This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160]
[Page 488]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart A [Reserved]
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec.
160.100 Eggs.
160.105 Dried eggs.
160.110 Frozen eggs.
160.115 Liquid eggs.
160.140 Egg whites.
160.145 Dried egg whites.
160.150 Frozen egg whites.
160.180 Egg yolks.
160.185 Dried egg yolks.
160.190 Frozen egg yolks.
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Source: 42 FR 14462, Mar. 15, 1977, unless otherwise noted.
Subpart A [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.100]
[Page 488]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.100 Eggs.
No regulation shall be promulgated fixing and establishing a
reasonable definition and standard of identity for the food commonly
known as eggs.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.105]
[Page 488-489]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.105 Dried eggs.
(a) Dried eggs, dried whole eggs are prepared by drying liquid eggs
that conform to Sec. 160.115, with such precautions that the finished
food is free of viable Salmonella microorganisms. They may be powdered.
Before drying, the glucose content of the liquid eggs may be reduced by
one of the optional procedures set forth in paragraph (b) of this
section. Either silicon dioxide complying with the provisions of
Sec. 172.480 of this chapter or sodium silicoaluminate may be added as
an optional anticaking ingredient, but the amount of silicon dioxide
used is not more than 1 percent and the amount of sodium silicoaluminate
used is less than 2 percent by weight of the finished food. The finished
food shall contain not less than 95 percent by weight total egg solids.
(b) The optional glucose-removing procedures are:
(1) Enzyme procedure. A glucose-oxidase-catalase preparation and
hydrogen peroxide solution are added to the liquid eggs. The quantity
used and the time of reaction are sufficient to substantially reduce the
glucose content of the liquid eggs. The glucose-oxidase-catalase
preparation used is one that is generally recognized as safe within the
meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act.
The hydrogen peroxide solution used shall comply with the specifications
of the United States Pharmacopeia, except that it may exceed the
concentration specified therein and it does not contain a preservative.
[[Page 489]]
(2) Yeast procedure. The pH of the liquid eggs is adjusted to the
range of 6.0 to 7.0, if necessary, by the addition of dilute, chemically
pure hydrochloric acid, and controlled fermentation is maintained by
adding food-grade baker's yeast (Saccharomyces cerevisiae). The quantity
of yeast used and the time of reaction are sufficient to substantially
reduce the glucose content of the liquid eggs.
(c) The name of the food for which a definition and standard of
identity is prescribed by this section is "Dried eggs" or "Dried
whole eggs" and if the glucose content was reduced, as provided in
paragraph (b) of this section, the name shall be followed immediately by
the statement "Glucose removed for stability" or "Stabilized, glucose
removed".
(d)(1) When either of the optional anticaking ingredients specified
in paragraph (a) of this section is used, the label shall bear the
statement "Not more than 1 percent silicon dioxide added as an
anticaking agent" or "Less than 2 percent sodium silicoaluminate added
as an anticaking agent", whichever is applicable.
(2) The name of any optional ingredient used, as provided in
paragraph (d)(1) of this section, shall be listed on the principal
display panel or panels of the label with such prominence and
conspicuousness as to render such statement likely to be read and
understood by the ordinary individual under customary conditions of
purchase.
(e) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.110]
[Page 489]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.110 Frozen eggs.
(a) Frozen eggs, frozen whole eggs, frozen mixed eggs is the food
prepared by freezing liquid eggs that conform to Sec. 160.115, with such
precautions that the finished food is free of viable Salmonella
microorganisms.
(b) Monosodium phosphate or monopotassium phosphate may be added
either directly or in a water carrier, but the amount added does not
exceed 0.5 percent of the weight of the frozen eggs. If a water carrier
is used, it shall contain not less than 50 percent by weight of such
monosodium phosphate or monopotassium phosphate.
