The Japanese government has released updated guidelines for THC limits in CBD products, but experts warn potential efforts to ease some of the world’s strictest regulations remain ‘insufficient’.
Japan’s upcoming reform of its near-century-old cannabis regulations are continuing to evolve following a public consultation earlier this year.
Just a month after detailing the proposed THC limits for ‘oils and powders’, ‘aqueous solutions’ and ‘others’, the Ministry of Health, Labour and Welfare’s (MHLW) Narcotics Control Division has moved to further clarify the definitions of each category in an effort to address confusion surrounding the guidelines raised by many industry operators.
Dr Yuji Masataka, MD, Japan’s first specialist in medical cannabis, told Business of Cannabis that despite these further clarifications, a number of key issues remain unaddressed.
What happened?
In early September, Business of Cannabis reported that the government had
released long-awaited guidance on THC limits enabling brands hoping to launch into the market to begin devising their strategies.
This followed a public comment period, launched in May 2024, for the upcoming legislation, which is set to regulate the country’s emerging cannabis and CBD industries.
The new regulations on cannabinoid (CBD) products in Japan are now expected to come into effect on December 12, 2024.
However, with their implementation fast approaching, the guidelines are continuing to evolve.
On October 04, 2024, the MHLW released further ordinance containing additional details on how each product will be categorised.
In this latest announcement, detailed definitions of ‘oils’ and ‘powders’ were provided.
According to the new definitions, oils are described as substances containing more than 90% of compounds formed by the combination of glycerin and fatty acids and must be in liquid form at room temperature (15-25°C). Powders are defined as substances with particle sizes of 850 μm or less.
Additionally, guidelines were issued regarding which threshold applies to various forms of cannabinoid products. The details are as follows:
Products likely to be subject to the 10 ppm threshold:
- CBD oil, hemp seed oil, cosmetic oils (plant oils)
- CBD powder, protein powder (powder-based products)
Products likely to be subject to the 0.1 ppm threshold:
- Soft drinks, alcoholic beverages, toners
- Milk, plant-based beverages (colloidal solutions)
Products likely to be subject to the 1 ppm threshold:
- Confectioneries, tablets, butter (solid products in general)
- E-cigarettes (products containing compounds formed by the combination of glycerin and fatty acids, and organic solvents without water)
- Shampoos, conditioners, lotions, creams, mayonnaise, balms, dressings, etc. (viscous products or water mixtures containing high levels of glycerin and fatty acid compounds, or both)
- Jellies (semi-solid products without compounds formed by the combination of glycerin and fatty acids)
Key issues remain unaddressed
According to Dr Masataka, this 1 ppm threshold is likely to apply to a raft of CBD raw materials.
During the public comment period, one concern stakeholders raised repeatedly was a lack of clarity surrounding a lack of specified thresholds for raw materials.
In response to concerns that applying the same standard to concentrated raw materials and finished products made by diluting them would inhibit their ability to import raw materials, the MHLW added a new ‘powder’ category to the 10 ppm threshold.
“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,” Dr Masataka explained.
“If the intention of adding the ‘powder’ category was to ease restrictions on cannabinoid raw materials, this design is insufficient.”
Furthermore, he suggested that the definition for oils is problematic. The terminology used in the ordinance states that ‘compounds formed by the combination of glycerin and fatty acids’.
This, according to Dr Masataka, refers to the ingredients of carrier oils, such as MCT oil, used to dilute cannabinoids.
“If the rule that oils must contain at least 90% of these compounds is strictly enforced, the maximum allowable cannabinoid content in oil products would be limited to 10%. (If the cannabinoid content exceeds 10%, the product would no longer meet the definition of oils, and the 1 ppm restriction would automatically apply.)
“The cannabinoid concentration of most CBD oils on the market typically ranges from 5% to 40%, meaning this definition could effectively function as a regulation on CBD oil concentrations. Furthermore, some concentrated raw materials, such as crude oil, may not fall under the definition of oils, making it difficult to import them into Japan.”
To address these issues which are continuing to ‘cause confusion for many businesses’, he suggests that additional categories should be added, such as ‘solid raw materials’ and ‘liquid raw materials’, alongside ‘powders’.
Additionally, the definition of oils should be revised to state that ‘more than 90% of the ingredients, excluding cannabinoids, must be compounds formed by the combination of glycerin and fatty acids.’
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Dr Yuji Masataka, MD, is a graduate of the Faculty of Medicine, Kumamoto University. After meeting medical cannabis specialist Dr Jeffrey Hergenrather in California in 2016, he decided to become Japan’s first specialist in medical cannabis. In 2017, while working in the Department of Neurology at Kumamoto University, he, as Representative Director, established the nonprofit organisation Green Zone Japan, which aims to raise awareness about medical cannabis. Currently, he also holds the position of Vice Chairman at the Japanese Society of Clinical Cannabinoid Research.
Dr Masataka also acts as a Key Opinion Leader for Astrasana Japan Co. Ltd., providing support to create a progressive and inclusive landscape in Japan, where CBD products are not only widely accepted but also celebrated for their potential health benefits and recognised as a valuable market opportunity.
