CBD regulations differ from one country to another. In this ongoing process, the laws often change on a monthly basis. This article brings the basic worldwide CBD regulations with the latest legislative developments.
CBD REGULATIONS 2021: NORTH AMERICA
In Canada, all phytocannabinoids are regulated under the Cannabis Act that came into force in 2018. Before the Act came into force, CBD was regulated under the Controlled Drugs and Substances Act, and it was illegal to produce, sell, import, or export CBD unless authorized for medical or scientific purposes.
Health Canada oversees the production of CBD products for medical purposes, and the provinces and territories are responsible for determining how cannabis is distributed and sold within their jurisdictions.
To grow cannabis for the commercial sale of CBD, the farmers need a federal license. In the case of hemp, they need an industrial hemp license under the Industrial Hemp Regulations. That license authorizes the cultivation of specific varieties with a THC content of no more than 0.3% in the flowering heads, branches, and leaves. The strains have to be incorporated into the list of approved hemp varieties, with required THC testing. Hemp growers are not allowed to extract the CBD themselves unless they also have a cannabis processing or research license.
Health Canada issues processing licenses for manufacturing products containing CBD for sale, and those can only be sold by a provincially or territorially authorized cannabis retailer or federally licensed seller of cannabis for medical purposes. A license is also needed for import and export unless there is an international agreement intended for scientific or medical purposes.
Hemp-seed oil is exempt from the Canadian Cannabis Act if it contains less than 10 parts per million of THC, and with no phytocannabinoid including THC or CBD added or concentrated by processing. Natural health products (NHPs) and veterinary health products (VHPs) can contain non-viable seeds or hemp-seed derivatives compliant with the Industrial Hemp Regulations. Mature stalks that do not include any leaves, flowers, seeds, or branches and fiber from such stalks, although excluded from the Cannabis Act, may not be used in VHPs.
The same restrictions also apply to cosmetics, which may only contain hemp derivatives. Deliberately adding phytocannabinoids to such products is forbidden.
Following the amendment to the Cannabis Act in 2019, edible cannabis, including processed hemp foods from dehulled hemp seed, hemp seed oil, protein concentrate, and toasted hemp seed is permitted for sale for human consumption. Hemp foods must contain less than 10 μg/g THC.
The additional regulations set out strict controls to reduce the appeal of cannabis to youth; risk of accidental consumption, especially with edible cannabis, risk of overconsumption associated with edible cannabis because of the delay in experiencing the effects; and risk of foodborne illness.
Edible cannabis is only available for human consumption.
In the US, the development of the CBD industry regulations started with the 2014 Farm Bill, which federally legalized hemp. Section 7606 of the bill defines industrial hemp as Cannabis Sativa containing 0.3% of THC or less. Since then, farmers growing hemp can obtain certificates from their state agricultural department. The Farm Bill also extended the jurisdiction for hemp production from the Drug Enforcement Administration (DEA) to the United States Department of Agriculture (USDA) and the United States Food and Drug Administration (FDA).
In late 2018, the Hemp farming Act got included in the Farm Bill. The Act defines hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
By this Act, hemp became an agricultural commodity removed from the controlled substances list and the oversight of the DEA. Any industrial hemp product has become legal in the US at a federal level, including CBD.
However, since the 2018 Farm Bill allows states restriction of hemp production, several states have taken that course of action. At the moment, the legal status of CBD oil products is still not cleared in Iowa, because state law still classifies CBD under Schedule I controlled substances.
This year, many US states passed laws, implemented, or proposed new regulations regarding hemp cultivation, processing, and CBD products. However, the legal status is still not completely clear in many US states.
The legal THC levels in CBD products range from 0.3% in most states for general use to 0.9-5% for medical use of CBD.
Even though CBD products derived from hemp are legal in most states, the intended use of the product and how it is labeled and marketed still play a legal role. Even if the product meets the definition of hemp under the 2018 Farm Bill, it still must comply with all other applicable laws, including the United States Federal Food, Drug, and Cosmetic Act (FD&C Act).
