Standards

Proposed standards for Cannabis and Cannabis products

Currently, there are no standards for Cannabis or for products containing Cannabis or cannabinoids in South Africa.

A tested and certified product should be the norm – growers, producers and consumers need to have accurate information about the product they are growing, manufacturing or consuming. An environment of testing and certification will enhance the reputation of producers, importers, suppliers of products, etc.

As a Cannabis analytics industry leader in South Africa, and part of the SABS technical committee to develop standards for Cannabis, Qure proposes the below set of standards that will give customers and consumers an indication of the quality of their products.

Our proposed standards are based on current international standards for Cannabis; World Health Organisation (WHO) recommendations for Cannabis; United States Pharmacopeial Convention (USP); and African and South African standards for herbal products and extracts. This wide range of references is necessary because no single source has all the parameters included in Qure’s proposed standards. Where multiple sources were available, Qure’s recommendations are based on the stricter requirements – to ensure maximum safety.

Parameters that affect the quality of cannabis products:

Potency
Cannabinoid profile
Foreign materials
Total ash
Heavy metals
Microbial impurities
Moisture content
Mycotoxins
Pesticides
Residual solvents
Terpenes

Potency
Potency is an indication of the strength of the CBD (cannabidiol) and THC (tetrahydrocannabinol) in a strain or product.
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QURE PROPOSED STANDARD:
As defined by the client or as required by regulation.
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Cannabinoid Profile
The Cannabinoid Profile is a sensitive and detailed test that identifies and quantifies cannabinoids in the plant or the product. It shows each of the cannabinoids as a percentage per mass of the tested plant or product.
More than 120 different cannabinoids have been identified. The more well-known cannabinoids include CBC, CBD, CBD-A, CBDV, CBG, CBG-A, CBL, CBN, THC, THC-A, THCV, and Δ8-THC.
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QURE PROPOSED STANDARD:
As defined by the client or as required by regulation.
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Foreign Material
Foreign matter can be hazardous or non-hazardous. Hazardous material includes foreign vegetable matter with allergenic or toxic properties; glass; metal; stones; or physical contaminants such as insects, faecal matter, feathers, soil, hair.
It is important to ensure that there are no foreign contaminants, particularly in plants that are to be used for medicinal purposes.
TEST: Visual inspection by the grower or producer themselves.
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QURE PROPOSED STANDARD:
< 2% by weight of dried plant material (in line with USP and WHO for herbal medicines).
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Total ash
Plants absorb inorganic compounds such as minerals.
It is important to ensure that the mineral content in plant material does not exceed safety standards.
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QURE PROPOSED STANDARD:
≤ 20.0% by weight of dried plant material (in line with USP and TGO).
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Heavy Metals

Metals that have a high density or atomic weight are called ‘heavy’ metals. These include Arsenic (As), Cadmium (Cd), Lead (Pb) and Mercury (Hg). The high degree of toxicity of these metals makes them significant with respect to human and animal health. Depending on your location and the history of the soil, these metals may be present to varying degrees. Cannabis roots will suck up and retain these harmful metals as well as other chemical contaminants, such as mining and industrial wastes, vehicle emissions, lead-acid batteries, fertilisers, paints and treated woods. (Hemp has been used successfully to decontaminate heavy metal polluted soils).

QURE PROPOSED STANDARDS as per the table below:

HEAVY METAL	MAX PARTS/MILLION	ALIGNS WITH
Arsenic (As)	< 2 ppm	Chinese limits
Cadmium (Cd)	< 0.3 ppm	WHO
Lead (Pb)	< 0.5 ppm	California Medical Marijuana Bureau
Mercury (Hg)	< 0.5 ppm	China, Malaysia and Singapore limits for herbal medicines
Chromium (Cr)	≤ 2 ppm	African Standard
Copper (Cu)	≤ 150 ppm	African Standard

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Microbial Impurities

Herbal medicines are all subject to microbial contamination from soil, air and water. Microbial contamination of plant materials is mainly attributed to aerobic bacteria, enterobacteria (e.g. E. coli, Salmonella), yeast and mould. The development of the contaminants is influenced by environmental factors such as temperature, humidity, harvesting, handling and storage. In order to maintain the appropriate quality, safety and efficacy of these natural products, growers and producers, therefore, need to ensure the lowest possible level of contamination – and the way to show no/low levels of contamination is to test the products.

