Baked bread for wholesale purchase

Wholesale food manufacturers produce, process, package, label, store, and distribute food products for sale to other businesses such as grocery stores, restaurants, convenience stores, distributors, and retail establishments. Wholesale food manufacturers must comply with applicable state and local food safety requirements before operating. 

Wholesale Food Manufacturing Basics:

“Wholesale” means the sale or provision of food to a retail food establishment or to another person engaged in retail sales who sells or provides the food directly to the consumer. The term does not include the sale or provision of food at retail.

“Wholesale food manufacturing establishment” means a facility and the facility’s buildings or structures used to manufacture or prepare food for human consumption at wholesale. The term does not include:

  • milk producers’ facilities, milk pasteurization facilities, or milk product manufacturing plants
  • slaughterhouses, meat packing plants, or meat depots
  • producers or harvesters of raw and unprocessed farm products.

“Establishment” means a wholesale food manufacturing establishment, wholesale food salvage establishment, wholesale food warehouse, wholesale ice manufacturer, or wholesale water bottler.

“Food” means an edible substance, beverage, or ingredient used, intended for use, or for sale for human consumption. The term includes dietary supplements. The term does not include nonprescription drugs.

Click here for additional definitions for Wholesale Food Manufacturing. 

Are you experiencing illness you believe may be linked to a wholesale food establishment?

Frequently Asked Questions

Wholesale food manufacturing generally includes producing, processing, packaging, labeling, or storing food products for sale to other businesses such as grocery stores, restaurants, convenience stores, distributors, or other retail establishments. 

Retail food establishments primarily sell food directly to the end consumer. 

Wholesale food manufacturers produce food products that are sold to other businesses for resale or service to customers. 

Some businesses may conduct both retail and wholesale food operations and may require additional licensing or approvals. 

Yes. Food products manufactured for sale to other businesses generally require a wholesale food manufacturing license. 

Licensing and Approval FAQ

Wholesale food manufacturers must complete a licensing process involving both the Gallatin City-County Health Department (GCCHD) and the Montana Department of Public Health and Human Services (MDPHHS) Environmental Health and Food Safety Section (EHFS). 

Generally, the process includes: 

  1. Contact GCCHD before signing a lease, purchasing equipment, remodeling, or beginning construction. 
  2. Submit a plan review application to GCCHD.  
  3. Complete and submit the Montana Wholesale Food Review Form and required documentation to EHFS.  
  4. Submit proposed product labels and manufacturing information for review.  
  5. Complete construction and equipment installation.  
  6. Receive a satisfactory Wholesale Food Review Report from EHFS.  
  7. Schedule and pass a pre-operational inspection with GCCHD.  
  8. Obtain licensure before manufacturing or distributing food products.  

Wholesale food manufacturers must complete reviews by both the Gallatin City-County Health Department (GCCHD) and the Montana Department of Public Health and Human Services Environmental Health and Food Safety Section (EHFS). 

EHFS reviews: 

  • Food products  
  • Product formulations  
  • Product labels  
  • Food manufacturing processes  
  • Specialized processing requirements  

GCCHD reviews: 

  • Facility design and construction  
  • Equipment and operational requirements  
  • Water supply  
  • Wastewater disposal  
  • HACCP plans, when applicable  
  • Compliance with applicable food safety requirements  

GCCHD also conducts inspections and issues the wholesale food license. However, GCCHD cannot approve a wholesale food manufacturing license until a satisfactory Wholesale Food Review Report has been received from EHFS. 

Yes. A plan review is required before opening a wholesale food manufacturing facility. Plan review allows GCCHD to evaluate the proposed facility, equipment, water supply, wastewater disposal, food manufacturing processes, HACCP plans when applicable, and other operational requirements before construction or operation begins. 

The wholesale food manufacturing plan review fee is [INSERT FEE]. 

GCCHD has up to 30 days to review a complete plan review application. Applications that are incomplete or require additional information may take longer to process. 

Applicants are encouraged to submit applications well in advance of their anticipated opening date and before beginning construction or remodeling. 

Yes. Applicants are strongly encouraged to contact GCCHD before purchasing property, signing a lease, beginning construction, or remodeling a facility. Early consultation can help identify facility, water supply, wastewater disposal, equipment, food processing, and regulatory requirements before significant expenses are incurred. 

No. Food manufacturing operations may not begin until all required approvals have been obtained, a satisfactory Wholesale Food Review Report has been received from EHFS, and the wholesale food license has been issued. 

