Regulation 1 Definition and
Standards
Section 1 Ice Cream and
Frozen Custard
(a) Description
(1) Ice cream is a food produced by
freezing, while stirring, a pasteurized mix consisting of one of the
optional dairy ingredients specified in paragraph (b) of this
section, and may contain one or more of the optional caseinates
specified in paragraph (c) of this section subject to the conditions
hereinafter set forth, and other safe and suitable nonmilk-derived
ingredients; and excluding other food fats, except such as are
natural components of flavoring ingredients used and are added in
incidental amounts to accomplish specific functions. Ice Cream is
sweetened with nutritive carbohydrate sweeteners and may or may not
be characterized by the addition of flavoring ingredients.
(2) Ice cream weighs not less than
4.5 pounds to the gallon and contains not less than 36% total solids
by weight. Ice cream contains not less than 10 percent milkfat, nor
less than 10 percent nonfat milk solids, except that when it contains
milkfat at 1 percent increments above the 10 percent minimum, it may
contain the following milkfat-to-nonfat milk solids levels:
| Minimum percent
nonfat | Percent milkfat milk solids |
|
10 |
10 |
|
11 |
9 |
|
12 |
8 |
|
13 |
7 |
|
14 |
6 |
Except that when one or more bulky flavors are used,
the weights of milkfat and total milk solids are not less than 10
percent and 20 percent, respectively, of the remainder obtained by
subtracting the weight of the bulky flavors from the weight of the
finished food; but in no case is the weight of milkfat or total milk
solids less than 8 percent and 16 percent, respectively, of the
weight of the finished food. Except in the case of frozen custard,
ice cream contains less than 1.4 percent egg yolk solids by weight of
the food, exclusive of the weight of any bulky flavoring ingredients
used. Frozen custard shall contain 1.4 percent egg yolk solids by
weight of the finished food: Provided, however, that when bulky
flavors added, but in no case is the content of egg yolk solids in
the finished food less than 1.12 percent. A product containing egg
yolk solids in excess of 1.4 percent, the maximum set forth in this
paragraph of ice cream, may be marketed if labeled as specified by
paragraph (e) (l) of this section.
(3) When calculating the minimum
amount of milkfat and nonfat milk solids required in the finished
food, the solids of chocolate or cocoa used shall be considered a
bulky flavoring ingredient. In order to make allowance for additional
sweetening ingredients needed when certain bulky ingredients are
used, the weight of chocolate or cocoa solids, used may be multiplied
by 2.5; the weight of fruit or nuts used may by multiplied by 1.4;
and the weight of partially or wholly dried fruit juices may be
multiplied by appropriate factors to obtain the original weights
before drying and this weight may be multiplied by
1.4.
(b)
Optional dairy ingredients. The optional dairy ingredients referred
to in paragraph (a) of this section are: cream, dried cream, plastic
cream, (sometimes known as a concentrated milk fat), butter, butter
oil, milk, concentrated milk, evaporated milk, sweetened condensed
milk, superheated condensed milk, dried milk, skim milk, concentrated
skim milk, evaporated skim milk, condensed skim milk, superheated
condensed skim milk, sweetened condensed skim milk, sweetened
condensed part skim milk, nonfat dry milk, sweet cream buttermilk,
condensed sweet cream buttermilk, dried sweet cream buttermilk, skim
milk that has been concentrated and from which part of the lactose
has been removed by crystallization, skim milk in concentrated or
dried form which has been modified by treating the concentrated skim
milk with calcium hydroxide and disodium phosphate, and whey and
those modified whey products (e.g., reduced lactose whey, reduced
minerals whey, and whey protein concentrate) that have been
determined by FDA to be generally recognized as safe (GRAS) for use
in this type of food. Water may be added, or water may be evaporated
from mix. The sweet cream buttermilk and the concentrated sweet cream
buttermilk or dried sweet cream buttermilk, when adjusted with water
to a total solids content of 8.5 percent, has a titratable acidity of
not more than 0.17 percent, calculated as lactic acid. The term
"milk" as used in this section means cow's milk. Any whey and
modified whey products used contribute, singly or in combination, not
more than 25 percent by weight of the total nonfat milk solids
content of the finished food. The modified skim milk, when adjusted
with water to a total solids content of 9 percent is substantially
free of lactic acid as determined by titration with 0.1N NaOH, and it
has a pH value in the range of 8.0 to 8.3.
(c) Optional caseinates. The
optional caseinates referred to in paragraph (a) of this section may
be added to ice cream mix containing not less than 20 percent total
milk solids are: Casein prepared by precipitation with gums, ammonium
caseinate, calcium caseinate, potassium caseinate, and sodium
caseinate. Caseinate may be added in liquid or dry form, but must be
free of excess alkali.
(d)
Methods of analysis. Fat content shall be determined by the following
methods contained in the "Official Methods of Analysis of the
Association of Official Analytical Chemists," 13th ed., 1980,
(A.O.A.C. Methods).
(1) Fat content
shall be determined by the method: "Fat; Roese-Gottlieb Method
Official Final Action," (A.O.A.C. section 16.287
).
(e)
Nomenclature.
(1) The name of the
food is "ice cream", except that when the egg yolk solids content of
the food is in excess of that specified for ice cream by paragraph
(a) of this section, the name of the food is "frozen custard" or
"french ice cream" or "french custard ice cream".
(2)
(i) If the food contains no
artificial flavor, the name on the principal display panel or panels
of the label shall be accompanied by the common or usual name of the
characterizing flavor, e.g., "vanilla", in letters not less than
one-half the height of the letters used in the words "ice
cream".
(ii) If the food
contains both a natural characterizing flavor and an artificial
flavor simulating it, and if the natural flavor predominates, the
name of the principal display panel or panels of the labels shall be
accompanied by the common name of the characterizing flavor, in
letters not less than one-half the height of the letters used in the
words "ice cream", followed by the word "flavored", in letters not
less than one-half the height of the letters in the name of the
characterizing flavor, e.g., "Vanilla flavored", or "Peach flavored",
or "Vanilla flavored and Strawberry flavored".