(c) When one of the optional ingredients specified in paragraph (b)
of this section is used, the label shall bear the statement "Monosodium
phosphate (or monopotassium phosphate) added to preserve color", or, in
case the optional ingredient used is added in a water carrier, the
statement shall be "Monosodium phosphate (or monopotassium phosphate),
with -- percent water as a carrier, added to preserve color", the blank
being filled in to show the percent by weight of water used in
proportion to the weight of the finished food. The statement declaring
the optional ingredient used shall appear on the principal display panel
or panels with such prominence and conspicuousness as to render it
likely to be read and understood under customary conditions of purchase.
(d) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.115]
[Page 489-490]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.115 Liquid eggs.
(a) Liquid eggs, mixed eggs, liquid whole eggs, mixed whole eggs are
eggs of the domestic hen broken from the shells and with yolks and
whites in their natural proportion as so broken. They may be mixed, or
mixed and strained, and they are pasteurized or otherwise treated to
destroy all viable Salmonella microorganisms. Pasteurization or such
other treatment is deemed to permit the adding of safe and suitable
substances (other than chemical preservatives) that are essential to the
method of pasteurization or other treatment used. For the purposes of
this paragraph, safe and suitable substances are those that perform a
useful function in the pasteurization or other treatment to render the
liquid eggs free of viable Salmonella microorganisms, and that are not
food additives as defined in section 201(s) of the Federal Food, Drug,
and Cosmetic Act; or, if they are food additives, they are used
[[Page 490]]
in conformity with regulations established pursuant to section 409 of
the act.
(b) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.140]
[Page 490]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.140 Egg whites.
(a) Egg whites, liquid egg whites, liquid egg albumen is the food
obtained from eggs of the domestic hen, broken from the shells and
separated from yolks. The food may be mixed, or mixed and strained, and
is pasteurized or otherwise treated to destroy all viable Salmonella
microorganisms. Pasteurization or such other treatment is deemed to
permit the adding of safe and suitable substances (other than chemical
preservatives) that are essential to the method of pasteurization or
other treatment used. Safe and suitable substances that aid in
protecting or restoring the whipping properties of liquid egg whites may
be added. For the purposes of this paragraph, safe and suitable
substances are those that perform a useful function as whipping aids or
in the pasteurization or other treatment to render liquid egg whites
free of viable Salmonella microorganisms and that are not food additives
as defined in section 201(s) of the Federal Food, Drug, and Cosmetic
Act; or, if they are food additives, they are used in conformity with
regulations established pursuant to section 409 of the act.
(b) Any optional ingredients used as whipping aids, as provided for
in paragraph (a) of this section, shall be named on the principal
display panel or panels of labels with such prominence and
conspicuousness as to render such names likely to be read and understood
by ordinary individuals under customary conditions of purchase.
(c) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.145]
[Page 490-491]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.145 Dried egg whites.
(a) The food dried egg whites, egg white solids, dried egg albumen,
egg albumen solids is prepared by drying liquid egg whites conforming to
the requirements of Sec. 160.140 (or deviating from that section only by
not being Salmonella free). As a preliminary step to drying, the
lysozyme and avidin contents may be reduced. If lysozyme and avidin
levels are reduced, cation exchange resins regulated for use under
Sec. 173.25 of this chapter shall be used. As a further preliminary step
to drying, the glucose content of the liquid egg whites is reduced by
adjusting the pH, where necessary, with food-grade acid and by following
one of the optional procedures set forth in paragraph (b) of this
section. If the food is prepared from liquid egg whites conforming in
all respects to the requirements of Sec. 160.140, drying shall be done
with such precautions that the finished food is free of viable
Salmonella microorganisms. If the food is prepared from liquid egg
whites that are not Salmonella free, the dried product shall be so
treated by heat or otherwise as to render the finished food free of
viable Salmonella microorganisms. Dried egg whites may be powdered.
(b) The optional glucose-removing procedures are:
(1) Enzyme procedure. A glucose-oxidase-catalase preparation and
hydrogen peroxide solution are added to liquid egg whites. The quantity
used and the time of reaction are sufficient to substantially reduce the
glucose content. The glucose-oxidase-catalase preparation used is one
that is generally recognized as safe within the meaning of section
201(s) of the Federal Food, Drug, and Cosmetic Act. The hydrogen
peroxide solution used shall comply with the specifications of the
United States Pharmacopeia, except that it may exceed the concentration
specified therein and it does not contain a preservative.