In December 2020, the Federal Trade Commission (FTC) took action against six companies selling CBD-based products for “making a wide range of scientifically unsupported claims about their ability to treat serious health conditions.” such as cancer, Alzheimer’s disease, and pain relief. Five out of these six companies had to pay a fine ranging from $20,000 to $85,000. That presented the first monetary sanctions issued by the FTC against CBD producers and sellers. Immediately after that action, dubbed CBDeciet, the FDA sent five warning letters to companies for violating the FD&C Act.
The letters stated that CBD products are especially concerning from a public health perspective due to the route of administration, including nasal, ophthalmic, and inhalation. In addition, they addressed the violations relating to the addition of CBD to food and the impermissible marketing of CBD products as dietary supplements. Two of the letters concerned CBD products illegally marketed for pets, including a product for use in the eye.
In general, the FDA has concluded that CBD products are excluded from the dietary supplement definition because they are an active ingredient in an approved drug product (Epidiolex) or have been authorized for investigation as a new drug with instituted clinical trials. This decision has brought some difficulties to several companies, from which the best-known case is that of Charlotte’s Web. It is possible for the FDA to make an exception to this rule, but has not done it so far, and is currently assessing whether such an exception should apply to CBD.
In February 2021, the US Congress introduced the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021, aimed at resolving this matter, but it is still to be seen if it will become a federal law. Another bill, Hemp Access and Consumer Safety Act, was introduced in May 2021, and it covers not only hemp-derived CBD and hemp-derived CBD-containing substances in dietary supplements, but also in food.
Medical cannabis with less than 1% THC, including CBD oils, has been legal in Mexico since 2017. After the Supreme Court ruled in 2018 that the prohibition of recreational marijuana was unconstitutional, 38 over-the-counter products were approved by the Mexican Federal Commission for the Protection Against Sanitary Risks.
In March 2021, the Mexican Lower House voted for the bill that would legalize cannabis for recreational purposes, but it was a different version than previously adopted by the Senate, so the Senate refused to accept the proposal.
CBD REGULATIONS 2021: CENTRAL AMERICA & THE CARIBBEAN
The countries of Central America are still in the process of introducing legalization laws, with Panama passing the medical marijuana law after five years of attempts, and Costa Rica opening the first store dedicated to the hemp plant. In October 2021, Costa Rica’s Congress approved the legalization of marijuana for medicinal purposes. Apart from those countries, cannabis laws reforms are expected to be passed in Belize, El Salvador, and Nicaragua.
In the Caribbean, only Jamaica has made regulatory changes to relax cannabis laws. In 2015, the Jamaican cannabis bill came to life after 38 years of parliamentary discussions. Apart from decriminalization, the law legalizes the use of cannabis for medicinal, spiritual, and religious purposes. The first company to acquire a license to grow hemp in late 2019 was Virtudes Hemp Farm.
CBD REGULATIONS 2021: LATIN AMERICA
In 2013, Uruguay became the first country in the world to legalize the use of cannabis among adults. Now, this South American pioneer is the first country in Latin America to consider the legalization of edible cannabis-infused products. The new regulations would allow the production and registration of edible products containing CBD as an ingredient.
Industrial hemp is legal with a limit of 1% THC in dry weight, while seeds cannot contain more than 0.5% THC. Hemp farmers require a government-issued license from the Ministry of Livestock, Agriculture, and Fisheries.
In 2020, Decree No. 19/2020 modified the National Bromatological Regulation to allow the use of hemp seed protein obtained from the seeds or nuts of industrial hemp, variety C. Sativa, by processing the remaining product from oil extraction with a maximum THC concentration for the ingredient in powder of up to 10 mg/kg.
In Colombia, the 2017 Decree regulated the cultivation and manufacturing of cannabis and its derivatives for medicinal and scientific purposes. It is legal to grow hemp under a government-issued license granted by the Ministry of Justice. Those who want to produce CBD and other cannabinoids need to obtain a license from the Ministry of Health.
Personal cultivation and consumption of cannabis in Colombia are decriminalized, but its commercial sale is prohibited. It is illegal for an individual to possess more than 20 grams of cannabis and can cultivate up to 20 plants. One can purchase CBD as medicine via prescription, or over-the-counter as a food supplement or cosmetics.
