[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR135.130]
[Page 370]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 135 FROZEN DESSERTS--Table of Contents
Subpart B Requirements for Specific Standardized Frozen Desserts
Sec. 135.130 Mellorine.
(a) Description. (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 percent fat and 2.7 percent protein having a
protein efficiency ratio (PER) not less than that of whole milk protein
(108 percent 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 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
other 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 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.
(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 following the methods contained in ``Official Methods
of Analysis of the Association of Official Analytical Chemists,'' 13th
Ed. (1980), which is incorporated by reference. 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.
(1) Fat content shall be determined by the method: ``Fat, Roese-
Gottlieb Method--Official Final Action,'' section 16.287.
(2) 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.
(3) PER shall be determined by the method: ``Biological Evaluation
of Protein Quality--Official Final Action,'' sections 43.212-43.216.
(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 Sec. 135.110(c).
(e) Label declaration. Each of the ingredients used shall be
declared on the label as required by the applicable sections of parts
101 and 130 of this chapter, except that sources of milkfat or milk
solids not fat may be declared in descending order of predominance
either by the use of the terms ``milkfat and nonfat milk'' when one or
any combination of two or more of the ingredients listed in Sec.
101.4(b)(3), (b)(4), (b)(8), and (b)(9) of this chapter are used, or
alternatively as permitted in Sec. 101.4 of this chapter.
[42 FR 19137, Apr. 12, 1977, as amended at 47 FR 11826, Mar. 19, 1982;
49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, Jan.
6, 1993; 63 FR 14035, Mar. 24, 1998]
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