Regulations
Does my facility need to be licensed?
All food processing facilities as defined in COMAR 10.15.04.02 must be licensed as stated in COMAR 10.15.04.21 & Md. HEALTH-GENERAL Code Ann. § 21-305. Types of Licensed Food Processing Facilities include: food processing or manufacturing, on-farm processing and storage, seafood plants, crab meat picking plants, shellfishoperations, canneries, soft drink and bottled water plants, warehouses, and food transportation vehicles.All facilities must continue to have a current license to operate. Facilities that operate without a license are subject to enforcement action.
What State of Maryland regulations apply to my facility?
10.15.04 Food and Drink Processing and Transportation
10.15.01 Low Acid and Acidified Food Canning
10.15.02 Crab Meat
10.15.07 Shellfish Sanitation
10.15.10 Procedures for the Safe Handling and Processing of Seafood
10.15.11 Bottled Water
10.15.12 Procedures for the Safe Handling and Processing of Juice
Will my facility be inspected? How often?
Food Processing Plants are inspected by Center for Food Processing (CFP) staff who are Licensed Environmental Health Specialists(LEHS) to ensure compliance with applicable State and Federal laws and regulations. Inspection frequency is determined by a risk analysis conducted during plan and process review. The facility must be available for inspection to remain licensed.
What if a product is to be added or changed in my licensed facility? What if equipment is added or the facility will be remodeled?
Plans must be submitted and approved if a food process is added or modified so that a plant or plant facilities require modification or process critical control points are added. Plans must all be submitted if a facility is remodeled or materially altered. Contact the Center for Facility and Process Review (FAPR) to determine the next steps.
What if the facility will be moving?
Plans and specifications must be submitted and approved before a food processing plant is constructed, remodeled, materially altered, or an existing building or structure is converted or remodeled for use as a food processing plant. Contact the Center for Facility and Process Review (FAPR) to determine the next steps.
Does my facility fall under FDA jurisdiction? What does that mean for my facility?
Facilities that manufacture, process, pack, and hold food and operate(receive or distribute) across state lines fall under FDA jurisdiction and must comply with the Code of Federal Regulations (21 CFR 117) Other facilities may also need to register, comply with portions of the regulation, or attest that they are exempt.
Facilities may be inspected by FDA staff or by CFP staff that are credentialed by FDA as part of a cooperative program between MDH & FDA.
Does my facility need to comply with the Food Safety Modernization Act(FSMA) or the PC Rule?
To find out which portions of the Food Safety Modernization Act apply to your facility please see our FDA,FSMA, and the PC Rule page.
Guidance Documents
Export Certificates
For an Export Certificate or Free Sale Certificate proceed to the FDA Online Export Certificate Application website.
For Certificates of Health, Certificates of Origin and Health, and GMP Certificates, please contact the Center for Food Processing at (410)767-8400 or mdh.envhealth@maryland.gov.
This page was last updated 11.19.2021
