Food manufacturing and storage

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.

Application for 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.

Approved source list

Monthly updated list of approved sources of all registered manufactured food businesses that are active.

Update: Wholesale Food, Industrial Hemp, and Shellfish registration renewals were mailed on May 23, 2022.

Registration process changes for new applicants

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.

The registration fees are:

Facilities with Gross Annual Sales above $150,000 or any industrial hemp facility - $300.
Facilities with Gross Annual Sales below $150,000 - $60.
Brewery, winery, spirit distillery, and grain storage - only a $100 non-refundable application fee.
Non-profit organizations must provide proof of tax status and have no application or registration fees.

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.

Food manufacturing resources

Food Safety Modernization Act (FSMA)

CDPHE/FDA vs USDA jurisdiction

Commercial kitchen minimum requirements

Industrial hemp

When to submit a new application

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.

Manufactured Food, Industrial Hemp or Storage Facility Registration

How to update your contact information

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.

Contact information change form

Manufactured food specialized processes

Depending on what you want to produce, there may be additional documentation or training requirements to register as a manufactured food company. All wholesale manufacturers, re-packers and warehouses must comply with the FDA's Code of Federal Regulations (CFR), Title 21, section 117, also known as the Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food.

Seafood

If you handle seafood, shell fish or seafood products, you'll need to ensure:

Full compliance with 21-CFR-123.
Each facility has a hazard analysis conducted by a trained person.
You have an approved Hazard Analysis and Critical Control Points (HACCP) plan.
Adequate training and plans, depending on your risk.
- For seafood HACCP training, visit the Association of Food and Drug Officials (AFDO) website.
- For shellfish-specific requirements, please visit the National Shellfish Sanitation Program.
- You can also view a list of current Interstate Certified Shellfish Shippers.
- National Shellfish Sanitation Program (NSSP) Model Ordinance, 2019 revision.

Juice

If you will be making, re-packing or storing juice and juice products, you'll need to ensure:

Full compliance with 21-CFR-120.
You have an approved HACCP plan.
- You can find more information on Juice HACCP on the FDA's Guidance for Juice Industries page.
For juice HACCP training, please use Cornell University Juice HACCP course or University of Florida Juice HACCP course.

Acidified Foods/Low Acid Canned Foods (LACF)

If your products are acidified, or if you're producing low-acid canned foods, you'll need to ensure:

Full compliance with 21-CFR-113, 21-CFR-114 and 21-CFR-108.
That you have your standardized recipe evaluated by a process authority.
- You can find a process authority in your area by visiting the AFDO Subject Matter Expert search page.
That you file your process and register with the FDA.
- For food canning establishments, visit the FDA's Guidance for Food Canning Industry page for further instructions.
- For acidified and low-acid canned foods, visit the FDA's Guidance for Acidified and LAFC page for further instructions.
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

Bottled water must satisfy all bacterial, chemical, physical and radiological standards listed in CFR 21-165. Additionally, review the following:

CFR 21-129, which outlines the conditions that water can bottled.
Bottled water is subject to specific labeling requirements:
- Nutritional Labeling and Education Act.
- Federal Fair Packaging and Labeling Act.
Hauling water to a facility other than its source is also regulated. If you\'re hauling water, you must ensure:
- Full compliance with Section 11.41 of the Colorado Primary Drinking Water regulations (page 271).

Dietary supplements

If you want to manufacture dietary supplements, you must ensure:

Full compliance with 21-CFR-111.

Food, drug, and cosmetic recalls

If you're looking for recalls related to consumer goods or products, go to the Consumer Product Safety Commission website. We don't post consumer product recalls on this page.