Manufactured Milk Products

Definition: Manufactured dairy products include concentrated and evaporated milk, hard cheese, soft cheese, ice cream, ice cream mix, dry milk products, butter, yogurt, cottage cheese, butter, cream, and whey products.

All milk products are defined by FDA under the Code of Federal Regulations (CFR), Cheeses and Cheese Related Products, while the definitions for fluid milk products are found in Milk and Cream. Each definition includes moisture, milk fat content, the inputs used (coloring, enzymes, flavoring, mold-inhibiting ingredients, stabilizers, sweeteners), processing (aging, curing, heating, pasteurizing, clarifying, bleaching), and final form of the food product (slices, blocks).

Cheeses: There are many varieties of cheese, determined by ingredients, processing, and characteristics of the cheese (Cornell, 2011). The compositions of many cheese varieties are defined by Standards of Identity in the Code of Federal Regulations. The label must declare each of the ingredients used in the food as required by the FDA. Cheese can be made using pasteurized or raw milk. Cheese made from raw milk imparts different flavors and texture characteristics to the finished cheese. For some cheese varieties, raw milk is given a mild heat treatment (below pasteurization) prior to cheese making to destroy some of the spoilage organisms and provide better conditions for the cheese cultures. Cheese made from raw milk must be aged for at least 60 days, as defined in the CFR, section 7 CFR 58.439, to reduce the possibility of exposure to disease causing microorganisms (pathogens) that may be present in the milk. For some varieties cheese must be aged longer than 60 days.

Cheese can be broadly categorized as acid or rennet cheese, and natural or process cheeses. Acid cheeses are made by adding acid to the milk to cause the proteins to coagulate. Fresh cheeses, such as cream cheese or queso fresco, are made by direct acidification. Most types of cheese, such as cheddar or Swiss, use rennet (an enzyme) in addition to the starter cultures to coagulate the milk. The term ‘natural cheese’ is an industry term referring to cheese that is made directly from milk. Process cheese is made using natural cheese plus other ingredients that are cooked together to change the textural and/or melting properties and increase shelf life.

Cheese processors in Colorado must comply with requirements for aging rooms, approved cheese molds and vats, dry storage, labeling and packaging equipment. The practice of aging for certain types of cheeses must also be approved by CDPHE’s Division of Environmental Health and Sustainability.  For all questions on inspection and licensing, contact CDPHE, Division of Environmental Health and Sustainability at 303-692-3633 or comments.CPD@state.co.us. Cheese production from cow’s milk, as well as from goats and sheep, follow these same regulations.

Contaminated cheese has been responsible for numerous documented foodborne illness outbreaks, with many cases resulting in severe illness and long-term health consequences. Soft cheeses may harbor Listeria monocytogenes and pregnant women are advised to avoid soft cheese made from raw milk (e.g. Feta, Brie, Camembert, blue-veined cheese, queso fresco, queso blanco, and Panela) (FDA, 2009; Dean and Kendall, 2006).

Only pasteurization, ultra-pasteurization or proper aging may be used to deactivate or remove  any microorganisms from cheeses or other dairy products. In the case of a properly aged product, culturing, coagulating and salting are permitted during the process.

Ice cream: To manufacture ice cream from a pre-made, pasteurized mix, you must obtain the blend from an approved source. Manufacturers who choose to use a pasteurized mix cannot add any ingredients other than colorings, flavorings, or items such as fruits or nuts to their concoctions. The inclusion of additional ingredients such as pasteurized creams, powders and sugars, etc. is strictly prohibited.

If, however, you would like to manufacture ice cream from raw milk, you must first fulfill the Manufactured Milk and Milk Products Regulations. For further information, inspection requirements, and licensing details concerning these rules, please contact the Colorado Department of Public Health and Environment’s Division of Environmental Health and Sustainability at (303) 692-3633.

In addition, consumers who wish to open ice cream operations that will be part of a retail food establishment, where the product will be eaten on the premises or served over the counter to customers, need to notify their local health department. However, if the business will only be a manufacturing operation and not part of a retail food establishment, consumers must instead contact the Colorado Department of Public Health and Environment’s Division of Environmental Health and Environment at (303) 692-3633 to alert the appropriate staff to plans for production.

Finally, all ice cream freezers have to be of an approved commercial type.

Food safety: Milk must be pasteurized to be sold to retail or wholesale customers in Colorado. Only Grade “A” pasteurized, ultra-pasteurized, or aseptically processed milk and milk products may be sold to the final consumer, to restaurants, soda fountains, grocery stores or similar establishments.