(iii) If the food contains both a
natural characterizing flavor and an artificial flavor simulating it,
and if the artificial flavor predominates, or if artificial flavor is
used alone the name on the principal display panel or panels of the
label shall be accompanied by the common name of the characterizing
flavor in letters not less than one-half the height of the letters
used in the words "ice cream", preceded by "artificial" or
"artificially flavored", in letters not less than one-half the height
of the letters in the name of the characterizing flavor, e.g.,
"artificial Vanilla", "artificially flavored Strawberry" or
"artificially flavored Vanilla and artificially flavored
Strawberry".
(3)
(i) If the food is
subject to the requirements of paragraph (e) (2) (ii) of this section
or if it contains any artificial flavor not simulating the
characterizing flavor, the label shall also bear the words
"artificial flavor added" or "artificial.....flavor added", the blank
being filled in with the common name of the flavor simulated by the
artificial flavor in letters of the same size and prominence as the
words that precede and follow it.
(ii) Wherever the name of the
characterizing flavor appears on the label so conspicuously as to be
easily seen under customary conditions of purchase, the words
prescribed by this paragraph shall immediately and conspicuously
precede or follow such name, in a size reasonably related to the
prominence of the name of the characterizing flavor and in any event
the size of the type is not less than 6-point on packages containing
at least 1 pint but less than one-half gallon, not less than 10-point
on packages containing at least one-half gallon but less than 1
gallon, and not less than 12-point on packages containing 1 gallon or
over: Provided, however, that where the characterizing flavor and a
trademark or brand are presented together, other written, printed, or
graphic matter that is a part of or is associated with the trademark
or brand, may intervene if the required words are in such
relationship with the trademark or brand as to be clearly related to
the characterizing flavor: And provided further, that if the finished
product contains more than one flavor of ice cream subject to the
requirements of this paragraph, the statements required by this
paragraph need appear only once in each statement of characterizing
flavors present in such ice cream, e.g., "Vanilla flavored,
Chocolate, and Strawberry flavored, artificial flavors
added".
(4) If
the food contains both a natural characterizing flavor and an
artificial flavor simulating the characterizing flavor, any reference
to the natural characterizing flavor shall, except as otherwise
authorized by this paragraph, be accompanied by a reference to the
artificial flavor, displayed with substantially equal prominence,
e.g., "Vanilla flavored, Chocolate, and Strawberry flavored,
artificial flavors added".
(5) An artificial flavor simulating
the characterizing flavor shall be deemed to predominate:
(i) In the case of vanilla beans or
vanilla extract used in combination with vanillin if the amount of
vanillin used is greater than 1 ounce per unit of vanilla
constituent, as defined in
21 CFR
169.3(c).
(ii) In the case of fruit or fruit
juice used in combination with artificial fruit flavor, if the
quantity of the fruit juice used is such that, in relation to the
weight of the fruit or fruit juice, as the case may be (including
water necessary to reconstitute partially or wholly dried fruits or
fruit juices to their original moisture content) is less than 2
percent in the case of berry or cherry ice cream, and 10 percent in
the case of ice cream prepared with other fruits.
(iii) In the case of nut meats used
in combination with artificial nut flavor, if the quantity of nut
meats is such that, in relation to the finished ice cream the weight
of the nut meats is less than 2 percent.
(iv) In the case of two or more
fruits or fruit juices, or nut meats, or both, used in combination
with artificial flavors simulating the natural flavors and dispensed
throughout the food, if the quantity of any fruit or fruit juice or
nut meat is less than one-half the applicable percentage specified in
paragraph (e) (5) (ii) or (iii) of this section. For example, if a
combination ice cream contains less than 5 percent of bananas and
less than 1 percent of almonds it would be "artificially flavored
banana-almond ice cream". However, if it contins more than 5 percent
of bananas and more than 1 percent of almonds it would be
"banana-almond flavored ice cream".
(6) If two or more flavors of ice
cream are distinctively combined in one package, e.g., "Neapolitan"
ice cream, the applicable provisions of this paragraph shall govern
each flavor of ice cream comprising the
combination.
(f)
Label declaration. Each of the optional ingredients used shall be
declared on the label as required by the applicable section of 21 CFR
101, except that sources of milkfat or milkfat soolids not fat may be
declared in descending order of predominance either by the use of all
the terms "milkfat and nonfat milk" when one or any combination of
two or more of the ingredients listed in the appropriate sections of
CFR 101.4. Pursuant to section 402(k) of the Federal Food, Drug and
Cosmetic Act artificial color need not be declared in ice cream.
Voluntary declaration of such color in ice cream is recommended.
Section 2 Ice
Milk
(a) Description. Ice Milk is
the food prepared from the same ingredients and in the same manner
prescribed in Section
1
for ice cream and complies with all the provisions of Section
1
including the requirements for label statement of optional
ingredients, except that:
(1) Its
content of milkfat is more than 2 percent but not more than 7
percent.
(2) Its content
of total milk solids is not less than 11 percent.
(3) Caseinates may be added when
the content of total milk solids is not less than 11
percent.
(4) The provision
for reduction in milkfat and nonfat milk solids content from the
addition of bulky flavors in Section
1
applies, except that in no case will the milkfat content be less than
2 percent, nor the nonfat milk solids content be less than 4 percent.
When the milk fat content increases in increments of 1 percent above
the 2 percent minimum, it may contain the following milkfat-to-nonfat
milk solids levels:
| Minimum percent
nonfat |
| Percent milkfat | milk
solids |
|
2 |
9 |
|
3 |
8 |
|
4 |
7 |
|
5 |
6 |
|
6 |
5 |
|
7 |
4 |
(5) The quantity of food solids is
not less than 30% by weight.
(6) When any artificial coloring is
used in ice milk, directly or as a component of any other
ingredients, the label shall bear the statement "artificially
colored", "artificial coloring added", "with added artificial color,
or "....., an artificial color added," the blank being filled in with
the common or usual name of the artificial color is a component of
another ingredient, ".....artificially colored."
(7) If both artificial color and
artificial flavoring are used, the label statements may be
combined.
(b)
Nomenclature. The name of the food is "ice milk".
Ice milk shall be offered for sale, sold or served
only in properly labeled factory-filled containers upon which shall
be conspicuously printed the words, "Ice Milk" in letters not smaller
than eight point type except when ice milk is sold at retail, direct
from a frozen dessert dispensing freezer. No person shall sell or
offer for sale any ice milk to a person who has requested ice
cream.
