In journalism and media industry for more than twenty years, worked for a number of media companies. Business editing, research and PR specialist. Covering industry and science news for Ilesol Pharmaceuticals.
CBD in Europe – Legislation at the EU and National Levels: In January 2019, the European Commission changed the entry in the novel foods catalog for cannabinoids. Novel Food is defined as food that had not been used for human consumption to a significant degree in the European Union before 15th May 1997. Previously to this decision, only enriched CBD was considered novel food. Now a new entry Cannabinoids was created, and it states all hemp extracts to be novel. Also, the entry of Cannabis sativa L. was changed and now only seed-derived products are considered food. The leaves and flowers are left in a ‘grey zone’.
The change in the form of the European Commission’s unbinding advice for the member states was disapproved by the European Industrial Hemp Association (EIHA). They called the measure ‘unnecessary, illogical and illicit’ and claimed that, although hemp extracts are not formally nor legally forbidden, many European states are now taking ‘disproportionate and unjustified’ measures. In 1998, the industry received a letter from the EU’s PAFF Standing Committee that encouraged many business decisions for the next twenty years. January’s decision marked the beginning of an important shift in legislation for the member states. At the level of the European Union, CBD is now considered to be the unauthorized new food.
Some of the measures European states are now taking can be illustrated by a recently adopted resolution proposed by the Agricultural Commission in the Italian parliament. It proposes a raise in the THC level in the industrial hemp that comes from EU varieties from 0.2 to 0.3 %. This would level it up with the rest of the global market since permitted levels of THC in CBD products in North America and Australia are 0.3 %. It also asks for the regulation on the sales of dried, chopped or pelleted biomass from the entire plant or its parts, with THC content not exceeding 0.2 %. There are no current guidelines on CBD or THC limits considering food in Italy, and this resolution calls for defining them.
In practice, to avoid leaves and flowers being left in the ‘grey area’ and to escape further regulatory confusion, some Italian companies started registering CBD hemp flower products as animal feed. However, registering pure cannabinoids such as CBD extracts as animal feed is not permitted. CBD for pet food is also forbidden.
Italians are not alone in this novel practice. Following the novel food change, many European companies approached the issue by relabelling their products. Austrian biotech company CannHelp recalled all of its CBD-based oils, foods, and cosmetics. The company has relabelled the oils so they are now categorized as “aromatic products” and, as such, placed back on the shelves.
The German Office for Consumer Protection and Food Safety (BVL) outlawed CBD in food and food supplements in March 2019. The products containing cannabidiol are prohibited unless they were authorized as a medicinal product or novel food. As of April, Nordic Oil and other German companies were subjected to a series of raids, with their products containing CBD confiscated. The simultaneous searches targeted a number of shops selling CBD products. Bavaria is considered to be the toughest German federal state when it comes to cannabinoids, but the shops in other parts of the country, e.g. Hamburg, were reportedly searched on suspicion of narcotics trafficking, too.
In April 2019, the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) issued guidance that stated CBD oils, regardless of whether its origin is natural or synthetic, as well as extracts and other parts of the plant Cannabis sativa L. (flowers, leaves, and stems) are considered novel food.
In June, the Swedish Supreme Court ruled CBD oil containing low levels of THC to be classified as a narcotic. Also, the court disagreed with the Swedish Medical Products Agency’s proposal to put the products for oral consumption or inhalation containing cannabidiol under pharmaceutical legislation. Industrial hemp is an exemption from Swedish anti-drug legislation, and it only applies to plants, not products. Since 2017, eight companies selling CBD oil as a dietary supplement have been banned from distributing their products by the Swedish Medical Products Agency. Sweden also leads the European Union’s member states in the number of CBD notifications submitted through the EU’s Rapid Alert System for Food and Feed (RASFF) portal. Out of 35 notifications, 14 are from Sweden.
Norway is not an EU member state. The Norwegian parliament decriminalized personal drug use in late 2017 and legalized the medical use of cannabis. CBD oil is legal as long as it contains 0% THC and is prescribed by a doctor. Growing hemp or other cannabis plants, as well as buying whole hemp and cannabis seeds is illegal.
In 2018 Denmark changed its regulations and introduced a threshold limit that made it possible to produce and sell cannabis-based products containing up to 0.2 % THC without contravening national drug control legislation.
Another news in European legislation came from Belgium in May, when Public Finance Service (FPS Finance) issued an announcement clarifying that “plant-based smoking products containing CBD and some THC content” were legal and belonged to the category of “other smoking tobaccos”. It defined the products as dried hemp flowers that are tobacco-free, which can be consumed through combustion if did not contain more than 0.2% THC. The Health, Food Chain Safety and the Environment (HFCSE) called the manufacturers to contact the authorities before placing any herbal product for smoking on the market. This move brings a tax of roughly 30% and an additional 21% for VAT on hemp flowers.