Pasteurization is a heat treatment that is effective in destroying the bacteria in milk that cause tuberculosis, salmonellosis, diphtheria, typhoid fever, and other illnesses without adversely affecting the milk’s nutritional content, flavor or quality. Rapid cooling of the milk following heat treatment and storage below 40 degrees F. help prevent milk spoilage and keep milk safe to drink.

Milk and other milk-based products naturally contain both beneficial and pathogenic bacteria. Beneficial bacteria, like Lactobacillus, help produce yogurt and other dairy foods and have a role in promoting gastrointestinal health. Harmful bacteria, such as Campylobacter jejuni, E. coli O157:H7, Listeria monocytogenes, and Salmonella, may get into milk through cross-contamination and grow in the nutrient-rich environment milk provides. Infections from these pathogens, especially in persons with compromised immune systems, can cause severe diarrhea, cramps, fever, nausea, vomiting, headache and dehydration, as well as more serious complications like hemolytic uremic syndrome.

Science-based research and numerous incidences of foodborne outbreaks clearly demonstrate the risk associated with the consumption of raw milk (FDA, 2011).  The Department of Health and Human Services, Centers for Disease Control and Prevention, and U.S. Food and Drug Administration strongly recommend that the public does not consume raw milk or raw milk products. Young children, pregnant women, the elderly, people with weakened immune systems are particularly susceptible to infections originating in raw milk. For more information on the health risks associated with raw milk, please see CDC’s website Food Safety and Raw Milk , FDA’s website, Raw Milk Misconceptions and the Danger of Raw Milk Consumption and FoodSafety.Gov’s Milk, Cheese, and Dairy Products: Myths About Raw Milk.

Because of the dangers of pathogenic bacteria, most milk is treated by pasteurization. The state of Colorado requires that the pasteurization process be done in an approved pasteurizer, equipped with an indicating and recording thermometer. Batch pasteurizers must also have an air space thermometer and a properly-designed outlet valve with stops. For more information please contact CDPHE at (303)  692-3633.

All Grade A milk and milk products sold in Colorado are required to be packaged and produced in a Grade A milk plant approved by the Colorado Department of Public Health and Environment’s Division of Environmental Health and Sustainability. Additionally, the raw milk supply for Grade A milk plants must be from dairy farms approved by the Colorado Department of Public Health and Environment’s Division of Environmental Health an Sustainability. If the raw milk is required to be transported to the plant for processing, an approved milk tanker must be used.

These regulations are the same as the Colorado Grade A Pasteurized Fluid Milk and Milk Product Regulations, which cover fluid milk and milk products formulated from cows’, sheep’s or goats’ milk. Among these articles are 1%, 2%, skim and whole milk, cottage cheese, half and half, sour cream, whipping cream and yogurt.  Some of the requirements that apply to Grade A milk plants include proper cleaning facilities, containers, hand washing facilities, lighting, pipelines, refrigeration, storage tanks, ventilation, waste disposal and water supply. The pasteurization process requires the use of an approved pasteurizer, equipped with an indicating and recording thermometer. Batch pasteurizers must also have an air space thermometer and a properly-designed outlet valve with stops.

From Colorado Retail Food Establishment Rules and Regulations: *3-305 Fluid Milk, Fluid Milk Products, and Frozen Dessert Mix.  Fluid milk and fluid milk products used, served or offered for sale shall comply with the Colorado Grade A Pasteurized Fluid Milk and Milk Products Regulation. Only pasteurized mix from an approved licensed dairy plant may be mixed and/or frozen by a counter freezer.

Using raw milk: Only products that are allowed by the Code of Federal Regulations (21 CFR 133.102 – 133.127 and 133.133 – 133.196 (1999)) and/or those deemed to be safe by CDPHE may be manufactured from raw milk. Products must be properly aged, for which the following conditions shall be met:

  • The manufacturing process shall be approved by CDPHE prior to implementation.
  • Proper aging may include culturing, coagulating and salting during the process.
  • The temperature during the aging process shall be maintained at no less than the minimum temperature specified by 21 CFR 133.102 – 133.127 and 133.133 – 133.196 (1999) for the product being manufactured.
  • The product shall be aged for no less than the minimum number of days as required by 21 CFR 133.102 – 133.127 and 133.133 – 133.196 (1999).
  • Process records shall include documentation that each lot/batch has met the time and temperature requirements as specified in 16p(F)2. and 16p(F)3.
  • A coding system shall be used to identify each lot/batch during the aging process.
  • Processing records shall be maintained for a minimum of two years and shall be available for review during inspection.