Section
3 Sherbet
(a)
Description
(1) Sherbet is a food
produced by freezing, while stirring, a pasteurized mix consisting of
one or more of the optional dairy ingredients specified in paragraph
(b) of this section, and may contain one or more of the optional
caseinates specified in paragraph (c) of this section subject to the
condition hereinafter set forth, and other safe and suitable
nonmilk-derived ingredients; and excluding other food fats, except
such as are added in small amounts to accomplish specific functions
or are natural components of flavoring ingredients used. Sherbet is
sweetened with nutritive carbohydrate sweeteners and is characterized
by the addition of one or more of the characterizing fruit
ingredients specified in paragraph (d) of this section or one of the
non-fruit-characterizing ingredients specified in paragraph (e) of
this section.
(2) Sherbet
weighs not less than 6 pounds to the gallon. The milkfat content is
not less than 1 percent nor more than 2 percent, the nonfat
milk-derived solids content is not less than 1 percent and the total
milk or milk-derived solids content is not less thaan 2 percent nor
more than 5 percent by weight of the finished food. Sherbet that is
characterized by a fruit ingredient shall have a titratable acidity,
calculated as lactic acid, of not less than 0.55
percent.
(b)
Optional dairy ingredients. The optional dairy ingredients referred
to in paragraph (a) of this section are: Cream, dried cream, plastic
cream, (sometimes known as concentrated milk fat), butter, butter
oil, milk, concentrated milk, evaporated milk, superheated condensed
milk, sweetened condensed milk, dried milk, skim milk, concentrated
skim milk, evaporated skim milk, condensed skim milk, superheated
condensed skim milk, sweetened condensed skim milk, sweetened
condensed part skim milk, nonfat dry milk, sweet cream buttermilk,
condensed sweet cream buttermilk, dried sweet cream buttermilk, skim
milk that has been concentrated and from which part of the lactose
has been removed by crystallization, and whey and those modified whey
products (e.g., reduced lactose whey, reduced minerals whey, and whey
protein concentrate) that have been determined by FDA to be generally
recognized as safe (GRAS) for use in this type of food. Water may be
added, or water may have evaporated from the mix. The sweet cream
buttermilk and the concentrated sweet cream buttermilk or dried sweet
cream buttermilk, when adjusted with water to a total solids content
of 8.5 percent, has a titratable acidity of not more than 0.17
percent, calculated as lactic acid. The term "milk" as used in this
section means cow's milk.
(c) Optional caseinates. The
optional caseinates referred to in paragraph (a) of this section
which may be added to sherbet mix are: Casin prepared by
precipitation with gums, ammonium caseinate, calcium caseinate,
potassium caseinate, and sodium caseinate. Caseinates may be added in
liquid or dry form, but must be free of excess alkali. Such
caseinates are not considered to be milk solids.
(d) Optional fruit-characterizing
ingredients. The optional fruit characterizing ingredients referred
to in paragraph (a) of this section are any mature fruit or juice of
any mature fruit. The fruit or fruit juice used may be fresh, frozen,
canned, concentrated, or partially or wholly dried. The fruit may be
thickened with pectin or other optional ingredients. The fruit is
prepared by the removal of pits, seeds, skins, and cores, where such
removal is usual in preparing that kind of fruit for consumption as
fresh fruit. The fruit may be screened, crushed, or otherwise
comminuted. It may be acidulated. In the case of concentrated fruit
or fruit juices, from which part of the water is removed, substances
contributing flavor volatilized during water removal may be condensed
and reincorporated in the concentrated fruit of fruit juice. In the
case of citrus fruits, the whole fruit, including the peel but
excluding the seeds, may be used, and in the case of citrus juice or
concentrated citrus juices, cold-pressed citrus oil may be added
thereto in an amount not exceeding that which would have been
obtained if the the whole fruit had been used. The quantity of fruit
ingredients used is such that, in relation to the weight of the
finished sherbet, the weight of fruit or fruit ujuice, as the case
may be (including water necessary to reconstitute partially or wholly
dried fruits or fruit juices to their original moisture content), is
not less than 2 percent in the case of berry sherbets, and 10 percent
in the case of sherbets prepared with other fruits. For the purpose
of this section, tomatoes and rhubarb are considered as kinds of
fruits.
(e) Optional
nonfruit characterizing ingredients. The optional nonfruit
characterizing ingredients referred to in paragraph (a) of this
section include but are not limited to the following:
(1) Ground spice or infusion of
coffee or tea.
(2)
Chocolate or cocoa, including sirup.
(3) Confectionery.
(4) Distilled alcoholic beverage,
including liqueurs or wine, in an amount not to exceed that required
for flavoring the sherbet.
(5) Any natural or artificial food
flavoring (except any having a characteristic fruit or fruit-like
flavor).
(f)
Nomenclature.
(1) The name of each
sherbet is as follows:
(i) The name
of each fruit sherbet is ".... sherbet", the blank being filled in
with the common name of the fruit or fruits from which the fruit
ingredients used are obtained. When the name of two or more fruits
are included, such names shall be arranged in order of predominance,
if any, by weight of the respective fruit ingredients used.
(ii) The name of each nonfruit
sherbet is ".... sherbet", the blank being filled in with the common
or usual name of the characterizing flavor or flavors; for example,
"peppermint", except that if the characterizing flavor used in
vanilla, the name of the food is ".... sherbet", the blank being
filled in as specified by Section
1(e) (2) and (5)
(i).
(2) When the optional ingredients,
artificial flavoring or artificial coloring are used in sherbet, they
shall be named on the label as follows:
(i) If the flavoring ingredient or
ingredients consists exclusively of artificial flavoring, the label
designation shall be "artificially flavored".
(ii) If the flavoring ingredients
are a combination of natural and artificial flavors, the label
designation shall be "artificial and natural flavoring
added".
(iii) The label
shall designate artificial coloring by the statement "artificially
colored", "artificial coloring added", "with added artificial
coloring", or "....., an artificial color added", the blank being
filled in with the name of the artificial coloring
used.
(g) Characterizing flavor(s).
Whenever there appears on the label any representation as to the
characterizing flavor or flavors of the food and such flavor or
flavors consist in whole or in part of artificial flavoring, the
statement required by paragraph (f) (2) (i) and (ii) of this section,
as appropriate, shall immediately and conspicuously precede or follow
such representation, without intervening written, printed, or graphic
matter (except that word "sherbet" may intervene) in a size
reasonably related to the prominence of the name of the
characterizing flavor and in any event the size of the type is not
less than 6-point on packages containing less than 1 pint, not less
than 8-point on packages containing at least 1 pint but less than
one-half gallon, not less than 12-point on packages containing 1
gallon or over.
