§ 58.812 Methods of official sample analysis.

Samples shall be tested according to the applicable methods of laboratory analysis contained in DA Instruction 918-109-2 and 918-109-3 as issued by the USDA, Agricultural Marketing Service, Poultry and Dairy Quality Division.

(60 Stat. 1087, 7 U.S.C. 1621 et seq.; 84 Stat. 1620, 21 U.S.C. 1031 et seq.)

[40 FR 47911, Oct. 10, 1975. Redesignated at 42 FR 32514, June 27, 1977, and amended at 43 FR 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, Dec. 31, 1981]

REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL IDENTIFICATION

§ 58.813 Dry whey.

The quality requirements for dry whey shall be in accordance with the U.S. Standards for Dry Whey.

SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING, PROCESSING, AND PACKAGING EVAPORATED AND CONDENSED MILK OR ULTRA-PASTEURIZED PRODUCTS

DEFINITIONS

§ 58.905 Meaning of words.

For the purpose of the regulations in this subpart, words in the singular form shall be deemed to impart the plural and vice versa as the case may demand. Unless the context otherwise

requires, the following terms shall have the following meaning:

(a) Evaporated milk. The liquid food made by evaporating sweet milk to such point that it contains not less than 7.5 percent of milkfat and not less than 25.5 percent of the total milk solids. The finished product shall conform to the requirements of §18.520 "Definitions and Standards of Identity for Milk and Cream," Food and Drug Administration (21 CFR 18.520).1

(b) Concentrated milk, plain condensed milk. The product which conforms to the standard of identity for evaporated milk except that it is not processed by heat to prevent spoilage. The container may be unsealed, and stabilizing ingredients are not used. The finished product shall conform to the requirements of § 18.525 "Definitions and Standards of Identity for Milk and Cream," Food and Drug Administration (21 CFR 18.525).1

(c) Sweetened condensed milk. The liquid or semi-liquid food made by evaporating a mixture of sweet milk and refined sugar (sucrose) or any combination of refined sugar (sucrose) and refined corn sugar (dextrose) to such point that the finished sweetened condensed milk contains not less than 28.0 percent of total milk solids and not less than 8.5 percent of milkfat. The quantity of sugar used is sufficient to prevent spoilage. The finished product shall conform to the requirements of §§ 18.530 or 18.535, respectively, "Definitions and Standards of Identity for Milk and Cream," Food and Drug Administration (21 CFR 18.530 and 18.535).1

(d) Ultra-pasteurized. The product shall have been thermally processed at or above 280 °F for at least 2 seconds, either before or after packaging, so as to produce a product which has an extended shelf life under refrigerated conditions.

EQUIPMENT AND UTENSILS

§ 58.912 General construction, repair and installation.

The equipment and utensils used for processing and packaging evaporated, condensed or ultra pasteurized dairy

121 CFR Part 18 was redesignated as Part 131 at 42 FR 14302, Mar. 15, 1977.

Both gravity and vacuum type fillers shall be of sanitary design and all product contact surfaces, if metal, shall be made of stainless steel or equally corrosion-resistant material; except that, certain evaporated milk fillers having brass parts may be approved if free from corroded surfaces and kept in good repair. Nonmetallic product contact surfaces shall comply with the requirements for 3-A Sanitary Standards for Plastic, and Rubber and RubberLike Materials. Fillers shall be designed so that they in no way will contaminate or detract from the quality of the product being packaged.

§ 58.915 Batch or continuous in-container thermal processing equip

ment.

Shall comply with title 21, chapter 1, subpart 128b-"Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers." The equipment shall be maintained in such a manner as to assure control of the length of time of processing, and to minimize the number of damaged containers.

§ 58.916 Homogenizer.

Homogenizers where applicable shall be used to reduce the size of the fat particles and to evenly disperse them in the product. Homogenizers shall comply with the applicable 3-A Sanitary Standards.

OPERATIONS AND OPERATING PROCEDURES

§ 58.917 General.

There are many operations and procedures used in the preparation of evaporated, condensed and ultra pasteurized dairy products that are similar, therefore, the following general requirements will apply when such operations or procedures are used.

§ 58.918 Standardization.

The standardization of the product to obtain a finished product of a given composition shall be accomplished by the addition or removal of milkfat, milk solids-not-fat and/or water. The ingredients added to accomplish the desired composition shall be of the same hygenic quality as the product being standardized.