Mandatory milk grades: Prior to sale, all Grade A milk and milk products sold in Colorado are required to be packaged and produced in a Grade A milk plant approved by the Colorado Department of Public Health and Environment’s Division of Environmental Health and Sustainability. Additionally, the raw milk supply for Grade A milk plants must be from dairy farms approved by CDPHE’s Division of Environmental Health and Sustainability, and if the raw milk is required to be transported to the plant for processing, an approved milk tanker must be used (Colorado Rules and Regulations Pertaining to Colorado Grade A Milk and Pasteurized Milk and Fluid Milk Products).

Grade A milk, also called fluid grade milk, refers to milk produced under sufficiently sanitary conditions to qualify for fluid (beverage) consumption. Only Grade A milk is regulated under federal milk marketing orders. Grade B milk (also referred to as manufacturing grade milk) does not meet fluid grade standards and can only be used in cheese, butter and nonfat dry milk.

Voluntary milk grading: Dairy products may also be voluntarily graded as AA, Extra Grade, and Quality Approved, as defined by the USDA Agricultural Marketing Service (see examples below and AMS Dairy Grading). Dairy grading assists the dairy industry in marketing high-quality dairy products by providing buyers and sellers with an impartial appraisal of product quality and to provide the consumer confidence in buying. Grades are based on nationally uniform standards developed by Dairy Programs’ experts in cooperation with industry representatives. Sellers can request grading services to assure that products meet specific grade or contract requirements and have good keeping quality properties. Buyers can request grading services to assure that products have uniform high quality. Those wishing to use the services must request them, qualify for them, and pay a fee commensurate with the cost of providing them. Two examples of such services are the grade label program for butter and Cheddar cheese, and the acceptance service for volume buyers. Under the grade label program, consumer packages bear an official identification indicating the U.S. grade. As a part of the acceptance service, the user has all deliveries examined by USDA to certify that they meet specifications.

Distribution Method (Expand All | Collapse All)

All milk products to be marketed in Colorado are required to be from approved sources, though no permit is necessary to sell the products in this state. If the products to be sold are manufactured by a Colorado-based operation, that organization must possess a State manufacturer’s license. Additionally, all products that the manufacturer wishes to market are required to be from sources that have been inspected by the staff of the Colorado Department of Public Health and Environment’s Division of Environmental Health and Sustainability.

You are selling your product at a farmers’ market, CSA, roadside stand, other direct to consumer outlet, store, restaurant, food cart, K-12 school, university, hospital, or other retail food establishment

Licensing: You must obtain a Grade A Dairy Farm License from the Colorado Department of Public Health and Environment before you receive, sell, buy or handle milk or cream including dairy, creamery, ice cream factory or cheese factory. Contact CDPHE at (303) 692-3633. A  Retail Food Establishment License, issued by your county health department, is also required for retail sales.

Sales Tax Liability: General sales tax information.

Labeling: All containers and packages containing manufactured milk products defined as Grade A (according to Pasteurized Milk Ordinance: 2009) must be labeled in accordance with the applicable requirements of the Federal Food, Drug and Cosmetic Act, the Nutrition Labeling and Education Act, and the Pasteurized Milk Ordinance: 2009. These containers and packages must be conspicuously marked with:

  1. The identity of the milk plant where pasteurized, ultra-pasteurized, aseptically processed, condensed and/or dried.
  2. The words “keep refrigerated after opening” in the case of aseptically processed milk and milk products.
  3. The common name of the hooved mammal producing the milk shall precede the name of the milk or milk product when the product is or is made from other than cattle’s milk. As an example, “Goat”, “Sheep”, “Water Buffalo”, or “Other Hooved Mammal” milk or milk products respectively. (Refer to the NOTE: on page 27 of the PMO: 2009.)
  4. The words “Grade “A”" on the exterior surface. Acceptable locations shall include the principal display panel, the secondary or informational panel, or the cap/cover.
  5. The word “reconstituted” or “recombined” if the product is made by reconstitution or recombination.
  6. In the case of condensed or dry milk products the following shall also apply: a) the identity of the Regulatory Agency issuing such permit; and if distributed by another party, the name and address of the distributor shall be shown by a statement, such as “Distributed by”; and b) a code or lot number identifying the contents with a specific date, run, or batch of the product, and the quantity of the contents of the container.

Also, all vehicles and milk tank trucks containing milk or milk products must be legibly marked with the name and address of the milk plant or hauler in possession of the contents.

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