---
kind: "section"
citation: "21 C.F.R. § 184.1472"
title: "21"
number: "184.1472"
heading: "Menhaden oil."
url: "https://uscodex.org/cfr/21/184.1472"
---

# §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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). 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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). The availability of this incorporation by reference is given in [paragraph (a)(2)(iii)](#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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). The availability of this incorporation by reference is given in [paragraph (a)(2)(iii)](#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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). The availability of this incorporation by reference is given in [paragraph (a)(2)(iii)](#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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). The availability of this incorporation by reference is given in [paragraph (a)(2)(iii)](#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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). The availability of this incorporation by reference is given in [paragraph (a)(2)(iii)](#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)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). The availability of this incorporation by reference is given in [paragraph (a)(2)(iii)](#a-2-iii) of this section.
  - (3) In accordance with [§ 184.1(b)(2)](/cfr/21/184.1.md?p=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:
  - (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)](/cfr/21/170.3.md?p=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)](/cfr/21/101.4.md?p=b-14) of this chapter.

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 321, 342, 348, 371.

### Source

Source: 42 FR 14653, Mar 15, 1977, unless otherwise noted.

### Amendments

[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]