Food manufacturing, warehousing, and wholesaling in Colorado is regulated by CDPHE, the FDA, and the USDA. Operators who manufacture foods and dietary supplements with less than 2% cooked meat must be registered with CDPHE and if ingredients or finished products have interstate commerce a registration with the FDA is also required. These registrations are required to be considered approved sources. Manufacturing or wholesaling of products above 2% cooked meat, unless in a sandwich, must register with the USDA. The State Health Department Manufactured Food Program regulates and inspects manufacturing operations as well as provides compliance assistance to help ensure safe food sources in Colorado and across the nation.
Colorado Wholesale Food, Industrial Hemp, and Shellfish Regulations
6 CCR 1010-21, adopted by the Board of Health on February 17, 2021; effective April 14, 2021.
Monthly updated list of approved sources of all registered manufactured food businesses that are active.
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New applicants: registration process
Effective September 1, 2021 the process for submitting and processing a manufactured food, storage facility, or industrial hemp facility application is the following:
- All applications require a non-refundable $100.00 application fee, payable by check or money order. We cannot accept cash.
- Please send the application fee only when submitting an application.
- Applications will be processed by the department. Then we will provide you with an invoice for the remaining registration fee, payable by check or money order. We cannot accept cash.
- Once you pay the remaining registration fee, we will issue your registration for a new facility.
Manufactured Food, Industrial Hemp or Storage Facility Registration
Renewals
All Manufactured Food registration renewals, including industrial hemp, are mailed in the summer.
- FDA Food Facility Biennial Registration Renewal.
- Commissary Agreement (only required if you're working out of a shared kitchen or commissary).
Additional licensing may be required
- Depending on the type of business, you may need some or all of the license types below:
- Business license: contact your local city office.
- Retail food license: if you make and sell your food to the public, you might also need a retail food license.
- City/county sales tax license: contact your local city/county taxation office.
- Get a sales tax license: you may be required to get a sales tax license from the Department of Revenue.
- Federal tax ID number: TIN, EIN, ITIN, etc.: Internal Revenue Service or visit your local IRS office.
- Building permit: contact your regional building department.
For registered facilities: certificate of free sale
If you already completed the registration application and received a copy of your registration, you can apply for the certificate of free sale. The certificate of free sale is for registered facilities, that are exporting products manufactured or warehoused in Colorado, that are subject to state and federal food regulations. The fee is $150 for each certificate.
Application for Certificate of Free Sale
Food manufacturing resources
Registration
Manufacturers, warehouses, re-packers, shellfish dealers, salvage operations, grain storage facilities and industrial hemp operations must be registered.
Food manufacturing and storage includes:
- Selling your food to retailers
- Re-packing
- Shellfish dealers
- Salvage operations
- Grain storage facilities
- Industrial hemp
When to submit a new application
Registration is specific to the owner and location. It is not transferable or prorated. If you started a new business, there is a change of owner or if the physical address of the facility changed, please submit a new application and fee. CDPHE does not register operations that are producing marijuana infused products. You need to contact the Department of Revenue, Marijuana Enforcement Division. You can download and fill out the PDF registration form on your computer or mobile device.
If the physical address of the facility and the owner did not change and you need to update your contact information (mailing address, email, phone number, trade name), please fill out Contact Information Change form.
Seafood
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Full compliance with 21-CFR-123.
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Each facility has a hazard analysis conducted by a trained person.
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You have an approved Hazard Analysis and Critical Control Points (HACCP) plan.
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Adequate training and plans, depending on your risk.
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For seafood HACCP training, visit the Association of Food and Drug Officials (AFDO) website.
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For shellfish-specific requirements, please visit the National Shellfish Sanitation Program.
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You can also view a list of current Interstate Certified Shellfish Shippers.
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National Shellfish Sanitation Program (NSSP) Model Ordinance, 2019 revision.
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Juice
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Full compliance with 21-CFR-120.
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You have an approved HACCP plan.
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You can find more information on Juice HACCP on the FDA's Guidance for Juice Industries page.
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- For juice HACCP training, please use Cornell University Juice HACCP course.
Acidified Foods/Low Acid Canned Foods (LACF)
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That you have your standardized recipe evaluated by a process authority.
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You can find a process authority in your area by visiting the AFDO Subject Matter Expert search page.
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That you file your process and register with the FDA.
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For food canning establishments, visit the FDA's Guidance for Food Canning Industry page for further instructions.
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For acidified and low-acid canned foods, visit the FDA's Guidance for Acidified and LAFC page for further instructions.
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That you or your qualified designee has completed the Acidified or Better Process Control School. You can find Better Process Control Schools at many land grant schools, for example:
Bottled water
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CFR 21-129, which outlines the conditions that water can bottled.
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Bottled water is subject to specific labeling requirements:
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Hauling water to a facility other than its source is also regulated. If you\'re hauling water, you must ensure:
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Full compliance with Section 11.41 of the Colorado Primary Drinking Water regulations (page 271).
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Dietary supplements
- Full compliance with 21-CFR-111.
Food and product recalls:
Contact
303-692-3645, option 2
cdphe_mfgfd@state.co.us
For invoicing questions
303-692-3645, option 4