§ 58.919 Pre-heat, pasteurization.

When pasteurization is intended or required by either the vat method, HTST method, or by the HHST method it shall be accomplished by systems and equipment meeting the requirements outlined in § 58.128. Pre-heat temperatures prior to ultra pasteurization will be those that have the most favorable effect on the finished product.

§ 58.920 Homogenization.

Where applicable concentrated products shall be homogenized for the purpose of dispersing the fat throughout the product. The temperature of the product at time of homogenization and the pressure at which homogenization is accomplished will be that which accomplishes the most desired results in the finished products.

§ 58.921 Concentration.

Concentrating by evaporation shall be accomplished with a minimum of chemical change in the product. The equipment and systems used shall in no way contaminate or adversely affect the desirability of the finished product.

§ 58.922 Thermal processing.

The destruction of living organisms shall be performed in one of the following methods: (a) The complete in-container method, by heating the container and contents to a range of 212 °F to 280 °F for a sufficient time; (b) by a continuous flow process at or above 280 °F for at least 2 seconds, then packaged aseptically; (c) the product is first processed according to methods as in paragraph (b) of this section, then packaged and given further heat treatment to complete the process.

§ 58.923 Filling containers.

(a) The filling of small containers with product shall be done in a sanitary manner. The containers shall not contaminate or detract from the quality of the product in any way. After filling, the container shall be hermetically sealed.

(b) Bulk containers for the product shall be suitable and adequate to protect the product in storage or transit. The bulk container (including bulk tankers) shall be cleaned and sanitized before filling, and filled and closed in a sanitary manner.

§ 58.924 Aseptic filling.

A previously ultra pasteurized product shall be filled under conditions which prevent contamination of the product by living organisms or spores. The containers prior to being filled shall be sterilized and maintained, in a sterile condition. The containers shall be sealed in a manner that prevents contamination of the product.

§ 58.925 Sweetened condensed.

After condensing, the sweetened condensed product should be cooled rapidly to about 85 °F to induce crystallization of the oversaturated lactose. When the desired crystallization is reached further cooling is resumed to 68°-70 °F.

§ 58.926 Heat stability.

Prior to thermal processing of concentrated products and where stabilizers are allowed, tests should be made on the heat stability of the product to determine necessity for, and the amount of stabilizer needed. Based on

the stability tests, safe and suitable stabilizers and emulsifiers may be added.

§ 58.927 Storage.

Finished products which are to be held more than 30 days should be stored at temperatures below 72 °F Precautions shall be taken to prevent freezing of the product.

§ 58.928 Quality control tests.

All dairy products and other ingredients shall be subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be made on flow samples as often as is necessary to check the effectiveness of processing and manufacturing and as an aid in correcting deficiencies. Routine analyses shall be made on raw materials and finished products to assure adequate composition control. For each batch or production run a keeping quality test shall be made to determine product stability.

§ 58.929 Frequency of sampling for quality control.

(a) Composition. Sampling and testing for composition shall be made on batches of product as often as is necessary to control composition. On continuous production runs, enough samples shall be taken throughout the run to adequately assure composition requirements.

(b) Other chemical analysis or physical analysis. Such tests shall be performed as often as is necessary to assure compliance with standards, specifications or contract requirements.

(c) Weight or volume control. Representative samples of the packaged products shall be checked during the filling operation to assure compliance with the stated net weight or volume on the container.

(d) Keeping quality and stability. A minimum of one sample from each batch of product or one representative sample per hour from a continuous production run shall be taken. For continuous runs, samples shall be taken at the start, each hour, and at the end of the run. Samples should also be taken

§ 58.935 Chocolate and cocoa.

Such products used as flavor ingredients shall meet the requirements of the Food and Drug Administration, "Definitions and Standards of Identity for Cocoa Products.”

REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL IDENTIFICATION

§ 58.936 Milk.

To process and package evaporated and condensed milk of ultra-pasteurized dairy products eligible for official identification with the USDA Quality Approved Inspection Shield the raw incoming milk shall meet the requirements as outlined in §§ 58.132 through 58.136. Unless processed within two hours after being received, it shall be cooled to, and held at a temperature of 45 °F or lower until processed.

§ 58.937 Physical requirements for evaporated milk.