QURE PROPOSED STANDARDS as per the table below:

TEST	MAX COLONY FORMING UNITS/GRAM
Total aerobic count	≤100 000 cfu/g
Yeast and mould	≤10 000 cfu/g
E. Coli	Absent/g
Salmonella	Absent/g or Absent/10g
Enterobacteriaceae	≤20 cfu/g
Staphylococcus aureus	Absent/g
Bile-tolerant gram-negative bacteria	≤1 000 cfu/g

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Moisture Content (applicable to flower only)
Dried herbs last longer than fresh herbs because they have less water than fresh plant material. Micro-organisms, especially mould, flourish in the presence of the right amount of water. When water is removed from plant material, the microbial growth cannot be sustained and the herb lasts much longer. However, there needs to be a balance – you do not want flower that is too dry. It has been found that a water content of 4% – 13% by weight is acceptable to minimise microbial growth.
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QURE PROPOSED STANDARD:
Water content at 4% – 13% of weight (incorporates guidelines from the Bureau of Medicinal Cannabis (BMC), California and the Association of Official Agricultural Chemists (AOAC).
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Mycotoxins
Mycotoxins are toxic chemicals produced by fungi. Contamination can occur during growth; with imperfect storage conditions, such as high humidity and high temperatures; or as a result of contact with insects or rodents. Mycotoxins that naturally occur in South Africa are Fumonisins. Aflatoxins are rare in South Africa but could be found in imported products. Deoxynivalenol (DON) is a mycotoxin primarily produced by Fusarium fungi, commonly found in Europe and occurring predominantly in cereal grains.
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QURE PROPOSED STANDARDS as per the table below:
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TOXIN MAX PARTS/BILLION

Fumonisins 2 000 ppb

Total Aflatoxins 20 ppb

Aflatoxin B1 5 ppb

DON 1 000 ppb

TOXIN	MAX PARTS/BILLION
Fumonisins	2 000 ppb
Total Aflatoxins	20 ppb
Aflatoxin B1	5 ppb
DON	1 000 ppb

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Pesticides

Despite the fact that pesticides are harmful, many growers still use pesticides to improve their yields. Setting limits on the maximum levels of pesticide residues ensures that plants and their products are safe to use and ingest. As a result of the wide range of pesticides used around the world, regions have diverse Pesticide Residue regulations. For South Africa, Qure suggests testing for pesticides referred to in the African Standard for African Traditional Medicine (“ATM”) and The South African Foodstuffs Act. Where discrepancies between the two are found, ATM is given precedence as it specifically applies to herbal medicines.

QURE PROPOSED STANDARDS as per the table below:

PESTICIDE	MAX PARTS/MILLION
Abamectin	0.01
Acephate	0.20
Acetamiprid	0.50
Aldicarb	0.07
Alpha-cypermethrin	0.05
Azinphos-methyl	0.50
Azoxystrobin	0.01
Benthiavalicarb-isopropyl	0.01
Beta-cyfluthrin	0.02
Bifenthrin	0.03
Boscalid	2.00
Bromide ion	400.00
Captan	15.00
Carbaryl	0.80
Carbendazim	0.10
Carbofuran	0.10
Carbosulfan	0.07
Cartap HCl	1.50
Chlorantraniliprole	0.50
Chlorothalonil	1.00
Chlorpyrifos	1.00
Chlorpyrifos methyl	0.30
Clothianidin	0.01
Copper oxychloride & other salts	20.00
Cyantranilipole	0.50
Cyfluthrin	0.03
Cyhalothrin	0.03
Cypermenthrin	0.10
Deltamethrin	0.03
Demeton-S	0.20
Diazinon	0.10
Dichlorophen	0.50
Dichlorphos (DDVP)	0.10
Dicofol (Dichlorobenzophenone)	0.10
Difenoconazole	0.10
Diflubenzuron	0.01
Dimethoate	0.50
Dimethomorph	0.01
Dimethyl didecyl ammonium chloride	0.20
Dinocap	0.50
Diquat	0.05
Disulfoton	0.05
Emamectin	0.01
Endosulfan	5.00
Epoxiconazole	0.01
Ethion	5.00
Ethoprop(hos)	0.01
Fenbutatin Oxide	0.20
Fenhexamid	5.00
Fenitrothion	1.00
Fenvalerate and Esfenvalerate	0.03
Fipronil	0.05
Fludioxonil	0.02
Fluopicolide	0.05
Fluquinconazole	0.10
Flusilazole	0.01
Flutriafol	0.10
Folpet	0.50
Furfural	0.50
Glyphosate	2.00
Guazatine	2.50
Hydrogen Phosphide	0.01
Indoxacarb	2.00
Imazalil	2.00
Iprodione	0.10
Kresoxim-methyl	0.05
Lambda-Cyhalomethrin	0.10
Lufenuron	0.10
Malathion	1.00
Mandipropamid	0.01
Mercaptothion	3.00
Metalaxyl	5.00
Methamidophos	0.10
Methiocarb	0.07
Methomyl	0.10
Methoxyfenozide	1.00
Metrafenone	0.50
Mevinphos	0.10
Milbemectin	0.01
Novaluron	0.05
Omethoate	0.01
Oxydemeton-Methyl	0.20
Parathion	0.20
Parathion-methyl	5.00
Permethrins	0.05
Phenthoate	7.00
Phorate	0.10
Phosalone	2.00
Piperonyl butoxide	5.00
Pirimicarb	5.00
Pirimiphos-methyl	0.50
Profenofos	0.07
Propioconazole	0.02
Propyzamide	0.10
Proquinazid	0.20
Prothioconazole	0.20
Pyraclostrobin	0.50
Pyrethrins	1.00
Pyridalyl	0.01
Pyrimethanil	0.50
Quinoxyfen	0.50
Quintozene	0.02
Spinetoram	0.05
Spinosad	0.02
Spirodiclofen	0.01
Spiroxamine	0.05
Sulfoxaflor	0.05
Tau-fluvalinate	0.05
Tebuconazole	0.50
Thiacloprid	1.00
Thiamethoxam	0.02
Triadimefon and Triadimenol	0.50
Triazophos	0.07
Trichlopyr	0.10
Trifloxystrobin	0.10
Trifluralin	0.05
Vinclozolin	0.05
Zoxamide	1.00