In Ecuador, since February 2021, processed foods and food supplements can include all parts of hemp or its nonpsychoactive derivates as an ingredient, with a THC concentration of less than 0.3% in the finished product. Nonpsychoactive cannabis or hemp is defined as consisting of oils, resins, tinctures, crude extracts, or other technological development innovations obtained from nonpsychoactive cannabis or hemp, with a THC content of less than 1%, including, cannabinoids, isomers, acids, terpenes, salts and salts of isomers, used or intended to be used as a raw material for the production of the finished product.
In Brazil, CBD was legalized for medical use in 2015. Cannabis sativa L remains, however, listed as a plant that cannot be cultivated, harvested, exploited, imported, exported, traded, extracted, handled, or used in Brazil. In December 2019 Brazilian Health Regulatory Agency (ANVISA) published Resolution RDC No. 327 to regulate the manufacture, import, commercialization, prescription, dispensation, monitoring, and inspection of a new category of products named ‘Cannabis Products’. The Resolution is valid for five years.
In this Resolution, ‘Cannabis Product’ refers to any product manufactured for medical use that contains, as active ingredients only, plant derivatives or phytopharmaceuticals. Local manufacturers must import the active ingredient in the form of a plant derivative, phytopharmaceutical, bulk, or industrialized product. The law permits oral or nasal administration only, and CBD can be consumed only on medical prescriptions.
In October 2021, Anvisa published the list of cannabis products that will have automatic approval for individual importation by Brazilian patients.
Similarly, in Argentina, Chile, Paraguay, and Peru, CBD is legal only for medical use. In Bolivia, Guayana, Surinam, and Venezuela, CBD is still illegal.
CBD REGULATIONS 2021: EUROPE
In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the THC content does not exceed 0.2 %.
CBD is regulated under novel food legislation. Novel Food is defined as food that had not been used for human consumption to a significant degree within the European Union before 15th May 1997. In January 2019, the European Commission changed the entry in the novel foods catalog for cannabinoids. Previously to this decision, only enriched CBD was considered novel food. With the new entry, the extracts of Cannabis Sativa L. and any products to which they are added as an ingredient became novel, as well as synthetic cannabinoids. Since then, in the EU market, CBD became unauthorized novel food.
As any novel food requires approval before placing on the market, the same rule applies to CBD. The central authority coordinating the authorization process is the European Commission. The Commission can ask the European Food Safety Authority (EFSA) to carry out a risk assessment in case of any health concerns. EFSA should adopt its opinion within nine months from the date of receipt of a valid application from the Commission. However, the clock may be stopped if EFSA requests additional information from the applicant.
The authorization to the applicants can be granted for five years if based on newly developed scientific evidence and proprietary data – which show that the novel food is safe to consume, with the most important part of the safety assessment being toxicological studies. Otherwise, authorizations are generic.
Within seven months from the date of the publication of the EFSA’s opinion, the Commission must submit a draft implementing act to the SCoPAFF authorizing the placing on the market of novel food and updating the Union list. If the act receives a favorable vote from SCoPAFF and is adopted and published by the Commission, the novel food can be lawfully placed on the EU market.
In 2020, the Commission paused all novel food applications for CBD and hemp products, as it is considering recategorizing CBD as a narcotic extract rather than as a food. After the ruling of the Court of Justice of the European Union (CJEU) in November 2020, when the highest European court ruled CBD is not a narcotic, the Commission announced resuming the verification of the applications. With the same verdict, the CJEU also ruled that CBD product produced legally in one member state is legal to market in all the other of the member states.
The CJEU decision marked a turning point for the European CBD industry, considering it presented a clear sign that the CBD will not be treated as a drug but as food.
Some products derived from the hemp plant or plant parts are not considered novel food in the EU. They are seeds, seed oil, hemp seed flour, and defatted hemp seed. The Commission has determined they have a history of consumption in the EU and are not novel.
In 2005 the European Industrial Hemp Association (EIHA) became the only pan-European membership body serving the industrial hemp sector. In 2019, the EIHA created the Novel Food Consortium, with the aim of sharing the costs of novel food applications. The Consortium proved to be very useful to the European producers, who would have to invest around €500,000 if registering as an individual company.
