1 Colo. Code Regs. § 212-3-4-210

Current through Register Vol. 47, No. 24, December 25, 2024

Section 1 CCR 212-3-4-210 - Regulated Marijuana Testing Program: Potency Testing

Basis and Purpose - 4-210

The statutory authority for this rule includes but is not limited to sections 44-10-202(1)(c), 44-10-203(1)(a), 44-10-203(1)(c), 44-10-203(1)(g), 44-10-203(1)(k), 44-10-203(2)(d), 44-10-203(2)(f), 44-10-203(3)(d), 44-10-203(3)(e), 44-10-501(6), 44-10-502(3), 44-10-503(8), 44-10-504(1)(b), 44-10-504(2), 44-10-601(4), 44-10-602(4), 44-10-603(6), 44-10-604(1)(b), and 44-10-604(2), C.R.S. Authority also exists in the Colorado Constitution at Article XVIII, Subsection 16(5)(a) (VII). The purpose of this rule is to protect the public health and safety by establishing potency testing procedures and rules for the Division's Regulated Marijuana sampling and testing program. This Rule 4-210 was previously Rules 4-115 and 4-125, 1 CCR 212-3, Rules M and R 1504, 1 CCR 212-1 and 1 CCR 212-2.

A.Potency Testing.

1.Cannabinoids Potency Profiles. A Regulated Marijuana Testing Facility may test and report results for any Cannabinoid provided the test is conducted in accordance with the Regulated Marijuana Testing Facility's Standard Operating Procedure.

2.Reporting of Results.

a. For potency tests on Regulated Marijuana, Regulated Marijuana Concentrate, Pre-Rolled Marijuana, and Infused Pre-Rolled Marijuana, results must be reported by listing a single percentage concentration for each Cannabinoid that represents an average of all Sample Increments within the Test Batch. This includes reporting the Total THC in addition to each Cannabinoid required in Rule 4-210.

b. For potency tests conducted on Regulated Marijuana Product, whether conducted on each individual Production Batch or via a Reduced Testing Allowance per Rule 4-210, results must be reported by listing the total number of milligrams contained within a single Regulated Marijuana Product unit for sale for each Cannabinoid and stating whether the THC content is homogenous as defined in Paragraph 4 of this subparagraph (E).

B.Potency Testing - Cannabinoid Profile. A potency test conducted pursuant to this Rule must at least determine the level of concentration of D8-THC, D9-THC, D-10 THC, Exo- THC, THCA, CBD, CBDA, and CBN.

C.Potency Testing for Regulated Marijuana.

1.Initial Potency Testing. A Regulated Marijuana Cultivation Facility must have potency tests conducted by a Regulated Marijuana Testing Facility on four Harvest Batches, created a minimum of one week apart, for each strain of Regulated Marijuana that it cultivates.

a. The first potency test must be conducted on each strain prior to the Regulated Marijuana Cultivation Facility Transferring or processing into a Medical Marijuana Concentrate any Medical Marijuana of that strain, or into a Retail Marijuana Concentrate any Retail Marijuana of that strain.

b. All four potency tests must be conducted on each strain six months after the Regulated Marijuana Cultivation Facility begins cultivating that strain.

2.Ongoing Potency Testing. After the initial four potency tests, a Regulated Marijuana Cultivation Facility shall have each strain of Regulated Marijuana that it cultivates tested for potency at least once per quarter.

a. If the Licensee that has completed testing required by subparagraph (C)(1) of this Rule fails to comply with subparagraph (C)(2) of this Rule, the Regulated Marijuana Cultivation Facility must test every Harvest Batch that they produce or comply with the testing requirements in subparagraph (C)(1) of this Rule.

3.Kief Potency Testing. Kief potency testing may follow Potency Testing for Regulated Marijuana if Kief is produced from the same strain of Regulated Marijuana. If Kief is produced from multiple strains, must comply with paragraph (D) of Rule 4-210.

D.Potency Testing for Regulated Marijuana Concentrate.

1. A Medical Marijuana Cultivation Facility or a Medical Marijuana Products Manufacturer must have a potency test conducted by a Medical Marijuana Testing Facility on every Production Batch of Medical Marijuana Concentrate that it produces prior to Transferring or processing into a Medical Marijuana Product any of the Medical Marijuana Concentrate from that Production Batch.

2. A Retail Marijuana Cultivation Facility, Accelerator Cultivator, Retail Marijuana Products Manufacturer, or an Accelerator Manufacturer must have a potency test conducted by a Retail Marijuana Testing Facility on every Production Batch of Retail Marijuana Concentrate that it produces prior to Transferring or processing into a Retail Marijuana Product any of the Retail Marijuana Concentrate from that Production Batch.

E.Potency Testing for Regulated Marijuana Product.

1.Potency Testing Required for Regulated Marijuana Product. A Regulated Marijuana Products Manufacturer shall have potency tests conducted by a Regulated Marijuana Testing Facility on every Production Batch of each type of Regulated Marijuana Product that it produces prior to Transferring any of the Regulated Marijuana Product from that Production Batch, unless the Regulated Marijuana Products Manufacturer has successfully achieved a Reduced Testing Allowance for potency and homogeneity for the particular type of Regulated Marijuana Product.

