7 CFR Ch. I (1–1–20 Edition)

§ 58.913 7 CFR Ch. I (1–1–20 Edition)

§ 58.913 Evaporators and vacuum evaporated, condensed and ultra pas- pans. teurized dairy products that are simi- All equipment used in the removal of lar, therefore, the following general re- moisture from milk or milk products quirements will apply when such oper- for the purpose of concentrating the ations or procedures are used. solids should comply with the require- § 58.918 Standardization. ments of the 3–A Sanitary Standards for Milk and Milk Products Evapo- The standardization of the product to rators and Vacuum Pans. obtain a finished product of a given composition shall be accomplished by § 58.914 Fillers. the addition or removal of milkfat, milk solids-not-fat and/or water. The Both gravity and vacuum type fillers ingredients added to accomplish the shall be of sanitary design and all prod- desired composition shall be of the uct contact surfaces, if metal, shall be same hygenic quality as the product made of stainless steel or equally cor- being standardized. rosion-resistant material; except that, certain evaporated milk fillers having § 58.919 Pre-heat, pasteurization. brass parts may be approved if free When pasteurization is intended or from corroded surfaces and kept in required by either the vat method, good repair. Nonmetallic product con- HTST method, or by the HHST method tact surfaces shall comply with the re- it shall be accomplished by systems quirements for 3–A Sanitary Standards and equipment meeting the require- for Plastic, and Rubber and Rubber- ments outlined in § 58.128. Pre-heat Like Materials. Fillers shall be de- temperatures prior to ultra pasteuriza- signed so that they in no way will con- tion will be those that have the most taminate or detract from the quality of favorable effect on the finished prod- the product being packaged. uct.

§ 58.915 Batch or continuous in-con- § 58.920 Homogenization. tainer thermal processing equipment. Where applicable concentrated products shall be homogenized for the pur- Batch or continuous in-container pose of dispersing the fat throughout thermal processing equipment shall the product. The temperature of the meet the requirements of the Food and product at time of homogenization and Drug Administration for thermally the pressure at which homogenization processed low-acid foods packaged in is accomplished will be that which ac- hermetically sealed containers (21 CFR complishes the most desired results in part 113). The equipment shall be main- the finished products. tained in such a manner as to assure control of the length of processing and § 58.921 Concentration. to minimize the number of damaged Concentrating by evaporation shall containers. be accomplished with a minimum of [67 FR 48977, July 29, 2002] chemical change in the product. The equipment and systems used shall in no § 58.916 Homogenizer. way contaminate or adversely affect Homogenizers where applicable shall the desirability of the finished product. be used to reduce the size of the fat particles and to evenly disperse them § 58.922 Thermal processing. in the product. Homogenizers shall The destruction of living organisms comply with the applicable 3–A Sani- shall be performed in one of the fol- tary Standards. lowing methods: (a) The complete in-container meth- OPERATIONS AND OPERATING od, by heating the container and con- PROCEDURES tents to a range of 212 °F to 280 °F for a sufficient time; § 58.917 General. (b) By a continuous flow process at or There are many operations and pro- above 280 °F for at least 2 seconds, then cedures used in the preparation of packaged aseptically;

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(c) The product is first processed ac- § 58.928 Quality control tests. cording to methods as in paragraph (b) All dairy products and other ingredi- of this section, then packaged and ents shall be subject to inspection for given further heat treatment to com- quality and condition throughout each plete the process. processing operation. Quality control § 58.923 Filling containers. tests shall be made on flow samples as often as is necessary to check the ef- (a) The filling of small containers fectiveness of processing and manufac- with product shall be done in a sani- turing and as an aid in correcting defi- tary manner. The containers shall not ciencies. Routine analyses shall be contaminate or detract from the qual- made on raw materials and finished ity of the product in any way. After products to assure adequate composi- filling, the container shall be hermeti- tion control. For each batch or produc- cally sealed. tion run a keeping quality test shall be (b) Bulk containers for the product made to determine product stability. shall be suitable and adequate to pro- tect the product in storage or transit. § 58.929 Frequency of sampling for The bulk container (including bulk quality control. tankers) shall be cleaned and sanitized (a) Composition. Sampling and testing before filling, and filled and closed in a for composition shall be made on sanitary manner. batches of product as often as is necessary to control composition. On con- § 58.924 Aseptic filling. tinuous production runs, enough sam- A previously ultra pasteurized prod- ples shall be taken throughout the run uct shall be filled under conditions to adequately assure composition re- which prevent contamination of the quirements. product by living organisms or spores. (b) Other chemical analysis or physical The containers prior to being filled analysis. Such tests shall be performed shall be sterilized and maintained, in a as often as is necessary to assure com- sterile condition. The containers shall pliance with standards, specifications be sealed in a manner that prevents or contract requirements. contamination of the product. (c) Weight or volume control. Rep- resentative samples of the packaged § 58.925 Sweetened condensed. products shall be checked during the After condensing, the sweetened con- filling operation to assure compliance densed product should be cooled rap- with the stated net weight or volume idly to about 85 °F to induce crys- on the container. tallization of the oversaturated lac- (d) Keeping quality and stability. A tose. When the desired crystallization minimum of one sample from each is reached further cooling is resumed batch of product or one representative to 68°–70 °F. sample per hour from a continuous production run shall be taken. For contin- § 58.926 Heat stability. uous runs, samples shall be taken at Prior to thermal processing of con- the start, each hour, and at the end of centrated products and where stabi- the run. Samples should also be taken lizers are allowed, tests should be made after resumption of processing fol- on the heat stability of the product to lowing an interruption in continuous determine necessity for, and the operation. Each sample shall be incu- amount of stabilizer needed. Based on bated at 90 °F to 100 °F for seven days. the stability tests, safe and suitable stabilizers and emulsifiers may be § 58.930 Official test methods. added. (a) Chemical. Chemical analysis, except where otherwise prescribed herein, § 58.927 Storage. shall be made in accordance with the Finished products which are to be methods described in the latest edition held more than 30 days should be of Official Methods of Analysis of the stored at temperatures below 72 °F Pre- AOAC or by the latest edition of Stand- cautions shall be taken to prevent ard Methods for the Examination of freezing of the product. Dairy Products.

