There appears to be something of a ‘gold rush’ atmosphere among entrepreneurs selling CBD products in Europe, with shops rapidly opening and closing, and the situation in flux. However, according to the new report from the European Monitoring Centre for Drugs and Drug Addiction, one of the products with the greatest potential for lasting demand is CBD oil.
In December 2020, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) published a report on low-THC cannabis products in Europe.
The report shows that low-THC cannabis products were being offered for sale in the majority of European countries. As the phenomenon has expanded to more countries, so has the range and variety of types of products available across sales outlets, with oil and herbal products being the most commonly identified forms.
The 2020 market expansion is seen as a continuous effect of the earliest developments of the European market that started with a legislative breakthrough in Switzerland in 2011 and caused the expansion in sales since 2016. The new products were observed in Austria from March 2017 and Italy from May 2017, before spreading to Germany, Belgium, and France by early 2018.
Consumer profile and motivation
The motivation and the profile of European consumers in this report are represented by two surveys from two already highly developed markets- Swiss and Austrian. A survey of over 1 500 CBD users conducted by Addiction Switzerland in 2019 showed that one-third of consumers use CBD products on more than 20 days a month. In this survey, three main motivations for use were identified: well-being (to combat stress or insomnia); health (to treat pain, depression, nausea); and to moderate their use of illicit cannabis (to reduce illegal use or the effects of THC). The study also found that people with health-related motivations for use had an older age profile than those motivated by lifestyle or an interest in experimenting with products similar to the established illicit cannabis products.
According to the survey, consumers with health motivations were more likely to purchase products from health/lifestyle shops and included respondents reporting mistrust of big pharmaceutical companies and seeking natural products as self medications or as food supplements. The respondents reporting motivations for use associated with their use of illicit cannabis were younger than the other two groups and more likely to purchase from tobacco/coffeeshops.
An Austrian market survey, conducted in July 2019, explored CBD-containing product awareness and use among a sample of internet users aged 16-69 years (sample size 1 009). Of the respondents, 14 % reported that they had an experience with CBD-containing products, and almost a quarter (23 %) said that they had acquaintances who had tried such products. Three-quarters of these said that they had a positive experience with the product, and 8 out of 10 suggested that they were likely to use CBD again in the future. Younger respondents (aged 16-29 years) were more likely to report having used CBD: 22 % reported that they had used CBD at some time, compared with 13 % of 30- to 49-year-olds and 10 % of 50- to 69-year-olds.
Variation in product quality
When it comes to CBD in Europe, the reports from the study published by EMCDDA indicate that there is wide variation in product quality and this gives rise to some concerns. These include whether the product matches what is claimed in terms of the actual content, particularly concerning levels of CBD and THC, and whether there are contaminants, which may be a particular issue for substances that will be ingested but can also apply more generally. Independent product testing was reported by several countries, including Austria, Czechia, Finland, Italy, Slovenia, and Sweden. In Austria, Italy, and Luxembourg, analyses of confiscated products were reported to show generally low THC but high CBD levels, with Italy reporting some samples with levels of CBD in the 50-60 % range. In Austria, from a sample of around 200 products, 49 were found to be above the legal limit for THC, with several showing 0.4-1.1 % THC rather than the 0.3 % permitted, putting the sellers at risk of prosecution. In Czechia, tests of 29 CBD oils in 2017-2018 found that one third had discrepancies with the amount of CBD stated on the label. THC was not mentioned on 60 % of labels, although one-quarter of the samples may have resulted in a driver testing positive after taking the recommended dose of oil. Some products sold as ‘high in CBD’ therefore contained levels of THC that could potentially have resulted in noticeable intoxication if consumed in sufficient volumes
Tests of CBD oils also found known carcinogens, including polycyclic aromatic hydrocarbons (PAHs) and benzopyrene, above the maximum levels set for oils and oil-containing food supplements in European Commission Regulations (EU) No 835/2011 and (EU) 2015/1933, respectively. In two batches tested, the maximum levels set for benzo(a)pyrene and the sum of four PAHs were exceeded in approximately half of the samples tested. The highest levels found were seven times the limit set for benzo(a)pyrene and almost 20 times the limit set for the sum of four PAHs. One batch of supposedly ‘organic’ products contained traces of a pesticide banned 20 years ago.
CBD in Europe: Marketing challenges
The EMCDDA has identified several regulatory challenges concerning the marketing and promotion of some CBD products. These include inadequate product labeling; inconsistent content; potentially poor product quality; a lack of acknowledgment of the limitations, or overstating, of the evidence concerning the effectiveness of CBD products for therapeutic use; and a lack of safety information or information on potential harms and possible contraindications. However, the Centre has noted that, while these issues may give rise to legitimate consumer protection and safety concerns, to date, there is very little evidence of any reported harms in Europe, either in the scientific literature or anecdotally associated with these products.