2.Required Tests. Potency and homogeneity tests conducted on Regulated Marijuana Product must determine the level of concentration of the required Cannabinoids and whether or not THC is homogeneously distributed throughout the product.

3.Partially Infused Regulated Marijuana Products. If only a portion of a Regulated Marijuana Product is infused with Regulated Marijuana, then the Regulated Marijuana Products Manufacturer must inform the Regulated Marijuana Testing Facility of exactly which portions of the Regulated Marijuana Product are infused and which portions are not infused.

4.Failed Potency Tests for Regulated Marijuana Product.

a. If the Cannabinoid content of Regulated Marijuana Product is determined not to be homogeneous, then it shall be considered to have failed potency testing. A Production Batch of Regulated Marijuana Product shall be considered homogeneous if a minimum of four servings from two packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label. A Production Batch of Regulated Marijuana Product shall be considered homogenous if a minimum of four servings from four individual single serve packaged units of a Test Batch has a relative standard deviation of less than 10 percent for each Cannabinoid listed on the label.

i. The potency for each of the four servings must be within the allowed potency variance set forth in subparagraph (E)(5) of this Rule 4-210. Any Cannabinoid that makes up less than 10 percent of the total amount of Cannabinoids in the Regulated Marijuana Product shall not be subject to the requirements set forth in this subparagraph (E)(4).

b. If an individually packaged Edible Medical Marijuana Product is determined to have more than the total milligrams of THC stated on the Container, or less than the total milligrams of THC stated on the Container, then the Test Batch shall be considered to have failed potency testing. Except that the potency variance provided for in subparagraph (E)(5) of this Rule 4-210 shall apply to potency testing.

c. If an individually packaged Edible Retail Marijuana Product is determined to have more than 100 milligrams of THC within it, then the Test Batch shall be considered to have failed potency testing. If an individually packaged Edible Retail Marijuana Product is determined to have more than the total milligrams of THC stated on the Container, or less than the total milligrams of THC stated on the Container, then the Test Batch shall be considered to have failed potency testing. If a single serving in an individually packaged Edible Retail Marijuana Product is determined to have more than 10 milligrams of THC then the Test Batch shall be considered to have failed potency testing. Except that the potency variance provided for in subparagraph (E)(5) of this Rule 4-210 shall apply to potency testing.

5.Potency Variance. Regulated Marijuana Product provided to the Regulated Marijuana Testing Facility must comply with the following potency variance:

a. For Regulated Marijuana Product with a Target Potency or making a potency claim for any Cannabinoid of more than 2.5 milligrams per serving the potency variance shall differ no more than plus or minus 15 percent.

b. For Regulated Marijuana Product with a Target Potency or making a potency claim for any Cannabinoid of 2.5 milligrams or less per serving the potency variance shall differ no more than the greater of plus or minus 0.5 mg or 40 percent per serving.

F.Potency Testing Required for Pre-Rolled Marijuana.

1. A Regulated Marijuana Business shall have potency tests conducted by a Regulated Marijuana Testing Facility on every Production Batch of each type of Pre-Rolled Marijuana product that it produces prior to Transferring or selling any of the Pre-Rolled Marijuana from that Production Batch if the Regulated Marijuana Business is using multiple strains from different sources (e.g. self-grown source, wholesale source) and/or selecting only a part of the Harvest Batch(es) that is not representative of the entire Harvest Batch each time they produce a certain type of Pre-Rolled Marijuana (e.g. using only the shake/trim out of a Harvest Batch).

2. If each type of Pre-Rolled Marijuana is created using select parts of a single strain (e.g. flower only, shake/trim only) or a specific ratio of strains from specified sources (e.g. self-grown source, wholesale source) defined by the Regulated Marijuana Business' Standard Operating Procedures, a Regulated Marijuana Business shall have potency tests conducted according to paragraph (F)(2)(a) and (b) of this Rule by a Regulated Marijuana Testing Facility for each type of Pre-Rolled Marijuana product that it produces prior to Transferring or selling any of the Pre-Rolled Marijuana from a Production Batch.

a.Initial Potency Testing. Initial potency tests shall be conducted by a Regulated Marijuana Testing Facility on four Production Batches, created a minimum of one week apart, for each type of Pre-Rolled Marijuana that is created using a single strain or a specific ratio of strains defined by the Regulated Marijuana Business' Standard Operating Procedures.

b.Ongoing Potency Testing. After the initial four potency tests, ongoing potency tests shall be conducted by a Regulated Marijuana Testing Facility at least once per quarter for each type of Pre-Rolled Marijuana that is created using a single strain or a specific ratio of strains defined by the Regulated Marijuana Business' Standard Operating Procedures.

G.Potency Testing Required for Infused Pre-Rolled Marijuana. A Regulated Marijuana Business shall have potency tests conducted by a Regulated Marijuana Testing Facility on every Production Batch of Infused Pre-Rolled Marijuana product that it produces prior to Transferring any of the Infused Pre-Rolled Marijuana from that Production Batch.

1 CCR 212-3-4-210

47 CR 21, November 10, 2024, effective 12/4/2024