The Consortium is investing € 3.2 M into registration. A big part of the cost is human clinical trials – THC tolerance tests and THC toxicology. These studies are extremely important because EIHA wants to prove that EFSA’s current guideline on a safe daily maximum THC intake of 1µg / kg body weight, which is not based on relevant scientific studies, is not accurate. EIHA intends to register products containing up to 0.2% THC.
In the cosmetic industry, the EIHA’s efforts bore the fruit in 2019, when a new entry was included in the Cosmetic ingredient (CosIng) database – Cannabis Sativa leaf extract, with no cosmetic or other restrictions. This opened the way to mass production and retail of CBD cosmetics in the European Union. Another milestone was achieved in early 2021 when, following the CJEU ruling, a new entry for cannabidiol was added to the CosIng list, allowing CBD derived from extract or tincture or resin of cannabis plant to be used as a cosmetic ingredient. That meant that natural CBD became a legal cosmetic ingredient in the EU. In April 2021, the Commission added cannabigerol (CBG) to the CosIng list.
Detailed national regulations in different European countries can be found here. The legal framework in the countries of ex-Yugoslavia is covered here. Global regulatory trends in CBD use in food and food supplements can be found here.
In the UK, the companies that want to grow hemp can apply to the British Home Office for a Controlled Drug Domestic License. The license only permits growing hemp for harvesting plant fiber and seeds. It is illegal to harvest hemp flowers that contain a high concentration of CBD, and the license to grow hemp does not allow the extraction of CBD.
After the Brexit, from 1 January 2021, the European Commission’s central regulatory role in the UK was transferred to the Food Standards Agency (FSA).
In February 2020 the FSA warned UK CBD companies they would not be allowed to remain on the market if they had not submitted Novel Food applications by March 31, 2021. Three-quarters of the 800-plus CBD Novel Food applications to the FSA have been rejected.
The deadline was pushed back to the end of April and then later to the end of June. In October, the FSA said to BusinessCann it is ‘unable to give a date as to when this task will be complete’.
The FSA approval is required for CBD sold as food and food supplements. When CBD is sold as cosmetics, it requires Cosmetic Product Safety Report (CPSR). Vape products are placed under non-nicotine e-liquid regulation. The producers do not require a license to sell CBD in the UK if THC is not detected, meaning there is no THC at 0.01% as verified by an accredited ISO lab. The sale of CBD flowers and buds is prohibited even if THC is below 0.2% and from the EU-approved origin countries.
In 2011 Switzerland increased the THC limit defining how the cannabis plant is classified under the Narcotics Control Act from 0.3 % to 1 %. CBD products, including CBD flowers with a THC level lower than 1 %, can be sold legally. In Switzerland, it is forbidden to sell hemp resin, even if the products contain less than 1% THC.
In September 2021, Czech Republic rose the THC limit from 0.3% to 1%. The amendment to the law on addictive substances was passed in the parliament and signed by the president, coming into force from January 1, 2022. At the moment, Czechia is the only EU member state with the legal THC content at the same level as the neutral European CBD pioneer Switzerland.
All cannabis products are illegal in Russia, regardless of how much THC they contain.
However, in 2020, Medical Marijuana announced that its subsidiary, Kannaway, was granted Russia’s first-ever certificate to import CBD products. The certification allows Kannaway to import a broad range of CBD products, including Medical Marijuana’s tinctures, oils, and skincare products.
In 2016, Turkey legalized sublingual cannabinoid medications (such as Sativex) for use with a doctor’s prescription. The use of whole-plant cannabis remains illegal.
In 2019, the Turkish Agriculture and Forestry Minister announced that the government will take steps to increase hemp production, which is now allowed in 19 of Turkey’s 81 provinces.
According to data from the Turkish Statistics Institute (TurkStat), there were 87.50 hectares cultivated in 2000, resulting in 140 tons of seeds and 2,500 tons of fibers. In comparison, in 2016, the total acreage of hemp was only 0.25 hectares, with a yield of 1 ton of seeds and 7 tons of fibers.