(a) Flavor. The product shall possess a sweet, pleasing and desirable flavor with not more than a definite cooked flavor. It shall be free from scorched, oxidized or other objectionable tastes and odors.

(b) Body and texture. The product shall be of uniform consistency and appearance. It shall be smooth and free from fat separation, lumps, clots, gel formation, coarse milk solids precipitate or sedimentation and extraneous material.

(c) Color. The color shall be of a natural white or light cream.

(d) Degree of burn-on. The interior walls of the container shall not show excessive burn-on of product (product fused to more than 75 percent of the inner surface of the can).

(e) Keeping quality. Samples incubated at 90-100 °F shall show no sensory, chemical or microbiological deterioration after seven days.

§ 58.938 Physical requirements and microbiological limits for sweetened condensed milk.

(a) Flavor. Shall be sweet, clean, and free from rancid, oxidized, scorched, fermented, stale or other objectionable tastes and odors.

(b) Color. Shall be white to light cream.

(c) Texture. Shall be smooth and uniform, free from lumps or coarse graininess. There shall not be sufficient settling of the lactose to cause a deposit on the bottom of the container.

(d) Body. Shall be sufficiently viscous so that the product upon being poured at room temperature piles up above the surface of that previously poured, but does not retain a definite form.

(e) Microbiological limits. (1) Coliforms, less than 10 per gram; (2) yeasts, less than 5 per gram; (3) molds, less than 5 per gram; (4) total plate count, less than 1,000 per gram.

(f) Keeping quality. Samples incubated at 90-100 °F shall show no physical evidence of deterioration after seven days.

(g) Composition. Shall meet the minimum requirements as set forth in the "Standards of Identity for Milk and Cream," Food and Drug Administration (21 CFR 18.530).1 In addition, the quantity of refined sugar used shall be sufficient to give a sugar-in-water ratio of not less than 61.5 percent.

(h) Sediment. The amount of sediment retained on a lintine disc after a sample composed of 225 grams of product dissolved in 500 ml. of 140 °F water has passed through it, shall not exceed 0.10 mg. as indicated by the USDA Sediment Standard for Milk and Milk Products (7 CFR 58.2726).

Subparts C-V [Reserved]

Subpart W-United States Department of Agriculture Standard for Ice Cream

SOURCE: 42 FR 56717, Oct. 28, 1977, unless otherwise noted. Redesignated at 46 FR 63203, Dec. 31, 1981.

§ 58.2825 United States Standard for ice cream.

(a) Ice cream shall contain at least 1.6 pounds of total solids to the gallon, weigh not less than 4.5 pounds to the gallon, and contain not less than 20 percent total milk solids, constitued of not less than 10 percent milkfat. In no

121 CFR parts 18 and 19 were redesignated as parts 131 and 133, respectively, at 42 FR 14302, Mar. 15, 1977.

case shall the content of milk solids not fat be less than 6 percent. Whey shall not, by weight, be more than 25 percent of the milk solids not fat.

(b) When one or more of the bulky optional ingredients, as approved by the Food and Drug Administration, are used, the weights of milk fat and total milk solids (excusive of such fat and solids in any malted milk used) are not less than 10 percent and 20 percent, respectively, of the remainder obtained by subtracting the weight of such optional ingredients, from the weight of the finished ice cream; but in no case is the weight of milk fat or total milk solids less than 8 percent and 16 percent, respectively, of the weight of the finished ice cream. In calculating the reduction of milk fat and total milk solids from the use of bulky optional ingredients, chocolate and cocoa solids used shall be considered the bulky ingredients. In order to make allowance for additional sweetening ingredients needed when bulky ingredients are used, the weight of chocolate or cocoa solids 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 multiplied by 1.4 The finished ice cream contains not less than 1.6 pounds to the gallon; except that when the optional ingredient microcrystalline cellulose is used, the finished ice cream contains not less than 1.6 pounds of total solids to the gallon and weighs not less than 4.5 pounds to the gallon exclusive, in both cases, of the weight of the microcrystalline cellulose.

(c) Optional characterizing ingredients, optional sweetening ingredients, stabilizers, and emulsifiers as approved by the Food and Drug Administration may be used.

§ 58.2826 General identification.

Consumer packaged product shall comply with the applicable labeling regulations of the Food and Drug Administration.

§ 58.2827 Official identification.

(a) The official symbol to be used to identify product meeting the USDA