The Food Standards Agency (FSA) has published new guidance for CBD novel food applications – including confirmation that these must include toxicology data.
In the latest guidance for CBD companies ahead of the March 2021 deadline, the FSA has confirmed that novel food applications will not be successful without the inclusion of toxicology safety data.
In February 2020, the UK Food Standards Agency set the deadline for the industry to apply for European Union safety evaluations for “novel food” status.
The new guidance, published on Thursday 24 September, highlights that applicants will need to include ‘details of the toxicological studies they have undertaken, or propose to undertake’ adding that without this it is ‘unlikely we will be able to validate an application’.
The FSA also states that applicants should consult the EFSA’s guidance on ‘the usual application process for all novel foods’, which includes the details of a 90 day rodent safety study.
Only products with this validation will be allowed on the market after 31 March 2021 – but the cost of generating this data is estimated to be between £300,000 and £1million.
The guidance has been welcomed by the Association for Cannabinoid Industry (ACI) which this week announced the launch of its ‘landmark’ safety study with a consortium of CBD companies.
In partnership with Advanced Development and Safety Laboratory (ADSL), the study will address the existing gaps in data identified by the Government Committee on Toxicity (COT) – including whether CBD causes potential drowsiness, liver toxicity or has any interaction with other drug substances.
It will also provide the safety information mandated by the novel foods application process.
In a statement the ACI said it was ‘leading the way’ for the global CBD industry.
“The safety information generated in this study will respond to future demands of regulatory authorities in the US and EU,” it said, adding that the approach would also minimise animal testing by allowing all the members to use the data from one OECD 408 rodent study, instead of many companies conducting their own.
Steve Moore, strategic counsel for the ACI described it as a ‘transformational’ time for the industry, he commented: “We’re seeing evidence from studies that shows there is a wide variance at the moment in terms of product quality, so it’s very obvious to us that regulation will improve the industry.
He continued: “It is going to be a transformation time for the sector.
“It’s clear that not all the organisations currently operating in this marketplace are going to be able to meet all the regulatory requirements and the industry will be structured very differently this time next year.”
With the cost of generating the toxicology data in the hundreds of thousands of pounds, there is widespread concern that the FSA regulations will drive smaller, ethical CBD companies out of business.
Professor Mike Barnes, head of the Medical Cannabis Clinicians Society, believes we should be promoting a more diverse and ‘dynamic’ industry to boost the economy.
“The CBD industry is in need of regulation. However, the new novel food regulations are like taking the proverbial sledgehammer to crack a nut,” he said
“If implemented as stated it will drive most, if not all, of the small cbd suppliers and retailers out of business and plays into the hands of ‘Big Cannabis’ – those that can afford the huge fees of the ACI for example.”
He added: “In a post-Covid era we should be encouraging a new dynamic industry like the CBD sector, which creates jobs and tax income and provides the consumer with choice.
“The novel food regulations and those who support them are doing the industry no favours.”
Read the latest FSA guidance at www.food.gov.uk/business-guidance/cannabidiol-cbd
What are the benefits of CBD?
The benefits of CBD are wide-ranging, here’s a few of the most common ways people find it helpful – and the evidence to back it up.
Over recent years, as the use of CBD has rocketed in popularity, there seems to be no end of uses that people have discovered for it.
However, the ways in which it can be used are often broken down broadly into a few key categories. Cannabis Health takes a look at some of the most common complaints CBD can be used for.
While the conditions may vary, one thing is clear; CBD is a valuable weapon in the fight against chronic pain.
As for the science, in December, a study of Canadian medical cannabis patients found that its use reduced the use of prescription painkillers.
The research found that, at the start of the six-month study, 28 per cent of participants were using opiate-based painkillers, which dropped to 11 per cent at the end.
Such findings are also good news for tackling the UK’s increasing addiction crisis; around 540,000 Britons are thought to be addicted to opioids.