CBD is still not regulated and stays in the legal grey zone.
CBD REGULATIONS 2021: AFRICA
On June 15, 2021, Morocco’s House of Representatives approved Organic Bill 13.21, which legalizes the cultivation and use of cannabis for medicinal and industrial purposes. A week earlier, it passed the upper House of Councilors. The new law limits production to six provinces: Al Hoceïma, Chefchaouen, Ouezzane, Taounate, Larache and Tétouan. All of the provinces are located in the Rif, a mountainous region in northern Morocco, planted with 47,500 hectares of cannabis.
The draft bill aims to regulate legal activities related to cannabis cultivation, production, manufacture, transport, and exchange activities with other countries.
The authorized farmers have to be members of a cooperative and licensed farmers’ cooperatives must enter into a contract with one or more licensed processors, and/or export companies.
The authorized processing company must sign purchase contracts with licensed producers. The legal status is set to ten years.
The law refers to medical cannabis only, while recreational cannabis remains illegal. Hemp and cannabis products that have been transformed and manufactured cannot be marketed and exported. Import of such products is illegal, except for medical, pharmaceutical, and industrial purposes.
In South Africa, hemp is still classified as cannabis, and it can be legally grown for commercial purposes with a special permit from the Department of Health and the South African Health Products Regulatory Authority. It is currently regulated under the Medicine and Related Substances Act as well as the Drugs and Drugs Trafficking Act. The cultivation, possession, trade, and use of hemp are prohibited.
The country decriminalized personal cultivation of cannabis through a ruling of its high court in 2018. The highest court ruled that section 4(b) of the Drugs and Drug Trafficking Act, 1992, read with Part III of Schedule 2 of that Act, is unconstitutional and therefore invalid to the extent that it criminalizes the personal and private use or possession of cannabis. The same year it began issuing licenses for commercial cultivation of medical marijuana.
In 2020, the government introduced Cannabis for Private Purposes Bill, aiming to further regulate the industry. The draft that divides hemp from high THC cannabis is presently still in the parliamentary procedures.
In March 2021, the country introduced the fifth version of the SA Cannabis Master Plan, with an interdepartmental team comprising representatives from various departments guiding the development of the sector. The involved institutions are the Department of Health, Trade Industry and Competition, SAPS, provincial legislatures, and the South African Health Products Regulatory Authority (SAHPRA). It was announced that, as of October 2021, the South African Ministry of Agriculture, Land Reform, and Rural Development would be issuing permits for the production of hemp in South Africa.
There are no approved quality standards currently available in South Africa and no quality control on products sold on the local market. The extraction of CBD or THC from the cannabis plant is considered to be ‘manufacturing’ in terms of the Medicines and Related Substances Amendment Act, 2015 (Act No14 of 2015) and requires a license to manufacture issued in terms of Section 22C of the Act. Hemp seed oil (if within the thresholds mentioned above) is excluded from the Medicines Act.
While the South African Ministry of Agriculture pushed for cannabis to be regulated as food, the Ministry of Health objects it has no nutritional value. Also, the Ministry of Health warned about concerns about adolescents, second-hand smoke, and the impact on drivers. The draft is amending the National Road Traffic Act, but the Ministry says it has not being done to the appropriate extent.
In 2017, Lesotho became the first nation to legalize medical cannabis on the African continent.
Lesotho Narcotics Bureau and the Ministry of Health are responsible for the issuing and the renewal of licenses. The expensive licensing process (€ 8.713 for cultivation or manufacturing, €29.043 for operating license) resulted in the domination of foreign companies, while local farmers are complaining that they are not benefiting from the industry. Lesotho has issued over 100 licenses, but the rural farmers outside of licensed premises are still being arrested and prosecuted.
The industry investment has come from Canadian, UK, and US producers. Lesotho-based Medigrow (MG Health), partially acquired by Canadian company Supreme Cannabis has become the first Africa-based cannabis firm to earn coveted EU Good Manufacturing Practices (GMP) certification. With this certificate, the company can do business in the EU market.
In 2018, Zimbabwe became the second African country to legalize cannabis cultivation for research and medicinal purposes. However, it seems that no licenses have yet been issued.
