What types of hemp products are there?
The production and use of hemp-containing foodstuffs (from commercial hemp / Cannabis sativa) has increased enormously in recent years. Consumers can legally buy hemp seeds, oils, hemp-containing teas and other hemp-containing beverages as well as hemp protein powder in supermarkets. Cosmetics and grooming products, as well as pet food, can also be infused with cannabis and purchased on the market.
CBD (cannabidiol) products are sold in the form of oils, chewing gum, creams, gels, or gummy bears. CBD products must also be approved by the EU Commission.
In addition, since 2017, general practitioners or specialists can also prescribe medicinal cannabis in the form of e.g. flowers or extracts in standardized quality.
The legal situation of cannabis, THC or CBD is evaluated and decided nationally. More and more countries are legalizing the use of medical cannabis.
- In Germany, all forms of cannabis are considered illegal, except for the so-called useful hemp (poor in cannabinoids), which may be cultivated with a license and also used in food.
- In the USA, cannabis is being legalized in more and more states. This is decided at the federal level. Medical use of cannabis is already allowed in a majority of states.
CBD (cannabidiol) products are legal if they are derived from commercial hemp and contain less than 0.2% THC (in Germany).
If the content of THC is higher than 0.2% and CBD is extracted from cannabis sativa, these products fall under the narcotics law. Only a prescription from a doctor is then legal.
Why are analyses necessary?
Different application possibilities, different ways of extracting cannabis and correspondingly different contents of THC and CBD require professional analyses of hemp products. Depending on the level of THC and the method of extraction, the product can be classified as novel food, food, medical product, pharmaceutical or dietary supplement.
Accordingly, it is necessary to perform the appropriate analyses so that you as a manufacturer can safely place your cannabis product on the market. This way, you can offer your customers a high-quality and clean product and also prove this by a certificate of analysis.
Special challenges in the analysis of hemp products
In order to be allowed to analyze products containing hemp, it is necessary to obtain a license from the Federal Opium Agency, as the active ingredient THC is a narcotic.
A special challenge in the analysis of hemp products is the determination of the cannabinoid profiles. Special and, above all, precise analysis methods are necessary in order to differentiate between the various profiles, some of which are very similar.
For this reason, it is essential to have a competent laboratory partner who is able to distinguish between the two profiles mentioned above and who can also determine the other profiles such as THCV, CBC or CBL.
The Tentamus laboratories have developed a special analysis method for this purpose, which makes it possible to determine many cannabinoid profiles. A detailed list can be found in the next section.
Cannabinoids are among the most important biologically active substances of cannabis and hemp plants. There are more than 80O of these chemical alkaloids. The focus here is mainly the THC due to its properties. The second most common active ingredient is CBD. Since some of them have pharmacological and medicinal effects, it is important to determine the most abundant cannabinoids.
As the number of hemp products increases, more detailed analyses, such as cannabinoid profile analysis, become necessary. This is done after extraction by HPLC with UV detection at 225nm and 306nm. This type of analytics is specifically tailored to cannabinoid profiles and thus provides fast and reliable results.
Our laboratories specialized in cannabis can analyze the following cannabinoid profiles for you:
- CBC (Cannabichromene)
- CBC‑A (cannabichromic acid)
- CBD (cannabidiol)
- CBD‑A (cannabidiol acid)
- CBDV (cannabidivarin)
- CBDV‑A (cannabidivaric acid)
- CBG (cannabigerol)
- CBG‑A (cannabigerolic acid)
- CBL (cannabicyclol)
- CBN (cannabinol)
- D8-THC (Δ8-tetrahydrocannabinol)
- D9-THC (Δ9-tetrahydrocannabinol)
- THC‑A (Δ9-tetrahydrocannabinolic acid)
- THCV (tetrahydrocannabivarin)
- THCV‑A (tetrahydrocannabivaric acid)
THC (d9-THC / tetrahydrocannabinol) is a substance found in the dried, resinous flowers of the female hemp plant (marijuana). It has a psychoactive effect and falls under the Narcotics Act in Germany from a content of 0.2%. They are allowed for medical or therapeutic treatments. Marijuana can be smoked under the above mentioned conditions or consumed in capsules or tinctures.
The spectrum of analysis includes tests of the DAB (German Pharmacopoeia) and Ph. Eur (Pharmacopoea Europaea) as well as the determination of the content of cannabinoids and impurities by, for example, pesticides, mycotoxins, heavy metals or microbiological germs.
Which analyses are used to determine THC?
- Potency test: Simplified analysis of THC content
- Cannabinoid profile analysis: Detailed analysis of cannabinoids
CBD (cannabidiol) is the second most common active ingredient in cannabis and is often used in the treatment of sleep disorders, anxiety, or chronic pain, as well as for sedation. Again, use is legal when the CDB is derived from commercial hemp and contains less than 0.2% THC.
