6 CCR 1010-24
DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT COLORADO HEMP PRODUCT AND SAFE HARBOR HEMP PRODUCT REGULATIONS 6 CCR 1010-24 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Adopted by the Board of Health on November 15, 2023.
24.1 Authority
This regulation is adopted pursuant to Sections 25-5-420(1) and 25-5-427, Colorado Revised Statute (C.R.S.) and is consistent with the requirements of the State Administrative Procedure Act, Section 24-4- 101, et seq., C.R.S.
24.2 Scope and Purpose
A. This regulation shall be applied for the protection of public health by ensuring that the premises or places wherein hemp products and safe harbor hemp products are produced, manufactured, packed, processed, prepared, treated, packaged, transported, or held for distribution are in accordance with the “Pure Food and Drug Law”, Section 25-5-401 et seq., C.R.S.
B. This regulation shall govern the registration of hemp product manufacturers or storage facilities and safe harbor hemp product manufacturers or storage facilities. In accordance with the powers and duties delineated in Sections 25-5-420 and 25-5-427, C.R.S., the department has the following powers and duties:
1. To grant or refuse to grant registration and to grant or refuse to grant the annual renewal of a registration;
2. To deny, suspend, or revoke a registration;
3. To issue a cease-and-desist order or clean-up order to address violations; and 4. To review any records of a hemp product manufacturers or storage facilities and safe harbor hemp product manufacturers or storage facilities necessary to verify compliance.
C. This regulation does not apply to:
1. Wholesale food manufacturers and the premises or places wherein manufactured foods are produced, manufactured, packed, processed, prepared, treated, packaged transported, or held for distribution governed by the Colorado Wholesale Food and Shellfish Regulations, 6 CCR 1010-21.
2. Retail food establishments governed by the Colorado Retail Food Establishment Regulations, 6 CCR 1010-2;
3. Facilities or conditions governed by the Colorado Milk and Dairy Products Regulations, 6 CCR 1010-4;
4. Entities engaged in the business of possessing, cultivating, dispensing, transferring, transporting, or testing Medical Marijuana or Retail Marijuana governed by the Colorado Marijuana Rules, 1 CCR 212-3;
5. The cultivation of hemp governed by the Rules Pertaining to the Administration and Enforcement of the Industrial Hemp Regulatory Program Act, 8 CCR 1203-23;
6. Entities that are manufacturing intermediate or finished hemp products from the fibrous material of the plant that are not intended for human consumption. These products include, but are not limited to, cordage, paper, fuel, textiles, bedding, insulation, construction materials, compost materials, hemp crete and industrial materials; and 7. Testing performed by a certified laboratory in accordance with the Hemp Testing Laboratory Certification, 5 CCR 1005-5.
D. Nothing in this rule shall be construed to limit the department’s statutory authority under the “Pure Food and Drug Law” at Section 25-5-401 et seq., C.R.S., the “Shellfish Dealer Certification Act” at Section 25-4-1801 et seq., C.R.S., disease investigation, reporting and control pursuant to Sections 25-1.5-101 and 25-1.5-102, C.R.S., or enforcement of “Sanitary Regulations” pursuant to Section 25-4-101 et seq., C.R.S.
24.3 Applicability
A. This rule establishes registration requirements for hemp manufacturers or storage facilities and safe harbor manufacturers or storage facilities in accordance with Section 25-5-427, C.R.S.
1. These regulatory requirements do not infer conformance with federal laws, nor do they determine the allowability of the sale and distribution of hemp products and safe harbor hemp products to other states or countries.
B. Pursuant to Section 24.6, this rule incorporates by reference 21 Code of Federal Regulations (CFR) 100-111, 113-170, and 172-190 (April 1, 2017).
C. This rule establishes enforcement standards for hemp product manufacturers or storage facilities and safe harbor hemp product manufacturers or storage facilities pursuant to Sections 25-1.5- 102(1)(c), 25-5-406, 25-5-420, and 25-5-427(8)(a)-(d), C.R.S.
