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9810.2205 CANNABIS AND HEMP CONCENTRATE; MANUFACTURING REQUIREMENTS.

Subpart 1.

Facilities.

Cannabis or hemp extraction and concentration systems must be designed to effectively and consistently function, operate safely, and provide sanitary production conditions. A cannabis or hemp manufacturer must have the manufacturer's electrical, gas, fire suppression, and exhaust systems and storage and disposal plans for hazardous substances certified by an industrial hygienist or a professional engineer qualified to conduct the certification through education, experience, or professional credentialing.

A.

A certifying individual must include the individual's qualifications in writing as part of a facility's record of certification.

B.

The certification of a facility must include an assessment of:

(1)

all electrical, gas, fire suppression, and exhaust systems in the facility; and

(2)

the facility's plan for safe storage and disposal of hazardous substances, including any volatile chemicals.

C.

A facility's certification must be completed by a certifying individual, documented, and approved by the office before the facility manufactures any product intended for sale or distribution.

Subp. 2.

Inactive ingredients.

A cannabis business may use cannabis-derived ingredients to manufacture cannabis concentrate or hemp-derived concentrate. A cannabis business may use only non-cannabis-derived inactive ingredients listed in the federal Food and Drug Administration inactive ingredient database to manufacture cannabis concentrate or hemp-derived concentrate that is intended for use through a vaporizer delivery device or pressurized metered dose inhaler.

Subp. 3.

Prohibited ingredients.

When manufacturing cannabis concentrate, a manufacturer must ensure that:

A.

any concentrate used to create a solution for vaporization or inhalation is 100 percent naturally occurring plant-derived terpene oil;

B.

a product for inhalation does not contain artificial or synthetic compounds;

C.

a solution prepared for vaporization or inhalation does not contain:

(1)

medium-chain triglycerides (MCT);

(2)

polyethylene glycol (PEG);

(3)

vegetable glycerin (VG);

(4)

vitamin E acetate;

(5)

diacetyl; or

(6)

squalene.

Subp. 4.

Requirements for manufacturers of artificially derived cannabinoid products.

An artificially derived cannabinoid product must not contain any artificially derived cannabinoids other than delta-9 tetrahydrocannabinol, except that a product may include artificially derived cannabinoids created during the process of creating delta-9 tetrahydrocannabinol that is added to the product, if no artificially derived cannabinoid is added to the ingredient containing delta-9 tetrahydrocannabinol and the ratio of delta-9 tetrahydrocannabinol to all other artificially derived cannabinoids is no less than 20 to one. An artificially derived cannabinoid product may contain nonpsychoactive naturally occurring cannabinoids, such as cannabidiol, cannabigerol, cannabinol, or cannabichromene.

Statutory Authority:

MS s 342.02

History:

49 SR 1143

Published Electronically:

April 25, 2025

Official Publication of the State of Minnesota
Revisor of Statutes