In December 2019, Zambia legalized cannabis for export and medicinal purposes only. The decision to legalize the cultivation and export of cannabis for the medical market came as the country was being stricken by a severe drought. The licenses should be obtained through the Ministry of Health and Zambia Medicines Regulatory Authority (ZAMRA).
On May 20, 2021, Zambia enacted two new laws, the Cannabis Act, and the Industrial Hemp Act. ZAMRA is issuing licenses for the cultivation of medical marijuana or hemp for three years. The THC limit for hemp is set to 0.3%. Any licensed activity has to be placed further than in a 15.5-mile radius of public or private schools, public parks, public libraries, and alcoholism or drug abuse treatment and rehabilitation centers.
In 2016, Malawi legalized hemp for industrial purposes. The Cannabis Act was adopted in 2020, establishing the Cannabis Regulatory Authority (CRA). The CRA issues one-year licenses for the growers who present a contract with an extract, flour, hempcrete, fabric, cosmetic, soap, or papermaking company.
The THC limit is set to 1%, and the strains have to be listed on the Industrial Crop Association (ICA) list. Invegrow, the first company in Malawi to be granted authorization by the government to conduct research on cannabis, offers four certified medicinal and industrial varieties and is recommended by the government bodies as a provider of the seeds.
In 2020, Ghana passed the Narcotics Control Commission Bill, first introduced in 2015. The new law legalizes the production of cannabis products that contain less than 0.3% THC for industrial, medical, and research purposes.
The Narcotics Control Board (NACOB), working under the Ministry of Interior Affairs, oversees the implementation of the new law.
Eswatini is world-famous for its marijuana variety “Swazi Gold,” but growing cannabis in the country is illegal. The government has announced it is working on a legal framework to legalize cannabis for medical purposes. The Ministry of Health will be issuing licenses.
Currently, there is only one legal Eswatini cannabis grower: the US-based Profile Solutions Inc has a license to grow and process medical cannabis and hemp for a minimum of 10 years.
In Uganda, the Industrial Hemp company acquired a license for growing and processing medical cannabis and hemp in 2012. The 2015 Narcotic Drugs and Psychotropic Substances Act legalized the cultivation, production, and exportation of medical marijuana, but the absence of guidelines prevented the industry from taking off. The government finally issued the guidelines in 2020.
More than 90 companies, both local and foreign, have applied for licenses. The first licenses were approved in late 2019, going to the Israeli company Together Pharma. Yohanan Danino, Together Pharma’s chairman, was previously the chief of the Israeli police force, working with the Ministry of Health to reform the medicinal cannabis law after seeing the benefits it brought to patients. Export restrictions in Israel made Uganda attractive to this company as an export base.
In Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Chad, Côte d’Ivoire, Egypt, Democratic Republic of Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Guinea, Guinea-Bissau, Kenya, Liberia, Libya, Madagascar, Mali, Mauritania, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, Sudan, Tanzania, Central African Republic (CAR), Congo, and Togo cannabis and its derivates are still illegal.
CBD REGULATIONS 2021: MIDDLE EAST
Israel is a global leader in cannabis research. Raphael Mechoulam, professor of Medicinal Chemistry at the Hebrew University of Jerusalem, is considered a father of cannabis research as he was the first scientist to isolate cannabinoids.
In 2016, Israel approved industrial hemp cultivation with a 0.2% THC limit. Hemp farmers can legally grow industrial hemp as well as hemp for CBD production. They require licensing and are restricted to only producing and selling CBD products within Israel.
In 1999, the Israeli Ministry of Health legalized medical cannabis. In 2017, with further relaxation, patients were allowed to consume and possess cannabis outside of their homes. Oil consumption is allowed anywhere, and vaping is allowed in non-prohibited areas. Also, cannabis got decriminalized, with fines replacing criminal penalties. By 2020, the number of registered cannabis patients reached 70,000. The same year, Israel surpassed Germany as the world’s largest importer of medical cannabis flowers.
After the change of the government in the summer of 2021, Israeli lawmakers rejected a bill that would have decriminalized recreational marijuana use.