24.4 Definitions
A. For the purpose of these rules and regulations, unless otherwise specified herein:
1. Approved Source means:
a. Cultivated hemp from a state that has an approved United States Department of Agriculture hemp program; or b. A product from a wholesale food manufacturer, hemp product manufacturer or storage facility registered with the department in accordance with Section 25-5- 426 or 427, C.R.S; or c. A substance that is Generally Recognized As Safe (GRAS); or d. Hemp products or ingredients from a state that inspects or regulates hemp products under a food safety program or equivalent criteria to ensure safety for human consumption; or e. If the state does not inspect or regulate hemp products or ingredients, the out-of- state hemp source can demonstrate equivalency by:
2. Broad spectrum means hemp products that contain multiple cannabinoids and no more than 0.05 milligrams per gram of total THC and no more than 6.0 milligrams of total THC per container.
3. Certified laboratory means a public or private laboratory or testing facility certified by the department to perform testing on hemp and hemp products in accordance with Hemp Testing Laboratory Certification, 5 CCR 1005-5.
4. Certificate of Analysis means an official document issued by a certified laboratory that shows the results of scientific tests performed on a product.
5. Cosmetics means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance or an article intended for use as a component of any such articles; except that such term does not include soap.
6. Department means the Colorado Department of Public Health and Environment.
7. Dietary supplement means a product taken by mouth that contains a dietary ingredient or a new dietary ingredient intended to supplement the diet.
8. Full spectrum means a hemp product that contains all phytochemicals naturally found in the plant, trace cannabinoids, terpenes, and essential oils, with no more than 1.75 milligrams of THC per serving and contains a ratio of cannabidiol to THC of greater than or equal to fifteen to one.
9. Generally Recognized As Safe (GRAS) means any substance that is intentionally added to food which is a food additive, that is subject to premarket review by the U.S. Food and Drug Administration (FDA), unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definitions of food additive.
10. Hemp has the meaning set forth in Section 35-61-101 (7) C.R.S.
11. Hemp manufacturer or storage facility means a facility where hemp products are manufactured or stored.
12. Hemp product means a finished product that contains hemp and that:
a. Is a cosmetic, a dietary supplement, a food, a food additive, or an herb;
b. Is intended for human use or consumption;
c. Contains any part of the hemp plant, including naturally occurring cannabinoids, compounds, concentrates, extracts, isolates, or resins;
d. Is produced from hemp;
e. Contains no more than 1.75 milligrams of tetrahydrocannabinol (THC) per serving; and f. Contains a ratio of cannabidiol (CBD) to THC of greater than or equal to 15 to one (15:1).
13. Herb means any plant with leaves, seeds, or flowers used as a flavoring, food, food additive, or dietary supplement ingredient.
14. Intoxicating cannabinoid means any of the following in an amount that exceeds the amount established by rule or, if no rule establishes the amount, in any amount:
a. Delta-10 THC and its isomers;
b. Delta-9 THC and its isomers;
c. Delta-8 THC and its isomers;
d. Delta-7 THC and its isomers;
e. Delta-6a, 10a THC and its isomers;
f. Exo-tetrahydrocannabinol;
g. Metabolites of THC, including 11-hydroxy-THC, 3-hydroxy-THC, or 7-hydroxy- THC;
h. Hydrogenated forms of THC, including hexahydrocannabinol, hexahydrocannabiphorol, and hexahydrocannabihexol;
i. Synthetic forms of THC, including dronabinol;
j. Ester forms of THC, including delta-8 THC-O-acetate, delta-9 THC-O-acetate, and hexahydrocannabinol-O-acetate;
k. Tetrahydrocannabivarins, including delta-8 tetrahydrocannabivarin but excluding delta-9 tetrahydrocannabivarin (THCV);
l. Analogues or tetrahydrocannabinols with alkyl chain of four or more carbon atoms, including tetrahydrocannabiphorols, tetrahydrocannabioctyls, tetrahydrocannabihexols, or tetrahydrocannabutols; and m. Any combination of the compounds, including hexahydrocannabiphorol-o-ester.
