Developments on regulation of CBD and Cannabis
Category: Cannabis law
What’s new on cannabis and CBD regulation in the Netherlands?
Cannabis and the extractions cannabidiol and cannabinoids are mentioned since 2019 in the Novel Food Catalogue (NFC). The NFC is a guideline that should be enforced by an EU member state itself. That makes the law on cannabis and its extracts like CDB fuzzy. Each member state may have different rules on cannabis and CDB and enforcement of the NFC. The good news is that some novel food applicants have received a positive note from the EU Commission that their CBD product is safe. So where do we stand now with CBD in products in Europe?
A recap on what CBD is
CBD or cannabidiol, is a prevalent active ingredient in cannabis (marijuana). CBD is generally well tolerated with a good safety profile and adverse effects may be a result of interactions with drugs as described above. It is established that CBD exhibits no effects indicative of any abuse or dependence potential. Most importantly, WHO stated that there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD. The latter is especially important due to the fact that CBD as an isolated compound is not psychoactive and does not represent a substance that would fall under the scope of narcotic drugs according to Single Convention on narcotic drugs from 1961. This text is from a notice from the EU Commission on one of the novel food applications for a cannabis extract.
Progress in the application procedure for CBD as novel food
Approximately 10 applicants that wish cannabis or an extract thereof to be registered as a novel food have received notices from the EU commission on the status of their application. You can check these notices on the list of the summary of novel food applications. Some already are compliant with European regulations and as a novel food does not pose a safety risk to human health. For example I mention a notice on an application for a powder of purified CBD 98-102%. Literature is confirmed as follows: “literature on CBD toxicology is huge and has recently been reviewed by internationally acknowledged authorities. More than 120 studies in healthy volunteers or patients, children or adults, show CBD is already largely used orally in Human with no serious adverse effects and at doses very above 1 mg/kg/d (70 mg/d CBD) as proposed for the Linnea CBD. CBD is generally well tolerated with a good safety profile. Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications. About allergenicity, the nutritional profile of CBD shows absence of protein and literature already shows CBD is unlikely to be allergenic.”
These are good steps for acceptance of CBD in food products. Please note that the Eu Commission opinion is base on the specific products applied for.
The Kanavape case on marketing of CBD produces in EU
The Court of Justice of the European Union (CJEU) ruled in a judgment of 19 November 2020 that a EU member state cannot prohibit the marketing of cannabidiol (CBD) lawfully produced in another Member State. The prohibition qualifies a measure having equivalent effect to quantitative restrictions within the meaning of Article 34 TFEU. It concerns CBD that is extracted from the Cannabis sativa plant in its entirety and not solely from its fibre and seeds. More specifically it was CBD produced in the Czech Republic Regulatory with a THC content not exceeding 0.2%. Legislation on CBD is only appropriate for securing the attainment of the objective of protecting public health and should not go beyond what is necessary for that purpose. The case is about French legislation prohibiting the marketing of products derived from parts of the Cannabis plant.
According to the Courts’s judgment the prohibition did not prohibit the marketing of synthetic CBD that had the same properties as CBD extracted from the Cannabis sativa plant. It is also confirmed that CBD at issue in the main proceedings is not a drug within the meaning of the Single Convention. And is not covered by the Convention on Psychotropic Substances.
Cannabis developments in Germany
Germany’s new goverment supports legalization of cannabis. The new government Germany’s announced in October 2021 that it would legalize recreational cannabis for adults in its coalition. The arrival of legal cannabis is being anticipated by businesses around Germany. The Kanavape case didn’t go unnoticed in Germany either. German companies are also allowed to sell CBD products products like tea or CBD-oil especially if they are imported from another EU country. However applications for makertin such products were denied by the authority. The judgement on the appeal is waited from the Administrative Court of Lower Saxony. In the courtcase an opinion by the Committee of Experts at BfArM (the German FDA) was filed which advises the federal government on amendments of the German Narcotics Act because it is held that CBD is not intoxicating. The outcome of this case may be a welcome moment for CBD producers. Clarity on the status of CBD in France and Germany may have effect on regulators in other member states.
Former cannabis frontrunner: the Netherlands
In the Netherlands we are awaiting the start of the wietexperiment, the experimental state cannabis project (experiment gesloten coffeeshopketen). 10 Dutch municipalities, and the coffeeshops in there territory, participate in this project which regulates government controlled growing, transport and sales of recreational cannabis through the coffeeshops in these municipalities. 7 state growers have already been selected, 3 more will be appointed. They are preparing production of recreational hemp. Elections and complications in the preparation of the experiment have caused delays. Regarding CBD we are still waiting on an notice from the Dutch supervisor Nvwa who promised to give an opinion on CBD already 2 years ago. In fact CBD products are allowed if they do not contain more than 0.05 % THC. CBD products are available in many shops and online.
Like other member states there is an apparent disinterest to make a clear statement of CBD, even after several positive notices on EU applications (see above), which is of course regrettable, since people may benefit from its use. More on regulation of cannabis in the Netherlands you can read here.
Blenheim advises companies in the cannabis industry. Feel free to contact us.