Japan’s Ministry of Health, Labor, and Welfare (MHLW) recently updated its guidelines on THC limits for CBD products as the country prepares for new regulations expected to roll out in December 2024. But according to some industry experts, the guidelines still leave some gaps.
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Dr. Yuji Masataka, Japan’s first medical cannabis specialist, shared his thoughts with Business of Cannabis, saying that while the new guidelines set THC thresholds for various product types like oils, powders, and aqueous solutions, they fail to address the needs for categories like raw materials or redefine oils more clearly.
One of the key updates in these new guidelines is the definition of oils, which now states that they must contain more than 90% glycerin and fatty acid compounds. This could potentially limit the concentration of CBD oil allowed. Additionally, the guidelines set a 10 ppm (parts per million) THC threshold for products like CBD oil, hemp seed oil, cosmetic oils, CBD powder, and protein powder.
Dr. Masataka pointed out that this 1 ppm limit is likely to affect a lot of CBD raw materials.
“However, most cannabinoid raw materials are highly viscous, and it is expected that only a limited number of products, such as CBD isolate powder, will be able to stably maintain the particle size below 850 μm, as stipulated in the latest guidelines,” he explained. He suggested that if the idea behind adding a "powder" category was to loosen restrictions on raw materials, the approach falls short.
He also raised concerns about the definition of oils. If the cannabinoid content in a product goes above 10%, it would no longer be classified as an oil, meaning the 1 ppm restriction would kick in automatically. To improve the situation, Dr. Masataka recommended adding more product categories, such as “solid raw materials.”
Europe’s Cannabis Landscape Faces Challenges
Over in Europe, the cannabis industry is facing its own set of hurdles. Italy is under scrutiny as the European Commission (EC) investigates the country's recent moves to ban CBD and hemp flowers. The proposed amendment to Italy's Security Bill would classify all cannabis and hemp flowers as narcotics, regardless of their THC content, potentially putting the hemp industry at risk.
Cannabis trade groups in Italy, including Canapa Sativa Italia (CSI) and Federcanapa, have raised concerns that this amendment violates European Union laws on free competition and the movement of goods. They argue that banning hemp flowers could jeopardize over 15,000 jobs and disrupt an industry worth 500 million euros ($546 million). The EC is expected to issue an opinion after completing its investigation.
Germany’s Growing Medical Cannabis Market
Meanwhile, in Germany, medical marijuana has become more accessible. A law that allows over 70% of physicians to prescribe medical marijuana without prior approval from statutory health insurance (GKV) went into effect recently. This is a significant step in simplifying medical cannabis use in the country, which had already partially legalized recreational cannabis earlier this year.
Germany’s cannabis market is projected to grow rapidly, with medical marijuana sales expected to reach €420 million in 2024 ($260.66 million) and climb to €1 billion by 2028. Although many patients still rely on private prescriptions, more pharmacies are now dispensing medical marijuana, and some are seeing profits as high as €50,000 per month.
While the changes are benefiting patients and pharmacies alike, there is concern that increased prescription rates could raise costs for insurance companies. However, the overall impact of these reforms will be evaluated in 2025.
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