(1) Mellorine is a
food produced by freezing, while stirring, a pasteurized mix consisting of safe
and 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 per cent fat and 2.7 per cent
protein having a protein efficiency ratio (PER) not less than that of whole
milk protein (108 per cent of casein) 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 per cent or the protein content
be less than 2.2 per cent. The protein to meet the minimum protein requirements
shall be provided by milk solids not fat, and/or other milk-derived
(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 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 be multiplied by 1.4; and the weight 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.
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.
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," 13th Ed., (1980)
(1) Fat content shall be
determined by the method: "Fat, Roese-Gottlieb Method-Official Final Action,"
(A.O.A.C., section 16.287).
Protein content shall be determined by one of the following methods:
"Nitrogen-Official Final Action," Kjeldahl Method, section 16.285, or Dye
Binding Method, section 16.286.
PER shall be determined by the method: Biological Evaluation of Protein
Quality-Official Final Action," sections 43.212-43.216.
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
common or usual name of each of the ingredients used shall be declared on the
label in accordance with section
except that sources of milkfat or milk
solids not fat may be declared, in descending order or predominance, either by
the use of the terms "milkfat, and nonfat milk" when one or any combination of
two or more ingredients listed in
21 CFR 101.4(b)
(3), (4), (8) and (9)
are used, or
alternatively as permitted in
. 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.