105 CMR 500.201
Licensure
(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.
A person who, outside Massachusetts, manufactures or bottles carbonated non
alcoholic 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
Statute
Regulated Activity
License or Permit
Issuing Agency
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.
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.
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.