It is understood that CBD’s pain-relieving properties stem largely from its anti-inflammatory effects – which is why it is also gaining popularity among athletes and sportspeople.
Sleep – or the lack of it – is a huge issue, and for many it has only got worse over the past 12 months. Studies suggest than one in four people are struggling to get to or stay asleep, with mothers, key workers and people from minority ethnic backgrounds the worst affected.
While the effect of cannabis on sleeping patterns remains an underdeveloped area of research, it is gaining momentum – with some promising signs.
One study from 2019 showed that levels of cortisol, the stress hormone, reduced significantly in participants who took between 300 and 600mg of CBD oil before bed.
However, another study in the same year found that a more regular dose was needed to improve their ability to fall and stay asleep. After a month on a 25mg dosage of CBD oil, 66.7 percent of patients said their sleep had improved.
Stress and anxiety
We could all do with a stress-reliever from time to time, and too many people still use alcohol or cigarettes for this very purpose.
However, increasing research shows that CBD is a safer and healthier alternative to both of the above, accounting for its rise in popularity amongst the wellness sector.
A landmark study in the US – thought to be the first of its kind – was launched in October last year to investigate CBD’s use as a formal anxiety treatment.
The Cannabinoid Anxiety Relief Education Study is targeting millions of CBD and cannabis users across the US to assess the potential role of cannabinoids in reducing anxiety and other co-morbid conditions, such as insomnia and depression.
And while research still ongoing, preliminary studies also suggest that CBD has been shown to reduce stress in animals such as rats.
Study subjects were observed as having lower behavioural signs of anxiety, and the physiological symptoms of anxiety, such as increased heart rate, also improved.
Medical cannabis to bring in £3 million annual boost for Isle of Man
The medical cannabis sector is expected to generate an additional £3 million a year for the Isle of Man economy after the go ahead was given for cultivation on the island.
The Isle of Man Government voted to approve regulations to issue licenses for the production, distribution and export of cannabis products from the Island.
The Isle of Man is self-governing jurisdiction and following a series of consultations, its Parliament, Tynwald, approved changes to the Misuse of Drugs Regulations which will permit commercial operators to produce medical cannabis products.
The sector, which is estimated to generate around £3 million in annual benefit in the coming years and considerably more through the growth of associated infrastructure – including financial and operational – to support the sector.
The Government also expects the medicinal cannabis sector to support and bring innovation to the Isle of Man’s Cleantech and construction sectors, as well as developing businesses from within and off the island.
The growing global cannabis market provides significant opportunity for economic development in the Isle of Man, with the global market forecasted to account for USD 82.19 billion by 2027.
The new regulatory framework responds to industry and consumer demand for stringent and flexible licensing of a broad range of cannabis products, ranging from outdoor grown industrial hemp to indoor grown medicinal products.
The framework only relates to an export industry and there are no changes to domestic legality of prescription medicinal cannabis or the legality of non-medical adult use of cannabis in the Isle of Man.
The Gambling Supervision Commission (GSC) will serve as the launch regulator for the sector and will be issuing guidance for hemp applications from Isle of Man growers soon.
For high-THC operators, the GSC is finalising its approach to its regulation and is consulting with relevant commercial and government stakeholders, and anticipates issuing guidance and accepting license applications in the first quarter of 2021.
Lawrie Hooper MHK, political member with responsibility for Business Isle of Man, said: “We are delighted to launch this exciting new sector in the Isle of Man and to take advantage of the expertise in regulating new, complex industries while providing stringent consumer safety. We’re confident that GSC’s regulation will once again attract quality businesses to the Island transforming the cannabis export sector into a key contributor to the Isle of Man’s post-COVID economic recovery.’
Mark Rutherford, responsible for preparing the new regulatory framework at the GSC, commented: “The Island has a track record as an early adopter of new sectors. Over the course of the past 20 years acting as the regulator for the Island’s eGaming sector, the GSC has developed expertise in keeping the industry crime free, protecting consumers and providing transparency, and this experience is complementary to the skills that will be required for this new and emerging sector.
