By / June 10, 2024

Japan Publishes New Proposed THC Limits for Its Cannabis Market

Last week, Japan officially launched a public consultation period for a draft legislation aimed at regulating the emerging cannabis and CBD industries in the country. After adopting the legislation in November 2023, the Japanese government has just released detailed proposals on the limits it intends to set for finished CBD products and hemp cultivators.

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New Proposal to Introduce Stict THC Limits for Japan

The proposals suggest that CBD will be approved for use in food in Japan, with strict limits on the amount of THC allowed, meaning the market is likely to be dominated by isolate-based products.

According to Dr. Yuji Masataka, a leading specialist in medical cannabis in Japan, these stringent thresholds “will make parallel imports of products difficult, which could keep CBD product prices high,” but could benefit analytical companies.

“Cannabis products are characterized by their diversity. Stricter THC standards will homogenize products, leading to the loss of the entourage effect.”

“It is uncertain whether users seeking to maintain their health will continue to benefit from the same advantages after the law’s revision. On the other hand, companies that can meet these strict standards may find an opportunity for market expansion.”

New THC Thresholds in Japan

Under the new proposals for Japan, for which interested parties have until June 13 or 29 to submit their comments, guidelines for “zero standards” have been advanced. Two types of zero standards are currently being considered, one for agricultural products and another for finished products.

For the former, the Japanese government has proposed limiting agricultural products to 0.3% THC, which aligns with limits set in other European markets.

While this proposal is “reasonable” as it aligns with many international markets, the limits on THC levels in finished products will be much stricter in Japan.

In the preliminary evaluation report 2 of the regulation, the proposed zero standard for CBD oils will be 10mg/kg or 0.001% (10ppm), dropping to 0.10mg/kg or 0.00001% (0.1ppm) for beverages, and to 1mg/kg or 0.0001% (1ppm) for “others,” which includes foods sold in Japan.

According to the proposal’s appendix, these zero standards were derived by referring to European food safety standards and estimating the amount a 50kg person would consume at one time.

Dr. Masataka questioned this methodology and suggested that another option would have been to refer directly to standards in other countries.

This means Japan would have a limit 1000 times stricter than European or American markets, a guideline that could have significant consequences for the industry in the future.

Additionally, he highlights that no standard has been set for raw materials in Japan, a contradiction that could cause confusion among businesses.

“From the justification provided in the document, it is clear that zero standards for products (oil, beverages, others) are designed to avoid any impact from a single intake. I am concerned that there are no specified standards for CBD raw materials,” he explained.

“It is common for CBD crystals or concentrated oils to be imported for domestic production of CBD oil and cosmetics. Since the zero standard is set as a ratio to total weight, the amount of THC in concentrated raw materials will be relatively higher, even if it is a very small amount.”

“In the absence of mention of raw materials, the implicit zero standard for raw materials would be 1ppm, which is extremely strict. There is an obvious contradiction in having a stricter zero standard for raw materials than for finished products like oil, which have a zero standard of 10ppm.”

Implications for Manufacturers and Testing

Dr. Masataka also noted that these strict standards in Japan could be difficult for manufacturers to meet, and even more so for those tasked with testing the products, given the equipment needed to detect such low levels of THC, meaning costs could rise.

It is also likely that broad-spectrum products will be driven out of the market, resulting in “the elimination of various minor cannabinoids,” raising concerns about “increased processes and costs passed on to consumers.”

Impact on Pharmaceutical Products in Japan

As no standard has been set for pharmaceutical products in Japan, the draft bill could also make Epidyolex, one of the only cannabis-based medications legalized in Japan, a narcotic substance.

Dr. Masataka stated: “Since off-label use of narcotics is not allowed, less than 1% of patients with refractory epilepsy would be prescribed this medication.”

(Featured image by Clay Banks via Unsplash)

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