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184.1472 Menhaden oil.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1472 Menhaden oil.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1472]

[Page 541-543]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  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

[[Page 542]]

the Office of Food Additive Safety, Center for Food Safety and Applied 
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or available for inspection at the Center 
for Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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 Sec.  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:

------------------------------------------------------------------------
                                            Maximum level of use in food
             Category of food                        (as served)
------------------------------------------------------------------------
Baked goods, baking mixes, Sec.             5.0 percent
 170.3(n)(1) of this chapter.
Cereals, Sec.   170.3(n)(4) of this         4.0 percent
 chapter.
Cheese products, Sec.   170.3(n)(5) of      5.0 percent
 this chapter.
Chewing gum, Sec.   170.3(n)(6) of this     3.0 percent
 chapter.
Condiments, Sec.   170.3(n)(8) of this      5.0 percent
 chapter.
Confections, frostings, Sec.   170.3(n)(9)  5.0 percent
 of this chapter.
Dairy product analogs, Sec.   170.3(n)(10)  5.0 percent
 of this chapter.
Egg products, Sec.   170.3(n)(11) of this   5.0 percent
 chapter.
Fats, oils, Sec.   170.3(n)(12) of this     12.0 percent
 chapter, but not in infant formula.
Fish products, Sec.   170.3(n)(13) of this  5.0 percent
 chapter.
Frozen dairy desserts, Sec.   170.3(n)(20)  5.0 percent
 of this chapter.
Gelatins, puddings, Sec.   170.3(n)(22) of  1.0 percent
 this chapter.
Gravies, sauces, Sec.   170.3(n)(24) of     5.0 percent
 this chapter.
Hard candy, Sec.   170.3(n)(25) of this     10.0 percent
 chapter.

[[Page 543]]


Jams, jellies, Sec.   170.3(n)(28) of this  7.0 percent
 chapter.
Meat products, Sec.   170.3(n)(29) of this  5.0 percent
 chapter.
Milk products, Sec.   170.3(n)(31) of this  5.0 percent
 chapter.
Nonalcoholic beverages, Sec.   170.3(n)(3)  0.5 percent
 of this chapter.
Nut products, Sec.   170.3(n)(32) of this   5.0 percent
 chapter.
Pastas, Sec.   170.3(n)(23) of this         2.0 percent
 chapter.
Plant protein products, Sec.                5.0 percent
 170.3(n)(33) of this chapter.
Poultry products, Sec.   170.3(n)(34) of    3.0 percent
 this chapter.
Processed fruit juices, Sec.                1.0 percent
 170.3(n)(35) of this chapter.
Processed vegetable juices, Sec.            1.0 percent
 170.3(n)(36) of this chapter.
Snack foods, Sec.   170.3(n)(37) of this    5.0 percent
 chapter.
Soft candy, Sec.   170.3(n)(38) of this     4.0 percent
 chapter.
Soup mixes, Sec.   170.3(n)(40) of this     3.0 percent
 chapter.
Sugar substitutes, Sec.   170.3(n)(42) of   10.0 percent
 this chapter.
Sweet sauces, toppings, syrups, Sec.        5.0 percent
 170.3(n)(43) of this chapter.
White granulated sugar, Sec.                4.0 percent
 170.3(n)(41) of this chapter.
------------------------------------------------------------------------

    (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 and partially hydrogenated menhaden oils. (1) 
Partially hydrogenated and hydrogenated menhaden oils are 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 
[deg]C and after 1 hour the temperature is raised to 180 [deg]C until 
the desired degree of hydrogenation is reached. Hydrogenated menhaden 
oil is fully hydrogenated.
    (2) Partially hydrogenated and hydrogenated menhaden oils meet the 
following specifications:
    (i) Color. Opaque white solid.
    (ii) Odor. Odorless.
    (iii) Saponification value. Between 180 and 200.
    (iv) Iodine number. Not more than 119 for partially hydrogenated 
menhaden oil and not more than 10 for fully hydrogenated menhaden oil.
    (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) Partially hydrogenated and hydrogenated menhaden oils are used 
as edible fats or oils, as defined in Sec.  170.3(n)(12) of this 
chapter, in food at levels not to exceed current good manufacturing 
practice.
    (4) If the fat or oil is fully hydrogenated, the name to be used on 
the label of a product containing it shall include the term 
``hydrogenated,'' or if it is partially hydrogenated, the name shall 
include the term ``partially hydrogenated,'' in accordance with Sec.  
101.4(b)(14) of this chapter.

[62 FR 30756, June 5, 1997, as amended at 70 FR 14531, Mar. 23, 2005]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1472


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