(h)
Display of statements required by paragraph (f) (2). Except as
specified in paragraph (g) of this section, the statements required
by paragraph (f) (2) of this section shall be set forth on the
principal display panel or panels of the label with such prominence
and conspicuousness as to render them likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use.
(i)
Label declarations. Each of the optional ingredients used shall be
declared on the label, as required by the applicable sections of 21
CFR 101.
Section
4 Non Fruit Sherbet
(a)
Description
(1) Non fruit sherbet
is a food having a characteristic fruit-like flavor but shall not
contain any fruit or fruit juice. Non fruit sherbet is prepared by
freezing while stirring a pasteurized mix consisting of one or more
of the optional dairy ingredients specified in paragraph (b) of this
section, and may contain one or more of the optional caseinates
specified in paragraph (c) of this section subject to the conditions
hereinafter set forth, and any other safe and suitable
non-milk-derived ingredients; and excluding other food fats, except
such as are added in small amounts to accomplish specific functions.
Non fruit sherbet is sweetened with nutritive carbohydrate sweeteners
and contains characteristic fruit like flavor.
(2) Sherbet weighs not less than 6
pounds to the gallon. The milkfat content is not less than 1 percent
nor more than 2 percent, the nonfat milk-derived solids content not
less than 1 percent, and the total milk or milk derived solids
content is not less than 2 percent nor more than 5 percent by weight
of the finished product.
(b) Optional dairy ingredients. The
optional dairy ingredients referred to in paragraph (a) of this
section are: Cream, dried cream, plastic cream (sometimes known as
concentrated milk fat), butter, butter oil, milk, concentrated milk,
evaporated milk, superheated condensed milk, sweetened condensed
milk, dried milk, skim milk, concentrated skim milk, evaporated skim
milk, condensed skim milk, superheated condensed skim milk, sweetened
condensed skim milk, sweetened condensed part skim milk, nonfat dry
milk, sweet cream buttermilk, condensed sweet cream buttermilk, dried
sweet cream buttermilk, skim milk that has been concentrated and from
which part of the lactose has been removed by crystallization, and
whey and those modified whey products (e.g., reduced lactose whey,
reduced minerals whey, and whey protein concentrate) that has been
determined by FDA to be generally recognized as safe (GRAS) for use
in this type of food. Water may be added, or water may be evaporated
from the mix. The sweet cream buttermilk and the concentrated sweet
cream buttermilk or dried sweet cream buttermilk, when adjusted with
water to be a total solids content of 8.5 percent, has a titratable
acidity of not more than 0.17 percent, calculated as lactic acid. The
term "milk" as used in this section means cow's milk.
(c) Optional caseinates. The
optional caseinates referred to in paragraph (a) of this section that
may be added to non fruit sherbet are: Casin prepared by
prescripitation with gums, ammonium caseinate, calcium caseinate,
potassium caseinate, and sodium caseinate. Caseinates may be added in
liquid or dry form, but must be free of excess alkali. Such
caseinates are not considered to be milk solids.
(d) Nomenclature. The name of the
food is "non fruit sherbet".
(e) In addition to all other
required information, the label shall:
(1) Contain a complete list of
ingredients, in accordance with provision of
21 CFR
101.4.
(2) Comply with the provisions of
21
CFR 101.22.
(3) Contain the following statement
"Imitation .... sherbet". The blank is to be filled in by the
characterizing flavor used. The letters in the word imitation shall
be the same size, type and color and on the same contrasting
background as the name of the characterizing flavor and the word
sherbet.
(4) The statement
required in paragraph (3) of this subsection shall be followed
immediately by the words "contains no fruit sherbet, it shall contain
the same information as required in paragraphs three and four of this
subsection.
(5) When a
sign is used at the point of purchase to advertise non fruit sherbet,
it shall contain the same information as required in paragraphs three
and four of this subsection.
(6) When non fruit sherbet is sold
other than in properly labeled factory filled containers a sign must
be conspicuously displayed on the sale premises or vehicle where it
can be clearly read by customers under normal conditions of purchase,
stating the information required in paragraphs 3 and 4 above. The
letters on such sign shall be bold face capitals at least three
inches in height and in contrasting color to the
background.
(7) The sign
required as per paragraph 6 above need not be used if each customer
is provided with a menu stating the information required by paragraph
3 and 4 above in bold face capitals as large as those used in listing
most food items.
Section 5 Water Ice
(a) Description. Water ices are the
foods each of which is prepared from the same ingredients and in the
same manner prescribed in Section
3
for sherbets, except that the mix need not be pasteurized, and
complies with all the provisions of Section
3
including the requirements for label statement of optional
ingredients except that no milk or milk derived ingredient and no egg
ingredient, other than egg white, is used.
(b) Nomenclature. The name of the
food is ".... ice", the blank being filled in, in the manner as
specified in Section
3(f)
(1) (i) and (ii) as appropriate.
Section 6 Non
Fruit Water Ice
Non fruit water ice is an ice having a characteristic
fruit-like flavor, but shall not contain any fruit or fruit juice.
Non-fruit water ice is prepared while stirring a mix composed
of:
(a) Characteristic
fruit-like flavors.
(b)
One or more nutritive sweeteners.
(c) Any other safe and suitable
ingredient approved by the Department. The finished non fruit water
ice weighs not less than six pounds per gallon.
In addition to all other required information of the
label shall:
(1) Contain a
complete list of ingredients, in accordance with the provisions of
21 CFR
101.4.
(2) Comply with the provisions of
21
CFR 101.22.
(3) Contain the following statement
"Imitation .... water ice". The blank to be filled in by the
characterizing flavor used. The letters in the word imitation shall
be the same size, type and color and on the same contrasting
background as the name of the characterizing flavor and the word
sherbet.
(4) The statement
required in paragraph (3) of this subsection shall be followed
immediately by the words "contains no fruit or fruit juice" in
letters at least half the size of those used in statement three
above.
(5) When a sign is
used at the point of purchase to advertise non fruit sherbet, it
shall contain the same information as required in paragraphs three
and four of this subsection.