Furthermore, according to current EU law, these CBD products are considered as novel and accordingly as Novel Food (Novel Food Regulation, VO (EU) 2015/2283). Before novel foods can be placed on the market, they must be approved by the EU Commission.
Due to the calming and anti-inflammatory effect, CBD oils and balms are also used for pets.
To ensure that your product can be marketed safely and in compliance with the law, the following laboratory analyses should be carried out:
- Labeling test including verification of health claims
- THC analysis or
- Cannabinoid profile analysis
- Residue and contamination analysis (pesticides, heavy metals, mycotoxins etc.)
We would be happy to advise you in a further discussion about individual analysis options for your product.
Analysis for useful hemp products
Hemp seeds, hemp protein powder and co. – more and more products containing hemp fill our supermarket shelves and are becoming increasingly popular among consumers. Also, for four-legged friends, more and more products (e.g. hemp oils or treats) are coming onto the market, which are supposed to provide more well-being and shiny fur.
However, in order for cannabis to be used as a food product, the content of psychoactive substances must be very low and the products must also comply with the legal requirements in other respects.
Due to the different varieties of hemp, some with significant levels of D9-tetrahydrocannabinol (THC), which is relevant under narcotics law, it is crucial for food producers to know the exact content of cannabinoids. The analysis requires special approval from the Federal Opium Agency, as the THC reference standard is a narcotic.
Since the hemp plant contains a lot of water, mold can easily form during storage. Aflatoxins in particular are very toxic and harmful to humans even in low concentrations. For this reason, the regulatory authorities have set the maximum permissible limits in Regulation (EC) No. 1881/2006. The following limits apply in the EU: 2 μg/kg-1for aflatoxin B1 and 4 μg/kg-1for the sum of aflatoxins B1, B2, G1, G2 in various foodstuffs.
Crop protection products and pesticides are used to increase yields in hemp cultivation. Therefore, these should also be analyzed in hemp products. The most common pesticides found in cannabis include the fungicide myclobutanil and the insecticides inidacloprid, abamectin, and spiromesifen.
One of the main problems with cannabis extracts is that pesticides and cannabinoids have similar chemical properties and are therefore equally likely to dissolve from the plant during extraction and thus enter the final product. Since the result of further processing is a concentrate of the active ingredients, the contaminant load is also up to ten times higher than that of the plant.
To ensure that your hemp products reach the market safely, it is important to have appropriate analyses carried out. Here you will find an overview of our analyses:
- Environmental monitoring program
- Pathogen tests
- Quality indicators
- Hygienic monitoring
- Shelf-life studies
- Heavy metals (As, Cd, Pb & Hg)
- Residues of solvents
One of the biggest challenges for medical cannabis companies is the regulatory and analytical requirements of the pharmaceutical industry.
The experts at the Tentamus Pharma laboratories can support you with pharmaceutical expertise throughout the lifecycle of your cannabis-based medicinal product. These services cover all aspects of a traditional pharmaceutical product, such as:
- Method development
- Bioanalyses of clinical and non-clinical studies
- Analyses in the commercial phase
Since medical cannabis does not have only one active ingredient, a large focus is on the analysis of the product. This is one of our strengths, as we offer a wide range of state-of-the-art and sensitive analytical and bioanalytical methods.
Our analytical laboratories are GMP, GLP, GCLP and ISO accredited and are present in Europe, Israel and the USA. Using microscopy, thin layer chromatography, HPLC, GC, LC-MS/MS, ICP-MS and the long experience and expert knowledge of our teams, we are able to offer you a complete package for the analysis of medical cannabis. Our services include:
- Analytical method development
- Qualification & validation of analytical methods
- Analyses for clinical and non-clinical studies
- Analyses for all classes of compounds in medical cannabis:
- Known cannabinoids (e.g. CBD, THC, 11-hydroxy-THC and CBN)
- Other cannabinoids (> 100)
- Impurities (e.g. heavy metals, pesticides)
- Release analysis (GMP, QP release)
- Stability studies
- Clinical studies
- Analyses within the scope of the GCLP
- Human samples (blood, plasma, urine)
- Non-clinical studies
- Analyses under GLP / non-GLP
- A variety of species (e.g. rodents & pigs).
- A variety of biological samples (e.g. plasma, brain, skin, CSF, fat).
The commercialization of cannabis products comes with challenges that can be a major hurdle, especially for small manufacturers and startups. To help you bring a safe product to market, our TentaStart program provides consulting and analytics to help you make your product marketable.