter | 10.0 percent |
| Jams, jellies, § 170.3(n)(28) of this chapter | 7.0 percent |
| Meat products, § 170.3(n)(29) of this chapter | 5.0 percent |
| Milk products, § 170.3(n)(31) of this chapter | 5.0 percent |
| Nonalcoholic beverages, § 170.3(n)(3) of this chapter | 0.5 percent |
| Nut products, § 170.3(n)(32) of this chapter | 5.0 percent |
| Pastas, § 170.3(n)(23) of this chapter | 2.0 percent |
| Plant protein products, § 170.3(n)(33) of this chapter | 5.0 percent |
| Poultry products, § 170.3(n)(34) of this chapter | 3.0 percent |
| Processed fruit juices, § 170.3(n)(35) of this chapter | 1.0 percent |
| Processed vegetable juices, § 170.3(n)(36) of this chapter | 1.0 percent |
| Snack foods, § 170.3(n)(37) of this chapter | 5.0 percent |
| Soft candy, § 170.3(n)(38) of this chapter | 4.0 percent |
| Soup mixes, § 170.3(n)(40) of this chapter | 3.0 percent |
| Sugar substitutes, § 170.3(n)(42) of this chapter | 10.0 percent |
| Sweet sauces, toppings, syrups, § 170.3(n)(43) of this chapter | 5.0 percent |
| White granulated sugar, § 170.3(n)(41) of this chapter | 4.0 percent |

(4) To ensure safe use of the substance, menhaden oil shall not be used in combination with any other added oil that is a significant source of eicosapentaenoic acid or docosahexaenoic acid.

(b) *Hydrogenated menhaden oil.*

(1) Hydrogenated menhaden oil is prepared by feeding hydrogen gas under pressure to a converter containing crude menhaden oil and a nickel catalyst. The reaction is begun at 150 to 160 °C and after 1 hour the temperature is raised to 180 °C until the menhaden oil is fully hydrogenated.

(2) Hydrogenated menhaden oil meets the following specifications:

(i) *Color.* Opaque white solid.

(ii) *Odor.* Odorless.

(iii) *Saponification value.* Between 180 and 200.

(iv) *Iodine number.* Not more than 4.

(v) *Unsaponifiable matter.* Not more than 1.5 percent.

(vi) *Free fatty acids.* Not more than 0.1 percent.

(vii) *Peroxide value.* Not more than 5 milliequivalents per kilogram of oil.

(viii) *Nickel.* Not more than 0.5 part per million.

(ix) *Mercury.* Not more than 0.5 part per million.

(x) *Arsenic (as As).* Not more than 0.1 part per million.

(xi) *Lead.* Not more than 0.1 part per million.

(3) Hydrogenated menhaden oil is used as edible fat or oil, as defined in § 170.3(n)(12) of this chapter, in food at levels not to exceed current good manufacturing practice.

(4) The name to be used on the label of a product containing hydrogenated menhaden oil must include the term “hydrogenated,” in accordance with § 101.4(b)(14) of this chapter.

[62 FR 30756, June 5, 1997, as amended at 70 FR 14531, Mar. 23, 2005; 81 FR 5596, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023; 88 FR 53773, Aug. 9, 2023]