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Novel Foods applicant responds to EFSA’s decision to pause evaluations

“This is standard in the pharmaceutical world but not in the food world,” said Linnea CEO. 



EFSA Novel Foods

19 Novel Foods applications have been put on hold since EFSA’s announcement last week. Cannabis Wealth hears from one of the companies about the impact the delays could have on the industry and patients.

Last week, EFSA’s expert Panel on Nutrition, Novel Foods and Food Allergens (NDA) paused all Novel Foods evaluations of CBD due to insufficient data and uncertainties about potential hazards related to the compound.

While toxicology studies on animals are already a requirement for applicants, the EU authority is now calling for studies on humans to determine the safety of CBD.

The European Food Safety Authority (EFSA) has so far received a total of 19 CBD Novel Foods applications. Only applications that are approved will legally be allowed to be sold in any EU Member States.

Linnea was one of the companies whose applications were put on hold. Speaking to Cannabis Wealth, Linnea’s CEO Susanne Caspar said that while the company was not surprised by the additional delays, she and her colleagues were “astonished” by the level of toxicology data that EFSA has called for.

A producer of botanical ingredients, Linnea was founded 40 years ago. In 2016, the company entered the cannabinoid market, producing GMP-certified full-spectrum CBD, isolate CBD and CBG extracts for the pharmaceutical, food and cosmetic industries.

The EU opened Novel Foods applications in mid-2020 and Linnea submitted its first documents and toxicology data by the beginning of 2021. Two years in, the company is resigned to the fact it will take significant time for the application process to reach its conclusion.

“I think EFSA is sometimes even more strict than the Health Authority,” Caspar said. “In the case of cannabinoids and with all the background and all the discussions in Europe, perhaps they are more careful than expected.

“I think the toxicology data are necessary but I’m not quite sure if it’s necessary on humans. This is standard in the pharmaceutical world but not in the food world.”

The European CBD market is among the most developed in the world with an estimated value of over €3.5 billion in 2021, but it continues to operate in a legal grey area. While there are hundreds of brands selling unregulated CBD, less than 20 Novel Foods applications have been submitted to the EFSA. Caspar believes this is due to the sheer amount of data needed to complete the application process.

“There are a lot of products on the market but only 19 dossiers on this list and two of these are coming from our side,” Caspar said.

“[This] is because you really need a lot of documents and start ups perhaps don’t produce unique stability data. We’ve had our isolate [CBD] stability data for four years now, but not every company can deliver all the documents needed for those processes,” Caspar said.

The question is, how much longer will it take for CBD producers to gain approval from the EFSA. It is yet to be seen what exactly the authority requires to continue with applications but Caspar believes toxicology will not be the only topic the regulator will want to cover.

As Novel Foods applications continue to be met with delays, Caspar’s primary concern is for consumers and patients who are continuing to purchase CBD from unregulated sources. Having conducted its own research on its competitors, Linnea discovered products that contained no CBD and others with THC levels significantly over the 0.2 per cent legal limit.

The lack of standards and quality control is causing risk to patients, Caspar said.

“This is a problem for patients. If you really want to get these products, you will try to get them and you will use channels which you don’t know are [trustworthy],” she added. I think this could be more of a problem and I hope that EFSA would be faster. The risk is much higher not to decide because people will try to get material from anywhere.”

While it waits for approval from EFSA, Linnea does not yet sell its cannabinoid extracts in Europe, focusing instead on the Australian and South American markets.

Caspar hopes that the Novel Food applications will make a positive change in the industry and ensure patients and consumers are using CBD that they can trust. “I’m convinced that this plant is helpful for a lot of indications, and therefore [patients] should really get what they need,” she said.

EFSA is holding an information session, open to applicants and other groups or individuals with an interest in novel food. The online event takes place on 28 June.


JM Wholesale sees 750 products included on FSA CBD list

The CBD stockist has described the development as a milestone for the company.



JM Wholesale sees 750 products included on FSA CBD list
Home » News » CBD » Novel Foods applicant responds to EFSA’s decision to pause evaluations

Following a partnership with the European Industrial Hemp Association (EIHA) and active participation with the Food Standards Agency (FSA), JM Wholesale has had more than 750 items included on the public CBD list.

