New Guidance on CBD in the UK

There is new guidance on CBD in the UK. On the 13th of January 2021, The Government Chemist published a document with guidance on the limits of controlled cannabinoids in CBD products. It applies to the supply or manufacture of CBD products in the categories of cosmetic or novel food.

The Government Chemist is a body that resolves scientific disputes, mainly in the food and feed sectors, gives advice to regulators and industry, and carry out research.

According to the guidance from the Home Office, the products on the market that can be exempted from the ban of the controlled substances are those whose components don’t contain more than one milligram of a controlled substance. The threshold of one milligram made it possible for CBD manufacturers to demonstrate that their products don’t have an over-the-limit presence of psychoactive substances and, as such, are legal in the UK.

However the amount appeared straightforward, it seems to have presented difficulties in interpretation and analysis, as the Government Chemist team pointed out in their new publication.

They found it unclear whether the threshold of one milligram applies to each illicit cannabinoid or the total sum of them, so they decided to take a worst-case approach, and assumed that the 1 mg threshold covers all psychoactive cannabinoids.

The psychoactive cannabinoid compounds

Following a review from the 2016 Advisory Council on the Misuse of Drugs, they identify twelve psychoactive cannabinoid compounds naturally present in the plant. The Government Chemist team notes that there are also precursors of these prohibited cannabinoids that can transform into the prohibited cannabinoids while being exposed to the heat conditions required by the analysis. One such cannabinoid is Δ9-THCA.

The detailed individual analysis of all the psychoactive compounds requires different techniques, with each compound needing to be precisely determined before deciding whether their sum exceeds the threshold.

To avoid costly analytical challenges, the list of twelve cannabinoids can be shortened to five that need to be taken into account for the analysis. Combined, they should efficiently represent the presence of psychoactive cannabinoids in a product. Those are Δ9-THC, Δ9-THCV, Δ8-THC, CBN, and cannabinol methyl ether-C5.

CBD in the UK: Concentration by the container

Following the interpretations of the UK’s Misuse of Drugs Act, the unit of measure for the 1mg threshold is the container, and not the typical dose of any product. This means that a 10 mL liquid product containing one milligram of a controlled drug will have the same total as a product consisting of 100 mL liquid. Of course, increasing volume results in decreasing concentration. The Government Chemist underlines that, in the case of the 100 mL product, you will have to have a ten times more sensitive detection system than for the 10 mL product to be able to demonstrate the content threshold has not been exceeded.

Combining factors

There are also combining factors to have in mind. The controlled drug may not consist of a single compound but could include all twelve psychoactive cannabinoid compounds that when added together may exceed the one-milligram threshold. Therefore, each psychoactive cannabinoid compound requires detection at a lower concentration.

There is no wholly satisfactory solution to this problem, as the GC points out. The psychoactive cannabinoid compounds can be present in varying proportions, so analytically the detection system should measure at least one-twelfth of the one-milligram content threshold (0.0833 mg or 0.0000833 g) for each compound (if present in equal amounts).

Also, factors such as matrix effects and measurement uncertainty need to be considered to be sure of detection.

CBD in the UK: The minimum required detection limit

The concentration of the controlled drug will be dependent on the quantity of preparation or product. In this guidance, the Government Chemist used the general retail pack size placed on the British market.

In the UK, the quantity of cosmetic products generally found on the market ranges from 200 mL for body lotions, 30 mL for face washes, and 15 g for lip balms.

The minimum required detection limit for an individual prohibited psychoactive cannabinoid in the cosmetic product are < 0.0004 mg/mL for 200 mL of body lotion, < 0.0028 mg/mL for 30 mL of face wash, and < 0.0055 mg/g for 15g of lip balm.

Novel foods containing CBD covers a wide range of products on the British market, including gummy bears each weighing 6 g where 30 gummy bears are in a container weighing 180 g, 30 mL oral sprays, 10 mL oral liquids, and capsules weighing 15 mg, where 30 capsules are in a container weighing 450 mg.

The minimum required detection limit for an individual prohibited psychoactive cannabinoid in the identified novel food product is at follows: < 0.0005 mg/g for 180 g of gummy bears, < 0.0028 mg/mL for 30 mL oral spray, < 0.0833 mg/mL for 10 ml oral liquid and < 0.185 mg/g for 450 mg of nutritional capsules.

For the analytical system requirements and calculation follow the link below:

https://www.gov.uk/government/publications/guidance-on-analytical-limits-for-controlled-cannabinoids

 

Reviewed by Sasha Bajilo, founder of ILESOL Pharmaceuticals, an industrial scale producer of CBD products and formulations. Expert on Hemp/Cannabis policy, member of the Croatian Ministry of Health regulatory commission for medical cannabis.