CBD has been available in pharmacies since 2017 when the Ministry of Justice removed it from the list of dangerous drugs. However, CBD can legally only be bought on prescription.
The Israeli police have clarified that CBD is not a banned or dangerous drug, and its possession or use is permitted as long as it is not part of the plant (inflorescence) and does not contain THC.
Lebanon became the first Arab country to legalize cannabis for medical and industrial use in 2020. Growing cannabis plants is allowed with less than 1% THC and varying levels of other cannabinoids, including CBD.
CBD stays a controlled substance and is legal only as a cosmetic or pharmaceutical ingredient.
UNITED ARAB EMIRATES
In the UAE, cannabis is regulated by the Anti-Narcotic Psychotropic Substances Law. Cannabis and CBD oil are illegal, and it is not possible to patent cannabis-related products.
In 2019, the Dubai Municipality declared that only the sale and purchase of hemp seed oil found in cosmetics, health care products, serums, lip balms, and facial oils, is legal.
In Syria, Iraq, Jordan, Saudi Arabia, Oman, and Yemen, cannabis and its derivates remain illegal.
CBD REGULATIONS 2021: ASIA
In Iran, Afghanistan, Turkmenistan, Tajikistan, Uzbekistan, Kyrgyzstan, and Mongolia, the law doesn’t make a difference between CBD and cannabis, so CBD is illegal.
In September 2020, the Pakistani Government approved industrial hemp production, legalizing hemp and allowing hemp farming in the agricultural sector.
The Japanese government never explicitly legalized CBD, but it’s present in the country since 2016. However, there are strict legal conditions. Only isolated hemp-derived CBD with no traces of THC is legal in Japan. CBD products have to come from the stems or the seeds because present regulation excludes the grown stalk of the cannabis plant and its products (excluding resin) and the seeds of the cannabis plant and its products from the cannabis definition. CBD flower is forbidden. Hemp-derived CBD can legally be imported as food if produced from mature stalks and the presence of THC is undetectable.
In the case of import, along with the certificates and substance analysis report, the application has to include photos of the raw material and the manufacturing process. The Ministry of Health, Labour, and Welfare (MHLW) then decide if the product meets the definition of cannabis or not.
In 2021, the Ministry of Health announced that marijuana use will be criminalized under revisions to Japan’s Cannabis Control Law, while cannabis-derived medicines will be permitted.
Hemp cultivation in Japan is permitted only to growers who have obtained a license from the prefectural governor. The 1948 Cannabis Control Law is expected to change in 2022.
In November 2018, the country’s Narcotics Control Act was amended and the use of medical cannabis became legal, making South Korea the first country in East Asia to legalize it.
The medical cannabis system of South Korea is controlled by the Ministry of Food and Drug Safety (MFDS) and the Korean Orphan Drug Center (KODC).
As for CBD, one needs a doctor’s prescription before ordering CBD products in South Korea. The CBD is controlled by the MFDS, and there is no licensing to buy or import CBD so far.
Hemp seed is also allowed as a food ingredient, provided that the shells (bracts and outer epidermis) have been completely removed.
Since 1985, cannabis in China is classified as a dangerous narcotic, and the possession of hemp seeds is illegal.
Hemp cultivation is allowed in three provinces: Yunnan, Heilongjiang, and Jilin. In 2019, Chinese hemp represented half of the world’s hemp resources. The THC limit is 0.3%.
A 2015 ordinance allowed the use of CBD from hemp and products containing less than 0.3% THC in cosmetic products available in the Chinese market. However, in May 2021, the Chinese drug regulator, the National Medical Products Administration (NMPA) banned the use of CBD in all cosmetics.
In Hong Kong, non-traceable THC CBD is not in the scope of the Dangerous Drug Ordinance and is therefore permitted for use in food.
In January 2021, Thailand legalized the use of nine low-THC cannabis and hemp ingredients in cosmetics. The Announcement of the Ministry of Public Health was issued under the 1979 Food Act.
The regulation establishes clear conditions for the use of hemp or hemp seeds, hemp seed oil, hemp seed protein in different food categories, including food supplements, and maximum limits of THC and CBD.