15. Labeling means a display of written, printed, or graphic matter upon a food, cosmetic, dietary supplement, ingredient container, or package and includes product inserts, and other promotional materials including digital communications.
16. Law means applicable local, state, and federal statutes, regulations and ordinances.
17. Manufacturing or processing, manufacturing, manufacture, process, or processing has the meaning set for in Section 25-5-426(2)(h) C.R.S.
18. Non-intoxicating cannabinoid means:
a. Full spectrum hemp extract that contains no more than 1.75 milligrams of THC per serving and contains a ratio of cannabidiol (CBD) to THC of greater than 15 to one (15:1);
b. Broad spectrum hemp extract;
c. Cannabidiol (CBD);
d. Delta-9 tetrahydrocannabivarin tetrahydrocannabivarin (THCV);
e. Cannabichromene (CBC);
f. Cannabicitran (CBT);
g. Cannabicyclol (CBL);
h. Cannabielsoin (CBE);
i. Cannabigerol (CBG);
j. Cannabidivarin (CBDV); and k. Cannabinol (CBN);
19. Packaging means any type of container, wrapping, or other type of vessel intended to protect both food, cosmetics or dietary supplements from damage, contamination, spoilage, pest attacks, and tampering, during transport, storage, and sale.
20. Physical separation means segregation of the operations of a regulated hemp facility:
a. Including the physical separation of hemp products and safe harbor hemp products during manufacture, production, storage, and distribution; and b. The use of separate equipment for the manufacture or production of hemp products and safe harbor hemp products.
21. Potentially intoxicating cannabinoid has the meaning set forth in Section 44-10-103(48.5), C.R.S.
22. Process Validation means the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
23. Registrant means a person registered under Section 25-5-427(5), C.R.S.
24. Regulated hemp facility means:
a. A hemp manufacturer or storage facility; or b. A safe harbor manufacturer or storage facility.
25. Safe harbor hemp product means a hemp-derived compound or cannabinoid, whether a finished product or in the process of being produced, that is permitted to be manufactured for distribution, produced for distribution, packaged for distribution, processed for distribution, prepared for distribution, treated for distribution, transported for distribution, or held for distribution in Colorado for export from Colorado but that is not permitted to be sold or distributed in Colorado.
26. Safe harbor hemp manufacturer or storage facility or safe harbor hemp facility means a facility that manufactures for distribution, produces for distribution, packages for distribution, processes for distribution, prepares for distribution, treats for distribution, transports for distribution, or holds for distribution a safe harbor hemp product.
27. Semi-synthetic cannabinoid means a substance that is created by a chemical reaction that converts one cannabinoid extracted from a cannabis plant directly into a different cannabinoid.
a. Semi-synthetic cannabinoid includes cannabinoids, such as cannabinol (CBN) that was produced by the conversion of cannabidiol (CBD).
b. Semi-synthetic cannabinoid does not include cannabinoids produced via decarboxylation of naturally occurring acidic forms of cannabinoids, such as tetrahydrocannabinolic acid, into the corresponding neutral cannabinoid, such as THC, through the use of heat or light, without the use of chemical reagents or catalysts, and that results in no other chemical change.
28. Serving means the size or portion customarily consumed per eating occasion, expressed in a common household measure as establish in Table 2 of 21 CFR 101.12.