(2) Controlled fermentation procedures--(i) Yeast procedure. Food-
grade baker's yeast (Saccharomyces cerevisiae) is added to the liquid
egg whites and controlled fermentation is maintained. The quantity of
yeast used and the time of reaction are sufficient
[[Page 491]]
to substantially reduce the glucose content.
(ii) Bacterial procedure. The liquid egg whites are subjected to the
action of a culture of glucose-fermenting bacteria either generally
recognized as safe within the meaning of section 201(s) of the Federal
Food, Drug, and Cosmetic Act or the subject of a regulation established
pursuant to section 409 of the act, and the culture is used in
conformity with such regulation. The quantity of the culture used is
sufficient to predominate in the fermentation and the time and
temperature of reaction are sufficient to substantially reduce the
glucose content.
(c)(1) Dried egg whites in which the lysozyme and avidin have been
reduced shall not be nutritionally inferior, as defined in
Sec. 101.3(e)(4)(i) of this chapter, and shall be considered
nutritionally equivalent to untreated egg whites if they meet the
conditions that the biological quality of the protein contained is equal
to or greater than that of untreated egg white from the same batch of
liquid egg white.
(2) Compliance with the biological quality of protein requirement of
paragraph (c)(1) of this section shall be determined by the analytical
method prescribed in "Official Methods of Analysis of the Association
of Official Analytical Chemists," 14th Ed. (1984), section 43.253-
43.257, "Protein Efficiency Ratio, Rat Bioassay, Final Action," which
is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
(d) When the dried egg whites are prepared from liquid egg whites
containing any optional ingredients added as whipping aids, as provided
for in Sec. 160.140(a), the common names of such optional ingredients
shall be listed on the principal display panel or panels of the label
with such prominence and conspicuousness as to render the names likely
to be read and understood by ordinary individuals under customary
conditions of purchase.
(e) The name of the food for which a definition and standard of
identity is prescribed in this section is alternatively "Dried egg
whites", Egg white solids", "Dried egg albumen", or "Egg albumen
solids". If the lysozyme and avidin content is reduced as provided in
paragraph (a) of this section, the name shall be immediately preceded or
followed by the statement "lysozyme and avidin reduced" when the dried
egg whites are sold as such. When the dried egg whites are used in a
fabricated food, the statement "lysozyme and avidin reduced" may be
omitted from any declaration of ingredients required under Sec. 101.4 of
this chapter.
(f) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14462, Mar. 15, 1977, as amended at 51 FR 11435, Apr. 3, 1986; 51
FR 25362, July 14, 1986; 54 FR 24895, June 12, 1989; 58 FR 2883, Jan. 6,
1993; 63 FR 14035, Mar. 24, 1998]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.150]
[Page 491]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.150 Frozen egg whites.
(a) Frozen egg whites, frozen egg albumen is the food prepared by
freezing liquid egg whites that conform to Sec. 160.140, with such
precautions that the finished food is free of viable Salmonella
microorganisms.
(b) When frozen egg whites are prepared from liquid egg whites
containing any optional ingredients added as whipping aids, as provided
for in Sec. 160.140(a), the common names of such optional ingredients
shall be listed on the principal display panel or panels of the label
with such prominence and conspicuousness as to render such names likely
to be read and understood by ordinary individuals under customary
conditions of purchase.
(c) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.180]
[Page 491-492]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.180 Egg yolks.
