The number of CBD products still in the running for full authorization in the UK has expanded following an announcement that 70 applications covering a total of 3,536 products were advanced by the Food Standards Agency (FSA).
Products on a list released Thursday, and those previously advanced by the FSA may remain on sale while those that failed inclusion and any other non-compliant products on the market must now be withdrawn from consumer outlets, and may not be traded or sold in the UK.
“Being on the list means that the application is credible and the FSA has, or is shortly expecting to receive, significant scientific evidence from the applicant with which to judge safety,” said FSA Chief Executive Emily Miles.
“I want to emphasize that the FSA is not endorsing products on the public list, and inclusion on the list is no guarantee that they will be authorized as they have not yet been fully assessed for safety,” Miles said.
“But we have taken the step of publishing the list so that local authorities, retailers and consumers can make informed judgments about what they stock and buy, as we gradually bring this growing market into compliance with the law,” Miles added
The newly listed products join those that previously reached the first stage of the UK’s three-stage food safety authorization process. The 70 new applications cover multiple products under the same producer or brand, and include those from two key European consortia.
The FSA list covers products sold in England and Wales. As an EU member state, Ireland operates under EU food safety rules; Northern Ireland is also under EU regulations as a result of the UK’s Brexit protocols.
Eagerly awaited list
Producers have eagerly anticipated the release of FSA announcements as they lick their chops over the UK’s plum market for consumer CBD products, estimated to be worth £690 million (~€814.5 million; ~$905.7 million) in 2021, according to the Association for the Cannabinoid Industry (ACI), which worked with the FSA in crafting the regime for CBD under the UK’s novel food rules.
ACI immediately urged businesses selling CBD products – including supermarkets, convenience stores, health food shops, pharmacies, online retailers, cafés and restaurants – to check their existing stocks against the FSA list to ensure they are compliant with the UK’s Trading Standards authority.
Sixty-five of the 70 newly approved applications, bearing 3,479 products, are now in the pre-validation (or “awaiting evidence”) stage. The remaining five applications, bearing 57 products, have reached validation (or “risk assessment”), the second stage, and await FSA’s decision on full authorization, the final stage.
“In some cases, the clock may need to be stopped during this next stage, and this may result in a slight delay” if additional evidence such as toxicology and other documentation is required, said Ruth Willis of the FSA’s novel foods team. ACI estimated that process will take up to seven months.
680 applications rejected
Of a total 900 novel food applications that have been submitted to FSA by CBD producers since Jan. 1, 2021, more than 680 have now been rejected while another 42 were voluntarily withdrawn by applicants, according to ACI.
ACI said in a media conference call there is no way to predict how many of the products that remain active in the FSA process could reach full authorization.
Publication of the newest list “demonstrates the progress the sector has made to meet compliance requirements and creates greater regulatory certainty which, in turn, will increase levels of consumer trust, encourage investment in the sector, and promote innovation,” said Steve Moore, ACI’s founder and strategic counsel.
The Association said among the 70 applicants which made the list, 46 came through an ACI-initiated consortium. All had their products approved, although the list does not indicate which ones came in under ACI.
EIHA Projects GmbH, a similar consortium organized by the European Industrial Hemp Association, submitted multiple applications covering CBD isolate and full-spectrum extract products. That consortium apparently had some products rejected, indicating in a press statement it observed “some inaccuracies, inconsistencies and indeed a few surprising absences on this list.” The EIHA consortium said it “will review these over the coming days and continue our open discussions with the FSA.”
ACI meanwhile said it has finished the live phase of a toxicology study under Organization for Economic Co-operation and Development (OECD) guidelines, which is required to validate food safety dossiers; data analysis is expected to be completed in June. The EIHA consortium said it is also in the midst of toxicological studies in support of its applications.
From 2019 to 2021, CBD sales more than doubled in the UK, making the non-EU country the world’s second-biggest consumer market in the world behind the USA, and the first jurisdiction globally to set specific rules for cannabis extracts, ACI said.