Earlier this year the FSA published its list of CBD products linked to what it deems as credible Novel Food applications. Products included on the list will be advancing through the final stages towards authorisation, expected by 2023. 

More than 900 applications for thousands of UK products have been submitted for approval, with the majority being rejected for lacking basic information such as toxicity levels.

JM Wholesale has announced that it has now had 750 of its products included on the public list.

Read more: FSA CBD list now closed for applications

Thomas Lowe, operations director at the Leicester-based company, said that, after 200 per cent business growth in the past 18 months and a resulting move to major new premises, JM Wholesale is now perfectly placed to consolidate its position as the UK’s premier CBD wholesaler.

Lowe commented: “We have a larger range of approved CBD products than any other distributor and this moment is another milestone for our company.

“We’ve worked hard to ensure that our customers and our business are protected, by getting rid of any products not published on the FSA’s website, regardless of how big those brands are.

“In fact we’ve always loved finding unique products, including those where the CBD can be absorbed in different ways. That way, more people from different walks of life can enjoy CBD no matter how they prefer to access it.

“From our distribution centre we now provide the largest range of isolate and full spectrum CBD products in the UK, all of which are 100 per cent accepted by the FSA.

“We are the first distributor to add the relevant Novel Food classification numbers to all of our relevant listed products.

“The past few months have been extremely challenging for our industry but we have made efforts to take an active role in the novel food submission process. We anticipated regulation of this industry, we were determined not to let it stand in the way of the growth of our business, and we’ve participated accordingly.

“All in all, this is excellent news for our customers and partners.”

The company has stated that it has experienced rapid growth off the back of increased awareness of the health benefits of CBD products in the UK, and that, alongside its consumer business, it also exports to suppliers in the UK and in 170 countries worldwide.

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FSA CBD list now closed for applications

An additional 6000 products added to the Food standards Agency’s (FSA) CBD list.



FSA CBD list now closed for applications
Home » News » CBD » Novel Foods applicant responds to EFSA’s decision to pause evaluations

The FSA has confirmed that the UK’s list of CBD products linked to credible Novel Foods applications is now closed.

The FSA has updated its public list of CBD products that can be marketed in England and Wales, adding almost 6000 products. These are products that are linked to a credible application submitted for authorisation to the FSA, and are not new to the market.

The organisation has confirmed that the public list, which was initially published in March, is now closed and has stated that any further requests to have products put on the public list or evidence sent are no longer being accepted.

Read more: FSA adds thousands of additional CBD products to public list

The FSA has previously reminded consumers that products on the list will be able to remain on the market as they progress towards final authorisation, but that, although these products are classed as “credible”, it does not guarantee they will be authorised for sale.

Rebecca Sudworth, director of policy at the FSA, stated: “This has been a long and complex process and we are grateful for the help and cooperation of the CBD industry as we reach this important milestone on the path to bringing CBD products into compliance and protecting consumers. 

“The only changes we envisage being made to the list now will be to reflect the status of products as we move to authorisation, and any routine corrections.

“We have seen the list, which contains almost 12,000 products, grow considerably since March when we first published it. The publication of the initial list prompted a number of companies to come forward with new evidence linking large numbers of individual products to existing applications, and so we made a final call for evidence to support businesses in achieving compliance for their products. 

“We think it is important we get this right, and it is encouraging that so many companies want to get their CBD products on the path to authorisation.”

Read more: Authorised UK CBD products expected by 2023

Businesses wanting to sell their products in Great Britain should now apply to the FSA’s regulated products process and those wanting to sell in Northern Ireland should apply to the European Commission. However, as new applications will not be eligible for the public list, they should not be put on sale until they have been authorised.

Validated applications on the CBD list are currently moving on to a full risk assessment stage of the application process, and those that are shown to be of a low enough risk must also go through a risk management process before a recommendation can be made to Ministers on authorisation.

At the time of the list’s initial publication in March, the FSA confirmed that, with a lengthy process still to go, it is unlikely any applications will be considered for authorisation before early to mid-2023, with any additional authorisations potentially taking another few years.

The FSA emphasises that there are currently no authorised CBD products on the market.