29. State licensing authority has the meaning set forth in Section 44-10-103(69), C.R.S.
30. Synthetic cannabinoid means a cannabinoid-like compound that was produced by using chemical synthesis, chemical modification, or chemical conversion, including by using in- vitro biosynthesis or other bioconversion of such a method.
a. Synthetic cannabinoid does not include:
31. Tetrahydrocannabinol (THC) means the substance contained in the plant cannabis species, in the resinous extracts of the cannabis species, or a carboxylic acid of, derivative of, salt of, isomer of, or salt or acid of an isomer of these substances.
a. Tetrahydrocannabinol (THC) includes:
b. Tetrahydrocannabinol or THC may also contain:
32. Tincture means a liquid hemp product that is packaged in a container of four fluid ounces or less, that is not a beverage or intended for drinking, and that consists of a solution:
a. Containing at least 25% non-denatured alcohol or a base of glycerin or plant- based oil;
b. Containing hemp, hemp concentrate, or hemp extract; and c. Intended for human use.
33. Total THC means the sum of the percentage by weight of the THCAs multiplied by 0.877 plus the percentage by weight of THC [i.e., (% THCA x 0.877) + % THC].
34. Unfinished hemp product means an oil, extract, concentrate or other substance that has a total THC concentration above 0.3%, is not for consumer use or retail distribution, and will undergo further refinement or processing into a hemp product or safe harbor hemp product.
24.5 Registration Requirements
A. Regulated hemp facilities in Colorado must be registered in accordance with Section 25-5-427(5), C.R.S.
1. The owner of any regulated hemp facility must submit to the department an application each year for registration, along with applicable application and registration fees, using forms provided by the department.
2. The owner of any regulated hemp facility must also submit to the department complete and accurate information about the facility’s operation and business size, using forms provided by the department.
B. In addition to the requirements in Section 24.5(A) of this rule, safe harbor hemp product manufacturers or storage facilities must demonstrate compliance with the federal current good manufacturing practices for food or dietary supplements before registering or within 12 months after the previous registration by submitting to the department:
1. Evidence of obtaining an inspection from a department-approved third-party auditor by July 1, 2024, and by July 1 of each year thereafter.
2. An attestation form, as provided by the department, by July 1 of each year that includes, but may not be limited to, the following:
a. The safe harbor hemp product manufacturer or storage facility does not export a safe harbor hemp product to a state where the safe harbor hemp product is prohibited by state law; and b. The safe harbor hemp product manufacturer or storage facility does not manufacture, produce, or distribute a synthetic cannabinoid; and c. The safe harbor hemp product is manufactured, produced, tested, labeled, stored, and distributed in accordance with all applicable rules; and d. The safe harbor hemp product manufacturer or storage facility is:
24.6 Incorporation by Reference
A. The department shall utilize material incorporated by reference as appropriate to assure that regulated hemp facilities comply with the “Pure Food and Drug Law”.
1. 21 CFR 100-190 (April 1, 2017) is hereby incorporated by reference into this rule. Such incorporation, however, excludes later amendments to or editions of the reference material.
B. Any provision included or incorporated herein by reference which conflicts with the Colorado Revised Statutes, including but not limited to Section 25-5-401 et seq., C.R.S., and Section 25- 1.5-102, C.R.S., shall be null and void. These regulations do not incorporate by reference:
1. 21 CFR 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
2. 21 CFR 171, Food Additive Petitions.
C. The incorporated material is available for public inspection during regular business hours at: Colorado Department of Public Health and Environment 4300 Cherry Creek Drive South Denver, Colorado 80246-1530 Pursuant to Section 24-4-103(12.5)(b), C.R.S., the agency shall provide certified copies of the material incorporated at cost upon request or shall provide the requestor with information on how to obtain a certified copy of the material incorporated by reference from the agency of the United States, this state, another state, or the organization or association originally issuing the code, standard, guideline or rule.
D. The incorporated materials are available at:
https://www.ecfr.gov/cgi-bin/text- idx?SID=2029b930ffb25f468e235e6ec9a86dea&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl
24.7 Regulated Hemp Facility Manufacturing Requirements
A. Prior to manufacturing, packaging, or distributing a regulated hemp facility must:
1. Be registered with the department;
2. Obtain any other necessary state or local licenses, permits, registrations or approvals.
3. Comply with state law, local ordinances, these governing regulations and all other applicable state and local regulations; and 4. Have conspicuously posted all applicable documentation in accordance with the law.
