Game-changing Events for the European CBD Industry

Cannabidiol (CBD) products grow in popularity across the European continent. The market development has been somewhat withheld because of the slow pace in legal changes on both national and the European union’s level. The situation in the European CBD industry began to move forward during the last couple of years, with some game-changing events occurring at the end of 2020.

The cycle of legislative changes started in January 2019, when the European Commission changed the entry in its novel food catalog, adding a new entry for cannabinoids, and stating all hemp extracts to be novel food. Previously, only enriched CBD was considered novel food. Now, the entry of Cannabis sativa L. was changed and only seed-derived products were considered food, with the leaves and flowers left in a ‘grey zone’.

The decision in the form of the European Commission’s non-binding advice to the member states was disapproved by the European Industrial Hemp Association (EIHA). They called the measure ‘unnecessary, illogical and illicit’ and warned that, although hemp extracts are not formally nor legally forbidden, many European states started taking ‘disproportionate and unjustified’ measures.

CBD is not a narcotic

The decision has caused further problems for the CBD industry with the verifications process for the novel food products halted after the European Commission started considering whether CBD can be defined as narcotic. After announcing its preliminary view in July 2020, when they stated that CBD extracted from the flowering tops of the Cannabis sativa L. plant should be considered a narcotic, the Commission stopped reviewing the applications. However, after many months of delay, the notion of CBD’s narcotic effects was finally dismissed.

This happened on the 2nd of December 2020, the same day that the UN decided to remove cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs. Simultaneously, following the ruling of the Court of Justice of the European Union (CJEU) from 19th of November 2020, the European Commission confirmed that CBD is not a narcotic, and announced it would start resuming the verification process for Novel Food applications. After the decision of the highest European court, there was no more doubt – CBD has no narcotic properties and can be marketed as food. The ruling from the CJEU also meant that a member state may not prohibit the marketing of CBD lawfully produced in another member state when it is extracted from the Cannabis sativa plant in its entirety, and not solely from its fiber and seeds.

Adjustment on national levels

Even before the ruling of the CJEU, Italy decided to revise its decision of listing CBD as a narcotic. In October 2020, the Italian Ministry of Health suspended such a decree just days before it came into effect.

The initial case that brought this U-turn started in France in October 2018 with the Marseille Criminal Court giving a verdict to two Marseille entrepreneurs, sentencing them at first instance to 18 and 15 months suspended imprisonment and 10,000 euros fine. The two men were sentenced for using an oil legally made in the Czech Republic containing CBD extracted from all parts of Cannabis Sativa, leaves and flowers included, while France only allows the use of seeds and fibers. The French court of appeal considered that the French regulations could not be compatible with those of the EU, and sent the case to the European Court of Justice. When the European Court of Justice overturned the decision of the Marseille court, it started a whole cascade of positive actions in the European legislation. The Union law can not be overridden by domestic laws, which now had to undergo some important changes.

European CBD industry: Lifting THC threshold

Those changes are now underway. In February 2021, the French National Assembly published a report with 20 proposals. Among other proposals, it called for an urgent change of the 1990 decree, definitive renouncing 0%THC threshold in end products, allowing marketing of CBD products from all parts of the hemp plant, and lifting the THC threshold in hemp crops to the levels between 0.6% and 1%. Also, the French lawmakers called upon the national authorities and the European countries to overcome their fears regarding cannabinoids, calling it disproportionate.

After the European Commission’s new entry into the novel food catalog, 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 a result of an intense discussion that lasted since April 2018, the German Federal Government recognized the difference between natural and enriched cannabinoids in March 2020. After this decision, hemp food products made from traditionally produced extracts with the natural full spectrum of the cannabinoids contained in the hemp plant are not considered novel foods in Germany.

Differences across the continent

In the UK, the biggest CBD market in Europe, only CBD isolated in its pure form is not listed as a controlled substance. Growing your 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 following The Food Supplements Regulations from 2003. The sale of hemp flowers and buds is prohibited. CBD extracts and other derived products are considered novel food and need to gain authorization. After the Brexit, the UK’s Food Standards Agency (FSA) continued with the verification of Novel Food applications without further help from the European Food Safety Authority (EFSA). In February 2020, UK’s The Food Standards Agency (FSA) has issued an announcement giving the CBD industry a deadline of 31 March 2021 to submit valid Novel Food authorization applications. After that date, only products that have submitted a valid application will be allowed to remain on the British market.

Also, Britons decided to have a different approach towards THC limits measurement. In the UK, there is no THC limit set per kg/bodyweight for hemp foods, but instead an arbitrary amount of 1mg per product, irrespective of the product size. In the European Union, the permitted levels are 1 mg per kg of body weight – 0.001 mg/kg BW. The industry is not happy with this level and works on its correction. As a comparison, in Canada, the permitted level is 0.014 mg per kg of body weight. In Switzerland, the only country in Europe that already has a legal level of THC set at 1%, it’s 0.007 mg per kg of body weight.

For hemp growers, CBD producers, and retailers, Switzerland is the most appealing country in Europe. In 2011, it increased the limit defining how the cannabis plant is classified under the Narcotics Control Act from 0.3 % to 1 % THC. The 1% THC is the natural level in the chemotype 3 hemp plant, so this decision meant easing the production and lessening its costs. The number of cannabis products containing CBD in Switzerland has seen big expansion since mid-2016.

European countries are still far from unified in CBD legislation. 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 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 in the Netherlands because it’s illegal to produce plant extracts. For that reason, hemp is being produced in the Netherlands and then processed abroad. Under Dutch law, with the legally permitted level for fiber hemp at 0.2% THC, the maximum level of THC in CBD products is 0.05%.

Some adjustments with the EU legal stands will be necessary for Sweden, too. In June 2019, the Swedish Supreme Court ruled CBD oil containing low THC levels has 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 were banned from distributing their products by the Swedish Medical Products Agency. Sweden also leads the European Union member states in the number of CBD notifications submitted through the EU Rapid Alert System for Food and Feed (RASFF) portal.

Other European countries also differ in CBD legal regulations. In some of them, CBD is still virtually illegal or even subjected to criminal law. Legislative unification expected at the European level will bring more safety for businesses and consumers across the continent.

Natural CBD cosmetics is now allowed in the EU

One of the major milestones was crossed in February this year when the European Commission introduced a new entry for CBD in its CosIng base, created to provide information on cosmetics substances and ingredients. Until then, only leaf extracts and synthetic CBD were allowed in cosmetics in the EU. Now the natural CBD is also allowed. That marked a beginning of a new era for CBD cosmetic producers in Europe, who can now develop a full range of products for one of the biggest CBD markets in the world.

Reviewed by Sasha Bajilo, founder of ILESOL Pharmaceuticals, an industrial scale producer of CBD products and formulations. Expert on Hemp/Cannabis policy, member of the Croatian Ministry of Health regulatory commission for medical cannabis.