“This is an exciting opportunity and we have a sophisticated framework for supervising gambling which can be easily adapted to regulate the cultivation and processing of cannabis. We recognise there is huge potential for this new sector to create real positive economic benefit so we need to ensure we treat the new cannabis sector like we have treated the gambling sector: that license stakeholders that are competent, credible and crime free from the outset.”
CBD in Northern Ireland – what you need to know about EFSA novel food applications
Northern Irish CBD companies have just ‘days’ to get European novel food applications under way if they have not already.
Hemp Federation Ireland has urged CBD companies in Northern Ireland to submit their European Food Standards Agency (EFSA) novel food applications imminently, in order to meet the spring deadline.
While the rest of the UK will fall under Food Standards Authority (FSA) regulations, Northern Ireland must continue to follow EU law after the end of the Brexit transition period.
As set out in the ‘Northern Ireland Protocol’, any companies seeking authorisation for a CBD product to be placed on the market will have to follow EU and EFSA rules.
This is to allow trade to continue uninterrupted between Northern and Southern Ireland.
However, the news has placed CBD companies in Northern Ireland, and those who wish to trade there, in a ‘difficult position’ with just weeks left before the deadline for novel food applications on 31 March.
Hemp Federation Ireland has been advising Northern Irish companies to proceed with the dual application process, allowing them to gain novel food status in both the UK and the EU.
But those who were not aware of this, or have not already begun the dual application process have now been left at a ‘considerable disadvantage’, Chris Allen, of Hemp Federation Ireland, told Cannabis Health.
“While Northern Ireland is still within UK customs territory it is still subject to the provisions of EU law, including food law.
“This does put companies in a difficult position because the time frame is so tight for applications to EFSA, which I believe will close in mid-February. They really want to have those applications well underway within the next couple of days if they want to be covered by EFSA regulations.
“In reality, there is about a 10 day window for them to get the house in order and when you consider the cost of the novel food application, I can only imagine that there are a lot of companies in the UK scratching their heads now.”
All applications must include 90-day toxicity data, with the cost of this estimated to be between £300,000 and £1million.
Stephen Oliver, of London-based cannabis consultancy firm, The Canna Consultants said it is likely that many companies in Northern Ireland will have already invested in the application process, believing they could remain on the market after this date.
“There is bound to be teething problems arising as a result of Brexit, but this does seem a little bit unfair to companies who didn’t know about it,” continued Allen.
“It does seem that UK and Northern Ireland stakeholders in the industry have been placed at a considerable disadvantage.”
As things stand, CBD brands elsewhere in the UK, will no longer be able to sell their validated products in Northern Ireland after March 2021.
England-based CBD firm Honest Hemp, which sells products in Northern Ireland, said the company was hoping to find a solution.
“It’s very sad to hear that the CBD companies based in Northern Ireland will now have their products deemed ‘unlawful’, despite going through the same extensive processes as the rest of us in the UK. So, we do feel very lucky to be able to continue operating as an England-based company, said marketing manager, Georgious Mesimeris.
“Here at Honest Hemp, we are working hard to find a solution that will allow us to continue selling to our customer base in Northern Ireland and ensure their needs are covered. Of course, it’s hard to predict the future in a time like this, but we can keep hoping that things work out for the best eventually.”
Hemp Federation Ireland is working with Irish companies on navigating the post-brexit regulations and is happy to advise on the EFSA application process.
“The whole industry has been constantly shifting in regulations over the past few years and it’s really not the fault of the companies themselves that they find themselves in this position now,” Allen added.
“There is poor understanding of the regulations in Ireland and that is not something that can continue long term, it will have to be resolved. The really important thing now is for people to know what their options are going forward and to understand how Brexit works from this side of the Irish Sea.”
Allen can be contacted by email on: firstname.lastname@example.org
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- What are the benefits of CBD?
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