(6) When non fruit water ice is
sold other than in properly labeled factory filled containers a sign
must be conspicuously displayed on the sale premises or vehicle where
it can be clearly read by customers under normal conditions of
purchase, stating the information required in paragraphs 3 and 4
above. The letters on such sign shall be bold face capitals at least
three inches in height and in contrasting color to the
background.
(7) The sign
required as per paragraph 6 above need not be used is each customer
is provided with a menu stating the information required by paragraph
3 and 4 above in bold face capitals as large as those used in listing
most food items.
Section 7 Mellorine
(a) Description.
(1) Mellorine is a food produced by
freezing, while stirring, a pasteurized mix consisting of safe
suitable ingredients including, but not limited to, milk-derived
nonfat solids and animal or vegetable fat, or both, only part of
which may be milkfat. Mellorine is sweetened with nutritive
carbohydrate sweetener and is characterized by the addition of
flavoring ingredients.
(2)
Mellorine contains not less than 1.6 pounds of total solids to the
gallon, and weighs not less than 4.5 pounds to the gallon. Mellorine
contains not less than 6 percent fat and 2.7 percent protein having a
protein efficiency ratio (PER) not less than that of whole milk
protein (108 percent of casine) by weight of the food, exclusive of
the weight of any bulky flavoring ingredients used. In no case shall
the fat content of the finished food be less than 4.8 percent or the
protein content be less than 2.2 percent. The protein to meet the
minimum protein requirements shall be provided by milk solids not
fat, and/or milk-derived ingredients.
(3) When calculating the minimum
amount of milkfat and protein required in the finished food, the
solids of chocolate or cocoa used shall be considered a bulky
flavoring ingredient. In order to make allowance for additional
sweetener ingredients needed when certain bulky ingredients are used,
the weight of chocolate or cocoa solids used may be multiplied by
2.5; the weight of fruit of partially or wholly dried fruits or fruit
juices may be multiplied by appropriate factors to obtain the
original weights before drying and this weight may be multiplied by
1.4.
(b)
Fortification. Vitamin A is present in a quantity which will ensure
that 40 international units (IU) are available for each gram of fat
in mellorine, within limits of good manufacturing practice.
(c) Methods of analysis. Fat and
protein content, and the PER shall be determined by the following
methods contained in the "Official Methods of Analysis of the
Association of Official Analytical Chemists," 12th ed., 1975
(A.O.A.C. Methods).
(1) Fat content
shall be determined by the method: "Fat, Roese-Gottlieb
Method-Official Final Action," (A.O.A.C., section 16.228).
(2) Protein content shall be
determined by the method: "Biological Evaluation of Protein
Quality-Official Final Action" sections 39.166 - 39-170.
(3) PER shall be determined by the
method: "Biological Evaluation of Protein Quality-Official Final
Action" sections 39-166 - 39.170.
(d) Nomenclature. The name of the
food is "mellorine." The name of the food on the label shall be
accompanied by a declaration indicating the presence of
characterizing flavoring in the same manner as is specified in
Section
1,
paragraph (e).
(e) Label
declaration. The common or usual name of each of the ingredients used
shall be declared on the label, in accordance with section
21 CFR
101.4 except that sources of
milkfat or milk solids not fat may be declared, in descending order
or predominance, either or the use of the terms "milkfat, and nonfat
milk" when one or any combination of two or more ingredients listed
in 21 CFFR 101.4. Mellorine shall be sold, held, offered for sale by
any manufacturer, wholesaler, retailer, or any other seller only in
factory-filled containers not larger than one-half gallon.
Section 8 Goats
Milk Ice Cream and Goats Milk Ice Milk
(a)
Goat's milk ice cream.
(1)
Description. Goats milk ice cream is a food prepared in
the same manner prescribed in Section
1
for ice cream, and complies with all the provisions o Section
1,
except that the only optional dairy ingredients that may be used are
those in paragraph (2) of this section; casinates may not be used;
and paragraphs (e) (1) and (f) of Section
1
shall not apply.
(2)
Optional dairy ingredients. The optional dairy ingredients referred
to in paragraph (1) of this section are goat's skim milk, goat's
milk, and goat's cream. These optional dairy ingredients may be used
in liquid, concentrated, and/or dry form.
(3) Nomenclature. The name of the
food is "goat's milk ice cream" or, alternatively, "ice cream made
with goat's milk", except that when the egg yolk solids content of
the food is in excess of that specified for ice cream in paragraph
(2) of Section
1,
the name of the food is "goat's milk frozen custard" or
alternatively, "frozen custard made with goat's milk", or "goat's
milk french ice cream" or, "goat's milk french custard ice cream", or
alternatively, "french custard ice cream made with goat's
milk".
(4) Label
declaration. Each of the optional ingredients used shall be declared
on the label as required by the applicable sections of Regulation 1
of these regulations.
(b) Goat's milk ice milk.
(1) Description. Goat's milk ice
milk is the food prepared in the same manner prescribed in section
(a) for goat's milk ice cream, except that paragraph (3) shall not
apply, and which complies with all the requirements of Section (a)
(1), (2), (4), (5), (6) and (7) for ice milk.
(2) Nomenclature. The name of the
food is "goat's milk ice milk" or, alternatively, "ice milk made with
goat's milk".
Section 9 Frozen Yogurt
Frozen yogurt is the food which is prepared by
freezing while stirring a pasteurized mix consisting of the
ingredients permitted for ice cream in Section
1.
Such ingredients are cultured after pasteurization by one or more
strains of Lactobacillus bulgaricus and Streptococcus thermophilus,
provided, however, fruit, nuts, or flavoring materials may be added
before and after the mix is pasteurized and cultured. The standard
plate count requirement for frozen desserts shall apply to the mix
prior to culturing. Frozen yogurt, exclusive of any flavoring
contains not less than 8.25 percent milk solids not fat and has a
titratable acidity of not less than 0.5 percent expressed as lactic
acid. This characteristic acidity is developed as a result of the
bacterial activity and no heat or bacteriostatic treatment, other
than refrigeration, which results in destruction or partial
destruction of the organisms, shall be applied to the product after
such culturing. The finished yogurt shall weigh not less than five
pounds per gallon. The name of the food is frozen yogurt. In addition
to all other required information, the label shall contain a complete
list of ingredients, in accordance with the provisions of
21 CFR
101.4, and comply with the
provisions of subdivision (h) and (i) of
21
CFR 101.22. On the label of frozen
yogurt the strains of bacteria may be collectively referred to as
yogurt culture.
