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Clearing the cannabis haze
When is cannabis, CBD or hemp legal in cosmetics and food products in South Africa? Janusz Luterek of Hahn & Hahn Attorneys provides an update on this topic in line with the 2020 regulations as the industry awaits the Cannabis for Private Purposes Act to be enacted.
There has been a haze surrounding the use of cannabis in South Africa ever since the Constitutional Court judgement in the Prince case in 2018. Since 22 May 2020, amendments to the scheduling regulations were published in terms of which, besides scheduling certain CBD medicinal products as Schedule 4, low CBD strength products were rescheduled as Schedule 0.
Currently, the Cannabis for Private Purposes Bill is awaiting enactment. The bill deals with personal private use of cannabis only. It falls under the Department of Justice and Correctional Services and deals mainly with penalties and offences relating to trafficable amounts, commercial amounts and defined limits for personal use and possession. There is a specific exclusion of hemp in this draft.
To understand the situation, the terminology must be understood. Both cannabis (marijuana/dagga) and hemp are varieties of the Cannabis sativa species with cannabis having a higher concentration of THC than CBD and is therefore psychoactive, whereas hemp has a higher concentration of CBD than THC and is therefore less psychoactive.
CANNABIS IN CAMs
The Constitutional Court did not legalise cannabis in all its forms for commercial use and, in a nutshell, merely ruled that it is not illegal for an adult to use cannabis in private. There is no legalisation of growing, distribution, or the manufacture of cannabis-derived products by the Constitutional Court and the normal laws still apply to all of these. Contravention of these laws can result in criminal prosecution and long jail sentences.
In terms of Regulation R586 of 22 May 2020, cannabidiol (CBD) is listed in Schedule 4, except:
a) in complementary medicines (CAMs) containing no more than 600mg cannabidiol per sales pack, providing a maximum daily dose of 20mg of cannabidiol, and making a general health enhancement, health maintenance or relief of minor symptoms (low-risk) claim
b) processed products made from cannabis raw plant material intended for ingestion containing 0.0075% or less of cannabidiol where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product.
Products that meet the conditions detailed in point a or b are now regulated as Schedule 0, which is a schedule that includes many over-thecounter medicines such as aspirin and supplements like vitamins.
This scheduling means that the only CBD-containing products which are allowed are those where the producers are registered as GMP-certified medicines manufacturers and the products themselves are registered as medicines (CAMs which are Schedule 0 or Schedule 4) through the South African Health Regulatory Authority (SAHPRA).
A CLOSER LOOK AT HEMP PROTEIN
CBD and cannabis may not be used in food, but what about hemp? Surely hemp protein and derivatives have been sold for a long time in South Africa (usually in health shops) as food? The difficulty is the distinction between hemp and cannabis and whether the hemp is really hemp. In the US, it has been shown that a large proportion of hemp and CBD supposedly derived from hemp actually have levels of THC associated with cannabis and in excess of the maximum permissible in the US (and thus in South Africa, even under the SAHPRA position).
Presuming that there is certainty that actual hemp is being used with no THC and no CBD then it is arguable that it can be used in foods as a food ingredient, such as hemp protein, or a food additive, such as a flavouring, in terms of the FCD Act (in that it is safe and is ordinarily eaten as a foodstuff). The matter is, however, complicated by a pending amendment to the Liquor Products Act Regulations which aims to prohibit the use of hemp flavourings or nature-identical hemp flavourings or extracts or anything derived from the genus cannabis in any liquor product.
Did you know?
In the US, hemp has a maximum of 0.3% THC whereas in South Africa this in 2020 appeared to be 0.2% THC. CBD or cannabidiol is a naturally occurring non-psychoactive cannabinoid found in the cannabis plant whereas THC, or tetrahydrocannabidiol, is the main psychoactive compound/cannabinoid found in the plant, in both cannabis and hemp.
CANNABIS AND HEMP IN COSMETICS
But can you put cannabis into a cosmetic (e.g. a face cream, face wash, body oil etc)? The short answer is, it’s a grey area.
R586 excludes CAMs and processed products made from cannabis raw plant material intended for ingestion containing 0.0075% or less from Schedule 4 and places them into Schedule 0, meaning it is still a medicine.
The above exclusion does not apply to cosmetics as it is specifically applied to CAMs (which is excluded in the definition of a cosmetic) and processed products intended for ingestion.
On the other hand, R586 states that any processed products made from cannabis containing 0.001% or less of THC would still fall under a Schedule 0 medicine.
So, a cosmetic containing any amount of THC would still fall under the MRS Act and would not be permissible.
There is a possibility for CBD to be added as an ingredient in a cosmetic provided there are no health claims and absolutely no THC (a certificate of analysis would be required to prove the contents of the formulation). Yet, the quantity of CBD that can be used in a cosmetic is still to be confirmed.
With regard to hemp, parts of the plant that do not contain THC and very little CBD can and have been used in cosmetics for quite some time and some big brands sell such products in South Africa.
THE CULTIVATION LICENSE REMAINS A PRIORITY
The Cannabis for Private Purposes Bill and the Hemp Bill which must follow, only deal with personal private use of cannabis. The Cannabis for Private Purposes, as the name says, prohibits all commercial use and deals mainly with penalties and offences relating to trafficable amounts, commercial amounts and defined limits for personal use and possession. This is still draft legislation but it seems it will in no way clarify commercial legality requirements other than the amounts considered as a criminal offence.
Commercial quantity offences are punishable with the highest class of offence of a fine or imprisonment of up to 15 years in terms of the draft.
There is a specific exclusion of hemp in this draft and a separate Hemp Bill must follow in due course.
Under all circumstances, a cultivation license is required in order to actually grow the cannabis or hemp prior to creating a product. This should be the first priority before starting a hemp or cannabis business. SAHPRA communication to stakeholders after the release of the R586 amendment of the schedules under the Medicines and Related Substances Act highlighted this as a requirement. In South Africa, only 16 cultivation licenses have been issued and can be found on SAHPRA’s website.
Thus, the haze can be partially lifted on the subject of the commercial use of cannabis and CBD but there are still grey areas, especially surrounding the use of hemp and its derivatives as a food ingredient. It is clear that government has no intention of legalising commercial trade in THC-containing consumables and high-potency CBD products, other than those regulated as medicines. •
ABOUT THE AUTHOR
Janusz Luterek holds degrees in both chemical engineering and law. He is a registered attorney, patent attorney, professional engineer and a partner of Hahn & Hahn. Luterek is also a custodian member of the South African Association for Food Science and Technology (SAAFoST) and serves on the FSI for some of his clients. In 2019, he received the SAAFoST President’s Award.
Hahn & Hahn Attorneys – www.hahnlaw.co.za SAHPRA – www.sahpra.org.za