In what would be a major boon to the regulated cannabis industry in the U.K., a Parliamentary group has now suggested that products containing cannabidiol should no longer be subjected to Novel Food regulations. Firms who wish to manufacture CBD-containing food products to date across Europe have all had to submit such applications to prove that cannabidiol is not hazardous to human health.
In both the U.K. and the E.U., this has been rocky territory.
On the British side, in March, the Food Safety Authority (FSA) gave 3,536 products preliminary approval before complaints caused the agency to expand that list to 6,000 with more to be added. Critics have said that the system is complex, costly, anti-competitive, and has no benefit for consumers.
Those wishing to amend that path to market also argue that submitting every CBD product to this process is like using an elephant gun to shoot a mouse. Here is why. Novel Food applications are usually required only of large corporations with international reach. There is almost no chance that smaller firms would have the wherewithal to perform such processes.
The British group has also suggested that the manufacturers of such products should be required to submit COAs—or certificates of analysis—to prove that they are not hazardous to human health.
This move would drastically speed up the development of this part of the industry, with implications for THC as well. COA analysis is also the standard used routinely in the backend of sourcing for the industry. People looking for bulk cannabis flower, distillate, or isolate share COAs before purchase agreements are signed—on both the medical and non-medical side.
These recommendations, as a result, are incredibly good news indeed, especially given the unbelievably bureaucratic and frustrating lack of progress so far on both sides of the Brexit divide.
In the U.K. at least, politicians appear to be listening.
The news is not so good on the E.U. side of the discussion. The fact that the European Food Safety Authority (EFSA) broke the news on Tuesday that they were delaying 19 pending applications is probably not coincidental. Even if it is, their decision puts the entire discussion about the process firmly in the spotlight within the E.U. too.
What Is Novel Food and Why Does This Matter to The E.U. Cannabis Industry?
For those outside of Europe, the idea of “Novel Foods” has never blighted the discussion about the acceptance of any cannabinoid. In fact, foreigners do not know what the fuss is about. This is also why edibles are now about half of the total U.S. market. They simply are not subjected to this analysis.
Those in Europe have had to face a bizarre series of regulatory hurdles—beyond the “normal” issues of legalization and certification—because CBD-containing products have been subjected to a regulation adopted at the beginning of the European Union. Novel Food regulation was implemented in 1997. The idea was to prevent food that is “foreign” and potentially hazardous to human health from entering distribution within the block. Approvals are an exceedingly long, arduous, and expensive process. On the U.K. side, after Brexit, the same structural regulatory process was also applied; it was just moved under the purview of a domestic agency, not a European one.
On one level of course this regulation (sans cannabis) makes a world of sense. In fact, similar regulation exists in the United States and Canada (as it does in most countries). Cannabis products, however, have not been subjected to this kind of scrutiny in either country because of the trajectory of cannabis reform. In Canada, the edibles business did not lead the discussion. In the United States, there has been no federal regulatory environment that applied to anything in the industry because so far, legalization has only existed on a state level.
In Europe that conversation has been very different.
This is unbelievably frustrating considering that hemp, much less extracted CBD, is not “novel”. It was widely consumed in the region long before there was an E.U.
Regulators, however, don’t share that perspective. Yet.
More Delays in Europe for Pending Applications
The new stance from the British Parliament is even more refreshing given current events on the ground.
On the E.U. side, as more delays were announced this week, according to Professor Dominique Turck, the chair of the Novel Foods and Food Allergens panel for the EFSA. “We have identified several hazards related to CBD intake and determined that the many data gaps on these health effects need filling before these evaluations can go ahead. It is important to stress at this point that we have not concluded that CBD is unsafe as food.”
The specific reason for the newest approval delay on the E.U. side is that the committee claims that there is insufficient data on the effect of CBD on the liver, gastrointestinal tract, endocrine, nervous system, and people’s psychological well-being.
As a small sop to companies with pending applications, Ana Alfonso, Head of Nutrition and Food Innovation at the agency said, “Stopping the clock on a novel food assessment is not unusual when information is missing. It’s the responsibility of applicants to fill data gaps. We are engaging with them to explain how the additional information can be provided to help address the uncertainties.”
The agency will hold an online session on June 28 which is open to applicants and other interested parties to discuss how applicants might provide information the agency claims is incomplete.
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