The Food Standards Agency looks set to recommend ministers authorise the sale of CBD products in the UK for the first time.
The FSA’s director of policy Rebecca Sudworth and deputy director of innovation Thomas Vincent will present a paper outlining recommendations for the authorisation of three cannabidiol (CBD) novel food applications to its board on 16 September.
Provided the board agrees with the paper’s recommendations, the FSA will advise ministers in England and Wales to approve the three CBD novel foods for sale, subject to the proposed conditions of authorisation.
“Thorough consideration of the risk management approach for these novel foods has led us to conclude that authorisation would be the most effective way to improve consumer safety and start bringing the CBD market into compliance,” the FSA paper states. “Subject to the board’s agreement, officials will finalise the ministerial advice package for submission to ministers in England and Wales as soon as possible.
“The final decision on whether to authorise the novel foods, and on any associated conditions of authorisation, rests with ministers following consideration of the FSA’s advice.”
The three CBD applications in question (RP7, RP350 and RP427) are the first to have successfully progressed past initial safety assessment. They are linked to more than a third of the 8,147 validated products on the FSA’s public list.
These include products from CBD brands including Pureis, Cannaray, Medahuman, Supreme, Orange County and Hip Pop.
Should ministers approve the proposals, it would mean that products containing CBD will be able to be sold legally in England and Wales for the first time, more than six years after the FSA first set out plans to regulate CBD as a novel food. The timeline for ministerial approval still remains unclear, however.
Presently, CBD food products are tolerated for sale provided they are on the FSA’s public list. However, no products have received legal authorisation.
“This [development] represents six years of scientific work and investment, and validates the decision [by Cannaray] early on to do this properly rather than quickly,” said Cannaray interim managing director Joshua Roberts. “Consumers deserve confidence that what they buy has been through rigorous safety assessment, and retailers deserve the same certainty.
“We look forward to the recommendation progressing to the ministerial review and authorisation stage at the FSA board meeting on 16 September.”
SPS concerns addressed
Meanwhile, the paper also addresses concerns that proposed Sanitary and Phytosanitary (SPS) dynamic alignment with the EU could result in CBD companies having to launch fresh novel foods applications into Europe.
“The proposal for dynamic alignment would mean that, once an SPS Agreement is in place, an EU market authorisation would be required to market novel foods, including CBD,” it states. “However, the EU has accepted there may be a limited number of areas where the UK will need to retain its own rules (referred to as ‘exceptions’).”
In the absence of any carve out for CBD, however, businesses would need to apply for fresh novel food authorisation under EU legislation, the FSA admitted.
Presently, The European Food Safety Authority (EFSA) has not yet published any positive safety assessments of CBD novel foods. Its safe CBD dose is currently set at 2mg per day for a 70kg adult, less than the 10mg per day acceptable daily intake (ADI) recommended by the FSA.
“We remain confident in the FSA’s provisional ADI of 10mg per day, which has been produced in line with established risk assessment principles and with the use of independent expert judgement,” the FSA said. “We remain committed to supporting the CBD industry in moving towards regulatory compliance and to keeping applicants and wider stakeholders informed and engaged as plans for an SPS Agreement take shape.”
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