Recently, CBD food products were qualified as Novel Foods requiring a market authorization. The lively trade in these products therefore currently seems to be at risk. However, not all cannabis derived products are Novel Foods. What is the current state of play regarding these products and how is enforcement going to look like?
Current state of play re. cannabis derived products
In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU's 'Common Catalogue of Varieties of Agricultural Plant Species' and the tetrahydrocannabinol (THC) content does not exceed 0.2 % weight per weight. The Common Catalogue is embodied in the EC Plant Variety database, which currently lists 68 species of Cannabis sativa. Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour and defatted hemp seed have a history of consumption in the EU and therefore, in principle, are not novel.
This is different for extracts derived from Cannabis sativa L. and derived products containing cannabinoids, such as cannabidiol (CBD). It follows from a recent clarification of the Novel Food Catalogue that these products are considered Novel Foods, as a history of consumption regarding these products has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient. If for instance CBD is added to hemp seed oil, the product can no longer be marketed just like that and requires market authorization. The status of Novel Food also applies to extracts of other plants containing cannabinoids and to synthetically obtained cannabinoids.
How does the market of CBD food products currently look like?
Currently, the market in CBD food products is flourishing. A variety of CBD nutraceutical products is being offered for sale, such as HempFlax CBD, CBD oil, but also CBD-infused tea, honey or sweets. Although there is no hard-scientific evidence, many health benefits are connected to CBD food products, such as stress reduction, good night rest and providing energy and increasing resistance. Contrary to products containing THC (tetrahydrocannabinol), which is also extracted from cannabis, you do not get high on CBD food products, as this is not a psychoactive substance.
Medicinal use of cannabis
The use of cannabis derived CBD in food is not to be confused with medicinal use of cannabis. In most cases of medicinally applied cannabis, the active ingredient is THC, not just CBD, or a combination of THC and CBD. Although medicinally applied cannabis does not play a role in the cure of diseases, scientific publications show it can alleviate suffering from diseases, for instance nausea, decreased appetite, slimming or weakening due to cancer.
Consequences for business of the change in legal framework
Due to the qualification of CBD food products as Novel Foods, the lively trade in these products is currently at risk. Any Novel Food has to obtain a market authorization in order to get market access. CBD food products currently marketed may face enforcement measures, unless they can benefit from the transition regime laid down in the Novel Foods Regulation. According to this transition regime, any product that did not fall within the scope of the former Novel Foods Regulation, was lawfully marketed prior to 1 January 2018 and for which an application for market authorization is filed before 2 January 2020, can continue to be marketed until an authorization decision has been taken. While this transition period is in principle drafted for Novel Foods that fall into one of the new novel food categories under the new Novel Foods Regulation, it is in the spirit of the transition regime to also include the CBD scenario.
Pending CBD-application and expected EFSA opinion
Currently, one application for the authorization of a CBD food supplement is pending. The application was made by the company Cannabis Pharma from the Czech Republic and is based on publicly available safety and toxicological information and toxicity reviews. More in particular, the scientific data has been gathered from acute and long-term toxicity studies in animals and tolerance studies in humans. The data package submitted aims to support the safety of the use of CBD in food supplements for adults with a daily intake of up to 130 mg or 1.86 mg/kg body weight. It is reported by various sources that an EFSA opinion is awaited this March (see here and here).
Any benefits for the CBD market of a positive EFSA opinion?
Contrary to the situation under the former Novel Foods Regulation, the authorizations granted under the current Regulation have a generic nature. This means that any other company meeting the conditions of use stated in the authorization, would be at liberty to market CBD food supplements as well. The pending application made by Cannabis Pharma is therefore followed with great interest by the CBD market. As they do not seem to rely on data protection, a granted authorization would pave the way for other food supplement companies. It is not certain if this will happen still this year. If and when EFSA grants a positive opinion this March, the European Commission still has 7 months to submit an implementing act to the PAFF Committee. Upon a positive opinion of the PAFF committee, such implementing act could be quickly adopted. If the PAFF Committee has no opinion or a negative opinion, 1 or 2 months should be added to the procedure as a minimum.
Ireland: some CBD food products can be marketed
Meanwhile, there is some guidance available at Member State level. The Irish Food Safety Authority notes that recently a large number of CBD food products entered the market, typically marketed as food supplements in liquid or capsule form. Depending on the manufacturing process applied, the trade in CBD oil is not prohibited, as this oil naturally contains low levels of CBD, which is considered a non-psychoactive compound. This applies to CDB oil obtained by cold-pressing the hemp seeds. If and when the oil is obtained by supercritical CO2 extraction, then a Novel Food authorization is mandatory.
Denmark: available guidance not crystal clear
According to the Danish Ministry of Environment and Food, a number of Cannabis-derived products are not considered Novel Food, notably hemp seeds, seed flour, protein powder from seeds and seed oil from the Cannabis sativa L. varieties listed in the EC Plant Variety Database that are free from or contain low levels of THC. If these products contain CBD, the regulatory status is not exactly clear. According to the guidance of the Danish Food Ministry, the current status is that pure cannabidiol as well as hemp products with high (concentrated) levels of CBD or other cannabinoids are covered by the Novel Foods Regulation. It is not explained what is understood by "high levels of CBD", but on the other hand an absolute prohibition to market these products in Denmark does not seem to apply.
Absolute prohibitions: Belgium and Austria
Other Member States seem to be stricter than Ireland or Denmark. For instance, the Austrian Health Ministry has made it perfectly clear that food products containing any type of cannabinoid extract without a Novel Food authorization are prohibited to be put on the market. In Belgium, the Federal Agency on Safety in the Food Chain has clarified that the production and marketing of food products based on cannabis is prohibited. The rationale is that the plant Cannabis sativa is mentioned in an annex to a national Decree listing dangerous plants that cannot be used for food production. The prohibition primarily seems to target the potentially dangerous substance of THC and allows derogations on a case-by-case basis, but not regarding food products containing CBD. These are considered Novel Foods requiring a market authorization.
Enforcement directed against (medical) claims in the Netherlands
Until CBD was declared a Novel Food, the trade in CBD food
products was not prohibited in the Netherlands. Contrary to the
substance TCH, the substance CBD is not mentioned in the Dutch
Opium Act, listing prohibited substances having a psycho active
effect. This does not mean that the trade in CBD food products was
allowed just like that. In practice, enforcement in the Netherlands
has been directed against the use of any unauthorized medical
claims. A medical claim is any information according to which a
food product could have a therapeutic or prophylactic effect. When
using such a claim, one comes into the realm of the
Medicinal Product Act, according to which it is prohibited to
market and advertise any medicinal product without a market
authorization. The Dutch Food Safety Authority announced fines up
€ 10.000 regarding the sale of CBD food products in several cases (see here and here). Any food business operator that is serious about his business in CBD food products will therefore not only check the applicability of the Novel Foods Regulation to his products, but also carefully draft his advertisement for this type of product.
The production and marketing of food products derived from Cannabis sativa L. in the EU has been considerably restricted since CDB food products were recently declared to be Novel Foods. However, not all cannabis-derived food products require market authorization. Pending the evaluation of the Novel Food application filed for a CBD food supplement by the Czech company Cannabis Pharma, it is worthwhile for other CBD food products to verify whether they can benefit from the so-called transition regime embodied in the Novel Foods Regulation. Due to differences between legislation in the Member States, this may differ from country to country. Also, it is important to carefully position your CBD food product, in order to avoid any medical claims.
The author ackowledges Jasmin Buijs, paralegal at Axon, and Max Luijkx, intern at Axon, for their valuable input.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.