Navigating the new Colorado Hemp Regulations, so you don’t have to.

“All ingredients shall be clearly identified to allow for appropriate traceability. Identification includes:

• Name of ingredient;
• Identifying batch or lot number from original package;
• Date the ingredient was manufactured;
• Date the ingredient was received at the facility; and
• Expiration, re-test, or use-by date.”

• Acetic acid. Acetone
• Anisole 1-Butanol
• 2-Butanol Butyl acetate
• Carbon dioxide tert-Butylmethyl ether
• Dimethyl sulfoxide Ethanol
• Ethyl acetate Ethyl ether
• Ethyl formate Formic acid
• Heptane Isobutyl acetate
• Isopropyl acetate Methanol
• 3-Methyl-1-butanol Methylene chloride
• Methyl acetate 2-Methyl-1-propanol
• Methylethyl ketone Pentane
• 1-Pentanol Propane
• 1-Propanol 2-Propanol (isopropyl alcohol)
• Propyl acetate Triethylamine”

• Certificates of analysis of ingredients;
• Source of ingredients;
• Batch production records including;
• Any records required based on department approval for co-ocation and use of equipment for hemp and safe harbor products in accordance with Section 24.8 of this rule. Certificate of analysis of finished products;
• Recalled product information; and Adverse health event reporting, including to the extent known after reasonable diligence to ascertain the information, the name and 18 contact information of the complainant, the date the complaint was 19 received, the nature of the complaint, the production batch or lot 20 number, any other identifying information found on the label of the 21 regulated hemp facility product, corrective steps taken, and recall 22 activities completed;

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 assign responsibility for taking those steps, to perform the following actions as appropriate to the facility:

• 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;
• Notify the public about any hazard presented by the product when appropriate to protect public health;
• Conduct effectiveness checks to verify that the recall is carried out; and 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).

• A comprehensive list of products being manufactured, including a list of cannabinoids in the products;
• Equipment used in production; Production methodologies; Procedures and chemicals used in cleaning equipment;
• Test results of equipment and products for residual cannabinoids;
• Environmental swab protocol to include frequency, location, contaminant or organism of concern, results and response to positive results;
• Packaging materials and distribution methods;
• Record keeping; and Quality assurance program, including change management.