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

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.

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