Manufactured Foods
What is a Food Processor?
A food processor regulated by the Missouri Department of Health and Senior Services (DHSS) Manufactured Food Program is any entity that manufactures, processes, packs, or holds food for human consumption, and does not provide the food directly to the consumer.
Examples include:
Food warehouses, Bakeries, Breweries, Seafood processors*, Water Bottlers*, Canneries*, Food ingredient manufacturers, Flour mills, Juice processors*, Sprout growers*, Frozen dessert processors*, Beverage bottlers, Distilleries, Coffee roasters, Spice blenders, Snack food manufacturers, Sauce and salad dressing manufacturers*, Candy manufacturers, Ice manufacturers, Culinary gas manufacturers, and many others.
*See also the section labeled, “Specialized Products”, below.
Foods and food facilities that are not routinely regulated by DHSS include:
- Meat and egg products that are regulated by the United States Department of Agriculture or by the Missouri Department of Agriculture.
- Grade-A Milk and milk products that are regulated by the Missouri Milk Board.
- Food that is sold directly to the consumer in retail food establishments that are subject to the requirements of the Missouri Food Code and/or a local retail food code.
- Farms and the handling of raw agricultural commodities on farms.
- Manufacturers of dietary supplements, drugs, and medical devices.
Is my business a food processing business?
- Does the business produce any product (except those listed above that are not regulated by DHSS) that is likely to be consumed by humans, or to be used as an ingredient in an item that is likely to be consumed by humans?
and
- Does the business sell any of those items to a business that will sell the product again, serve it to customers, or use it in a product that will be sold or served to customers (wholesale sales)?
If the answer to both of these is yes, your business is a food processor that may be regulated by the DHSS Manufactured Food Program.
Safe Food Processing Regulations
Food processors in Missouri must adhere to Federal and State of Missouri requirements for processing safe food.
Federal law requires that all food processors be in compliance with the Food, Drug and Cosmetic Act (FD&C Act), which outlines good manufacturing practices standards, as well as labeling and registration requirements.
Food processors must also be aware of any food safety risks associated with their product(s) in particular, and have appropriate controls in place to manage those risks.
New Food Safety Regulations - The Food Safety Modernization Act
By Sept. 17, 2018, all food processors must comply with the Food Safety Modernization Act (FSMA,) which addresses risk-based food safety programs. Information about FSMA can be found online.
This FDA brochure provides an excellent overview of preventive controls, a new key food safety requirement.
Good Manufacturing Practices and Food Safety Plans
All foods must be processed in accordance with the Code of Federal Regulations, 21 CFR 117. This code outlines the requirements for current Good Manufacturing Practices (GMPs), training of supervisors and food handlers, development of a food safety plan, control of food allergens, development of a recall plan, and required records of food processing.
Missouri has adopted 21 CFR 117 by reference, so that there is no difference between Federal and State requirements for operating a food processing facility.
Labeling
Products that are packaged for retail sale will need to be correctly labeled. Helpful information on food labeling regulations can be found in the United States Food and Drug Administration’s (FDA) Guidance for Industry document on food labeling.
Very small processors may be qualified for an exemption from the nutrition information panel only of the labeling requirements. Get information on filing for the exemption.
While neither our DHSS nor FDA has a formal label approval process, processors are welcome to contact our central office to request a review of label designs for major errors or omissions before they are sent for printing.
Labels that have been reviewed are not considered to be “approved”, but we are happy to assist in identifying problems before businesses incur the cost of printing.
Inspections
Inspections of food processors are conducted by the Missouri Department of Health and Senior Services (DHSS) and/or by the United States Food and Drug Administration (FDA).
Routine inspections of processing facilities are conducted by DHSS approximately once per year. Routine inspections of warehouses are conducted an average of once every three years.
There is no fee for routine inspections.
Processing Facility Construction
While DHSS does not conduct formal plan reviews, processors may contact our central office to request a review of plan designs prior to construction.
Plans that undergo this informal review are not considered to be “approved,” but our agency is happy to assist in identifying ways in which the facility described in the plan would not be in compliance with GMPs.
Specialized Products
Some foods carry inherent risk of foodborne illness, and have additional applicable regulations designed to mitigate that risk.
These products include acidified foods (like pickles, salsa, bottled tea, and other shelf-stable foods preserved with acids), bottled water, juice, seafood, raw sprouts, frozen desserts, and low-acid canned foods (like canned corn, sweet potatoes, beans, etc.)
Contact the DHSS central office for more information about the additional regulations and requirements for processing these products prior to beginning operation.
FDA Food Facility Registration
Each food processor must register with FDA under the requirements of the 2002 Bioterrorism Act prior to beginning processing food. The Food Safety Modernization Act (FSMA) requires that this registration be updated every two years. Registration is free and is done online.
Licensing and Permits
The State of Missouri Department of Health and Senior Services (DHSS) requires that manufacturers of frozen desserts obtain a license to operate.
No other food processing businesses are required to be licensed or permitted by DHSS, though all processors must register with FDA, as described above.
Contacts
Contact DHSS with any questions about opening or operating a food processing business in Missouri:
Bureau of Environmental Health Services
Section for Environmental Public Health
Missouri Department of Health and Senior Services
PO Box 570
Jefferson City, MO 65102-0570
Phone: 573-751-6095 or (toll-free) 866-628-9891
Fax: 573-526-7377
Email: info@health.mo.gov