Most CBD firms and trade groups have welcomed the Food Standard Agency (FSA) March 31 2021 deadline as something that will bring much-needed regulatory clarity – along with its recommended daily CBD consumption of 70mg/day – and turned attention to the expensive task of rapidly compiling dossiers to meet European Union-determined safety and efficacy demands.
Initial applications need to land with the FSA by December 31 this year, the day Britain’s Brexit transition period formally ends, although the FSA has so far indicated it is sticking to EU novel food guidelines.
It hopes to end the legal haze in one of the world’s most dynamic CBD markets that has seen upmarket retailer Selfridges strip CBD products from its shelves while major health food chains like Holland & Barrett and pharmacies like Boots stock a range of CBD products.
The FSA has been explicit about potential CBD-linked health concerns particularly for pregnant and breastfeeding women and people taking medications.
UK groups like the Association for the Cannabinoid Industry (ACI) have welcomed the regulatory putsch and accepted the data-building challenge, while others like the German-based European Industrial Hemp Association (EIHA) and the UK-based Cannabis Trades Association (CTA) continue lobbying against CBD’s EU novel food requirement and tendency to group full spectrum CBD and CBD isolates together.
“Wikipedia cut and paste jobs won’t cut it.”
ACI spokesperson Steve Moore told NutraIngredients each of its 30 members were engaged in dossier construction – with some aspects such as toxicology data being compiled collectively.
What’s required in an EU Novel Foods dossier?
- Details of the ingredients and production process
- The composition of the food and stability data
- History of use, proposed uses, use levels and anticipated intake
- Details of absorption, distribution, metabolism and excretion
- Nutritional information
- Toxicological and clinical data
- Allergenicity
“We are working hard to ensure the dossiers our members submit to the FSA will be high quality,” Moore said, adding, “There is sure to be an influx of low-quality dossiers.”
Moore said those firms that invested often hundreds of thousands of euros in science to remain on-market “should be rewarded” and predicted a growing market intolerance for “shysters” that may struggle to compile dossiers and meet label claims regarding banned psychoactive THC/CBN thresholds, along with other contaminants.
There would be growing interest from risk-averse major food and beverage companies that may have been reluctant to enter such an uncertain market amid the regulatory chaos.
ACI members include Colorado-based Mile High Labs and UK-based start-ups like Sativa Group and CBD Science Group.
Mark Tucker, CEO of UK pharma group, TTS, told us his company had submitted a preliminary dossier in December last year that could end up costing north of €1m once Tier 1 and 2 toxicology studies and stability trials were completed.
“We’ve spent 9-10 months putting together the application, it’s 100s of pages,” Tucker said. He too warned of low-quality dossiers clogging up the system.
“Wikipedia cut and paste jobs won’t cut it.”
Veteran nutritionist and EU food law expert Dr Mark Tallon, managing director of UK firm, Legal Foods, said CBD isolates were more likely to win approval “and even then additional studies will be needed on toxicology.”
“For us it will be better”
Major Los Angeles-based CBD player MedTerra is another that has welcomed the FSA move. Amsterdam-based CEO of its rapidly expanding year-old European operation, Koen Ridder, said “for us it will be better” in a market it recently launched in.
What about Brexit?
In 2021 Britain will officially go it alone although the FSA has indicated it will utilise EU safety criteria but possibly differing criteria in other areas like health claims.
Sian Edmunds from the Burgess Salmon legal firm in the UK told The Grocery Insider podcast last week that in 2020 it is “pretty much business as usual” in terms of the UK following EU law. After that is anybody’s guess.
“The last time I spoke to the FSA about this they were unclear themselves about where the line was going to fall.”
Dr Mark Tallon said there would “likely be a need to apply some focus on consumptions patterns for the UK and devolved parts like Wales and Scotland in relation to dose and safety etc.”
“We are still figuring out if the UK will have other requirements because of Brexit but we are working on our dossier and at the moment our products are as compliant as we can be.”
He said MedTerra, which sponsors the likes of surfers, skateboarders, snowboarders, models, cyclists and golfers and sold 1m bottles of its coconut oil- CBD infusion in the US in 2019, was set to launch in Greece, Spain and France in the coming weeks.
MedTerra sources all its CBD isolates from its industrial hemp farms in Kentucky in the US but Ridder said the firm was considering more expensive European cultivars to comply with EU Cosmetics Act stipulations that CBD be sourced within the EU bloc.
So far only a handful of CBD novel foods applications have been made across the EU.
Important milestone: German Ministry backs some hemp extracts
Last week the sector achieved what the European Industrial Hemp Association (EIHA) called an “important milestone” after it said the German Federal Ministry of Food and Agriculture (BMEL) acknowledged parts of the hemp plant had a lengthy history of use across European nations and did not require novel foods approval.
“Thus, hemp food products made from traditionally produced extracts with the natural full spectrum of the cannabinoids contained in the hemp plant are not novel foods,” EIHA president Daniel Kruse said of BMEL’s stance.
“For the German hemp food industry this statement by the government and the ministry is an important milestone.”
However the BMEL position contradicts Germany’s Federal Office of Consumer Protection and Food Safety (BVL) which has backed the mainstream EU position that CBD extracts require novel foods approval.
“It now only remains to be seen whether the BVL will finally amend and correct the content of its previous blanket and undifferentiated publication on this topic of 20.03.2019, which has already led to avoidable irritation and legal errors on the part of many state and local authorities, as well as in some cases individual courts in Germany,” EIHA state, referencing at least one recent German regional court ruling that found CBD extracts require novel foods authorisation.
“It also remains to be seen whether the BVL will now agree to a meeting of experts, which EIHA has already requested several times.”
‘In the human food chain for millennia’
The EIHA argues whole plant hemp extracts like those derived from hemp flowers and leaves – at the very least – should be permitted for use in foods in the EU as they have been “in the human food chain for millennia”.
The group references a letter from an EU food safety committee in 1998 that acknowledged this history of use and approved hemp leaf and flower extracts in the EU; EIHA says the letter is being ignored by contemporary EU novel foods authorities.
Brightfield Group predicts Europe’s CBD food, cosmetics and vape oil market will be worth €1.5bn by 2023. Analyst Cowen Inc projects the global market will be worth €14.4bn by 2025.
