Cannabis Legal Activity Update | 8th November 2018
Importing cannabis products into the EU
The licensing of cannabis containing drugs in the UK for specific medical conditions like epilepsy in children is being reviewed. MHRA have declared that CBD (cannabidiol) to be medicinal by function potentially affecting the CBD supplements market and cannabis in all its forms used recreationally is an illegal drug.
The current position on the use of Cannabis sativa/hemp seed oil and distilled or extracted oil from the flowering tops in relation to cosmetics is outlined below but first, let's understand the different terms for cannabis.
Cannabis oil, hemp oil, industrial hemp oil and similar descriptions all describe extracts from Cannabis sativa, typically grown for its fibre known as hemp. There are two oils extracted from Cannabis sativa, cold-pressed seed oil and a distilled oil from the leaves, stems and flowers often referred to as flowering tops.
CBD oil is a proprietary product that contains a known concentration (dose) of pure CBD (Cannabidiol) and is sold for medicinal/nutritional purposes. MHRA the UK medicines regulator has declared that CBD is medicinal by function and products marketed as medicines containing CBD will have to be licensed.
Cannabis, the dry plant material, the drug (pot, hash, scunk etc.) and oils made from the resin typically from Cannabis indica contains high levels of the psychoactive THC (Tetrahydrocannabinol) and are illegal to grow and be in possession of contrary to the Psychoactive Substances Act 2016
Both Cannabis sativa and Cannabis indica contain CBD used primarily for its anti-inflammatory benefits and THC the psychoactive substance albeit in varying concentrations. All species of the genus Cannabis are included in the legal definition of cannabis and are equally illegal unless specially licensed.
Cannabis sativa plant is intended to be used for its fibre to make rope and other fibre products but it is not illegal to extract oil from it, the problem comes when you come to supply it. There are two different oils from Cannabis sativa, the seed oil and the distilled oil.
According to the single convention updated since 1961 “Cannabis” means the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated’
So the seeds are not controlled by the single convention and so it is reasonable to conclude that an extract from the seeds is not controlled either.
The oil distilled from the flowering tops is a little more complicated. It meets the legal definition of cannabis. It contains or is likely to contain THC, typical concentrations are likely to be in the order of 0.035% +/-0.0002 %, it could equally be below the level of detection. There is a specific method of analysis for THC/CBD ratios and it is not the same as the typical GC-MS method used for essential oil analysis. The problem comes with the Psychoactive Substances Act Cannabis and THC are illegal psychoactive substances and the act does not provide for a minimum activity level. It is illegal to possess or supply a substance with any detectable level of THC and in any case, the oil itself may be considered to be cannabis and therefore illegal in any case. There has been no test case yet involving the definition of psychoactive in relation to this act, as far as I am aware there is no legally enforceable test for psychoactive. This means that there are no guidelines for the police or the CPS to base a decision not to prosecute in the case of very low levels from what is in effect an essential oil intended for external use, but none the less could be ingested.
There is the issue of CBD content in Cannabis sativa oil typically around 0.77%. There is no indication yet as to what MHRA would consider a therapeutic dose the CBD trade association is trying to get MHRA to agree to a sub-therapeutic dose that could then be considered to be a food supplement. The CBD level in Cannabis sativa oil at 0.8% is quite high and could well be considered, subject to confirmation, a sub-therapeutic dose
Furthermore, the standard safety assessment and microbiological cosmetic challenge testing will be required for your products and approval granted before selling in this market will be permitted.
On the ability to sell indigestible in the market the current situation is as follows.
Indigestible containing CBD is considered ‘Novel foods’ or health foods. They fall into the
same bracket as nutritional supplements. They need to be assessed by the HFRC (Health
food claim regulator) before the sale is possible. Again the indictable THC levels are
required within this product and no medicinal clam can be made.
For the purposes of the cosmetic regulation cannabis sativa seed oil is not subject to the annex II prohibition because the seeds and therefore the oil produced from them are not controlled by the single convention. In addition they do not contain THC so the oil cannot contain THC, and so is not narcotic and the seeds are excluded from the definition of cannabis, so the oil must be too. Concluding that hemp seed oil, the carrier oil is legal to use in the EU
As described above the seed oil is not included in the definition of cannabis and is suitable for use in cosmetic products (skin and hair care) and for use in food products subject to compliance with the food regulations. The properties are those of a typical cold pressed oil being rich in polyunsaturated and saturated fatty acid glycerol esters
Cannabis extract containing CBD can be used and imported as long as there is no detectable levels of THC and no medicinal claims on the products. This should remain the case until, or if the MHRA reaches a decision and defines the therapeutic dose however there is no indication that a conclusion on this will be reached in the near future.
Just an FYI, if a therapeutic level is agreed upon some day in the future and your product contains more CBD than that defined level, your product will fall under a medicine, not a cosmetic and then measures will be needed to adhere to EU medical regulation.
1 – All the above information relates to EU law only.
2 - The UK currently falls under EU regulations here however as from 29 March 2019 due to Brexit the UK will begin to create their own regulatory body, regulations and policies. The current suggestion is that the UK regulations will align with REACH (the current EU standards) but be aware these regulations are not written as of yet. Regardless when they do go live a sperate UK only regulation will need to adhere too and a new portal notification registration required if you want to see your products in the UK. Your EU safety assessor and/or a responsible person can guide on this in more detail come the new year.
Further reading if interested