Bulgaria in contention to be first EU country to allow open sale of CBD

By Will Chu

- Last updated on GMT

©GettyImages/LPettet
©GettyImages/LPettet
Bulgaria could be the first country in Europe to permit the sale of hemp-derived cannabidiol (CBD) nutraceutical products on the open market, granting authorisation to US-based firm Kannaway.

The country’s food authorities issued a Free Certificate of Sale to the Californian-based firm last month effectively allowing the export of Kannaway’s imported goods sold in Bulgaria’s open markets.

“As the EU continues to navigate its stance on CBD, we are proud to continue paving the way for the acceptance of CBD in Bulgaria just as we have in many other countries around the world,”​ said Kannaway CEO Blake Schroeder.

“With this authorisation, we hope that we can establish our company as pioneers in Bulgaria’s CBD industry and leaders in CBD education throughout Europe.”

If confirmed, the decision by Bulgaria’s Ministry of Agriculture, Food and Forestry, and the Bulgarian Food Safety Agency, marks the first time a country within the EU has taken such a decision.

Media reports​ state Kannaway’s products “comply fully with relevant requirements of the Law on Foodstuffs of Republic of Bulgaria and of Regulation (EC) No 852/2004 of European Parliament and the Council on the hygiene of foodstuffs”.

Traditional food

According to the documents, authorities class the products sold by Kannaway, a subsidiary of Medical Marijuana Inc, as “traditional foods”​ specifically food supplements, therefore bypassing the EU’s current classification of CBD products.

In February, the European Commission (EC) reclassified CBD as a “Novel Food”​ meaning the EC considered it a food “not consumed to a significant degree by humans in the EU before 15 May 1997.”

While the ruling has no legal status, in principle, it means retailers can legally sell CBD products as a novel food but require a pre-market approval to do so, essentially adding further regulatory obstacles to enter the EU market.

Currently, Czech firm Cannabis Pharma remain the only applicant with the EU to have an authorisation of a CBD food supplement pending.

The submitted dossier, which looks to support the safety of CBD use in food supplements for adults, suggests a daily maximum intake of 130 milligrams (mg) or 1.86 mg/kg body weight.

"The novel foods issue is a major one for the European CBD industry and there is no doubt that the details of Kannaway’s authorisation in Bulgaria will be studied with interest by its competitors across the continent," ​said Barnaby Page, editorial director at market intelligence firm CBD-Intel.

"If it prompts further applications in other jurisdictions, then that is likely to help clarify the issue, especially if manufacturers can bring substantive evidence to the table.

"And it may, of course, also encourage others to enter the relatively small Bulgarian market – although clearly any shift in attitudes at EU-wide level would be far more significant.

"However, we don’t think that this is a case of “problem solved” by any means. While there is a degree of centralisation in terms of the Novel Food Catalogue, in practice member states nevertheless have a great deal of discretion in how they apply the rules.

"Bulgaria’s opinion in itself is unlikely to change the minds of those countries – including the UK, France and Germany – which have been cautious about CBD edibles and favoured novel food restrictions.

"So it is a step forward, but certainly not the last one."

The patchwork of legislation that governs the European CBD market is a far cry from the progress made in the US, where the 2018 Farm Bill separates hemp from current drug laws dictating its psychotropic counterpart, marijuana.

The ruling could mean good news for various industries as research and testing into the plant will be permitted for pharmaceutical uses as well as for health, wellness and general nutrition,

“As a company of firsts, we look forward to trailblazing the international CBD market as advocates of this supplement’s potential benefits,”​ said Alex Grapov, Kannaway’s international vice president.

“We have met with all of the appropriate regulatory bodies to ensure that our operations are within the bounds of the law creating a stable opportunity for our customers and Brand Ambassadors.”

Switzerland CBD situation

While the amendment to the Novel Foods Catalogue is relatively recent, current approaches to CBD by Member States vary considerably.

The Irish Food Safety Authority classifies CBD products according to the manufacturing method employed.

CBD oil extracted via the cold-pressing of hemp seeds can be sold on the assumption that the oil comprises a low CBD level.

In contrast, supercritical CO2-extracted CBD would be classed as Novel Foods by the Irish authority in which pre-market approval would be needed.

In mainland Europe, authorities in Belgium and Austria do not allow CBD products to be marketed under any condition.

Although a non-EU country, Switzerland’s laws remain relatively relaxed with the sale of some CBD products permitted. However, in March a Swiss court ruled the sale of cannabis flowers would be taxed at 25% - the same rate that currently applies to tobacco.

The Swiss Federal Administrative Court ruled the drug’s floral buds was smoked in a similar way to cigarettes.

Current legislation in Switzerland permits the sale of cannabis with less than 1% Tetrahydrocannabinol (THC). THC, the psychoactive chemical has been sold in tobacco outlets in Switzerland since 2017.

Possession approaching 10 grams of the more potent type results in a €89 (CHF100) penalty.

In April, The European Parliament’s agriculture committee approved amended proposals that permit farmers to grow hemp varieties with an increased maximum THC level from 0.2% to 0.3%.

The proposal, to come into effect on 1 January 2021, read, “Areas used for the production of hemp shall only be eligible hectares if the varieties used have a tetrahydrocannabinol [THC] content not exceeding 0.3 %.”

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