B. Ingredients 1. All ingredients must come from approved sources;
2. All ingredients shall be clearly identified to allow for appropriate traceability. Identification includes:
a. Name of ingredient;
b. Identifying batch or lot number from original package;
c. Date the ingredient was manufactured;
d. Date the ingredient was received at the facility; and e. Expiration, re-test, or use-by date.
3. Spoiled, unwholesome, adulterated, vermin- or insect-infested ingredients are not allowed into the facility and shall be:
a. Removed immediately from the premises and properly disposed; or b. Placed in a quarantine area temporarily until proper disposal if:
C. Approved Solvents 1. The use of solvents for manufacturing within a regulated hemp facility is limited to those listed in the following table:
D. Testing 1. Analytical testing shall be performed by a certified laboratory in accordance with the department’s Hemp Testing Laboratory Certification rules, located at 5 CCR 1005-5.
2. Any exceedance of the potency or contaminant action limits presented in this Section 24.7(D) shall be reported to the department by the regulated hemp facility within 48 hours of receipt of the confirmed analytical testing results.
a. If a regulated hemp facility product is found to contain a contaminant at levels exceeding those permissible under this regulation, then it shall be considered to have failed contaminant testing.
b. Notwithstanding the permissible levels established in this regulation, the department reserves the right to determine, upon good cause and reasonable grounds that a particular hemp product or safe harbor hemp product may present a risk to public health or safety, and may request additional laboratory testing to demonstrate a product does not present a risk to public health or safety.
3. All certificates of analysis provided as documentation of conformance with the established testing requirements shall be furnished from a certified hemp testing laboratory.
4. Regulated hemp facilities are responsible for ensuring the testing requirements listed in subparagraphs 24.7(D)(5) and (6) of this rule are met, and must maintain certificates of analysis on any regulated hemp products they produce or transfer to ensure safety on all lots or batches. The testing requirements contained in this regulation are the minimum required and approved testing standards.
5. THC and Other Cannabinoid Content a. All regulated hemp facility products must have testing results for any cannabinoid that is a known component and for any ingredient for which there is a label claim. Any unidentified peak present at more than 1.0% of the total peak area in a regulated hemp facility product will be investigated and, if determined to be an unlabeled cannabinoid, will be considered to have failed THC and other cannabinoid testing.
b. Hemp products must have laboratory test results indicating the product is:
c. Safe harbor hemp products must have test results indicating cannabinoid levels, including listing THC and other intoxicating or potentially intoxicating cannabinoid levels.
6. Contaminant Testing Requirements and Limits a. Microbials (Bacteria and Fungus)
b. Mycotoxins Action Limits Substance Parts per billion (ppb)
< 20 Aflatoxins (B1, B2, G1, and G2)
(total of B1 + B2 + G1 + G2)
c. Pesticides The following pesticides are not allowed in regulated hemp facility products and should not be detected during laboratory testing at the limits of quantification
d. Heavy Metals Action Limits Substance Parts per million (ppm)
e. Residual Solvents Substance Action Limits Parts per million (ppm)
E. Packaging and Labeling Requirements (effective June 1, 2024) 1. Packaging shall be food-grade or GRAS 2. Labeling of safe harbor products at point of retail sale to consumer shall be in accordance with the requirements listed in 24.7(E), unless compliance with these provisions is not in conformance with the requirements of the state to which the product is being distributed.
a. Safe harbor product labels and packaging shall include a notice that identifies that the product is approved for sale outside of Colorado.