Section
10 Frozen Lowfat or Lowfat Frozen Yogurt
Frozen lowfat yogurt or lowfat frozen yogurt is the
food which is prepared by freezing while stirring a pasteurized mix
consisting of the ingredients permitted for ice cream in Section
1.
Such ingredients are cultured after pasteurization by one or more
strains of Lactobacillus bulgaricus and Streptococcus thermophilus,
provided however, fruit, nuts, and other flavoring materials may be
added before or after the mix is pasteurized and cultured. The
standard plate count requirement for frozen desserts shall apply only
to the mix prior to culturing. The food, exclusive of any flavoring,
contains not less than 0.5 percent nor more than 2 percent milkfat
and not less than 8.25 percent milk solids not fat, and has a
titratable acidity of not less than 0.5 percent, expressed as lactic
acid. This characteristic acidity is developed as a result of the
bacterial activity and no heat or bacteriostatic treatment, other
than refrigeration, which results in destruction or partial
destruction of the organisms, shall be appplied to the product after
such culturing. The finished food shall weigh not less than five
pounds per gallon. The name of the food is frozen lowfat yogurt or
lowfat frozen yogurt.
The label on a package of this food, in addition to
all other required information shall:
(1) Contain a complete list of
ingredients, in accordance with the provisions of
21 CFR
101.4.
(2) Contain nutrition information
as required by
21 CFR
101.9.
(3) Comply with the provisions of
subdivision (h) & (i) of
21
CFR 101.22 On the label, the
strains of bacteria may be collectively referred to as yogurt
culture.
Section
11 Frozen Nonfat Yogurt or Nonfat Frozen Yogurt
Frozen nonfat yogurt or nonfat frozen yogurt is the
food which is prepared by freezing while stirring a pasteurized mix
consisting of the ingredients permitted for ice cream in Section
1.
Such ingredients are cultured after pasteurization by one or more
strains of Lactobacillus bulgaricus and Streptococcus thermophilus,
provided, however, fruit, nuts, or other flavoring materials may be
added before and after the mix is pasteurized and cultured. The
standard plate count requirement for frozen desserts shall apply only
to the mix prior to culturing. The food, exclusive of any flavoring,
contains less than 0.5 percent milkfat, not less than 8.25 percent
milk solids not fat and has a titratable acidity of not less than 0.5
percent expressed as lactic acid. This characteristic acidity is
developed as a result of the bacterial activity and no heat or
bacteriostatic treatment other than refrigeration, which results in
destruction or partial destruction of the organisms, shall be applied
to the product after such culturing. The finished food shall weigh
not less than five pounds per gallon. The name of the food is frozen
nonfat yogurt or nonfat frozen yogurt. The label on a package of this
food in addtiion to all other information shall:
(1) Contain a complete list of
ingredients, in accordance with the provisions of
21 CFR
101.4.
(2) Contain nutrition information
as required by
21 CFR
101.9.
(3) Comply with the provisions of
subdivision (h) & (i) of
21
CFR 101.22.
On the label, the strains of bacteria may be
collectively referred to as yogurt
culture.
Section
12 Quiescently Frozen Confection
Quiescently frozen confection means the frozen
product made from sweetening agent, harmless natural or artificial
flavoring, water, and it may contain milk solids, harmless coloring,
organic acids, and any safe and suitable functional ingredient
approved by the Department. The finished product shall contain not
less than seventeen per centum by weight of total food solids. The
name of the food is quiescently frozen confection. In the manufacture
of this product, freezing has not been accomplished by stirring or
agitation (generally known as quiescent freezing.) In the production
of this quiescently frozen confection, no processing or mixing prior
to quiescent freezing shall be used that develops in the finished
confection mix any physical expansion in excess of ten per centum.
This confection must be manufactured in the form of servings,
individually packaged, bagged or otherwise wrapped, properly labeled
and purveyed to the consumer in its original factory-filled package.
The individually wrapped confection need not be labeled if it
contained in a multiple package which is properly labeled if it is
contained in a multiple package which is properly labeled and is
purveyed unopened to the consumer. In addition to all other required
information, the label shall contain a complete list of ingredients,
in accordance with the provisions of
21 CFR
101.4, and comply with the
provisions of subdivision (h) & (i) of
21
CFR 101.22.
Section 13 Quiescently Frozen Dairy
Confection
Quiescently frozen dairy confection means the frozen
product made from milk products, sweetening agents, harmless natural
or artificial flavoring, water and it may contain harmless coloring,
and any safe and suitable functional ingredient approved by the
Department. The finished product contains not less than thirteen per
centum by weight of total milk solids, not less than thirty-three per
centum by weight of total food solids. The name of the food is
quiescently frozen dairy confection. In the manufacture of this
product, freezing has not been accompanied by stirring or agitation
(generally known as quiescently freezing.) In the production of this
quiescently frozen dairy confection, no processing or mixing prior to
quiescent freezing shall be used that develops in the finished
confection mix any physical expansion in excess of ten per centum.
This confection must be manufactured in the form of servings,
individually packaged, bagged or otherwise wrapped, properly labeled
and purveyed to the consumer in it's original factory-filled package.
The individually wrapped confection need not be labeled if it is
contained in a multiple package which is properly labeled and is
purveyed unopened to the consumer. In addition to all other required
information, the label shall contain a complete list of ingredients,
in accordance with the provisions of
21 CFR
101.4, and comply with the
provisions of subdivision (h) and (i) of
21
CFR 101.22.
Section 14 Frozen Dietary Dairy
Dessert
(1) Frozen dietary dessert
means a frozen dessert prepared for persons who wish to restrict
their intake of ordinary sweetening ingredients. It is produced by
freezing while stirring a pasteurized mix consisting of the
ingredients permitted for ice cream in Section
1.
The minimum fat content shall be three percent, it shall contain no
sugars other than those naturally present in milk solids or flavoring
agents which have been added thereto, and it may contain edible
carbohydrates other than sugars. The edible carbohydrates must be
approved by the Department.
(2) The name of the food is frozen
dietary dairy dessert.
(3)
The label on a package of frozen dietary dairy dessert in addition to
other required information shall:
(a) Contain a complete list of
ingredients, in accordance with the provisions of
21 CFR
101.4.
