Following the United Kingdom’s CBD Novel Foods Application Deadline, European CBD producers and distributors are now holding their breath in anticipation of what this means for potential European Union legislation. The UK was the first European nation to create a formal, legal process for the sale and distribution of CBD. Companies that wish to sell their products in grocery stores and CBD businesses themselves now require approval from the Food Standards Agency (FSA).
The transition towards this process, however, has not been easy, and has resulted in a series of deadline complications, product seizures, and continued legal ambiguity. Other European countries, and the EU as a whole, must not evaluate whether or not an application process such as this is worthwhile, and whether or not it may benefit the CBD industry or crush it completely.
The Reasoning Behind the FSA’s CBD Novel Food Deadline
The FSA initially set its CBD Novel Foods Deadline back in February 2020 when it announced its plans to improve CBD product safety by increasing the legal requirements for vendors and manufacturers. In their initial press release, the agency highlighted the need for improved CBD regulations and described the process by which they would address said issue: by enforcing a strict authorisation process. Any retailer in the UK CBD industry would, from the deadline on, be required to submit a valid novel food authorisation application prior to the sale and distribution of their products. Only once the applications had been approved by the FSA would the company be legally permitted to sell CBD commodities in the United Kingdom.
The driving force behind this movement was the overwhelming fear of unsafe consumption. While this press release was published prior to the UN’s retraction of CBD’s narcotic status, the amount of information regarding CBD and its long-term health effects is still not clear. That is why the FSA’s novel food deadline release was followed up by their first-ever CBD public safety announcement. In the statement, the FSA recommends that, based on the recent findings by the government’s Committee on Toxicity (COT), CBD users do not exceed an upper limit of 70mg of consumption per day. This is in spite of the Chair of the COT, Professor Alan Boobis, acknowledging, “We don’t know enough to be sure about such a risk.” While most users are considered to be safe during their CBD consumption, this recommendation was primarily targeted towards vulnerable groups such as pregnant women or breastfeeding mothers.
Recognizing the amount of work required by the FSA and CBD industry players to facilitate this transition, the UK set the CBD novel food deadline on 31 March 2021. Despite having over a year to prepare, however, there have been more problems than solutions.
Measuring the Success of the Deadline
In 2019, the European Union determined that CBD required premarket novel food authorization because it did not encompass the organization’s list of novel food ingredients established in 1997. Even after leaving the EU, the UK government continues to embrace this sentiment and push for stricter CBD regulations, particularly around the removal of unauthorized CBD products. The fundamental issue with this ideal is the deadline and the application approval process. Both of these have run into serious challenges.
Originally, the FSA had intended for all CBD novel food applications to be submitted by early February so as to provide a sufficient amount of time for review. According to the FSA, applications are subjected to an 8-day admin check prior to being completely validated – a process that could take up to 30 working days to complete. A validation process this long led to a lot of issues, especially with regards to submission punctuality.
As March began, the FSA received a massive wave of CBD novel food applications, likely from firms who expected an authorisation procedure that was faster than 38 days. Unable to process all of these applications all at once, the FSA announced that it was extending its application deadline to 31 March 2021. What complicates this issue is that only CBD products on sale prior to the 13 February 2020 announcement and are linked to a validated novel foods application will remain on the market past 1 April 2020. This means that newer products from businesses with potentially validated applications, may have to be removed from the market altogether. Moreover, companies that eventually have their applications rejected could have been selling unsafe or unauthorized products well into April. This, combined with the low number of businesses that have successfully received validated applications, has been a huge concern for the CBD industry as a whole.
The Ramifications for European CBD Regulations
As of 20 April 2021, after a chaotic stretch of deadlines, extensions, and application submissions, only three CBD producers have had their products approved. The caveat is that these products may still be subject to bans or seizures should the FSA’s final decision on their authorizations be unfavourable. Additionally, the FSA emphasized that “Inclusion on the list is no guarantee of eventual authorization; that will be determined on the strength of evidence of safety submitted by the companies.” A lack of definitive approval calls into question the reason for an initial CBD novel foods application process. Why initially validate certain CBD products if they will be later removed upon further evaluation?
The confusion and frustration that has resulted from this transition has forced several other prominent European governments, such as Germany, to evaluate how it should further legalize the sale and distribution of CBD and its products. If only a few companies have been approved after months of applications, is the process conducive for a healthy and sustainable CBD market?
As a distributor looking to qualify for future validated novel foods applications, the success of your business rests heavily upon the quality of your product. Without a legitimate, safe, and reputed supplier, the likelihood of future approval becomes increasingly difficult. Fortunately, CanX can reliably provide its clients with high-quality CBD products in an EU GMP-certified pharmaceutical-grade environment. To learn more about CanX, our process, and our services, contact our team today.