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CBD market and legislation trends
With every passing moment, the popularity of CBD increases steadily, and the focus of new interest in this product has been overwhelming. Right from recreational use to constituent adjuncts in pharmaceuticals and a product traded in fluid currency on the stock market, CBD has more potential than meets the eye. In 2019, a business analysis report published by Forbes relied on current market indices and projected that the CBD market could reach $20 billion by 2024. A compound growth rate of 49 percent is also expected by 2024, with the assumption that all distribution channels remain active.
The 2018 Farm Bill legalized the supervised use of CBD derived from hemp under specified conditions—one of which dictates that a packaged CBD product should contain less than 0.3 percent volume of controlled cannabinoids such as THC and CBN. This legislation opens up the way for similar regulations in Asia and some other regions of the world. However, the use of CBD is still prohibited in most regions of Africa.
The legislation governing the use, sale, and commodity status of CBD has also put in place a few strict rules on quality assurance and total CBD product constituents. Accurate analysis and quality assurance tests are required to ascertain the quality level and potency rate of CBD. These tests are especially important for medical CBD products that are required by law to have no traces of pesticides, solvents, heavy metals, mycotoxins, and production stages contaminants.
Procedures for CBD testing
About 75 percent of the world’s total cannabinol production is channeled towards human use and as chemical agents in industrial production processes. There is a need that this product is obtained in pure forms without synthetic contaminants. The testing methods developed for the quality assessment of CBD generally involves sensitive and reproducible analytical procedures and instrumentations that can detect minute levels of contamination. These tests have special use in pharmaceuticals and medicine –pharmaceutical labels require an exact strength indication, and the CBD:THC ratio is an important consideration in prescribing CBD products.
There are several analytical methods designed for CBD testing. These analysis tests include gas chromatography and mass spectrometry (GC-MS), ultra-performance liquid chromatography (UPLC), and nuclear magnetic resonance spectrometry (NMR). Generally, these methods are acceptable standards for screening and quantifying cannabinoids levels at low concentrations. However, the method of choice depends on the quantity and reasons for the test. A paired test method of high-pressure liquid chromatography and mass spectrometer (HPLC/MS) is a popular method for CBD testing. This method evaluates potency, composition, and mycotoxin level –when paired with a fluorescence detector. The pesticide test is necessary to determine the maximum contaminant level (MCL) and verify quantity compliance with recommended limits.
CBD testing facilities also offer a Chemical Contaminant Test service. This is especially important in the detection of terpene and residual solvent levels. Terpenes impart a characteristic smell and test on CBD isolates and consequently reduce the medicinal quality of the final product. Isolates can also become partially bonded with residual chemical solvents, including acetone and ethanol. CBD products that are used as industrial distillates are required to be presented in pure isolates. Verification testing for these products is done with quantitative nuclear magnetic resonance spectroscopy.
Type 8 CBD testing license
Accredited testing constitutes an essential aspect of CBD use. Testing procedures are strictly governed by legislation and can only be undertaken by a licensed laboratory. In every region where CBD use is backed by law, a laboratory requires a valid license to verify product quality due to potential medico-legal issues. The best-recommended lab for CBD testing is an accredited CBD lab with a valid license for THC testing. Different government bureaus are responsible for a license granting and enforcing full regulatory compliance.
In California, the Bureau of Cannabis Control (BCC) regulates the commercial licensing of CBD use for medical purposes. Licensing for CBD-related trades involving retailers, microbusinesses, distributors, and laboratories fall under the direct jurisdiction of the BCC. A Type 8 CBD license allows a laboratory within the California region to perform CBD qualitative analysis assessments as might be required by individuals, production facilities, and corporate outlets. Type 8-licensed laboratories are also required to obtain and maintain ISO/IEC 17025 accreditation.
Requirements considered to secure a Type 8 license
The evaluation requirements and guidelines considered for granting a Type 8 CBD license for CBD are specified by Health Canada in a manner as determined by the Minister. Securing a Type 8 license starts with a filed application to confirm the need for an analytical testing license. As contained in the application guidelines, “analytical testing activities may include, but are not limited to, any combination of the following testing processes: chemical contaminants, microbial contaminants, cannabinoid content, dissolution or disintegration, sterility, stability, and pesticide testing.”
Following a successful application, the laboratory is required to create an account in the cannabis tracking and licensing system (CTLS). This digitalized portal of Health Canada enables the submission of applications, license renewal, and, most importantly, assessment of monthly tracking reports for CBD products. Laboratories are required to create a corporate profile account which involves linking individual accounts of responsible persons to a single corporate profile on the CTLS. A corporate user profile can only be created with specific requirements –full legal name, incorporation number, business contact, controlling organizations, certificate of incorporation, and the corporate organizational chart. Laboratories are further required to provide site information detailing site addresses and analytical testing procedures.
Site personnel with personal account profiles on the CTLS are also required to disclose records of academic qualifications and certifications. Detailed information of the adopted destruction method for disposing of CBD samples commissioned for analysis within 90 days of the batch collection is also required. Physical security requirements adopted by the laboratory to prevent unauthorized access to the testing facility and guarantee batch safety. Laboratories are also expected to submit a feasible plan for record-keeping and tracking of test samples—a copy of government-issued identification and signed attestation form id required to complete the application. On successful submission of an application, Health Canada reviews the application entries and updates the CTLS profile of the laboratory’s corporate profile to reflect application status—application status can be Draft, Submitted, In-progress, and Pending Information.
In all Type 8 license applications and evaluations, Health Canada reserves the right to grant or refuse to issue a license under the provisions outlined in the Cannabis Act and Cannabis Regulation.