(b) Contain a statement as follows:
(Diabetics: This product may be useful in your diet
on the advice of physician. This food is not a reduced calorie
food).
(c)
Immediately preceding or following the name of the product a
statement as follows: "Contains .....% milkfat". The blank to be
filled in with the percentage of milkfat in the product.
(d) Comply with the provisions of
21 CFR
101.9 and subdivision (h) and (i)
of
21
CFR 101.22.
(4) The product shall not be sold
in any manner other than in sealed or unbroken packages or
containers.
Section
15 Dietary Frozen Dessert or Low Fat Frozen Dairy
Dessert
(a) Dietary frozen dessert
is the food prepared by freezing while stirring, a pasteurized mix
consisting of the ingredients permitted for ice cream in Section
1.
The finished product contains less than two percent by weight of
either extractable fat, its' content of total milk solids consisting
of ingredients listed in paragraph (b) of Section
1 is
not less than seven percent by weight. The product weighs no less
than 4.5 pounds per gallon and the quantity of food solids per gallon
is not less than 1.1 pounds nor more than 1.55 pounds, exclusive of
any microcrystalline cellulose used as an ingredient.
(b) One or more vitamins and/or
minerals listed in CFR Title 21, Section 101.9(c) (7) (iv) may be
added to the product. If vitamins and/or minerals are added, the name
of the food on the principal display panel and each alternate
principal display panel shall be immediately preceded or followed by
the word "fortified" in the same style and at least one-half the size
of the type used for the name "dietary frozen dessert" and on the
same contrasting background. If vitamins and/or minerals are added,
then each four fluid ounce serving of finished product shall provide
no less than eight percent nor more than 20 percent of the U.S.
Recommended Daily Allowance for such vitamins and/or
minerals.
(c) The name of
the food is dietary frozen dessert.
(d) The label on dietary frozen
dessert, in addition to all other required information shall:
(1) Contain a complete list of
ingredients, in accordance with the provisions of
21
CFR 101.22.
(2) Comply with the provisions of
21 CFR
101.9 and subdivision (h) and (i)
of
21
CFR 101.22.
(e) Dietary frozen dessert may be
sold in properly labeled factory-filled containers, except it may be
served directly from a dispensing freezer at the time of a direct
request from a customer. When dietary frozen dessert is sold directly
from a dispensing freezer at the time of a direct request from the
customer, the name of the food, nutrition information required by
21 CFR
101.9, and a complete listing of
ingredients in accordance with the provisions of
21 CFR
101.4 shall appear on the container
used.
Section 16
Lactose Reduced Ice Cream and Lactose Reduced Ice Milk
Lactose reduced ice cream is the product resulting
from the treatment of ice cream, as defined in section
1 of
these regulations, by the addition of safe and suitable enzymes to
convert sufficient amounts of lactose to glucose and/or galactose so
that the remaining lactose is less than thirty percent of the lactose
in ice cream.
The name of the food is "lactose reduced ice
cream."
Wherever the name appears on the container, the words
lactose reduced shall be in the same type style and size and in the
same color and contrasting background as the words ice
cream.
Section 17
Manufactured Desserts Mix
"Manufactured desserts mix", whipped cream
confection, bisque tortoni means a frozen dessert made with milk
product, sweetening agents, flavoring agents, with or without
harmless coloring or any other safe and suitable ingredients approved
by the Commissioner. The product must contain not less than eighteen
per centum by weight of milk fat, and not more than twelve per centum
of milk solids not fat, and may be packaged with harmless gas causing
it to fluff upon ejection from the package or container.
In addition to all other required information, the
label shall contain a complete list of ingredients in accordance with
the provisions of
21 CFR
101.4.
Section 18 Freezer Made Shake -
Freezer Made Milk Shake
(a) Freezer
made milk shake means a pure, clean, wholesome semi-viscous drink
prepared by stirring while freezing a pasteurized mix consisting of
the ingredients prescribed for ice milk in Section
2 of these
regulations except that:
(1) It
shall contain not less than three and one-fourth percent and not more
than six percent milk fat.
(2) Its' content of milk solids not
fat shall not be less than than ten percent.
(b) Other freezer made shakes
including jumbo shake, thick shake, T.V. shake, or any coined or
trade name containing the word "shake" shall meet the requirements of
paragraph (a), except that the minimum percent of milk fat may be
less than three and one-fourth percent.
(c) "Shakes" not meeting the
requirement for "milk shakes" shall not be advertised, sold or served
as milk shakes.
(d) When
any freezer made milk shake or other freezer made shake purports to
be or is represented for any special dietary use by man, it shall be
sold only in a container with an ingredient listing in accordance
with the provisions of
21 CFR
101.4, and nutrition information as
required by
21 CFR
101.9.
Section 19 Parevine
(a) Parevine is the food which is
prepared by freezing while stirring a pasteurized mix composed of
(1) one or more edible vegetable
oils or fats;
(2) protein
and carbohydrate food ingredients from other than milk or meat
sources;
(3) nutritive
sweeteners other than lactose;
(4) characterizing ingredients
except any containing meat or milk; and
(5) any other safe and suitable
ingredient which is not milk or meat or a product or derivative of
milk or meat.
This product shall not contain any milk, milk
product, meat or meat products of any of their derivatives of any
kind.
(b) Its' fat content shall not be
less than 10 percent except that when bulky optional characterizing
ingredients are used, the fat content may be reduced, as a result of
the addition of such ingredients, but shall in no case be less than
eight percent.
(c) Its'
content of food solids shall not be less than 1.3 pounds per gallon
of the finished product.,
(d) The name of the food is
"parevine".
(e) Parevine
shall be sold, held, offered for sale by any manufacturer,
wholesaler, retailer, or any other seller only in properly labeled
factory-filled containers, except parevine may be served other than
in a properly labeled factory filled container if a sign is
conspicuously displayed where it can easily be read under normal
conditions of purchase stating "PAREVINE SOLD HERE". Letters on such
sign shall be bold face capitals at least three inches in height and
in contrasting color to the background. No such sign need be
displayed if each customer is provided with a menu on which there is
stated "PAREVINE SERVED HERE" in bold face capitals as large as those
used in listing most food items.
(f) The label on packages of
parevine shall, in addition to all other required information include
a complete list of all ingredients, in accordance with the provisions
of
21 CFR
101.4.
