In one of our previous blogs we explained the basics and current legal situation of cannabidiol (CBD) products that are classified as novel foods in the EU.
What about the UK, which is one of the biggest CBD markets in Europe? Is the situation there the same?
As you know, the UK has left the EU and consequently this country must establish its’ own rules on literally everything that has been covered up until now by the EU. This includes the novel food regulations and novel food authorisation procedures. The authorities from the Food Standards Agency (FSA) in the UK have been active in this field. For example, they have announced that during the transition period all EU legislation applies in the UK and they are also constantly updating the very useful information on their official webpage.
In addition, the FSA has given special attention to CBD products that are currently sold on the UK market as food supplements or foodstuffs. This became clear on the 13th of Feb 2020 when the FSA announced that businesses that sell CBD products in the UK need to submit, and then have a validated novel food authorisation application by the 31st of March 2021. After this date, only products for which the FSA reviewed and assigned the corresponding application as valid will be allowed to remain on the market. It is clear that the FSA decided to act in a different way using a more reasonable approach compared to the EU.
What does this decision mean for businesses that have CBD products currently on the market?
At the moment, all such businesses can sell their existing CBD products in the UK, provided they are not incorrectly labelled, are not unsafe and do not contain substances that fall under UK drugs legislation. The period of “free sale” ends in March next year. Until then businesses need to submit a novel food application for all their existing CBD products. In addition, the FSA must confirm the received application as valid prior to the end of March 2021. Then the process of evaluating the application in terms of risk assessment and risk management begins. As we learned in a previous blog, the evaluation is a time-consuming process and typically lasts longer than a year.
And what about the new products that are just entering the market?
The FSA clearly stated that new CBD products cannot be sold until they have a novel food authorisation. In other words, the rule of only having validated applications by the end of March 2021 does not apply to any new CBD product. Instead, a business needs to get a full authorisation for new CBD products before putting them on the shelves.
If you read the blog on novel food status in the EU you will be aware of the EC’s preliminary opinion that CBD might be classified as a drug. While this opinion regarding the classification of CBD remains open at the moment, the UK has already chosen the opposite direction. Namely, the UK authorities remain of the opinion that CBD extracts do not fall within the scope of the UN Convention on, unless they contain other controlled substances such as tetrahydrocannabinol (THC).
This sounds reasonable, because CBD is not psychoactive. Moreover, it is in line with the World Health Organisation (WHO), which is considering a re-scheduling on cannabis and cannabis-related substances. Namely, the WHO recommends that “Preparations containing predominantly cannabidiol and not more than 0.2 per cent of delta-9-tetrahydrocannabinol are not under international control”.
Useful information for businesses that would like to submit novel food application for authorisation in the UK
In the EU there is an established e-submission system where applications for the authorisation of novel foods can be uploaded and submitted. Due to the transition period, such a system is not yet available in the UK, but according to the FSA it will become so on January 1st, 2021. In the meantime, applicants are advised to send their applications to the FSA by mail.
The situation regarding the status of CBD and CBD-related products is rather complex, as you can see. Regardless, at Pharmahemp, we decided to be proactive and follow the legal requirements. Therefore, we applied for the authorisation of CBD products as novel foods with both the, EC and the UK authorities. We are looking forward to their response. Follow us and we will keep you updated about our progress.