FOLLOWING days of uncertainty food regulators have today clarified their position on the path to compliance for CBD companies looking to continue to operate in the UK market next year.
On Monday, this week, the Association for the Cannabinoid Industry (ACI) said it had secured new guidance from the Food Standards Agency (FSA) on the toxicology testing data required to achieve Novel Food compliance.
This appeared to show a shift in the position of the FSA from the one it had outlined to the market in July, prompting much uncertainty for CBD businesses.
However, the FSA today updated its guidance, confirming that its position has not changed from the one previously outlined.
Monday’s ACI Claims
In July, UK regulators the FSA said in a public question and answer session with The Canna Consultants that Novel Food ‘Validations’ could be secured without toxicology tests having been undertaken.
However, earlier this week in press and social media statements and a pre-recorded video – which can be viewed here – the ACI summarised the FSA’s stance as follows.
-Novel foods applications will not be validated without the inclusion of toxicology safety data.
-This data does not exist and must be generated. Relying on data in the public domain is not sufficient.
FSA Outlines Its Position
Today the FSA’s updated guidance outlines its position, saying:
An important part of any application will be a consideration of the product’s safety.
Applicants will need to include details of the toxicological studies they have undertaken, or propose to undertake with clear details of the reasoning for these particular tests.
Where all information isn’t available at the time of submission, a justification for the delay and when results will be available must also be included. Without such information it is unlikely we will be able to validate an application.
Toxicology Testing Is Required
In February, this year the FSA raised concerns about the safety of CBD and said it expected companies to comply with its Novel Food regulations by March 31, 2021.
It said it had concerns in relation to CBD’s potential impact on the liver and with certain groups such as mums-to-be and breast-feeding mums.
To secure a Novel Food Authorisation businesses must submit applications detailing the components of the CBD products and also demonstrate its safety for public consumption.
With CBD being such a relatively new phenomenon there is little available safety data and, it had become clear that this would have to be generated using in-vivo trials – most probably on rodents.
However, the FSA is still awaiting further guidance from its scientific advisors the Committee on Toxicity, therefore some businesses looking to undertake tests are still awaiting further guidance on what they need to test for.
With this not expected until near the end of the year many had been holding off, and in July, the FSA confirmed it would Validate Novel Food applications, as long as clear details of what the tests would examine were annotated in applications.
This has been confirmed today.
Novel Food – A Two-Stage Process
The Novel Food Authorisation process involves is a two-stage one, which sees an application initially Validated, which means it ticks all of the boxes required to move on to the next stage which is Authorisation.
The Authorisation stage can take up to nine months and sees the FSA examine all relevant data in relation to safety of the products to the consumer.
The Novel Food application and testing process is quite expensive with the ACI estimating it could cost between £300,000 to £1m.
The ACI had earlier announced plans to launch a study with a consortium of companies to demonstrate the safety of CBD.