What is the legal status of CBD in Spain?
CBD, or cannabidiol, is a cannabinoid found in cannabis with many therapeutic applications. It has become famous because it has no psychoactive effects, it does not get you high, and the scientific community attributes to it anti-inflammatory, antidepressant and neuroprotective properties, among others. As a result, the market is filling up with new CBD products such as flowers, cosmetics, drinks and oils for topical or food use. But are they all legal? How are CBD products controlled?
CBD is neither addictive nor harmful to health
This first point does not refer to a law, but it is vital when considering the cannabinoid’s impact on public health. “Cannabidiol is neither addictive nor harmful to health.” That was the conclusion of an Expert Committee on Drug Dependence of the World Health Organization in December 2017. According to this report , which marked a turning point in the history of CBD, the experts reached several conclusions in favour of the use of cannabidiol. On the one hand, they concluded that CBD does not cause dependence in those who use it. On the other, that even if the substance is abused, abusive use would have no harmful effects on humans. They also confirmed that using cannabidiol has no psychoactive effects (it does not alter human mental functioning) or cardiovascular effects. With its conclusions, this expert committee laid the foundations for further scientific and medical research into the properties it attributed to this cannabinoid. There were no legal changes in Spain regarding CBD as a result of this report, but the most prestigious international health agency had given its favourable opinion on the use of cannabidiol.
Legal status of CBD in Spain
In Spain there is no specific law regulating the production or consumption of CBD, so the substance is subject to the interpretation of international conventions and national and international case law. The regulation, or lack of it, of CBD in Spain takes as its first reference the 1961 Single Convention on Narcotic Drugs, in which cannabidiol is not specifically controlled, unlike THC, but cannabis extracts, tinctures and resins are, so it could be argued that, as CBD is an extract of the plant, it would be controlled. Remember that this United Nations list was drawn up even before CBD, first synthesised by the scientist Raphael Mechoulam in 1964, was discovered, and it therefore considers the Cannabis sativa plant as a whole, without distinguishing between its cannabinoids.
It does distinguish, however, between prohibited and non-prohibited parts of the plant. When the substance comes from the seeds or leaves of cannabis, they are not prohibited. When it comes from the flower, fruit or bud, they are.
The Court of Justice of the European Union, in favour of selling CBD in Europe
In November 2020, the Court of Justice of the European Union handed down a ruling that set a very favourable precedent for the sale of CBD products. Contrary to the United Nations view that any substance derived from the tincture or resin extracted from the cannabis bud should be controlled, in this ruling concerning a French company that had previously been convicted by a French court, the CJEU held that “a Member State may not prohibit the marketing of cannabidiol (CBD) lawfully produced in another Member State when it is extracted from the Cannabis sativa plant in its entirety and not solely from its fibre and seeds”. The Court argued that if the legislator had intended to control or prohibit CBD or the other cannabinoids, it would have included them specifically in the control lists, as it did with THC. Therefore, CBD cannot be controlled at international level.
The Spanish Agency of Medicines and Medical Devices (AEMPS), against legalising CBD
The Spanish Agency of Medicines and Medical Devices (AEMPS) does not agree with interpreting CBD in the way the Court of Justice has done, even though it would be responsible for regulating cannabidiol if it were produced for therapeutic and medical purposes. When our firm, S&F Abogados, contacted the AEMPS to ask about hemp production and subsequent CBD extraction, it replied that since all extracts of the plant are controlled under the international conventions, so was CBD, ruling out any interpretation favourable to the production and extraction of this cannabinoid.
CBD is not illegal, but it cannot be sold for human consumption
Cannabidiol still cannot be sold for human consumption in Spain because it is not classified either by the Spanish Agency of Medicines (AEMPS), if its use were assessed exclusively for medical reasons, or by the Spanish Food Safety Agency (AESAN), if we stick to its intake as a food supplement. In fact, in Spain CBD has not yet been registered on AESAN’s list of authorised food supplements. These products would also have to be registered at European level to obtain approval from EFSA (the European Food Safety Authority), and some time ago the European Commission put applications to register CBD as a food supplement on hold, given the avalanche of applications received. They are now being processed again. So much so that in 2018 officers in several Spanish regions seized oils and other food products containing CBD, because the substance is not considered fit for human consumption. The seizures were prompted by guidelines from the European Food Safety Authority (EFSA), which ordered the withdrawal of food supplements containing cannabidiol because these foods required prior authorisation. Remember that currently the only CBD product authorised for human consumption in the European Union and Spain is Epidiolex (Epidyolex in Europe), a cannabis-based medicine for the treatment of rare and severe forms of epilepsy, produced by GW Pharmaceuticals, which was launched in the United States in 2018 and approved in Europe in 2019.
Legal status of CBD in Europe
At European level there is no uniform legal position on CBD, its production, consumption or sale. Apart from the Court of Justice ruling mentioned above, each country applies its own laws. In fact, as we saw in the ruling, the CJEU considered the sale of CBD legal as long as it had been lawfully produced in another member state. In that case, the CBD had been produced in the Czech Republic, where it is legal to produce it. But explaining in which European countries CBD is legal, for which uses and at which levels, deserves a post of its own.
Legality of CBD for external use
When we talk about CBD for external use we mean topical applications of cannabidiol: creams, ointments or oils. These products can be classed as cosmetics, and in this case the AEMPS applies the same criterion described above. Since cannabis resin, extract and tincture are on List I of the 1961 Single Convention on Narcotic Drugs and are subject to international control, only cosmetics made from the uncontrolled parts (seeds and leaves) can be legally produced in Spain. This requires a responsible declaration and registration of the product at national and European level. This is due to article 14 of Regulation 1223/2009, which states that cosmetic products must not contain the prohibited substances listed in annex II, which includes all the substances in lists I and II of the 1961 Single Convention on Narcotic Drugs. The company responsible for each cosmetic product must therefore provide the necessary and sufficient information to show that the cannabidiol does not come from controlled parts of the plant, and must demonstrate the safety of the product in accordance with Regulation 1223/2009. Of course, cosmetics with CBD extracted from the flowering part of the cannabis plant can be sold in Spain as long as that CBD was grown in countries where it is legal to do so. But we will talk about that, and the world of CBD cosmetics, in our next article.
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