CBD

UK parliamentary group urges radical overhaul of CBD approval system

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A parliamentary group in the UK has recommended the government abandon the current system for approving CBD products through the regime for new or “novel” foods, and in its place institute a food-safety system based on certificates of analysis (COAs).

The recommendation would radically alter the CBD hemp landscape in the UK, unlocking the country’s full potential to meet growing domestic demand estimated at roughly £690 million (~€814.5 million; ~$905.7 million) and create export opportunities for producers. It is among six key suggestions in a proposed agreement that has been put before the Secretariat of the All-Party Parliamentary Group (APPG) on CBD by a core group that makes up the Secretariat Advisory Board (SAB).

A second key recommendation would allow for total THC and other controlled cannabinoids at a level up to 10% of a product’s CBD content. Other recommendations would lift current bans on harvesting hemp flowers and CBD extraction, allow the use of non-EU-approved hemp varieties, and raise the maximum level for THC in hemp plants “on the field” from 0.2% to 1.0%.

The proposed changes are based on a paper published earlier this year by the UK Cannabis Industry Council that has already been distributed to relevant ministries, according to the APPG.

Novel food vs COAs

The recommended change in the method for qualifying CBD products for the market would mean shifting from a process already underway by the UK’s Food Safety Authority (FSA), which is now reviewing more than 6,000 products under novel food guidelines.

Under a COA-based process, independent laboratories would produce reports on the finished products, taking into consideration total cannabinoids, and accepted tolerance for heavy metals, pesticides, residual solvents, microbiological, mycotoxins, terpenes and flavonoids – a process that is common practice in other countries.

In an appendix to the agreement, the SAB urges a break from the FSA process, which is based on the European Union’s model for approving CBD products.

“On the 31st of January 2020 the UK stopped being a member of the European Union (EU) enabling the UK to do things differently, better, more efficiently and that applies to self-generated EU bureaucracy that has left the UK lagging behind other countries,” the APPG advisory board said.

“The FSA chose to inherit this costly and counterproductive approach from the EU rather than build upon post-Brexit freedoms most likely due to a lack of experience and understanding of the hemp farming industry as a whole and CBD products,” the agreement observes.

Bumpy start for FSA

The FSA’s novel food process for CBD has had a bumpy start. After first giving 3,536 products preliminary approval at the end of March, the agency doubled back after complaints from companies whose products did not make an initial list released in April. The list then grew to roughly 6,000 products that remain in the running for market qualification, and others are expected to be added.

Calling the FSA’s novel food process “flawed from the outset,” the APPG agreement said the system is complex and costly, is anti-competitive and ultimately provides no benefit to consumers.

“Novel Food Primary Dossier applications are initially required and only large multi-national corporations have the capital, resource, infrastructure and scale to submit these to the FSA,” the advisory group said. “This approach significantly limits, controls and monopolises the supply,” resulting in “absolutely no possibility of the creation, the innovation of a UK hemp CBD product industry; at a minimum, it chokes and stifles existing, small UK CBD research companies and offers no encouragement to start-ups compares to other industries that have flourished,” the advisors noted.

Seeking transparency

Furthermore, the FSA’s novel food regime offers “no transparency, governance, accountability, regulatory oversight including auditing of the process, appeals process with independent adjudication that is fair, open and consistent,” the SAB observed.

“Transparency is key . . . as to the main regulatory points that need to be evolved for the benefit of all: consumers, patients, hemp farmers, manufacturers, research, the economy, our environment and all the services that interlink our industry,” said Charles Clowes, Director of the Cannabis Industry Council, one of the stakeholder groups on the APPG SAB.

THC in products

Setting a clear barrier for total THC and other cannabinoids (CBN & THCV) in consumer products is critical to the development of compliant CBD formulas.

Establishing the limit at 10% of a product’s CBD content would clear up misunderstanding and avoid a potential calamity implied by earlier recommendations from the UK’s Advisory Council on the Misuse of Drugs (ACMD).

ACMD last December issued guidance suggesting a THC limit of 50 micrograms (mcg) per serving – a highly restrictive level that disincentivizes production. The proposal in the APPG agreement works out to 7mg per daily intake of 70 mg of CBD, which would bring the UK more in line with limits in Europe and other parts of the world.

Studies have shown only a small percentage of human subjects begin to reach mild effects of THC after having taken 10 times the level recommended by the ACMD. The proposal is even lower than the outdated, much-derided current guidance value of the European Food Safety Authority (EFSA) which is .07 ppm per unit of consumption – defined as the typical “single serving” of a CBD product consumed on one occasion. So far, EFSA has not re-set a limit for the EU, giving UK producers a potential advantage in the marketplace. 

Freedom for flowers

Overcoming bans on the harvesting and processing of hemp flowers would open the way for a domestic supply of CBD and raise the fortunes of UK hemp farmers as well as producers, who are now forced to import raw materials and finished CBD goods.

“As it stands today, 99.9% of all hemp CBD products purchased by UK consumers is imported from either the EU, America, Switzerland, Israel and China,” according to the agreement from the APPB SAB.

Allowing UK farmers to plant non-EU-certified varieties also would boost the fortunes of CBD stakeholders because CBD rises in proportion to THC in hemp plants, resulting in more efficient production. Most EU cultivars have been bred for fiber and grain, and have much lower CBD levels than latter-day strains developed primarily in the United States.

Helping farmers

Increasing the limit for THC in hemp crops from 0.2% to a full 1.0% would put the domestic CBD sector on a par with leading producer nations which have abandoned the more commonly observed global limit of 0.3%. It would also give UK producers an advantage over member states in the European Union, which next year will institute a negligible increase from 0.2% to 0.3% for hemp “on the field.”

That change would help UK farmers overcome hotter temperatures and drought conditions that naturally increase THC concentration in all hemp varieties and put growers at risk of their crops going “hot” or over the THC limit, meaning they must be destroyed. That has been a problem for Scottish growers who sow Finola, a Finnish hemp variety, the APPG SAB noted.

In the final key recommendation, the APPG advisory board noted that while most CBD products are made from “natural” CBD obtained from hemp plants, synthetic products made through chemical or biological processes in a lab should be labeled accordingly.

The CBD APPG advisory board claims to represent trade bodies the Medical Cannabis Clinicians Society, the Cannabis Industry Council, the Cannabis Trades Association, the Scottish Hemp Association, the European Industrial Hemp Association (EIHA), the British Hemp Alliance (BHA) and the Cannabis Services Advisory Board (Jersey). London-based Tenacious Labs, a private CBD company, serves as secretariat of the APPG, which includes lawmakers and claims representation among more than 700 companies.

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