Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 500.000 - Good Manufacturing Practices For Food
Administration and Enforcement
Section 500.201 - Licensure

Universal Citation: 105 CMR 500.000 MA Code of Regs 500.201

Current through Register 1531, September 27, 2024

(A) License and Permit Requirements; Applicable Regulatory Agency. The following types of food-related operations require a license or permit from the following regulatory agencies. In some circumstances, a person may require more than one license or permit.

(1) A person who operates a residential kitchen that prepares food for wholesale sale: a license issued by the Department pursuant to M.G.L. c. 94, § 305C.

(2) A person who operates as a retail seafood dealer or a wholesale seafood dealer or who operates a wholesale seafood truck: a permit issued jointly by the Department and the Division of Marine Fisheries pursuant to M.G.L. c. 130, § 80.

(3) A person who cooks, smokes, or otherwise processes seafood, or combines seafood with non-seafood ingredient(s), for sale at wholesale: a license issued by the Department pursuant to M.G. L. c. 94, § 305C.

(4) A person who slaughters livestock or poultry, processes meat or poultry for sale at wholesale, custom slaughters livestock or poultry, or custom processes meat or poultry: a license issued by the Department pursuant to M.G. L. c. 94, § 120.

(5) A person who operates a milk pasteurization plant: a license (which may be called a permit) issued by the board of health pursuant to M.G.L. c. 94, § 48A.

(6) A person who manufactures butter or cheese in Massachusetts for sale at wholesale in a facility separate from a pasteurization plant (i.e. does not hold a license under M.G.L. c. 94, § 48A): a license issued by the Department pursuant to M.G. L. c. 94, § 305C.

(7) A person who manufactures frozen desserts or frozen dessert mix within Massachusetts for sale at wholesale or retail: a license (which may be called a permit) issued by the board of health pursuant to M.G.L. c. 94, § 65H.

(8) A person who manufactures frozen desserts or frozen dessert mix outside Massachusetts and sells such products in Massachusetts: a license issued by the Department pursuant to M.G. L. c. 94, § 65H.

(9) A person who, within Massachusetts, manufactures or bottles carbonated non-alcoholic beverages or bottled water, whether carbonated or non-carbonated, for human consumption: a license (which may be called a permit) issued by the board of health pursuant to M.G.L. c. 94, § 10A.

(10) A person who, outside Massachusetts, manufactures or bottles carbonated nonalcoholic beverages or bottled water, whether carbonated or non-carbonated, for human consumption and sells such products in Massachusetts: a license issued by the Department pursuant to M.G. L. c. 94, § 10A.

(11) A person who manufactures juice or apple cider for sale at wholesale: a license issued by the Department pursuant to M.G. L. c. 94, § 305C.

(12) A person who manufactures or processes any food not specifically named in 105 CMR 500.201(A)(1) through (11), including dietary supplements, for sale at wholesale: a license issued by the Department pursuant to M.G. L. c. 94, § 305C.

(13) A person who operates a cold storage or refrigerating warehouse: a license issued by the Department pursuant to M.G. L. c. 94, § 66.

(14) A person who operates a food warehouse: a license issued by the Department pursuant to M.G. L. c. 94, § 305C.

(15) A person who transports or causes to be transported any bakery product into Massachusetts for the purpose of sale: a license issued by the Department pursuant to M.G.L. c. 94, § 305E.

Table 2 summarizes these requirements.

TABLE 2

Statute

Regulated Activity

License or Permit

Issuing Agency

M.G.L. c. 94, § 305C

Residential kitchen that prepares food for wholesale sale

License

DPH

M.G.L. c. 130, § 80

Retail seafood dealer

Permit (joint)

DPH and Division of Marine Fisheries

M.G.L. c. 130, § 80

Wholesale seafood dealer

Permit (joint)

DPH and Division of Marine Fisheries

M.G.L. c. 130, § 80

Wholesale seafood truck

Permit (joint)

DPH and Division of Marine Fisheries

M.G.L. c. 94, § 305C

Process, etc. seafood for sale at wholesale

License

DPH

M.G.L. c. 94, § 120

Slaughter or custom slaughter livestock or poultry; process or custom process meat or poultry

License

DPH

M.G.L. c. 94, § 48A

Operate a milk pasteurization plant

License (may be called a permit)

Local board of health

M.G.L. c. 94, § 305C

Manufacture butter or cheese for sale at wholesale in a facility separate from a pasteurization plant

License

DPH

M.G.L. c. 94, § 65H

Manufacture frozen desserts or frozen dessert mix within MA for sale at wholesale or retail

License (may be called a permit)

Local board of health

M.G.L. c. 94, § 65H

Manufacture frozen desserts or frozen dessert mix outside MA and sell them in MA

License

DPH

M.G.L. c. 94, § 10A

Manufacture or bottle within MA carbonated non-alcoholic beverages or bottled water for human consumption

License (may be called a permit)

