At global innovation and clinical research consultancy analyse & realize (www.a-r.com) a core service is writing novel food dossiers, so Steffi Dudek, senior scientific consultant for the firm, is one of the best placed to provide predictions for the future of the market.
But she explains that no amount of expertise can predict what’s next in this market.
Where things stand today
CBD food products are ‘novel’ and therefore need to be assessed for safety before being placed on the market. They must be authorised to ensure they have been through an independent safety assessment.
Since Brexit, the regulatory process in Europe and the UK is divided with EFSA providing legislation for Europe and the FSA providing for the UK.
Both authorities provide lists of CBD products linked to novel food applications providing sufficient data to progress towards validation and safety assessment.
In Europe, no CBD food product is allowed on the market unless authorised by EFSA. In the UK, brands applying or reapplying after 31 March 2021 should not put their products on the market until they are authorised. Those on the market and with their dossier sent in before this date can remain on the market unless removed from the list.
However, after beginning this process EFSA made an announcement last summer stating that its scientists cannot currently establish the safety of cannabidiol (CBD) as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake.
It stated: “It has become clear that there are knowledge gaps that need to be addressed before a conclusion on the safety of CBD can be reached. Consequently, EFSA has issued this statement, summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed. Literature searches for both animal and human studies have been conducted to identify safety concerns.”
Dudek notes that EFSA has also stated that often dossiers haven’t made it clear what CBD extract was the subject of studies referenced in dossiers. This has occurred as a result of individual applicants or consortiums of CBD clients referencing safety data from one study to substantiate a number of different products.
Filling in data gaps will require, at the very least, product-specific 90-day toxicology studies in animals for the specific ingredient used in the products, rather than general safety data.
EFSA’s statement continued: “The effect of CBD on liver, gastrointestinal tract, endocrine system, nervous system and on psychological function needs to be clarified. Studies in animals show significant reproductive toxicity, and the extent to which this occurs in humans generally and in women of child‐bearing age specifically needs to be assessed. Considering the significant uncertainties and data gaps, the Panel concludes that the safety of CBD as a NF cannot currently be established.”
In Europe, most novel food applications were withdrawn following this EFSA statement, however, approximately 50 applications are currently being processed.
What next for CBD products in Europe?
Dudek explains things won’t move quickly in this region. The data gaps identified by EFSA call for complex and time-consuming studies.
While in the UK, more than 2,000 novel CBD food products were listed on the FSA’s public list, more than 400 were removed in quick succession in recent weeks.
Speaking to NutraIngredients about the reason behind so many removals, Lisa Nelson, senior communications manager at FSA, said this is part of the ‘day-to-day working through of the applications’ and is not directly related to the EFSA statement.
“Items can come off the list at different times for different reasons. These 400 or so products will have been removed for different reasons,” she explained.
Discussing what this removal meant for these products, she said: “Technically the enforcement is with the local authorities. Anything not on the public list or removed from the list should be removed from sale. Businesses should be voluntarily withdrawing their products and local authorities can consider more measures if they find they are not being removed.”
The novel foods application process is made even trickier by the new transparency regulation in Europe, notes Dudek. The aim of the new regulation is to increase the transparency of risk assessment in the food chain, strengthen the reliability, objectivity and independence of the scientific studies submitted to EFSA and reinforce the governance of EFSA to ensure the Authority's long-term sustainability.
“The requirement of the transparency regulation means the first phase of the validation process which would have taken a few weeks, now may take more than a year.”
Speaking about what lies ahead for the market, she adds: “CBD extracts, no matter how they are packaged, in principle, are not completely officially legal as food at this point of time.”
“There’s a risk for those bringing these products to market and there may be a risk for some consumers buying them and consuming those products at uncontrolled high doses”.
“The UK is much more liberal and has a more open market compared to in the rest of Europe in that products on the market before March 2021 can stay on the market pending the safety assessment.”
She also points out that, in Europe, products sold on the internet also continue to sell well. But regulators won’t go easy just because of thriving industry.
“Regulators say one thing and the market does another so until legal action is taken, it will continue to be this way,” Dudek asserts.
“I don’t think the scientific stance will change just because of the market demand.”
“A few companies we speak to really do very serious work with almost pharma like internal requirements on quality control and management. For those companies, I would say they have a chance to gather the necessary data to demonstrate the safety of their products.”.”
And in the UK?
Discussing the future for the UK, Dudek says the recent removal of so many products from the public list indicates that action should be taken in stores but there are many more products still selling in this market.
“The FSA has now taken a visible step for products to be taken off the market by taking more than 400 products off its list.
“It’s hard to predict what they will do next in that market. I would not dare make a prediction on what FSA will do with the remaining products on the market.
“I think the industry has put so much commercial effort into keeping the products on the market that interaction between industry and the FSA will continue. Nevertheless, there will be a consolidation on the UK CBD market, with winners and losers.”