No country or state is without its regulations, especially when it comes to cannabis. A government can manage these regulations in a seemingly endless number of ways. And we have seen nearly the full spectrum in Europe. From the liberal German CBD and cannabis market to a non-existent formal commercial cannabis Portugal market (coming soon), it is clear that regulations and the ways in which they are written can heavily dictate how these markets grow in any country.
What type of regulations is Europe under?
World Health Organization
In January of 2019, the World Health Organization (WHO) formally recommended the rescheduling of cannabis and cannabis resin within the 1961 Convention on Narcotic Drugs, which currently sets global standards for drug policy. The recommendation was addressed to United Nations (UN) Secretary-General António Guterres - former Prime Minister of Portugal who was in office when universal drug decriminalization took place in the country - and suggested cannabis be formally rescheduled under international drug treaties in the following important ways:
1. Whole-plant cannabis and cannabis resin would remain Schedule I but removed from Schedule IV – the most restrictive category of the Single Convention on Narcotic Drugs (1961). Compounded pharmaceutical cannabis preparations, such as Sativex, would be placed in less restrictive Schedule III of the 1961 Convention.
Though a positive step toward greater international acceptance of cannabis, given that the recommended rescheduling would make the official UN policy toward cannabis less restrictive, Schedule I status would continue to limit the production, manufacture, export, import, distribution, trade, use and possession of cannabis to medical and scientific purposes exclusively. Essentially, it would allow more leniency in medical cannabis regulation, though it would not give states carte blanche to regulate these markets as they wish, nor would it support the enactment or operation of recreational or adult-use programs. The formal UN vote on the recommended rescheduling has been delayed from its originally slated date in March 2019, and will not be carried out until later in the year, or even 2020.
2. Cannabidiol (CBD) and CBD-focused preparations containing no more than 0.2% THC would no longer be subject to international control.
Though not offering a significant change to the cannabis industry overall, the recommendations bode very well for the global and European CBD industries, explicitly allowing for CBD and its preparations to operate outside of international control so long as these products contain <0.2% THC content. This policy change, if adopted by the UN, would permit for the cultivation, production, sales, etc. of CBD products outside cannabis supply chains, without qualifying medical conditions as a prerequisite, and would facilitate international commerce.
Novel Foods Regulations
“Under EU regulations, any food that was not consumed “significantly” prior to May 1997 is considered to be a novel food. The category covers new foods, food from new sources, new substances used in food as well as new ways and technologies for producing food.”
Although they are not legally binding, authorities of European countries use Novel Foods regulations as a reference to enforce laws inside their borders. Following the recent definition of cannabis and its derivatives as “Novel Foods” - meaning they are permitted for “external use only” unless otherwise authorized - these regulations have begun to affect the cannabis and CBD markets in Europe, creating ambiguity and in some cases, inconsistent enforcement. In France, Spain, Austria and the United Kingdom, for example, authorities have raided stores and forced owners and employees to remove CBD products from shelves.
On a brighter note, the Novel Foods regulations as they apply to CBD are currently under review by the European Food Safety Agency (ESFA), which is considering the authorization of the use of CBD in food supplements for adults with a daily intake of up to 130 mg - with a final decision expected in March 2019. Based on the ESFA’s decision, the European Commission will implement and act accordingly, and if the decision falls in favor of CBD, the Commission must authorize the use of CBD food supplement products within seven months, according to European food regulation company SCS.2
This is similar to what the United States is going through with the FDA. The USDA is in charge of regulating the hemp market altogether and the FDA covers food, drugs, and cosmetics - an umbrella which many CBD products fall under. However, the Administration must design clear legal pathways for companies to enter the space with ingestible products in order for the market to scale to its full potential.