With much of Europe facing increasing uncertainty when it comes to the regulation of CBD, the UK has recently sought to clarify the country’s Novel Food Application process in a bid to ensure that the UK CBD industry has clear guidance on the procedure.
A recent announcement from the UK’s Food Standards Authority (FSA) has provided greater clarity on the requirements for the safety certification documents that manufacturers will need to submit. With applications due before March 31, 2021, the guidance has been welcomed by industry stakeholders.
A statement from the Advisory Council for Novel Foods and Processes committee (ACNFP), who are an advisory committee to the FSA, highlighted key points relating to the data requirements for manufacturers making novel food applications, including:
The industry has been calling for the FSA to provide clarification for some time. Previously unclear was whether CBD product toxicity reports would need to be defined and submitted by each company or if there would be a standardised testing procedure.
The Committee on Toxicology (COT), which advises the ACNFP has now released the minutes of meetings which intend to help clarify this process.
“The Committee noted that the primary source of current toxicology data is from studies to support the authorisation of >98% pure CBD as a medicine, with brand name Epidiolex. This is a CBD-based medicine licenced to treat certain forms of epilepsy. The Committee noted that medical trials are not designed to support the safety of food products as exposure patterns, co-consumption, purity of the CBD and recorded outcomes differ and therefore results from these studies may only be useful in supporting novel food applications for CBD in certain circumstances. The ACNFP noted that there are still gaps in the toxicological data package around systemic toxicity and human bioavailability.”
The COT concluded that due to the insufficiency of publicly available data and the fact that existing data is derived from studies supporting a single medicinal product, individual toxicity reports will need to be produced.
According to the UK’s Association for the Cannabinoid Industry (ACI), “it is reasonable to infer from this that relying solely on the publicly available data, specifically, Epidiolex data, will not be sufficient to satisfy the FSA and therefore further toxicity studies will need to be conducted.”
The committee also noted that “separate applications should be submitted for each product, but they could share study data and evidence between them if the use of such data can be scientifically justified as part of their risk assessment.”
The committee suggested that individual products will require separate applications as variation between the purity of the extracts destined for use in foods, and proportions of minor components present, will differ between novel food applications and therefore product specific characterisation data will be important.
Members also noted that bioavailability is likely to vary considerably between CBD in different matrices or when co-consumed with foods and data to support the properties and human systemic exposure from each product will be important.
This is significant for manufacturers, as it will mean that companies will be unable to make one single novel food application that will provide blanket coverage for different product lines. Instead, individual applications will be required for specific products. While the committee has highlighted that data, where relevant, can be shared across applications, it will mean additional cost and administrative burden for manufacturers.
Many CBD companies have already spent hundreds of thousands of pounds developing their application dossiers and this clarification will now likely mean additional costs going forward.
According to the ACI website, many brands have contacted them directly to ask for clarity on what the responsibility of a brand is in regards to their products. It is clear from the above, that individual finished products will potentially require further bioavailability studies to prove their safety and will be required to be included in a novel foods dossier.
The ACNFP committee also hinted about their expectations for a novel food dossier and the data required for a successful application. Comments on the two dossiers they have informally reviewed include, concerns that, “both applications used data from the Epidiolex submission to support the safety of their product but did not provide safety data on their specific product.” Therefore, the Committee agreed that applicants should carry out their own toxicological data where their CBD substance differed from medical grade or provide bridging studies to make sure the toxicology data being used to assure safety was relevant for the purity and composition of their CBD product.
The ACI has highlighted to its members that it is clear that relying solely on existing literature will not be sufficient for a successful application, and it is the responsibility of the companies in the sector to produce the data. The ACI have maintained, for some time, that toxicology studies would be required, as would further bioavailability studies, potentially at a product level. As part of the organisations activities in this area it is working with a consortium of CBD companies in an attempt to produce data that can be used collectively, where applicable. The new guidance has supported this type of approach, providing that it is appropriate to rely upon those collective toxicology studies etc.
According to ACNFP, “Applicants of small and medium-sized companies have requested a reference range of acceptable levels of cannabinoids and other components of their products to account for variability between company’s batches. ACCNFP Members were very wary of setting numerical limits for tolerances. The database, as it currently stands, does not provide enough information for the committee to be able to do this. Each product will be different. The applicants know the details of their product and the onus is on them to be able to scientifically justify the information they have provided.”
It is therefore clear that the responsibility of setting a range in order for one data package to be representative of many products falls on the responsibility of the group sharing the data package, and not the regulatory authorities.
The clarification of standards and procedures lends a further advantage to the UK CBD industry as EU policy remains restrictive. Many international companies are viewing the UK as an increasingly attractive region to promote products.
Author: Matthew Driver, Senior Analyst