Local board of health

M.G.L. c. 94, § 10A

Manufacture or bottle carbonated non-alcoholic beverages or bottled water for human consumption outside MA and sell them in MA

License

DPH

M.G.L. c. 94, § 305C

Manufacture juice or apple cider for sale at wholesale

License

DPH

M.G.L. c. 94, § 66

Operate a cold storage or refrigerating warehouse

License

DPH

M.G.L. c. 94, § 305C

Operate a food warehouse

License

DPH

M.G.L. c. 94, § 305E

Transport or cause to be transported any bakery product into MA for purpose of sale

License

DPH

M.G.L. c. 94, § 305C

Manufacture or process any food not specifically named above, including dietary supplements

License

DPH

(B) No person, unless exempted pursuant to 105 CMR 500.000, shall conduct an activity requiring a license, permit, approval, or certification pursuant to 105 CMR 500.000 without a valid license, permit, approval, or certification, or in violation of the terms of a valid license, permit, approval, or certification or the applicable requirements of 105 CMR 500.000.

(C) No person, unless exempted, shall sell, exchange, deliver, advertise, offer, expose for sale or exchange, attempt to deliver, or have in his or her possession with intent to do so, any food for human consumption unless the manufacturer or processor thereof holds a license or permit issued pursuant to 105 CMR 500.000 then in full force.

(D) A person who desires to conduct an activity named in 105 CMR 500.201(A) shall submit an application for a license or permit to the appropriate regulatory agency, together with the fee required by statute and any other information required by the regulatory agency. Such application shall be on a form prescribed by the regulatory agency.

(E) A new applicant for a license or permit from the Department shall notify the local board of health in the city or town where the facility is located of his or her intent to operate and of the type of business.

(F) Only a person who complies with the requirements of 105 CMR 500.000 shall be entitled to receive and retain a license, permit, approval, or certification. A license, permit, approval, or certification shall be valid only for the licensee or permit holder and for the location indicated on it.

(G) A license, permit, approval, or certification shall remain in effect for the term specified, unless it is surrendered, suspended, or revoked.

(H) A license or permit may be renewed by applying at least 30 days prior to the expiration date. Application for renewal shall be made in writing on a form prescribed by the regulatory agency.

(I) All Licenses and Permits are Non-transferable.

(1) No licensee or permit holder shall transfer or assign a license or permit in any manner, voluntarily or involuntarily, directly or indirectly, or by transfer of control of any company.

(2) No person shall conduct an activity named in 105 CMR 500.201(A) pursuant to a license or permit transferred or assigned by any person.

(3) No licensee or permit holder shall transfer an operation to a new location without obtaining a new license or permit.

(J) Notification to the Regulatory Agency.

(1) Mailing Address. Each applicant, licensee, and permit holder shall provide the regulatory agency with its complete and correct mailing address, and shall notify the regulatory agency within seven calendar days of the change of its mailing address. The last address provided to the regulatory agency shall be deemed the appropriate address for the service of all orders and notices from the regulatory agency.

(2) Change of Ownership. A licensee or permit holder shall notify the regulatory agency prior to, or within ten days after, a change of ownership, and shall surrender the license or permit upon change of ownership. The new owner shall submit to the regulatory agency an application for a new license or permit, and shall not operate until such license or permit is issued.

(3) Change of Name. A licensee or permit holder shall notify the regulatory agency at least 30 days prior to any change of the name of the business. The licensee or permit holder shall submit to the regulatory agency an application for an amended license or permit, together with written documentation stating the change of name.

(4) Change of Location. A licensee or permit holder shall notify the regulatory agency at least 30 days prior to a change of location of the business, and shall surrender its license or permit upon closure of the business at the former location. The licensee or permit holder shall submit to the regulatory agency an application for a new license or permit, and shall not operate until such license or permit is issued.

(5) Remodeling. A licensee or permit holder shall promptly notify the regulatory agency any time that a facility is being remodeled. Upon notification, the regulatory agency may inspect the facility to verify compliance with 105 CMR 500.000.

(6) Imminent Danger. A licensee or permit holder shall notify the regulatory agency immediately when an imminent danger to the public health is present in the facility.

(7) Change in Operations. A licensee or permit holder shall notify the regulatory agency of any change in the types of products that it manufactures or distributes.

(K) No person shall transport or cause to be transported any bakery product into Massachusetts for the purpose of sale without obtaining a license from the Department, pursuant to M.G.L. c. 94, § 305E.

(1) After receipt of an application for a license, the Department shall review the application and any documents filed with it. To determine the extent of the facility's compliance with 105 CMR 500.000, the Department may accept reports of the responsible authorities in the jurisdiction where the facility is located. When information reveals that the applicable requirements of 105 CMR 500.000 have been met, the Department shall issue a license to the applicant.

(2) Each license granted by the Department pursuant to 105 CMR 500.201(K) shall apply to one facility only, and shall be valid throughout Massachusetts.

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