The UK Food Standards Agency (FSA) has given the first positive safety assessment to a consortium application in the CBD Novel Foods approval process, after the European Industrial Hemp Association (EIHA)'s RP427 application progressed to the 'risk management' stage. announced.
The announcement comes just months after the first two individual applications were given positive risk assessments in May, and is another major step forward in the UK CBD industry's difficult path towards full regulation.
EIHA's RP427 application represents over 160 companies across the UK, Europe and the US and includes over 1,000 products.
Given the complexity of trying to approve hundreds of products at once, a strategy not initially allowed by regulations, EIHA imposes strict guidelines on starting materials and extraction methods, standardizing the entire procedure. I aimed for that.
EIHA Managing Director Lorenza Romanese told Business of Cannabis: Therefore, it took a lot of effort to work with partners to standardize the product.
“We have gone to great lengths to standardize our processes across consortium members and ensure they adhere to strict rules to ensure compliance with what we test. ”
Tony Reeves, EIHA board member and UK representative, said: “This is really great news for our sector and a landmark moment not only for EIHA members but also for the market in general. “This is because it shows real potential to increase consumer confidence and increase consumer confidence.” Increase retailer confidence and encourage investment in the industry. ”
What's included?
In October last year, the FSA released a shocking update to its consumer guidance on recommended daily doses of CBD.
The FSA has lowered the Recommended Daily Intake (ADI) from 70mg a day to just 10mg a day, according to new “scientific evidence” said to come from toxicological studies submitted by the industry itself.
Given that hundreds of companies had already completed and submitted their documents to the FSA, this late provision would create significant complexity across the industry and could limit the effectiveness of the CBD at these levels. This has raised concerns about consumer distrust of the industry.
Both previously successful applications fell within this threshold, so many took this as confirmation that the 10mg limit was a prerequisite for successful applications.
But EIHA says its application supports an ADI of 17.5mg a day for “six weeks,” while the FSA recommends an ADI of 10mg a day for life.
In its evaluation, the “Committee (ndr ACNFP)'' determined that the applicant has sufficient evidence to ensure that the isolated CBD detailed in application RP427, which is a novel food product, is safe under the proposed conditions of use. It was concluded that the relevant information had been provided. The expected intake and suggested use in foods and dietary supplements are not considered nutritionally unfavorable. ”
Ms Romanese explained: “We submitted what the science has shown us, which is that the ADI is 17.5mg per day. Supplements should be taken over a six-week period and are probably more conservative in the long term.
The Financial Services Agency will make a final decision on this ADI at the next 'risk management' stage.
EIHA’s CBD consortium application clears first hurdle with FSA approval
EIHA explained that the guidelines given to its members to comply with standardization include starting materials for industrial hemp grown from varieties listed in the European Catalog.
Each oil product must contain natural (non-synthetic) CBD extracts in vegetable oils, extracted using traditional extraction methods in accordance with EU directives.
The association said in a statement: “This classification not only highlights our commitment to safety and compliance, but also provides significant benefits to EIHA members. The documentation supporting this classification is based on toxicological data paid for by EIHA members. This data is kept confidential for five years.
“As a result, only EIHA members have the exclusive right to sell these products under this classification. This exclusivity only benefits those who contribute to research and adhere to strict standards. This is very important because it prevents free riders from taking advantage of your efforts without investing in the process.”
CIC CEO Mike Morgan-Giles commented: “We congratulate EIHA on advancing the Novel Food Application to the next stage of the approval process. We hope this development marks a turning point for the consumer CBD industry.”
long-awaited progress
The risk assessment stage marks the latest significant advance in the approval process that has stalled the industry since 2021.
After publishing a “public list” of verified CBD applications in June 2022 and allowing companies that have submitted complete documentation to the Financial Services Agency to continue trading, the included companies moved to the “risk assessment” stage.
This step is widely considered to be the most difficult part of the approval process and aims to establish whether these CBD novel food products are safe under the proposed conditions of use submitted by each applicant. I did.
After more than a year without meaningful progress, in May 2024 the FSA announced that Chanel McCoy subsidiaries Pulis and Canaray had received a positive risk assessment for their application for the first time. did.
Earlier this week, EIHA announced that the consortium established in 2019 has also moved to the next stage, dramatically increasing the number of products that could be fully approved for sale in the UK.
Romanese explained: Always remember that when we started the consortium in 2019, joint filings were prohibited. So I really think we have to recognize the courage and long-term vision of the EIHA Board.
“There's no point in killing millions of rats and spending a lot of money, so we said, let's join forces. We currently have probably the largest share of the market and have achieved a positive risk assessment. The first consortium was born.
“However, the battle is not over yet. We still need to advance all applications to the risk assessment stage and both need to be approved in Europe.
When asked about the success of EIHA's application, a spokesperson for the Financial Services Agency said the safety assessment had not yet been published and would comment only once it was published.
Now that the product has passed the risk assessment process, we move on to the risk management phase.
According to the FSA, this will take into account “other legitimate factors in its use, such as labeling considerations”. and a public consultation before sending advice to ministers across the country on whether to authorize it.