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(b) Microbiological. Microbiological Approved Inspection Shield the raw in- determinations shall be made in ac- coming milk shall meet the require- cordance with the methods described in ments as outlined in §§ 58.132 through the latest edition of Standard Methods 58.136. Unless processed within two for the Examination of Dairy Products. hours after being received, it shall be cooled to, and held at a temperature of § 58.931 General identification. 45 °F or lower until processed. Bulk shipping containers shall be leg- ibly marked with the name of the prod- § 58.937 Physical requirements for uct, net weight, name and address of evaporated milk. manufacturer, processor or distributor, (a) Flavor. The product shall possess a lot number and coded date of manu- a sweet, pleasing and desirable flavor facture. Consumer sized containers with not more than a definite cooked shall meet the applicable regulations flavor. It shall be free from scorched, of the Food and Drug Administration. oxidized or other objectionable tastes and odors. QUALITY SPECIFICATIONS FOR RAW (b) Body and texture. The product MATERIALS shall be of uniform consistency and ap- pearance. It shall be smooth and free § 58.932 Milk. from fat separation, lumps, clots, gel The raw milk shall meet the require- formation, coarse milk solids precipi- ments as outlined in §§ 58.132 through tate or sedimentation and extraneous 58.138. Unless processed within two material. hours after being received, it shall be (c) Color. The color shall be of a nat- cooled to, and held at a temperature of ural white or light cream. 45 °F or lower until processed. (d) Degree of burn-on. The interior walls of the container shall not show § 58.933 Stabilizers. excessive burn-on of product (product Shall be those permitted by the Food fused to more than 75 percent of the and Drug Administration’s ‘‘Standards inner surface of the can). of Identity’’ as optional ingredients for (e) Keeping quality. Samples incu- specific products. Stabilizers shall be bated at 90–100 °F shall show no sen- free from extraneous material, be of sory, chemical or microbiological dete- food grade quality and not be in viola- rioration after seven days. tion of the Federal Food, Drug and Cos- metic Act. § 58.938 Physical requirements and microbiological limits for sweet- § 58.934 Sugars. ened condensed milk. Any sugar used in the manufacture of (a) Flavor. Shall be sweet, clean, and sweetened condensed or sterilized milk free from rancid, oxidized, scorched, products shall be refined, and of food fermented, stale or other objectionable grade quality. tastes and odors. (b) Color. Shall be white to light § 58.935 Chocolate and cocoa. cream. Such products used as flavor ingredi- (c) Texture. Shall be smooth and uni- ents shall meet the requirements of the form, free from lumps or coarse graini- Food and Drug Administration, ‘‘Defi- ness. There shall not be sufficient set- nitions and Standards of Identity for tling of the lactose to cause a deposit Cocoa Products.’’ on the bottom of the container. (d) Body. Shall be sufficiently viscous REQUIREMENTS FOR FINISHED PRODUCTS so that the product upon being poured BEARING USDA OFFICIAL IDENTIFICA- at room temperature piles up above the TION surface of that previously poured, but does not retain a definite form. § 58.936 Milk. (e) Microbiological limits. (1) Coli- To process and package evaporated forms, less than 10 per gram; (2) yeasts, and condensed milk of ultra-pasteur- less than 5 per gram; (3) molds, less ized dairy products eligible for official than 5 per gram; (4) total plate count, identification with the USDA Quality less than 1,000 per gram.

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