Section 39.22. 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 6.0% fat and 2.7% protein having a protein efficiency ratio (PER) not less than that of whole milk protein—108% 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% or the protein content be less than 2.2%. The protein to meet the minimum protein requirements shall be provided by milk solids, not fat, 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 bulk 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 protein efficiency ratio 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).

(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) The protein efficiency ratio 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 § 39.12(e) (relating to ice cream and frozen custard).

(e) Label declaration. The common or usual name of each of the ingredients used shall be declared on the label, in accordance with 21 CFR 101.4 (relating to food; designation of ingredients) 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 ingredients listed in 21 CFR 101.4(b)(3), (4), (8) and (9) are used, or alternatively as permitted in 21 CFR 101.4.

(f) Sales. Mellorine shall be sold, held, offered for sale by any manufacturer, wholesaler, retailer, or any other seller only in properly labeled factory filled containers except in the following instances:

(1) Mellorine may be sold from a dispensing freezer. When mellorine is sold in such manner from a dispensing freezer a sign or menu board shall be displayed where it can be easily read by customers under normal conditions of sale, stating ‘‘Mellorine Served Here.’’ When items containing mellorine are listed on a sign or menu board, the statement ‘‘Mellorine Served Here’’ shall be included on the menu board in reasonable proximity to the items containing mellorine. The letters in the statement shall be bold face capitals at least as large as the letters used in listing items containing mellorine and on a contrasting background.

(2) No sign or menu board declaration shall be required if the only method of advising customers on what items are being offered for sale is a menu furnished to the customer. In such a case the menu shall contain the statement ‘‘Mellorine Served Here.’’ The statement shall be in reasonable proximity to the menu items containing mellorine, and the letters on the statement shall be bold face capitals at least as large as the letters used in listing items containing mellorine. Any menu listing mellorine or items prepared with mellorine shall conform to this paragraph.

(3) Mellorine may be dipped from a properly labeled bulk container. If mellorine is served in this manner, a sign or menu board shall be displayed where it can be easily read by customers under normal conditions of sale stating ‘‘Mellorine Served Here.’’ When items containing mellorine are listed on a sign or menu board the statement ‘‘Mellorine Served Here’’ shall be included in reasonable proximity to the items containing mellorine. The letters in the statement shall be bold face capitals at least as large as the letters used in listing items containing mellorine.

(4) No sign or menu board declaration shall be required if the only method of advising customers on what items are being offered for sale is a menu furnished to the customer. In such a case, the menu shall contain the statement ‘‘Mellorine Served Here.’’ The statement shall be in reasonable proximity to the menu items containing mellorine, and the letters on the statement shall be bold face capitals at least as large as the letters used in listing items containing mellorine. Any menu listing mellorine or items prepared with mellorine shall conform to this paragraph.

The provisions of this § 39.22 adopted March 25, 1970; amended June 29, 1984, effective June 30, 1984, 14 Pa.B. 2242. Immediately preceding text appears at serial page (1513).