[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.385]
[Page 52-53]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
Subpart D Special Dietary and Nutritional Additives
Sec. 172.385 Whole fish protein concentrate.
The food additive whole fish protein concentrate may be safely used
as a food supplement in accordance with the following prescribed
conditions:
(a) The additive is derived from whole, wholesome hake and hakelike
fish, herring of the genera Clupea, menhaden, and anchovy of the species
Engraulis mordax, handled expeditiously and under sanitary conditions in
accordance with good manufacturing practices recognized as proper for
fish that are used in other forms for human food.
(b) The additive consists essentially of a dried fish protein
processed from the whole fish without removal of heads, fins, tails,
viscera, or intestinal contents. It is prepared by solvent extraction of
fat and moisture with isopropyl alcohol or with ethylene dichloride
followed by isopropyl alcohol, except that the additive derived from
herring, menhaden and anchovy is prepared by solvent extraction with
isopropyl alcohol alone. Solvent residues are reduced by conventional
heat drying and/or microwave radiation and there is a partial removal of
bone.
(c) The food additive meets the following specifications:
(1) Protein content (N x 6.25) shall not be less than 75 percent by
weight of the final product, as determined by the method described in
section 2.057 in ``Official Methods of Analysis of the Association of
Official Analytical Chemists'' (AOAC), 13th Ed. (1980). Protein quality
shall not be less than 100, as determined by the method described in
sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by
reference, and copies may be obtained from the AOAC INTERNATIONAL, 481
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be
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.
(2) Moisture content shall not exceed 10 percent by weight of the
final product, as determined by the method described in section 24.003
of the AOAC. See paragraph (c)(1) of this section for availability of
the material incorporated by reference.
(3) Fat content shall not exceed 0.5 percent by weight of the final
product, as determined by the method described
[[Page 53]]
in section 24.005 of the AOAC. See paragraph (c)(1) of the this section
for availability of the material incorporated by reference.
(4) The additive may contain residues of isopropyl alcohol and
ethylene dichloride not in excess of 250 parts per million and 5 parts
per million, respectively, when used as solvents in the extraction
process.
(5) Microwave radiation meeting the requirements of Sec. 179.30 of
this chapter may be used to reduce residues of the solvents used in the
extraction process.
(6) The additive shall contain not in excess of 100 parts per
million fluorides (expressed as F).
(7) The additive shall be free of Escherichia coli and pathogenic
organisms, including Salmonella, and shall have a total bacterial plate
count of not more than 10,000 per gram.
(8) The additive shall have no more than a faint characteristic fish
odor and taste.
(d) When the additive is used or intended for use in the household
as a protein supplement in food for regular consumption by children up
to 8 years of age, the amount of the additive from this source shall not
exceed 20 grams per day (about one heaping tablespoon).
(e) When the additive is used as a protein supplement in
manufactured food, the total fluoride content (expressed as F) of the
finished food shall not exceed 8 ppm based on the dry weight of the food
product.
(f) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of consumer-sized or bulk containers of the additive
shall bear the name ``whole fish protein concentrate''.
(2) The label or labeling of containers of the additive shall bear
adequate directions for use to comply with the limitations prescribed by
paragraphs (d) and (e) of this section.
(3) Labels of manufactured foods containing the additive shall bear,
in the ingredient statement, the name of the additive, ``whole fish
protein concentrate'' in the proper order of decreasing predominance in
the finished food.
[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984;
54 FR 24897, June 12, 1989]
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