3. Labeling shall be performed in accordance with 21 CFR 101, subparts A–G and the department’s labeling requirements for hemp products, which include:
a. All information appearing on the principal display panel or the information panel must appear prominently and conspicuously, but in no case may the letters and numbers be less than one-sixteenth inch (1/16”) in height unless the regulated hemp facility product meet the exemption pursuant to section 24.7(10).
b. Product Identity Statement which indicates the common or usual name of the ingredient;
c. Net Weight Statement placed as a distinct item parallel to the base of the package in the bottom third of the principal display panel.
d. Identify on the principal display panel or the information panel that the product is produced from hemp, then sequentially:
e. Identify, in milligrams, the total THC content per serving, total THC content per individual product package, and the ratio of cannabidiol (CBD) to THC per serving in the ingredient list or directly below the ingredient list in bold type;
f. Any major food allergens, milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, sesame, wheat and soybeans shall be clearly identified and listed separately.
g. For hemp products, the serving and number of servings per product package in accordance with Table 2, 21 CFR 101.12.
h. Manufacturing address or a qualifying phrase which states the firm's relation to the product if contract manufactured, relabeled, or distributed by another company (e.g., “manufactured for” or “distributed by”).
i. A code or numbering system that identifies the date and location of manufacturing and packaging.
4. Qualified health claims for hemp products must follow Federal Trade Commission (FTC) and FDA regulations and guidance, including marketing materials and electronic communications.
5. A manufacturer, distributor, or seller shall not include on the label of the product, or publish or disseminate in marketing or electronic communications, any claims that the product can, or is intended to, diagnose, cure, mitigate, treat, or prevent disease.
6. Labeling of a cosmetic shall bear a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product. This applies to qualified claims on products as well as ingredients, aerosol products, deodorant products, foaming detergent bath products, coal tar hair dyes, sun-tanning and sunscreen products.
7. With the exception of broad spectrum products and cosmetics, the label of regulated hemp facility products that contains any tetrahydrocannabinol (THC), potentially intoxicating cannabinoids, or intoxicating cannabinoids must include a consumer notice statement that discloses the presence of the tetrahydrocannabinol (THC), potentially intoxicating or intoxicating cannabinoids, and includes at least the following notices:
a. The potential for these products to cause a positive drug test result;
b. The potential for these products to create impairment;
c. Statement that these products have not been evaluated for safety or efficacy;
d. Recommending those who are pregnant, may become pregnant, or are breastfeeding to consult with their physician about the use of these products; and e. Statement to keep out of the reach of children.
8. The label of regulated hemp facility products that contain cannabidiol (CBD) must include a consumer notice statement that discloses the presence of the CBD, and includes at least the following notices:
a. Recommending those who are pregnant, may become pregnant, or are breastfeeding to consult with their physician about the use of these products; and b. The product may cause health problems including liver injury, damage to male reproductive health, and sedative effects that may impair your ability to drive a motor vehicle or operate machinery.
9. The consumer notice statement requirements in 24.7(E)(7) and (8) must appear on the label in at least one-sixteenth inch (1/16”) letter height and in bold type.
10. If tincture or small product package labeling requires a type size smaller than one- sixteenth inch (1/16”), the product must be accompanied by labeling, such as a marketing layer, attached to the package that appears prominently and conspicuously and meets the above type-size requirements.
11. Labels and packaging shall not be designed to appeal to children. Labels on regulated hemp facility products shall not contain any content that reasonably appears to target individuals under the age of 21, including but not limited to cartoon characters or similar images.
F. Record Keeping 1. The following records shall be maintained:
a. Certificates of analysis of ingredients;
b. Source of ingredients;
c. Batch production records including;
d. Certificate of analysis of finished products;
e. Recalled product information;
f. Adverse health event reporting, including to the extent known after reasonable diligence to ascertain the information, the name and contact information of the complainant, the date the complaint was received, the nature of the complaint, the production batch or lot number, any other identifying information found on the label of the regulated hemp facility product, corrective steps taken, and recall activities completed;
g. Consumer complaints; and h. Other records as required by the department (e.g., corrective action logs, equipment calibration records, equipment cleaning records as applicable).
