Could the UK Abolish Cannabis Novel Food Regulations?

In what would be a major boon for the UK’s regulated cannabis industry, a parliamentary group has now proposed that products containing cannabidiol should no longer be subject to novel food regulations. So far, companies that want to produce foods containing CBD have had to submit all such applications across Europe in order to prove that cannabidiol is harmless to human health.

In both the UK and the EU, this was rocky terrain.

On the UK side, the Food Safety Authority (FSA) gave provisional approval to 3,536 products in March, before complaints led the agency to expand that list to 6,000 and add more. Critics said the system was complex, costly, anti-competitive and of no benefit to consumers.

Those who want to change this route to market also argue that submitting any CBD product in the process is like shooting a mouse with an elephant gun. Here’s why. Novel food applications are typically only required from large companies with an international reach. Smaller companies would hardly have the opportunity to carry out such processes.

The UK group has also suggested that manufacturers of such products should be required to provide COAs – or Certificates of Analysis – to prove they are not dangerous to human health.

This move would drastically accelerate the development of this part of the industry, which would also affect THC. The COA analysis is also the standard routinely used in the backend of procurement for the industry. Individuals looking for bulk cannabis flower, distillates, or isolates share COAs before signing purchase agreements—both medical and non-medical.

These recommendations are therefore incredibly good news indeed, especially given the incredibly bureaucratic and frustrating lack of progress on either side of the Brexit divide.

In Britain at least, politicians seem to be listening.

The news is not so good on the EU side of the discussion. It is probably no coincidence that the European Food Safety Authority (EFSA) announced on Tuesday that it was delaying 19 pending applications. Even if this is the case, her decision puts the entire discussion about the procedure in the spotlight, even within the EU.

What is novel food and why does it matter to the EU cannabis industry?

For those outside of Europe, the idea of ​​“novel foods” has never tainted the discussion of cannabinoid acceptance. In fact, foreigners don’t know what the fuss is about. It’s also why edibles make up about half of the entire US market today. They are simply not subjected to this analysis.

Those in Europe have had to face a bizarre set of regulatory hurdles – beyond the “normal” questions of legalization and certification – as CBD-containing products became subject to a regulation passed early in the European Union. The Novel Food Regulation was introduced in 1997. The idea was to prevent food that is “foreign” and potentially dangerous to human health from entering distribution within the bloc. Approvals are an extremely long, tedious and expensive process. The same structural regulatory process was also applied on the British side after Brexit; it was simply placed under the jurisdiction of a domestic authority, not a European one.

On one level, of course, this regulation (without cannabis) makes sense. In fact, the United States and Canada (like most countries) have similar regulations. However, due to the course of cannabis reform, cannabis products have not been subject to such scrutiny in either country. In Canada, the edibles business did not lead the discussion. In the United States, there has not been a federal regulatory environment that applies to anything in the industry as legalization has only existed at the state level.

In Europe, this conversation was very different.

This is incredibly frustrating considering hemp, let alone extracted CBD, is not “novel”. It was widely consumed in the region long before there was an EU

However, regulators do not share this view. Still.

Further delays in Europe with pending applications

The UK Parliament’s new stance is even more refreshing given current events on the ground.

On the EU side, further delays were announced this week, according to Professor Dominique Turck, Chair of EFSA’s Panel on Novel Foods and Food Allergens. “We have identified several hazards associated with CBD intake and determined that the many data gaps on these health effects need to be filled before these assessments can be conducted. It is important to emphasize here that we have not concluded that CBD is unsafe as a food.”

The specific reason for the latest approval delay on the EU side is that the committee claims that there is insufficient data on the effects of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and mental well-being of people are.

As a small consolation for companies with pending applications, Ana Alfonso, head of the agency’s nutrition and food innovation department, said: “It is not uncommon to stop the clock in a novel food assessment when information is lacking. It is the applicant’s responsibility to fill in data gaps. We are working with them to explain how the additional information can be provided to remove the uncertainties.”

The agency will hold an online meeting open to applicants and other interested parties on June 28 to discuss how applicants could provide information that the agency claims is incomplete.