The use of product labeling and disclaimers may indicate how retailers of CBD in Europe are mindful of the legal frameworks that may permit or restrict the sale of such products. Examples include praising the taste, yet stating that the product is not for consumption or selling, for example, herbal products with warnings that the products are only collectibles. Some disclaimers state that the product should not be used to treat diseases or that the sellers are not responsible if the product is misused. The user-related disclaimers state that the product is not for use by minors, not recommended for women who are pregnant or breastfeeding, and not to be used while driving.
In Europe, there are variations in the levels set by countries, there are also differences in how levels of THC are set in different types of legislation, with laws applying to industrial uses, narcotics laws, and assessments of food safety taking different approaches in establishing acceptable levels of THC. In 2018 Denmark changed its regulations and introduced a threshold limit that made it possible to produce and sell cannabis-based products containing up to 0.2 % THC without contravening national drug control legislation, while in 2019 Italy passed a decree defining the maximum levels of THC in food as 2 milligrams per kilogram for hemp seeds and hemp flour and 5 milligrams per kilogram for hemp seed oil.
There are also national differences in the way CBD is regulated. If CBD is considered to have medicinal properties, it may be controlled and distributed under medicinal product regulations. Its access to the market will depend on the interest of companies to present applications for marketing authorization for a specific product. The EU framework for medicinal products does not allow for broad recognition of a substance as a medicine.
While permitted THC levels are commonly stated in legislation at the national level, this does not appear to be the case for CBD levels. The EMCDDA warned that there is a range of extracts marketed as CBD with no clear definition of their exact content and a lack of evidence for their effects in humans. Generally, there seem to be few quantitative limits for CBD content but more focus on the conditions attached to its sale. In Romania, for example, any consumable product originating from cannabis is controlled under criminal law. In Denmark, CBD products are considered likely to have a pharmacological effect (based on product type, strength, and dosage), and so they are regarded as medicinal products. In Finland, CBD has been classified as a medicinal product, and the unlicensed sale is not permitted.
In July 2019 Belgium issued a list of herbal products for smoking that could be marketed as long as the business operators are registered to pay excise tax – many product names are cannabis-related (e.g. ‘kush’, ‘diesel’). The smoking products containing CBD must contain less than 0.2 % THC and must not be presented as having therapeutic properties, or as herbal teas or potpourri. In some countries, the legality of marketing the product may depend on the source of the CBD, the format of the product, or how the product is presented.
Inconsistencies between laws
Currently, there may be an inconsistency between laws applying to industrial uses and narcotics laws concerning whether the percentage or the weight is used to determine the amount of THC in a product. It may be possible for a product (e.g. oil) containing a low percentage of THC that is within the permitted industrial levels to exceed the total weight of THC permitted under narcotics laws.
For example, 500 milliliters of ‘CBD oil’ containing 0.2 % THC will contain approximately 1 gram of THC, a threshold for narcotics possession or sale offenses in some countries. Canada and the US state of Colorado have set limits of 10 milligrams of THC in one ‘unit’ of a (recreational) edible product for intoxication, such as one (square of) a chocolate bar. In Canada, 10 milligrams of THC is sold in a 32-gram bar of chocolate, resulting in an intoxicating dose being sold at a concentration of barely 0.03 %.
The European Food Safety Agency (EFSA) uses the acute reference dose of a substance when carrying out risk assessments of food products and contaminants; the acute reference dose is the maximum dose per kilogram of body weight per day that is deemed safe. The EFSA reference dose for THC of 1 microgram per kilogram was calculated using an uncertainty factor of 30.
In Austria and Switzerland, the uncertainty factor has been reduced to 10. In New Zealand, the maximum safe daily THC intake is 7 micrograms per kilogram bodyweight with no apparent problems reported, and Canada’s industrial hemp regulations of 2019 exclude products from the Cannabis Act if they contain no more than 10 micrograms of THC per gram of product.
The sale of low-THC cannabis herb and resin products, therefore, poses a new challenge for law enforcement, as distinguishing between low- and high-THC cannabis on the street, in shops, or at the border is not simple, and it is impractical and costly to test all products. In Austria, Italy, and Switzerland, the police now have a rapid reagent test for use on the street; some portable tests can analyze whether a product contains THC or not and others analyze the amount of THC. Not all law enforcement agencies across Europe have these instruments available.
Some manufacturers are finding ways to make THC water-soluble, which increases its bioavailability, so there is the potential for drinks containing THC to be more potent.
CBD in Europe: Situation in flux
In its new report, the EMCDDA notes the appearance of a ‘gold rush’ atmosphere among entrepreneurs selling low-THC products, with shops rapidly opening and closing, and the situation in flux. Keeping abreast of regulatory changes will be a challenge for small businesses, and increasing regulation is likely to favor bigger companies.
In terms of the products sold, there are some indications that one of the products with the greatest potential for lasting demand is CBD oil. It remains to be seen if the demand for cosmetic products containing cannabis extracts grows in the future. There is also a debate on the extent to which low-THC cannabis products are likely to be attractive to consumers seeking a legal substitute for illicit cannabis, given that these products do not produce the intoxicating effects associated with illicit cannabis.