No. Approval by GCCHD does not constitute approval under all other applicable federal, state, local, zoning, building, fire, business licensing, labeling, or land use requirements. Operators are responsible for obtaining all other required approvals and permits. 

Those with Existing Retail Food Establishments FAQ

If you currently operate a licensed retail food establishment and would like to add wholesale food manufacturing, you must submit a minor plan review application to GCCHD. 

Additional documentation may be required regarding the products being manufactured, food processes, product labels, facility layout, equipment, storage, and HACCP plans when applicable. A satisfactory Wholesale Food Review Report from EHFS may also be required before wholesale food manufacturing can begin. 

Operators should contact GCCHD before beginning wholesale food manufacturing activities to discuss specific licensing and review requirements. 

Possibly. 

If you are selling food directly to the end consumer, a retail food license is generally required. 

If you are manufacturing food products for sale to other businesses such as grocery stores, restaurants, convenience stores, distributors, or other retailers, a wholesale food license is generally required. 

Some businesses conduct both retail and wholesale food operations and may require both licenses. Contact GCCHD if you are unsure which licensing requirements apply to your operation. 

Facility Requirement FAQs

Yes. Wholesale food products must generally be manufactured in an approved commercial facility that complies with applicable food safety requirements. 

Generally, no. Foods intended for wholesale distribution are typically required to be produced in an approved food manufacturing facility. 

Yes. Facilities must have an approved and adequate potable water supply. 

Yes. Facilities must have an approved wastewater disposal system capable of handling the proposed operation. 

Possibly. Private wells may be used if they meet applicable requirements. Additional testing and documentation may be required before licensure. 

Possibly. Documentation may be required to demonstrate that the wastewater system was approved for the proposed use and has adequate capacity for the operation. 

Product Labels and Food Processes FAQ

Yes. Product labels must be submitted as part of the Wholesale Food Review process. EHFS reviews labels and product information to verify compliance with applicable requirements before products are offered for sale. 

Product labels should be submitted as early as possible during the licensing process. Delays in label review may delay final approval and licensure. 

Depending on the product, labels may be required to include: 

  • Statement of identity  
  • Ingredient list  
  • Net quantity statement  
  • Name and address of the manufacturer  
  • Allergen declarations  
  • Nutrition labeling when applicable  

Food labels are reviewed by the Montana Department of Public Health and Human Services Environmental Health and Food Safety Section (EHFS). 

Yes. EHFS may require information regarding ingredients, formulations, processing methods, packaging, storage, distribution, and other manufacturing information as part of the Wholesale Food Review process. 

Possibly. Significant changes to ingredients, formulations, manufacturing processes, or labels may require additional review. 

Specialized Food Processes FAQ

Possibly. Certain food manufacturing processes require a HACCP plan. HACCP plans, when required, are reviewed by GCCHD as part of the licensing process. 

Yes. Certain food manufacturing processes may require additional review, documentation, process authority evaluations, laboratory testing, or HACCP plans. 

Examples may include: 

  • Acidified foods  
  • Reduced oxygen packaging  
  • Canned foods  
  • Fermented foods  
  • Juice processing  
  • Seafood processing  

Additional information may be required depending on the product being manufactured and the processing methods used. 

No. A satisfactory Wholesale Food Review Report from EHFS is required before GCCHD can complete the licensing process. 

Inspections and Regulations FAQ

Yes. Wholesale food manufacturing facilities receive pre-operational inspections and routine inspections to verify compliance with applicable food safety requirements. 

Contact GCCHD once construction is complete, equipment is installed, EHFS review requirements have been satisfied, and the facility is ready to operate. 

Call 406-582-3120
Email ehs@gallatin.mt.gov

Corrections must be completed before licensure can be issued. Depending on the nature of the violations, a follow-up inspection may be required. 

Inspection frequency varies depending on the operation, products manufactured, processing methods, and compliance history. 

Wholesale food manufacturers must comply with applicable federal, state, and local requirements. Depending on the operation, applicable regulations may include: 

Additional requirements may apply depending on the products being manufactured and the processes being used. 

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Questions?

If you have questions regarding wholesale food manufacturing, product label review, food processing, plan review, inspections, or licensing requirements, please contact the Gallatin City-County Health Department Environmental Health Division. 

Please note: Approval by GCCHD does not constitute approval under all other applicable federal, state, local, zoning, building, fire, business licensing, labeling, or land use requirements. Operators are responsible for obtaining all other required approvals and permits. 

Contact Us:

Call: 406-582-3120
Email: ehs@gallatin.mt.gov

Temporary Office Location:

400 E. Babcock Street, Bozeman