Hemp leaves, stalks, stems, and roots are erased from the countries Type 5 narcotics list. Seeds and flowers stay forbidden.
Legal entities, government offices, community enterprises, and companies register with the Food and Drug Administration (FDA) to use the legal parts of cannabis and hemp for medical purposes and in the textile, pharmaceutical, and cosmetics industries.
Use of CBD oil, from hemp seeds only, is allowed in foods and food supplements.
In Thailand, cosmetics produced domestically may contain cannabis-based allowed ingredients, but cosmetics containing these ingredients can not be imported.
In February 2022, Thailand brought a measure officially dropping cannabis from a list of controlled drugs. The new rule comes into force on June 9. Anutin Charnvirakul, the public health minister, announced the country will give out one million free cannabis plants to the citizens to celebrate the occasion.
In 2017, Uttarakhand became the first Indian state to legalize medicinal and industrial cannabis/hemp production with a THC limit of 0.3%. The Indian Industrial Hemp Association became the first to cultivate hemp in Uttarakhand.
In India, CBD oil is licensed and manufactured under the 1940 Drugs and Cosmetics Act.
In Myanmar, Vietnam, Malaysia, the Philippines, and Indonesia, CBD is still illegal.
CBD REGULATIONS 2021: OCEANIA
In 2016, the Australian Therapeutic Goods Administration (TGA) classified CBD as a Schedule 4 (Prescription Medicine) drug.
In 2017, trans-Tasman ministers from Australia and New Zealand approved a change to the Australia New Zealand Food Standards Code to allow the sale of hemp seeds as a food or ingredient for human consumption, provided that the only cannabinoids in or on the seeds are naturally present.
In November 2018, several amendments to food and drug regulations came into force, establishing conditions of the use of hemp seeds, including extracts, oils, and beverages.
In December 2020, the TGA announced a final decision to down-schedule certain low-dose CBD preparations from Schedule 4 to Schedule 3 (Pharmacist Only Medicine). Since February 2021, Australian adults can buy up to a maximum of 150 mg of CBD per day without prescription. The THC limit in Australia is 2%.
On 22 November 2021, the TGA introduced the changes that will enable easier prescription for cannabis products. The Special Access Scheme (SAS) and Authorised Prescriber applications for ‘unapproved’ medicinal cannabis products can now be made by active ingredient, under one of five categories based on cannabinoid content, and not by trade name.
Although CBD is legal in Australia, the products containing it have to be approved by the Australian Register of Therapeutic Goods (ARTG).
For a CBD product to be approved by the ARTG, CBD has to be either plant-derived or when synthetic, only containing the (-)-CBD enantiomer. Furthermore, CBD has to comprise 98% or more of the total cannabinoid content of the preparation. Any cannabinoids, other than CBD, must be only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the preparation. THC can only comprise 1% of the total cannabinoid content. The maximum recommended daily dose is 150 mg or less, and the products have to be packed in blister or strip packaging or in a container fitted with a child-resistant closure. The packs can’t contain more than 30 days’ supply, and the products must be for adult use only (18+). The products can be oral, oromucosal, or sublingual preparations.
In New Zealand, amendments to the Misuse of Drugs Act in 2018 allowed the cultivation of industrial hemp and processing and trading in the seeds and stalk to produce hemp food and fiber products. The cultivation is permitted for the production of hempseed oil and hemp seeds, as well as for fiber. The THC limit is 2%.
On April 1st, 2020, the Ministry of Health introduced the Medical Cannabis Scheme. According to this regulation, CBD products can be prescribed by any doctor registered to practice in New Zealand.
A Certificate of Analysis from the supplier is required to determine the quantities of CBD and specified substances. If a product contains CBD but does not meet the definition of a CBD product, it is a ‘controlled drug’ and is subject to the regulatory requirements of the Misuse of Drugs Act.
The import of CBD products to New Zealand is illegal.
CBD in Papua New Guinea is still illegal.
On December 2nd, 2020, the United Nations Commission on Narcotic Drugs (CND) voted on six World Health Organization (WHO) recommendations issued in January 2019. Deleting cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs prompted a cascade of positive effects for the cannabis industry.