2. Records shall:
a. Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records;
b. Contain the actual values and observations obtained during monitoring and, as appropriate, during verification activities;
c. Be accurate, indelible, and legible;
d. Be created concurrently with performance of the activity documented;
e. Be as detailed as necessary to provide history of work performed, and include:
3. Records shall be retained:
a. At the plant or facility for at least 2 years after the date they were prepared for products identified as foods, food additives and cosmetics; and b. For one year past the shelf life date, if shelf life dating is used, or two years beyond the date of distribution of the last batch of dietary supplements.
G. Recalls 1. Regulated hemp facilities shall establish a written recall plan in accordance with 21 CFR 117.139, Recall Plan, that includes procedures that describe the steps to be taken, and assigns responsibility for taking those steps, to perform the following actions as appropriate to the facility:
a. Directly notify the direct consignees of the hemp product or safe harbor hemp product being recalled, including how to return or dispose of the affected product;
b. Notify the public about any hazard presented by the product when appropriate to protect public health;
c. Conduct effectiveness checks to verify that the recall is carried out; and d. Appropriately dispose of recalled product (e.g., through reprocessing or reworking as appropriate, or diverting to a use that does not present a safety concern, or destroying the product).
H. Transportation 1. Transfer of hemp products shall be conducted in accordance with all applicable transportation laws.
2. Hemp products and safe harbor products shall be transported in a manner where they will be protected from adulteration, allergen cross-contact, environmental contamination and any other hazards.
I. Waste and Hazardous Waste Management 1. Waste THC shall be diluted to a concentration of less than 0.3%, converted, or disposed of in accordance with the department’s Hazardous and Waste Management Division’s Marijuana and Marijuana-Related Waste Disposal Compliance Bulletin.
2. The facility owner/operator is responsible to secure and limit access to hemp-derived THC with a concentration greater than 0.3%.
3. Waste management shall be conducted in accordance with the Colorado Hazardous Waste Regulations (6 CCR 1007-3) and the Colorado Solid Waste Regulations (6 CCR 1007-2).
24.8 Additional Requirements for Safe Harbor Manufacturers
A. Safe harbor hemp product manufacturers shall maintain records for at least two years indicating:
1. Distributor, retailer or individual that purchased the safe harbor product;
2. The state the sale was made to, and records documenting the product is not prohibited in the state where sale was completed;
3. THC or other cannabinoid concentration limits from the receiving state per serving and/or per container for each product; and 4 Labeling requirements from the receiving state that differ from those listed in this rule in section 24.7(E).
And B. Physical separation, as defined in Section 24.4(20) of this rule, is required for a safe harbor hemp manufacturer or storage facility and a hemp product manufacturer or storage facility. Or C. The safe harbor hemp product registrant has received approval from the department on a process validation that demonstrates no cross contamination between products and includes all of the following:
1. A comprehensive list of products being manufactured, including a list of cannabinoids in the products;
2. Equipment used in production;
3. Production methodologies;
4. Procedures and chemicals used in cleaning equipment;
5. Test results of equipment and products for residual cannabinoids;
6. Environmental swab protocol to include frequency, location, contaminant or organism of concern, results and response to positive results;
7. Packaging materials and distribution methods;
8. Record keeping; and 9. Quality assurance program, including change management. Or D. The safe harbor hemp product registrant has received approval from department for production, storage and distribution procedures. Procedures must include elements listed in 24.8(C)(1-4, 6, 7, 8, 9) along with:
1. Sampling protocols for testing finished products for residual cannabinoids;
2. Product hold or release criteria; and 3. Enhanced recall response procedures that ensures notification to consumers, distributors and retailers of contaminated product and when necessary, removal of product from commerce and the market.
24.9 Offenses
A. The manufacture, production, or distribution of a hemp product or safe harbor hemp product that is also a synthetic cannabinoid is prohibited.
B. The manufacture, production, or distribution of a hemp product that contains potentially intoxicating cannabinoids is prohibited, unless specifically allowed by regulation.
C. The manufacture, production, or distribution of a hemp product that contains intoxicating cannabinoids other than THC within allowed limits is prohibited.
