CBD Industry Group Commits To Compliance With EU Novel Food Law
Executive Summary
Seeking to end the current impasse between regulators and the CBD industry, the Centre For Medicinal Cannabis is launching a quality charter for its members to put their products “on the path to regulatory compliance.”
“There is no ambiguity in what the regulators want. They want fully legally compliant products on the market,” says Dr. Andy Yates of trade group Centre For Medicinal Cannabis on the debate raging over the legality of CBD in the UK.
“The doors have closed for the current approach used by some manufacturers by claiming that the rules are somehow different for the cannabis industry.”
CMC is looking to end the current impasse between regulators and industry by launching a quality charter for its members to put CBD in the UK “on the path to regulatory compliance.” It is also proposing a cannabis “kitemark” which compliant CBD products could carry to give consumers trust in what they are buying.
“This new initiative exists to ensure that our members are fully compliant to an agreed set of terms with the relevant regulatory bodies,” says Yates, “ensuring consumers can continue to access legal, safe and quality CBD products.”
The charter's seven pillars
Legal frameworks - Signatories to the charter must pursue the necessary authorizations to legally distribute CBD products, CMC says. All CBD producers and sellers must have an understanding of the laws and regulations in their respective sectors, enabling full compliance.
Testing - The CMC will facilitate a program whereby each submission of a raw material or finished product will be tested at accredited laboratories. Quality and safety is established through robust testing, the association says.
Labeling - Signatories must adhere to a set of labeling guidelines to ensure that the consumer understands what they are buying and is not misled.
Manufacturing - Using the ISO 9001 framework and cGMP, the charter includes a set of principles based on best practice accreditation organisations from around the world which members must adhere to.
Controlled drugs - Members will adhere to the UK’s laws on scheduled substances, specifically zero detectable amounts of CBN and THC. The CMC will work with the relevant authorities to establish a definition of the term ‘detectable’.
Marketing ethics - All advertising, whether online, offline or in-store, should not make reference to medical claims (as defined by MHRA), sexuality, violence, illegal behavior, political affiliation or religious references through its imagery or language.
Sustainability & social impact - The charter outlines principles for members that help tackle pressing problems concerning land and natural resource use, responsible waste management, fair employment and plastic pollution.
Comprising seven pillars, the charter sets out rules for CBD firms on a wide range of subjects from regulation and labeling, to manufacturing and testing (see sidebar.)
Signatories to the charter must commit to gaining authorization to market their CBD products in the UK under the EU’s novel food regulation. CMC says it wants to work with the European Food Safety Authority and UK regulator the Foods Standards Agency to ensure its members are “on the road to full compliance within an acceptable and agreed time frame.”
For CBD products already on the market, CMC will seek a grace period from FSA for those firms that have submitted a novel food application.
To help firms navigate the novel foods pathway, the association has partnered with consultancy firm Global Regulatory Services, which has 12 years-experience of gaining product approvals through the regulation.
As novel food applicants can request data protection for their submission – which can last up to five years – firms will likely have to make individual applications to EFSA.
“All novel foods are closely linked to the process of extraction or production,” consultant Janet Worrell told HBW Insight earlier this year. “A novel food application needs to provide data on the specification of the product, its production process, use and intakes, nutrition, microbiology, toxicology and allergy information.” (Also see "With CBD Poised To Become A Novel Food In Europe, Industry Must Think Ahead To Gain Advantage" - HBW Insight, 7 Feb, 2019.)
Under the regulation, each production process results in a distinct approval, which is then valid across all EU member states.
CMC’s decision to pursue the novel foods route place it at odds with the approach taken by other trade bodies to resist increased regulation of CBD. The Cannabis Trades Association UK has initiated a legal challenge against the European Commission’s decision to classify CBD as a novel food, while industry group Cannabis Professionals has threatened legal action against the UK’S FSA for its handling of the CBD quandary. (Also see "Cannabis Industry Taking Legal Action Against EU Regulators Over CBD Novel Food Classification " - HBW Insight, 20 Mar, 2019.) (Also see "Cannabis Trade Group Threatens FSA With Legal Action As CBD Novel Food Row Intensifies" - HBW Insight, 9 Apr, 2019.)
Time For Industry To 'Wake Up'
For Greer Deal, director of CMC’s partner GRS, the UK CBD industry must start working with regulators, not against them.
“Full compliance with the relevant regulatory bodies is the only way that the future cannabis industry can exist. It’s time that those operating within this sector wake up to this reality and embark on the journey to becoming serious and sustainable participants,” Deer argues. “This is the opportunity for the cannabis industry to shine in Europe.”
CMC member Mile High Labs has come out in support of the proposed quality charter, insisting that self-regulation is “critical to the longevity of the CBD industry.”
Expect Tougher Regulation
The UK’s CBD market has to date benefited from the “hands off approach” to regulation adopted by FSA, CMC points out. However, the association expects that to change with its recent research revealing that not all products on the market reflect what is indicated on the label putting pressure on FSA to clamp down.
A third-party blind test of 30 CBD oil products currently on the market in the UK found that almost half (45%) had measurable levels of psychoactive substance tetrahydrocannabinol (mean content 0.04%) and were thus “technically illegal.”
Furthermore, 11 of the oils tested had less than 50% of the advertised CBD content, CMC reported, with one CBD oil sold in a high street pharmacy containing 0% CBD yet retailing for £90 ($110). (Also see "UK Body Calls For 'Clear Guidance' On THC Levels In CBD Oils" - HBW Insight, 12 Jul, 2019.)
While major retailers such as continue to stand by their decision to sell CBD, pharmacy groups have warned their members that such products could be considered controlled drugs due to the presence of THC. (Also see "Confusion Reigns In UK CBD Market As Regulatory Vacuum Allowed To Continue" - HBW Insight, 19 Jul, 2019.)