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Residual Solvents

Residual Solvents are residues of organic solvents used to process herbal extractions. Testing for residual solvents gives an indication of whether or not the extraction solvent was removed properly. Solvents are classified into three categories, based on their potential to cause harm. Class 1 solvents should be avoided. They include carcinogens, toxic substances and environmental hazards, for example, benzene, carbon tetrachloride, dichloroethane. Class 2 solvents have limited toxic potential. Examples include methanol, hexane, chloroform. Limits for daily exposure to each of these have been individually determined. Class 3 solvents have low toxicity. However, the residual solvent should not exceed 0.5% of the final medicinal product. Examples include ethanol, acetone, isopropanol, butane.

QURE PROPOSED STANDARDS:
Class 1: Absent
Classes 2 and 3: as per the table below

SOLVENT	CLASS	MAX FOR INHALATION	MAX OTHER
Acetone	3	750 ppm	5 000 ppm
Acetonitrile	2	60 ppm	410 ppm
Butane	3	800 ppm	5 000 ppm
Chloroform	2	2 ppm	60 ppm
Cyclohexane	2	20 ppm	3 880 ppm
Dichloroethane (1,2-Dichloroethane)	2	2 ppm	5 ppm
Dichloromethane (DCM, Methylene chloride)	2	125 ppm	600 ppm
Diethyl ether (Ether, Ethyl ether)	3	500 ppm	5 000 ppm
Ethanol	3	1 000 ppm	5 000 ppm
Ethyl acetate	3	400 ppm	5 000 ppm
Heptane	3	500 ppm	5 000 ppm
Hexane	2	50 ppm	290 ppm
Isopropanol (Isopropyl aclohol, Isoprop)	3	500 ppm	5 000 ppm
Methanol	2	250 ppm	3 000 ppm
Pentane	3	750 ppm	5 000 ppm
Propane	3	2 100 ppm	5 000 ppm
Toluene	2	150 ppm	890 ppm
Trichloroethene (Trichloroethylene)	2	25 ppm	80 ppm
Xylene	2	150 ppm	2 170 ppm

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Terpenes
Terpenes are fragrance molecules. They typically occur in amounts of less than 1% in Cannabis flower, but even in these low quantities, they contribute significantly to the flavour experience and medicinal value. Terpene analysis gives the quantity of each terpene present in the sample, enabling plant cultivators, processors, healthcare providers, consumers and researchers to identify terpenes; ascertain which terpenes are best suited in medicinal applications; build information on flavour profiles between growth batches – facilitating consistency and allowing growers to selectively modulate the terpene ratios of their strains so as to maximise desired benefits, and provide proof that the product/s contains certain amounts of specific terpenes; etc.
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QURE PROPOSED STANDARDS:
No standards are necessary for terpenes in Cannabis, as each grow will have its unique combination.
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BOOK A TEST

Standards

Proposed standards for Cannabis and Cannabis products

Parameters that affect the quality of cannabis products:

Potency

Cannabinoid Profile

Foreign Material

Total ash

Heavy Metals

Microbial Impurities

Moisture Content (applicable to flower only)

Mycotoxins

Pesticides

Residual Solvents

Terpenes

Qure | April 2023

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