Dedicated to protecting and improving the health and environment of the people of Colorado

June 15, 2016

Jim Burack, Director
Marijuana Enforcement Division
Colorado Department of Revenue
455 Sherman Street, Suite 390
Denver, CO 80203
RE: Regulation Change for Permissible Levels of Residual Solvents in R712(E)(2) and M712(E)(2)
Dear Mr. Burack:
We recommend changing the acceptable limits of residual solvents in R712(E)(2) and M712(E)(2) to
reflect conservative health-based criteria. The specific changes for each solvent are reflected in Table
1 below. The proposed limits are consistent with those adopted by international organizations1 for
residual solvents in pharmaceuticals and by the Association of Public Health Laboratories2 for residual
solvents in cannabis extracts. These proposed health-based limits (except benzene) are based on the
toxicity of individual solvents and the magnitude of exposure expected to occur from consuming 10
grams. The proposed limit for benzene is an absolute limit based on its status as a carcinogen.
Table 1 Current and proposed acceptable residual solvent limits
Solvent
Current Acceptable Limits
Proposed Acceptable Limits
R712(E)(2) and M712(E)(2)
(ppm)
(ppm)
Butanes
<800
<5,000
Heptanes
<500
<5,000
Benzene
<1
<2
Toluene
<1
<890
Hexane
<10
<290
Xylenes
<1
<2,170
The documents linked in the footnotes of this letter provide the complete scientific justification.
Please let me know if additional justification or description is necessary.
Sincerely,
Mike Van Dyke, Ph.D., CIH
Chief, Environmental Epidemiology, Occupational Health, and Toxicology Branch
Mike.vandyke@state.co.us

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for

Human Use, ICH Harmonized Tripartite Guideline, Impurities: Guideline for Residual Solvents Q3C (R5) (ICH Q3C),
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Step4/Q3C_R5_Step4.pdf
2
Association of Public Health Laboratories, Guidance for State Medical Cannabis Testing Programs, May 2016,
http://www.aphl.org/aboutAPHL/publications/Documents/EH-Guide-State-Med-Cannabis-052016.pdf

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