Changes on the Horizon for CBD Products
The Japanese government has unveiled updated guidelines regarding THC limits in CBD products, but experts caution that these adjustments may not be enough to alleviate some of the world’s strictest cannabis regulations. As Japan prepares to reform its nearly century-old cannabis laws, the Ministry of Health, Labour and Welfare (MHLW) is striving to clarify the definitions and categories of cannabis products, following a public consultation earlier this year. However, industry insiders remain skeptical about the effectiveness of these changes.
What’s New in the Guidelines?
In early September, the government released long-awaited guidance on THC limits, aiming to help brands strategize their entry into the market. This followed a public comment period initiated in May 2024, which sought input on upcoming legislation intended to regulate Japan’s burgeoning cannabis and CBD industries. The new regulations are expected to take effect on December 12, 2024.
On October 4, 2024, the MHLW further clarified how different cannabis products will be categorized. The latest announcement includes detailed definitions for ‘oils’ and ‘powders’. According to these definitions, oils must consist of over 90% compounds formed by glycerin and fatty acids and must remain liquid at room temperature. Powders are defined as substances with particle sizes of 850 μm or smaller.
Understanding the New THC Thresholds
The updated guidelines specify various THC thresholds for different product categories:
- 10 ppm threshold: CBD oil, hemp seed oil, cosmetic oils, CBD powder, protein powder.
- 0.1 ppm threshold: Soft drinks, alcoholic beverages, toners, milk, and plant-based beverages.
- 1 ppm threshold: Confectioneries, tablets, butter, e-cigarettes, shampoos, lotions, and jellies.
Experts Voice Concerns Over Key Issues
Despite the clarity provided by the MHLW, Dr. Yuji Masataka, Japan’s first specialist in medical cannabis, highlights that several critical issues remain unresolved. During the public consultation, stakeholders expressed concerns over the lack of specified THC thresholds for raw materials. The MHLW introduced a new ‘powder’ category under the 10 ppm threshold, but Dr. Masataka argues that this may not sufficiently ease restrictions on cannabinoid raw materials.
He notes that most cannabinoid raw materials are highly viscous, making it challenging for products like CBD isolate powder to maintain the required particle size. “If the goal was to relax restrictions on cannabinoid raw materials, this design falls short,” he explains.
Potential Regulatory Conflicts
Dr. Masataka also points out that the definition of oils poses additional challenges. The ordinance states that oils must contain at least 90% of compounds formed by glycerin and fatty acids, which could severely limit the allowable cannabinoid content in oil products to just 10%. This restriction could inadvertently regulate the concentrations of CBD oils available in the market, which typically range between 5% and 40% cannabinoid content.
Moreover, some concentrated raw materials, including crude oil, may not fit within the new definition of oils, complicating their import into Japan. To address these ongoing issues, Dr. Masataka suggests that the MHLW should consider adding more categories, such as ‘solid raw materials’ and ‘liquid raw materials,’ and revise the definition of oils to exclude cannabinoids from the 90% requirement.
Looking Ahead: The Future of CBD in Japan
As Japan stands on the brink of significant changes to its cannabis regulations, the path forward remains uncertain. While the new guidelines represent a step toward clarity, many experts believe that further adjustments are necessary to support a thriving CBD market. With the implementation date fast approaching, industry stakeholders are left grappling with the implications of these regulations and their potential impact on the future of cannabis in Japan.
Dr. Masataka, who has been a pioneer in advocating for medical cannabis in Japan, continues to work towards creating a landscape where CBD products are not only accepted but celebrated for their potential health benefits. As the country navigates these regulatory changes, the need for clear and effective guidelines will be paramount for the growth of this emerging industry.