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British Cannabis™ launches premium CBD products in Selfridges

The CBD by British Cannabis™ collection will be showcased in the Beauty Hall at Selfridges London.



British Cannabis™ launches premium CBD products in Selfridges
Home » News » CBD » Novel Foods applicant responds to EFSA’s decision to pause evaluations

British Cannabis™ is launching its premium, flagship range of CBD products in Selfridges.

British Cannabis™ will launch its super-premium collection of 100 per cent cannabis supplements and cosmetics in Selfridges on 4 July, 2022.

All of the food supplement products in the CBD by British Cannabis™ collection were recently included on the Food Standards Agency’s (FSA) public list of products that are legal for sale on the UK market. 

The products’ appearance on the list followed the company’s successful submission of Novel Foods applications. 

Read more: British Cannabis celebrates 310 products on FSA CBD list

A recent update by the FSA saw British Cannabis™ ranked as the UK’s largest CBD manufacturer by number of publicly listed CBD products manufactured.

CEO, Thomas Whettem, commented: “This is yet another great milestone in the British Cannabis™ story. It is a testament to the levels of excellence we demand within our supply chain and products, that we are now stocked at an iconic, prestige retailer in Selfridges.

“We set out to create ‘the champagne of CBD oils’, with more beneficial cannabis phytochemicals than any other CBD products compliant and legal for sale today. 

“Our premium, THC-free products are both UK-born and UK-manufactured, thus debuting in Selfridges London seems very appropriate.”

British Cannabis™ launches premium CBD products in Selfridges

CBD by British Cannabis™ products have won multiple awards in recent years, including the Highly Commended 2021, P3 MVP Award for 1000mg CBD Cannabis Oils, ICP magazine’s 2022 CBD Product of The Year, and Your Healthy Living magazine’s 2022 Silver Award for Best CBD Products (for CBD by British Cannabis™ Dermal Patches 500mg).

The 100 per cent cannabis products contain hundreds of other beneficial cannabis compounds, terpenes, flavonoids, phenols and more, whilst still being compliant with regulations and legal for sale within the UK. 

Each product is rigorously tested for accuracy, purity, and THC-free status for consumer peace of mind.

Every product contains the knowledge and expertise that has been amassed over the last seven years of British Cannabis™ existence, evidenced in the growing, extraction, research, development, and manufacturing that saw this British start-up grow to be the leading authority in consumer cannabis products within the UK.

The company launched a television campaign in March 2022 for the range as part of a half a million pound investment in awareness building and consumer recruitment 2022/23.

The campaign aimed to break down barriers to legal cannabis-derived products, gaining broadcaster approval to make more industry-specific references than any campaign to date.

Shown across dozens of premium channels on the SKY and Channel 5 networks, this marked the first time that the SKY network had opened its doors to CBD advertisers on their linear stations since 2019.

Read more: CBD by British Cannabis launches nationwide TV ad campaign

British Cannabis™ managing director, David Ralson, commented: “As proud as we are of our tested, trusted, super-premium CBD supplements and cosmetics, we are equally proud to now be bringing them to the world-class shopping experience at Selfridges, as part of our distribution expansion plans.

“For over a century, Selfridges have brought premium health and beauty products to the forefront in exciting ways – and especially in their new Feel Good Bar. As one of the UK’s original British-made CBD ranges, with a heritage in this young industry of nearly seven years, the match of Selfridges and CBD by British Cannabis™ seems a perfect fit.

“I hope that Selfridges shoppers grow to love and trust our CBD range as much as our existing loyal customer base, who over the years have given us over 1,500 5-star reviews on Trustpilot.”

With sales of wellbeing supplements, superfoods and ingestibles up almost 125 per cent at Selfridges since last year and almost 700 per cent compared to pre-pandemic, The Feel Good Bar will launch as a new permanent wellbeing destination at Selfridges London. 

The bar will be a place for visitors to explore more than 250 of the latest and best products in wellbeing innovation, ranging from gut health to hormones, hangover cures and sleep hacking. 

The destination will be anchored by a new energy-lifting bar concept brought by JENKI, introducing a menu of matcha and alternative drinks that reimagine drinking culture.

British Cannabis™ launches premium CBD products in Selfridges

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