Utah Admin. Code 70-580-5

Current through Bulletin 2024-23, December 1, 2024

Section R70-580-5 - Certificate of Analysis

1) At a minimum, the certificate of analysis for each batch of kratom product shall include the following test results:

(a) the contents of mitragynine and 7-hydroxymitragynine in the kratom product certifying compliance with this rule and Subsection 4-45-104(1);

(b) the level of pathogens in the kratom product does not exceed the amounts listed in Table 1 when one gram or greater sample is tested; and

TABLE 1
Microbial Analytes and Action Levels	Microbial Limit Requirement
Total Aerobic Microbial Count	NMT <=10,000,000 cfu/g
Total Combined Yeast and Mold	NMT <=100,000 cfu/g
Total Bile-tolerant Gram-negative Bacteria	NMT <10,000 cfu/g
Salmonella spp. & E. coli	Absence in 100g

(c) that the levels of heavy metals in the kratom product do not exceed the amounts listed in Table 2.

TABLE 2 Heavy Metals
Metals	Natural Health Products Acceptable limits in parts per million
Arsenic	<2
Cadmium	<0.82
Lead	<1.2
Mercury	<0.4

2) Testing shall be performed on finished kratom products as identified by lot or batch number.

3) The certificate of analysis shall also include the following information:

a) the lot or batch identification number of the tested product;

b) the date received;

c) the date of testing completion;

d) the method of analysis for each test conducted;

e) a photo of the kratom product that was tested;

f) the name and address of the kratom processor that manufactured the product; and

g) the name and address of the laboratory that completed the testing.

4) The lot or batch number on the certificate of analysis shall match the lot or batch number on the kratom product and shall be conspicuously placed on the container or label of the kratom product.

5) Upon receipt of an adverse or non-compliant test result, the kratom processor shall be required to produce a new certificate of analysis from an independent third-party laboratory on the reported product to affirm compliance.

6) Failure to submit a new certificate of analysis shall be cause for withdrawal or denial of product registration.

7) Mycotoxin testing of a kratom product may be required if the department has reason to believe that mycotoxins may be present.

Utah Admin. Code R70-580-5

Adopted by Utah State Bulletin Number 2021-08, effective 4/2/2021

Amended by Utah State Bulletin Number 2023-06, effective 2/27/2023