If you’re one of the many North American cannabis companies looking at expanding into the EU market, you’re onto something big. While the US and Canada have well and truly broken in the legal cannabis industry, countries across the EU are also making ground – largely in the CBD industry.
Cannabinoid solutions have become extremely popular in the EU, with interest and consumer activity continuing to grow every year. According to the Association for the Cannabinoid Industry, the UK’s CBD industry alone is now a third higher than what it was valued at in 2019, reaching a very healthy £690 million in 2021. Across the EU, the CBD market surpassed $1.9 billion (USD) in 2020 and has bloomed even more since, supported by a total of $128.5 million (USD) million invested across 34 CBD companies in 2019.
Evidently, this is a big old pie that it would be rude not to take a slice of! Particularly for innovative CBD brands that have the knowledge and expertise to deliver something special to what is admittedly an over-saturated market.
But, it’s not as easy as hopping across the pond and getting your North American-compliant cannabinoid products sold in UK stores. There are vastly different regulations in Europe, spanning 44 countries, varying levels of legal THC, the recent Novel Foods compliance issues, and even problems with banking. It’s definitely a tricky market to navigate, but if you get it right, it’ll be well worth it.
It’s now essential for all CBD products sold in the UK are granted Novel Food approval from both the FSA (Foods Safety Authority) and EFSA (European Foods Safety Authority). Although right now Novel Food evaluations are on hold ‘pending new data’, if your CBD products don’t meet the standards you’re likely to come up against pretty huge problems down the line. So huge they might prevent you from selling your products in the EU entirely.
The obvious solution is simply to ensure your products go through the Novel Foods process and tick all the boxes. However, this comes at an expense and, for many North American companies, may even require entirely new products to be formulated that meet the criteria. Obviously this isn’t possible for everyone, but that doesn’t mean the EU and UK markets are closed off to you. Certain products, such as cosmetics, vapes, patches and cold pressed hemp oil fall outside of Novel Foods jurisdiction, so you can get these over the line without Novel Foods’ approval.
While many areas of North America now allow high THC cannabis products to be legally sold, the same can’t be said for most countries in Europe. Just to make things even more complex, the legal limits for THC vary across the 44 EU countries and seem to be changing every 5 minutes! In Switzerland, the THC limit is 1%, whereas in Europe, it has a 0.2-0.3% upper limit, and many brands feel safer omitting THC entirely. (In the U.K., the limit is technically zero.)
Chances are you’ll have to tailor your cannabinoid products to meet legal THC (and other controlled cannabinoids, such as CBN and THCV) limits across Europe. You may feel safer going for zero THC products to avoid complications, but if you’re keen to market a full spectrum product, it’s essential you team up with a formulation lab team who really know their stuff when it comes to EU THC limits. Fortunately, you’re in the right place, because True North Labs are all about attention to detail. Want to discuss this further? Get in touch.
As we’re on the subject of compliance, another area where you must be cautious in is the language you use to advertise your products. The MHRA (Medicines and Healthcare products Regulatory Agency) has very strict rules on what you can and can’t say about CBD products. In the UK and across the EU, you’re not permitted to make any explicit medical claims about your product, offer any advice or product to treat any specific condition, imply your products can or have traditionally been used to treat any illness and much more! You can claim products help to “maintain” or “support” health or a healthy lifestyle. Labelling is also very important to get right, with accurate cannabinoid content, instructions for use (including the EU recommended upper limit for CBD dosage of 70mg a day) and ingredients in the right language, as supported by 3rd party lab results.
As advertising cannabis and CBD products is also extremely restricted in the EU, and most mentions of it on social media will be removed, strong SEO copy is key to brand visibility in the global CBD industry. However, given the tight regulations on what you can and can’t say it’s highly advisable that you hire a writer who understands the rules, rather than attempt to do it yourself.
There are some major differences in what the US FDA approves vs. what is allowed in the EU. Hint, the EU is a lot tougher and transferring recipes from North America and working to simplify to the EU standards will need some considerations and expertise of local knowledge. Certain actives that are allowed in the US can’t be used here.
For example, take a look at Titanium dioxide. Titanium dioxide (E171) is a food additive used as a white food colour in products such as confectionery and supplements. The safety of food colours like titanium dioxide has long been debated, but in markets where regulations do not limit their use, such food colours remain prevalent. There is still wide use of this colouring in North America.
The EC ban on titanium dioxide follows EFSA's 2021 opinion on the safety of this food additive, which concluded that concern for the genotoxicity of titanium dioxide nanoparticles could not be ruled out.
It only just hit the news, but using cheap questionable ingredients in your product can open up legal problems. Just last week, a class-action lawsuit was filed against Mars Inc, for concealing information from consumers about an alleged toxic ingredient called titanium dioxide!
You need to find a team that is not only capable of working with cannabinoids but also needs to draw on food scientists and other professionals in their team. Having in-house expertise and breadth of knowledge will be key to successfully launching a complaint product in different regions. Try and find a team that can help work within the system to deliver an exceptional product. Ask your team if they have experience with various formats, such as isolates, distillates, emulsions, galenic forms, powder sachet, liposomal, WS emulsions, terpenes, CRD, and have experience working with other actives or adaptogens.
Also, having in-house and external HPLC testing relationships can save you a lot of money in the product development phase. The majority of products don’t meet spec as a majority skip on testing. You want to get your product iterations perfected before you spend your testing allowance on the quality testing service provider. Lastly, don’t forget, that your product will need a Swiss, EU, or UK legal address.