Section 20 Lo-Mel
(a) "Lo-mel" means a pure, clean,
wholesome semi-viscious drink prepared by stirring while freezing in
a dispensing freezer a pasteurized mix composed of edible fats or
oils other than milk fat, milk solids not fat, and water. It may
contain optional sweetening ingredients and any other safe and
suitable ingredients approved by the department.
(b) Lo-mel may only be served or
sold directly from a dispensing freezer and may not be sold hard
frozen.
(c) When Lo-mel is
sold a sign must be prominently and conspicuously displayed not more
than 18 inches above each dispensing freezer, where it can be clearly
read by customers under normal condition of purchase, stating "LO-MEL
SERVED HERE", in bold face capitals at least three inches in height
and in contrasting color to the background. Such sign shall include a
list of all ingredients in a manner acceptable to the department,
provided, however, that the name of the edible fats or oils used must
be specified. The letters on such sign to be of sufficient size to be
read by consumers under normal conditions of purchase. No such list
of ingredients need be included on the sign if the list of
ingredients is printed on the side of the container in which the
product is served to the customer.
(d) When any lo-mel purports to be
or is represented for any special dietary use by man, it shall be
sold only in a container with an ingredient listing in accordance
with the provisions of
21 CFR
101.4 and nutrition information as
required by 101.9.
Regulation
9 Pasteurization
(a)
Pasteurization. All frozen desserts mix with the exception of water
ice mix and flavoring agents used in frozen desserts shall be
pasteurized.
(b)
Pasteurization temperatures. Pasteurization of frozen desserts mix
provided in subdivision (a) of this section shall be done in a plant
and with equipment conforming to the provisions of this part, by
heating every particle:
(1) to a
temperature of at least 155 [degrees] F and held at such temperature
of at least 30 minutes, or
(2) to a temperature of at least
160 [degrees] F and held at such temperature for at least 15 minutes,
or
(3) to a temperature of
at least 165 [degrees] F and held at such temperature for at least 10
minutes, or by short term pasteurization with controls approve by the
commissioner.
(4) to a
temperature of at least 175 [degrees] F and held at such temperature
for at least 25 seconds, or
(5) to a temperature of at least
180 [degrees] F and held at such temperature for at least 15 seconds,
or
(6) to a temperature of
at least 200 [degrees] F and held at such temperature for at least
three seconds, or
(7) to a
temperature of at least 210 [degrees] F with no holding time, or to
such equivalent temperature and period of holding as the commissioner
shall approve in writing.
(8) In the case of ice milk mix, to
a temperature of at least 166 [degrees] F for at least 15 seconds,
or
(9) to a temperature of
at least 161 [degrees] F for at least 25 seconds.
(10) to a temperature and time to
aseptically process. Aseptically processed frozen dessert mixes are
hermetically sealed in a container and so thermally processed and in
conformance with the requirements for low acid canned foods and the
provisions of these regulations so as to render the product
commercially sterile, free of micro-organisms capable of reproducing
in the product under normal non-refrigeration conditions of storage
and distribution. The product shall be free of viable micro-organisms
(including spores) of public health significance. A hermetically
sealed container is designed and intended to be secure against the
entry of micro-organisms and thereby maintain the commercial
sterility of the contents after processing.
(c) High temperature short time
pasteurizers shall have the thermal limit controller set and sealed
so that forward flow controller set and sealed so that forward flow
of product cannot start unless the temperature at the controller
sensor is above the appropriate required temperature. The seal shall
be applied after test, by the representative of the commissioner, and
shall not be removed without immediately notifying the commissioner.
The system shall be so designed that no product can be by-passed
around the controller sensor which shall not be removed from its
proper position during the pasteurization process.
(d) Cooling. After pasteurization
all mix shall be cooled immediately to a temperature of not more than
40 [degrees] F until subject to freezing. Any milk, cream, and other
fluid milk products other than aseptically processed, sterilized,
evaporated or sweetened condensed milk in hermetically sealed
containers shall also be stored at temperatures of not more than 40
[degrees] F. This requirement shall be deemed:
(1) to require the use of
refrigerated vehicles or approved insulated containers in
transporting frozen desserts mix from the manufacturing or other
plant to retail manufactures, and
(2) to apply to conveying mix from
coolers or refrigeration units in manufacturing plants to freezers by
means of pipes, tubing, or other means.
Regulation
14 Frozen Dessert Products at Retail Manufacturing
Outlets
(a) All premises where
frozen desserts are frozen and dispensed shall be maintained in a
clean and sanitary condition, and all openings properly screened and
protected against files and dust.
(b) Suitable toilets shall be
provided for the use of employees, and all toilets shall be
maintained in a clean and sanitary condition, and be screened against
flies. No toilet shall open directly into a room used in the freezing
or dispensing of frozen dessert products.
(c) Suitable wash basins and single
service towels shall be provided on the premises for use of
employees.
(d) Frozen
dessert products, fruits, flavors, colors, cones, etc., shall be
protected from flies, dust and dirt.
(e) An adequate supply of hot and
cold running water shall be provided for washing purposes, and all
utensils which are not in constant use, shall be thoroughly washed
after each use by cleaning with hot water and a suitable cleaner and
then given a bacterial treatment before re-using.
(f) Utensils, single service cups,
dishes, spoons and drinking straws, etc., shall be protected from
flies, dust and dirt.
(g)
Frozen dessert product cabinets shall be clean and present a neat
appearance. The holes and wells containing bulk or package frozen
dessert products shall be clean and free from objectionable odor, and
where bulk frozen dessert products are dispensed, the holes shall be
kept covered, except when products are being dispensed therefrom or
placed therein.
(h)
Utensils and devices such as scoops or spoons used in dispensing
frozen products shall be kept clean and in running water or in water
maintained at not less than 170 [degrees] F.
(i) Frozen dessert product
containers shall be used for no other purpose than to store frozen
dessert products.
(j)
Every person while engaged in dispensing or manufacturing frozen
dessert products shall wear clean clothing, and shall avoid contact
with any substance that may contaminate frozen dessert
products.
(k) No person
who has any communicable disease shall be employed in any capacity
where frozen dessert products are dispensed.
(l) Places where suitable
facilities for washing utensils are not available shall sell frozen
dessert products only in the original container packaged in an
approved frozen desserts plant.