In October 2021, Luxembourg announced it will become the first European country to legalize growing and using cannabis. Under the legislation announced by the government, adults will be able to legally grow up to four cannabis plants per household for personal use. Seed trade will also be permitted without any limit on the quantity, or levels of THC. The place of cultivation will be limited to the usual place of residence, indoors or outdoors, on a balcony, terrace, or garden. The consumption and transport of cannabis or cannabis products in public will remain illegal. The sale of cannabis or cannabis products other than seeds also stays illegal.
The new regulation may cover the sale of CBD, which is legal with the THC limit of 0,3%.
In Poland, tax classification places CBD oils in the same group as cooking oils and margarine, and therefore subjects to a 5% value-added tax (VAT) rate, comparing to a 23% rate for medical cannabis. Local reports say the Chief Sanitary Inspectorate and the police have intensified their enforcement activities on retail stores that sell CBD products. More than 20 Polish CBD stores were subjected to confiscation of their goods by law enforcement bodies.
On September 14, 2021, Czech MEPs adopted an amendment to the law on addictive substances, accepting 1% THC in hemp products. It will come into effect on 1 January 2022. Farmers growing varieties of industrial hemp from the common European catalog will not have to prove the THC content of hemp plants – they will only submit a certificate of origin. All cannabis extracts that have a THC content of up to 1 percent by weight and which at the same time do not have narcotic effects will be completely exempted from the substance abuse regime.
Ukraine has kept its THC level at 0.08% (for seed and fiber production), and Slovakia is the only country in the European Union where CBD and THC are still illegal. Only the cultivation of industrial hemp varieties approved by the EU and with less than 0.2% THC is legal in Slovakia, and it cannot be cultivated to extract CBD. The local pharmaceutical business is also seeking approval for the development and manufacture of cannabinoid-based drugs in both states.
In Romania, any consumable product originating from cannabis is controlled under criminal law. However, in 2019, a report by the European Monitoring Centre for Drugs and Drug Addiction showed that there are herbs, oils, and e-liquid at the Romanian market.
Not all EU member states have announced the enforcement of novel food catalog guidelines on CBD, and there are unconfirmed reports that Bulgaria recently issued a license that would permit the sale of CBD food products.
The Netherlands, as the biggest European hemp producer, has a legislative framework derived from the Opium Act introduced in 1912, and amended in 1976, when the distinction between ‘hard’ and ‘soft’ drugs was introduced. By this Act, CBD is not legal but tolerated as a soft drug. The Opium Act was amended in 1999 when hemp that is produced exclusively for the fiber hemp market with a THC content of less than 0.2% was legalized. It’s still illegal to produce CBD oils because it’s illegal to produce plant extracts, so the hemp is being produced in the Netherlands and then processed abroad. Furthermore, under Dutch law, the maximum level of THC in CBD products is 0.05%. CBD isolates and THC extracts are prohibited for sale to the public but allowed for export.
In Switzerland, the legal level of THC is at 1%. In 2011 Switzerland increased the limit defining how the cannabis plant is classified under the Narcotics Control Act from 0.3 % to 1 % THC. The number of cannabis products on offer containing CBD has expanded since mid-2016 when one company marketed a large amount of ‘low-THC’ cannabis product, regulated as a ‘tobacco substitute product’ with associated health warnings and taxation levels. Once the information began to disseminate that products containing less than 1 % THC were not subject to cannabis legal controls in Switzerland, the marketing of these low-THC cannabis products increased.
In Great Britain, the biggest CBD market in Europe, THC is listed as a controlled substance under the Misuse of Drugs Act 1971. CBN (Cannabinol) and CBDV (Cannabidivarin) are also class B controlled substances. Only CBD isolated in its pure form is not listed as a controlled substance. Growing your own cannabis and hemp is allowed with a license from the UK Home Office for licensed medical distributors or companies that sell nutritional supplements. CBD products sold as nutritional supplements must be labeled in accordance with The Food Supplements Regulations from 2003. The sale of hemp flowers and buds is prohibited. CBD extracts and other derived products are considered novel foods and need to gain authorization. As we are informed by the Food Standards Agency (FSA), currently there are no CBD extract products authorized as novel foods in the UK, and the products on the market are in contravention of the novel food regulations.
The ‘grey zone’ of the European legislative becomes even greyer knowing CBD was never listed as a food supplement in the EU. The reference EU legislation in the area of food supplements is Directive 2002/46/EC, but the use of substances other than vitamins or minerals in the manufacture of food supplements may be governed by national rules or may be subject to other specific EU legislation.
Medicinal products: Directive 2001/83/EC (medicinal products directive)
Foods: Regulation (EC) No 178/2002
Food supplements: Directive 2002/46/EC
Novel foods: Regulation (EU) 2015/2283
Cosmetics: Regulation (EC) No 1223/2009
Tobacco products: Directive 2014/40/EU
Nutrition and health claims on foods: Regulation (EC) No 1924/2006
In October 2021, we published an article about global CBD regulations that can be found here.