D. The chemical modification, conversion, or synthetic derivation of cannabinoids or other hemp- derived compounds, except for those defined as non-intoxicating cannabinoids, for use as a hemp product or ingredient in a hemp product is prohibited.
E. The manufacture of a product containing hemp that is not a cosmetic, a dietary supplement, a food, a food additive or an herb is prohibited.
F. The manufacture of a hemp product that contains more than 1.75 milligrams of total THC per serving is prohibited.
G. The manufacture of a hemp product that has a ratio of cannabidiol (CBD) to THC of less than fifteen to one (15:1) is prohibited.
H. The manufacture of a hemp product in a package with more than five servings is prohibited if the hemp product:
1. Has more than 1.25 milligrams of total THC per serving with a ratio of cannabidiol (CBD) to THC of less than fifteen to one (15:1).
2. This Section does not apply to:
a. Broad spectrum hemp products;
b. Tinctures;
c. Cosmetics; or d. A hemp product that the United States Food and Drug Administration has determined is general recognized as safe under the “Federal Food, Drug and Cosmetic Act”, 21 U.S.C. Sec. 301 et seq.
I. The manufacture of a hemp product in a package with more than thirty servings is prohibited if the hemp product:
1. Has more than 1.25 milligrams of total THC per serving with a ratio of cannabidiol (CBD) to THC of less than twenty to one (20:1).
2. This Section does not apply to:
a. Broad spectrum hemp products;
b. Tinctures;
c. Cosmetics; or d. A hemp product that the United States Food and Drug Administration has determined is general recognized as safe under the “Federal Food, Drug and Cosmetic Act”, 21 U.S.C. Sec. 301 et seq.
J. The distribution of a hemp product without the required age labeling and consumer notice statements as listed in Sections 24.7(E)(3)(c)(1) and 24.7(E)(7) and (8) of this rule is prohibited.
K. The distribution of a safe harbor product in Colorado or to a state that prohibits the product is prohibited.
24.10 Enforcement
A. Hemp product manufacturers or storage facilities that fail to submit a complete and accurate annual application for registration, or fail to remit fees in accordance with Section 25-5-427(5), C.R.S., are not considered an approved source for introduction of hemp products into commerce.
B. Safe harbor hemp product manufacturers or storage facilities that fail to submit a complete and accurate annual application for registration, an attestation form, evidence of inspection from an approved third party auditor, or fail to remit fees in accordance with Section 25-5-427(5), C.R.S., are prohibited from introducing safe harbor hemp products into commerce.
C. Adulterated or misbranded hemp products and safe harbor hemp products, including hemp products and safe harbor hemp products from unapproved sources, may be embargoed in accordance with Section 25-5-406, C.R.S.
D. In accordance with Section 25-1.5-102(1)(c), C.R.S., the department may require hemp product or safe harbor hemp product manufacturers to recall adulterated or misbranded products in order to investigate and control the causes of epidemic and communicable diseases affecting public health.
E. Pursuant to Sections 25-5-420 and 25-5-427(9), C.R.S., if the department has reasonable cause to believe a violation of this regulation has occurred and immediate enforcement is necessary, it may issue a cease-and-desist order, which shall set forth the provisions alleged to have been violated, the facts constituting the violation, and the requirement that all violating actions immediately cease.
1. At any time after service of the order to cease and desist by certified mail, the person for whom such order was served may request a hearing to determine whether such violation has occurred. Such hearing will be conducted in conformance with the provisions of article 4 of title 24, C.R.S. and shall be determined promptly.
F. To the extent and manner authorized by law, the department may issue letters of admonition or may deny, suspend, refuse to renew, restrict, or revoke any regulated hemp facility the regulated hemp facility has:
1. Refused or failed to comply with any provision of this regulation, requirements of 25-5- 427 C.R.S., or any lawful order of the department;
2. Refused to provide the department with reasonable, complete, and accurate information when requested by the department; or 3. Falsified records or information submitted to the department. _________________________________________________________________________ Editor’s Notes History New rule eff. 01/14/2024.