(a) Egg yolks, liquid egg yolks, yolks, liquid yolks are yolks of
eggs of the domestic hen so separated from the whites thereof as to
contain not less
[[Page 492]]
than 43 percent total egg solids, as determined by the method prescribed
in "Official Methods of Analysis of the Association of Official
Analytical Chemists," 13th Ed. (1980), sections 17.006 and 17.007 under
"Total Solids, Vacuum Method (3)--Official Final Action," which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC. They may be mixed, or mixed and strained, and they are
pasteurized or otherwise treated to destroy all viable Salmonella
microorganisms. Pasteurization or such other treatment is deemed to
permit the adding of safe and suitable substances (other than chemical
preservatives) that are essential to the method of pasteurization or
other treatment used. For the purposes of this paragraph, safe and
suitable substances are those that perform a useful function in the
pasteurization or other treatment to render the egg yolks free of viable
Salmonella microorganisms, and that are not food additives as defined in
section 201(s) of the Federal Food, Drug, and Cosmetic Act; or, if they
are food additives, they are used in conformity with regulations
established pursuant to section 409 of the act.
(b) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14462, Mar. 15, 1977, as amended at 47 FR 11832, Mar. 19, 1982;
49 FR 10102, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2883, Jan.
6, 1993; 63 FR 14035, Mar. 24, 1998]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.185]
[Page 492-493]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.185 Dried egg yolks.
(a) Dried egg yolks, dried yolks is the food prepared by drying egg
yolks that conform to Sec. 160.180, with such precautions that the
finished food is free of viable Salmonella microorganisms. Before
drying, the glucose content of the liquid egg yolks may be reduced by
one of the optional procedures set forth in paragraph (b) of this
section. Either silicon dioxide complying with the provisions of
Sec. 172.480 of this chapter or sodium silicoaluminate may be added as
an optional anticaking ingredient, but the amount of silicon dioxide
used is not more than 1 percent and the amount of sodium silicoaluminate
used is less than 2 percent by weight of the finished food. The finished
food shall contain not less than 95 percent by weight total egg solids.
(b) The optional glucose-removing procedures are:
(1) Enzyme procedure. A glucose-oxidase-catalase preparation and
hydrogen peroxide solution are added to the liquid egg yolks. The
quantity used and the time of reaction are sufficient to substantially
reduce the glucose content of the liquid egg yolks. The glucose-oxidase-
catalase preparation used is one that is generally recognized as safe
within the meaning of section 201(s) of the Federal Food, Drug, and
Cosmetic Act. The hydrogen peroxide solution used shall comply with the
specification of the United States Pharmacopeia, except that it may
exceed the concentration specified therein and it does not contain a
preservative.
(2) Yeast procedure. The pH of the liquid egg yolks is adjusted to
the range of 6.0 to 7.0, if necessary, by the addition of dilute,
chemically pure hydrochloric acid, and controlled fermentation is
maintained by adding food-grade baker's yeast (Saccharomyces
cerevisiae). The quantity of yeast used and the time of reaction are
sufficient to substantially reduce the glucose content of the liquid egg
yolks.
(c) The name of the food for which a definition and standard of
identity is prescribed by this section is "Dried egg yolks", or
"Dried yolks", and if the glucose content was reduced, as provided in
paragraph (b) of this section, the name shall be followed immediately by
the statement "Glucose removed for stability" or "Stabilized, glucose
removed".
(d)(1) When either of the optional anticaking ingredients specified
in paragraph (a) of this section is used, the label shall bear the
statement "Not more than 1 percent silicon dioxide added as an
anticaking agent" or "Less than 2 percent sodium silicoaluminate added
as an anticaking agent", whichever is applicable.
[[Page 493]]
(2) The name of any optional ingredient used, as provided in
paragraph (d)(1) of this section, shall be listed on the principal
display panel or panels of the label with such prominence and
conspicuousness as to render such statement likely to be read and
understood by the ordinary individual under customary conditions of
purchase.
(e) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR160.190]
[Page 493]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 160--EGGS AND EGG PRODUCTS--Table of Contents
Subpart B--Requirements for Specific Standardized Eggs and Egg Products
Sec. 160.190 Frozen egg yolks.
(a) Frozen egg yolks, frozen yolks is the food prepared by freezing
egg yolks that conform to Sec. 160.180, with such precautions that the
finished food is free of viable Salmonella microorganisms.
(b) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
[42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2884, Jan. 6, 1993]

